CHATHAM, N.J., Nov. 09, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced a poster presentation by an academic collaborator at Neuroscience 2022 by the Society for Neuroscience being held November 12-16, 2022, at the San Diego Convention Center in San Diego, Calif.
Poster Presentation Details:
Title:
In Vitro Impact of Oxytocin on Human Sensory Neurons
Session:
Poster Session I
Date:
November 14, 2022
Time:
1:00 p.m. – 2:00 p.m. PT
Authors:
David C. Yeomans, Ph.D., Associate Professor, Anesthesiology, Perioperative and Pain Medicine, Stanford University and David Hsu, Ph.D., Senior Scientist, Tonix Pharmaceuticals
Presenter:
David C. Yeomans, Ph.D., Associate Professor, Anesthesiology, Perioperative and Pain Medicine, Stanford University
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. 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 first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease 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 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 and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
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; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, 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.
MELVILLE, N.Y.–(BUSINESS WIRE)–Nov. 8, 2022– November 8, 2022 – Comtech (NASDAQ: CMTL) today announced that it will participate in the 14th annual Southwest IDEAS Investor Conference on Wednesday, November 16, 2022, at the Westin Dallas Downtown in Dallas, TX. The Company’s presentation is scheduled to begin at 8:00AM CT. The presentation will be webcast and may be accessed through the conference host’s main website: www.IDEASconferences.com and in the investor relations section of the Company’s website: http://www.comtech.com.
Comtech management will provide an overview of the Company and its business opportunities. The Company will also conduct one-on-one meetings with investors throughout the day.
About Comtech
Comtech Telecommunications Corp. is a leading global provider of next-generation 911 emergency systems and secure wireless communications technologies to commercial and government customers around the world. Headquartered in Melville, New York and with a passion for customer success, Comtech designs, produces and markets advanced and secure wireless solutions. For more information, please visit www.comtech.com.
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 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.
On July 5, 2022 (“Closing Date”), Vectrus, Inc. (“Vectrus”) completed its merger (“the Merger”) with Vertex Aerospace Services Holding Corp. (“Vertex”), thereby forming V2X, Inc. Third quarter “reported results” reflect the contributions of Vectrus from July 1, 2022, through September 30, 2022 and Vertex from the Closing Date through September 30, 2022, unless otherwise noted. Comparisons to historical periods are relative to legacy Vectrus results, unless otherwise noted.
Third Quarter Highlights:
Solid third quarter revenue of $958.2 million; Pro forma revenue of $961.3 million, +10% y/y
Reported operating income (inclusive of Merger related costs) of $4.5 million; Adjusted operating income1 of $73.6 million
Adjusted EBITDA1 of $79.0 million with an adjusted EBITDA margin1 of 8.2%
Third quarter diluted EPS of ($0.56); Adjusted diluted EPS1 of $1.33
Strong third quarter operating cash flow of $80.1 million; Adjusted operating cash flow1 of $121.2 million
Reduced net debt by $87 million dollars or 7% since the Merger closed on July 5, 2022
Guidance: Raising guidance mid-point for revenue, adjusted EBITDA1, and adjusted operating cash flow1
MCLEAN, Va., Nov. 8, 2022 /PRNewswire/ — V2X, Inc. (NYSE:VVX) announced third quarter 2022 financial results. “I’m pleased to report a strong start for V2X with third quarter results that demonstrate our ability to grow, generate substantial cash flow, and increase value for shareholders,” said Chuck Prow, President and Chief Executive Officer of V2X. “Our adjusted operating cash flow1 of $121 million in the quarter was significant and highlights the robust cash generative nature of our business. Additionally, adjusted EBITDA margin1 was 8.2%, which was driven by our teams’ successful efforts in delivering solid performance that was also ahead of schedule. We also continue to make significant progress on integration milestones and remain on track to deliver our previously communicated cost synergies. Based on our current momentum, significant progress on integration, and third quarter performance, we are increasing the mid-point of our guidance for revenue, adjusted EBITDA1 and adjusted operating cash flow1. I’d like to thank all of our employees for their focus on delivering results and achieving significant progress on integration, while providing high quality uninterrupted service and support to our clients.”
Mr. Prow continued, “We remain excited about the potential opportunities that lie ahead for V2X to lead in the converged environment. The key metrics and leading indicators of our business remain strong. Recent wins have driven our total backlog to $13 billion, which represents over three times V2X’s annualized revenue, providing substantial visibility. Additionally, the company does not currently have any contracts that generate more than two percent of revenue up for recompete for at least the next two and half years. With limited recompetes and solid revenue visibility, V2X is focusing on capturing new opportunities and contract expansion. Our $20 billion combined pipeline of new business currently submitted and / or expected to be submitted over the next twelve months provides additional opportunity to further grow the business. Furthermore, V2X has identified revenue synergies that are incremental to our current pipeline that are currently being assessed for resource allocation and pursuit. In aggregate, we believe V2X is well positioned to create additional value for our stakeholders.”
Third Quarter Results
Third quarter 2022 revenue of $958.2 million; Pro forma revenue of $961.3 million
Operating income of $4.5 million, or 0.5% margin, including Merger and integration related costs of $44.9 million and amortization of acquired intangible assets of $24.2 million
Adjusted operating income1 of $73.6 million or 7.7% adjusted operating margin1
Adjusted EBITDA1 for the quarter of $79.0 million with an 8.2% adjusted EBITDA margin1
Diluted EPS for the third quarter of 2022 of ($0.56) and includes Merger and integration related costs
Adjusted diluted EPS1 of $1.33 in the quarter
Operating cash flow for the quarter of $80.1 million
Adjusted operating cash flow1 for the quarter of $121.2 million (excluding Merger related payments)
Net debt on September 30, 2022, of $1,220.7 million, representing an $87 million decrease from the closing on July 5, 2022
The Company was undrawn on its revolver at quarter end
Total backlog as of September 30, 2022 of $12.7 billion
“Our third quarter financial results were strong and a great start for V2X,” said Susan Lynch, Senior Vice President and Chief Financial Officer. “Pro forma revenue increased 10% year-over-year to $961.3 million. Pro forma revenue takes into consideration the four days of our third quarter where Vertex was not part of V2X. Organic revenue growth was 10% for legacy Vectrus and was driven by continued strong performance on LOGCAP V, growth associated with the Fort Benning Eagle contract award and volume associated with rapid response and contingency efforts in Europe as well as INDOPACOM. Organic revenue from INDOPACOM increased 113% year-over-year, a noteworthy achievement especially given the revenue contribution from the Pacific Defender exercise during the prior year period. Total topline expansion was driven by the Merger with Vertex on July 5, 2022, which includes the ramp of new business including the E-6B, Advanced Helicopter Training System, Navy Test Wing Atlantic, and Global Strike programs.”
Ms. Lynch continued, “Our strong performance coupled with a focus on cash collections and process improvement in the quarter yielded strong results with significant cash generated from operating activities of $80.1 million. Excluding Merger related payments of $41.1 million, adjusted operating cash flow1 in the quarter was $121.2 million. This solid performance resulted in a $87.0 million dollar or 7% reduction in the company’s net debt since the Merger Closing Date, which exemplifies V2X’s ability to generate strong cash flow with low capital requirements. Total consolidated indebtedness to EBITDA1 (total leverage ratio) was 3.7x, a 0.3x improvement from Merger close. Importantly, we have been able to reduce our leverage ahead of plan, which was previously expected to be 3.7x by the end of this year. We anticipate our net debt will show further improvement in Q4 2022.”
Guidance Ms. Lynch concluded, “Given our current momentum, significant progress on integration, and third quarter performance, we are increasing the mid-point of the second half 2022 guidance for revenue, adjusted EBITDA1 and adjusted operating cash flow1.”
Guidance for the second half (2H) 2022 is as follows:
$ millions, except for EBITDA margins and per share amounts
V2X 2H 2022 Guidance (previous)
V2X 2H 2022 Guidance (current)
Revenue
$1,900
to
$1,940
$1,920 to $1,940
Adjusted EBITDA1
$140
to
$150
$145 to $150
Adjusted Diluted Earnings Per Share1
$1.94
to
$2.19
$2.14 to $2.28
Net Cash Provided by Operating Activities Excluding M&A Costs
$130
to
$150
$140 to $150
Forward-looking statements are based upon current expectations and are subject to factors that could cause actual results to differ materially from those suggested here, including those factors set forth in the Safe Harbor Statement below.
