SASKATOON, Saskatchewan, Canada, September 1, 2023 – MustGrow Biologics Corp. (TSXV: MGRO) (OTC: MGROF) (FRA: 0C0) (the “Company” or “MustGrow”), today announced that the board of directors of the Company authorized and approved the grant of a total of 612,757 deferred share units (“DSUs”) and 177,035 restricted share units (“RSUs”) to certain directors, officers, and consultants of the Company, effective August 31, 2023. This grant of DSUs and RSUs is made pursuant to the Company’s Omnibus Equity Incentive Plan (the “Plan”).
The RSUs will vest on March 28, 2024. Once vested, each RSU will entitle the recipient to receive one common share in the capital of the Company or a cash payment equivalent thereof at the discretion of the Company. The DSUs will vest in accordance with the terms of the Plan immediately upon grant. Settlement of the DSUs will occur when a holder ceases to be a director, officer or employee of the Company or any of its affiliates, as applicable. On settlement, each DSU will entitle the recipient to receive one common share in the capital of the Company or a cash payment equivalent thereof at the discretion of the Company.
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About MustGrow
MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertily markets. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid products could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility. MustGrow has approximately 50.1 million basic common shares issued and outstanding and 56.3 million shares fully diluted. For further details, please visit www.mustgrow.ca.
This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.
Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.
After months of scrutiny, including a lawsuit filed by the Federal Trade Commission, the FTC has given drug giant Amgen the go-ahead to proceed with their planned acquisition of Horizon Therapeutics, a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs for people affected by rare, autoimmune and severe inflammatory diseases.
The planned acquisition was originally announced late in 2022 but has been held up due to concerns that the deal may stifle competition in the pharmaceutical industry. One key point resolved in an agreement announced Friday stipulates that Amgen is prohibited from “bundling” two of Horizon’s key drugs. A “bundling” tactic could involve rebates or promotions to insurers for recommending or favoring those Horizon products.
Horizon Therapeutics is up slightly in early market trading on Friday following the announcement. The company currently has a market cap of $26.4bn. The merger, valued at $27.8bn, is expected to be completed in Q4 of 2023.
Explore Noble Capital Markets’ Biotechnology Analyst Robert LeBoyer’s coverage list for detailed analysis on other biotech stocks.
Company to Provide Updates on Multiple Phase 2 Clinical Trials
for GEO-CM04S1 and Gedeptin®
ATLANTA, GA, August 31, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it will present a company overview and host investor meetings during the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023 in New York City.
Presentation Details:
Presenter: David Dodd, Chairman & CEO
Date/Time: 2:30pm ET, September 11, 2023
Location: Lotte New York Palace Hotel, New York, NY
Webcast: A webcast of the presentation will be available here:
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
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Last updated: 31 August 2023 13:05
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Company to Provide Updates on Multiple Phase 2 Clinical Trials
for GEO-CM04S1 and Gedeptin®
ATLANTA, GA, August 31, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it will present a company overview and host investor meetings during the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023 in New York City.
Presentation Details:
Presenter: David Dodd, Chairman & CEO
Date/Time: 2:30pm ET, September 11, 2023
Location: Lotte New York Palace Hotel, New York, NY
Webcast: A webcast of the presentation will be available here:
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , 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.
2Q2023 Results. MustGrow reported zero revenue and a net loss of CAD$1.2 million, or a loss of $0.02 per share, during the quarter. We estimated revenue of CAD$1,000 and a net loss of $1.0 million. Similar to last quarter, we anticipate comparable quarterly results going forward until MustGrow receives regulatory approval in at least one market.
Capital and Cash Flows. MustGrow had cash of CAD$5.0 million at the end of the second quarter, down from CAD$6.1 million in the previous quarter, with the Company using cash of CAD$1.1 million of CFFO. We estimate that the Company currently has an approximate 14 month runaway before needing new capital.
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.
Company to Provide Updates on Multiple Phase 2 Clinical Trials
for its Next-Generation COVID-19 Vaccine and Cancer Immunotherapy Programs
ATLANTA, GA, August 29, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, is pleased to announce that it has been invited to present at the Emerging Growth Conference on September 6, 2023. This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s Chairman and CEO, David Dodd, in real time.
