HOUSTON, Nov. 13, 2023 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced the Company has placed 108th on the Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech and energy tech companies in North America, now in its 29th year. During the measurement period, Direct Digital Holdings grew 1,325%, making it the 8th ranked company in Deloitte’s Digital Content / Media / Entertainment division. The Company placed among the top 20% of all companies on the list and was ranked #6 in Texas.
“We are honored to be included on this prestigious list of fellow industry-leading companies, and I would personally like to thank Deloitte for recognizing our company,” said Mark D. Walker, Chairman and Chief Executive Officer of Direct Digital Holdings. “This recognition is a testament to the strength and effectiveness of our business model as well as our technological capabilities and highly diversified customer base. We remain committed to providing best-in-class advertising solutions to our partners as our number of clients, average client-size and total impressions per month all continue to increase.”
The Company attributes its significant growth to current market dynamics benefitting its technology-driven and differentiated approach to advertising solutions. On November 9, 2023, the Company reported its third quarter earnings ended September 30, 2023. Direct Digital Holdings’ sell-side advertising segment revenue grew to $51.6 million or 174% growth over the $18.9 million of sell-side revenue in the same period of 2022. The Company’s buy-side advertising segment revenue grew to $7.9 million or 10% growth over the $7.1 million of buy-side revenue in the same period of 2022.
Direct Digital Holdings’ subsidiaries bring distinct offerings to the ecosystem, contributing to the Company’s advancement. Colossus SSP is focused on connecting brands of all sizes with a full range of diverse and multicultural audiences, as well as the general market, serving as a one-stop-shop for media inventory needs. On the buy-side, with Huddled Masses and Orange142, the Company provides data-driven digital marketing solutions to businesses in the underserved SMB and middle market landscape. Those two buy-side companies also work seamlessly with Colossus SSP to bring the benefits of its inclusive marketplace and approach to SMB and middle market clients – with significant results.
“We are pleased that the recent strategic and operational investments in our technology stack have resulted in industry-leading growth across our sell-side advertising platforms,” said Anu Pillai, Direct Digital Holdings’ Chief Technology Officer. “As we also continue to capitalize on the shift in media spend from traditional to digital, as well as the growing media spend targeted at the middle market, the result has been advertising solutions that are utilized by businesses across all industries due to the strength of our technology stack and our proven, differentiated approach. We are proud to collaborate with fellow leaders in the industry such as Amazon Publisher Services, FreeWheel’s Beeswax and HPE GreenLake, and look forward to continuing to offer the high-quality advertising solutions we have become known and trusted to provide.”
Statements from Deloitte “Each year, I look forward to reviewing the progress and innovations of our Technology Fast 500 winners as these companies truly demonstrate how important new ideas are to progressing our society and the world, especially during difficult times,” said Paul Silverglate, Vice Chair, Deloitte LLP and U.S. Technology Sector Leader. “While software and services and life sciences continue to dominate the top 10, I am encouraged to see other categories making their mark. Congratulations to all the winners who show us how creativity, hard work and perseverance can lead to success.”
“As a growing company, it’s always rewarding to be recognized for the ongoing commitment it takes to navigate obstacles, transform when necessary and ultimately create a thriving business,” said Christie Simons, partner, Deloitte & Touche LLP and industry leader for technology, media and telecommunications within Deloitte’s audit and assurance practice. “Over the nearly 30 years we’ve been compiling the Technology Fast 500 we’ve seen new categories emerge, growth rates explode, and certain regional markets shine from the bright talent they attract. We are proud of all the winners for achieving this well-deserved honor.”
About Direct Digital Holdings Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.
About the 2023 Deloitte Technology Fast 500 Now in its 29th year, the Deloitte Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2019 to 2022.
In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company’s operating revenues. Companies must have base-year operating revenues of at least US$50,000, and current-year operating revenues of at least US$5 million. Additionally, companies must be in business for a minimum of four years and be headquartered within North America.
Net Income of $1.1 Million, Down 68% Year-over-Year
Adjusted EBITDA (non-GAAP) of $13.9 Million, Up 21% Year-over-Year
Reiterates Full Year 2023 Guidance for Revenue and Adjusted EBITDA
ATLANTA, Nov. 13, 2023 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, today reported financial results for the third quarter ended September 30, 2023. Bitcoin Depot will host a conference call and webcast at 11:00 a.m. ET today. An earnings presentation and link to the webcast will be made available at ir.bitcoindepot.com.
“Our results this quarter continue to demonstrate the strength of our business model and how we’re able to deliver strong results irrespective of the market environment or price of Bitcoin,” said Brandon Mintz, CEO and Founder of Bitcoin Depot. “We’ve made significant progress in advancing our growth strategy and this quarter we continued to fortify our industry-leading position with sustained strength in customer traffic and transaction volume. We remain well-positioned to capitalize on potential expansion opportunities to become the most trusted, quickest and most efficient way to purchase Bitcoin with cash across the largest network of retail locations possible.”
Third Quarter 2023 Financial Results
Revenue in the third quarter of 2023 was $179.5 million, up 3% from $174.8 million for the third quarter of 2022.
Adjusted Gross Profit, a non-GAAP measure, in the third quarter of 2023 was $26.9 million, up 26% from $21.3 million for the third quarter of 2022. Adjusted Gross Profit margin (non-GAAP) in the third quarter of 2023 was 15.0% compared to 12.2% in the third quarter of 2022.
Total operating expenses were $19.5 million for the third quarter of 2023, compared to $16.5 million for the third quarter of 2022.
Net income for the third quarter of 2023 was $1.1 million, compared to a net income of $3.3 million for the third quarter of 2022 and a net loss of $4.0 million for the second quarter of 2023.
Adjusted EBITDA, a non-GAAP measure, in the third quarter of 2023 was $13.9 million, up 21% from the third quarter of 2022. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.
Cash and cash equivalents were $29.7 million as of the end of the third quarter of 2023.
Recent Business Highlights
Amended existing PIPE Agreement dated June 23, 2023 (the “PIPE Agreement”) to accelerate the five remaining Reference Periods (as defined in the PIPE Agreement) and set the Settlement Price (as defined in the PIPE Agreement) in connection with the consummation of the proposed private sale by the Subscribers of 3,475,000 shares of Series A Convertible Preferred Stock of the Company to certain third parties.
Announced a share repurchase program pursuant to which Bitcoin Depot is authorized to repurchase up to $10 million of its outstanding Class A common stock through June 30, 2024.
Expanded BDCheckout program into 400 new locations across Iowa and Louisiana through an ongoing partnership with a leading global payments technology company with a nationwide retail network. BDCheckout is now available at 246 total locations in Iowa across a variety of convenience store partners such as Kum & Go, Kwik Trip and Pilot Travel Centers. BDCheckout is also expanding into 166 locations in Louisiana.
Signed an exclusive retail partnership with Jacksons Food Stores, a nationally recognized chain of more than 300 convenience stores.
Hired a new Chief Technology Officer to lead software development efforts.
Guidance
Based on current market conditions, Bitcoin Depot expects consolidated revenue in 2023 to range between $700 million and $730 million, an 8% to 13% improvement compared to $647 million in 2022. Bitcoin Depot expects Adjusted EBITDA (non-GAAP) in 2023 to range between $56 million and $59 million compared to 2022 when Bitcoin Depot generated net income of $3.5 million and Adjusted EBITDA of $41 million, representing a 37% to 44% year-over-year increase in Adjusted EBITDA. For important disclosures about Adjusted EBITDA, see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.
Conference Call
Bitcoin Depot will hold a conference call at 11:00 a.m., Eastern time (8:00 a.m. Pacific time), today to discuss its financial results for the third quarter ended September 30, 2023.
Call Date: Monday, November 13, 2023 Time: 11:00 a.m. Eastern time (8:00 a.m. Pacific time) U.S. dial-in: 646-307-1963 International dial-in: 800-715-9871 Conference ID: 8247570
The conference call will broadcast live and be available for replay here following the call.
Please call the conference telephone number approximately 10 minutes before the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Bitcoin Depot’s investor relations team at 1-949-574-3860.
A replay of the call will be available beginning after 3:00 p.m. Eastern time on November 13, 2023 through November 20, 2023.
U.S. replay number: 609-800-9909 International replay number: 800-770-2030 Conference ID: 8247570
About Bitcoin Depot
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to Bitcoin at Bitcoin Depot’s kiosks and at thousands of name-brand retail locations through its BDCheckout product. The Company has the largest market share in North America with approximately 6,400 kiosk locations as of September 30, 2023. Learn more at www.bitcoindepot.com.
This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, our ability to strengthen our financial profile, worldwide growth in the adoption and use of cryptocurrencies, and our guidance regarding our generation of revenue and Adjusted EBITDA for 2023. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,” “plan,” “potential,” “priorities,” “project,” “pursue,” “seek,” “should,” “target,” “when,” “will,” “would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.
These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; risks relating to the uncertainty of our projected financial information; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.
We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.
Explanation and Reconciliation of Non-GAAP Financial Measures
Bitcoin Depot reports its financial results in accordance with accounting principles generally accepted in the United States of America (“GAAP”). This press release includes both historical and projected Adjusted EBITDA, Adjusted Gross Profit, and certain ratios and other metrics derived therefrom such as Adjusted EBITDA margin and Adjusted Gross Profit margin, which are not prepared in accordance with GAAP.
Bitcoin Depot defines Adjusted EBITDA as net income before interest expense, income tax expense, depreciation and amortization, non-recurring expenses, stock-based compensation, expenses related to the PIPE financing and miscellaneous cost adjustments. Such items are excluded from Adjusted EBITDA because these items are non-cash in nature, or because the amount and timing of these items is unpredictable, not driven by core results of operations and renders comparisons with prior periods and competitors less meaningful. In addition, Bitcoin Depot defines Adjusted Gross Profit (a non-GAAP financial measure) as revenue less cost of revenue (excluding depreciation and amortization) and depreciation and amortization adjusted to add back depreciation and amortization. Bitcoin Depot believes Adjusted EBITDA and Adjusted Gross Profit each provide useful information to investors and others in understanding and evaluating Bitcoin Depot’s results of operations, as well as provide a useful measure for period-to-period comparisons of Bitcoin Depot’s business performance. Adjusted EBITDA and Adjusted Gross Profit are each key measurements used internally by management to make operating decisions, including those related to operating expenses, evaluate performance and perform strategic and financial planning. However, you should be aware that Adjusted EBITDA and Adjusted Gross Profit are not measures of financial performance calculated in accordance with GAAP and may exclude items that are significant in understanding and assessing Bitcoin Depot’s financial results, and further, that Bitcoin Depot may incur future expenses similar to those excluded when calculating these measures. Bitcoin Depot primarily relies on GAAP results and uses both Adjusted EBITDA and Adjusted Gross Profit on a supplemental basis. Neither Adjusted EBITDA or Adjusted Gross Profit should be considered in isolation from, or as an alternative to, net income, cash flows from operations or other measures of profitability, liquidity or performance under GAAP and may not be indicative of Bitcoin Depot’s historical or future operating results. Bitcoin Depot’s computation of both Adjusted EBITDA and Adjusted Gross Profit may not be comparable to other similarly titled measures computed by other companies because not all companies calculate such measures in the same fashion. As such, undue reliance should not be placed on such measures.
Due to the high variability and difficulty in making accurate forecasts and projections of some of the information excluded from the projections of Adjusted EBITDA, together with some of the excluded information not being ascertainable or accessible, Bitcoin Depot is unable to quantify certain amounts that would be required to be included in the most directly comparable GAAP financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable GAAP measures is included and no reconciliation of the forward-looking non-GAAP financial measures is included.
The following table presents a reconciliation of revenue to Adjusted EBITDA for the periods indicated:
Contacts:
Investors Cody Slach, Alex Kovtun Gateway Group, Inc. 949-574-3860 BTM@gateway-grp.com
Media Zach Kadletz, Brenlyn Motlagh, Ryan Deloney Gateway Group, Inc. 949-574-3860 BTM@gateway-grp.com
Enrollment underway in Phase 1 trial with novel protease inhibitor CDI-988, the first potential dual coronavirus-norovirus oral antiviral
Dosing expected to begin later this year in Phase 2a human challenge trial with oral CC-42344 for the treatment of pandemic and seasonal influenza A
Phase 1 trial with inhaled CC-42344 expected to begin in the first half of 2024
BOTHELL, Wash., Nov. 13, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) reports financial results for the three and nine months ended September 30, 2023, and provides updates on its antiviral pipeline, upcoming milestones and business activities.
“We are making excellent progress in the clinical development of potent antivirals that address some of the world’s leading viral diseases,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “With our novel oral PB2 inhibitor CC-42344 for the treatment of pandemic and seasonal influenza A, we expect to dose the first subjects in a Phase 2a human challenge study before year-end. We also are on track to begin a Phase 1 healthy volunteer trial in the first half of 2024 with inhaled CC-42344 as a potential therapeutic and prophylactic treatment for influenza A.
“Enrollment is underway in a Phase 1 trial with our first-in-class pan-coronavirus and pan-norovirus protease inhibitor CDI-988,” added Dr. Lee. “This oral potent antiviral candidate could reduce severity and death from pandemic outbreaks of highly contagious viral infections. CDI-988 has shown activity against multiple coronavirus and norovirus strains, including the genogroup II, genotype 4 (GII.4) norovirus strain, which is responsible for major norovirus outbreaks. With no approved treatments or vaccines, norovirus represents a significant unmet medical need.”
“With three clinical-stage antiviral programs in high-value unmet medical indications, the coming year promises to be active and potentially transformational for Cocrystal,” said James Martin, CFO and co-CEO. “I’m pleased to report that under our cost-efficient business model, we believe our current cash position is sufficient to fund planned operations beyond the next 12 months.”
Antiviral Product Pipeline Overview
We are developing therapeutics that inhibit the viral replication function of RNA viruses that cause acute and chronic diseases. Our drug-discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level. By designing and selecting antiviral drug candidates that interrupt the viral replication process and have specific binding characteristics, we seek to develop drugs that are effective against the virus and mutants of the virus, and also have reduced off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes.
Influenza Programs
Influenza is a severe respiratory illness caused by the influenza A or B virus that results in disease outbreaks mainly during the winter months. Influenza is a major global health threat that may become more challenging to treat in the future due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals.