Third Quarter 2022 Conference Call
Management will conduct a conference call with analysts and investors at 4:30 p.m. ET on Tuesday, November 8, 2022. U.S.-based participants may dial in to the conference call at 877-506-6380, while international participants may dial 412-542-4198. A live webcast of the conference call as well as an accompanying slide presentation will be available here: https://app.webinar.net/anKV0d7G8Q9.
A replay of the conference call will be posted on the V2X website shortly after completion of the call and will be available for one year. A telephonic replay will also be available through November 22, 2022, at 844-512-2921 (domestic) or 412-317-6671 (international) with passcode 10171765.
Presentation slides that will be used in conjunction with the conference call will also be made available online in advance at https://investors.vectrus.com/. V2X recognizes its website as a key channel of distribution to reach public investors and as a means of disclosing material non-public information to comply with its obligations under the U.S. Securities and Exchange Commission Regulation FD.
Footnotes: 1 See “Key Performance Indicators and Non-GAAP Financial Measures” for descriptions and reconciliations.
About V2X V2X is a leading provider of critical mission solutions and support to defense clients globally, formed by the 2022 Merger of Vectrus and Vertex to build on more than 120 combined years of successful mission support. The Company delivers a comprehensive suite of integrated solutions across the operations and logistics, aerospace, training and technology markets to national security, defense, civilian and international clients. Our global team of approximately 14,000 employees brings innovation to every point in the mission lifecycle, from preparation, to operations, to sustainment, as it tackles the most complex challenges with agility, grit, and dedication.
Safe Harbor Statement
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 (the “Act”): Certain material presented herein includes forward-looking statements intended to qualify for the safe harbor from liability established by the Act. These forward-looking statements include, but are not limited to, all the statements and items listed under “Guidance” above and other assumptions contained therein for purposes of such guidance, other statements about our 2022 performance outlook, five-year growth plan, revenue, DSO, contract opportunities, the potential impact of COVID-19, and any discussion of future operating or financial performance.
Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” “could,” “potential,” “continue” or similar terminology. These statements are based on the beliefs and assumptions of the management of the Company based on information currently available to management.
These forward-looking statements are not guarantees of future performance, conditions, or results, and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside our management’s control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the Company’s historical experience and our present expectations or projections. For a discussion of some of the risks and uncertainties that could cause actual results to differ from such forward-looking statements, see the risks and other factors detailed from time to time our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the U.S. Securities and Exchange Commission.
We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
GEVO TO HOST CONFERENCE CALL TODAY AT 4:30 P.M. ET
ENGLEWOOD, Colo., Nov. 08, 2022 (GLOBE NEWSWIRE) — Gevo, Inc. (NASDAQ: GEVO) (“Gevo”, the “Company”, “we”, “us” or “our”) today announced financial results for the third quarter of 2022 and recent corporate highlights.
Recent Corporate Highlights
On September 15, 2022, Gevo held a groundbreaking ceremony at the future site of its first commercial-scale sustainable aviation fuel (“SAF”) facility known as Net-Zero 1 (“NZ-1”) to be constructed in Lake Preston, South Dakota.
On September 19, 2022, the U.S. Department of Agriculture (“USDA”) tentatively selected Gevo’s Climate-Smart Farm to Flight proposal for a grant providing up to $30 million.
As part of the oneworld® Alliance, Qatar Airways (“Qatar”) has entered into a new fuel sales agreement with Gevo for 5 million gallons of sustainable aviation fuel (“SAF”) per year over five years with delivery of fuel expected to begin in 2028.
Iberia Airlines also entered into a new fuel sales agreement with Gevo for 6 million gallons of SAF per year over five years with delivery of fuel expected to begin in 2028
Gevo now has more than 375 million gallons per year (“MGPY”) of financeable SAF and hydrocarbon fuel supply agreements, which based on current market projections and operating assumptions, represent approximately $2.3 billion in expected revenue per year, inclusive of the value of environmental benefits.
The Company recently signed an agreement with Summit Carbon Solutions (“Summit”), whereby Summit is expected to safely capture, transport, and permanently store Gevo’s renewable CO2 from its Net-Zero 1 (“NZ-1”) plant in Lake Preston, South Dakota which will further reduce the carbon intensity of the fuel to be produced at NZ-1 and thus increase the expected value of associated environmental benefits.
2022 Third Quarter Financial Highlights
Ended the quarter with cash, cash equivalents, restricted cash and marketable securities of $500.4 million compared to $546.8 million as of the end of Q2 2022 and $475.8 million as of the end of Q4 2021
Revenue of $0.3 million for the quarter is related to initial sales of RNG from Gevo’s RNG project and compares to $0.1 million in Q3 2021
Loss from operations of $(43.7) million for the quarter includes a $24.7 million impairment loss and compares to $(14.7) million in Q3 2021
Non-GAAP cash EBITDA loss1 of $(37.8) million for the quarter compared to $(9.3) million in Q3 2021
GAAP net loss per share and non-GAAP adjusted net loss per share2 of $(0.19) for the quarter includes $(0.10) of impairment loss per share and compares to $(0.07) in Q3 2021
Management Comment
Commenting on the third quarter of 2022 and recent corporate events, Dr. Patrick R. Gruber, Gevo’s Chief Executive Officer, said “We are moving forward on our NZ-1 site in Lake Preston, South Dakota. Temporary roads are being constructed around the location while significant volumes of dirt are being moved in advance of initial foundation work. We are planning to get as much of this preliminary infrastructure done as possible before winter weather in South Dakota limits consistent access to the site. We are excited to be making visible progress on NZ-1 and we will finalize engineering plans as well as the debt financing package for the project over the next few quarters. Once that is complete, the pace of construction activities are expected to increase significantly.”
Net-Zero 1 Status
Following the recent groundbreaking ceremony in Lake Preston, South Dakota, the NZ-1 project is on schedule with initial volumes of SAF expected to be delivered in 2025. NZ-1 is being currently designed to produce approximately 62 million gallons per year (“MGPY”) of total hydrocarbon volumes, including 55 MGPY of SAF, which would fulfill part of Gevo’s more than 375 MGPY of SAF and hydrocarbon supply agreements. Construction activities at NZ-1 in 2022 are for site preparation purposes and will make the location ready for more substantial construction work that is expected to begin in 2023. In an effort to remain on schedule for a 2025 start-up, Gevo will fund initial construction activities from cash reserves. The Company expects to arrange debt and third-party equity financing in 2023 that, when combined with Gevo’s equity contribution, will fully fund NZ-1’s construction and commissioning.
The transition to an ethanol-to-SAF design from Gevo’s original isobutanol-to-SAF and isooctane design continues to yield improved output expectations as pre-project planning has been completed through phase 2 of front-end loading work (“FEL-2”). The results of this work, combined with support from the Clean Fuel Production Credit (“CFPC”) that was included in the Inflation reduction Act that was signed into law in August, have led to a forecasted, base-case Project EBITDA3 for NZ-1 to be approximately $300 million per year, a 50% increase from the prior estimate of $200 million per year. The total installed cost for NZ-1, including the capital required for the alcohol-to-jet fuel plant as well as any site development costs, is currently forecasted to be approximately $850 million, a 33% increase from the prior estimate of $640 million. This increase is primarily due to increased steel, equipment, and supply chain costs related to the inflationary environment.
Progress on Key NZ1 Development Milestones
Through year-end 2022:
Close the purchase of the land for NZ1 in Lake Preston, South Dakota
Execute development agreements for:
Wind energy
Wastewater (design no longer requires)
Green hydrogen
Select engineering, procurement, and construction (“EPC”) contractor
Select fabricator for hydrocarbon plant modules
Substantial Completion of Front End Engineering Design
Break ground and begin site preparation at Lake Preston
Through first-half 2023:
Close the construction financing, including non-recourse debt
Order long lead equipment
Throughout the remainder of 2022 and 2023, Gevo expects to update stockholders about certain key milestones related to the development, financing, and construction of NZ-1 as well as subsequent Net-Zero plants. Updates to those milestones will be found in the Company’s press releases and investor presentations in the Investor Relations section of Gevo’s website.