Please register here to ensure you are able to attend the conference and receive any updates that are released.
Following his presentation, Mr. Dodd will open the floor for questions. Please submit your questions in advance to Questions@EmergingGrowth.com or ask your questions during the event and Mr. Dodd will do his best to get through as many of them as possible.
About the Emerging Growth Conference
The Emerging Growth Conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community. The conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of individual and institutional investors, as well as investment advisors and analysts. All sessions are conducted through video webcasts and take place in the Eastern time zone.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Patent Covers Multiple Component Vaccine for Both Prevention and Treatment
Atlanta, GA, August 28, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/726,254 titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria”.
The allowed claims cover compositions comprising GeoVax’s modified vaccinia Ankara (MVA) vector expressing Plasmodium antigens and methods of inducing an immune response to malaria utilizing the compositions. The compositions and methods covered in the allowed claims are useful both prophylactically and therapeutically and may be used to prevent and/or treat malaria.
According to data from the World Health Organization, globally, malaria causes 227 million infections and 619,000 deaths annually. Despite decades of vaccine research, vaccine candidates have failed to induce substantial protection. Most of these vaccines are based on individual proteins that induce immune responses targeting only one stage of the malaria parasite’s life cycle. GeoVax’s MVA-VLP malaria vaccine candidates incorporate antigens derived from multiple stages of the parasite’s life cycle and are designed to induce an immune response with durable functional antibodies and CD4+ and CD8+ T cell responses, all hallmarks of an ideal vaccine-induced immune response.
David Dodd, GeoVax President and CEO, commented, “We remain strongly committed to advancing innovation towards improving public health worldwide and this patent allowance reflects a potentially significant advancement relative to malaria prevention. Our development priorities continue to be our next-generation COVID-19 vaccine, currently in Phase 2 clinical trials, and our cancer immunotherapy program, with Gedeptin® as our lead product in a Phase 1/2 clinical trial for Advanced Head and Neck cancer. However, developing vaccines against global public health threats, such as malaria, is also part of our longer-term commitment focus. This patent allowance adds to our growing portfolio of wholly owned, co-owned, and in-licensed intellectual property, now standing at over 115 granted or pending patent applications spread over 24 patent families.”
About the GV-MVA-VLPTM Platform
GeoVax’s GV-MVA-VLPTM vaccine platform utilizes modified vaccinia Ankara (MVA), a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into virus-like particles (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated can mimic the virus production that occurs in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
MALVERN, Pa., Aug. 23, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series C Preferred Stock, par value $0.01 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 p.m. Eastern Time on September 5, 2023. The shares of Series C Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Time on September 7, 2023. The outstanding shares of Series C Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a proposal to approve a reverse stock split, as well as any proposal to adjourn any meeting of shareholders called for the purpose of voting on the reverse stock split, and will not be entitled to vote on any other matter, except to the extent required under the Pennsylvania Business Corporation Law. Subject to certain limitations, each outstanding share of Series C Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series C Preferred Stock).
All shares of Series C Preferred Stock that are not present in person or by proxy at the meeting of shareholders held to vote on the reverse stock split as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company and shall have no voting power. Any outstanding shares of Series C Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by the Company’s Board of Directors or automatically upon the approval by the Company’s shareholders of an amendment to the Company’s articles of incorporation effecting the reverse stock split at such meeting.
The Series C Preferred Stock will be uncertificated, and no shares of Series C Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series C Preferred Stock equal to the number of shares of the Company’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.
Further details regarding the Series C Preferred Stock will be contained in a report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.
About Baudax Bio
Baudax Bio/TeraImmune is a biotech company focused on innovative products for certain auto-immune conditions, of which many but not all, are orphan drug conditions as well as acute care and related settings. The combined company will further the development of Treg therapy specific to HA (pipeline candidate TI-168). TI-168 is a next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitor. By combining the patented Treg culture method and TeraImmune designed FVIII-specific TCR, the Company has successfully demonstrated the therapeutic concept of FVIII TCR-Treg therapy in controlling of FVIII ADA in a hemophilic animal model. The lead program TI-168 has shown encouraging pre-clinical data and the FDA has cleared an IND to commence a Phase 1/2a clinical trial for the treatment of Hemophilia A with inhibition.
