Category: Health

Dyadic to Report Third Quarter 2020 Financial Results on Thursday, November 12, 2020

 

JUPITER, FL / ACCESSWIRE / October 29, 2020 / Dyadic International, Inc. (“Dyadic”) (NASDAQ:DYAI), a global biotechnology company focused on further improving and applying its proprietary C1 expression system to speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today announced that it will report its financial results for quarter ended September 30, 2020 after the market close on Thursday, November 12, 2020 and it will host a conference call that day at 5:00 p.m. Eastern Time to discuss those results.

Conference Call Information

Date: Thursday, November 12, 2020

Time: 5:00 p.m. Eastern Time

Dial-in numbers: (877) 407-8033 (U.S. or Canada) or +(201) 689-8033 (International)

No pass code is needed

Webcast Link: https://www.webcaster4.com/Webcast/Page/2031/38362

An archive of the webcast will be available approximately three hours after completion of the live event and will be accessible on the “Investors” section of the Company’s website at http://www.dyadic.com. To access the replay of the webcast, please follow the Webcast link above. A dial-in replay of the call will also be available to those interested. To access the replay, please dial 1 (877) 481-4010 (U.S. or Canada) or 1 (919) 882-2331 (International) and enter replay pass code: 38362.

About Dyadic International, Inc.

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1. The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Certain other research activities are ongoing which include the exploration of using C1 to develop and produce certain metabolites and other biologic products. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.

Please visit Dyadic’s website at http://www.dyadic.com for additional information, including details regarding Dyadic’s plans for its biopharmaceutical business.

Safe Harbor Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding Dyadic International’s expectations, intentions, strategies and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors, including those described in the Company’s most recent filings with the SEC. Dyadic assumes no obligation to update publicly any such forward-looking statements, whether as a result of new information, future events or otherwise. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at http://www.dyadic.com.

Contact:

Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: mailto:prawson@dyadic.com

SOURCE: Dyadic International, Inc.

 

Ceapro Inc. Announces Increased Financial Contribution from National Research Council of Canada for Innovative PGX Technology Project

 

Amendment Includes Additional Task To Develop Yeast Beta Glucan As An Inhalable Therapeutic For Covid-19

 

EDMONTON, Alberta, Oct. 22, 2020 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced that the National Research Council of Canada (NRC) has approved an amendment to Ceapro’s project entitled, “Positioning Canadian Innovation on a Global Stage Using Ceapro’s Disruptive PGX Platform Technology,” announced on August 15, 2019. The amended contribution will now provide a non-reimbursable financial contribution up to $590,000 through the Industrial Research Assistance Program (IRAP).

“We are pleased with the additional support from the NRC IRAP for this important project. While one of the key objectives for this project was to fine tune the PGX Demo Plant to optimize the impregnation process of bioactives involved in the production of several new chemical complexes targeting oral and dermal delivery systems, this enlarged project now includes an additional task related to the development of PGX yeast beta glucan (PGX-YBG) as an inhalable therapeutic for COVID-19 patients. More specifically, our team is looking at establishing the feedstock for mass production of PGX-YBG, optimizing the process for large scale industrial manufacturing of PGX-YBG and to modify the PGX Demo Plant to generate PGX-YBG for a human clinical trial,” commented Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro.

About Pressurized Gas eXpanded Liquid Technology (PGX)

Ceapro’s patented Pressurized Gas eXpanded (PGX) technology is a unique and disruptive technology with several key advantages over conventional drying and purification technologies that can be used to process biopolymers into high-value, fine-structured, open-porous polymer structures and novel biocomposites. PGX is ideally suited for processing challenging high-molecular-weight, water-soluble biopolymers. It has the ability to make ultra-light, highly porous polymer structures on a continuous basis, which is not possible using today’s conventional technologies. PGX was invented by Dr. Feral Temelli from the Department of Agricultural, Food & Nutritional Science of the University of Alberta (U of A) along with Dr. Bernhard Seifried, now Senior Director of Engineering Research and Technology at Ceapro. The license from U of A provides Ceapro with exclusive worldwide rights in all industrial applications.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions.

For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: czo@jtcir.com

Issuer:

Gilles R. Gagnon, M.Sc., MBA
President & CEO
T: 780-421-4555

This press release does not express or imply that the Company claims its product has the ability to eliminate, cure or contain the SARS-2-CoV-2 (COVID-19) at this time.

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.

Source: Ceapro Inc.

