MALVERN, Pa., March 06, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced the appointment of Quan A. Vu to Chief Financial Officer & Chief Business Officer.
“Quan has quickly become a tremendous asset for Ocugen and his comprehensive healthcare and financial expertise is providing valuable insight toward reaching our corporate goals,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “With Quan now overseeing both finance and business development, there will be a fully integrated approach to financial strategy—pursuing new partnerships and engaging with the investment community.”
Mr. Vu joined Ocugen on February 1, 2023, and has been working closely across multiple, key corporate functions—understanding short- and long-term business and financial needs of the Company along with the potential of its differentiated scientific platforms. With his additional appointment as Chief Financial Officer, and aside from his management and oversight of the finance and accounting functions, Mr. Vu will partner closely with Dr. Musunuri to enhance the Company’s forward-looking, value-additive financial initiatives by leveraging the Company’s anticipated clinical milestone achievements to bolster fundamental shareholder composition, expand interactions with the investor community, and ensure reputable capital markets and equity research support.
“I am excited about this new role and the ability to work alongside the leadership team to advance Ocugen at such a pivotal time,” said Mr. Vu. “We will continue to work collaboratively to position the Company for future success.”
Before joining Ocugen, Mr. Vu was most recently Chief Operating Officer/Chief Business Officer for 180 Life Sciences. He began his career in healthcare investment banking at both Morgan Stanley and Goldman Sachs, and then held leadership roles of increasing responsibility at Opiant Pharmaceuticals, Impax Laboratories, Anthem, and Amgen. Mr. Vu obtained his BA in Economics from UCLA, graduating summa cum laude with College Honors and Economics Departmental Honors. He is also a Certified Treasury Professional (inactive).
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on 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.
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.
Contact:
Tiffany Hamilton Head of Communications IR@ocugen.com
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
PDS0301 Data Published. The peer-reviewed journal International Immunopharmacology published a paper from scientists at the National Institutes of Health describing studies with PDS0301. The paper provides data showing how PDS0301 stimulates an immune response and its correlation with efficacy in Phase 2 studies. We see the publication as a positive that supports the clinical progress and use of PDS0301 in immuno-oncology.
Development and Actions. The article describes how PDS0301 was developed as a fusion protein, consisting of an antibody conjugated to Interleukin 12 (IL-12). Its targeting mechanism directs PDS0301 to the DNA/histones in tumor-necrotic regions of the tumor, avoiding the bloodstream and concentrating IL-12 in the tumor microenvironment. This avoids the systemic toxicity and serious adverse events that have limited dosing and efficacy of recombinant IL-12.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Financial Results Were Within Expectations. Ocugen reported 4Q22 and FY2022 Net Loss of $21.9 million or $(0.10) per share, and $81.4 million or $(0.38) per share for FY2022. Cash on hand as of December 31 was $90.9 million or $0.41 per share, which management projects will fund operations through 1Q24. On its quarterly conference call, management discussed recent milestones and development programs in gene therapy, cellular therapy, and vaccines.
Ophthalmology Programs Are Advancing. Ocugen filed an IND for OCU200 to begin Phase 1 clinical trial in diabetic macular edema (DME), meeting the expected timeframe. Trial enrollment is expected to begin in 2Q23. A second IND filing is expected during 2Q23 for OCU410 in dry AMD and OCU410ST in Stargardt disease. The Phase 1/2 dose testing OCU400 in retinitis pigmentosa (RP) escalation phase previously completed enrollment for the RP cohort, with enrollment continuing in the Leber congenital amaurosis (LCA) patient cohort. Phase 3 is expected to start by year-end 2023.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Triple Therapy Advances. PDS Biotech announced that the FDA has agreed to requirements for a registration trial using PDS0101 “Triple Combination” therapy in head and neck cancer. The study will test the combination of PDS0101, PDS0301, and a commercially available checkpoint inhibitor. We believe the changes from the previous trial should make regulatory approval faster, with additional tumor types added after market entry.