Third Quarter 2022 Financial Results
Revenue. During the three months ended September 30, 2022, the Company sold 41,791 MMBtu of renewable natural gas (“RNG”) from Gevo’s RNG Project in Northwest Iowa. Revenue increased $0.2 million during the three months ended September 30, 2022, compared to the three months ended September 30, 2021, which consisted of ethanol and hydrocarbons from the Company’s development plant in Luverne, Minnesota (the “Luverne Facility”). In the third quarter of 2022, the Company’s RNG production began ramping up resulting in biogas commodity sales of $0.3 million, while the activities at the Luverne Facility were minimized to care and maintenance, as the Company has shifted focus to its Net Zero projects.
Cost of production. Cost of production decreased $2.1 million during the three months ended September 30, 2022, compared to the three months ended September 30, 2021, primarily due to moving the Luverne Facility to care and maintenance status.
Idle facility costs. The Company incurred $2.3 million of idle facility costs during the three months ended September 30, 2022, due to putting Gevo’s Luverne Facility into care and maintenance status in the third quarter of 2022. Included in idle facility costs are those costs related to removing flammable and other hazardous items from the site, writing off certain patents related to production at the Luverne Facility and costs related to the workforce adjustments. The Company plans to utilize the Luverne Facility to advance the Company’s technology and operational knowledge to help us in achieving operational success as we scale up the production and delivery of SAF for Gevo’s customers through the Company’s Net-Zero Projects.
Depreciation and amortization. Depreciation and amortization in cost of goods sold increased $0.1 million during the three months ended September 30, 2022, compared to the three months ended September 30, 2021, mainly due to placing the RNG Project assets into service in third quarter of 2022.
Research and development expense. Research and development expense was relatively flat for the three months ended September 30, 2022, compared to the three months ended September 30, 2021. These costs are primarily employee and consultant related expenses, along with some patent and lab supply costs.
Selling, general and administrative expense. Selling, general and administrative expense increased $1.9 million during the three months ended September 30, 2022, compared to the three months ended September 30, 2021, primarily due to increases in personnel costs related to strategic hiring and professional fees, as well as non-cash stock-based compensation which reflects higher amortization expense for the stock awards issued in the prior period with higher market value.
Preliminary stage project costs. Preliminary stage project costs are related to the Company’s future Net-Zero Projects and Verity project and consist primarily of employee expenses, preliminary engineering and technical consulting costs. Preliminary stage project costs increased $0.6 million during the three months ended September 30, 2022, compared to the three months ended September 30, 2021, primarily due to increases in personnel costs, consulting and professional fees for the Company’s Net Zero Projects and Verity project.
Other operations. Other operations expense increased $1.3 million during the three months ended September 30, 2022, compared to the three months ended September 30, 2021, primarily due to increases in engineering personnel and other non-capitalizable costs for NZ1.
Impairment loss. The Company recorded a $24.7 million impairment loss on long-lived assets, which reduced the carrying value of certain property, plant, and equipment, and a leased right of use (“ROU”) asset, at the Agri-Energy segment to its fair value. The impairments recorded to date relate to the determination to suspend production at the Luverne Facility and shift the plant into an idled, care and maintenance status during the third quarter of 2022.
Depreciation and amortization expense. Depreciation and amortization expense increased $0.3 million during the three months ended September 30, 2022, compared to the three months ended September 30, 2021, primarily due to the amortization of the Company’s patents.
Loss from operations. Excluding the one-time charge of $24.7 million for impairment, the loss from operations increased by $4.2 million during the three months ended September 30, 2022, compared to the three months ended September 30, 2021, primarily due to the increased activities for the Company’s Net Zero platform and Verity projects, as well as non-capitalizable cost for NZ1.
Interest expense. Interest expense increased $0.6 million during the three months ended September 30, 2022, compared to the three months ended September 30, 2021, primarily due to the interest on the RNG bonds and the imputed interest on the Company’s RNG related dairy leases, both of which were capitalized into construction in process during the construction phase of Gevo’s RNG Project in the previous periods.
Interest and dividend income. Interest and dividend income increased $0.6 million during the three months ended September 30, 2022, compared to the three months ended September 30, 2021, primarily due to the interest earned on the Company’s investments.
Other income (expense). Other income (expense) for the three months ended September 30, 2022, consists primarily of losses on disposal of fixed assets.
During the nine months ended September 30, 2022, net cash used for operating activities was $36.8 million compared to $28.7 million for the nine months ended September 30, 2021. Non-cash charges primarily consisted of an impairment loss of $24.7 million, depreciation and amortization of $4.5 million, non-cash interest expense of $2.8 million related to debt issuance costs, stock-based compensation expense of $12.6 million. The net cash outflow from changes in operating assets and liabilities increased $7.9 million, primarily due to an increase of cash outflows of $4.0 million in prepaid expenses and other current assets due to the payments for licensing fees and deposits to secure long-lead equipment power transmission and distribution facilities for NZ1, partially offset by $4.2 million of decreased cash payments for the RNG Project.
Webcast and Conference Call Information
Hosting today’s conference call at 4:30 p.m. ET will be Dr. Patrick R. Gruber, Chief Executive Officer, L. Lynn Smull, Chief Financial Officer, and John Richardson, Director of Investor Relations. They will review Gevo’s financial results and provide an update on recent corporate highlights.
To participate in the live call, please register through the following event weblink: https://register.vevent.com/register/BIc9b140adb9fa4b89a10bb2deaacbece5. After registering, participants will be provided with a dial-in number and pin.
To listen to the conference call (audio only), please register through the following event weblink: https://edge.media-server.com/mmc/p/pasbrjrz.
A webcast replay will be available two hours after the conference call ends on November 8, 2022. The archived webcast will be available in the Investor Relations section of Gevo’s website at www.gevo.com.
About Gevo
Gevo’s mission is to transform renewable energy and carbon into energy-dense liquid hydrocarbons. These liquid hydrocarbons can be used for drop-in transportation fuels such as gasoline, jet fuel, and diesel fuel, that when burned have potential to yield net-zero greenhouse gas emissions when measured across the full lifecycle of the products. Gevo uses low-carbon renewable resource-based carbohydrates as raw materials, and is in an advanced state of developing renewable electricity and renewable natural gas for use in production processes, resulting in low-carbon fuels with substantially reduced carbon intensity (the level of greenhouse gas emissions compared to standard petroleum fossil-based fuels across their lifecycle). Gevo’s products perform as well or better than traditional fossil-based fuels in infrastructure and engines, but with substantially reduced greenhouse gas emissions. In addition to addressing the problems of fuels, Gevo’s technology also enables certain plastics, such as polyester, to be made with more sustainable ingredients. Gevo’s ability to penetrate the growing low-carbon fuels market depends on the price of oil and the value of abating carbon emissions that would otherwise increase greenhouse gas emissions. Gevo believes that it possesses the technology and know-how to convert various carbohydrate feedstocks through a fermentation process into alcohols and then transform the alcohols into renewable fuels and materials, through a combination of its own technology, know-how, engineering, and licensing of technology and engineering from Axens North America, Inc., which yields the potential to generate project and corporate returns that justify the build-out of a multi-billion-dollar business.
Gevo believes that Argonne National Laboratory GREET model is the best available standard of scientific based measurement for life cycle inventory or LCI.
Learn more at Gevo’s website: www.gevo.com
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to a variety of matters, including, without limitation, whether our fuel sales agreements are financeable, the timing of our Net-Zero 1 project, our financial condition, our results of operation and liquidity, our business development activities, our Net-Zero Projects, financial projections related to our business, our RNG project, our fuel sales agreements, our plans to develop our business, our ability to successfully develop, construct and finance our operations and growth projects, our ability to achieve cash flow from our planned projects, the ability of our products to contribute to lower greenhouse gas emissions, particulate and sulfur pollution, and other statements that are not purely statements of historical fact These forward-looking statements are made based on the current beliefs, expectations and assumptions of the management of Gevo and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Gevo undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Gevo believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Gevo in general, see the risk disclosures in the Annual Report on Form 10-K of Gevo for the year ended December 31, 2021 and in subsequent reports on Forms 10-Q and 8-K and other filings made with the U.S. Securities and Exchange Commission by Gevo.