In addition, over time, the combined company will advance the development of TeraImmune’s innovative immune-cell therapies, leveraging a dual Treg manufacturing platform consisting of both natural regulatory Tregs isolated from patients and induced Tregs converted from a patient’s T-effector (“Teff”) cells. This Treg platform technology is designed for conditions that suppress unwanted immune reactions and includes the allogenic, or off-the-shelf, Tregs obtained from Umbilical Cord Blood for the treatment of skin diseases such as Atopic Dermatitis. For more information, please visit www.baudaxbio.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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, and TeraImmune or its management, are intended to identify such forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Baudax Bio’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, clinical results and other future conditions. There are a number of important factors that could cause Baudax Bio’s actual results to differ materially from those indicated or implied by such forward-looking statements including, without limitation: whether Baudax Bio will be able to successfully integrate the TeraImmune operations and realize the anticipated benefits of the acquisition of TeraImmune; whether Baudax Bio’s shareholders approve the conversion of the Series X Preferred Stock and the required cash payment of the then-current fair value of the Series X Preferred Stock if such approval is not provided; whether Baudax Bio’s cash resources will be sufficient to fund Baudax Bio’s continuing operations and the newly acquired TeraImmune operations, including the liabilities of TeraImmune incurred in connection with the completion of the Merger; whether Baudax Bio’s collaborations will be successful; whether Baudax Bio will be able to advance its current product candidate pipeline through preclinical studies and clinical trials, that interim results may not be indicative of final results in clinical trials, that earlier-stage trials may not be indicative of later-stage trials, the approvability of product candidates; whether Baudax Bio will be able to comply with the financial and other covenants under its credit facility; and whether Baudax Bio will be able to maintain its listing on the Nasdaq Capital Market. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Baudax Bio may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Baudax Bio’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward looking statement speaks only as of the date on which it was made. Neither Baudax Bio, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Baudax Bio’s views as of any date subsequent to the date hereof.
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 Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Dramatic changes. The Company has undergone a transformation since the end of 2022, first with the discontinuation of ANJESO, and the subsequent June 30, 2023 announced acquisition of privately-held TeraImmune. With the acquisition, the Company expanded its pipeline with a new IND-cleared therapeutic (TI-168) and could have another IND filed asset by yearend with the anticipated filing of its neuromuscular blocking reversal agent (BX3000).
2Q 2023 Results. ANJESO related activities have been reclassified as a discontinued operation. As a continuing operation, the Company in 2Q 2023 reported overall lower R&D and SG&A expenses of $4 million, compared to our $4.8 million outlook. However, this was more than offset by a change in warrant valuation of $2.87 million. Total loss from continuing operations was $7.3 million compared with our expectations for a $5.3 million loss.
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.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines.The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
2Q23 Included Data Presentations and Preparations For New Trials. Ocugen reported a 2Q23 loss of $23.7 million or $(0.10) per share. The R&D expense of $14.2 million included a non-cash impairment charge of $4.3 million related to COVAXIN supplies and fixed assets. Excluding the non-cash charge, R&D of $9.7 million was consistent with our expectations. Cash on June 30, 2023 was $70.6 million.
Two New Products Are Expected To Start Phase 1/2 Trials. During the quarter, IND applications to start clinical trials for OCU410ST in Stargardt disease and OCU410 in Geographic Atrophy (GA) in dry age-related macular degeneration (dry AMD) were filed as expected and cleared FDA review. Phase 1/2 trials for both products are expected to begin before year-end.
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.