New Combination Eliminates An Unapproved Checkpoint Inhibitor. The new Triple Combination uses PDS010 to stimulate an immune response against the HPV antigen, PDS0301 to stimulate a robust immune response, and a checkpoint inhibitor to allow the immune system to recognize the tumor cells. The previous trial included bintrafusp alfa, an experimental checkpoint inhibitor. We believe the change to an approved checkpoint inhibitor simplifies the regulatory path.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Received guidance on registrational path for combination in recurrent/metastatic, immune checkpoint inhibitor refractory head and neck cancer
FLORHAM PARK, N.J., Feb. 27, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced the successful completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) for a combination therapy of PDS0101, PDS0301 and an FDA-approved immune checkpoint inhibitor (ICI) for the treatment of recurrent/metastatic human papilloma virus (HPV)-positive, ICI refractory head and neck cancer. Head and neck cancers are the most common of all HPV-positive cancers and the number of cases is growing rapidly, according to the National Cancer Institute (NCI), one of the National Institutes of Health (NIH). There remains a critical unmet medical need to develop new treatment options for patients who have failed treatment with ICIs.
In recent interactions with the FDA, PDS Biotech has confirmed the required contents of the study design for a potential registrational trial of the combination of PDS0101, PDS0301 and a commercial immune checkpoint inhibitor. PDS0101, PDS Biotech’s lead candidate, is a Versamune® based investigational immunotherapy designed to stimulate a potent targeted T cell attack against HPV16-positive cancers. PDS0301 is a novel, proprietary investigational tumor-targeting fusion protein of Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment, and is designed to overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors. The combination of Versamune® and IL-12 is patented by PDS Biotech. In a National Cancer Institute (NCI)-led clinical trial in advanced HPV-positive ICI refractory patients, the combination of PDS0101 and PDS0301 administered with an investigational bi-functional ICI resulted in a median overall survival of 21 months, which compares favorably to the historical median survival of 3-4 months.
“We are pleased with the guidance from the FDA on key elements of a study design to progress the development of our assets, PDS0101 and PDS0301, in combination with a commercial immune checkpoint inhibitor,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “This concurrence to substitute an FDA-approved commercially available ICI for the investigational agent studied in the NCI trial simplifies the regulatory pathway for this triple combination.”
Dr. Bedu-Addo continued, “Versamune® based investigational immunotherapies in combination with PDS0301 represent a potentially transformative treatment approach for recurrent/metastatic, ICI refractory cancer patients with poor survival prognosis. We remain committed to addressing unmet needs in cancer with more effective immunotherapy.”
About PDS0101 PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS
Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.
Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Baudax Bio reported 4Q 2022. While we had removed 4Q ANJESO revenues with the announced ANJESO discontinuation at the end of December, the Company reported 4Q revenues of $0.310 million in the quarter. Net loss per share for 4Q 2022 was $12.33 per share as compared to our outlook of $9.76 per share loss as the Company took additional write-offs related to ANJESO.
Baudax Bio reported full year 2022. For the year 2022, Baudax Bio generated revenues of $1.27 million, up from $1.08 million in the 2021 year. The Company took a write-down for impairment of intangibles of $19.7 million. The full year impairment write-down for property and equipment totaled $4.2 million. The reported full year 2022 net loss was $58.8 million or a loss of $177.30 per share compared to our full year 2022 expected loss of $55.3 million or $189.44 per share.
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Company Focuses on Development of Neuromuscular Blocking Agents
Phase II Randomized Trial for BX1000 Initiated, Positive Interim Results Announced; Completion of Study Enrollment Expected Q1 2023, Top Line Results Expected Early Q2 2023
BX2000 Dose Escalation Study Progressing
$5 Million in Financing Secured through Public Offering
MALVERN, Pa., Feb. 23, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (Nasdaq:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for hospital and related settings, today reported financial results for the fourth quarter and year ended December 31, 2022, updated the status of the neuromuscular blocking (NMB) agent development program, and provided an overview of other corporate and financial developments.