Non-GAAP Financial Information
This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), including non-GAAP cash EBITDA loss, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share. Non-GAAP cash EBITDA loss excludes depreciation and amortization and non-cash stock-based compensation from GAAP loss from operations. Non-GAAP adjusted net loss and adjusted net loss per share exclude non-cash gains and/or losses recognized in the quarter due to the changes in the fair value of certain of Gevo’s financial instruments, such as warrants, convertible debt and embedded derivatives, from GAAP net loss. Management believes these measures are useful to supplement its GAAP financial statements with this non-GAAP information because management uses such information internally for its operating, budgeting and financial planning purposes. These non-GAAP financial measures also facilitate management’s internal comparisons to Gevo’s historical performance as well as comparisons to the operating results of other companies. In addition, Gevo believes these non-GAAP financial measures are useful to investors because they allow for greater transparency into the indicators used by management as a basis for its financial and operational decision making. Non-GAAP information is not prepared under a comprehensive set of accounting rules and therefore, should only be read in conjunction with financial information reported under U.S. GAAP when understanding Gevo’s operating performance. A reconciliation between GAAP and non-GAAP financial information is provided in the financial statement tables below
1Cash EBITDA loss is a non-GAAP measure calculated by adding back depreciation and amortization and non-cash stock-based compensation to GAAP loss from operations. A reconciliation of cash EBITDA loss to GAAP loss from operations is provided in the financial statement tables following this release. 2Adjusted net loss per share is a non-GAAP measure calculated by adding back non-cash gains and/or losses recognized in the quarter due to the changes in the fair value of certain of our financial instruments, such as warrants, convertible debt and embedded derivatives, to GAAP net loss per share. A reconciliation of adjusted net loss per share to GAAP net loss per share is provided in the financial statement tables following this release. 3Project EBITDA is a non-GAAP financial measure that we define as total operating revenues less total operating expenses for the project.
Gevo, Inc. Condensed Consolidated Balance Sheets Information (Unaudited, in thousands, except share and per share amounts)
Gevo, Inc. Condensed Consolidated Statements of Operations Information (Unaudited, in thousands, except share and per share amounts)
Gevo, Inc. Condensed Consolidated Statements of Comprehensive Income (Unaudited, in thousands, except share and per share amounts)
Gevo, Inc. Condensed Consolidated Statements of Stockholders’ Equity Information (Unaudited, in thousands, except share amounts)
Gevo, Inc. Condensed Consolidated Cash Flow Information (Unaudited, in thousands)
Gevo, Inc. Reconciliation of GAAP to Non-GAAP Financial Information (Unaudited, in thousands, except share and per share amounts)
Report offers unparalleled insights into audience consumption of gaming and esports content, which continues to attract the most difficult demographic for companies to access
Insights highlight unique, untapped media activation opportunities as engagement continues to increase within the industry
NEW YORK, NY / ACCESSWIRE / November 8, 2022 / Video gaming and esports live streaming analytics company, Stream Hatchet, a wholly-owned subsidiary of Engine Gaming and Media, Inc. (GAME) (“Engine” or the “Company”) (NASDAQ:GAME)(TSXV:GAME), today announced that it has published its Video Game Streaming Trends Third Quarter 2022 Report. This essential read provides an in-depth study on the current state of the live streaming and video games industry, offering unparalleled insights into the performance of the industry, as well as top performing creators, games, releases and more. Importantly, these insights highlight the opportunity to tap into an audience increasingly hard to reach for brands.
The Stream Hatchet team works with a consortium of industry-leading analysts and business leaders to understand and report on key trends related to the impact of live streaming audiences on gaming creators, esports and the broader video games industry.
Key findings include:
Viewership is nearly double pre-pandemic levels. Additionally, esports viewership is up 40% year-over-year compared to Q3 2021 last year; the industry has seen consistent growth over the last 4 years.
Facebook Gaming lost meaningful marketing share in Q3 ‘22, dropping from 14% in Q3 ‘21 to 5%. Amazon-owned Twitch continues to increase its market share to 72%, holding a steady command of the streaming landscape, while YouTube Gaming grew modestly to 15%, reclaiming its second largest market share position.
VTubers (Virtual YouTubers), a term to describe virtual avatars that stream content on platforms like YouTube and Twitch, continue to grow in live streaming now representing 50% of the top female streaming creators in Q3. The top 10 VTubers grew an average of 30% in Q3 2022 as compared to Q2 2022.
Gambling live streaming viewership on Twitch hit its peak in Q3 2022. Since, the platform announced a ban on streaming unlicensed gambling sites in the U.S. The ban went into effect in October, and Stream Hatchet will continue to monitor the impact into Q4 2022.
“The collection of this data is extremely valuable as it not only illustrates Stream Hatchet’s ability to provide market leading data across the video game and live-streaming landscape, but also offers marketers, researchers, and analyst actionable insights on how best to reach the 18- to 35-year-old demographic, which continues to be increasingly difficult to reach,” said Eduard Monstserrat, CEO at Stream Hatchet. “As brands strategize on how to connect with this hard-to-reach demographic, they are able to leverage our insights to better understand the top performing streamers and media properties. We power insightful, informed decisions leading to innovation and growth through the aggregation of dynamic, granular data.”
About Stream Hatchet Stream Hatchet is the market leader in live-streaming viewership data analytics for the world’s leading video game streaming platforms. Stream Hatchet provides deep insights to leading brands, creator networks, esports leagues, game publishers, and other businesses measuring the impact of video game live streaming. Stream Hatchet is a wholly-owned subsidiary of Engine Gaming and Media.
About Engine Gaming and Media, Inc. Engine Gaming and Media, Inc. (NASDAQ:GAME) (TSXV:GAME) provides unparalleled live streaming data and social analytics, influencer relationship management and monetization, and programmatic advertising to support the world’s largest video gaming companies, brand marketers, ecommerce companies, media publishers and agencies to drive new streams of revenue. The company’s subsidiaries include Stream Hatchet, the global leader in gaming video distribution analytics; Sideqik, a social influencer marketing discovery, analytics, and activation platform; and Frankly Media, a digital publishing platform used to create, distribute, and monetize content across all digital channels. Engine generates revenue through a combination of software-as-a-service subscription fees, managed services, and programmatic advertising. For more information, please visit www.enginegaming.com.
Initiated dosing in the third and final cohort of U.S. Phase 1/2 OCU400 gene therapy clinical trial
Expanded product pipeline with OCU500—Ocugen’s mucosal COVID-19 vaccine and OCU410ST for Stargardt disease
Completed enrollment of U.S. Phase 2/3 COVAXIN™ (BBV152) clinical trial
MALVERN, Pa., Nov. 08, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today reported financial results for the quarter ended September 30, 2022, and provided a general business update.
“We achieved several important milestones in the third quarter of 2022,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “We expanded our vaccines pipeline by adding a second asset to combat COVID-19, OCU500, through our exclusive license agreement with Washington University to develop, manufacture, and commercialize a mucosal vaccine in the United States, Europe, and Japan.”
“Our modifier gene therapy platform has significant potential to address multiple blindness diseases,” said Dr. Musunuri. “The OCU400 clinical trial is on track, and we are also pleased to announce the addition of OCU410ST to our pipeline as a potential therapy for Stargardt disease—an orphan disease.”
“We continue to deliver on our near-term commitments as we advance our longer-term strategy and goal of bringing solutions to patients with debilitating diseases for whom no appropriate treatment options exist. We are passionate about this goal and anticipate achieving multiple milestones across our programs next year,” Dr. Musunuri concluded.
Business Updates
Vaccines
COVAXIN™ – enrollment was completed, and dosing continues, in the Phase 2/3 immuno-bridging and broadening clinical trial. No safety concerns have been identified to date and efficacy is being continuously monitored. Top line data is expected in early 2023.
OCU500 – a novel adenovirus-vectored mucosal vaccine, specifically designed to block COVID-19 infection at the portal of virus entry and that could prevent transmission as well as provide protection against new variants. This approach represents a potential universal booster, regardless of previous COVID-19 vaccination. Obtaining mucosal immunity has been published as a potential way to prevent infection and transmission, thus limiting the origin of new variants. Mucosal vaccines similar to the Company’s approach are already authorized in China and India. Ocugen intends to work closely with government agencies tasked with pandemic preparedness and response to initiate clinical trials.
Gene Therapies
OCU400
Dosing of subjects with NR2E3 and RHO-related retinitis pigmentosa in Cohort 2 was completed. Based on a review of safety data by the independent Data and Safety Monitoring Board for the clinical trial, dosing has begun in Cohort 3, and enrollment is expected to be completed by the end of the year.
The current clinical trial will also start enrolling patients with Leber congenital amaurosis associated with CEP290 mutations.
OCU410 and OCU410ST – Filings of Investigational New Drug (IND) applications for both dry age-related macular degeneration and Stargardt disease are planned for Q2 2023.
