Avivagen Selects Meyenberg International Group to Spearhead Expansion Efforts in Central and South America

Ottawa, ON / February 24, 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 enhance feed intake and safely support immune function, thereby supporting general health and performance, is pleased to announce that it has chosen Meyenberg International Group to lead expansion efforts in key regions in Central and South America. Meyenberg has been critical to Avivagen’s recent success in Mexico and will begin by overseeing the process to seek registrations for OxC-betaTM Livestock in Costa Rica, Colombia, Peru, Uruguay and Argentina.

“Meyenberg International Group has been instrumental in both the approval for, and rapid adoption of OxC-beta Kym Anthony, Chief TM Livestock in Mexico over the past 18 months,” says Executive Officer, Avivagen, Inc. “We’re very excited to have founder Alejandro Meyenberg and his team expand on that success in other important livestock regions throughout Central and South America.”

The combined annual livestock feed consumption in Costa Rica, Colombia, Peru, Uruguay and Argentina was approximately 40 million tonnes in 2020, on par with the 38 million tonnes consumed in Mexico each yeari.

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.

Meyenberg has been central to establishing key client relationships in Mexico including Industrias Melder, which increased purchase order size rapidly from an initial 50 kg order to a 10 tonne order in a six-month span, and Transformadora Agricola, which placed a six tonne order in January 2021. The strategic working relationship with Meyenberg also enabled Avivagen to join Asociación Nacional de Fabricantes de Alimentos Para Consumo Animal. S.C (ANFACA) and Asociación Mexicana de Productores de Alimentos, A.C. (AMEPA) in Mexico, two of the most important and influential feed and dairy production associations in the country.

About Avivagen

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

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

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

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

Forward Looking Statements

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

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

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Phone: 416-540-0733
E-mail: [email protected]

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

SOURCE: Avivagen

Non-Invasive Vagus Nerve Stimulation (nVNS) Enters New Stage of COVID-19 Research

electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company and the Hospital Clínico Universitario de Valencia in Spain, announced the completion of patient enrollment in SAVIOR-1, or “Prospective, Randomized, Controlled Study to Evaluate the Effect of Non-Invasive Electrical Vagus Nerve Stimulation on Respiratory Symptoms due to COVID-19.” This study was supported in part by electroCore. Closing enrollment for this study is an important step to better understanding the clinical benefit of non-invasive vagus nerve stimulation (nVNS) and how it can help patients suffering from COVID-19 respiratory distress.

“Vagus nerve stimulation offers potential promise for the medical and scientific community studying COVID-19 as an effective treatment to assist with respiratory function,” says the principal investigator of the Savior study, Dr. Carlos Tornero, Head of the Department of Anesthesiology, Resuscitation and Pain Therapeutics of the Hospital Clínico Universitario de Valencia, Spain. “We look forward to studying the clinical benefit of nVNS in COVID-19 patients suffering from respiratory distress.”

Identifying novel therapies to treat COVID-19 respiratory symptoms remains top of mind in the medical community. In fact, the most downloaded 2020 article in the Journal of Neuromodulation was The Use of Non?invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated With COVID?19: A Theoretical Hypothesis and Early Clinical Experience. “The concept and article’s popularity not only suggests interest in nVNS and its role in treating breathing difficulties seen in COVID-19 patients, but also emphasizes the medical community is still looking for answers that can help address various COVID-19 symptoms,” says Peter S. Staats, MD, Chief Medical Officer of electroCore. “gammaCore SapphireTM CV (nVNS) is unique in it’s ability to be used early in the course of disease, at home or in a health care setting. Research should be focused on identifying novel therapies with strong clinical rationale that can be used throughout the course of disease.”

gammaCore SapphireTM CV (nVNS) received Emergency Use Authorization from the FDA in July of 2020 to treat patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow.

“Because the virus is novel we began with almost no information whatsoever. Mobilizing COVID-19 survivors to support all medical, scientific and academic research is part of Survivor Corps’s fundamental mission,” according to Diana Berrent, founder of Survivor Corps, a grassroots group of over 150,000 COVID-19 survivors, the largest in the world, that has become a hub for facilitating medical and scientific research on the Coronavirus. “We applaud all research conducted to study potential treatments that could bring relief to those who are suffering.”

“We eagerly await the results of SAVIOR-1 as the outcome will increase our knowledge regarding potential treatments for respiratory symptoms associated with COVID-19 that hospitals, healthcare professionals, and patients struggle to treat and endure,” says Dr. Staats.

