Release – Lineage Cell Therapeutics (LCTX) – Announces Appointment Of Anula Jayasuriya M.D. Ph.D., M.B.A, To Board Of Directors

 


Lineage Announces Appointment Of Anula Jayasuriya, M.D., Ph.D., M.B.A., To Board Of Directors

 

Successful Health Care Investment Executive with Extensive Business, Scientific and Medical Knowledge, as well as Broad Industry and Investment Experience

CARLSBAD, Calif.–(BUSINESS WIRE)–May 5, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions, today announced the appointment of  Anula Jayasuriya, M.D., Ph.D., M.B.A., to the Company’s Board of Directors, effective as of 
May 4, 2021Dr. Jayasuriya is a successful healthcare private equity executive and venture capitalist with extensive clinical, industry, entrepreneurial, and investment experience.  Dr. Jayasuriya is the Founder & Managing Director of 
EXXclaim Capital, an early-stage venture fund focused on catalyzing innovation, entrepreneurship and investment in Women’s Health, and a Co-founder of 
Evolvence India Life Science Fund (EILSF), the first fund in 
India to focus exclusively on healthcare and invest in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya received a B.A. from 
Harvard University summa cum laude, a  M. Phil. in pharmacology from the 
University of Cambridge, an M.D. and Ph.D. (in Microbiology and Molecular Genetics) from 
Harvard Medical School and an M.B.A. with distinction from 
Harvard Business School.

“Dr. Jayasuriya is a successful healthcare investment executive with deep insights and experience in the clinical development of a wide range of medical products. We are delighted she will be joining our Board of Directors,” stated  Al Kingsley, Lineage’s Chairman of the Board. “Dr. Jayasuriya’s appointment reflects an overall commitment to ensuring that our Board reflects a broad range of expertise and perspectives as Lineage works to position itself as a leader in the field of cell therapy and regenerative medicine.”

“I am excited to join Lineage’s Board at a transformational time in the Company’s history,” stated  Dr. Jayasuriya. “Lineage is pioneering a new branch of medicine by advancing its off-the-shelf cell transplant therapies toward later stage clinical trials. These products have the potential to address multi-billion-dollar market opportunities and greatly improve the lives of patients. I look forward to helping the Company as it positions itself for success in 2021 and beyond.”

Anula Jayasuriya, M.D., Ph.D., M.B.A.

Dr. Jayasuriya is the Founder & Managing Director of 
EXXclaim Capital, an early-stage venture fund focused on catalyzing innovation, entrepreneurship and investment in Women’s Health, and a Co-founder of 
Evolvence India Life Science Fund (EILSF), the very first fund in 
India to focus exclusively on health care and invest in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya has applied deep business, scientific, and medical knowledge in her career as a pharmaceutical company executive, private equity executive, and venture capitalist, providing her with a broad experience base spanning clinical, executive, entrepreneurial, and financial roles. She was among the first investors to recognize the untapped opportunity in the unmet needs in women’s health.

Integrating her passion with her investing expertise, in 2013 Dr. Jayasuriya founded 
EXXclaim Capital, which has invested in a portfolio of diverse Women’s Health companies ranging from digital health, medical devices, and diagnostics to consumer products. EXXclaim’s first investment, nVision Medical, was acquired in 2018 by 
Boston Scientific Inc. In 2006, she co-founded EILSF, focusing exclusively on investment in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya was previously a partner with 
Skyline Ventures in 
Palo Alto, and prior to that with the German/US venture capital firm TVM, in 
San Francisco. Her prior positions include VP Business Development at 
Genomics Collaborative Inc., Vice President, Global Drug Development at Hoffman-La Roche for opportunistic infections in AIDS and Transplantation, and Director, 
Outcomes Research at 
Syntex Laboratories.

Dr. Jayasuriya received a BA from Harvard summa cum laude, and an MD and PhD (in Microbiology and Molecular Genetics) from 
Harvard Medical School. She interned in Pediatrics at Boston Children’s Hospital and received an MBA with distinction from 
Harvard Business SchoolDr. Jayasuriya also holds a  M. Phil. in pharmacology from the 
University of Cambridge, in 
England.

