Cocrystal Pharma Extends Drug Discovery Collaboration with HitGen and InterX

 

BOTHELL, Wash, March 10, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, the SARS-CoV-2 virus, hepatitis C viruses and noroviruses, announces an extension of its drug discovery collaboration with HitGen, a biotech company with an innovative DNA Encoded Library technology, and InterX Inc., a computer software company with a biomolecular simulation for drug discovery. The collaboration was initiated in September 2017 and will now continue through August 2023.

Through this collaboration, Cocrystal, HitGen and InterX scientists are applying HitGen’s DNA-encoded library (DEL) technology platform, Cocrystal’s structure-based drug discovery platform technology, and InterX’s computational science to develop novel antiviral lead candidates. The DEL technology combines the power of molecular biology, combinatorial chemistry, high throughput sequencing and advanced informatics to identify potential drug candidates. Cocrystal applies its technology to determine the cocrystal structures of the potential drug candidates identified from the DEL library. This structural information is then combined with InterX’s advanced computer algorithms to predict inhibitor-target interactions. A Joint Steering Committee comprised of representatives from all three companies is overseeing the collaboration.

“This collaboration represents a truly innovative and important approach to drug discovery in which we combine three novel platforms to generate and select molecules that could lead to superior drugs,” said Gary Wilcox, Ph.D., Chairman and Chief Executive Officer of Cocrystal. “We view this collaboration as a long-term relationship with the potential to build Cocrystal’s platform and expand our pipeline with high-value compounds for future development.”

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected term and the results of Cocrystal’s collaboration with HitGen and InterX. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, HitGen’s DNA Encoded Library technology and InterX software performing as expected, potential disagreements with HitGen or InterX resulting in delays or termination of the collaboration, and the results of future preclinical and clinical studies. The economic and unknown impacts of Covid-19 could result in unanticipated material adverse effects on HitGen, InterX or Cocrystal. Further information on our risk factors is contained in our filings with the SEC, including our Prospectus Supplement dated August 26, 2020 and our Annual Report on Form 10-K for the year ended December 31, 2020, as amended and supplemented by the Quarterly Reports on Form 10-Q for the three months ended June 30, 2020 and the three months ended September 30, 2020. 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.

Investor Contact:

LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

 

Lineage Cell Therapeutics Raises $35.9 Million From Sales Of Marketable Securities Holdings And An At-The-Market Equity Offering

 

Improved Cash Position Expected to Fund Operations for More Than Two Years

CARLSBAD, Calif.–(BUSINESS WIRE)–Mar. 8, 2021– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported that it raised $11 million in new capital from sales of its holdings of marketable securities, including shares of OncoCyte Corporation (Nasdaq: OCX) and Hadasit Bio-Holdings (TASE: HDST), as well as $25 million in gross proceeds from its at-the-market (“ATM”) offering. Lineage expects its approximately $57 million of cash and cash equivalents as of March 5, 2021 to fund operations well into 2023, by which time the Company expects to have achieved value-creating clinical and product development milestones. Lineage’s strengthened balance sheet also provides it with strategic flexibility in its ongoing partnership discussions.

“During the past six months, appreciation in our share price and that of marketable securities we owned has provided us with opportunities to monetize our investments and raise additional capital through our ATM offering,” stated Brian Culley, Lineage’s CEO. “These sales underscore that Lineage has created substantial value for its shareholders over time not only by advancing our product candidates toward later-stage clinical trials, but also by making and now harvesting significant early investments in OncoCyte and Hadasit and from aggressive and prudent expense reductions we previously reported. We expect that Lineage is now funded well into 2023, by which time we expect to have reached additional significant milestones, explored new areas to deploy our technology, and moved Lineage ever closer to our goal of becoming the preeminent allogeneic cell transplant company. Our stronger balance sheet also can provide us with optionality with respect to our ongoing partnership discussions.”