Thursday, October 22, 2020

Neovasc (NVCN)(NVCN:CA)

The FDA Panel to Decide on Reducer Commercialization in the US

As of April 24, 2020, Noble Capital Markets research on Neovasc is published under ticker symbols (NVCN and NVCN:CA). The price target is in USD and based on ticker symbol NVCN. Research reports dated prior to April 24, 2020 may not follow these guidelines and could account for a variance in the price target.

Neovasc Inc is a specialty medical device company. The company develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Tiara for the transcatheter treatment of mitral valve disease and the Neovasc Reducer for the treatment of refractory angina. Neovasc is developing the Tiara for the treatment of mitral valve disease. Neovasc operates its business in one segment.

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

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

The FDA panel is scheduled for October 27, 2020. Neovasc submitted a premarket approval application (PMA) for the Reducer device in December 2019 seeking approval for Reducer in the U.S. for the treatment of patients suffering from refractory angina. The FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will review the PMA for the Neovasc Reduce device on October 27, 2020.


What do we expect? We believe the decision from the FDA’s panel will be positive.  In our view, Reducer represents a solid case based on the benefit demonstrated in patients in the clinical trials (COSIRA and REDUCER-1), the post-market studies demonstrating similar results to the clinical studies, and the strong unmet need in the refractory angina landscape …

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. 

Conversion Labs Appoints Former White House Physician and U.S. Navy Rear Admiral, Dr. Connie Mariano, to Board of Directors

 

NEW YORK, Oct. 21, 2020 (GLOBE NEWSWIRE) — Conversion Labs, Inc. (OTCQB: CVLB), a direct-to-consumer telemedicine and wellness company, has appointed healthcare veteran, Dr. Connie Mariano, to its board of directors. Following her appointment, the board will have eight members, with five serving independently.

Board certified in internal medicine, Dr. Mariano brings 30 years of executive leadership in healthcare to Conversion Labs. She will advise company management on health care services and product development related to the company’s telemedicine brands, including Rex MD™, Shapiro MD™, SOS Rx™, Veritas MD™ and others under development.

Dr. Mariano has been a pioneer in breaking down barriers and shattering glass ceilings, including becoming the first Filipino American promoted to the rank of U.S. Navy Rear Admiral and the first military woman to be appointed White House Physician. She later became director of the White House Medical Unit and served for nine years at the White House as physician to three sitting presidents.

“A phenomenal healthcare leader, Dr. Mariano brings to our board extensive knowledge and experience in providing the best in quality health care,” noted Justin Schreiber, chairman and CEO of Conversion Labs. “Her background in internal medicine and concierge care represents a valuable addition to our board. We look forward to her insights and guidance as we continue to enhance and expand our telehealth platform.”

After leaving the White House, Dr. Mariano became a consultant in the executive health program at the Mayo Clinic in Scottsdale, Arizona, where she provided holistic health evaluations for senior executives. She later founded the Center for Executive Medicine, a concierge medical practice that provides ‘presidential-quality’ care to CEOs and their families.

She earned her bachelor’s degree with honors from Revelle College at the University of California, San Diego. She received her medical degree from the Uniformed Services University School of Medicine in Bethesda, Maryland, where she was commissioned as a U.S. Navy lieutenant upon graduation.

“Conversion Labs has earned a strong reputation of delivering quality, cutting-edge telehealth products and services, which is evident in its strong customer growth over the past year,” commented Dr. Mariano. “There is a growing need for telemedicine services in today’s post-COVID world, and I believe Conversion Labs is uniquely positioned to address this need. I look forward to contributing my knowledge and experience to support Conversion Labs’ growth in this very important field.”

Conversion Labs has seen an acceleration in its operational and financial performance since the beginning of the year. The company recently reported its annualized revenue run rate hit $46.8 million versus $12.5 million for all of 2019 — a more than three-fold increase.

About Conversion Labs

Conversion Labs, Inc. is a telemedicine company with a portfolio of online direct-to-consumer brands. The company’s brands combine virtual medical treatment with prescription medications and unique over-the-counter products. Its network of licensed physicians offers telemedicine services and direct-to-consumer pharmacy to consumers across the U.S. To learn more, visit Conversionlabs.com.