Our novel oral PB2 inhibitor CC-42344 has shown excellent in vitro antiviral activity against influenza A strains including pandemic and seasonal strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
In March 2022 we initiated enrollment in a randomized, double-controlled, dose-escalating Phase 1 trial to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered CC-42344 in healthy adults.
In July 2022 we reported PK results from the single-ascending dose portion of the trial that support once-daily dosing.
In December 2022 we reported favorable safety and tolerability results from the CC-42344 Phase 1 trial.
In October 2023 we announced authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct a Phase 2a human challenge trial and we expect to begin treating influenza-infected subjects in this trial during the fourth quarter of 2023.
Preclinical development is underway with inhaled CC-42344 as a potential therapeutic treatment and prophylaxis for influenza A. We expect to begin a Phase 1 clinical trial with inhaled CC-42344 in Australia in the first half of 2024.
Pandemic and Seasonal Influenza A/B Program
In January 2019 we entered into an Exclusive License and Research Collaboration Agreement with Merck Sharp & Dohme Corp. (Merck) to discover and develop certain proprietary influenza antiviral agents that are effective against influenza A and B strains. This agreement includes milestone payments of up to $156 million plus royalties on sales of products discovered under the agreement.
In January 2021 we announced completion of all research obligations under the agreement, making Merck solely responsible for further preclinical and clinical development of these compounds.
In early 2023 Merck notified us of its intent to continue development of the compounds discovered under this agreement and of their filing on behalf of both companies of multiple U.S. and international patent applications associated with these compounds. Merck continues to be responsible for managing the patents.
COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and protease, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Our main SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses that cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis. Driven by the anticipated emergence of new COVID-19 variants, the global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031.
Oral Protease Inhibitor CDI-988
In October 2022 we announced the selection of CDI-988 as our lead candidate for development as a potential oral treatment for SARS-CoV-2. Designed and developed using our proprietary structure-based drug discovery platform technology, CDI-988 targets a highly conserved region in the active site of SARS-CoV-2 3CL (main) protease required for viral RNA replication.
CDI-988 exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against variants of concern, and demonstrated a safety profile and PK properties that support once-daily dosing.
In May 2023 we announced approval of our application to the Australian regulatory agency for a planned randomized, double-blind, placebo-controlled Phase 1 trial to evaluate the safety, tolerability and PK of oral CDI-988 in healthy volunteers.
In September 2023 we dosed the first subject in the CDI-988 Phase 1 trial.
Intranasal/Pulmonary Protease Inhibitor CDI-45205
CDI-45205 is our novel SARS-CoV-2 3CL (main) protease inhibitor and was among the broad-spectrum viral protease inhibitors we obtained from Kansas State University Research Foundation (KSURF) under an exclusive license agreement announced in April 2020. We believe the protease inhibitors obtained from KSURF have the ability to convert the inactive SARS-CoV-2 polymerase replication enzymes into an active form.
CDI-45205 and several analogs showed potent in vitro activity against the main SARS-CoV-2 variants, surpassing the activity observed with the original Wuhan strain of the virus.
CDI-45205 delivered via intraperitoneal injection demonstrated good bioavailability in mouse and rat PK studies, and no cytotoxicity against a variety of human cell lines. CDI-45205 also demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir.
In January 2022 we received guidance from the FDA regarding further preclinical and clinical development of CDI-45205.
Norovirus Program
Norovirus is a highly contagious infection and is the most common cause of acute gastroenteritis, accounting for nearly one in five cases. According to the Centers for Disease Control and Prevention (CDC), an estimated 685 million cases and an estimated 200,000 deaths are attributed to norovirus each year worldwide, with an estimated societal cost of $60 billion.
In August 2023 we announced our selection of the novel broad-spectrum 3CL protease inhibitor CDI-988 as our lead potential oral treatment for norovirus. CDI-988 is being evaluated in a first-in-human trial in healthy volunteers in Australia. The CDI-988 trial is expected to serve as a Phase 1 trial for both our norovirus and our coronavirus programs.
In September 2023 we dosed the first subject in our dual norovirus-coronavirus oral CDI-988 Phase 1 trial.
Third Quarter Financial Results
Research and development (R&D) expenses for the third quarter of 2023 were $4.2 million, compared with $3.9 million for the third quarter of 2022. The increase was primarily due to the influenza CC-42344 product candidate moving into a Phase 2a clinical trial and the ongoing Phase 1 clinical trial of CDI-988 for norovirus-coronavirus. General and administrative (G&A) expenses for the third quarters of 2023 and 2022 were relatively stable at $1.8 million.
During the third quarter of 2023, the Company received a $1.6 million refund from the registry of the court reflecting the recovery of funds following a successful appeal in the Company’s litigation with an insurer, which created a positive impact by reducing operating expenses by that amount.
Total other income, net for the third quarter of 2023 was $0.3 million, which was primarily related to interest earned on cash in bank accounts. This compared with minimal other expense, net for the third quarter of 2022.
The net loss for the third quarter of 2023 was $4.2 million, or $0.41 per share, compared with the net loss for the third quarter of 2022 of $5.7 million, or $0.70 per share.
Nine Month Financial Results
R&D expenses for the nine months ended September 30, 2023 were $10.9 million, compared with $9.1 million for the nine months ended September 30, 2022, with the increase primarily due to clinical advancement of our Influenza A and norovirus-coronavirus programs. G&A expenses for the first nine months of 2023 were $4.6 million, compared with $4.5 million for the first nine months of 2022.
During the first nine months of 2023, the Company received a $1.6 million refund from the registry of the court, as noted above. The Company obtained a summary judgment during the second quarter of 2022 and accounted for a potential $1.6 million adverse award by expensing the same amount during the first nine months of 2022.
During the first nine months of 2022, the Company recorded a $19.1 million non-cash goodwill impairment. There was no comparable impairment charge during the first nine months of 2023.
Total other income, net for the first nine months of 2023 was $0.4 million, compared with minimal other expense, net for the first nine months of 2022.
The net loss for the nine months ended September 30, 2023 was $13.5 million, or $1.43 per share. The net loss for the nine months ended September 30, 2022 was $34.3 million, or $4.23 per share, and reflected the litigation expense and non-cash impairment charge described above.
Cocrystal reported unrestricted cash as of September 30, 2023 of $29.7 million, compared with $37.1 million as of December 31, 2022. Net cash used in operating activities for the first nine months of 2023 was $11.3 million, compared to $16.5 million for the first nine months of 2022. The Company had working capital of $30.3 million and 10.2 million common shares outstanding as of September 30, 2023.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical drug candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including, preparation, commencement and advancement of clinical studies for certain product candidates in 2023 and beyond, the viability and efficacy of potential treatments for diseases our product candidates are designed to treat, expectations for the markets for certain therapeutics, our ability to execute our clinical and regulatory goals and deploy regulatory guidance towards future studies, the expected sufficiency of our cash balance to advance our programs and fund our planned operations, and our liquidity. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from interest rate increases in response to inflation, uncertainty in the financial markets, the possibility of a recession and geopolitical conflict in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions on our ability to proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, and the outcome of the ongoing litigation with the insurance company. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Operating lease right-of-use assets, net (including $57 and $99 respectively, to related party)
111
274
Total assets
$
32,614
$
40,840
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses
$
1,806
$
976
Current maturities of finance lease liabilities
–
7
Current maturities of operating lease liabilities (including $57 and $59 respectively, to related party)
118
233
Total current liabilities
1,924
1,216
Long-term liabilities:
Operating lease liabilities (including $0 and $42 respectively, to related party)
–
57
Total liabilities
1,924
1,273
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value 150,000 shares authorized as of September 30, 2023, and December 31, 2022; 10,174 and 8,143 shares issued and outstanding as of September 30, 2023 and December 31, 2022
10
8
Additional paid-in capital
342,130
337,489
Accumulated deficit
(311,450
)
(297,930
)
Total stockholders’ equity
30,690
39,567
Total liabilities and stockholders’ equity
$
32,614
$
40,840
COCRYSTAL PHARMA, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share data)
Children with Autism Spectrum Disorder are at Risk for Low Bone Density
Preliminary Data Suggest that the Administration of Oxytocin May Favorably Impact Bone Formation and Strength
Recent Meta-Analysis Reported that Plasma Oxytocin Levels Tend to be Lower in Children with Autism Spectrum Disorder than Controls1
CHATHAM, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the first participant was enrolled in an investigator-initiated Phase 2 study of TNX-1900 (intranasal potentiated oxytocin) for improving bone health in children with autism spectrum disorder (ASD), named the BOX study, at Massachusetts General Hospital (MGH). The aim of this Department of Defense-funded study is to investigate the efficacy and safety of TNX-1900 as a novel therapeutic agent to increase bone density and improve bone structure and strength in children with ASD. Tonix is providing active drug and placebo for the BOX study as part of a drug donation agreement with MGH. MGH is the sponsor of the trial, which is being conducted under an investigator-initiated investigational new drug (IND) application.
“Low bone density in ASD is a serious problem,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Intranasal potentiated oxytocin is a potential treatment option that addresses the biology of bone loss specific to ASD which is different from osteoporosis in post-menopausal women. Intranasal oxytocin has a long history of being tested for the treatment of ASD, but results have been inconsistent. Tonix’s magnesium-potentiated intranasal oxytocin is designed to improve consistency in clinical effects, because it reduces the ‘high-dose’ inhibition seen in the ‘inverted U’ dose response in animals.”2
Madhusmita Misra, M.D., MPH, Chief, Division of Pediatric Endocrinology, Department of Pediatrics, Mass General for Children, and principal investigator of the study said, “The childhood and adolescent years are critical for bone mass accrual towards achievement of peak bone mass, a key determinant of future bone health and fracture risk. Preliminary data show that over a four-year period, children with ASD fail to catch-up with typically developing children for bone health measures despite optimizing calcium and vitamin D intake3. The difference between these groups often becomes more drastic over time.”
Elizabeth A. Lawson, M.D., M.M.Sc., Director, Interdisciplinary Oxytocin Research Program in the Neuroendocrine Unit, Department of Medicine, MGH, who is a co-investigator on the study continued, “Preclinical studies indicate that, in addition to its known central prosocial effects,4 oxytocin is an important mediator of bone homeostasis, promoting bone formation over resorption.5-7 Pilot data indicate strong associations between low levels of oxytocin and worse bone health in both sexes and across clinical populations, supporting the critical role of oxytocin in bone metabolism.”8-11
“Preclinical studies and some clinical trials have shown prosocial effects of oxytocin in individuals with autism,” reported Ann Neumeyer, M.D., Medical Director of Lurie Center for Autism, Department of Pediatrics and Neurology, Mass General for Children and also a co-investigator. “This research study will further investigate effects of oxytocin on social impairment associated with autism as a secondary outcome.”12
Dr. Lederman continued, “Given the increasing prevalence of ASD in children and its association with impaired bone health, lower oxytocin levels in those with ASD than neurotypical controls, and preclinical data showing that oxytocin can favorably impact bone health, a study examining the role of oxytocin in improving bone health in children with ASD is both timely and essential.”
The Phase 2 investigator-initiated BOX study is a randomized, placebo-controlled study to evaluate the effects of twice daily administration of TNX-1900 on bone measures in children with ASD. Study subjects, ages six to 18 years old, will be randomized 1:1 to receive TNX-1900 twice per day or placebo for 12 months in the double-blind phase, followed by a six-month open label phase during which all study subjects will receive TNX-1900 twice daily. The primary endpoint is the difference between TNX-1900 compared to placebo groups in 12-month change in whole body less head bone mineral density Z-scores. A Z-score compares one’s bone density to the average bone density of age and gender matched controls.
John S and Jaeggi, AV. Autism. 2021. 25:2152-2161.
Bharadwaj VN, et al. Pharmaceutics. 2022. 14(5):1105.
Neumeyer AM, et al. J Pediatr. 2017. 181:195-201 e196.5274559
Marsh N, et al. Neuroscientist. 2021. 27(6):604-619.
Tamma R, et al. Proc Natl Acad Sci U S A. 2009. 106:7149-7154.
Colucci S, et al. Biochem Biophys Res Commun. 2002. 297:442-445.
Copland JA, et al. Endocrinology. 1999. 140:4371-4374.
Fazeli PK, et al. J Clin Psychiatry. 2018. 79:17m11585.
Lawson EA, et al. J Clin Psychiatry. 2011. 72:1546-1551.
Aulinas A, et al. Neuroendocrinology. 2021. 111:87-98.
Hu L, et al. Eur J Clin Pharmacol. 2023. doi: 10.1007/s00228-023-03545-w. Epub ahead of print. PMID: 37540265.
About TNX-1900
TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for prevention of chronic migraine and other conditions. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter within the central nervous system (CNS). Oxytocin has no recognized addiction potential. It has been observed that low oxytocin levels in the body are associated with increases in migraine headache frequency, and that increased oxytocin levels are associated with fewer migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin levels. Migraine attacks are caused, in part, by the activity of pain-sensing trigeminal neurons which, when activated, release calcitonin gene-related peptide (CGRP) which binds to receptors on other nerve cells and starts a cascade of events that is believed to result in headache. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system1 resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release.2 Blocking CGRP release is a distinct mechanism compared with CGRP antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor. With TNX-1900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding3 as well as oxytocin’s inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models4. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children5. Targeted nasal delivery results in low systemic exposure and lower risk of non-CNS, off-target effects, which could potentially occur with systemic CGRP antagonists such as anti-CGRP antibodies6. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally-targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and patients greater control. In addition to chronic migraine, TNX-1900 will be developed for treatment of episodic migraine, binge eating disorder, and craniofacial pain conditions. Tonix also has a license with the University of Geneva for the use of TNX-1900 in the treatment of insulin resistance and related conditions.
About TNX-2900
TNX-2900 is another intranasal potentiated oxytocin-based therapeutic candidate, being developed for the treatment of Prader-Willi syndrome, or PWS. The technology for TNX-2900 was licensed from the French National Institute of Health and Medical Research. PWS, an orphan condition, is a rare genetic disorder of failure to thrive in infancy, associated with uncontrolled appetite later in childhood.