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 advancing its off-the-shelf cell transplant therapies toward later stage clinical trials and the potential of those products to address multi-billion-dollar market opportunities and greatly improve the lives of patients and Lineage’s positioning for future success. 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 described in Lineage’s filings with the 
Securities and Exchange Commission (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 most recent Annual Report on Form 10-K filed with the 
SEC 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@soleburytrout.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.

Release – Cocrystal Pharma (COCP) – Announces $40 Million Bought Deal Offering of Common Stock


Cocrystal Pharma Announces $40 Million Bought Deal Offering of Common Stock

 

BOTHELL, Wash., May 04, 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, coronaviruses, hepatitis C viruses and noroviruses, today announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 26,000,000 shares of common stock of the Company, at a price to the public of $1.54 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about May 7, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The gross proceeds to Cocrystal, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $40 million. The Company intends to use the net proceeds from this offering for the expansion of its COVID-19 and Influenza treatment development programs and general corporate purposes and working capital.

The shares of common stock are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-237738) originally filed with the Securities and Exchange Commission (the “SEC”) on April 17, 2020, and declared effective by the SEC on May 13, 2020. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to, and describing the terms of, the offering will be filed with the SEC and will be available on the SEC’s website at https://www.sec.gov/. Electronic copies of the final prospectus supplement and accompanying prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at placements@hcwco.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

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 coronaviruses (including SARS-CoV-2), influenza viruses, 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.

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 complete the offering, our intended use of proceeds and other statements that are not historical fact. 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 risk that the offering may not close, risks arising from our reliance on continuing collaboration with Merck Sharp & Dohme Corp. under the collaboration agreement entered into last year, market and other conditions, the availability of products manufactured by third parties, the future results of preclinical and clinical studies, the research organization’s inability to recruit subjects and complete the Phase 2a study in a timely manner or at all, including as the result of civil unrest and political instability in Hong Kong, general risks arising from clinical trials, receipt of regulatory approvals, our ability to find and enter into agreements with suitable collaboration partners, unanticipated litigation and other expenses and factors that affect the capital markets in general and early stage biotechnology companies specifically. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 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.

 

Genprex (GNPX) – Initiates Site Recruitment for Acclaim-2 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer


Genprex Initiates Site Recruitment for Acclaim-2 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer

 

Acclaim-2 Clinical Trial Combines REQORSA™ immunogene therapy with Merck & Co’s Keytruda®

Company Expects to Recruit Approximately 15 Sites Across the United States

AUSTIN, Texas — (May 4, 2021) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, is pleased to announce it has commenced clinical trial site recruitment for its upcoming Acclaim-2 clinical trial for the treatment of non-small cell lung cancer (NSCLC).

Acclaim-2 is an open-label, multi-center Phase 1/2 clinical trial that combines Genprex’s lead drug candidate, REQORSA™ immunogene therapy, with Merck & Co, Inc’s Keytruda in patients with late-stage NSCLC who are low expressors (1% to 49%) of the protein programmed death-ligand 1 (“PD-L1”).

“Our clinical team remains focused on engaging with leading clinical investigators and esteemed research institutions in order to further our mission of bringing hope to lung cancer patients who are in need of new treatment options,” said Rodney Varner, President and Chief Executive Officer of Genprex. “We look forward to selecting the most optimal study sites, which will help to further fuel the success of our clinical trials.”

The Company plans to conduct the Acclaim-2 clinical trial in approximately 15 sites with about 150 patients in an adaptive Phase 1/2 design. The final protocol is subject to change based on input from investigators.Additional information on the Acclaim-2 clinical trial will be posted on ClinicalTrials.gov.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with TagrissoFor more information, please visit the Company’s web site at www.genprex.com or follow Genprex on TwitterFacebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes;  Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships including the scale up of the manufacture of its product candidates; and Genprex’s intellectual property and licenses. 