Important Cautions Regarding Forward-Looking Statements

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things our plans, strategies and prospects — both business and financial. Although we believe that our plans, intentions and expectations reflected in or suggested by these forward-looking statements are reasonable, we cannot assure you that we will achieve or realize these plans, intentions or expectations. Forward-looking statements are inherently subject to risks, uncertainties and assumptions. Many of the forward-looking statements contained in this news release may be identified by the use of forward-looking words such as “believe,” “expect,” “anticipate,” “should,” “planned,” “will,” “may,” “intend,” “estimated,” and “potential,” among others. Important factors that could cause actual results to differ materially from the forward-looking statements we make in this news release include market conditions and those set forth in reports or documents that we file from time to time with the United States Securities and Exchange Commission. All forward-looking statements attributable to Conversion Labs, Inc. or a person acting on its behalf are expressly qualified in their entirety by this cautionary language.

Trademarks are the property of their respective owners.

Company Contact
Conversion Labs
Juan Manuel Piñeiro Dagnery
CFO

Contact

Media and Investor Relations Contact
Ron Both or Grant Stude
CMA Investor Relations
Tel (949) 432-7566
Contact

Cocrystal Pharma Provides Update on Influenza A Program

 

• New in vitro data demonstrating antiviral activity with lead compound CC-42344 against Xofluza (baloxavir)-resistant H1N1 strain
• Company continues to advance IND-enabling studies for Phase 1 clinical study in 2021

BOTHELL, WA, Oct. 19, 2020 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the “Company”), announces promising in vitro and 7-day toxicity data for its influenza A preclinical lead molecule, CC-42344, that is currently being evaluated in IND-enabling studies for the treatment of both seasonal and pandemic influenza strain A.

The Company’s fully owned drug candidate CC-42344 is a potent, broad spectrum inhibitor of the influenza replication enzyme targeting the PB2 subunit, and has strong synergistic effects when combined with approved influenza antiviral drugs including Tamiflu (oseltamivir) and Xofluza (baloxavir). Cocrystal’s recent data shows that CC-42344 retained single digit nanomolar potency (EC50 = 0.5 nM) against Xofluza (baloxavir) resistant influenza A strain (H1N1, I38T). This can potentially show CC-42344 drug superiority when seeking FDA approval. Additionally, the Company reported a favorable safety profile from the ongoing IND-enabling studies including 7-day rat and dog toxicology studies, genotoxicity, and safety pharmacology. The results show a no adverse effect level (NOAEL) of CC-42344 greater than or equal to 1,000 mg/kg in both rat and dog. The Company plans to complete the ongoing IND-enabling studies and enter into clinical trials in 2021.

“We continue to make progress with this important program and are working to finalize the Phase 1 study protocol and initiate the Phase 1 study in 2021,” commented Sam Lee, Ph.D., President of Cocrystal. “Influenza continues to be a major global health concern, even during the current COVID-19 pandemic with authorities warning about a potential double pandemic this upcoming flu season. We are encouraged by the recent in vitro potency data of CC-42344 against the existing Xofluza (baloxavir) H1N1 resistant strain containing mutation I38T and believe we have the potential to significantly improve the treatment of influenza.”

Cocrystal is applying its proprietary platform technology to develop novel, broad spectrum influenza antivirals that are specifically designed to be effective against all significant A strains of the influenza virus and to have a high barrier to resistance due to the mechanism used to target the virus’s replication machinery. CC-42344, the Company’s lead molecule for the treatment of influenza A, binds to a highly conserved PB2 site on the influenza polymerase complex and exhibits a novel mechanism of action that inhibits viral replication.

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, SARS-CoV-2 virus, hepatitis C viruses, and norovirus. Cocrystal employs unique, proprietary, 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 related to our ability to show CC-42344 drug superiority when seeking FDA approval and our plans regarding the completion of the IND-enabling studies and the beginning of clinical trials. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the impact of the COVID -19 pandemic, the availability of products manufactured by third parties, and the future results of preclinical and clinical studies. Further information on our risk factors is contained in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended June 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 and Media Contact:

JTC Team, LLC
(833) 475-8247
COCP@jtcir.com

Source: Cocrystal Pharma, Inc.