Advanced clinical development initiatives for Cholesterol Efflux Mediator™ VAR 200, with planned initiation of a Phase 2a clinical trial in diabetic kidney disease (DKD) in the first quarter of 2024
Granted a European patent covering Phase 2a-ready Cholesterol Efflux MediatorTM VAR 200 (2-hydroxypropyl-beta-cyclodextrin) for use in diabetic nephropathy/diabetic kidney disease
Published new white paper detailing the critical role of inflammasome ASC in inflammatory diseases, and the potential of Inflammasome ASC Inhibitor IC 100 to address multiple CNS and non-CNS diseases
Added Dr. Douglas Golenbock to ZyVersa’s Inflammatory Disease Scientific Advisory Board to support advancement of Inflammasome ASC Inhibitor IC 100
WESTON, Fla., Aug. 21, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq-GM: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, today provides a corporate update and reports financial results for the second quarter of 2023 ending June 30, 2023.
“The second quarter of 2023 was a period of continued progress at ZyVersa as we completed key corporate, developmental, regulatory and financial initiatives designed to position the company to achieve value-building milestones involving our Cholesterol Efflux Mediator™ VAR 200 and Inflammasome ASC Inhibitor IC 100,” said Stephen C. Glover, Co-founder, Chairman, Chief Executive Officer, and President of ZyVersa. “We are pleased to report our VAR 200 program is progressing as planned, and we anticipate initiation of a Phase 2a clinical trial in diabetic kidney disease (DKD) in the first quarter of 2024. For our Inflammasome ASC Inhibitor IC 100, we are completing final preclinical activities to enable submission of an Investigational New Drug (“IND”) application and initiation of a first-in-human clinical trial in 2024.”
Mr. Glover concluded: “This is a very exciting time for ZyVersa as we seek to create shareholder value through the development of first-in-class drugs at the forefront of renal and inflammatory diseases. Significant value-building milestones are expected to be achieved for Cholesterol Efflux MediatorTM VAR 200 and Inflammasome ASC Inhibitor IC 100 over the remainder of 2023 and early 2024 to increase shareholder value.”
SECOND QUARTER AND RECENT PROGRAM UPDATES
Phase 2a-Ready Cholesterol Efflux Mediator™ VAR 200
European patent was granted covering VAR 200 for use in diabetic nephropathy/diabetic kidney disease
Planning and key initiatives are underway to initiate a Phase 2a clinical trial in patients with DKD, with initial patient enrollment expected by first quarter 2024
Inflammasome ASC Inhibitor IC 100
Continued to provide support for the mechanism of action of Inflammasome ASC Inhibitor IC 100 with consistent evidence across peer-reviewed academic literature on the role of inflammasomes in the pathogenesis of a broad range of diseases including Parkinson’s disease, Alzheimer’s disease, lupus nephritis, peripheral arterial disease, juvenile idiopathic arthritis, and alcoholic hepatitis
Enhanced Inflammatory Disease Scientific Advisory Board with the addition of Dr. Douglas Golenbock, a pioneer and internationally recognized authority in the field of innate immunity
Dr. Golenbock is The Neil and Margery Blacklow Chair in Infectious Diseases and Immunology and Professor and Chief, Division of Infectious Diseases and Immunology at the UMass Chan Medical School
SECOND QUARTER FINANCIAL RESULTS
Since its inception in 2014 through June 30, 2023, ZyVersa has not generated any revenue and has incurred significant operating losses and negative cash flows from its operations. Based on our current operating plan, we expect our cash of $0.2 million as of June 30, 2023, will only be sufficient to fund our operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations. ZyVersa will seek to fund its operations through public or private equity or debt financings or other sources, which may include government grants and collaborations with third parties.
Research and development expenses were $1.2 million for the three months ended June 30, 2023, an increase of $0.5 million or 69.7% from the three months ended June 30, 2022. The increase is primarily attributable to an increase of $0.5 million in the costs of manufacturing of IC 100.
General and administrative expenses were $3.9 million for the three months ended June 30, 2023, an increase of $2.8 million or 237.5% from the three months ended June 30, 2022. The increase is primarily attributable to $1.2 million of common stock granted to certain stockholders in exchange for increasing the duration of their lockup period for certain common stockholdings, $0.5 million in professional fees associated with being a public company, a $0.5 million increase in marketing costs for investor and public relations, $0.4 million in director and officer insurance, and $0.2 million for bonus accruals.