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.
(877) 774-GNPX (4679)

Investor Relations
GNPX Investor Relations
(877) 774-GNPX (4679) ext. #2
investors@genprex.com

Media Contact
Genprex Media Relations
(877) 774-GNPX (4679) ext. #3
media@genprex.com

electroCore Inc. (ECOR) – Announces U.S. Department of Veterans Affairs Study of gammaCore Sapphire™ (Non-Invasive Vagus Nerve Stimulator) for the Treatment of Post-Traumatic Headache


electroCore, Inc. Announces U.S. Department of Veterans Affairs Study of gammaCore Sapphire™ (Non-Invasive Vagus Nerve Stimulator) for the Treatment of Post-Traumatic Headache

 

ROCKAWAY, NJ
May 04, 2021 (GLOBE NEWSWIRE) — — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the 
U.S. Department of Veterans Affairs is starting an investigator-initiated study of the use of gammaCore SapphireTM non-invasive vagus nerve stimulation (nVNS) for the treatment of post-traumatic headache (PTH). PTH accounts for approximately 4% of all symptomatic headache disorders1 and is one of the most common consequences of mild traumatic brain injury (mTBI),2,3 also known as concussion. Estimates suggest that 69 million people per year experience a traumatic brain injury (TBI) worldwide.4 In addition, patients with PTH commonly suffer from comorbidities such as anxiety and depression,5 both of which are among the leading causes of disability worldwide.6

The study (GAP-PTH) is a randomized, multi-center, double-blind, parallel, sham-controlled trial enrolling up to 100 veterans and directed by the Veterans Health Administration’s 
Headache Center of Excellence (HCoE) at the 
West Haven VA Medical Center in 
West Haven, CT. PTH is a critical area of concern for the 
VA and it is estimated that more than 350,000 service members have headaches resulting from TBIs sustained in combat. PTH in veterans is most often caused by the kind of TBIs experienced during combat, including blast wave injuries

“PTH is one of the most common presentations among veterans who come to our 
VA Headache Centers of Excellence around 
the United States. Last year the 
Veterans Health Administration was caring for more than 140,000 veterans diagnosed with headache related to head trauma,” commented Dr. Jason Sico, National Director of the 
VA Headache Centers of Excellence Program and Associate Professor of Neurology (Headache Medicine and Vascular Neurology) and Internal Medicine (General Medicine) 
Yale School of Medicine.

“We have been using gammaCore nVNS successfully in veterans suffering from cluster headache and migraine at our center,” commented Dr.  Emmanuelle Schindler, Medical Director of the HCoE at 
VA Connecticut Healthcare System, Assistant Professor of Neurology at 
Yale School of Medicine, and primary investigator of the GAP-PTH study. “This will be among the first Randomized Controlled Trials (RCTs) for PTH and we look forward to demonstrating how gammaCore nVNS can help our veterans with PTH.”

“We appreciate the opportunity to work with  Dr. SchindlerDr. Sico and their team to evaluate the potential of gammaCore as an acute and/or preventive option for PTH” said  Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “gammaCore is being used across the 
Department of Veterans Affairs and 
Department of Defense for both cluster and migraine headache and we believe that the same mechanisms of action that support the efficacy of gammaCore in primary headaches could also provide relief to our servicemen, servicewomen, and veterans suffering from post-traumatic headache.”

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCoreTM

gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

  • gammaCore is contraindicated for patients with:
    • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
    • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
    • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
  • Safety and efficacy of gammaCore have not been evaluated in the following patients:
    • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
    • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
    • Pediatric patients (younger than 12 years)
    • Pregnant women
    • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat post-traumatic headache or traumatic brain injury and related disorders and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.


1 Seifert, T. D. & Evans, R. W. Posttraumatic headache: a review. Curr. Pain Headache Rep. 14, 292–298 (2010).
2 Nampiaparampil, D. E. Prevalence of chronic pain after traumatic brain injury: a systematic review. JAMA. 300, 711–719 (2008).
3 Mullally, W. J. Concussion. Am. J. Med. 130, 885–892 (2017).
4 Dewan, M. C. et al. Estimating the global incidence of traumatic brain injury. J. Neurosurg. 27, 1–18 (2018)
5 Minen, M. T., Boubour, A., Walia, H. & Barr,  W. Post-concussive syndrome: a focus on post- traumatic headache and related cognitive, psychiatric, and sleep issues. Curr. Neurol. Neurosci. Rep. 16, 100 (2016). A review that details the clinical characteristics and associated comorbidities of PTH.
6 GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the global burden of disease study 2015. 
Lancet. 388, 1545–1602 (2016).


Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Lineage Cell Therapeutics (LCTX) – To Report First Quarter 2021 Financial Results And Provide Business Update On May 13 2021

 


Lineage Cell Therapeutics To Report First Quarter 2021 Financial Results And Provide Business Update On May 13, 2021

 

CARLSBAD, Calif.–(BUSINESS WIRE)–May 4, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its first quarter 2021 financial and operating results on 
Thursday, May 13, 2021, following the close of the 
U.S. financial markets. Lineage management will also host a conference call and webcast on 
Thursday, May 13, 2021, at 
4:30 p.m. Eastern Time/
1:30 p.m. Pacific Time to discuss its first quarter 2021 financial and operating results and to provide a business update.

Interested parties may access the conference call by dialing (866) 888-8633 from the 
U.S. and 
Canada and (636) 812-6629 from elsewhere outside the 
U.S. and 
Canada and should request the “Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through 
May 21, 2021, by dialing (855) 859-2056 from the 
U.S. and 
Canada and (404) 537-3406 from elsewhere outside the 
U.S. and 
Canada and entering conference ID number 4996965. 

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.

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

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.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.

Avivagen Inc. (VIVXF)(VIV:CA) – Another Contract, This Time for 72 Tonnes

Tuesday, May 04, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
Another Contract, This Time for 72 Tonnes

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.

    New Order. Yesterday, Avivagen announced it entered into a contract for a four tonnes per month recurring order from Meyenberg International, the Company’s consultant in Mexico. The contract, which has a term of 18 months, includes an order for 500 kilograms delivered April 30th and a commitment to purchase a minimum of four tonnes per month, commencing July 2021 and ending October 2022. This contract should contribute some $2.4 million of revenue in 2021.

    Order Momentum.  The Meyenberg order continues the order momentum for Avivagen, building off the April 26th announcement that Avivagen received a purchase order for a single shipment of 4.4 metric tonnes of OxC-beta Livestock, the largest single shipment purchase order of OxC-beta to date …



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. 

Release – Lineage Cell Therapeutics (LCTX) – To Report First Quarter 2021 Financial Results And Provide Business Update On May 13 2021

 


Lineage Cell Therapeutics To Report First Quarter 2021 Financial Results And Provide Business Update On May 13, 2021

 

CARLSBAD, Calif.–(BUSINESS WIRE)–May 4, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its first quarter 2021 financial and operating results on 
Thursday, May 13, 2021, following the close of the 
U.S. financial markets. Lineage management will also host a conference call and webcast on 
Thursday, May 13, 2021, at 
4:30 p.m. Eastern Time/
1:30 p.m. Pacific Time to discuss its first quarter 2021 financial and operating results and to provide a business update.

Interested parties may access the conference call by dialing (866) 888-8633 from the 
U.S. and 
Canada and (636) 812-6629 from elsewhere outside the 
U.S. and 
Canada and should request the “Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through 
May 21, 2021, by dialing (855) 859-2056 from the 
U.S. and 
Canada and (404) 537-3406 from elsewhere outside the 
U.S. and 
Canada and entering conference ID number 4996965. 

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.

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

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.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.

Release – electroCore Inc. (ECOR) – Announces U.S. Department of Veterans Affairs Study of gammaCore Sapphire (Non-Invasive Vagus Nerve Stimulator) for the Treatment of Post-Traumatic Headache


electroCore, Inc. Announces U.S. Department of Veterans Affairs Study of gammaCore Sapphire™ (Non-Invasive Vagus Nerve Stimulator) for the Treatment of Post-Traumatic Headache

 

ROCKAWAY, NJ
May 04, 2021 (GLOBE NEWSWIRE) — — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the 
U.S. Department of Veterans Affairs is starting an investigator-initiated study of the use of gammaCore SapphireTM non-invasive vagus nerve stimulation (nVNS) for the treatment of post-traumatic headache (PTH). PTH accounts for approximately 4% of all symptomatic headache disorders1 and is one of the most common consequences of mild traumatic brain injury (mTBI),2,3 also known as concussion. Estimates suggest that 69 million people per year experience a traumatic brain injury (TBI) worldwide.4 In addition, patients with PTH commonly suffer from comorbidities such as anxiety and depression,5 both of which are among the leading causes of disability worldwide.6

The study (GAP-PTH) is a randomized, multi-center, double-blind, parallel, sham-controlled trial enrolling up to 100 veterans and directed by the Veterans Health Administration’s 
Headache Center of Excellence (HCoE) at the 
West Haven VA Medical Center in 
West Haven, CT. PTH is a critical area of concern for the 
VA and it is estimated that more than 350,000 service members have headaches resulting from TBIs sustained in combat. PTH in veterans is most often caused by the kind of TBIs experienced during combat, including blast wave injuries

“PTH is one of the most common presentations among veterans who come to our 
VA Headache Centers of Excellence around 
the United States. Last year the 
Veterans Health Administration was caring for more than 140,000 veterans diagnosed with headache related to head trauma,” commented Dr. Jason Sico, National Director of the 
VA Headache Centers of Excellence Program and Associate Professor of Neurology (Headache Medicine and Vascular Neurology) and Internal Medicine (General Medicine) 
Yale School of Medicine.