“During our fourth quarter we refocused our priorities on our NMB portfolio, initiating our Phase II trial for BX1000 and advancing our Phase I dose escalation trial for BX2000,” said Gerri Henwood, Baudax Bio’s President and Chief Executive Officer. “The encouraging interim data we announced from the BX1000 trial showed all patients treated to date have met the criteria for Good or Excellent intubating conditions at 60 seconds, and that BX1000 has been generally well tolerated. We believe these data speak to the potential of our NMB portfolio to improve patient management and deliver cost efficiencies in procedures where NMB is required. We expect to complete enrollment in the BX1000 trial during the first quarter of 2023, and to announce top line data early in the second quarter of 2023. Concurrently, BX2000, our ultrashort acting NMB, is continuing through its dose escalation study, which we expect to complete by the end of 2023. BX3000, our NMB reversal agent, remains on track, and we expect to complete the nonclinical and manufacturing studies needed to support an IND filing for BX3000, the NMB reversal agent in the summer of 2023. Data from these trials will provide us with insight on the profiles of the two blocking agents, which will contribute to decisions to move forward later in 2023.”
“Due to persistent economic challenges facing hospitals, as previously disclosed, we have taken the strategic decision to discontinue commercialization of ANJESO,” continued Ms. Henwood. “We continue to believe in ANJESO’s advantages over other non-opioid pain therapies, as well as its potential to overcome many of the issues associated with commonly prescribed opioid therapeutics.”
Fourth Quarter 2022 and Recent Business Highlights
NMBs
BX1000 (IV Intermediate duration of action). Results for a planned interim analysis of the Phase II trial for BX1000 were announced in January 2023. This randomized, double-blind, active-controlled clinical trial comparing three different doses of BX1000 to a standard dose of rocuronium (rocuronium bromide 0.6 mg/kg IV Bolus) is planned to enroll a total of 80 adult patients undergoing elective surgery utilizing total intravenous anesthesia currently at a single clinical site in the U.S. The primary efficacy endpoint is the proportion of patients meeting criteria for Good or Excellent intubating conditions using a standardized scale. Additionally, the trial is evaluating the safety and tolerability profile of BX1000 and rocuronium in this patient population.
BX1000 Interim Data. The pre-planned interim analysis evaluated the intubating conditions for each randomized patient after administration of study drug in a blinded fashion. In the 20-patient cohort, 5 patients per group received one of the study medications. All 20 patients were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds. Nineteen of the subjects were successfully intubated following the assessment at 60 seconds, with one remaining subject successfully intubated following the assessment at 90 seconds. Study treatments were generally well tolerated with no occurrence of severe or serious adverse events. This blinded interim analysis did not result in the decision to drop any of the four study groups nor any decision to adjust planned study enrollment numbers.
BX2000 (IV Ultra-short duration of action). Cohort enrollment is ongoing for the Phase I dose escalation study evaluating the safety, tolerability, and pharmacokinetics of BX2000 in intubated healthy volunteers. This study is comprised of likely seven or eight dosing cohorts and each cohort is planned to enroll eight patients. The first and second cohorts have been dosed and enrollment of the third cohort is underway. The Company expects to complete enrollment of the remaining cohorts in the study by the end of 2023.
BX3000 (Reversal agent). Baudax Bio expects to complete nonclinical studies and manufacturing data required to support the IND for BX3000 in the summer of 2023. Early single agent clinical trials of BX3000 will not require intubation and so would be expected to progress quickly once the IND is active, and trials are ready to initiate. The Company believes progress towards a reversal study using BX3000 in patients who have received BX1000 could begin before the end of 2023.
The Company believes the data from the ongoing clinical trials for BX1000 and BX2000 will contribute to decisions to move forward later in 2023.
ANJESO
ANJESO U.S. Commercialization Discontinued. Despite having distinct benefits as the first and only once-daily, non-opioid IV analgesic, market conditions are not favorable for the introduction and commercialization of a new pain management product in the hospital market. As a result, Baudax Bio has formally discontinued the commercialization of ANJESO and the product is currently on hold due to these business conditions.
Corporate and Financial
Closed $5 million public offering – on December 6, 2022 the Company closed a public offering of an aggregate of 1,042,787 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-3 warrants to purchase up to 1,042,787 shares of common stock and Series A-4 warrants to purchase 1,042,787 shares of common stock, at a combined public offering price of $4.795 per share (or pre-funded warrant) and accompanying warrants. The Series A-3 warrants have an exercise price of $4.50 per share, are exercisable immediately upon issuance and expire five years from the date of issuance, and the Series A-4 warrants have an exercise price of $4.50 per share, are exercisable immediately and expire thirteen months from the date of issuance. The Company intends to use the net proceeds from this offering for working capital, pipeline development activities and general corporate purposes. In January 2023, 961,787 warrants were exercised providing $4.3 million in cash to the Company.