1. Yeomans DC, et al. Transl Psychiatry. 2021. 11(1):388. 2. Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50. 3. Antoni FA and Chadio SE. Biochem J. 1989. 257(2):611-4. 4. Cai Q, et al., Psychiatry Clin Neurosci. 2018. 72(3):140-151. 5. Yeomans, DC et al. 2017. US patent US2017368095 6. MaassenVanDenBrink A, et al. Trends Pharmacol Sci. 2016. 37(9):779-788
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and enrollment has completed in a Phase 2 proof-of-concept study with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, including the intended use of proceeds from the public offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
CALGARY, AB, Nov. 9, 2023 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company“) today announced that the Toronto Stock Exchange (“TSX“) has accepted InPlay’s notice of intention to renew its normal course issuer bid for a further one year term (the “NCIB“). The previous NCIB expired on October 16, 2023. Pursuant to the Company’s previous NCIB, the Company purchased in the open market through the facilities of the TSX and through other alternative Canadian trading platforms and cancelled an aggregate of 190,400 common shares (“Common Shares“) of the Company at an average price paid of $2.84 per Common Share.
Under the NCIB, InPlay may purchase for cancellation, from time to time, as InPlay considers advisable, up to a maximum of 6,637,064 Common Shares, which represents 10% of the Company’s public float of 66,370,643 Common Shares as at October 31, 2023. As of the same date, InPlay had 90,925,401 Common Shares issued and outstanding. Purchases of Common Shares may be made on the open market through the facilities of the TSX and through other alternative Canadian trading platforms at the prevailing market price at the time of such transaction. The actual number of Common Shares that may be purchased for cancellation and the timing of any such purchases will be determined by InPlay, subject to a maximum daily purchase limitation of 43,809 Common Shares which equates to 25% of InPlay’s average daily trading volume of 175,239 Common Shares for the six months ended October 31, 2023. InPlay may make one block purchase per calendar week which exceeds the daily repurchase restrictions. Any Common Shares that are purchased by InPlay under the NCIB will be cancelled.
The NCIB will commence on November 14, 2023 and will terminate on November 13, 2024 or such earlier time as the NCIB is completed or terminated at the option of InPlay.
InPlay believes that renewing the NCIB is a prudent step in this volatile energy market environment, when at times, the prevailing market price does not reflect the underlying value of its Common Shares. The timely repurchase of the Company’s Common Shares for cancellation represents confidence in the long term prospects and sustainability of its business model. This reduction in share count adds per share value to InPlay’s shareholders and adds another tool to management’s disciplined capital allocation strategy.
With the base dividend of $0.015/share per month, NCIB share repurchases and the Company’s continued efforts towards towards overall production per share growth, InPlay will be able to continue with its strategy of providing strong returns to shareholders.
About InPlay Oil Corp.
InPlay Oil is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The Company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The Common Shares on the Toronto Stock Exchange under the symbol IPO and the OTCQX under the symbol IPOOF.
For further information please contact:
Doug Bartole President and Chief Executive Officer InPlay Oil Corp. Telephone: (587) 955-0632
This news release contains certain statements that may constitute forward-looking information within the meaning of applicable securities laws. This information includes, but is not limited to InPlay’s intentions with respect to the NCIB and purchases thereunder and the effects of repurchases under the NCIB. Although InPlay believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because InPlay can give no assurance that they will prove to be correct. Since forward-looking statements address future events and conditions by their very nature they involve inherent risks and uncertainties. Actual results could defer materially from those currently anticipated due to a number of factors and risks. Certain of these risks are set out in more detail in InPlay’s Annual Information Form which has been filed on SEDAR+ and can be accessed at www.sedarplus.com.
The forward-looking statements contained in this press release are made as of the date hereof and InPlay undertakes no obligation to update publically or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.
MALVERN, Pa., Nov. 10, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in its Phase 1/2 GARDian clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease, a rare genetically inherited disease that directly affects the retina, often resulting in slow progressive vision loss in children and adults.
“There is a significant unmet medical need for the approximate 35,000 patients in the U.S. living with Stargardt disease,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “It is critical to our mission to develop innovative treatments for inherited retinal diseases and this milestone is an important step in bringing our novel modifier gene therapies to people who desperately need them.”
This Phase 1/2 trial will assess the safety of unilateral subretinal administration of OCU410ST in subjects with Stargardt Disease and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose ranging study. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which adult and pediatric subjects will be randomized in a 1:1:1 ratio to either one of two OCU410ST dose groups or to an untreated control group.
OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathway links to Stargardt disease such as lipofuscin formation, oxidative stress, compliment formation, inflammation, and cell survival networks.
“It is important and exciting to pursue novel therapies for untreatable blinding diseases,” said Charles Wykoff, MD, PhD, Director of Research, Retina Consultants of Texas. “Initiation of this trial program investigating a new mechanism of action for the treatment of Stargardt disease is inspiring and brings hope to patients and families.”
About Stargardt Disease
Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.
Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Third orphan drug designation (ODD) granted to THIO by the FDA; drug also holds ODDs for hepatocellular carcinoma and small cell lung cancer
Benefits include 7 years of U.S. market exclusivity after drug approval and tax credits for qualified clinical testing
Expected glioblastoma market growth from $2.2 billion to $3.2 billion globally in the next three years
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead asset THIO, a cancer telomere-targeting agent, for the treatment of glioblastoma. This is the third orphan drug designation granted to THIO, following the receipt of orphan drug designations for hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC) in 2022.
“We are pleased to receive a third orphan drug designation for THIO, further highlighting FDA’s recognition of THIO’s potential in the treatment of multiple cancer indications, including rare ones such as glioblastoma,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Each year, globally, more than 300,000 people are diagnosed with brain tumors, of which, 25,000 are in the United States. Glioblastoma represents the majority of these cases in the U.S., with 15,000 new patients diagnosed and more than 10,000 deaths yearly, making it an orphan indication. Given this prevalence there is significant room for growth in the $2.2 billion glioblastoma market, which is expected to reach $3.2 billion globally in the next three years.1 We consider this ODD an important milestone for our development strategy and for glioblastoma patients who could benefit from a potentially revolutionary therapy.”
“In the data presented to the FDA, THIO successfully penetrated the blood brain barrier (BBB) in syngeneic and humanized mouse models of telomerase-expressing brain cancers. Treatment with THIO resulted in potent anticancer activity and significant expansion of the animal lifespan for several difficult to treat cell lines and xenograft mouse models,” added Sergei Gryaznov, Ph.D., MAIA’s Chief Scientific Officer. “These results stem from THIO’s remarkable mechanism of action and its BBB penetrating property that allows for direct targeting of brain tumors in vivo and potentially in glioblastoma patients.”
“Glioblastoma is the most aggressive and most common type of cancer that originates in the brain. With very limited treatment options available, glioblastoma patients have exceptionally short survival durations, and only 7% remain alive five years after being diagnosed with the condition,”2 said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. “We are optimistic about our telomere-targeting agent’s ability to provide clinical benefit in patients with glioblastoma, and we look forward to studying THIO for the treatment of this highly unmet medical indication in a future trial.”
Enrollment is ongoing in a Phase 2 trial of THIO, THIO-101, evaluating the drug candidate in patients with advanced non-small cell lung cancer (NSCLC). THIO is the only direct telomere targeting agent currently in clinical development.
About Orphan Drug Designation
The FDA’s Orphan Drug Act of 1983 was designed to incentivize the development of therapies that demonstrate promise for the treatment of rare (orphan) diseases or conditions. A disease is classified as “rare” if it affects fewer than 200,000 people total in the U.S., or if the cost of developing a drug and making it available in the U.S. for such diseases will exceed any potential profits from its sale due to the small target population size. The FDA’s ODD program provides multiple incentives to make orphan drug development more financially possible for companies to pursue, such as up to seven years of market exclusivity for the approved orphan drug, up to 20 years of 25% federal tax credit for expenses incurred in conducting clinical research within the U.S. and waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, a value of approximately $2.9 million in 2021.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD1 agent will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
____________________________
1 Market size and forecast from the Business Research Company
Topline Results from Phase 3 Potentially NDA-Enabling Study of TNX-102 SL in Fibromyalgia Expected Late December 2023: Centrally-Acting Non-Opioid Analgesic
Topline Results from Phase 2 Proof-of-Concept Study ofTNX-1900 in Chronic Migraine Expected Early December 2023: Intranasal Potentiated Oxytocin
Meaningful Progress Made in Obtaining External Support for Clinical Trials from U.S. Government Agencies and Other Institutions
Revenue from Marketed Acute Migraine Products: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) Included in Third Quarter Financial Statements
CHATHAM, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced financial results for the third quarter ended September 30, 2023, and provided an overview of recent operational highlights.
“Tonix expects topline results from its Phase 3 fibromyalgia study and Phase 2 chronic migraine study before year end,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “The Phase 3 RESILIENT trial in fibromyalgia, if successful, is expected to be the final efficacy trial required for submitting a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets). In the Phase 2 proof-of-concept PREVENTION study in chronic migraine of TNX-1900 (intranasal potentiated oxytocin), all patients have completed their final visit and topline results are expected in early December 2023.”
Dr. Lederman continued, “We are continuing to shift the expense of clinical trials from our operating budget to U.S. government agencies and other institutions through partnerships. The U.S. Department of Defense (DoD) is supporting the upcoming Phase 2 study of TNX-102 SL in acute stress disorder, being conducted and sponsored by University of North Carolina (UNC). The U.S. National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID), through its Project NextGen, will conduct the Phase 1 study of our vaccine candidate TNX-1800 (modified recombinant horsepox virus, live vaccine). The National Institute of Drug Abuse (NIDA) is supporting our Phase 2 study of TNX-1300 (recombinant double mutant cocaine esterase) for cocaine intoxication. Massachusetts General Hospital (MGH) is conducting Phase 2 studies of TNX-1900 in binge eating disorder and pediatric obesity, and the University of Washington is conducting a Phase 2 study of TNX-1900 in social anxiety disorder. Finally, we continue to collaborate with MGH on several preclinical non-human primate studies for TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody), currently in a Phase 1 study being conducted by Tonix. These outside collaborations leverage our internal resources and allow us to progress our clinical programs in a capital efficient manner.”
Partnerships with External Funding – Recent Highlights
NIH/NIAID selected Tonix’s vaccine candidate, TNX-1800, as part of Project NextGen; a Phase 1 study is expected to start in the second half of 2024. NIH/NIAID will cover the full cost of the clinical trial, while Tonix will supply the vaccine candidate.
NIDA is supporting a Phase 2 study on TNX-1300 for cocaine Intoxication; expected to start enrolling patients in the fourth quarter of 2023.
DoD is supporting a Phase 2 investigator-initiated study of TNX-102 SL for acute stress disorder at UNC for motor vehicle accident victims; expected to start enrolling patients in 2024.
MGH/Harvard Medical School is conducting Phase 2 investigator-initiated studies of TNX-1900 in binge eating disorder and adolescent obesity.
The University of Washington is conducting a Phase 2 investigator-initiated study of TNX-1900 in social anxiety disorder.
Marketed Products – Recent Highlights
In September 2023, Tonix announced that it is committed to meeting potential increased demand for Tosymra® (sumatriptan nasal spray) 10 mg after GlaxoSmithKline’s planned discontinuation of Imitrex® (sumatriptan) nasal spray 5 mg and 20 mg products after January 2024. Tonix is preparing for potential increased demand for Tosymra to help avoid possible drug shortages for patients who suffer from migraines. Tosymra nasal spray is approved on the basis of bioequivalence to Imitrex injection 4 mg.
Tonix completed the acquisition of Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra from Upsher-Smith Laboratories, LLC in June 2023. Both products are indicated for the treatment of acute migraine with or without aura in adults.
Key Product Candidates* — Recent Highlights
Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual tablets): once-daily at bedtime small molecule for the management of fibromyalgia (FM) – a centrally-acting, non-opioid analgesic.
The Company announced in August 2023 that it completed enrollment of its potentially confirmatory Phase 3 RESILIENT trial of TNX-102 SL 5.6 mg in FM. 457 participants were randomized in the trial, which, if successful, is expected to serve as the final, well-controlled efficacy trial required for submission of NDA for approval by the FDA. RESILIENT is a registration-quality, double-blind, placebo-controlled study. Topline results from the RESILIENT trial are expected in late December of 2023.
TNX-102 SL for the treatment of acute stress reaction (ARS) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)
In September 2023, the Company announced that the UNC Institute for Trauma Recovery has been awarded a $3 million grant from the DoD to investigate the potential of Tonix’s TNX-102 SL to reduce the frequency and severity of adverse effects of acute trauma, which include ASR and ASD, and development of PTSD. The proposed Phase 2, Optimizing Acute Stress Reaction Interventions with TNX-102 SL (OASIS) study will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department (ED) after a motor vehicle collision (MVC). The study will enroll approximately 180 MVC trauma survivors at ED study sites in the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL or placebo.
Initiation of patient enrollment in the proposed investigator-sponsored OASIS study is anticipated in the beginning of 2024, subject to clearance by the FDA of an investigator-initiated Investigational New Drug (IND) application.
TNX-102 SL for the treatment of Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)
In September 2023, the Company announced topline results from its Phase 2 PREVAIL proof-of-concept study of TNX-102 SL for fibromyalgia-type Long COVID. TNX-102 SL showed a robust Cohen’s d effect size of 0.5 in improving fatigue relative to placebo; and it showed consistent activity across secondary measures of sleep quality, cognitive function, disability and Patient Global Impression of Change, but did not meet the primary endpoint of multi-site pain reduction at week 14. TNX-102 SL was generally well tolerated and no new safety signals were observed.
The Company intends to request an End-of-Phase 2 meeting with the FDA to discuss a potential Phase 3 program based on a proposed primary outcome measure using the PROMIS Fatigue scale. The meeting is expected to take place in the first quarter of 2024.
TNX-1900 (intranasal potentiated oxytocin): small peptide for migraine, craniofacial pain, social anxiety disorder (SAD), insulin resistance and related disorders, and adolescent obesity and binge eating disorder
In October 2023, the Company announced it completed the clinical phase of the PREVENTION study, a Phase 2 proof-of-concept study of TNX-1900 for the prevention of migraine headaches in chronic migraineurs, as the last of 88 enrolled patients completed their final study visit. PREVENTION is a registration-quality, double-blind, placebo-controlled study.