Cash and cash equivalents as of December 31, 2020 were $32.6 million and reflected $5.1 million in gross proceeds from sales on the ATM (which excluded $0.3 million in cash in transit related to 2020 sales that settled in 2021) and $0.8 million in gross proceeds from sales of Hadasit shares during the fourth quarter. From January 1, 2021 through March 5, 2021, Lineage raised an additional $19.9 million in gross proceeds through the ATM offering (which included $0.3 million in cash in transit related to 2020 sales that settled in 2021), as well as $10.1 million in gross proceeds from sales of OncoCyte shares and $21,000 in gross proceeds from sales of Hadasit shares. Lineage incubated OncoCyte and funded its initial product development before spinning it out as a separate public company in January 2016. As of March 5, 2021, OncoCyte’s market capitalization was over $300 million and Lineage has realized $32.5 million in total sales of its OncoCyte shares over time. The Company continues to hold 1,122,401 shares of OncoCyte stock valued at approximately $4.2 million and 169,167 shares of Hadasit stock valued at approximately $330,000, in each case based on the closing prices of those shares on March 5, 2021. Previously, Lineage also incubated and funded the initial product development of AgeX Therapeutics (NYSE American: AGE), and subsequently spun it out as a separate public company in November 2018, ultimately raising nearly $50 million from sales of its securities. Lineage believes that its broad technology platform and intellectual property portfolio may allow it to create additional value for shareholders through the advancement of its own novel pipeline as well as through the incubation and development of other products and companies, and through strategic corporate partnerships.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s expected eligibility for grants. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (the SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@troutgroup.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

Research coverage of Lineage Cell Therapeutics (LCTX) on Channelchek is provided by Noble Capital Markets, Inc. Please refer to the research disclosures on the most recent LCTX report for more information.

Friday, March 05, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
First Quarter 2021 Results

Avivagen Inc is a Canadian based company operating in the healthcare sector. It develops science-based, natural health products for animals. It develops and commercializes products for livestock feeds to replace antibiotics for growth promotion and to help prevent disease by supporting the animal’s own health defenses. Its product range includes OxC-beta, Vivamune health chews, Oximunol chewable tablets, and Carotenoid Oxidation products.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

1Q21 Results. Avivagen reported fiscal first quarter revenue of $261,987 and a net loss of $1.27 million, or $0.03 per share. We had projected revenue of $700,000 and a net loss of $1.25 million, or $0.03 per share. During the quarter, Avivagen shipped 2,325 kg of product to the Philippines, Thailand, and Taiwan. We had expected shipments into Mexico too during the quarter but the shipments moved into the second quarter.


Increasing Volume.  Although 1Q21 fell short of our expectations, so far in fiscal 2021 Avivagen has announced order volumes for fiscal 2021 that are larger than all of fiscal 2020. All shipping arrangements for the 10 tonne Mexican order have been finalized and shipments will commence in 2Q21. The 6 tonne order will begin in April 2021. We expect to see additional orders from UNAHCO, as well as…

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. 

Avivagen Announces Proposed Extension of Warrants

 

Ottawa, ON /Business Wire/ March 5, 2021 / – Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen” or the “Corporation”),a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhance and support immune function, thereby supporting general health and performance, announces that it will be requesting approval from the TSX Venture Exchange for the extension of the expiration date of warrants exercisable to purchase 2,774,992 common shares at $0.90 per share, which were originally issued on June 1, 2016. These warrants currently have an expiration date of March 31, 2021. Subject to TSX Venture Exchange approval, the new date of expiry for such warrants will be June 1, 2021. All other terms of such warrants will remain unchanged.

About Avivagen

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications. By unlocking an overlooked facet of beta-carotene activity, a path has been opened to safely and economically support immune function, thereby promoting general health and performance in animals. Avivagen is a public corporation traded on the TSX Venture Exchange under the symbol VIV and on the OTCQB Exchange in the U.S. under the symbol VIVXF, and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada and Charlottetown, Prince Edward Island. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock

Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about beta-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Taiwan, New Zealand, Thailand, Australia and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to the future plans of Avivagen’s customers and the potential for additional and/or increased orders from such customers, Avivagen’s expectations as to growth of its branding in certain jurisdictions, continued distribution and acceptance of Avivagen’s technology, anticipated growth in demand for Avivagen’s products, the potential for Avivgen’s products to be commercialized in human applications, the anticipated date of fulfillment for the order described, the possibility for OxCbeta ™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded and the size of market opportunities are all forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, the order described may not result in new orders for Avivagen’s products, the customer plans may change due to many reasons, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s brand recognition may not increase as anticipated or could be impacted by negative events, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications, including human applications, and may not be widely accepted as a replacement for antibiotics in livestock feeds, new market access may not occur in the timeline or manner expected by Avivagen, timing of fulfillment of the order may be delayed beyond current expectation for a number of reasons which would push fulfillment and recognition of revenues for this order into a future quarter and the market opportunities may not be as large as Avivagen anticipates, in each case due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Head Office Phone: 613-949-8164
Website: www.avivagen.com

SOURCE: Avivagen

Avivagen Announces Upcoming Research Publication Highlighting The Benefits Of OxC-betaTM Livestock for Broiler Poultry

 

• Study to be published soon in leading peer-reviewed journal Poultry Science.
• Poultry Science is an internationally renowned journal, known as the authoritative source for a broad range of poultry information and high-caliber research.

Ottawa, ON /Business Wire/ March 4, 2021 / – Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen” or the “Corporation”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that enhance feed intake and safely support immune function, thereby supporting general health and performance, has announced that a manuscript reporting the benefits of OxC-betaTM Livestock (“OxC-beta”) for broiler poultry has been approved for publication by Poultry Science, a leading peer-reviewed journal.

The paper, entitled “Effect of Oxidized ?-Carotene (OxBC) on the Growth and Feed Efficiency of Broilers” reports on the positive results of two dietary supplementation trials in which OxC-beta was used with broiler poultry. In both trials, birds in the OxC-beta groups achieved significantly improved growth performance measures, including average daily weight gain and feed utilization efficiency, when compared to birds in control groups. These findings demonstrate that dietary supplementation with OxC-beta helps broiler poultry achieve their full growth potential under real world commercial conditions without the use of antibiotics.

The first of the two comprehensive studies was conducted in Canada, with birds being reared under typical commercial conditions for broiler production in Ontario. The second study was conducted in Scotland under typical commercial conditions for broiler production in the United Kingdom.

“We are very excited about the publication of the study in a highly credible peer-reviewed journal like Poultry Science,” says Kym Anthony, Chief Executive Officer, Avivagen. “This publication provides an additional level of scientific validation supporting the commercially meaningful benefits of using OxC-beta for broiler poultry, providing additional value to Avivagen’s current and future customers committed to eliminating or reducing antibiotic use in their operations.’

About Avivagen

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications. By unlocking an overlooked facet of beta-carotene activity, a path has been opened to safely and economically support immune function, thereby promoting general health and performance in animals. Avivagen is a public corporation traded on the TSX Venture Exchange under the symbol VIV and on the OTCQB Exchange in the U.S. under the symbol VIVXF, and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada and Charlottetown, Prince Edward Island. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock

Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about beta-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Taiwan, New Zealand, Thailand, Australia and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to the future plans of Avivagen’s customers and the potential for additional and/or increased orders from such customers, Avivagen’s expectations as to growth of its branding in certain jurisdictions, continued distribution and acceptance of Avivagen’s technology, anticipated growth in demand for Avivagen’s products, the potential for Avivgen’s products to be commercialized in human applications, the anticipated date of fulfillment for the order described, the possibility for OxCbeta ™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded and the size of market opportunities are all forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, the order described may not result in new orders for Avivagen’s products, the customer plans may change due to many reasons, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s brand recognition may not increase as anticipated or could be impacted by negative events, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications, including human applications, and may not be widely accepted as a replacement for antibiotics in livestock feeds, new market access may not occur in the timeline or manner expected by Avivagen, timing of fulfillment of the order may be delayed beyond current expectation for a number of reasons which would push fulfillment and recognition of revenues for this order into a future quarter and the market opportunities may not be as large as Avivagen anticipates, in each case due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Head Office Phone: 613-949-8164
Website: www.avivagen.com

SOURCE: Avivagen

Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech shares Phase 3 Interim Results of COVAXIN, Demonstrates Efficacy of 81%

 

• Data from 25,800 participants in Phase 3 trial in India, received vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated and demonstrated 81% efficacy in preventing COVID-19 in those without prior infection after the second dose.
• Clinical trial to continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of COVAXIN in additional secondary study endpoints.