“We have been using gammaCore nVNS successfully in veterans suffering from cluster headache and migraine at our center,” commented Dr.  Emmanuelle Schindler, Medical Director of the HCoE at 
VA Connecticut Healthcare System, Assistant Professor of Neurology at 
Yale School of Medicine, and primary investigator of the GAP-PTH study. “This will be among the first Randomized Controlled Trials (RCTs) for PTH and we look forward to demonstrating how gammaCore nVNS can help our veterans with PTH.”

“We appreciate the opportunity to work with  Dr. SchindlerDr. Sico and their team to evaluate the potential of gammaCore as an acute and/or preventive option for PTH” said  Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “gammaCore is being used across the 
Department of Veterans Affairs and 
Department of Defense for both cluster and migraine headache and we believe that the same mechanisms of action that support the efficacy of gammaCore in primary headaches could also provide relief to our servicemen, servicewomen, and veterans suffering from post-traumatic headache.”

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCoreTM

gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

  • gammaCore is contraindicated for patients with:
    • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
    • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
    • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
  • Safety and efficacy of gammaCore have not been evaluated in the following patients:
    • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
    • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
    • Pediatric patients (younger than 12 years)
    • Pregnant women
    • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat post-traumatic headache or traumatic brain injury and related disorders and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.


1 Seifert, T. D. & Evans, R. W. Posttraumatic headache: a review. Curr. Pain Headache Rep. 14, 292–298 (2010).
2 Nampiaparampil, D. E. Prevalence of chronic pain after traumatic brain injury: a systematic review. JAMA. 300, 711–719 (2008).
3 Mullally, W. J. Concussion. Am. J. Med. 130, 885–892 (2017).
4 Dewan, M. C. et al. Estimating the global incidence of traumatic brain injury. J. Neurosurg. 27, 1–18 (2018)
5 Minen, M. T., Boubour, A., Walia, H. & Barr,  W. Post-concussive syndrome: a focus on post- traumatic headache and related cognitive, psychiatric, and sleep issues. Curr. Neurol. Neurosci. Rep. 16, 100 (2016). A review that details the clinical characteristics and associated comorbidities of PTH.
6 GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the global burden of disease study 2015. 
Lancet. 388, 1545–1602 (2016).


Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Release – Genprex (GNPX) – Initiates Site Recruitment for Acclaim-2 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer


Genprex Initiates Site Recruitment for Acclaim-2 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer

 

Acclaim-2 Clinical Trial Combines REQORSA™ immunogene therapy with Merck & Co’s Keytruda®

Company Expects to Recruit Approximately 15 Sites Across the United States

AUSTIN, Texas — (May 4, 2021) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, is pleased to announce it has commenced clinical trial site recruitment for its upcoming Acclaim-2 clinical trial for the treatment of non-small cell lung cancer (NSCLC).

Acclaim-2 is an open-label, multi-center Phase 1/2 clinical trial that combines Genprex’s lead drug candidate, REQORSA™ immunogene therapy, with Merck & Co, Inc’s Keytruda in patients with late-stage NSCLC who are low expressors (1% to 49%) of the protein programmed death-ligand 1 (“PD-L1”).

“Our clinical team remains focused on engaging with leading clinical investigators and esteemed research institutions in order to further our mission of bringing hope to lung cancer patients who are in need of new treatment options,” said Rodney Varner, President and Chief Executive Officer of Genprex. “We look forward to selecting the most optimal study sites, which will help to further fuel the success of our clinical trials.”

The Company plans to conduct the Acclaim-2 clinical trial in approximately 15 sites with about 150 patients in an adaptive Phase 1/2 design. The final protocol is subject to change based on input from investigators.Additional information on the Acclaim-2 clinical trial will be posted on ClinicalTrials.gov.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with TagrissoFor more information, please visit the Company’s web site at www.genprex.com or follow Genprex on TwitterFacebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes;  Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships including the scale up of the manufacture of its product candidates; and Genprex’s intellectual property and licenses. 