Topline results from the PREVENTION Phase 2 trial are expected in early December 2023.
In September 2023, the Company announced that David C. Yeomans, Ph.D. presented data relevant to the proposed mechanism of TNX-1900 in treating chronic migraine in a poster and an oral presentation at the 2023 International Headache Congress (IHC) in Seoul, South Korea. The poster and oral presentation titled, “Human trigeminal ganglia possess oxytocin receptors on CGRP positive neurons: expression increased by inflammation,” include research sponsored by and licensed to Tonix. The presentations show that oxytocin receptors are co-expressed with calcitonin gene-related peptide (CGRP) on human trigeminal ganglia neurons, which is similar to Professor Yeomans’ previous findings in animal trigeminal ganglia. The inflammatory cytokine IL-6 upregulated expression of oxytocin receptors on human trigeminal neurons, consistent with the previously observed impact of inflammation on the potency of oxytocin on its receptor. In animals, oxytocin has been shown to functionally inhibit the excitability of trigeminal neurons, which is consistent with oxytocin inhibiting the release of CGRP at trigeminal nerve terminals.1
Tonix announced in July 2023 that the first participant was enrolled in the investigator-initiated Phase 2 STROBE Study of TNX-1900 for the treatment of binge-eating disorder at MGH. Tonix is supporting the STROBE study through a clinical trial agreement with MGH.
Tonix announced in July 2023 that the first participant was enrolled in a Phase 2 investigator-initiated, proof-of-concept study of TNX-1900 for enhancing social safety learning in SADSAD. Tonix entered into an agreement with the University of Washington to examine the potential role of TNX-1900 in enhancing vicarious extinction learning in SAD, compared to healthy controls.
Tonix announced in July 2023 that the first participant was enrolled in the Phase 2 POWER study of TNX-1900 for the treatment of pediatric obesity with MGH. MGH is the sponsor of the NIH-funded trial, being conducted under an investigator-initiated IND.
Tonix expects to initiate a Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in the fourth quarter of 2023. In 2022, Tonix was awarded a Cooperative Agreement grant from NIDA, part of the NIH, to support development of TNX-1300.
TNX-1300 has been granted Breakthrough Therapy designation by the FDA.
Rare Disease Pipeline
TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)
In October 2023, Herbert Harris, M.D., Ph.D., Executive Vice President, Translational Medicine of Tonix Pharmaceuticals, provided an overview of Tonix’s TNX-2900 program at the Foundation for Prader-Willi Research (FPWR) Family Conference in Denver, CO. The presentation highlights preclinical data showing the enhancing effects of magnesium (Mg2+) on the activation of oxytocin receptors. The Mg2+ enhanced formulation of intranasal oxytocin is the basis for TNX-2900, in development to treat hyperphagia, or pathological over-eating, in children and adolescents with PWS. In preclinical studies, Mg2+ increases the potency of oxytocin, which is a peptide hormone that reduces appetite and signals fullness, potentially improving receptor binding and resulting in improved therapeutic action.
Immunology Pipeline
TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.
In October 2023, the Company announced data from two oral presentations which were delivered recently at the American College of Surgeons (ACS) Clinical Congress 2023, and The International Pancreas and Islet Transplant Association (IPITA), the International Xenotransplantation Association (IXA), and the Cell Transplant and Regenerative Medicine Society (CTRMS) Joint Congress by faculty at the Center for Transplantation Sciences, MGH. The oral presentations titled, “Pilot Evaluation of a Clinical Xeno Heart Transplant Regimen in a Preclinical Model” and “Extended Survival of 9- and 10-Gene Edited Pig Heart Xenografts with Ischemia Minimization and CD154 Costimulation Blockade-Based Immunosuppression” by Dr. Ikechukwu Ileka et al. include data demonstrating the use of TNX-1500 as maintenance therapy after xeno heart transplant in non-human primates. In both studies, genetically engineered (GE) pigs in baboon transplants were treated with cold-perfused ischemia minimization and a novel costimulation-based immunosuppressive regimen that includes TNX-1500.
In October 2023, Tonix announced that a study published in the Journal Nature2 by faculty at the Center for Transplantation Sciences, MGH in collaboration with biotechnology company, eGenesis, utilized TNX-1500 as part of the immune modulating regimen to prevent organ transplant rejection. The Nature article titled, “Design and testing of a humanized porcine donor for xenotransplantation” includes data that provide additional support for TNX-1500’s activity in preventing pig xenograft organ rejection and for its safety and tolerability in non-human primates.
In August 2023, Tonix announced the initiation of a Phase 1 single ascending dose study of TNX-1500 in healthy volunteers. The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous TNX-1500. This first-in-human study is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients.
The first indication for TNX-1500 will be prophylaxis of organ rejection in adult patients receiving a kidney transplant, but multiple additional indications are possible, including autoimmune diseases. Two peer reviewed publications described the work at the MGH on allogeneic transplants in animals were published.3,4
Infectious Disease Pipeline
TNX-1800 (modified recombinant horsepox virus, live vaccine): potential vaccine to protect against COVID-19 designed to express the SARS-CoV-2 spike protein
In November 2023, Tonix announced that NIAID, a part of the NIH, will conduct a Phase 1 clinical trial with TNX-1800 as part of Project NextGen. The Phase 1 trial of TNX-1800 is expected to start in the second half of 2024. NIAID will cover the full cost of the clinical trial, including operations and related analyses. Tonix will be responsible for providing clinical trial materials, and upon completion will have the right to rely on the findings in regulatory filings with the FDA to support the approval of its COVID-19 vaccine and other vaccines based on the RPV platform.
TNX-801 (recombinant horsepox virus, live vaccine): potential vaccine to protect against mpox disease and smallpox.
In August 2023, Tonix received the official written response from a Type B pre-IND meeting with the FDA to develop TNX-801 as a potential vaccine to protect against mpox disease (formerly known as monkeypox) and smallpox. Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1/2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND.
*All of Tonix’s product candidates are investigational new drugs or biologics and none have been approved for any indication.
1Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
2Anand R.P., et al. Nature. 2023. 622, 393–401.
3Lassiter, G., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate renal allograft survival. American Journal of Transplantation. https://doi.org/10.1016/j.ajt.2023.03.022
4Miura, S., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate cardiac allograft survival. American Journal of Transplantation. https://doi.org/10.1016/j.ajt.2023.03.025
Recent Highlights—Financial
As of September 30, 2023, Tonix had approximately $6.9 million of cash and cash equivalents, compared to $120.2 million as of December 31, 2022. Additionally, Tonix had inventory totaling approximately $13.3 million as of September 30, 2023. In August 2023, Tonix received net proceeds of approximately $6.3 million through a public offering of common stock, after deducting underwriting discount and other offering expenses. Cash used in operations was approximately $79.7 million for the nine months ended September 30, 2023, compared to $75.8 million for the same period in 2022. Cash used by investing activities for the nine months ended September 30, 2023 was approximately $28.6 million.
On September 28, 2023, the Company sold 4,050,000 shares of common stock, pre-funded warrants to purchase up to 4,950,000 shares of common stock, and accompanying common A warrants to purchase 9,000,000 shares of common stock and common B warrants to purchase up to 9,000,000 shares of common stock in a public offering for net proceeds of approximately $4.0 million, after deducting underwriting discount and other offering expenses. This public offering closed on October 3, 2023.
Third Quarter 2023 Financial Results
Net product revenue for the third quarter 2023 was approximately $4.0 million. As a reminder, Tonix completed the acquisition of two currently marketed products from Upsher-Smith Laboratories, LLC on June 30, 2023.
During the three months ended September 30, 2023, Tonix received $0.4 million from NIDA for the TNX-1300 study to treat cocaine intoxication.
R&D expenses for the third quarter 2023 were approximately $21.1 million, compared to $22.2 million for the same period in 2022. This decrease is predominantly due to decreased non-clinical and manufacturing expenses, offset by an increase in clinical, employee-related and professional expenses.
SG&A expenses for the third quarter 2023 were $8.7 million, compared to $7.4 million for the same period in 2022. The increase was primarily due to sales and marketing associated with the Company’s recently acquired marketed products.
Net loss available to common stockholders was $28.0 million, or $1.83 per share, basic and diluted, for the third quarter 2023, compared to net loss available to common stockholders of $29.0 million, or $4.24 per share, basic and diluted, for the same period in 2022. The basic and diluted weighted average common shares outstanding for the third quarter 2023 was 15,327,558 compared to 6,843,099 shares for the same period in 2022.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and enrollment has completed in a Phase 2 proof-of-concept study with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
REVENUE:
Product revenue, net
$
3,989
$
—
$
3,989
$
—
COSTS AND EXPENSES:
Cost of revenue
$
2,374
$
—
$
2,374
$
—
Research and development
21,050
22,201
69,537
57,202
Selling, general and administrative
8,712
7,390
23,129
22,161
32,136
29,591
95,040
79,363
Operating loss
(28,147
)
(29,591
)
(91,051
)
(79,363
)
Interest income, net
172
610
1,715
825
Net loss
(27,975
)
(28,981
)
(89,336
)
(78,538
)
Preferred stock deemed dividend
—
—
—
4,255
Net loss available to common stockholders
$
(27,975
)
$
(28,981
)
$
(89,336
)
$
(82,793
)
Net loss per common share, basic and diluted
$
(1.83
)
$
(4.24
)
$
(7.40
)
$
(18.58
)
Weighted average common shares outstanding, basic and diluted
15,327,558
6,843,099
12,079,583
4,455,943
See the accompanying notes to the condensed consolidated financial statements
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands)
(Unaudited)
September 30, 2023
December 31, 20221
Assets
Cash and cash equivalents
$
6,914
$
120,229
Inventory
13,317
–
Receivables, net
1,562
–
Prepaid expenses and other
9,544
10,548
Total current assets
31,337
130,777
Other non-current assets
107,945
94,913
Total assets
$
139,282
$
225,690
Liabilities and stockholders’ equity
Total liabilities
$
18,449
$
18,508
Stockholders’ equity
120,833
207,182
Total liabilities and stockholders’ equity
$
139,282
$
225,690
1The condensed consolidated balance sheet for the year ended December 31, 2022 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
Zembrace® SymTouch® (sumatriptan Injection): IMPORTANT SAFETY INFORMATION
Zembrace SymTouch (Zembrace) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, dihydroergotamine.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace include: pain and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired.
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace. For more information, ask your provider.
This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INDICATION AND USAGE
Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.
Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Tosymra is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.
Do not use Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
severe liver problems
hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any ingredient in Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.
This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INDICATION AND USAGE Tosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults.
Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches.
Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age.
Third Quarter 2023 Revenue Up 129% Year-Over-Year to $59.5 Million
Company Raises Full-Year 2023 Revenue Guidance to $170 Million – $190 Million
HOUSTON, Nov. 9, 2023 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced financial results for the third quarter ended September 30, 2023.
Mark D. Walker, Chairman and Chief Executive Officer, commented, “In recent quarters, we have made significant investments in our technology stack, advertising platform and operational structure. We initially expected to see the impact of these investments in 2024, however, we are pleased to report that these benefits have arrived much earlier in 2023. Our strong technology partnerships and our overarching business strategy have enabled us to meet a growing number of customers’ demands and further the capabilities of our sell-side technology platform. On both the sell-side and the buy-side, increased spend from our buying partners has resulted in an associated increase in our impression count and organic growth profile with a direct positive impact on net income and adjusted EBITDA(1).”
Keith Smith, President, added, “The growth seen in this quarter, as well as the past year, has been fueled by a combination of our strategic investments and partnerships, our differentiated approach to advertising solutions, as well as a set of market dynamics which have been highly beneficial to our position in the industry. We have capitalized on the shift in ad spend towards digital media on both the sell- and buy-side and will continue to grow our presence in the space through our recent partnerships and advancements of our technology stack. We remain committed to executing on the same growth and investment initiatives that led us to the strong third quarter results we are reporting today.”
Third Quarter 2023 Business Highlights
For the third quarter ended September 30, 2023, Direct Digital Holdings processed over 400 billion monthly impressions through its sell-side advertising segment, an increase of 220% over the same period of 2022.
In addition, the Company’s sell-side advertising platforms received over 34 billion monthly bid responses in the third quarter of 2023, an increase of over 210% over the same period in 2022. Sell-side revenue per advertiser for the third quarter of 2023 increased 241% compared to the same period of 2022.
The Company’s buy-side advertising segment served approximately 228 customers in the third quarter of 2023 and buy-side revenue per customer increased 14% compared to the same period of 2022.
Third Quarter 2023 Financial Highlights:
Revenue was $59.5 million in the third quarter of 2023, an increase of $33.5 million, or 129% over the $26.0 million in the same period of 2022.
Sell-side advertising segment revenue grew to $51.6 million and contributed $32.8 million of the increase, or 174% growth over the $18.9 million of sell-side revenue in the same period of 2022.
Buy-side advertising segment revenue grew to $7.9 million and contributed $0.7 million of the increase, or 10% growth over the $7.1 million of buy-side revenue in the same period of 2022.
Consolidated operating income in the third quarter of 2023 was $4.5 million compared to consolidated operating income of $1.8 million in the same period of 2022, an increase of 144% year-over-year.
Net income was $3.4 million in the third quarter of 2023, compared to net income of $0.8 million in the same period of 2022, an increase of 313% year-over-year.
Adjusted EBITDA(1) was $5.4 million in the third quarter of 2023, compared to $2.4 million in the same period of 2022, an increase of 123% year-over-year.
Financial Outlook
Assuming the U.S. economy does not experience any major economic conditions that deteriorate or otherwise significantly reduce advertiser demand, we are increasing our previously issued estimate as disclosed in our second quarter 2023 update:
For fiscal year 2023, we expect revenue to be in the range of $170 million to $190 million, or 101% year-over-year growth at the mid-point.
“We are thrilled to announce the raising of our fiscal year 2023 revenue guidance to $180 million at the midpoint, a 101% increase over full-year 2022 results. This increase reflects our belief in our ability to execute on our various growth strategies, demonstrates the strength of our operating leverage and highlights the favorable market trends that we expect to continue for the remainder of this year,” commented Diana Diaz, Chief Financial Officer.