Financial Results for the Three Months Ended December 31, 2022
As of December 31, 2022, Baudax had cash and cash equivalents of $5.3 million.
Net product revenue related to sales of ANJESO in the U.S., recognized according to U.S. GAAP, for the three months ended December 31, 2022 was $0.3 million. This compares to $0.4 million for the three months ended December 31, 2021, a decrease of $0.1 million, resulting from the impact of the reduction in our field staff in 2022 and the impact of our discontinuation of commercialization in the fourth quarter of 2022. While utilizing the title model of distribution, product revenue was recognized as shipments were made to the Company’s third-party logistics provider.
Cost of sales for the three months ended December 31, 2022 was $4.8 million, compared to $0.6 million for the three months ended December 31, 2021, an increase of $4.2 million, and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO, including supply chain and quality costs. The increase of $4.2 million was primarily a result of an increase in the non-cash charge for inventory reserve expense of $4.4 million, partially offset by the decrease in fixed personnel related costs of $0.2 million. Certain product costs of ANJESO units recognized as revenue during the three months ended December 31, 2022 and 2021 were expensed prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the related periods.
Research and development expense for the three months ended December 31, 2022 was $1.0 million compared to $0.5 million for the three months ended December 31, 2021, an increase of $0.5 million, which was a result of an increase in NMB clinical trial costs of $0.9 million, partially offset by a decrease in personnel costs of $0.3 million.
Selling, general and administrative expenses for the three months ended December 31, 2022 were $2.1 million, of which $0.2 million was attributable to selling expense and $1.9 million was attributable to general and administrative expense. This compares to $11.5 million for the same prior year period, of which $6.5 million was attributable to selling expense and $5.0 million was attributable to general and administrative expense. Selling expenses decreased $6.3 million, primarily as a result of a reduction in personnel costs of $4.4 million, a decrease in marketing costs of $1.6 million and a decrease in associated travel expenses of $0.3 million. The decrease of $3.1 million in general and administrative costs was primarily a result of a decrease in personnel costs of $2.2 million, a decrease in public company costs of $0.5 million and a decrease in both consulting costs and travel expenses of $0.2 million.
As a result of the discontinuation of commercialization of ANJESO, Baudax Bio evaluated the intangible asset carrying value attributed to ANJESO as of December 31, 2022 and recorded a non-cash impairment loss of $1.9 million to eliminate the carrying value of the asset. The value of its construction in progress related to the construction of an additional manufacturing suite for ANJESO was further reduced by $0.5 million.
Baudax Bio reported net loss of $9.2 million, or $(12.33) per share, including non-cash charges of $6.1 million (primarily related to the inventory reserve expense discussed above), for the three months ended December 31, 2022. Adjusted net loss* was $3.1 million for the three months ended December 31, 2022. Net income for the three months ended December 31, 2021 was $29.4 million, or $437.19 per diluted share, including a non-cash benefit of $41.3 million. Adjusted net loss* was $11.9 million for the three months ended December 31, 2021.
Financial Results for the Year Ended December 31, 2022
Net product revenue related to sales of ANJESO in the U.S., recognized according to U.S. GAAP, for the year ended December 31, 2022 was $1.3 million. This compares to $1.1 million for the year ended December 31, 2021, an increase of $0.2 million, which was attributable to increased demand at existing accounts. While utilizing the title model of distribution, product revenue was recognized as shipments were made to the Company’s third-party logistics provider.
Cost of sales for the year ended December 31, 2022 was $7.0 million, compared to $2.4 million for the year ended December 31, 2021, an increase of $4.6 million, and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO, including supply chain and quality costs. The increase of $4.6 million was primarily a result of the increase in the non-cash charge for inventory reserve expense of $5.2 million, partially offset by the reduction in personnel related costs of $0.4 million and the reduction in production and storage costs of $0.2 million. Certain product costs of ANJESO units recognized as revenue during the year ended December 31, 2022 and 2021 were expensed prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the related periods.