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.
(877) 774-GNPX (4679)

Investor Relations
GNPX Investor Relations
(877) 774-GNPX (4679) ext. #2
investors@genprex.com

Media Contact
Genprex Media Relations
(877) 774-GNPX (4679) ext. #3
media@genprex.com

QuickChek – May 4, 2021



Aurania Finds New Epithermal Target: Gold Found In Streams

Aurania Resources reported on a new epithermal target called Kuripan in its Lost Cities – Cutucu Project in southeastern Ecuador

Research, News & Market Data on Aurania Resources

Watch recent presentation from NobleCon17



Cocrystal up 100% on plans of a new antiviral drug development

Cocrystal has made progress on its Covid-19 antiviral drug candidates and plans to expand development

Research, News & Market Data on Cocrystal Pharma

Watch recent presentation from NobleCon17



Genprex Initiates Site Recruitment for Acclaim-2 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer

Genprex announced it has commenced clinical trial site recruitment for its upcoming Acclaim-2 clinical trial for the treatment of non-small cell lung cancer

Research, News & Market Data on Genprex

Watch recent presentation from NobleCon17



Comtech Telecommunications Corp. Awarded $6.5 Million of Funding for Cyber Training Solutions

Comtech Telecommunications announced that during its third quarter of fiscal 2021, its Government Solutions segment was awarded an additional $6.5 million of funding for its Joint Cyber Analysis Course Training solutions

Research, News & Market Data on Comtech

Watch recent presentation from NobleCon17



ACCO Brands Corporation Declares Quarterly Dividend

ACCO Brands announced that its board of directors has declared a quarterly cash dividend of $0.065 per share

Research, News & Market Data on ACCO Brands

Watch recent presentation from NobleCon17



electroCore, Inc. Announces U.S. Department of Veterans Affairs Study of gammaCore Sapphire

electroCore announced the U.S. Department of Veterans Affairs is starting an investigator-initiated study of the use of gammaCore Sapphire™ non-invasive vagus nerve stimulation (nVNS) for the treatment of post-traumatic headache

Research, News & Market Data on electroCore



Lineage Cell Therapeutics To Report First Quarter 2021 Financial Results And Provide Business Update On May 13, 2021

Lineage Cell Therapeutics announced that it will report its first quarter 2021 financial and operating results on Thursday, May 13, 2021

Research, News & Market Data on Lineage Cell Therapeutics

Watch recent presentation from NobleCon17

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Cocrystal Pharma (COCP) – Provides Update on its COVID-19 Antiviral Discovery and Development Programs


Cocrystal Pharma Provides Update on its COVID-19 Antiviral Discovery and Development Programs

 

BOTHELL, Wash., May 03, 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, coronaviruses, hepatitis C viruses and noroviruses, announces progress in developing broad-spectrum antiviral drug candidates that target coronaviruses including SARS-CoV-2, the coronavirus that causes COVID-19. Cocrystal initiated its COVID-19 program in March 2020 and has since expanded the program with additional development and licensing.

“We are aggressively developing novel coronavirus protease inhibitors for COVID-19 prophylactic and therapeutic use,” said Sam Lee, Ph.D., President of Cocrystal. “These drug candidates bind to a highly conserved region of the active site of SARS-CoV-2 protease that is required for SARS-CoV-2 viral replication. Our high-resolution x-ray cocrystal structures further confirmed the specific covalent interaction with this conserved region of the proteases of the coronaviruses SARS-CoV-2, SARS-CoV and MERS-CoV viruses.

“We believe that, due to their novel mechanism of action, our protease inhibitors are likely to be effective against new variants of SARS-CoV-2. This may include the recent variants first identified in the United Kingdom, South Africa, Brazil and India, which may be more contagious forms of the virus and may evade immunity produced by vaccines or previous infection,” he added.

Lead candidate CDI-45205

In December 2020 Cocrystal announced the selection of CDI-45205 as its lead coronavirus development candidate among a group of protease inhibitors obtained under an exclusive license agreement with Kansas State University Research Foundation (KSURF) announced in 2020.