Pre-tax losses were $86.3 million for the three months ended June 30, 2023, an increase of $84.3 million compared to a pre-tax loss of approximately $2.0 million, for the three months ended June 30, 2022. The higher net loss reported for the three months ended June 30, 2023 is primarily due to the impairment of in-process research and development and impairment of goodwill of $69.3 million and $11.9 million, respectively, compared to none for the three months ended June 30, 2022. The impairment is a result of the decline in ZyVersa’s market capitalization as of June 30, 2023.
Net losses were $78.5 million for the three months ended June 30, 2023, an increase of $76.5 million compared to a net loss of approximately $2.0 million for the three months ended June 30, 2022. A deferred tax benefit of $7.8 million for the three months ended June 30, 2023, compared to no tax benefit or expense during the three months ended June 30, 2022, resulted from the impairment of the in-process research and development.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq-GM: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s additional financing and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
Corporate and IR Contact Karen Cashmere Chief Commercial Officer kcashmere@zyversa.com 786-251-9641
Media Contacts Casey McDonald cmcdonald@tiberend.com 646-577-8520
Dave Schemelia Dschemelia@tiberend.com 609-468-9325
ZYVERSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
Successor
June 30,
December 31,
2023
2022
(Unaudited)
Assets
Current Assets:
Cash
$
228,693
$
5,902,199
Prepaid expenses and other current assets
886,911
225,347
Vendor deposits
–
235,000
Total Current Assets
1,115,604
6,362,546
Equipment, net
12,133
17,333
In-process research and development
30,806,158
100,086,329
Goodwill
–
11,895,033
Security deposit
–
46,659
Operating lease right-of-use asset
53,898
98,371
Total Assets
$
31,987,793
$
118,506,271
Liabilities, Temporary Equity and Stockholders’ Equity
Current Liabilities:
Accounts payable
$
8,144,033
$
6,025,645
Accrued expenses and other current liabilities
2,281,026
2,053,559
Operating lease liability
59,625
108,756
Total Current Liabilities
10,484,684
8,187,960
Deferred tax liability
1,441,467
10,323,983
Total Liabilities
11,926,151
18,511,943
Commitments and contingencies (Note 8)
Successor redeemable common stock, subject to possible redemption,
0 and 65,783 shares outstanding as of June 30, 2023 and
December 31, 2022, respectively
–
331,331
Stockholders’ Equity:
Successor preferred stock, $0.0001 par value, 1,000,000 shares authorized:
Series A preferred stock, 8,635 shares designated, 200 and 8,635 shares issued
and outstanding as of June 30, 2023 and December 31, 2022, respectively
–
1
Series B preferred stock, 5,062 shares designated, 5,062 shares issued
and outstanding as of June 30, 2023 and December 31, 2022
1
1
Successor common stock, $0.0001 par value, 110,000,000 shares authorized;
23,669,074 and 9,016,139 shares issued at June 30, 2023 and December 31, 2022,
respectively, and 23,666,915 and 9,016,139 shares outstanding as of
June 30, 2023 and December 31, 2022, respectively
2,367
902
Additional paid-in-capital
107,044,663
104,583,271
Accumulated deficit
(86,978,221
)
(4,921,178
)
Treasury stock, at cost, 2,159 and 0 shares at June 30, 2023
and December 31, 2022, respectively
(7,168
)
–
Total Stockholders’ Equity
20,061,642
99,662,997
Total Liabilities, Temporary Equity and Stockholders’ Equity
Conference Call and Webcast Tomorrow at 8:30 a.m. ET
• Investigational New Drug (IND) Applications Cleared for Novel Gene Therapies for Geographic Atrophy Secondary to AMD and for Stargardt Disease
• OCU400 Clinical Study Results Update Expected This Quarter
MALVERN, Pa., Aug. 21, 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 reported second quarter 2023 financial results along with a general business update.