Research and development expenses for the year ended December 31, 2022 were $3.9 million compared to $3.1 million for the year ended December 31, 2021. The increase of $0.8 million was primarily due to the increase in the NMB portfolio clinical trial costs of $1.0 million and an increase of $0.2 million related to the pediatric clinical trial costs for ANJESO. These costs were partially offset by a decrease in personnel related costs of $0.4 million.
Selling, general and administrative expenses for the year ended December 31, 2022 were $24.1 million, of which $9.4 million was attributable to selling expense and $14.7 million was attributable to general and administrative expense. This compares to $45.3 million for the same prior year period, of which $22.4 million was attributable to selling expense and $22.9 million was attributable to general and administrative expense. Selling expenses decreased $13.0 million, primarily as a result of a reduction in personnel costs of $7.9 million, a decrease in marketing costs of $4.7 million and a decrease in travel expenses of $0.4 million compared to 2021. The decrease of $8.2 million in general and administrative expenses was primarily a result of a decrease in personnel costs of $4.7 million, a decrease in public company costs of $2.3 million, a decrease in consulting costs of $0.9 million and a decrease in other costs of $0.3 million.
As a result of the discontinuation of commercialization of ANJESO, Baudax Bio evaluated the intangible asset carrying value attributed to ANJESO as of December 31, 2022 and recorded a non-cash impairment loss of $19.7 million to eliminate the carrying value of the asset. Additionally, the value of its construction in progress related to the construction of an additional manufacturing suite for ANJESO was reduced by $4.2 million.
Baudax Bio reported net loss of $58.8 million, or $(177.30) per share, including net non-cash charges of $30.9 million, for the year ended December 31, 2022. Adjusted net loss* was $27.9 million for the year ended December 31, 2022. For the year ended December 31, 2021 net loss was $19.8 million, or $(361.16) per share, including net non-cash benefit of $26.4 million. Adjusted net loss* was $46.2 million for the year ended December 31, 2021.
Non-GAAP Financial Measures
To supplement the Company’s financial results determined by U.S. generally accepted accounting principles (“GAAP”), the Company is reporting certain non-GAAP information for its business, including adjusted net loss. Adjusted net loss is net loss as determined under GAAP, excluding the changes in fair values of contingent consideration and warrant valuations, gain on extinguishment of debt, interest, depreciation, amortization, stock-based compensation, losses on impairment of construction in progress and intangible assets and the write off of inventory. The Company believes this non-GAAP financial measure is helpful in understanding its business as it is useful to investors in allowing for greater transparency of supplemental information used by management. This measure is used by investors, as well as management in assessing the Company’s performance. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared. Please see the section of this press release titled “Reconciliation of GAAP to Non-GAAP Financial Measures” for a reconciliation of non-GAAP adjusted net loss to its most directly comparable GAAP measure.
About Baudax Bio
Baudax Bio is a pharmaceutical company focused on innovative products for hospital and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one undergoing a Phase II clinical trial and an additional unique NMB undergoing a dose escalation Phase I clinical trial, as well as a proprietary chemical reversal agent specific to these NMBs, which is currently undergoing nonclinical and manufacturing studies to prepare for an expected IND filing in the summer of 2023. For more information, please visit www.baudaxbio.com.
Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.
To supplement the Company’s financial results determined by U.S. generally accepted accounting principles (“GAAP”), the Company has disclosed in the tables below the following non-GAAP information about adjusted net loss.
Adjusted net loss is net loss as determined under GAAP, excluding the changes in fair values of contingent consideration and warrant valuations, gain on extinguishment of debt, interest, depreciation, amortization, stock-based compensation, losses on impairment of construction in progress and intangible assets and the write off of inventory.
The Company believes that non-GAAP financial measures are helpful in understanding its business as it is useful to investors in allowing for greater transparency of supplemental information used by management. Adjusted net loss is used by investors, as well as management in assessing the Company’s performance. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared.