CDI-45205 showed good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and also no cytotoxicity against a variety of human cell lines. The Company recently demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV-2 infected mice. Cocrystal has obtained promising preliminary pharmacokinetic results and is continuing to further evaluate CDI-45205.

“The immediate next steps in the process of advancing this candidate toward clinical development require scale-up synthesis and the subsequent manufacture of several kilograms of the active pharmaceutical ingredient (API) to support Investigational New Drug (IND)-enabling studies and Phase 1 trials,” said Dr. Lee. “Similar to our influenza CC-42344 program, we are exploring multiple routes of administration of preclinical lead molecules including oral, inhalation and injection. We will also be examining in vitro activities of our compounds against the SARS-CoV-2 variants.”

Novel SARS-CoV-2 replication inhibitors

Cocrystal has leveraged its antiviral development expertise by using its proprietary technology and drug discovery platform to launch a second COVID-19 program with additional antiviral compounds developed.

“While we are highly encouraged by preclinical progress with CDI-45205, we continue developing a new class of SARS-CoV inhibitors. We applied our proprietary drug discovery platform technology and high-throughput protein crystallography approach to design new chemical scaffolds to improve in vitro potency and pharmacokinetic properties,” explained Dr. Lee. “Lead discovery and optimization are ongoing. We anticipate identifying another SARS-CoV-2 preclinical lead for oral administration this year. In addition to these two SARS-CoV-2 protease programs, we are also developing novel SARS-CoV-2 inhibitors that block viral replication and transcription. Our goal is to rapidly advance multiple SARS-CoV-2 lead molecules to the clinical trial stage.”

“Public health officials are calling for the urgent development of potent antivirals that inhibit the replication cycle of SARS-CoV-2,” said Gary Wilcox, Ph.D., Chairman and Chief Executive Officer of Cocrystal. “Among the significant challenges scientists face is inhibiting viral replication without damaging the inner workings of healthy cells. Cocrystal’s approach to drug discovery could provide a solution for designing antivirals for use against a range of viruses, including coronaviruses, with limited off-target interaction.

“Our established, proprietary drug discovery platform is comprised of computation, medicinal chemistry and x-ray crystallography together with extensive knowledge of viruses and drug targets. This is a far different approach from traditional, empirical, medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes,” Dr. Wilcox concluded.

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 coronaviruses (including SARS-CoV-2), influenza viruses, 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 future effectiveness of the protease inhibitors, including against new variants of SARS-CoV-2, our expectations regarding the identification of another SARS-CoV-2 preclinical lead for oral administration, and the ability of our approach to drug discovery to yield effective antivirals with limited off-target interaction. 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, the risks and uncertainties arising from the impact of the COVID-19 pandemic on the national and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our coronavirus program, our ability to recruit patients into clinical trials, the results of future preclinical and clinical studies, and general risks arising from clinical trials. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 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

Release – Dyadic (DYAI) – Dyadic to Present at Upcoming Events

 


Dyadic to Present at Upcoming Events

 

JUPITER, Fla., May 03, 2021 (GLOBE NEWSWIRE) — Dyadic International, Inc. (“Dyadic”, or the “Company”) (NASDAQ: DYAI) a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today announced that the Company will participate in the following upcoming events:

KOL Fireside Chat
Title: The Potential of the Transformative Dyadic C1 Protein Technology in Helping Meet Global Health Challenges
Time: Tuesday, May 4, 2021 10:00 AM Eastern Time

The conversation will be moderated by Dr. David Bramhill, a veteran in the biotechnology industry with extensive experience using a wide array of protein production technologies.

The discussion will include the following Key Opinion Leaders (KOLs):

  • Alain Townsend, Ph.D. – Weatherall Institute – Oxford University
  • Albert Osterhaus, P.V.M, Ph.D. – Erasmus Medical Centre
  • Cecil Nick – Parexel (Clinical & Regulatory Support)
  • Joris Vandeputte – International Alliance for Biological Standardization

World Vaccine Congress
Presenter: Mark Emalfarb, CEO
Event Link: https://www.terrapinn.com/conference/world-vaccine-congress-washington/index.stm

Track: COVID-19 Vaccine Response & Approaches
Title: Dyadic C1-Cells – Flexible Scale Manufacturing of NexGen MonoValent & MultiValent Recombinant Antigen Vaccines & Antibodies
Time: Tuesday, May 4, 2021 4:30 PM to 4:45 PM Eastern Time