Biologicals
OCU200 – Ocugen is currently executing IND-enabling studies. The filing of an IND application targeting DME is planned for Q1 2023.
Cell Therapies
NeoCart® – Ocugen continues to work with the U.S. Food and Drug Administration to finalize the Phase 3 protocol necessary for the clinical development program of NeoCart®. Ocugen is building its own manufacturing suites to prepare for a NeoCart® clinical trial and as part of an overall research and development expansion.
Third Quarter 2022 Financial Results
The Company’s cash, cash equivalents, and restricted cash totaled $101.6 million as of September 30, 2022, compared to $95.1 million as of December 31, 2021. The Company believes that its current cash and cash equivalents balance will enable it to fund its operations into Q4 2023. The Company had 216.7 million shares of common stock outstanding as of September 30, 2022.
Research and development expenses for the three months ended September 30, 2022, were $15.6 million compared to $6.3 million for the three months ended September 30, 2021. General and administrative expenses for the three months ended September 30, 2022, were $7.5 million compared to $4.5 million for the three months ended September 30, 2021.
Ocugen reported a $0.10 net loss per share for the three months ended September 30, 2022, compared to a $0.05 net loss per share for the three months ended September 30, 2021.
Conference Call and Webcast Details Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.
Attendees are invited to participate on the call or webcast using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s 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 Twitter and LinkedIn.
Cautionary Note on 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.
NEW YORK, NY / ACCESSWIRE / November 7, 2022 / Engine Gaming and Media, Inc. (“Engine” or the “Company”) (NASDAQ:GAME)(TSXV:GAME),a data-driven, gaming, media and influencer marketing platform company, today announced that it will issue a press release promptly after the market close on Tuesday, November 29, 2022, summarizing its financial results for the fiscal fourth quarter of 2022 ended August 31, 2022. The Company will also host a conference call the same day at 4:30 p.m. Eastern Time to discuss its financial results in further detail. The call will conclude with Q&A from participants.
Please dial in at least 10 minutes before the start of the call to ensure timely participation.
A playback of the call will be available through December 6, 2022, on Engine Gaming and Media, Inc.’s Investor Relations website at ir.enginemediainc.com
About Engine Gaming and Media, Inc.
Engine Gaming and Media, Inc. (NASDAQ:GAME)(TSXV:GAME) provides unparalleled live streaming data and social analytics, influencer relationship management and monetization, and programmatic advertising to support the world’s largest video gaming companies, brand marketers, ecommerce companies, media publishers and agencies to drive new streams of revenue. The company’s subsidiaries include Stream Hatchet, the global leader in gaming video distribution analytics; Sideqik, a social influencer marketing discovery, analytics, and activation platform; and Frankly Media, a digital publishing platform used to create, distribute, and monetize content across all digital channels. Engine generates revenue through a combination of software-as-a-service subscription fees, managed services, and programmatic advertising. For more information, please visit www.enginegaming.com.
Cautionary Statement on Forward-Looking Information
This news release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Engine to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. In respect of the forward-looking information contained herein, Engine has provided such statements and information in reliance on certain assumptions that management believed to be reasonable at the time. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Actual results could differ materially from those currently anticipated due to a number of factors and risks. Accordingly, readers should not place undue reliance on forward-looking information contained in this news release.
The forward-looking statements contained in this news release are made as of the date of this release and, accordingly, are subject to change after such date. Engine does not assume any obligation to update or revise any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf, except as required by applicable law.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Company Contact:
Lou Schwartz 647-725-7765
Investor Relations Contact:
Shannon Devine MZ North America Main: 203-741-8811 [email protected]
CALGARY, AB, Nov. 7, 2022 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces initial results from the first interval tested in our 183-B1 well on our 100% owned and operated Block 183 and October 2022 sales volumes.
In July 2022, we completed drilling the 183-B1 exploration well to a total measured depth (“MD”) of 2,917 metres. Based on open-hole wireline logs and fluid samples confirming hydrocarbons, the well discovered hydrocarbons in multiple formations with a total of 34.3 metres of potential net hydrocarbon pay, with an average porosity of 10.6% and average water saturation of 29.0% using a 6% porosity cut-off, 50% Vshale cut-off and 50% water saturation cut-off.
Alvopetro has completed the 183-B1 formation test in the Sergi formation, the deepest of three formations with hydrocarbons shows during drilling of the well. We perforated a total of 26.5 metres in the Sergi formation at various intervals between 2,811 metres MD and 2,886 metres MD. We initially swabbed 63 bbls of oil and 7 bbls of completions fluid during the initially clean-up period. After a short shut-in we then initiated the production test. Cumulatively, over the duration of the 72-hour production test, we recovered 59 bbls of 43°API oil, 7 bbls of water identified as completion fluid, and 0.28 MMcf of associated gas. The daily oil rate recovered during swabbing operations averaged 20 bopd.
The 183-B1 well has now been shut-in to measure reservoir pressure and obtain pressure build‑up data to undertake a pressure transient analysis, which will help predict productivity of this first zone. After completing the pressure build-up test, the first interval will be suspended temporarily with a bridge plug and the test will proceed up-hole to test the Agua Grande formation.
October Sales Volumes
October sales volumes averaged 2,720 boepd, including natural gas sales of 15.6 MMcfpd and associated natural gas liquids sales from condensate of 124 bopd, based on field estimates, an increase of 3% over our average daily sales volumes in the third quarter. October sales volumes include initial sales volumes from our 183(1) well on our Murucututu project where we commenced production in mid-October following completion of the commissioning of field production facility. Our team continues to optimize the field production facility at the wellsite. Since coming on production, the well has averaged approximately 0.42 MMcfpd based on field estimates.
Q3 2022 Results Webcast
Alvopetro anticipates announcing Q3 2022 results on November 15, 2022 after markets close and will host a live webcast to discuss the results at 9:00 am Mountain time on November 16, 2022. Details for joining the event are as follows:
The webcast will include a question-and-answer period. Online participants will be able to ask questions through the Zoom portal. Dial-in participants can email questions directly to [email protected].
Alvopetro Energy Ltd.’svision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé natural gas field and our strategic midstream infrastructure.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
All amounts contained in this new release are in United States dollars, unless otherwise stated and all tabular amounts are in thousands of United States dollars, except as otherwise noted.
Abbreviations:
API
=
American Petroleum Institute
°API
=
an indication of the specific gravity of crude oil measured on the API gravity scale.
bbls
=
barrels
boepd
=
barrels of oil equivalent (“boe”) per day
bopd
=
barrels of oil and/or natural gas liquids (condensate) per day
MMcf
=
million cubic feet
MMcfpd
=
million cubic feet per day
BOE Disclosure. The term barrels of oil equivalent (“boe”) may be misleading, particularly if used in isolation. A boe conversion ratio of six thousand cubic feet per barrel (6Mcf/bbl) of natural gas to barrels of oil equivalence is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. All boe conversions in this news release are derived from converting gas to oil in the ratio mix of six thousand cubic feet of gas to one barrel of oil.
Testing and Well Results. Data obtained from the 183-B1 well identified in this press release, including hydrocarbon shows, open-hole logging, net pay and porosities and initial testing data, should be considered to be preliminary until detailed pressure transient and other analysis and interpretation has been completed. Hydrocarbon shows can be seen during the drilling of a well in numerous circumstances and do not necessarily indicate a commercial discovery or the presence of commercial hydrocarbons in a well. There is no representation by Alvopetro that the data relating to the 183-B1 well contained in this press release is necessarily indicative of long-term performance or ultimate recovery. The reader is cautioned not to unduly rely on such data as such data may not be indicative of future performance of the well or of expected production or operational results for Alvopetro in the future.
Forward-Looking Statements and Cautionary Language. This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward‐looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning potential hydrocarbon pay in the 183-B1 well, anticipated production from our Murucututu project, exploration and development prospects of Alvopetro and the expected timing of certain of Alvopetro’s testing and operational activities. The forward‐looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to expectations and assumptions concerning testing results of the 183-B1 well and the 182-C2 well, equipment availability, the timing of regulatory licenses and approvals, the success of future drilling, completion, testing, recompletion and development activities, the outlook for commodity markets and ability to access capital markets, the impact of the COVID-19 pandemic, the performance of producing wells and reservoirs, well development and operating performance, foreign exchange rates, general economic and business conditions, weather and access to drilling locations, the availability and cost of labour and services, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors. Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our annual information form which may be accessed on Alvopetro’s SEDAR profile at www.sedar.com. The forward-looking information contained in this news release is made as of the date hereof and Alvopetro undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.