Conference Call and Webcast Details
Direct Digital will host a conference call on Thursday, November 9, 2023 at 5:00 p.m. Eastern Time to discuss the Company’s third quarter 2023 financial results. The live webcast and replay can be accessed at https://ir.directdigitalholdings.com/. Please access the website at least fifteen minutes prior to the call to register, download and install any necessary audio software. For those who cannot access the webcast, a replay will be available at https://ir.directdigitalholdings.com/ for a period of twelve months.
Footnotes
(1) “Adjusted EBITDA” is a non-GAAP financial measure. The section titled “Non-GAAP Financial Measures” below describes our usage of non-GAAP financial measures and provides reconciliations between historical GAAP and non-GAAP information contained in this press release.
Forward Looking Statements
This press release may contain forward-looking statements within the meaning of federal securities laws, including the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are subject to certain risks, trends and uncertainties.
As used below, “we,” “us,” and “our” refer to the Company. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.
All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Our forward-looking statements are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. Although we believe that these forward-looking statements are based on reasonable assumptions, many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; our limited operating history, which could result in our past results not being indicative of future operating performance; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, on receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the Securities and Exchange Commission that we make from time to time. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.
CONSOLIDATED BALANCE SHEETS (unaudited)
September 30, 2023
December 31, 2022
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
5,481,949
$
4,047,453
Accounts receivable, net
54,637,634
26,354,114
Prepaid expenses and other current assets
1,426,925
883,322
Total current assets
61,546,508
31,284,889
Property, equipment and software, net of accumulated depreciation and amortization of $219,386 and $34,218, respectively
625,028
673,218
Goodwill
6,519,636
6,519,636
Intangible assets, net
12,172,396
13,637,759
Deferred tax asset, net
5,082,424
5,164,776
Operating lease right-of-use assets
674,846
798,774
Other long-term assets
127,492
46,987
Total assets
$
86,748,330
$
58,126,039
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable
$
45,021,034
$
17,695,404
Accrued liabilities
4,071,128
4,777,764
Liability related to tax receivable agreement, current portion
41,141
182,571
Notes payable, current portion
1,146,250
655,000
Deferred revenues
1,044,069
546,710
Operating lease liabilities, current portion
49,977
91,989
Income taxes payable
113,355
174,438
Related party payables
1,428,093
1,448,333
Total current liabilities
52,915,047
25,572,209
Notes payable, net of short-term portion and deferred financing cost of $1,722,716 and $2,115,161, respectively
22,323,534
22,913,589
Economic Injury Disaster Loan
150,000
150,000
Liability related to tax receivable agreement, net of current portion
4,245,234
4,149,619
Operating lease liabilities, net of current portion
717,632
745,340
Total liabilities
80,351,447
53,530,757
COMMITMENTS AND CONTINGENCIES (Note 9)
STOCKHOLDERS’ EQUITY
Class A common stock, $0.001 par value per share, 160,000,000 shares authorized, 2,991,792 and 2,900,000 shares issued and outstanding, respectively
2,992
2,900
Class B common stock, $0.001 par value per share, 20,000,000 shares authorized, 11,278,000 shares issued and outstanding
11,278
11,278
Additional paid-in capital
8,782,092
8,224,365
Accumulated deficit
(2,399,479)
(3,643,261)
Total stockholders’ equity
6,396,883
4,595,282
Total liabilities and stockholders’ equity
$
86,748,330
$
58,126,039
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
For the Three Months Ended
For the Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
Revenues
Buy-side advertising
$
7,850,058
$
7,130,736
$
27,092,816
$
22,283,044
Sell-side advertising
51,622,066
18,854,639
89,006,018
36,333,976
Total revenues
59,472,124
25,985,375
116,098,834
58,617,020
Cost of revenues
Buy-side advertising
3,113,491
2,471,170
10,650,541
7,694,987
Sell-side advertising
44,605,815
16,053,461
77,189,787
30,344,670
Total cost of revenues
47,719,306
18,524,631
87,840,328
38,039,657
Gross profit
11,752,818
7,460,744
28,258,506
20,577,363
Operating expenses
Compensation, taxes and benefits
4,747,081
3,845,918
12,934,406
9,895,646
General and administrative
2,512,330
1,770,002
8,717,584
5,187,875
Total operating expenses
7,259,411
5,615,920
21,651,990
15,083,521
Income from operations
4,493,407
1,844,824
6,606,516
5,493,842
Other income (expense)
Other income
83,331
—
175,472
47,982
Forgiveness of Paycheck Protection Program loan
—
—
—
287,143
Loss on redemption of non-participating preferred units
—
—
—
(590,689)
Contingent loss on early termination of line of credit
—
—
(299,770)
—
Interest expense
(1,059,890)
(905,605)
(3,104,684)
(2,269,643)
Total other expense
(976,559)
(905,605)
(3,228,982)
(2,525,207)
Income before taxes
3,516,848
939,219
3,377,534
2,968,635
Tax expense
165,994
128,436
165,658
215,112
Net income
$
3,350,854
$
810,783
$
3,211,876
$
2,753,523
Net income per common share:
Basic
$
0.23
$
0.06
$
0.23
$
0.23
Diluted
$
0.23
$
0.06
$
0.22
$
0.23
Weighted-average number of shares of common stock outstanding:
Basic
14,268,168
14,178,000
14,216,211
11,846,601
Diluted
14,827,165
14,545,241
14,817,770
11,996,969
CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)
For the Nine Months Ended September 30,
2023
2022
Cash Flows Provided By Operating Activities:
Net income
$
3,211,876
$
2,753,523
Adjustments to reconcile net income to net cash provided by operating activities:
Amortization of deferred financing costs
434,847
463,008
Amortization of intangible assets
1,465,363
1,465,364
Amortization of right-of-use assets
123,928
94,974
Amortization of capitalized software
159,057
—
Depreciation of property and equipment
26,112
—
Stock-based compensation
545,504
85,437
Forgiveness of Paycheck Protection Program loan
—
(287,143)
Deferred income taxes
82,352
(40,591)
Payment on tax receivable agreement
(45,815)
—
Loss on redemption of non-participating preferred units
—
590,689
Contingent loss on early termination of line of credit
299,770
—
Bad debt expense
97,740
2,717
Changes in operating assets and liabilities:
Accounts receivable
(28,381,260)
(13,520,067)
Prepaid expenses and other assets
(524,098)
482,190
Accounts payable
27,325,629
10,008,327
Accrued liabilities
(513,138)
1,555,037
Income taxes payable
(61,083)
94,440
Deferred revenues
497,359
(201,907)
Operating lease liability
(69,720)
(75,396)
Related party payable
—
(70,801)
Net cash provided by operating activities
4,674,423
3,399,801
Cash Flows Used In Investing Activities:
Cash paid for capitalized software and property and equipment
(136,978)
—
Net cash used in investing activities
(136,978)
—
Cash Flows Used In Financing Activities:
Proceeds from note payable
—
4,260,000
Payments on term loan
(491,250)
(412,500)
Payments of litigation settlement
(193,500)
—
Payments on lines of credit
—
(400,000)
Payment of deferred financing costs
(442,181)
(525,295)
Proceeds from Issuance of Class A common stock, net of transaction costs
—
11,167,043
Redemption of common units
—
(7,200,000)
Redemption of non-participating preferred units
—
(7,046,251)
Proceeds from options exercised
215
—
Proceeds from warrants exercised
12,100
—
Distributions to members
(1,988,333)
(916,433)
Net cash used in financing activities
(3,102,949)
(1,073,436)
Net increase in cash and cash equivalents
1,434,496
2,326,365
Cash and cash equivalents, beginning of the period
4,047,453
4,684,431
Cash and cash equivalents, end of the period
$
5,481,949
$
7,010,796
Supplemental Disclosure of Cash Flow Information:
Cash paid for taxes
$
348,862
$
133,401
Cash paid for interest
$
2,667,283
$
1,744,365
Non-cash Financing Activities:
Transaction costs related to issuances of Class A shares included in accrued liabilities
$
—
$
1,000,000
Outside basis difference in partnership
$
—
$
3,234,000
Tax receivable agreement payable to Direct Digital Management, LLC
$
—
$
278,900
Tax benefit on tax receivable agreement
$
—
$
485,100
Issuance related to vesting of restricted stock units, net of tax withholdings
$
90
$
—
NON-GAAP FINANCIAL MEASURES
In addition to our results determined in accordance with U.S. generally accepted accounting principles (“GAAP”), including, in particular operating income, net cash provided by operating activities, and net income, we believe that earnings before interest, taxes, depreciation and amortization (“EBITDA”), as adjusted for stock compensation expense, loss on early termination of line of credit, and loss on early extinguishment of debt, and loss on early redemption of non-participating preferred units (“Adjusted EBITDA”), a non-GAAP financial measure, is useful in evaluating our operating performance. The most directly comparable GAAP measure to Adjusted EBITDA is net income (loss).
In addition to operating income and net income, we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-GAAP financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons:
Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as depreciation and amortization, interest expense, provision for income taxes, and certain one-time items such as acquisition transaction costs and gains from settlements or loan forgiveness that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired;
Our management uses Adjusted EBITDA in conjunction with GAAP financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and
Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-GAAP financial measures to supplement their GAAP results.
Our use of this non-GAAP financial measure has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under GAAP. The following table presents a reconciliation of Adjusted EBITDA to net income (loss) for each of the periods presented:
NON-GAAP FINANCIAL METRICS (unaudited)
For the Three Months Ended September 30,
For the Nine Months Ended September 30,
2023
2022
2023
2022
Net income
$
3,350,854
$
810,783
$
3,211,876
$
2,753,523
Add back (deduct):
Interest expense
1,059,890
905,605
3,104,684
2,269,643
Amortization of intangible assets
488,455
488,455
1,465,364
1,465,364
Stock-based compensation
241,491
70,030
545,504
85,438
Depreciation and amortization of capitalized software, property and equipment
63,689
—
185,169
—
Contingent loss on early termination of line of credit
—
—
299,770
—
Tax expense
165,994
128,436
165,658
215,112
Forgiveness of PPP loan
—
—
—
(287,163)
Loss on early redemption of non-participating preferred units
Reported updated data from ongoing Phase 1b trial further supporting the potential of tegoprubart as a novel kidney transplant immunosuppressive therapy to prevent rejection and better preserve organ function
First participant dosed in Phase 2 BESTOW trial evaluating tegoprubart for the prevention of rejection in kidney transplantation
IRVINE, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported its third quarter operating and financial results and reviewed recent business highlights.
“We were thrilled recently to report updated results from our ongoing Phase 1b study that continue to validate tegoprubart’s potential as an immunosuppressive agent that can prevent the rejection of transplanted kidneys,” said David-Alexandre C. Gros, M.D., Chief Executive Officer. “Tegoprubart demonstrated not only the potential to preserve, but also to improve graft function in comparison to the current standard of care treatment. Additionally, during the quarter we initiated our Phase 2 BESTOW trial and had the historic opportunity to support the second ever transplant of a genetically modified heart from a pig to a human. We continue to make significant progress toward our mission of bringing a much-needed, new treatment option to the growing number of patients undergoing kidney transplantation,” Dr. Gros continued.
Recent Corporate Developments
Reported data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing kidney transplantation at the American Society of Nephrology Kidney Week 2023 Annual Meeting that took place in Philadelphia, PA from November 2-5, 2023. Data from 11 participants demonstrated that tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated. Aggregate mean eGFR was above 70 mL/min/1.73m2 at all reported time points after day 90 supporting tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation.
Announced that tegoprubart was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human. The procedure was completed on September 20th at University of Maryland Medical Center on a 58-year-old male suffering from heart failure.
Dosed the first participant in the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.
Enrolled the first participant in the Phase 2 open-label extension (OLE) study which will evaluate the long-term safety, pharmacokinetics, and efficacy of tegoprubart in participants who have completed one year of treatment in the ongoing Phase 1b study, or the Phase 2 BESTOW study.
Announced the publication of results from a study evaluating tegoprubart as an immunomodulatory monotherapy in nonhuman primate kidney and islet allotransplants in Science Translational Medicine. Results from the study showed that treatment with tegoprubart as a monotherapy promoted long-term kidney and islet allograft survival and function in nonhuman primates, indicating its potential as an immunomodulatory agent for organ transplantation.
Strengthened leadership team with appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer.
Appointed industry veteran James Robinson and renowned transplant surgeon Allan Kirk, M.D., Ph.D., to its Board of Directors.
Upcoming Anticipated 2024 Milestones
First Half 2024: Report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation.
End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
Third Quarter Financial Results
The company reported a net loss of $10.3 million, or $0.35 per share, for the three months ended September 30, 2023, compared to a net loss of $10.5 million, or $0.73 per share, for the same period in 2022.
Research and development expenses were $7.9 million for the three months ended September 30, 2023, compared to $7.5 million for the comparable period in 2022, an increase of $0.4 million. The increase in research and development expenses was primarily driven by an increase in expenses related to the production of clinical trial materials of $0.8 million. The increase was partially offset by a decrease in employee compensation and benefits primarily driven by lower non-cash stock-based compensation expenses and a decrease in clinical development expenses with external contract research organizations.
General and administrative expenses were $3.3 million for the three months ended September 30, 2023, compared to $3.1 million for the comparable period in 2022, a decrease of $0.2 million. The increase in general and administrative expenses was primarily driven by an increase in employee compensation and benefits primarily driven by higher non-cash stock-based compensation expenses.
The company had approximately $59.6 million in cash and cash equivalents and short-term investments as of September 30, 2023, compared to $56.4 million in cash and cash equivalents as of December 31, 2022.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
CALGARY AB, Nov. 8, 2023 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company”) announces its financial and operating results for the three and nine months ended September 30, 2023. InPlay’s condensed unaudited interim financial statements and notes, as well as Management’s Discussion and Analysis (“MD&A”) for the three and nine months ended September 30, 2023 will be available at “www.sedar.com” and our website at “www.inplayoil.com“.
Third Quarter 2023 Financial & Operating Highlights
Realized average quarterly production of 9,003 boe/d(1) (57% light crude oil and NGLs), a 6% increase compared to 8,474 boe/d (57% light crude oil and NGLs) in the second quarter of 2023 despite extended curtailments and unplanned downtime experienced in the quarter of approximately 550 boe/d.