Opregen Data Update To Be Featured In Presentation By Christopher D. Riemann, Md At 2020 American Academy Of Ophthalmology Meeting

 

Lineage Also Will be Featured in Separate Presentation Focused on Cell Based Therapies for AMD by Allen C. Ho, MD

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Oct. 15, 2020– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that updated interim results from a Phase 1/2a study of its lead product candidate, OpRegen®, a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), will be presented at the 2020 American Academy of Ophthalmology Annual Meeting (AAO 2020), to be held virtually (November 13-15, 2020). The presentation, “Phase 1/2a Study of Subretinally Transplanted hESC-Derived RPE Cells in Advanced Dry-Form AMD Patients” will be featured as part of the Original Paper Session, OP02V Retina, Vitreous Original Papers on November 15, 2020 between 7:40am to 8:25am Pacific Time by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine. (abstract number 30063541). In addition, data from Lineage will be shown in a presentation by Allen C. Ho, M.D. FACS, Wills Eye Hospital Attending Surgeon and Director of Retina Research, Professor of Ophthalmology, Thomas Jefferson University, entitled: “Cell Based Therapies and Surgical Strategies for Atrophic Age-Related Macular Degeneration 2020,” which is being presented as part of the AAO 2020 Retina Subspecialty Day, on November 13, 2020 at 1:38pm Eastern Time.

The American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, the AAO protects sight and empowers lives by setting the standards for ophthalmic education and advocating for our patients and the public. AAO innovates to advance our profession and to ensure the delivery of the highest-quality eye care. For more information, please visit www.aao.org or follow the academy on Twitter @AAO.

About Dry AMD

Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with dry AMD.

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 and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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.

Wednesday, October 14, 2020

Lineage Cell Therapeutics (LCTX)

Early VAC2 Data Shows Promise

Lineage Cell Therapeutics, Inc. (NYSE American: LCTX) 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 and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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

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

VAC2 preliminary Phase 1 study results. Lineage disclosed data from the Phase 1 clinical study of VAC2 for the treatment of non-small cell lung cancer (NSCLC), sponsored by partner Cancer Research UK (CR UK). The results showed induction of immune responses (significant induction of antigen-specific T cells) in four patients dosed to date. In addition, one patient (1/4 patients) experienced a radiological response (a measure of tumor response to therapy).


What does it mean? We believe this preliminary data is positive and shows clues of potential clinical activity.  While the data is encouraging, it is still early in the process and was assessed in a small population (four patients). Lineage used its option to reacquire VAC2 to further develop the asset in the clinic, announced in May 2020. The company plans to initiate a Phase 1/2 clinical trial …

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 Record Four Tonne Order from UNAHCO

 

• Four tonne order is the largest one-time purchase in Avivagen’s history, and follows UNAHCO’s three tonne order in April of this year, a previous record order
• Order comprised of two separate two tonne shipments that demonstrate UNAHCO’S expanded use of OxC-betaTM throughout the region.

Ottawa, ON / Business Wire/ October 13, 2020 / – Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), 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, is pleased to announce a four tonne order from UNAHCO, its largest purchase to date.

“UNAHCO has adopted and scaled an increasing use of our product, as is demonstrated by this record order and UNAHCO’s recent expansion of OxC-beta™ for use in poultry as well as swine,” said Kym Anthony, Avivagen’s CEO. “UNAHCO and their customers continue to see the benefits of using OxC-betaTM in their livestock feed, while our unique relationship with UNAHCO has served as a successful case study on how to test, adopt and scale as a business model with mutual benefit – for Avivagen and its customers – and we look forward to continuing to grow this important relationship.”

Avivagen is working diligently with its procurement partner on this order and is uncertain whether the entire order will be fulfilled and the related revenue included in its current fiscal quarter, ending October 31, 2020.

The Philippines continues to be an important and growing feed market for Avivagen, with an estimated annual feed production of 18.2 million metric tonnes for 2020, up dramatically from 11.75 million metric tonnes in 2016.

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 ?- 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 ?-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, Mexico, Brazil, 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

Lineage Cell Therapeutics And Cancer Research UK Announce Encouraging Preliminary Phase 1 Study Results With Vac2 For The Treatment Of Non-Small Cell Lung Cancer

 

• Potent Induction of Immune Responses Observed with VAC2 Vaccine
• Peripheral Antigen-specific Immunogenicity Above 3% Observed at Multiple Timepoints
• VAC2 Appears Well Tolerated with No Unexpected Adverse Events

CARLSBAD, Calif. & LONDON–(BUSINESS WIRE)–Oct. 13, 2020– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, and Cancer Research UK, the world’s leading cancer charity dedicated to saving lives through research, today announced encouraging preliminary results from an ongoing Phase 1 clinical study of VAC2 in non-small cell lung cancer (NSCLC). VAC2 demonstrated remarkably potent induction of immune responses in all patients dosed to date, with high levels of peripheral antigen-specific immunogenicity observed at multiple time points and confirmed by multimer staining. On the basis of these findings, and following completion of the ongoing VAC2 clinical study in NSCLC, Lineage will seek to evaluate VAC2 in combination with therapies considered biologically complementary to VAC2, such as chemotherapy and the immune cell protectant properties offered by anti-PD1 immunotherapy.