“We continue to advance our pipeline to provide solutions for patients living with serious diseases but without effective treatment options,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “It remains our plan to start dosing patients across all of our ophthalmology programs by the end of the year and we are very enthusiastic about the FDA clearance of our INDs for OCU410 and OCU410ST for a form of Geographic Atrophy and Stargardt disease, respectively.”
During important meetings in the second quarter of 2023, including The Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting and BIO International, the Company continued to educate key stakeholders about the science behind its innovative modifier gene therapy platform and next-generation inhalation vaccine candidates aimed at enhancing durability and reducing transmission.
This quarter, Ocugen plans to share updated data results on OCU400 from its Phase 1/2 clinical trial in patients with retinitis pigmentosa. The Company also continues to have ongoing conversations with government agencies towards obtaining support of its inhaled vaccines for COVID-19 and flu.
“We remain dedicated to our mission to develop cutting-edge therapies with a commitment to ensuring global market access,” said Dr. Musunuri. “We are executing plans consistent with our long-term strategy of delivering multiple products to market targeting unmet medical needs utilizing first-in-class platform technologies in gene therapies, cell therapies and vaccines.”
Ophthalmic Gene Therapies
OCU400 – Phase 3 adult trial to be initiated near the end of 2023/early 2024, subject to the outcome of the ongoing Phase 1/2 trial and discussions with the FDA on the proposed Phase 3 trial plan.
OCU410 and OCU410ST – IND applications to initiate Phase 1/2 trials for both OCU410 and OCU410ST were cleared by the FDA and the Company plans to initiate Phase 1/2 trials by the end of 2023.
Regenerative Cell Therapies
NeoCart® – Manufacturing facility construction for NeoCart is on target to be completed by the end of 2023, as planned. The Company plans to initiate the Phase 3 trial in the second half of 2024.
Vaccines Portfolio
Inhaled Mucosal Vaccine Platform – The Company is continuing the internal development of its inhaled mucosal vaccine platform to achieve IND readiness and intends to submit an IND application in 2024, provided it receives government funding. The Company has submitted multiple proposals to obtain government funding and is continuing discussions with relevant government agencies regarding developmental support for its inhaled mucosal vaccine platform.
Second Quarter 2023 Financial Results
The Company’s cash, cash equivalents, and investments totaled $70.6 million as of June 30, 2023, compared to $90.9 million as of December 31, 2022. The Company had 256.5 million shares of common stock outstanding as of June 30, 2023.
Total operating expenses for the three months ended June 30, 2023 were $23.7 million and included research and development expenses of $14.2 million and general and administrative expenses of $9.6 million. Research and development expenses for the three months ended June 30, 2023 included a non-recurring, non-cash expense of $4.4 million as a result of the impairment of the short-term asset for the advanced payment for the supply of COVAXIN as well as the associated loss on the disposal of related fixed assets. This compares to total operating expenses for the three months ended June 30, 2022 of $19.6 million that included research and development expenses of $9.0 million and general and administrative expenses of $10.6 million.
Ocugen reported a $0.10 net loss per common share for the three months ended June 30, 2023 compared to a $0.09 net loss per common share for the three months ended June 30, 2022.