Generated strong quarterly adjusted funds flow (“AFF”)(2) of $25.2 million ($0.28 per basic share(3)), an increase of 16% from the second quarter of 2023.
Returned $4.0 million ($12.0 million in the first nine months of 2023) directly to shareholders through our monthly base dividend.
Increased revenues by 17% to $46.7 million compared to $39.8 million in the second quarter of 2023.
Improved field operating netbacks(3) by 8% compared to the second quarter of 2023.
Achieved net income of $7.5 million ($0.08 per basic share; $0.08 per diluted share). InPlay has now returned to a retained earnings position on the balance sheet demonstrating that the Company has generated positive earnings since inception (net of dividends paid).
Invested $27.5 million to drill, complete and equip three (2.9 net) Extended Reach Horizontal (“ERH”) wells in Willesden Green, three (3.0 net) ERH wells in Pembina and one (0.35 net) non-operated ERH well in Willesden Green.
Fourth Quarter Operational Update:
Drilled and completed two (1.6 net) ERH wells in Willesden Green which were recently put on production.
The three (3.0 net) Pembina ERH wells brought on production shortly before start of the quarter are producing at strong rates of approximately 260 boe/d(1) (87% light crude oil and NGLs) per well.
Brought online our second natural gas facility upgrade at Leafland, which has increased operated facility capacity by 66% while improving our liquids yield by 40%. Production benefits are already being realized through reduced back pressure on wells, lower declines and providing more consistent runtimes.
Current production is 9,700 boe/d(1) (60% light crude oil and NGLs) based on field estimates., excluding the impact of the two (1.6 net) ERH wells in Willesden Green showing strong flowback rates in the early clean up stage.
Third Quarter 2023 Financial & Operations Overview:
The third quarter of 2023 was a capital intensive quarter for the Company. InPlay invested $27.5 million drilling, completing and equipping three (2.9 net) ERH wells in Willesden Green and three (3.0 net) ERH wells in Pembina. The Company also participated in one (0.35 net) non-operated ERH well in Willesden Green not previously budgeted.
In addition to the upgrade of a natural gas facility in the second quarter, the Company completed a second material upgrade of a gas facility during the third quarter which was brought back on-line in early October. This project modernized existing infrastructure in the Leafland area of Willesden Green and has resulted in an approximate 66% increase to the natural gas processing capability of this facility. The addition of a refrigeration plant to this facility has also improved NGL recoveries by approximately 40%. This additional capacity has lowered field pressures in the area which is expected to improve production and reduce declines on existing wells and future drilling locations. This upgrade is expected to accommodate future development in Leafland and provide more consistent and reliable processing capacity within the Company’s operational control.
The Company has been focused on a high oil weighted drilling program. Three (2.9 net) Willesden Green ERH wells came on production in August into high pressure pipeline systems with average initial production (“IP”) rates per well of 203 boe/d(1) (94% light crude oil and NGLs) over their first 30 days and 215 boe/d(1) (93% light crude oil and NGLs) over their first 60 days. The impact of our facility improvements has enabled these wells to have multiple weeks of flat to improving production rates and after two months they continue to produce at an average rate of approximately 280 boe/d(1) (87% light crude oil and NGLs) per well. The production witnessed from the most recent six wells drilled in Willesden Green have recently benefitted from reduced field pressures and consistent facility runtimes resulting from our operated natural gas facility expansions.
In addition, three (3.0 net) Pembina ERH wells came on production at the end of September with average initial production (“IP”) rates per well of 227 boe/d(1) (88% light crude oil and NGLs) over their first 30 days. These wells have also continued to clean up after completions and are currently producing approximately 260 boe/d(1) (87% light crude oil and NGLs) per well.
Production for the three months ended September 30, 2023 averaged 9,003 boe/d(1) (57% light crude oil and NGLs), 6% higher compared to the three months ended June 30, 2023. Third quarter production was impacted by approximately 550 boe/d (52% light crude oil and NGLs) primarily due to the continuation of multiple third-party natural gas takeaway constraints on our operations and the commissioning of our expanded gas facility that slightly exceeded the anticipated startup timeline. The continued third-party facility outages forced the redirection of associated natural gas to less favorable third-party facilities impacting production through increased back pressure on producing wells as well as higher operating costs.
InPlay generated AFF(2) of $25.2 million ($0.28 per basic share) an increase of 16% from the second quarter of 2023. The Company achieved net income of $7.5 million ($0.08 per basic share; $0.08 per diluted share) and has returned to a retained earnings position on the balance sheet. This is evidence of the long-term sustainability of the Company as positive earnings have been generated since inception (net of dividends paid).
Outlook and Operations Update(5)
The majority of InPlay’s capital program for the year has been completed. The Company’s drilling program for the fourth quarter is underway with two (1.6 net) ERH wells in Willesden Green having been drilled to date. These two wells have been completed and are in the early stages of production. In addition, a 1.0 net Belly River well is now planned to be drilled in the fourth quarter and anticipated to come online in December with its first full month of production expected to commence in January 2024. This well replaces a previously planned one (0.8 net) Willesden Green well.
The investments made in increasing natural gas takeaway capacity through the two facility upgrades in Willesden Green will be important in alleviating potential production issues from third party facility outages going forward. These upgrades have increased our natural gas processing and takeaway capacity in Leafland from approximately 8,400 mcf/d to 17,300 mcf/d. These projects have already shown their importance by reducing back pressure on wells, lowering declines and providing more consistent runtimes, and the reduction in field pressures has the added benefit of improving our liquids weighting. Current production is approximately 9,700 boe/d(1) (60% light crude oil and NGLs) based on field estimates, excluding the impact of two (1.6 net) ERH wells in Willesden Green which are in early stage cleanup and with only four days of production are showing strong flowback rates.
As a result, the fourth quarter is forecasted to be our highest production quarter of the year and given the strong crude oil pricing environment and weak Canadian dollar, the fourth quarter is also projected to be our highest AFF quarter for the year. As the majority of the 2023 capital program was completed by the end of the third quarter, significant free adjusted funds flow (“FAFF”)(3) is expected to be generated in the fourth quarter resulting in a sizeable reduction to net debt prior to year-end.
The Company’s updated 2023 drilling program will be more active than previously planned by approximately 0.6 net wells consisting of 21 (17.1 net) horizontal wells. The changes include an additional one (0.35 net) non-op ERH Willesden Green well and a 1.0 net Belly River well instead of a previously planned one (0.8 net) Willesden Green well. As a result, InPlay has revised its 2023 development capital expenditure guidance to approximately $83 million(5). The timing of the Belly River well will not materially add to 2023 production but will pave the way for potentially an increased Belly River program in 2024 given the high oil weighting and high netback nature of this play. This area is defined by high light-oil weightings that receive a premium to the Mixed Sweet Blend (“MSW”), our pricing benchmark. Our two recent horizontal wells drilled in the area came online in November 2022 and have had operating netbacks of approximately $71.25/boe since being brought on production, and light oil and liquids weightings of approximately 94% to date. These wells have had very low decline rates over this period with average IP rates per well of 98 boe/d (97% light crude oil and NGLs) and 115 boe/d (92% light crude oil and NGLs) over their first 90 and 335 days respectively.
The Company remains committed to providing strong returns to shareholders. Our monthly base dividend of $0.015/share represents approximately a 7% yield at the current share price. To date, the Company has returned $16 million to shareholders through dividends since our inaugural dividend was declared in November 2022, representing approximately 7% of our current market capitalization while maintaining a strong financial position. The generation of shareholder returns through significant FAFF, top-tier production per share growth while maintaining low leverage all remain top priorities of InPlay.
InPlay would like to thank our staff, contractors, and suppliers for their continued dedication and execution, and thank the Board of Directors and shareholders for their continued guidance and support. We look forward to releasing our 2024 capital budget and associated guidance in January.
For further information please contact:
Doug Bartole President and Chief Executive Officer InPlay Oil Corp. Telephone: (587) 955-0632
See “Production Breakdown by Product Type” at the end of this press release.
2.
Capital management measure. See “Non-GAAP and Other Financial Measures” contained within this press release.
3.
Non-GAAP financial measure or ratio that does not have a standardized meaning under International Financial Reporting Standards (IFRS) and GAAP and therefore may not be comparable with the calculations of similar measures for other companies. Please refer to “Non-GAAP and Other Financial Measures” contained within this press release.
4.
Supplementary financial measure. See “Non-GAAP and Other Financial Measures” contained within this press release.
5.
See “Reader Advisories – Forward Looking Information and Statements” for key budget and underlying assumptions related to our previous and updated 2023 capital program and associated guidance.
Reader Advisories
Non-GAAP and Other Financial Measures
Throughout this press release and other materials disclosed by the Company, InPlay uses certain measures to analyze financial performance, financial position and cash flow. These non-GAAP and other financial measures do not have any standardized meaning prescribed under GAAP and therefore may not be comparable to similar measures presented by other entities. The non-GAAP and other financial measures should not be considered alternatives to, or more meaningful than, financial measures that are determined in accordance with GAAP as indicators of the Company performance. Management believes that the presentation of these non-GAAP and other financial measures provides useful information to shareholders and investors in understanding and evaluating the Company’s ongoing operating performance, and the measures provide increased transparency and the ability to better analyze InPlay’s business performance against prior periods on a comparable basis.
Non-GAAP Financial Measures and Ratios
Included in this document are references to the terms “free adjusted funds flow”, “operating income”, “operating netback per boe”, “operating income profit margin”, “Net Debt to EBITDA”, “Net Corporate Acquisitions”, “Debt adjusted production per share” and “EV / DAAFF”. Management believes these measures and ratios are helpful supplementary measures of financial and operating performance and provide users with similar, but potentially not comparable, information that is commonly used by other oil and natural gas companies. These terms do not have any standardized meaning prescribed by GAAP and should not be considered an alternative to, or more meaningful than “profit (loss) before taxes”, “profit (loss) and comprehensive income (loss)”, “adjusted funds flow”, “capital expenditures”, “corporate acquisitions, net of cash acquired”, “net debt”, “weighted average number of common shares (basic)” or assets and liabilities as determined in accordance with GAAP as a measure of the Company’s performance and financial position.
Free Adjusted Funds Flow
Management considers FAFF an important measure to identify the Company’s ability to improve its financial condition through debt repayment and its ability to provide returns to shareholders. FAFF should not be considered as an alternative to or more meaningful than AFF as determined in accordance with GAAP as an indicator of the Company’s performance. FAFF is calculated by the Company as AFF less exploration and development capital expenditures and property dispositions (acquisitions) and is a measure of the cashflows remaining after capital expenditures before corporate acquisitions that can be used for additional capital activity, corporate acquisitions, repayment of debt or decommissioning expenditures or potentially return of capital to shareholders. Refer to the “Forward Looking Information and Statements” section for a calculation of forecast FAFF.
Operating Income/Operating Netback per boe/Operating Income Profit Margin
InPlay uses “operating income”, “operating netback per boe” and “operating income profit margin” as key performance indicators. Operating income is calculated by the Company as oil and natural gas sales less royalties, operating expenses and transportation expenses and is a measure of the profitability of operations before administrative, share-based compensation, financing and other non-cash items. Management considers operating income an important measure to evaluate its operational performance as it demonstrates its field level profitability. Operating income should not be considered as an alternative to or more meaningful than net income as determined in accordance with GAAP as an indicator of the Company’s performance. Operating netback per boe is calculated by the Company as operating income divided by average production for the respective period. Management considers operating netback per boe an important measure to evaluate its operational performance as it demonstrates its field level profitability per unit of production. Operating income profit margin is calculated by the Company as operating income as a percentage of oil and natural gas sales. Management considers operating income profit margin an important measure to evaluate its operational performance as it demonstrates how efficiently the Company generates field level profits from its sales revenue. Refer below for a calculation of operating income, operating netback per boe and operating income profit margin.
(thousands of dollars)
Three Months Ended September 30
Nine Months Ended September 30
2023
2022
2023
2022
Revenue
46,672
56,985
131,735
180,429
Royalties
(5,387)
(10,607)
(16,178)
(28,017)
Operating expenses
(12,677)
(10,946)
(36,343)
(30,660)
Transportation expenses
(698)
(888)
(2,190)
(2,802)
Operating income
27,910
34,544
77,024
118,950
Sales volume (Mboe)
828.3
873.5
2,411.2
2,438.1
Per boe
Revenue
56.35
65.24
54.63
74.00
Royalties
(6.50)
(12.14)
(6.71)
(11.49)
Operating expenses
(15.31)
(12.53)
(15.07)
(12.58)
Transportation expenses
(0.85)
(1.02)
(0.90)
(1.15)
Operating netback per boe
33.69
39.55
31.95
48.78
Operating income profit margin
60 %
61 %
58 %
66 %
Net Debt to EBITDA
Management considers Net Debt to EBITDA an important measure as it is a key metric to identify the Company’s ability to fund financing expenses, net debt reductions and other obligations. EBITDA is calculated by the Company as adjusted funds flow before interest expense. When this measure is presented quarterly, EBITDA is annualized by multiplying by four. When this measure is presented on a trailing twelve month basis, EBITDA for the twelve months preceding the net debt date is used in the calculation. This measure is consistent with the EBITDA formula prescribed under the Company’s Senior Credit Facility. Net Debt to EBITDA is calculated as Net Debt divided by EBITDA. Refer to the “Forward Looking Information and Statements” section for a calculation of forecast Net Debt to EBITDA.
Net Corporate Acquisitions
Management considers Net corporate acquisitions an important measure as it is a key metric to evaluate the corporate acquisition in comparison to other transactions using the negotiated consideration value and ignoring changes to the fair value of the share consideration between the signing of the definitive agreement and the closing of the transaction. Net corporate acquisitions should not be considered as an alternative to or more meaningful than “Corporate acquisitions, net of cash acquired” as determined in accordance with GAAP as an indicator of the Company’s performance. Net corporate acquisitions is calculated as total consideration with share consideration adjusted to the value negotiated with the counterparty, less working capital balances assumed on the corporate acquisition. Refer below for a calculation of Net corporate acquisitions and reconciliation to the nearest GAAP measure, “Corporate acquisitions, net of cash acquired”.
