Ocugen Inc. to present pre-clinical data for OCU410 at 2nd Annual Dry AMD Therapeutic Development Conference

 

MALVERN, Pa., Oct. 19, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that its head of Research and Development, Arun Upadhyay, PhD, will present pre-clinical data demonstrating how the company’s second modifier gene therapy candidate, OCU410, could potentially be an effective therapeutic for Dry Age-related Macular Degeneration (Dry AMD).

The presentation, at the 2^nd Annual Dry AMD Therapeutic Development conference, will showcase how the use of a specific nuclear hormone receptor called RORA presents a unique opportunity to treat people with Dry AMD. Dry AMD accounts for 85 to 90 percent of all cases of age-related macular degeneration, which is estimated to be about 196 million people globally. RORA plays a central role in many physiological activities, including lipid metabolism, oxidative stress, regulation of Th17 cells (which are involved in many immune-mediated diseases), the reduction of inflammation, and obesity. In his presentation, “OCU410: A Novel Modifier Gene Therapy Product using a Multi-Factor Approach for Dry AMD,” Dr. Upadhyay will show evidence highlighting how influencing the RORA receptor can attack several underlying factors of this serious blindness disease.

Dr. Upadhyay will be speaking on October 20, 2021, at 3:15pm Eastern Time. The 2nd Annual Dry AMD Therapeutic Development conference requires registration for attendance.

OCU410 is the second drug candidate from Ocugen’s Modifier Gene Therapy Platform, which is expected to enter clinical trials in 2022. Ocugen recently announced a collaboration with CanSinoBIO for the chemistry, manufacturing, and controls (“CMC”) development and manufacture of clinical supplies of OCU410 to advance the program. Modifier Gene Therapy is different from traditional gene augmentation. Rather than replacing a defective gene, a modifier gene, such as the nuclear hormone receptor, RORA, regulates cellular and genetic activities, much like how a conductor directs an orchestra. More about this technology can be found in the pipeline section of Ocugen.com.

About Dry AMD
Dry AMD is the most prevalent, chronic form of age-related macular degeneration, accounting for about 90 percent of all cases. Dry AMD is a progressive disease, taking several years to go through three stages: early (no symptoms), intermediate (mild blurriness in central vision or difficulty seeing in low light) and late (distorted vision, a blurry area near the center of one’s vision). According to the National Eye Institute, there are no treatments available for late dry AMD.

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, qualitative assessments of available data, potential benefits of our product candidates, if approved, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including with respect to our OCU410 product candidate. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as the uncertainties inherent in research and development, including our ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials or regulatory submission dates, including the risk that such dates are not met due to impacts from the ongoing COVID-19 pandemic, and risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data or unfavorable results from further analyses of existing clinical trial data, as well as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com

Ocugen Inc. to present pre-clinical data for OCU410 at 2nd Annual Dry AMD Therapeutic Development Conference

 

MALVERN, Pa., Oct. 19, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that its head of Research and Development, Arun Upadhyay, PhD, will present pre-clinical data demonstrating how the company’s second modifier gene therapy candidate, OCU410, could potentially be an effective therapeutic for Dry Age-related Macular Degeneration (Dry AMD).

The presentation, at the 2^nd Annual Dry AMD Therapeutic Development conference, will showcase how the use of a specific nuclear hormone receptor called RORA presents a unique opportunity to treat people with Dry AMD. Dry AMD accounts for 85 to 90 percent of all cases of age-related macular degeneration, which is estimated to be about 196 million people globally. RORA plays a central role in many physiological activities, including lipid metabolism, oxidative stress, regulation of Th17 cells (which are involved in many immune-mediated diseases), the reduction of inflammation, and obesity. In his presentation, “OCU410: A Novel Modifier Gene Therapy Product using a Multi-Factor Approach for Dry AMD,” Dr. Upadhyay will show evidence highlighting how influencing the RORA receptor can attack several underlying factors of this serious blindness disease.

Dr. Upadhyay will be speaking on October 20, 2021, at 3:15pm Eastern Time. The 2nd Annual Dry AMD Therapeutic Development conference requires registration for attendance.

OCU410 is the second drug candidate from Ocugen’s Modifier Gene Therapy Platform, which is expected to enter clinical trials in 2022. Ocugen recently announced a collaboration with CanSinoBIO for the chemistry, manufacturing, and controls (“CMC”) development and manufacture of clinical supplies of OCU410 to advance the program. Modifier Gene Therapy is different from traditional gene augmentation. Rather than replacing a defective gene, a modifier gene, such as the nuclear hormone receptor, RORA, regulates cellular and genetic activities, much like how a conductor directs an orchestra. More about this technology can be found in the pipeline section of Ocugen.com.