Lineage recently conducted an early exercise of its option to acquire data from Cancer Research UK and assumed responsibility for further development of the VAC2 product candidate as well as future development opportunities derived from the VAC platform, while Cancer Research UK’s Centre for Drug Development concludes the ongoing clinical study.

“Based on review of all available data, the therapy was safe and well tolerated in all patients. While the safety profile was expected, the immunogenicity data are remarkable and highly provocative,” stated Christian Ottensmeier, MD, PhD, FRCP, Professor of Experimental Medicine at the University of Southampton and Chief Investigator on the VAC2 clinical study. “Antigen-reactive pentamer staining data induced by VAC2 suggest that the vaccine is highly potent, inducing significantly higher levels of antigen-specific T cells, compared with that invoked by alternative vaccine approaches, such as DNA- and RNA-based vaccines. From my perspective as an immuno-oncologist these data support rapid phase II testing, focused on clinical benefit.”

Brian Culley, Chief Executive Officer of Lineage, said: “Interestingly, one patient experienced a radiological response following chemotherapy subsequent to VAC2 treatment. Although anecdotal and occurring after the patient had completed the VAC2 trial, responses in this setting are rare and support further investigation. Dendritic cells are the most potent antigen-presenting cells in the body and harnessing their power to accurately deliver information about foreign material is re-emerging as an attractive therapeutic modality based on their consistent safety profile and increasing knowledge of how to deploy them in the clinical setting. As a leader in the field of cell therapy, Lineage aims to advance the current VAC2 product candidate and identify ways to expand the VAC platform through internally-owned and externally-partnered antigens.”

Dr. Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said: “We are pleased to see, after several years of development, the clinical progress that VAC2 has made and the impact it could have for people with lung cancer, which is the third most common cancer in the UK. We are excited to continue our support of the next phase of development of VAC2 and assist with the expansion of those efforts into additional cancers, and other potential areas with significant unmet medical need.”

About VAC2

VAC2 is an allogeneic, or non-patient specific, off-the-shelf cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry any antigen, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 clinical study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

About T Cell Induction

Lopes A, Vandermeulen G, Préat V. Cancer DNA vaccines: current preclinical and clinical developments and future perspectives. J Exp Clin Cancer Res. 2019;38(1):146.; Sebastian M, Schröder A, Scheel B, et al. A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer. Cancer Immunology, Immunotherapy 2019;68(5):799-812.

About Cancer Research UK’s Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.

About Cancer Research UK’s Commercial Partnerships Team

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.

About Cancer Research UK

• Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
• Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
• Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
• Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
• Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
• Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured.

For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

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 and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. 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 plans to advance the VAC2 platform. 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.

Dyadic Updates Market on COVID-19 Initiatives

 

• C1 Expression of SARS-CoV-2 Monoclonal Antibody Achieved
• Ten On-going Animal Trials of C1 Expressed SARS-CoV-2 Receptor Binding Domain (RBD) Antigen by Seven Different Collaborators
• Record Expression Level of C1 SARS-CoV-2 RBD Antigen (3 g/l in 5 days)
• Non-Exclusive Technology Usage Agreement with Epygen Biotech of India

JUPITER, FL / ACCESSWIRE / October 12, 2020 / Dyadic International, Inc. (“Dyadic” or the “Company”) (NASDAQ:DYAI), a global biotechnology company focused on further applying its proprietary C1 gene expression platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today is updating the market on the progress made in certain of its coronavirus (COVID-19) programs globally.

Dyadic’s C1 Rapid Recombinant Protein Manufacturing Platform has demonstrated that it can manufacture monoclonal antibodies (mAbs) more efficiently and faster than currently existing CHO mAb technology, potentially broadening access to this therapeutic treatment. Dyadic has expressed a SARS-CoV-2 monoclonal antibody in collaboration with a biotech company that is developing antibody cocktails to treat COVID-19 patients.