(thousands of dollars)
Three Months Ended September 30
Nine Months Ended September 30
2023
2022
2023
2022
Corporate acquisitions, net of cash acquired
–
89
–
501
Share consideration
–
–
–
–
Non-cash working capital acquired
–
–
–
–
Derivative contracts
–
–
–
–
Net Corporate acquisitions
–
89
–
501(1)
(1) During the nine months ended September 30, 2022, the acquired amount of Property, plant and equipment was adjusted by $0.5 million as a result of adjustments relating to the acquisition of Prairie Storm, with a corresponding increase in the recognized amounts of Accounts payable and accrued liabilities.
Production per Debt Adjusted Share
InPlay uses “Production per debt adjusted share” as a key performance indicator. Debt adjusted shares should not be considered as an alternative to or more meaningful than common shares as determined in accordance with GAAP as an indicator of the Company’s performance. Debt adjusted shares is a non-GAAP measure used in the calculation of Production per debt adjusted share and is calculated by the Company as common shares outstanding plus the change in net debt divided by the Company’s current trading price on the TSX, converting net debt to equity. Debt adjusted shares should not be considered as an alternative to or more meaningful than weighted average number of common shares (basic) as determined in accordance with GAAP as an indicator of the Company’s performance. Management considers Debt adjusted share to be a key performance indicator as it adjusts for the effects of capital structure in relation to the Company’s peers. Production per debt adjusted share is calculated by the Company as production divided by debt adjusted shares. Management considers Production per debt adjusted share is a key performance indicator as it adjusts for the effects of changes in annual production in relation to the Company’s capital structure. Refer to the “Forward Looking Information and Statements” section for a calculation of forecast Production per debt adjusted share.
EV / DAAFF
InPlay uses “enterprise value to debt adjusted AFF” or “EV/DAAFF” as a key performance indicator. EV/DAAFF is calculated by the Company as enterprise value divided by debt adjusted AFF for the relevant period. Debt adjusted AFF (“DAAFF”) is calculated by the Company as adjusted funds flow plus financing costs. Enterprise value is a capital management measure that is used in the calculation of EV/DAAFF. Enterprise value is calculated as the Company’s market capitalization plus working capital (net debt). Management considers enterprise value a key performance indicator as it identifies the total capital structure of the Company. Management considers EV/DAAFF a key performance indicator as it is a key metric used to evaluate the sustainability of the Company relative to other companies while incorporating the impact of differing capital structures. Refer to the “Forward Looking Information and Statements” section for a calculation of forecast EV/DAAFF.
Capital Management Measures
Adjusted Funds Flow
Management considers adjusted funds flow to be an important measure of InPlay’s ability to generate the funds necessary to finance capital expenditures. Adjusted funds flow is a GAAP measure and is disclosed in the notes to the Company’s financial statements for the three months ended March 31, 2023. All references to adjusted funds flow throughout this MD&A are calculated as funds flow adjusting for decommissioning expenditures and transaction and integration costs. Decommissioning expenditures are adjusted from funds flow as they are incurred on a discretionary and irregular basis and are primarily incurred on previous operating assets. Transaction costs are non-recurring costs for the purposes of an acquisition, making the exclusion of these items relevant in Management’s view to the reader in the evaluation of InPlay’s operating performance. The Company also presents adjusted funds flow per share whereby per share amounts are calculated using weighted average shares outstanding consistent with the calculation of profit per common share.
Net Debt / Working Capital
Net debt / working capital is a GAAP measure and is disclosed in the notes to the Company’s financial statements for three months ended March 31, 2023. The Company closely monitors its capital structure with the goal of maintaining a strong balance sheet to fund the future growth of the Company. The Company monitors net debt / working capital as part of its capital structure. The Company uses net debt / working capital (bank debt plus accounts payable and accrued liabilities less accounts receivables and accrued receivables, prepaid expenses and deposits and inventory) as an alternative measure of outstanding debt. Management considers net debt / working capital an important measure to assist in assessing the liquidity of the Company.
Supplementary Measures
“Average realized crude oil price” is comprised of crude oil commodity sales from production, as determined in accordance with IFRS, divided by the Company’s crude oil production. Average prices are before deduction of transportation costs and do not include gains and losses on financial instruments.
“Average realized NGL price” is comprised of NGL commodity sales from production, as determined in accordance with IFRS, divided by the Company’s NGL production. Average prices are before deduction of transportation costs and do not include gains and losses on financial instruments.
“Average realized natural gas price” is comprised of natural gas commodity sales from production, as determined in accordance with IFRS, divided by the Company’s natural gas production. Average prices are before deduction of transportation costs and do not include gains and losses on financial instruments.
“Average realized commodity price” is comprised of commodity sales from production, as determined in accordance with IFRS, divided by the Company’s production. Average prices are before deduction of transportation costs and do not include gains and losses on financial instruments.
“Adjusted funds flow per weighted average basic share” is comprised of adjusted funds flow divided by the basic weighted average common shares.
“Adjusted funds flow per weighted average diluted share” is comprised of adjusted funds flow divided by the diluted weighted average common shares.
“Adjusted funds flow per boe” is comprised of adjusted funds flow divided by total production.
Forward-Looking Information and Statements
This news release contains certain forward–looking information and statements within the meaning of applicable securities laws. The use of any of the words “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “project”, “should”, “believe”, “plans”, “intends”, “forecast” and similar expressions are intended to identify forward-looking information or statements. In particular, but without limiting the foregoing, this news release contains forward-looking information and statements pertaining to the following: the Company’s business strategy, milestones and objectives; the Company’s planned 2023 capital program including wells to be drilled and completed and the timing of the same; the expectation that our Leafland gas facility upgrade will accommodate full development, provide consistent and reliable processing capacity, improve production on existing wells and future drilling locations and reduce production declines; accommodate full development in Leafland and provide consistent and reliable processing capacity within the Company’s operational control; 2023 guidance based on the planned capital program and all associated underlying assumptions set forth in this press release including, without limitation, forecasts of 2023 annual average production levels, debt adjusted production levels, adjusted funds flow, free adjusted funds flow, Net Debt/EBITDA ratio, operating income profit margin, and Management’s belief that the Company can grow some or all of these attributes and specified measures; light crude oil and NGLs weighting estimates; that the fourth quarter is forecasted to be our highest production and AFF quarter of the year with significant FAFF generated resulting in a sizeable reduction to net debt and a material reduction to our leverage metrics; expectations regarding future commodity prices; future oil and natural gas prices; future liquidity and financial capacity; future results from operations and operating metrics; future costs, expenses and royalty rates; future interest costs; the exchange rate between the $US and $Cdn; future development, exploration, acquisition, development and infrastructure activities and related capital expenditures, including our planned 2023 capital program; the amount and timing of capital projects; forecasted spending on decommissioning; expectations regarding third party processing constraints and maintenance shut ins and the timing and impact of the same; that the Company has the financial capability to deliver consistent return to shareholders and the dividend is supportable at a $55 WTI pricing environment until 2025; the potential for an increased Belly River program in 2024; the timing of the release of the Company’s 2024 capital budget and associated guidance; and methods of funding our capital program.
Without limitation of the foregoing, readers are cautioned that the Company’s future dividend payments to shareholders of the Company, if any, and the level thereof will be subject to the discretion of the Board of Directors of InPlay. The Company’s dividend policy and funds available for the payment of dividends, if any, from time to time, is dependent upon, among other things, levels of FAFF, leverage ratios, financial requirements for the Company’s operations and execution of its growth strategy, fluctuations in commodity prices and working capital, the timing and amount of capital expenditures, credit facility availability and limitations on distributions existing thereunder, and other factors beyond the Company’s control. Further, the ability of the Company to pay dividends will be subject to applicable laws, including satisfaction of solvency tests under the Business Corporations Act (Alberta), and satisfaction of certain applicable contractual restrictions contained in the agreements governing the Company’s outstanding indebtedness.
Forward-looking statements or information are based on a number of material factors, expectations or assumptions of InPlay which have been used to develop such statements and information but which may prove to be incorrect. Although InPlay believes that the expectations reflected in such forward-looking statements or information are reasonable, undue reliance should not be placed on forward-looking statements because InPlay can give no assurance that such expectations will prove to be correct. In addition to other factors and assumptions which may be identified herein, assumptions have been made regarding, among other things: the impact of increasing competition; the general stability of the economic and political environment in which InPlay operates; the timely receipt of any required regulatory approvals; the ability of InPlay to obtain qualified staff, equipment and services in a timely and cost efficient manner; drilling results; the ability of the operator of the projects in which InPlay has an interest in to operate the field in a safe, efficient and effective manner; the ability of InPlay to obtain debt financing on acceptable terms; the anticipated tax treatment of the monthly base dividend; field production rates and decline rates; the ability to replace and expand oil and natural gas reserves through acquisition, development and exploration; the timing and cost of pipeline, storage and facility construction and the ability of InPlay to secure adequate product transportation; future commodity prices; that various conditions to a shareholder return strategy can be satisfied; the ongoing impact of the Russia/Ukraine conflict and war in the Middle East; currency, exchange and interest rates; regulatory framework regarding royalties, taxes and environmental matters in the jurisdictions in which InPlay operates; and the ability of InPlay to successfully market its oil and natural gas products.
The forward-looking information and statements included herein are not guarantees of future performance and should not be unduly relied upon. Such information and statements, including the assumptions made in respect thereof, involve known and unknown risks, uncertainties and other factors that may cause actual results or events to defer materially from those anticipated in such forward-looking information or statements including, without limitation: the continuing impact of the Russia/Ukraine conflict and war in the Middle East; inflation and the risk of a global recession; changes in our planned 2023 capital program; changes in our long range plan; changes in our approach to shareholder returns; changes in commodity prices and other assumptions outlined herein; the risk that dividend payments may be reduced, suspended or cancelled; the potential for variation in the quality of the reservoirs in which we operate; changes in the demand for or supply of our products; unanticipated operating results or production declines; changes in tax or environmental laws, royalty rates or other regulatory matters; changes in development plans or strategies of InPlay or by third party operators of our properties; changes in our credit structure, increased debt levels or debt service requirements; inaccurate estimation of our light crude oil and natural gas reserve and resource volumes; limited, unfavorable or a lack of access to capital markets; increased costs; a lack of adequate insurance coverage; the impact of competitors; and certain other risks detailed from time-to-time in InPlay’s continuous disclosure documents filed on SEDAR including our Annual Information Form and our MD&A.
This press release contains future-oriented financial information and financial outlook information (collectively, “FOFI”) about InPlay’s financial and leverage targets and objectives, InPlay’s long-term forecast, and potential dividends, all of which are subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraphs. The actual results of operations of InPlay and the resulting financial results will likely vary from the amounts set forth in this press release and such variation may be material. InPlay and its management believe that the FOFI has been prepared on a reasonable basis, reflecting management’s reasonable estimates and judgments. However, because this information is subjective and subject to numerous risks, it should not be relied on as necessarily indicative of future results. Except as required by applicable securities laws, InPlay undertakes no obligation to update such FOFI. FOFI contained in this press release was made as of the date of this press release and was provided for the purpose of providing further information about InPlay’s anticipated future business operations and strategy. Readers are cautioned that the FOFI contained in this press release should not be used for purposes other than for which it is disclosed herein.
The internal projections, expectations, or beliefs underlying our Board approved 2023 capital budget and associated guidance, as well as management’s preliminary estimates and targets in respect of plans for 2024 and beyond (which are not based on Board approved budgets at this time), are subject to change in light of, among other factors, the impact of world events including the Russia/Ukraine conflict, ongoing results, prevailing economic circumstances, volatile commodity prices, and industry conditions and regulations. InPlay’s financial outlook and guidance provides shareholders with relevant information on management’s expectations for results of operations, excluding any potential acquisitions or dispositions, for such time periods based upon the key assumptions outlined herein. In this document reference is made to the Company’s longer range 2024 and beyond internal plan and associated economic model. Such information reflects internal estimates and targets used by management for the purposes of making capital investment decisions and for internal long-range planning and budget preparation. Readers are cautioned that events or circumstances could cause capital plans and associated results to differ materially from those predicted and InPlay’s guidance for 2023, and more particularly 2024 and beyond, may not be appropriate for other purposes. Accordingly, undue reliance should not be placed on same.
The forward-looking information and statements contained in this news release speak only as of the date hereof and InPlay does not assume any obligation to publicly update or revise any of the included forward-looking statements or information, whether as a result of new information, future events or otherwise, except as may be required by applicable securities laws.
Risk Factors to FLI
Risk factors that could materially impact successful execution and actual results of the Company’s 2023 capital program and associated guidance and long-term preliminary plans and estimates include:
volatility of petroleum and natural gas prices and inherent difficulty in the accuracy of predictions related thereto;
the extent of any unfavourable impacts of wildfires in the province of Alberta.
changes in Federal and Provincial regulations;
the Company’s ability to secure financing for the Board approved 2023 capital program and longer-term capital plans sourced from AFF, bank or other debt instruments, asset sales, equity issuance, infrastructure financing or some combination thereof; and
those additional risk factors set forth in the Company’s MD&A and most recent Annual Information Form filed on SEDAR
Key Budget and Underlying Material Assumptions to FLI
The Company’s 2023 guidance remains the same as previously released August 14, 2023, with updated capital expenditures to $83 million. The 2023 guidance calculations which are impacted by this change are outlined below.