Symptoms of Long COVID, Like Multi-Site Pain, Fatigue and Insomnia, are the Hallmarks of Chronic Pain Syndromes Like Fibromyalgia and Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)
Event Co-Hosted by the Biotechnology Innovation Organization (BIO) and Solve M.E., an Advocacy Group for CFS/ME
CHATHAM, N.J., Feb. 22, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that during a virtual event co-hosted by BIO and Solve M.E. titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?”, Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, presented emerging research describing the role of infections in triggering fibromyalgia or CFS/ME and other fibromyalgia-type illnesses, and discussed Tonix’s ongoing Phase 2 study of TNX-102 SL in fibromyalgia-type Long COVID. Symptoms of Long COVID, like multi-site pain, fatigue and insomnia, are the hallmarks of chronic pain syndromes like fibromyalgia and CFS/ME.
“The U.S. Department of Health and Human Services National Research Action Plan on Long COVID1, released in August 2022, addresses the overlap of Long COVID with CFS/ME, which, like fibromyalgia, is one of the overlapping chronic pain syndromes with central sensitization,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Furthermore, a recent survey2 found comparable pain, fatigue and function between Long COVID, fibromyalgia and CFS/ME.”
Enrollment continues in the Phase 2 PREVAIL study of TNX-102 SL as a potential treatment for patients with Long COVID syndrome whose symptoms overlap with fibromyalgia. PREVAIL is a randomized, double-blind, placebo-controlled study in the U.S. that is expected to enroll approximately 470 patients. One unblinded interim analysis is anticipated based on the first 50% of randomized participants.
1Department of Health and Human Services, Office of the Assistant Secretary for Health. 2022. National Research Action Plan on Long COVID, 200 Independence Ave SW, Washington, DC 20201.
2Haider S, et al. Pain. 2023;164(2):385-401.
About Solve M.E.
Solve M.E. is a non-profit organization that serves as a catalyst for critical research into diagnostics, treatments, and cures for CFS/ME, Long COVID and other post-infection conditions.
About BIO
BIO is the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries.
About Long COVID or Post-Acute Sequelae of SARS-CoV-2 (PASC)
Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. These individuals experience a constellation of symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 virus from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in approximately 19% of people who recover from COVID.1 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.2 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 2021.3 While the vaccines available in the U.S. under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.”
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. 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 second quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is being studied in a potential pivotal Phase 2 study that initiated enrollment in the first quarter of 2023 and for which interim data is expected in the fourth quarter of 2023. 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 second quarter of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801; a next-generation vaccine to prevent COVID-19, TNX-1850; a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600; and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800; and a class of broad-spectrum small molecule oral antivirals, TNX-3900. 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 the second half of 2023.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
2Briggs, Andrew, and Anna Vassall. “Count the cost of disability caused by COVID-19.” (2021): 502-505.
3The NIH provision of Title III Health and Human Services, Division M–Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.
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.
Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.
Joe Gomes, Managing Director – Generalist Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
New Acquisitions. Continuing to build out its Colorado dispensary network, Schwazze has announced definitive documents to acquire certain assets of Cannabis Care Wellness Centers, LLC and Green Medicals Wellness Center #5, LLC (d/b/a “Smokey’s”). The proposed transaction includes the adult use Smokey’s dispensaries located at 2515 7th Avenue in Garden City as well as 5740 S. College Ave. in Fort Collins. These two vibrant cannabis markets have limited licenses and present Schwazze with more opportunities to serve customers in northern Colorado.
Details. The consideration for the proposed acquisition is $7.5 million and will be paid as $3.75M in cash and $3.75M in stock at closing. The acquisition is expected to close in the second quarter of 2023 after Colorado Marijuana Enforcement Division and local licensing approvals.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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THIO Is A First-In-Class Cancer Therapeutic With A Dual Mechanism Of Action. MAIA Biotechnology is in Phase 2 development with THIO, a drug directed at the telomeres of cancer cell chromosomes. These are structures at the distal tips of the chromosomes that protect the coding DNA regions and have functions needed for DNA replication. THIO is a modified nucleoside analogue that targets the chromosome’s telomeres, leading to cell death, and stimulates the immune system to attack remaining cancer cells.