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 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 gammaCore TM

gammaCore TM (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

In the United States, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders, such as COVID-19-associated acute respiratory stress disorder. Refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.

The U.S. FDA has cleared the gammaCore Sapphire CV device under an emergency use authorization for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved pharmacologic therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (nVNS) on either side of the patient’s neck.

gammaCore Sapphire CV has not been cleared or approved for acute use in the home or healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved pharmacologic therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (nVNS) on either side of the patient’s neck during pandemic Coronavirus Disease 2019 (COVID-19).

gammaCore Sapphire CV has been authorized only for the duration of the statement that circumstances exist that warrant authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbbb-3(b)(1), until the authorization is terminated or revoked.

More information can be found at:

Letter of authorization: https://www.fda.gov/media/139967/download
Fact sheet for healthcare workers: https://www.fda.gov/media/139968/download
Patient information sheet: https://www.fda.gov/media/139969/download
Instructions for use of gammaCore https://www.fda.gov/media/139970/download

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 business, operating or financial impact of such studies; the commercial potential of nVNS generally and gammaCore in particular in the UK 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.

Investors:
Hans Vitzthum
LifeSci Advisors
617-430-7578

[email protected]

Media Contact:
Jackie Dorsky
electroCore

973-290-0097

[email protected]

SOURCE: electroCore

Onconova Therapeutics Regains Compliance With Nasdaq Continued Listing Requirement

NEWTOWN, Pa., Feb. 24, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a biopharmaceutical company focused on discovering and developing novel products for patients with cancer, announces receipt of notification from Nasdaq that the Company has regained compliance with the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2) because the Company’s common stock had a closing price of at least $1.00 per share for a minimum 10 consecutive business days. As previously reported, the Company was granted until April 5, 2021 to meet this requirement.

Steven Fruchtman, M.D., President and Chief Executive Officer of Onconova Therapeutics, said, “We are pleased that we have regained compliance with Nasdaq’s minimum bid requirement for continued listing of our stock. We appreciate the investor support and confidence we have seen recently. 2021 will continue to be a decisive year for Onconova as ON 123300 enters the clinic in the U.S. in a Phase 1 trial, and we are on target to initiate this trial in patients with advanced cancer in the next few months.”

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a biopharmaceutical company focused on discovering and developing novel products to treat cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is planned to begin a dose-escalation and expansion Phase 1 trial in the U.S. in the first half of 2021, and a dose-escalation and expansion Phase 1 trial is currently underway in China. Onconova’s product candidate oral rigosertib is currently in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ lung adenocarcinoma in combination with nivolumab. In addition, Onconova has commenced preclinical work investigating rigosertib in COVID-19. For more information, please visit www.onconova.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the registered direct offering, its patents and clinical development plans including [patient enrollment timelines and] indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680

[email protected]
https://www.onconova.com/contact

Investor Contact:
LHA Investor Relations
Kim Sutton Golodetz
212-838-3777

[email protected]

SOURCE: Onconova Therapeutics, Inc.

electroCore Announces Two-Year Extension of gammaCore(TM) Listing in the NHS Supply Chain Catalogue

Extension maintains listing through June 3, 2023

ROCKAWAY, N.J., Feb. 23, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that gammaCore will continue to be listed in the NHS Supply Chain catalogue for an additional two years through June 3, 2023. The original listing, which commenced on June 4, 2019, was scheduled to terminate on June 3, 2021.

“We are pleased that this extension will allow NHS trusts and healthcare organizations the option to continuously procure gammaCore Sapphire™ (nVNS) through the NHS Supply Chain online catalogue for an additional two years,” stated Iain Strickland, Vice President of European Operations at electroCore. “Importantly, inclusion in this catalogue helps ensure gammaCore therapy is broadly accessible to patients across the UK who may benefit from non-invasive vagus nerve stimulation.”

The role of the NHS Supply Chain is to help the NHS deliver clinically assured, quality products at the best value to its patients. The inclusion of gammaCore in the catalogue allows hospitals to purchase gammaCore Sapphire™ for their primary headache patients, taking into account their own budgetary restrictions. The listing of gammaCore Sapphire™ as an e-Direct product marks a key milestone in the Company providing its medical technologies to UK patients, in an easier, cost-effective way.

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 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 gammaCore TM

gammaCore TM (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

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 business, operating or financial impact of such studies; the commercial potential of nVNS generally and gammaCore in particular in the UK 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.

Investors:
Hans Vitzthum
LifeSci Advisors
617-430-7578

[email protected]

Media Contact:
Jackie Dorsky
electroCore

973-290-0097

[email protected]

SOURCE: electroCore