Actuals FY 2022
Updated Guidance FY 2023
Previous Guidance FY 2023(1)
Adjusted Funds Flow
$ millions
$131
$103 – $108
$103 – $108
Capital Expenditures
$ millions
$77.6
$83
$75 – $80
Free Adjusted Funds Flow
$ millions
$53
$20 – $25
$23 – $33
Actuals FY 2022
Updated Guidance FY 2023
Previous Guidance FY 2023(1)
Adjusted Funds Flow
$ millions
$131
$103 – $108
$103 – $108
Interest
$/boe
1.49
1.00 – 1.50
1.00 – 1.50
EBITDA
$ millions
$136
$108 – $113
$108 – $113
Working Capital (Net Debt)
$ millions
($33)
($35) – ($30)
($31) – ($27)
Net Debt/EBITDA
0.2
0.2 – 0.3
0.2 – 0.3
Actuals FY 2022
Updated Guidance FY 2023
Previous Guidance FY 2023(1)
Production
Boe/d
9,105
9,100 – 9,500
9,100 – 9,500
Opening Working Cap. (Net Debt)
$ millions
($80.2)
($33)
($33)
Ending Working Cap. (Net Debt)
$ millions
($33)
($35) – ($30)
($31) – ($27)
Weighted avg. outstanding shares
# millions
86.9
88.7
88.7
Assumed Share price
$
3.39(4)
2.75
2.75
Prod. per debt adj. share growth(3)
51 %
(3%) – 3%
0% – 5%
Actuals FY 2022
Updated Guidance FY 2023
Previous Guidance FY 2023(1)
Share outstanding, end of year
# millions
87.0
89.4
89.4
Assumed Share price
$
3.03(5)
2.75
2.75
Market capitalization
$ millions
$263
$246
$246
Working Capital (Net Debt)
$ millions
($33)
($35) – ($30)
($31) – ($27)
Enterprise value
$millions
$296
$276 – $281
$273 – $277
Adjusted Funds Flow
$ millions
$131
$103 – $108
$103 – $108
Interest
$/boe
1.49
1.00 – 1.50
1.00 – 1.50
Debt Adjusted AFF
$ millions
$136
$108 – $113
$108 – $113
EV/DAAFF
2.2
2.7 – 2.5
2.6 – 2.4
The Company’s 2024 and 2025 preliminary plans remains the same as previously released January 18, 2023, with net debt (working capital) updated to reflect the updated forecast 2023 ending net debt. The 2024 and 2025 preliminary plan guidance calculations which are impacted by this change are outlined below.
Updated Preliminary Plan FY 2024(6)
Updated Preliminary Plan FY 2025(6)
Previous Preliminary Plan FY 2024(2)(6)
Previous Preliminary Plan FY 2025(2)(6)
Adjusted Funds Flow
$ millions
$138 – $150
$144 – $154
$138 – $150
$144 – $154
Interest
$/boe
0.00 – 0.10
0.00 – 0.10
0.00 – 0.10
0.00 – 0.10
EBITDA
$ millions
$138 – $150
$144 – $154
$138 – $150
$144 – $154
Working Capital (Net Debt)
$ millions
$2 – $14
$45 – $56
$5 – $17
$48 – $59
Net Debt/EBITDA
(0.0) – (0.1)
(0.3) – (0.4)
(0.0) – (0.2)
(0.3) – (0.5)
Updated Preliminary Plan FY 2024(6)
Updated Preliminary Plan FY 2025(6)
Previous Preliminary Plan FY 2024(2)(6)
Previous Preliminary Plan FY 2025(2)(6)
Production
Boe/d
10,250 – 11,250
10,950 – 11,950
10,250 – 11,250
10,950 – 11,950
Opening Working Cap. (Net Debt)
$ millions
($35) – ($30)
$2 – $14
($31) – ($27)
$5 – $17
Ending Working Cap. (Net Debt)
$ millions
$2 – $14
$45 – $56
$5 – $17
$48 – $59
Weighted avg. outstanding shares
# millions
89.1
89.1
89.1
89.1
Assumed Share price
$
2.75
2.75
2.75
2.75
Prod. per debt adj. share growth(3)
28% – 48%
21% – 39%
28% – 48%
21% – 39%
Updated Preliminary Plan FY 2024(6)
Updated Preliminary Plan FY 2025(6)
Previous Preliminary Plan FY 2024(2)(6)
Previous Preliminary Plan FY 2025(2)(6)
Share outstanding, end of year
# millions
89.4
89.4
89.4
89.4
Assumed Share price
$
2.75
2.75
2.75
2.75
Market capitalization
$ millions
$246
$246
$246
$246
Working Capital (Net Debt)
$ millions
$2 – $14
$45 – $56
$5 – $17
$48 – $59
Enterprise value
$millions
$232 – $244
$190 – $201
$229 – $241
$187 – $198
Adjusted Funds Flow
$ millions
$138 – $150
$144 – $154
$138 – $150
$144 – $154
Interest
$/boe
0.00 – 0.10
0.00 – 0.10
0.00 – 0.10
0.00 – 0.10
Debt Adjusted AFF
$ millions
$138 – $150
$144 – $154
$138 – $150
$144 – $154
EV/DAAFF
1.8 – 1.5
1.4 – 1.2
1.8 – 1.5
1.4 – 1.2
(1)
As previously released August 14, 2023.
(2)
As previously released January 18, 2023.
(3)
Production per debt adjusted share is calculated by the Company as production divided by debt adjusted shares. Debt adjusted shares is calculated by the Company as common shares outstanding plus the change in working capital (net debt) divided by the Company’s current trading price on the TSX, converting working capital (net debt) to equity. Future share prices are assumed to be consistent with the current share price.
(4)
Weighted average share price throughout 2022.
(5)
Ending share price at December 31, 2022.
(6)
InPlay’s estimates and plans for 2024 and beyond remain preliminary in nature and do not, at this time, reflect a Board approved capital expenditure budget.
See “Production Breakdown by Product Type” below
Quality and pipeline transmission adjustments may impact realized oil prices in addition to the MSW Differential provided above
Changes in working capital (net debt) are not assumed to have a material impact between the years presented above.
Test Results and Initial Production Rates
Test results and initial production (“IP”) rates disclosed herein, particularly those short in duration, may not necessarily be indicative of long-term performance or of ultimate recovery. A pressure transient analysis or well-test interpretation has not been carried out and thus certain of the test results provided herein should be considered to be preliminary until such analysis or interpretation has been completed.
Production Breakdown by Product Type
Disclosure of production on a per boe basis in this press release consists of the constituent product types as defined in NI 51–101 and their respective quantities disclosed in the table below:
Light and Medium Crude oil(bbls/d)
NGLs(boe/d)
Conventional Natural gas(Mcf/d)
Total(boe/d)
Q1 2022 Average Production
3,571
1,307
20,054
8,221
Q2 2022 Average Production
3,865
1,333
23,191
9,063
Q3 2022 Average Production
3,717
1,432
26,075
9,495
2022 Average Production
3,766
1,402
23,623
9,105
Q1 2023 Average Production
3,788
1,458
22,648
9,020
Q2 2023 Average Production
3,658
1,187
21,772
8,474
Q3 2023 Average Production
3,697
1,420
23,316
9,003
2023 Annual Guidance
4,105
1,332
23,175
9,300(1)
2024 Annual Preliminary Plan
4,655
1,565
27,180
10,750(2)
2025 Annual Preliminary Plan
4,900
1,685
29,190
11,450(2)
Current Production
4,365
1,455
23,280
9,700
Q3 Pembina Wells (per well) – IP30
197
4
156
227
Q3 Pembina Wells (per well) – Current
220
5
210
260
Q3 WG Wells (per well) – IP30
188
3
72
203
Q3 WG Wells (per well) – IP60
196
3
96
215
Q3 WG Wells (per well) – Current
236
8
215
280
Notes:
1.
This reflects the mid-point of the Company’s 2023 production guidance range of 9,100 to 9,500 boe/d.
2.
This reflects the midpoint of the Company’s annual production preliminary estimate range.
3.
With respect to forward–looking production guidance, product type breakdown is based upon management’s expectations based on reasonable assumptions but are subject to variability based on actual well results.
References to crude oil, light oil, NGLs or natural gas production in this press release refer to the light and medium crude oil, natural gas liquids and conventional natural gas product types, respectively, as defined in National Instrument 51-101, Standards of Disclosure for Oil and Gas Activities (“Nl 51-101”).
BOE equivalent Barrel of oil equivalents or BOEs may be misleading, particularly if used in isolation. A BOE conversion ratio of 6 mcf: 1 bbl is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. Given that the value ratio based on the current price of crude oil as compared to natural gas is significantly different than the energy equivalency of 6:1, utilizing a 6:1 conversion basis may be misleading as an indication of value.
BY THE COMTECH EDITORIAL TEAM – NOV 9, 2023 | 3 MIN READ
MELVILLE, N.Y. — November 9, 2023 — Comtech (NASDAQ: CMTL), a global technology leader, announced today, the receipt of a $20.0 million order from the company’s UK-based partners, Spectra Group. The order will allow Spectra Group, the appointed regional distributor of Comtech’s Compact Over-the-Horizon Transportable Terminal (COMET), to service multiple orders already received, and several expected follow-on orders from undisclosed customers in the NATO and European regions.
Comtech’s feature-rich, network agnostic COMET system is designed to be easily integrated with other Department of Defense (DoD) and coalition tactical, mobile, and fixed communications systems to provide resilient, secure beyond-line-of-sight (BLOS) capabilities in some of the world’s most challenging environments. Each Comtech COMET is an end-to-end, rapidly deployable BLOS system that utilizes a single fully integrated Troposcatter hub, which includes the company’s CS67PLUS Troposcatter radio. The CS67PLUS is also embedded across each of Comtech’s next generation Family of Systems (FoS).
“Through this order from Spectra Group, Comtech is helping expand network agnostic, secure, and interoperable BLOS communications capabilities for our NATO and EU regional partners,” said Ken Peterman, President and CEO, Comtech. “As the DoD looks to enhance interoperable communications capabilities for coalition operations, Comtech’s Troposcatter FoS are uniquely designed to bring forward blended BLOS capabilities needed to enhance mission effectiveness and deter near-peer threats in all-domain environments.”
“These multiple customers for whom we’ve placed this order for stock, prove the confidence in Comtech’s COMET Troposcatter system and underline Comtech as being a world leader in this technology,” said Simon Davies, CEO, Spectra Group. “The COMET Troposcatter system provides low latency, high throughput BLOS communications in austere environments in what is a challenging satellite denied environment against a sophisticated enemy with a high electronic warfare capability. I’m delighted to be working with Comtech as their appointed distributor helping them to reach new customers with COMET.”
Comtech’s next generation Troposcatter FoS, which includes the company’s market leading COMET systems, provide military operators and other end users with innovative BLOS capabilities by scattering microwave radio signals off the upper layers of the troposphere. Today, we believe Comtech has the most deployed next generation Troposcatter systems in the world, which will help the DoD and coalition nations move to blended networks that can support Combined Joint All-Domain Command and Control (CJADC2) operations.
In September 2023, Spectra Group announced the receipt of a $8.0 million order from UK MoD to equip 3 (UK) Division with Comtech’s COMET systems. Spectra Group is now close to receiving additional orders for large quantities of Comtech’s COMET systems from other key NATO and European regional customers.
About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.
About Spectra Group (UK) Ltd
Spectra has a proven record of accomplishment – with over 15 years of experience in delivering solutions for governments around the globe; elite militaries; and private enterprises of all sizes. As a dynamic, agile, security accredited organisation, Spectra can leverage this experience to deliver Cyber Advisory and secure Hosted and Managed Solutions on time, to spec and on budget, ensuring compliance with industry standards and best practices. Spectra’s gold-level partnerships with third-party vendors ensure best value and leading edge technology is used. On 23 November 2017, Spectra Group (UK) Ltd announced that it had recently been listed as a Top 100 Government SME Supplier for 2015-2016 by the UK Crown Commercial Services. Spectra Group (US) Inc was established in 2018 to directly support the US market.
Spectra Group were awarded the 5-year contact to be the UK distributor of Troposcatter COMET for US company COMTECH Systems Inc in late 2019. Comtech is a leading global provider of next-generation 911 emergency systems and critical wireless and satellite communication technologies.
Spectra’s CEO, Simon Davies, was awarded 2017 Businessman of the Year by Battlespace magazine.
Spectra was awarded the prestigious Queen’s Award for Enterprise (Innovation) in 2019 for SlingShot. Founded in 2002, the Company is based in Hereford, UK and holds ISO 9001:2015, ISO 27001 and Cyber Essentials Plus accreditation.
Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.
ATLANTA, Nov. 09, 2023 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”) (NASDAQ: BTM), a U.S.-based Bitcoin ATM operator and leading fintech company, today announced its partnership with CORD Financial Services, LLC (CORD), a leading provider of innovative ATM solutions, to distribute Bitcoin Depot kiosks across the U.S.
CORD and Bitcoin Depot will secure Bitcoin ATM placements within CORD’s established base of customers and to customers new to CORD. In addition to now offering Bitcoin ATM services, CORD is a leader in the ATM Services Business, offering full-service ATM placements, cash management, transaction processing, merchant services, ATM equipment, sales, and 24/7 customer and technical support.
“This partnership will allow Bitcoin Depot to expand our retail locations while leveraging CORD’s expertise and customer relationships in the ATM industry,” said Bitcoin Depot CEO Brandon Mintz. “CORD has an impressive history of reliable ATM services and a demonstrated mastery of the conventional ATM space. We look forward to leveraging their relationship network and brand awareness to drive additional placement opportunities for our business.”
“Our mission is to deliver comprehensive ATM business solutions with the highest value and professional integrity,” said CORD Financial President Kenneth Gilbert. “Bitcoin Depot is the ideal partner to advance that objective, and we look forward to bringing a financial technology-driven Bitcoin ATM solution to our customer base.”
The combination of CORD’s robust infrastructure and network positions them as a fitting partner for distributing Bitcoin Depot’s state-of-the-art Bitcoin ATMs to the market, broadening Bitcoin Depot’s mission of bringing Bitcoin to the masses.
About Bitcoin Depot Bitcoin Depot (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to Bitcoin at Bitcoin Depot’s kiosks and at thousands of name-brand retail locations in 48 U.S. states through its BDCheckout product. The Company has the largest market share in North America with approximately 6,400 kiosk locations as of June 30, 2023. Learn more at www.bitcoindepot.com.
About Cord Financial: CORD Financial Services is a leading provider of innovative ATM solutions, products, and services that support merchants with responsive, knowledgeable, and caring people. CORD offers full -service ATM placements, cash management, ATM transaction processing, ATM equipment sales, ATM parts, and outstanding 24/7 customer and technical support.
Contacts:
Investors Cody Slach, Alex Kovtun Gateway Group, Inc. 949-574-3860 BTM@gateway-grp.com
Media Zach Kadletz, Brenlyn Motlagh, Ryan Deloney Gateway Group, Inc. 949-574-3860 BTM@gateway-grp.com