Track: COVID-19 Trials & Infectious Diseases
Title: DYADIC C1-CELLS – Realizing Full Global Potential of MonoValent and/or MultiValent Recombinant Antigen Vaccines & Antibodies
Time: Wednesday, May 5, 2021 5:00 PM to 5:15 PM Eastern Time

Track: COVID-19 Manufacture & Supply
Title: Dyadic C1- Cells, industrially proven hyper productive thermophilic filamentous fungus for manufacturing safe, effective and affordable recombinant protein antigen vaccines & antibodies for world population
Time: Thursday, May 6, 2021 3:30 PM to 3:45 PM Eastern Time

17th Annual PEGS Boston
Presenter: Mark Emalfarb, CEO
Track: Accelerating Vaccine Development for COVID-19
Title: Making Vaccines in Large Quantities, Flexible Commercial Scales More Affordable – C1 Cells
Time: Thursday May 13, 2021 2:40 PM -3:00 PM Eastern Time
Event Link: https://www.pegsummit.com/

Dyadic Management will be available during the events for one-one-one meetings. Interested industry partners may request a one-on-one meeting at jlatiuk@dyadic.com or contact Dyadic at (561) 743-8333. If you are registered for any of the events, you can also request a meeting through the event platform.

About Dyadic International, Inc.

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical protein production 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.

Contact:

Dyadic International, Inc.
Mark Emalfarb, CEO
Phone: (561) 743-8333
Email: memalfarb@dyadic.com

Avivagen (VIVXF)(VIV:CA) – Announces Recurring Order for OxC-beta Livestock


Avivagen Announces Recurring Order for OxC-beta™ Livestock

 

• Largest purchase amount and longest duration purchase to-date
• Four tonne per month order secured
• Order follows five successful OxC-beta™ Livestock commercial trials conducted with various species over the past six months

Ottawa, ON / Business Wire/ May 3, 2021 / 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 enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce that Meyenberg International Group, Avivagen’s consultant in Mexico, has entered into a contract which secures a four tonne per month recurring order for OxC-beta™ Livestock in Mexico.

The contract, which is 18 months from signing and includes an order for 500 Kgs delivered April 30th, is a commitment to purchase a minimum of four tonnes monthly, commencing in July, 2021 and ending October, 2022

“As we continue to see successful commercial trials conclude in those jurisdictions where OxC-beta™ Livestock is approved, we anticipate increased demand to follow, as has recently been demonstrated in Mexico and Thailand,” said Kym Anthony, Chief Executive Officer of Avivagen.  “With numerous other commercial trials currently underway and nearing completion, it is our belief that the continued success of such company conducted trials will help to accelerate the adoption and use of OxC-beta™ Livestock in approved jurisdictions and beyond. It is our belief that OxC-beta™ Livestock, once started by a customer, becomes core to their continued operations and will drive recurring orders for years to come.”

Meyenberg International Group
With a client base across North America and a well-earned reputation for enabling rapid growth for clients expanding into LATAM, Meyenberg’s experience in Mexico has enabled Avivagen to quickly establish and grow sales in the country since securing regulatory approval in August 2019.

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, Mexico, Taiwan, New Zealand, Thailand, 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.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance.  It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

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 recurring nature of the orders under the contract described above, the anticipated date of fulfillment for the order described,  Avivagen’s expectation that the customer in question will live up to its contractual commitment to purchase product monthly, anticipated increase in demand for Avivagen’s products,  Avivagen’s expectation that commercial trials currently underway will be completed and yield positive results, the anticipated impact of the results of such trials on demand for product, expectations as to the recurring and long term nature of a customer’s purchases once they begin using Avivagen’s products and  the possibility for OxC-beta™ 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 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 Avivagens products,  the customer plans may change due to many reasons, 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 or cause such order to be cancelled, the parties to the contract described may not live up to their contractual commitments and/or may agree to amend such contract to reduce the commitments described above, demand for Avivagens products may not continue to grow and could decline,  commercial trials may not be completed and, if completed, may not yield results that are positive or which lead to additional demand for Avivagen’s products, except as otherwise stated, customers are under no obligation to continue using Avivagen’s products and Avivagens 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, , in each case due to many factors, many of which are outside of Avivagens control.  Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagens most recent managements 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