Conference Call and Webcast Details Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET tomorrow 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 Conference ID: 6803433 Webcast: Available on the events section of the Ocugen investor site
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, 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. 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 include, but are not limited to, statements regarding our clinical development activities and related anticipated timelines. 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
(Tables to follow)
OCUGEN, INC. CONSOLIDATED BALANCE SHEETS (in thousands) (Unaudited)
June 30, 2023
December 31, 2022
Assets
Current assets
Cash and cash equivalents
$
70,578
$
77,563
Marketable securities
—
13,371
Prepaid expenses and other current assets
2,874
7,558
Total current assets
73,452
98,492
Property and equipment, net
11,720
6,053
Other assets
3,804
4,087
Total assets
$
88,976
$
108,632
Liabilities and stockholders’ equity
Current liabilities
Accounts payable
$
3,881
$
8,062
Accrued expenses and other current liabilities
7,787
9,900
Operating lease obligations
526
498
Current portion of long term debt
1,266
—
Total current liabilities
13,460
18,460
Non-current liabilities
Operating lease obligations, less current portion
3,308
3,587
Long term debt, net
1,472
2,289
Other non-current liabilities
455
244
Total liabilities
18,695
24,580
Stockholders’ equity
Convertible preferred stock
1
1
Common stock
2,566
2,217
Treasury stock
(48
)
(48
)
Additional paid-in capital
320,181
294,874
Accumulated other comprehensive income
22
26
Accumulated deficit
(252,441
)
(213,018
)
Total stockholders’ equity
70,281
84,052
Total liabilities and stockholders’ equity
$
88,976
$
108,632
OCUGEN, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) (Unaudited)
Three months ended June 30,
Six months ended June 30,
2023
2022
2023
2022
Operating expenses
Research and development
$
14,169
$
9,007
$
23,727
$
16,922
General and administrative
9,564
10,558
17,757
20,677
Total operating expenses
23,733
19,565
41,484
37,599
Loss from operations
(23,733
)
(19,565
)
(41,484
)
(37,599
)
Other income (expense), net
808
94
2,061
109
Net loss
$
(22,925
)
$
(19,471
)
$
(39,423
)
$
(37,490
)
Shares used in calculating net loss per common share — basic and diluted
238,311,498
215,862,977
231,952,888
210,806,330
Net loss per share of common stock — basic and diluted
Phase 1/2 Clinical Trial of TNX-801 for the Prevention of Mpox and Smallpox to Commence Following Submission of an IND
TNX-801 is Based on a Proprietary Live Virus Vaccine Platform Designed to Stimulate Durable T-Cell Immunity
TNX-801 Vaccination Protected Animals from a Lethal Challenge with Monkeypox in Preclinical Testing
CHATHAM, N.J., Aug. 21, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it received the official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-8011 (recombinant horsepox virus, live vaccine) as a potential vaccine to protect against mpox disease (formerly known as monkeypox) and smallpox. Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1/2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND.
“The FDA’s response to the pre-IND meeting marks an important milestone in the development of TNX-801 since we have FDA concurrence on the proposed manufacturing, toxicology studies, and the Phase 1/2 clinical design,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “TNX-801 is believed to be closely related to Edward Jenner’s original smallpox vaccine.2-10 Jenner’s live virus smallpox vaccine – the first vaccine – remains one of the most effective vaccines in history, since it typically provided lifetime immunity with a single dose, prevented forward transmission of the smallpox virus, and ultimately eradicated the disease. TNX-801 has an attenuated phenotype relative to modern vaccinia viruses, which comprise a group of vaccine viruses that evolved from Jenner’s vaccine during passage in man and animals for over 100 years. When live virus vaccinia vaccination was routinely practiced in Africa, mpox was kept out of the human population.”2,11
TNX-801 is a live replicating attenuated vaccine based on horsepox that is believed to protect against smallpox and mpox, primarily by eliciting a T-cell response evidenced by the “take”. The “take” is a functional measure of protective T-cell immunity validated by the eradication of smallpox. TNX-801 is administered with a single dose, can be readily scaled up for manufacturing using proven technology and can be distributed and stored without requiring a costly and cumbersome ultra-cold supply chain. Live replicating vaccines have the potential to induce durable T-cell immunity, prevent serious illness after infection and block forward transmission. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with mpox.12
“More than 30,000 people have contracted mpox in the U.S. so far during the 2022-23 epidemic,”13 said Dr. Zeil Rosenberg, Executive Vice President, Medical at Tonix. “The recent cluster of mpox in Chicago revealed breakthrough cases of mpox in individuals who had been vaccinated with the currently authorized non-replicating vaccine, which is administered in two doses.14 In contrast, TNX-801 is delivered intradermally with only one dose and therefore may achieve higher rates of community protection by eliminating drop-out between doses and limiting forward transmission. Moreover, relying on only one approved mpox vaccine at present is a risk for the global supply chain that has already led to insufficient availability of vaccine to meet global health needs, especially in Africa.”