Company to host conference call and webcast at 4:30 p.m. Eastern Time on Monday, November 14, 2022
NEWTOWN, Pa., Nov. 07, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company intends to release its third quarter 2022 financial results on Monday, November 14, 2022. Management plans to host a conference call and live webcast at 4:30 p.m. ET on the same day to discuss these results and provide an update on its pipeline programs.
Conference Call and Webcast Information
Interested parties who wish to participate in the conference call may do so by dialing (800) 715-9871 for domestic and (646) 307-1963 for international callers and using conference ID 6078502.
Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.
Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.
UPDATE BRINGS NEW CARS AND TRACKS TO THE PLATFORM, MARKING FIRST TIME CIRCUITS HAVE BEEN LASER-SCANNED INTO A COMMERCIAL SIM RACING PRODUCT
MIAMI, Nov. 07, 2022 (GLOBE NEWSWIRE) — Motorsport Games Inc. (NASDAQ: MSGM) (“Motorsport Games”), a leading racing game developer, publisher and esports ecosystem provider of official motorsport racing series throughout the world, announced today a content update to rFactor 2, one of the most authentic sim racing platforms available to racers around the world.
This quarter’s content update contains new cars for users to experience behind the wheel. Following the partnership between the British Touring Car Championship (BTCC), Motorsport Games and Studio 397, a fifth real world car will be part of the roster – the BMW 330i M Sport NGTC BTCC (trailer here). The rear- wheel drive car – developed by West Surrey Racing – marks the manufacturer’s official entry into the BTCC. Further, the Vanwall Vandervell LMH (trailer here) will be added, built to Le Mans Hypercar specifications and created with data derived from the real car and the same engineering team.
New tracks will be added into the platform as well, all of which mark the first time any of them have been laser (LIDAR) scanned into a commercially available product. British circuits Thruxton (Hampshire) and Croft (North Yorkshire) have been laser-scanned into rFactor 2, alongside the ExCeL London Circuit, featuring an innovative indoor/outdoor layout. Adding to the British circuits, the Bahrain International Circuit will make its debut in rFactor 2 and will feature a full day/night cycle and four distinct track layouts. More information about each track can be found here:
Thruxton – The fastest circuit in the United Kingdom, home to the daunting Church Corner. Founded in 1968, it is used by leading real-world national motorsport championships. This year, the BTCC visited the circuit twice and it will return in 2023, June 3rd and 4th. It first held a round at the venue 43 years ago. Trailer found here: https://youtu.be/-AV4IpCGx44
Croft Circuit – The only permanent national-level circuit in the Northeast of England. It is known for its mix of high-speed curves and a tight final sector, culminating in one of the slowest corners in UK motorsport – in direct contrast to Thruxton. Trailer found here: https://youtu.be/hPMVA0lmooA
ExCeL London Circuit – First created and used by Formula E in 2021, the world-first venue in London mixes tight hairpins and narrow confines within an indoor section. It debuted virtually during the Formula E: Accelerate esports competition in July 2022, won by Frede Rasmussen. Trailer found here: https://www.youtube.com/watch?v=Jv2zrOCOXFE
Bahrain International Circuit – The venue used for series such as Formula 1 and the FIA World Endurance Series made its rFactor 2 debut within the opening 2022-23 Le Mans Virtual Series round in September 2022, won by Floyd Vanwall-Burst (LMP) and Oracle Red Bull Racing (GTE). Four layouts are included: Grand Prix, Endurance, Outer and Paddock. Trailer found here: https://youtu.be/hvOFlUO5YpY
“As rFactor 2 continues to expand and define what top simulation platforms should look like, we are excited for our fans to get behind the wheel and race with new cars and on new tracks with this update,” said Zach Griffin, Director of Technology at Motorsport Games. “Through our partnership with the BTCC and by being the official esports partner of Formula E, as well as rFactor 2 being the official simulation platform of Formula E, we are able to bring to life the elements of real-world racing into the simulation and provide an authentic experience for all. The new laser-scanned tracks, the first time they have been implemented into a product to this scale, also marks a new chapter for sim racing and we are proud to be at the forefront of this innovation.”
Several quality-of-life updates to rFactor 2 will be launching today as well, including:
Thoroughly revised AI performance (smoother and more naturalistic)
Track limit system updates
Increased virtual reality (VR) exposure
User interface tweaks (increased navigation speed)
Increased package installation speed
Headlight pulse option
The new content and changes follow the addition of a native in-game store, which removed the need to exit the platform, showcasing bundle offers and previously purchased content which was implemented in October 2022.
Fans have already gotten a taste of the latest BTCC content to be added at the four race activations this year (Snetterton, Thruxton, Silverstone National and Brands Hatch GP). The latest car and track additions to rFactor 2 bring the totals to six layouts and five car types respectively from the BTCC represented in the simulation, including the two Brands Hatch layouts.
The pricing breakdown for the newly released content is as follows:
Q4 pack: approximate price = €27.99 (31.5% Off)
Includes: BMW 330i M Sport BTCC, Vanwall Vandervell LMH, Bahrain International Circuit, Croft Circuit, Thruxton Circuit, ExCeL London Circuit
British Track Pack: approximate price = €19.99 (37.5% off)
Croft Circuit, Brands Hatch, Donington Park, Thruxton Circuit
Individual Items
Vanwall Vandervell LMH – €4.99
BMW 330i M Sport BTCC – €4.99
Vauxhall Astra BTCC – €4.99
Croft Circuit – €6.99
Thruxton Circuit – €6.99
ExCeL London Circuit – €7.99
Bahrain International Circuit – €8.99
About Motorsport Games: Motorsport Games, a Motorsport Network company, is a leading racing game developer, publisher and esports ecosystem provider of official motorsport racing series throughout the world. Combining innovative and engaging video games with exciting esports competitions and content for racing fans and gamers, Motorsport Games strives to make the joy of racing accessible to everyone. The Company is the officially licensed video game developer and publisher for iconic motorsport racing series across PC, PlayStation, Xbox, Nintendo Switch and mobile, including NASCAR, INDYCAR, 24 Hours of Le Mans and the British Touring Car Championship (“BTCC”), as well as the industry leading rFactor 2 and KartKraft simulations. rFactor 2 also serves as the official sim racing platform of Formula E, while also powering F1 Arcade through a partnership with Kindred Concepts. Motorsport Games is an award-winning esports partner of choice for 24 Hours of Le Mans, Formula E, BTCC, the FIA World Rallycross Championship and the eNASCAR Heat Pro League, among others. Motorsport Games is building a virtual racing ecosystem where each product drives excitement, every esports event is an adventure and every story inspires.
Forward-Looking Statements: Certain statements in this press release which are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are provided pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected benefits of the content updates to rFactor 2, related products and features and the positive attributes of the platform, such as the Company’s belief that rFactor 2 is one of the most authentic sim racing platforms available to racers around the world. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Motorsport Games and are difficult to predict. Examples of such risks and uncertainties include, without limitation: difficulties, delays in or unanticipated events that may impact the timing and expected benefits of the rFactor 2 updates and/or related products and features, such as due to unexpected release delays. Factors other than those referred to above could also cause Motorsport Games’ results to differ materially from expected results. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in Motorsport Games’ filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, its Quarterly Reports on Form 10-Q filed with the SEC during 2022, as well as in its subsequent filings with the SEC. Motorsport Games anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Motorsport Games assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law. Forward-looking statements speak only as of the date they are made and should not be relied upon as representing Motorsport Games’ plans and expectations as of any subsequent date. Additionally, the business and financial materials and any other statement or disclosure on, or made available through, Motorsport Games’ website or other websites referenced or linked to this press release shall not be incorporated by reference into this press release.
Website and Social Media Disclosure: Investors and others should note that we announce material financial information to our investors using our investor relations website (ir.motorsportgames.com), SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media and blogs, to communicate with our investors and the public about our company and our products. It is possible that the information we post on our websites, social media and blogs could be deemed to be material information. Therefore, we encourage investors, the media and others interested in our company to review the information we post on the websites, social media channels and blogs, including the following (which list we will update from time to time on our investor relations website):
Patients with high-risk, locally advanced cervical cancer on IMMUNOCERV demonstrated increased tumor-infiltrating polyfunctional CD8+ (killer) T cells, and 1-year overall survival of 100%
Data from study across several checkpoint inhibitor refractory HPV-positive cancers demonstrate an increase in HPV-specific T cells following treatment with PDS0101-based triple combination
FLORHAM PARK, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced upcoming poster presentations of clinical data from two Phase 2 clinical trials of PDS0101 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2022) being held November 8-12, 2022 in Boston. PDS0101 is PDS Biotech’s lead candidate being developed as a potential treatment for HPV-positive cancers.