“The recent successful use of monoclonal antibody cocktails for the treatment of COVID-19 has also highlighted important production and supply constraints. Our C1 platform has the potential to generate 3x to 4x greater quantities of monoclonal antibodies in the same timeframe when compared to the current production methods using CHO cells. While that is still not yet enough to meet anticipated global demand, it certainly is a significant step in potentially helping to ensure greater access to patients, and at a lower cost,” said Dyadic CEO, Mark Emalfarb.

Dyadic has developed a COVID-19 vaccine antigen from its proprietary and patented C1 cell line that can be produced at three grams per liter (3 g/l) in only five days. The proprietary C1 expressed receptor binding domain (RBD) of the SARS-CoV-2 spike protein is being used in animal trials by seven different research groups, governmental agencies and biopharma companies (including the Israel Institute for Biological Research (IIBR) and a collaboration of European Union scientists that participated with Dyadic in the ZAPI program). These parties are testing the C1 expressed RBD vaccine candidate(s) in animal trials on a stand-alone basis as well as testing the C1 RBD with nanoparticles and adjuvants. The Company currently expects up to ten animal trials to be completed by the end of 2020. These programs are in addition to the previously announced activities with the Frederick National Laboratory, Jiangsu Hengrui Medicine and other third-party collaborations which are working with Dyadic’s C1 expression platform to express their own COVID-19 and other vaccine and antibody candidates for a number of animal and human health applications.

Data generated by a number of these third parties confirmed that the C1 expressed RBD has the correct structure resulting in high binding and neutralizing capacity. Additionally, the recently concluded IIBR mice study shows that the C1 RBD has the potential to generate excellent immunogenicity responses with very high titers and neutralizing antibodies against the SARS-CoV-2 coronavirus.

“The initial mice trial, as reported to us by the IIBR, was very successful, and we expect to have additional data to disclose after a number of these animal trials are completed and their data is analyzed further. Going forward, we expect there will be follow-on animal studies which will include challenge studies with hamsters and human Ace2 transgenic mice, as well as additional studies including a toxicology study,” continued Mr. Emalfarb. “Further, our C1 technology can express high levels of proteins more rapidly at flexible commercial scales more affordably using single use or stainless-steel bioreactors. We believe that our C1 platform, developed initially for high-volume low-cost industrial use, easily enables affordable, regional production of vaccines, antibodies and other therapeutic proteins, which has driven a heightened interest in our C1 technology.”

Dyadic has recently entered into a non-exclusive technology usage agreement with Epygen Biotech of India, who after obtaining required funding, expects to produce cGMP clinical trial material at their facility and conduct clinical trials in India using Dyadic’s C1 expressed RBD antigen of the SARS-CoV-2 Spike Protein.

“The Epygen agreement demonstrates how potential collaborators globally can develop and eventually manufacture vaccines and drugs on a regional basis that are affordable, safe and effective. Debayan Ghosh, President and Founder of Epygen, is intimately familiar with our technology from his work at Biocon as a biotechnologist, his time spent working for Dyadic in the late 90’s and, most recently, as a result of Epygen’s interest in the manufacturing of cGMP clinical grade C1 expressed RBD antigens. It is especially gratifying for us to be working with someone who understands, firsthand, C1’s success in industrial biotech and appreciates how the technology can be broadly applied to biopharmaceuticals,” concluded Mr. Emalfarb.

About Dyadic International, Inc.

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1. The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Certain other research activities are ongoing which include the exploration of using C1 to develop and produce certain metabolites and other biologic products. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.

Please visit Dyadic’s website at http://www.dyadic.com for additional information, including details regarding Dyadic’s plans for its biopharmaceutical business.

Safe Harbor Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding Dyadic International’s expectations, intentions, strategies and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors, including those described in the Company’s most recent filings with the SEC. Dyadic assumes no obligation to update publicly any such forward-looking statements, whether as a result of new information, future events or otherwise. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at http://www.dyadic.com.

Contact:

Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: mailto:prawson@dyadic.com

SOURCE: Dyadic International, Inc.

 

Does it Matter if the President and FDA Disagree on What’s Best?

Vaccines and therapeutics typically require years, even decades, of research and laboratory testing before being elevated to clinical trials.  Today, pharmaceutical companies, with support from the government, are racing to produce an effective SARS-CoV-2 vaccine by year-end 2020.  Researchers are now evaluating for safety and efficacy 44 vaccines in clinical trials on humans, 91 preclinical vaccines are at an earlier stage where they are being tested in animals.