Dr. Rosenberg added, “We believe TNX-801 could make a global impact on mpox and the risk of smallpox because of its potential durable T-cell immune response, the ability to manufacture at scale, to use a lower dose than non-replicating vaccines. The current formulation is a frozen liquid, but we believe that future lyophilized versions can be stored and shipped at standard refrigeration. Moreover, we believe the low dose of TNX-801 makes this technology amenable for future implementation in microneedle delivery systems.”
Dr. Lederman concluded, “In addition to its potential use as a vaccine, TNX-801 also has the potential as a viral vector platform, for which versions can be developed to protect against a host of infectious diseases beyond smallpox and mpox, including COVID-19. In light of the recent resurgence in COVID cases across the country with the new EG.5 “Eris” variant, we believe that the horsepox recombinant pox virus platform may provide next generation vaccines to prevent future outbreaks.”
About TNX-801* TNX-801 is a live virus vaccine based on horsepox2,11. Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor. TNX-801 is believed to be more closely related to Jenner’s vaccinia vaccine than modern vaccinia vaccines, which appear to have evolved by deletions and mutations to a phenotype of larger plaque size in tissue culture and greater virulence in mice. Molecular analysis shows that horsepox is closer than modern vaccinia vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner.2-10 Vaccine genome researchers have recently shown the contemporaneous use of horsepox and horsepox-related viruses in the United States as smallpox vaccines in the 1860’s9,10. Additionally they found a remarkable degree of identity with the circa 1860 U.S. smallpox vaccine VK05 and the 1976 Mongolian horsepox isolate called MNR-76, upon which Tonix’s TNX-801 is based.3,5 These recent discoveries are further steps in establishing that what is called ’horsepox‘ today was used to vaccinate against smallpox in the 19th century. Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox2. ‘Cow’ is ‘vacca’ in Latin. However, Dr. Jenner suspected that cowpox originated from horsepox.2 Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’. Equination and vaccination were practiced side-by-side in Europe6. The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate12. Relative to vaccinia, horsepox has substantially decreased virulence in mice3. Tonix’s TNX-801 vaccine candidate is administered intradermally. The major cutaneous reaction or “take” to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s.
TNX-801 is in the pre-IND stage and has not been approved for any indication.
Jenner E. “An Inquiry Into the Causes and Effects of the Variole Vaccinae, a Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire and Known by the Name of the cow‐pox.” London: Sampson Low, 1798.
Noyce RS, et al. (2018) PLoS One. 13(1):e0188453
Schrick L, et al. (2017) N Engl J Med 377:1491-1492
Tulman ER, et al. (2006) J Virol. 80(18):9244-58.
Esparza J, et al. (2017) Vaccine. 35(52):7222-7230.
Esparza J, et al. (2020) Vaccine. 38(30):4773-4779.
Qin L, et al. (2015) J Virol. 89(3):1809-24.
Brinkmann A, et al, (2020) Genome Biology 21:286
Duggan A, et al. (2020) Genome Biology 21:175 https://doi.org/10.1186/s13059-020-02079-z
Noyce RS, et al., (2023) Viruses. 15(2):356.
Trindade GS, et al. (2016) Viruses. 8(12):328.
McQuiston JH, et al. (2023) The CDC Domestic Mpox Response — United States, 2022–2023. MMWR Morb Mortal Wkly Rep. 72(20):547–552
Faherty EAG, et al.(2023) Emergence of an mpox cluster primarily affecting persons previously vaccinated against mpox-Chicago, Illinois, March 18-June 12, 2023. MMWR Morb Mortal Wkly Rep. , 72(25);696-698.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results are expected in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Tonix Medicines has contracted to acquire the Zembrace SymTouch and Tosymra registered trademarks. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
MALVERN, Pa., Aug. 18, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s second quarter 2023 financial results and provide a business update at 8:30 a.m. ET on Tuesday, August 22, 2023.
Ocugen will issue its 2Q23 financial results on Monday, August 21, 2023. Following the press release, the Company will hold the conference call on Tuesday, August 22 at 8:30 a.m. ET. Attendees are invited to participate in the call using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 6803433 Webcast: Available on the events section of the Ocugen investor site
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, 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. 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.