MALVERN, Pa., March 03, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that its co-development partner, Bharat Biotech, announced the results of the first interim analysis of its Phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN demonstrated a vaccine efficacy of 81%.

“We are thrilled with the interim efficacy results of Bharat Biotech’s Phase 3 trial of COVAXIN in India. These results, which in part suggest significant immunogenicity against the rapidly emerging UK variant, represent an additional step towards outlining the regulatory pathway for EUA and approval in the United States. COVAXIN, a whole virion based vaccine candidate, is designed to fill a significant unmet need in our national arsenal of vaccines against COVID-19,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“Today’s results from the interim analysis of Bharat Biotech’s Phase 3 trial of COVAXIN mark a milestone in the development of another critical vaccine option for the US market. COVAXIN has been shown to induce immune responses against multiple protein antigens of the virus potentially reducing the possibility of mutant virus escape. This breadth of immune responses has been demonstrated by ability of antibodies induced by COVAXIN to neutralize the UK variant of SARS-Cov-2,” said Dr. Bruce Forrest, member of the vaccine scientific advisory board of Ocugen.

Interim Phase 3 Results as Reported by Bharat Biotech

Bharat Biotech’s Phase 3 clinical trial enrolled 25,800 participants between 18-91 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the COVAXIN group, resulting in a point estimate of vaccine efficacy of 80.6%.

The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. The trial’s conduct and monitoring are as per Good Clinical Practice guidelines and have been outsourced to IQVIA.

Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains, which has been published in bioRxiv.

Bharat Biotech expects to share further details of the trial results as additional data become available. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication.

About COVAXIN

COVAXIN™, India’s COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.

In addition to generating strong immune response against multiple antigens, COVAXIN™ is shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to several other vaccines, COVAXIN™ is packaged in multi-dose vials that can be stored at 2-8oC.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to fight COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the US market. For more information, please visit www.ocugen.com.

About Bharat Biotech:

Bharat Biotech has established an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries, and World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 6 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first tetanus-toxoid conjugated vaccine for Typhoid.

Bharat’s commitment to global social innovation programs and public private partnerships resulted in the introduction of path breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The recent acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest rabies vaccine manufacturer in the world. To learn more about Bharat Biotech visit www.bharatbiotech.com

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 forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data that is the subject of this release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. 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.

Ocugen Contact:

Ocugen, Inc.
Sanjay Subramanian
Chief Financial Officer and Head of Corporate Development
ir@ocugen.com

Media Contact:

For Ocugen:

LaVoieHealthScience
Emmie Twombly
etwombly@lavoiehealthscience.com
+1 857-389-6042

Lisa DeScenza
ldescenza@lavoiehealthscience.com

+1 978-395-5970

SOURCE: Ocugen

Thursday, February 25, 2021

Onconova Therapeutics Inc. (ONTX)
Positive Trajectory, Raising Price Target

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Onconova regained compliance and will continue listing on Nasdaq. The compliance was attributed to the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2), as the Company’s common stock had a closing price of at least $1.00 per share for a minimum 10 consecutive business days.


Recent financial deals.  The company raised equity in two public offerings in Q1 2021, $8.7 million public offering (19,550,562 shares of its common stock at a purchase price of $0.445 per share) in January 2021 and $25 million common stock at a public offering price of $1.00 per share in February 2021. With those, the company has approximately $50 mm cash and cash equivalent over 235 mm shares …

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. 

Thursday, February 25, 2021

Onconova Therapeutics Inc. (ONTX)
Positive Trajectory, Raising Price Target

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Onconova regained compliance and will continue listing on Nasdaq. The compliance was attributed to the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2), as the Company’s common stock had a closing price of at least $1.00 per share for a minimum 10 consecutive business days.


Recent financial deals.  The company raised equity in two public offerings in Q1 2021, $8.7 million public offering (19,550,562 shares of its common stock at a purchase price of $0.445 per share) in January 2021 and $25 million common stock at a public offering price of $1.00 per share in February 2021. With those, the company has approximately $50 mm cash and cash equivalent over 235 mm shares …

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.