The first abstract accepted for presentation, titled, “IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers,” highlights data from The University of Texas MD Anderson Cancer Center-led IMMUNOCERV Phase 2 clinical trial (NCT04580771). The study is investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the potential treatment of cervical cancer in patients with large tumors over 5cm in size and/or cancer that has spread to the lymph nodes (lymph node metastasis). Highlights from the study being presented at SITC 2022 include:
17 patients have been enrolled in the trial.
8 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer.
87.5% (7/8) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease.
In comparison, 74.1% (40/54) of locally advanced patients who received CRT alone and were monitored at The University of Texas MD Anderson Cancer Center on a prospective protocol independent of IMMUNOCERV had a CR on PET CT at Day 170.
The 1-year overall survival is 100% (8/8) in patients treated with the combination of PDS0101 and CRT.
The observed 1-year disease-free survival rate for IMMUNOCERV patients is 87.5% (7/8).
Patients treated with the combination of PDS0101 and CRT had a 71% increase in multi-cytokine-inducing (polyfunctional) killer (CD8+) T cells within the tumors from baseline to end of treatment (38% to 65%). This increase in activated T cells was not seen in patients receiving standard-of-care CRT.
Toxicity of PDS0101 was limited to low-grade local injection site reactions.
The second abstract, titled “Immune Correlates Associated with Clinical Benefit in Patients with Checkpoint Refractory HPV-Associated Malignancies Treated with Triple Combination Immunotherapy,” reports data from the Phase 2 triple combination trial (NCT04287868), which is being led by the Center for Cancer Research at the National Cancer Institute (NCI), part of the National Institutes of Health. The study is investigating PDS0101 in combination with two investigational immune-modulating agents: M9241, a tumor-targeting IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/ TGF-β). The triple combination is being studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy. For most patients who are CPI refractory, there is no effective therapy. The immune correlates before and after treatment in the CPI refractory patient population were studied. Highlights from the study being presented at SITC 2022 include:
A more than two-fold increase in HPV16-specific T cells in the blood of 79% (11/14 tested) of the evaluated patients.
Immune responses were associated with increases in natural killer cells, soluble granzyme B (associated with active killer T cells), IFN-γ, TNF-α, etc., two weeks after the first treatment cycle thus signaling a pro-inflammatory response.
These immunogenicity findings highlight the potential role of the combination in altering immune suppressive forces, and support previously announced results documenting promising clinical outcomes in the CPI-refractory population receiving the triple combination.
“We are very pleased that research describing PDS0101’s therapeutic potential will be highlighted in two poster presentations at SITC 2022, including encouraging preliminary efficacy results from the ongoing IMMUNOCERV Phase 2 clinical trial,” said Dr. Frank Bedu-Addo, CEO of PDS Biotech. “Taken together, the data being presented at SITC 2022 demonstrate the potential ability of PDS0101 to elicit in patients the right type and quality of therapeutic immune response. This seems to allow PDS0101 to work in combination with a variety of therapeutic agents to generate clinical responses that appear to exceed current standards of care and allow for improved outcomes in patients with HPV-positive cancers. We look forward to continued progression of our Phase 2 clinical trials evaluating the efficacy, safety and tolerability of PDS0101 in combination with other therapies.”
Details of the posters being presented at SITC 2022 are as follows:
Abstract Number: 674 Abstract Title: IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers Presenting Author: Dr. Ann Klopp, The University of Texas MD Anderson Cancer Center Session Date: Friday, Nov. 11
Abstract Number: 695 Abstract Title: Immune correlates associated with clinical benefit in patients with checkpoint refractory HPV-associated malignancies treated with triple combination immunotherapy Presenting Author: Dr. Meg Goswami, National Cancer Institute Session Date: Thursday, Nov. 10
About PDS Biotechnology PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
About PDS0101
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A National Cancer Institute-supported Phase 2 clinical study of PDS0101 in a triple combination therapy is also being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers. A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being led by The University of Texas MD Anderson Cancer Center. A final Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients HPV16+ head and neck cancer patients is being conducted at the Mayo Clinic.
KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.
Tourism Marketing Leader to Drive Growth for Orange142 & Its Brand Clients
HOUSTON, TX (November 7, 2022) – Direct Digital Holdings, a leading advertising and marketing technology platform, announced today that Scott Schult will be joining Orange142, a demand generation and digital advertising company, in the newly created role of Head of Strategy. Schult will help Orange142’s sales, account management, and marketing teams construct a more strategic approach to client outreach, retention, and production innovation. Schult comes to Orange142 from the Nashville Convention and Visitors Corporation, where he served as Chief Marketing Officer.
Before leading marketing at the Nashville Convention and Visitors Corporation, Schult worked as Executive Vice President and Chief Marketing Officer for the Myrtle Beach Area Chamber of Commerce. Earlier in his career, he held key roles at the St. Petersburg/Clearwater Area Convention and Visitors Bureau, Primco Capital Management, Sierra Health Services, and Marriott Hotels.
“Scott brings unparalleled experience and innovative thought leadership in the travel and tourism industry, along with years of insights and relationships that will serve us well in helping Orange142 grow marketshare and market our services to a broad reach of industries,” said Mark Walker, CEO, Direct Digital Holdings.
“Orange142 is a high-performance digital media company that successfully delivers unmatched value and transparency to its clients,” said Schult. “Their solutions are a big win for the travel and tourism brands I know well, as well as for a range of marketers looking for significant ROI from a team that understand the needs of mid-market businesses.”
Schult holds a B.S. in Hospitality & Tourism Management and an M.S. in Marketing, both from Purdue University.
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 approximately 90,000 clients monthly, generating over 100 billion impressions per month across display, CTV, in-app and other media channels. The company has been named a top minority-owned business by The Houston Business Journal.
About Orange142
Part of Direct Digital Holdings, Inc. (Nasdaq: DRCT), Orange142, LLC combines demand-side technology with real-time intelligence and data-driven strategy to support omnichannel marketing. Based in Austin, Texas, Orange142, LLC specializes in driving strong results for mid-market clients in CPG, higher education, government, travel/tourism, and wellness/beauty. For more information, visit www.orange142.com.
Media Contact: Laura Goldberg LBG Public Relations for Direct Digital Holdings [email protected] +1-347-683-1859
Five Potentially Pivotal Phase 2 or 3 Studies for CNS Programs Expected to be in the Clinic by First Quarter 2023
Data from Planned Interim Analyses of TNX-102 SL in Phase 3 Fibromyalgia Study and Phase 2 Long COVID Study Expected Second Quarter 2023
Advanced Development Center in Dartmouth, Mass. and Infectious Disease Research and Development Facility in Frederick, Md. Operational
Cash and Cash Equivalents Totaled Approximately $140 Million at September 30, 2022
CHATHAM, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the third quarter ended September 30, 2022, and provided an overview of recent operational highlights.
“Tonix continues to make meaningful progress in the development of multiple programs within its robust pipeline, having already commenced a confirmatory Phase 3 study for fibromyalgia in the second quarter of this year and a potentially pivotal Phase 2 study for Long COVID in the third quarter of this year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We look forward to the interim data from both of these TNX-102 SL studies in the second quarter of 2023. Additionally, we look forward to advancing our other central nervous system or CNS product candidates including TNX-102 SL for PTSD, TNX-1900 for chronic migraine, TNX-1300 for cocaine intoxication, and TNX-601 ER for depression, all of which we expect to be in the clinic by first quarter 2023. Finally, we continue to make strides in immunology with TNX-1500 for preventing organ transplant rejection expected to enter into a Phase 1 study in the first half of 2023, as well as in infectious diseases with TNX-801, a vaccine to prevent smallpox and monkeypox, expected to enter into a Phase 1 study also in the first half of next year.”
Recent Highlights—Key Product Candidates*
Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual tablet): small molecule for the management of fibromyalgia (FM)
Enrollment continues in the RESILIENT study, a double-blind, randomized, placebo-controlled, potentially pivotal confirmatory Phase 3 study of TNX-102 SL for the management of fibromyalgia. Results from a planned interim analysis are expected in the second quarter of 2023.