This is a rampant pace. Work began deciphering the COVID-19 genome as early as January. The first human vaccine safety trials began just a few months later; by any measure, this is a fast track pace, fraught with uncertainty as short-term and long-term results are unknowable.

Role of the FDA

The Food and Drug Administration (FDA) regulates vaccines and other medications. After a rigorous review of laboratory and clinical results to ensure safety, benefits, and side effects, a product may be approved to be used for a specific illness. There are currently no vaccines available for the prevention of COVID-19. An approval cycle that typically takes years is being expedited. In the case of the 2020 pandemic, the FDA  has shortened standard testing periods and is providing timely advice and closer than normal interactions with vaccine developers. The FDA is also supporting product development and scaling up of manufacturing capacity for high-priority vaccines to be used against COVID-19.

Can You Rush Success?

Some things cannot be known with any vaccine or therapeutic without years of study. Certainty only comes with approved use in the broader population over time. The FDA has allowed an emergency pace for the development of treatment and preventatives to the novel coronavirus, and first-generation treatments are in the final phase of testing. The results and approved products are expected to become available in the coming months. The FDA guidelines related to COVID-19 allow a fast pace by any measure; however, the White House believes the country would be served better if the rollout was accelerated even quicker.

Are the White House and the FDA at Odds?

The FDA’s instructions are that vaccine developers follow test-case patients for at least two months to rule out safety issues before they seek emergency approval. This requirement does not sit well with the White House as they believe there is “no clinical or medical reason” for the additional requirement. They have taken steps to “overrule” this two-month step.

On the FDA side, Commissioner Stephen Hahn has been acting to shore up public confidence in the FDA’s vaccine fast pace review for weeks. He has vowed not to be swayed by any political agenda to get a cure or preventative out sooner than prudence would dictate. He believes career scientists, not politicians, are best suited to decide if a new product is safe and effective for mass vaccination.

President Trump has insisted that a vaccine could be authorized before Election Day; his motivations are based more on returning the country to a pre-COVID state as soon as humanly possible. Scientists involved at the FDA are not as comfortable ignoring cautionary protocols.

Actual Impact of White House Impatience

Beyond the strained relationship and perception of overruling the Food and Drug Administration, the impact of the White House action to block current vaccine guidelines may be inconsequential.

Only one drug maker, Pfizer (PFE) has suggested it meets all the criteria and could provide data on the safety and effectiveness of its vaccine before November. Afterward, the FDA would need to closely review the scientific studies and approve or reject their product. This would take time. Pfizer’s competitors Moderna (MRNA), AstraZeneca (AZN), and Johnson & Johnson (JNJ) are working on longer researcher timelines.

It is not out of the question that therapeutics currently under study will reach the approval process sooner than a vaccine. Any vaccine approval may be followed by more effective options later on by companies working on a longer timeline.

 

Suggested Videos:

Genprex Virtual Road Show

PDS Biotechnology C-Suite Series

Dyadic Int’l C-Suite Series

 

Dyadic International (DYAI) Wednesday October 14 1:00pm EDT Virtual Meeting With: Mark Emalfarb – President & CEO Register Now

 

Sources:

White House nixes updated FDA guidelines on vaccine approval

Everything you need to know about what it would take for the FDA to approve a COVID-19 vaccine

Coronavirus Vaccine Tracker

When Will You Be Able to Get a Coronavirus Vaccine?

White House Takes Issue With FDA’s Plans for Authorizing a Covid-19 Vaccine

Photo: Jernej Furman,  Vaccine Syringes With Flag of the United States of America (Changes made to height)

Tuesday, October 06, 2020

PDS Biotechnology Corp (PDSB)

PDS’s Diverse Portfolio in Broad Therapeutic Areas Is Highly Appealing

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

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

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

What do we like? The applicability of the platform technology. In our view, PDS remains under the Street’s radar with a clinical pipeline as well as a versatile technology platform enabling growth in new directions. As we look forward, we believe that both oncology and infectious disease portfolios may provide dynamic catalysts for the medium term, while the technology platform with multiple Phase 2 clinical trials provides fundamental depth to future value.


Portfolio diversification is utmost in the near-term.  The value-generating catalyst in the near-tear is predominantly based on the commencement of two Phase 2 clinical trials in Q4 2020 – PDS0101 for the treatment of i) recurrent/metastatic head and neck cancer (HNC) and ii) advanced cervical cancers. The company also broadened infectious disease programs to include the development of vaccines for …

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.