THIO Is Phase 2 With A Checkpoint Inhibitor. The direct killing and stimulation of an immune response increases the number of immune killing cells in the tumor that can attack remaining cancer cells. Preclinical studies testing THIO in combination with checkpoint inhibitors showed complete killing and long-term durability of its effects. The current Phase 2 clinical trial program is testing THIO in combination with Libtayo, a PD-1 inhibitor from Regeneron, in non-small cell lung cancer (NSCLC).
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.
Joe Gomes, Managing Director – Generalist Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Buying Shares. A Form 4 was released Wednesday showing CEO Justin Dye purchasing 500,000 shares of Schwazze at a price of $1.50 per share under Dye LLLP for a total cost of $750,000. Mr. Dye now indirectly owns 1,868,062 SHWZ common shares through Dye LLLP and indirectly owns 9,287,500 SHWZ common shares through Dye Capital & Company, equating to 20.5% of the total outstanding shares.
New Officer. Wednesday also had a press release from Schwazze announcing the Company added Christine Jones to the management team as Chief Legal Officer. Ms. Jones has over 25 years of experience as a corporate counsel for several companies and most recently was a Senior Vice President, Legal and Corporate Secretary of Long Play, Inc. Long Play is a vertically integrated cannabis company with cultivation, manufacturing, retail, and a portfolio of brands, similar to Schwazze. We believe the addition of Ms. Jones will be beneficial to the Company.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Item 9 Labs Corp. (OTCQX: INLB) is a vertically integrated cannabis operator and dispensary franchisor delivering premium products from its large-scale cultivation and production facilities in the United States. The award-winning Item 9 Labs brand specializes in best-in-class products and user experience across several cannabis categories. The company also offers a unique dispensary franchise model through the national Unity Rd. retail brand. Easing barriers to entry, the franchise provides an opportunity for both new and existing dispensary owners to leverage the knowledge, resources, and ongoing support needed to thrive in their state compliantly and successfully. Item 9 Labs brings the best industry practices to markets nationwide through distinctive retail experience, cultivation capabilities, and product innovation. The veteran management team combines a diverse skill set with deep experience in the cannabis sector, franchising, and the capital markets to lead a new generation of public cannabis companies that provide transparency, consistency, and well-being. Headquartered in Arizona, the company is currently expanding its operations space by up to 640,000-plus square feet on its 50-acre site, one of the largest properties in Arizona zoned to grow and cultivate flower. For additional information, visit https://investors.item9labscorp.com/.
Joe Gomes, Managing Director – Generalist Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
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1Q23 Results. Item 9 Labs reported revenue of $5.0 million and a net loss of $3.26 million, or a loss of $0.03 per share. Revenue grew from the $4.0 million reported in the fourth quarter of fiscal 2022. Notably, gross margin also improved, to 52.4% in the most recent quarter, from 16.1% in the fourth quarter and 38.8% in the year ago period. We had forecast revenue of $4.5 million, gross margin of 35.6%, and a net loss of $4.9 million, or a loss of $0.05 per share.
Sessions Acquisition. Earlier this week, Item 9 Labs announced it has secured the necessary financing to complete the acquisition of Sessions Cannabis, a deal first announced in May 2022. Sessions is one of Canada’s largest cannabis retail franchisors. The total cash purchase price of the transaction is $12.8 million, which is being fully funded through an Acquisition Line of Credit with a 5-year term from a commercial lender. The acquisition will create the largest international cannabis retail franchiser and publicly traded cannabis franchise company in North America.
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Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
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Grant awarded for $3.472 million (C$). ChitogenX yesterday announced the award. The Company had applied for the grant, through its partnership with Polytechnique Montréal, in third quarter 2022. The grant was received from The Natural Sciences and Engineering Research Council of Canada (NSERC) and Prima Québec. The NSERC is Canada’s largest supporter of innovation, funding explorers searching for scientific and technical breakthroughs. Prima Québec is an advanced materials research and innovation hub.
Uses of the grant. The 4-year grant will be used to advance development, expand indication possibilities, develop new regenerative medicine biomaterials and accelerate the Company’s ORTHO-R commercial readiness. These potential indications and applications include not only tendinopathies like tennis elbow and Achilles heel injuries, but possibly also areas like cardiology, wound healing and oncology. In the first year of the grant, ChitogenX plans to focus on potential applications that deliver other biologic products using their chitosan biopolymer matrix.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