TNX-102 SL for the treatment of Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)
Enrollment continues in the PREVAIL study, a potentially pivotal Phase 2 study of TNX-102 SL for Long COVID. Results from a planned interim analysis are currently anticipated in the second quarter of 2023.
Tonix presented data from a previously announced retrospective observational database study in patients with Long COVID at the International Association for the Study of Pain (IASP) 2022 World Congress on Pain. The poster presentation titled, “Retrospective Observational Database Study of Patients with Long COVID with Multi-site Pain, Fatigue, and Insomnia: A Real-World Analysis of Symptomatology and Opioid Use,” included data showing that approximately 40% of patients had fibromyalgia-like multi-site pain, the rate of opioid use in Long COVID patients with multi-site pain was 34%, which increased to approximately 50% when sleep disturbance was also present. These findings support the feasibility of the currently enrolling Phase 2 study for patients with Long COVID whose symptoms overlap with fibromyalgia.
TNX-102 SL for the treatment of Posttraumatic Stress Disorder (PTSD)
Tonix expects to begin enrolling a Phase 2 study of TNX-102 SL in police in Kenya in the fourth quarter of 2022.
Tonix expects to initiate a new, potentially pivotal, Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in the first quarter of 2023, pending agreement with the U.S. Food and Drug Administration (FDA).
In August 2022, Tonix received a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support development of TNX-1300.
TNX-1300 has been granted Breakthrough Therapy designation by the FDA.
TNX-1900 (intranasal potentiated oxytocin): small peptide for migraine, craniofacial pain, insulin resistance and related disorders, and obesity associated binge eating disorder
The Company expects to begin enrollment in a Phase 2 study of TNX-1900 for the prevention of migraine headache in chronic migraineurs in the fourth quarter of 2022.
Tonix announced that U.S. Patent 11,389,473 issued in July 2022. The patent, entitled “Magnesium-Containing Oxytocin Formulations and Methods of Use” claims methods and compositions for treating pain, including migraine headaches, using intranasal magnesium-containing oxytocin formulations. This patent, excluding possible patent term extensions, is expected to provide Tonix with U.S. market exclusivity until January 2036.
TNX-601 ER (tianeptine hemioxalate extended-release tablets): a once-daily small molecule for the treatment of major depressive disorder (MDD), PTSD, and neurocognitive dysfunction associated with corticosteroid use.
In October 2022, Tonix announced that the FDA has cleared the Investigational New Drug (IND) application to support a Phase 2 study of TNX-601 ER for the treatment of MDD, which the Company expects to initiate in the first quarter of 2023.
TNX-601 ER is being developed as a monotherapy and first-line treatment for MDD. No tianeptine-containing product has been approved by the FDA.
Rare Disease Pipeline
TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)
In July 2022, Tonix delivered a presentation titled, “TNX-2900 (Intranasal Oxytocin + Magnesium) in Development for the Treatment of Hyperphagia in Adolescents and Young Adults with Prader-Willi Syndrome” at the World Orphan Drug Congress USA.
TNX-2900 has been granted Orphan Drug designation from the FDA for the treatment of PWS.
Immunology Pipeline
TNX-1500 (anti-CD40L monoclonal antibody): third generation monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.
Tonix announced data from three oral presentations at the 29th International Congress of The Transplantation Society (TTS 2022) by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital for TNX-1500 targeting CD40-ligand (CD40L), which is also known as CD154.
The presentations titled, “Long-Term Rejection Free Renal Allograft Survival with Fc-Modified Anti-CD154 Antibody Monotherapy in Nonhuman Primates,” and “Monotherapy with TNX-1500, a Fc-Modified Anti-CD154mAb, Prolongs Cardiac Allograft Survival in Cynomolgus Monkeys,” include data demonstrating that TNX-1500 treatment showed activity in preventing organ rejection and was well tolerated in non-human primates. These presentations suggested that blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity in non-human primate cardiac and kidney allograft models without clinical thrombosis
The presentation titled, “Long-term (>1 year) Rejection-Free Survival of Kidney Xenografts with Triple Xenoantigen Knockout and Multiple Human Transgenes in NonHuman Primates,” includes data demonstrating that TNX-1500 treatment showed activity in preventing xenograft kidney rejection and was well tolerated in non-human primates. These presentations suggested that blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic xenoimmunity in non-human primate kidney xenograft models without clinical thrombosis.
A Phase 1 study of TNX-1500 is expected to start in the first half of 2023.
Infectious Disease Pipeline
TNX-801 (live horsepox virus vaccine for percutaneous administration): vaccine against smallpox and monkeypox designed as a single-administration vaccine to elicit T cell immunity
As previously mentioned, Tonix announced a collaboration with the Kenya Medical Research Institute (KEMRI) to plan, seek regulatory approval for and conduct a Phase 1 clinical study in Kenya to develop TNX-801 as a vaccine to protect against monkeypox and smallpox. The study is expected to start in the first half of 2023.
Tonix presented data from a research collaboration with The University of Alberta in a poster presentation at the 4th Symposium of the Canadian Society for Virology on June 5, 2022. The poster titled, “Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox,” describes data from animals vaccinated with TNX-801 to protect against monkeypox. The poster presentation reports that all animals (n=8) vaccinated with TNX-801 were fully protected with sterilizing immunity from a challenge with intra-tracheal monkeypox. The vaccinations with TNX-801 were well tolerated. Synthetic horsepox virus is the basis for the Company’s TNX-801 vaccine in development to protect against monkeypox and smallpox and for the Company’s Recombinant Pox Virus (RPV) platform to protect against other pathogens, including SARS-CoV-2.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
Recent Highlights–Financial
As of September 30, 2022, Tonix had $140.0 million of cash and cash equivalents, compared to $178.7 million as of December 31, 2021.
In October 2022, Tonix issued 1,400,000 shares of Series A convertible redeemable preferred stock and 100,000 shares of Series B convertible redeemable preferred stock to certain institutional investors in a private placement for gross proceeds of $15.0 million. The Company expects to use the proceeds to redeem the preferred stock.
Cash used in operations was approximately $23.5 million for the three months ended September 30, 2022, compared to $12.9 million for the same period in 2021. The increase in cash outlays was primarily due to an increase in research and development activities. Capital expenditures were approximately $8.8 million for the three months ending September 30, 2022 compared to $7.8 million for the same period in 2021. The increase was primarily due to the continued buildout of the ADC in North Dartmouth, Mass.
Third Quarter 2022 Financial Results
Research and development (R&D) expenses for the three months ended September 30, 2022 were $22.2 million, compared to $13.1 million for the same period in 2021. The increase is predominately due to increased clinical, manufacturing, non-clinical, employee-related and laboratory expenses. The Company continues to expect R&D expenses to increase throughout the remainder of 2022 as it moves its clinical development programs forward and invests in its development pipeline.
General and administrative (G&A) expenses for the three months ended September 30, 2022 were $7.4 million, compared to $5.5 million for the same period in 2021. The increase is primarily due to increased employee-related and financial reporting expenses.
Net loss available to common stockholders was $29.0 million, or $0.69 per share, basic and diluted, for the three months ended September 30, 2022, compared to net loss of $18.5 million, or $1.60 per share, basic and diluted, for the same period in 2021. The basic and diluted weighted average common shares outstanding for the three months ended September 30, 2022 was 41,944,289 compared to 11,581,367 shares for the same period in 2021.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute-COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. 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 first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease 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 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 and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
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; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, 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,
2022
2021
2022
2021
COSTS AND EXPENSES:
Research and development
$
22,201
$
13,082
$
57,202
$
46,542
General and administrative
7,390
5,453
22,161
16,291
29,591
18,535
79,363
62,833
Operating loss
(29,591
)
(18,535
)
(79,363
)
(62,833
)
Interest income, net
610
7
825
99
Net loss
(28,981
)
(18,528
)
(78,538
)
(62,734
)
Preferred stock deemed dividend
—
—
4,255
—
Net loss available to common stockholders
$
(28,981
)
$
(18,528
)
$
(82,793
)
$
(62,734
)
Net loss per common share, basic and diluted
$
(0.69
)
$
(1.60
)
$
(3.06
)
$
(6.02
)
Weighted average common shares outstanding, basic and diluted
1The condensed consolidated balance sheet for the year ended December 31, 2021 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.
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