About Dry AMD
Dry AMD is the most prevalent, chronic form of age-related macular degeneration, accounting for about 90 percent of all cases. Dry AMD is a progressive disease, taking several years to go through three stages: early (no symptoms), intermediate (mild blurriness in central vision or difficulty seeing in low light) and late (distorted vision, a blurry area near the center of one’s vision). According to the National Eye Institute, there are no treatments available for late dry AMD.

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, qualitative assessments of available data, potential benefits of our product candidates, if approved, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including with respect to our OCU410 product candidate. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as the uncertainties inherent in research and development, including our ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials or regulatory submission dates, including the risk that such dates are not met due to impacts from the ongoing COVID-19 pandemic, and risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data or unfavorable results from further analyses of existing clinical trial data, as well as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com

Tuesday, October 19, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
6.3 Tonne Order Received

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.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

New Order. Avivagen signed a significant new purchase agreement to supply its largest customer in Asia with a 6.3 tonne order of OxC-beta Livestock. The shipment represents a 43% increase in size over the customer’s previous order and continues a trend of increased reorder size among this and other OxC-beta customers worldwide.


UNAHCO.  Although the Company did not release the name of the customer, we believe it is UNAHCO, out of the Philippines. Since its initial November 2016 order of 150 kilograms of OxC-beta, the growth in UNAHCO’s orders is stunning. Just starting in November 2019, orders grew from 2.1 tonnes, to 3.0 tonnes in April 2020, to 4.0 tonnes in October 2020, to 4.4 tonnes in April 2021, to the 6.3 tonne …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Avivagen Secures Large OxC-beta™ Livestock Order in Asia

 

• 3 tonne order represents a 43% increase over most recent shipment to same customer
• Growth during pandemic signals strong impact on market share through use of OxC-beta™

Ottawa, ON / Business Wire/ October 18, 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 it has signed a significant new purchase agreement to supply its largest customer in Asia with a 6.3 tonne order of OxC-beta™ Livestock. The shipment represents a 43% increase in size over the customer’s previous order and continues a trend of increased reorder size among this and other OxC-beta™ customers worldwide.

“We’re extremely pleased to see the continued growth of this important customer in Asia, one of the most important regions worldwide for livestock feed production,” says Kym Anthony, Chief Executive Officer, Aviagen Inc. “We believe that the fact that Avivagen’s customers continue to increase order size for OxC-beta™ amid a global pandemic is a clear sign of the positive impact that integration of our products can have on our customer’s bottom line.  We’re excited by the growth potential ahead of us in both Asia and around the world.”

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.

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, 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.

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, anticipated growth in demand for Avivagen’s products, the anticipated date of fulfillment for the order described,  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 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 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 or, in the worst case, cause the order to be terminated and the market opportunities may not be as large as Avivagen anticipates, in each case due to many factors, many of which are outside of Avivagen’s control.  Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

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

For more information:

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

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

Avivagen Secures Large OxC-beta™ Livestock Order in Asia

 

• 3 tonne order represents a 43% increase over most recent shipment to same customer
• Growth during pandemic signals strong impact on market share through use of OxC-beta™

Ottawa, ON / Business Wire/ October 18, 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 it has signed a significant new purchase agreement to supply its largest customer in Asia with a 6.3 tonne order of OxC-beta™ Livestock. The shipment represents a 43% increase in size over the customer’s previous order and continues a trend of increased reorder size among this and other OxC-beta™ customers worldwide.

“We’re extremely pleased to see the continued growth of this important customer in Asia, one of the most important regions worldwide for livestock feed production,” says Kym Anthony, Chief Executive Officer, Aviagen Inc. “We believe that the fact that Avivagen’s customers continue to increase order size for OxC-beta™ amid a global pandemic is a clear sign of the positive impact that integration of our products can have on our customer’s bottom line.  We’re excited by the growth potential ahead of us in both Asia and around the world.”

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.

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, 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.

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, anticipated growth in demand for Avivagen’s products, the anticipated date of fulfillment for the order described,  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 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 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 or, in the worst case, cause the order to be terminated and the market opportunities may not be as large as Avivagen anticipates, in each case due to many factors, many of which are outside of Avivagen’s control.  Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

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

For more information:

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

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

Cocrystal Pharma to Present at the Dawson James 2021 Small Cap Growth Conference on October 21, 2021

 

BOTHELL, Wash., Oct. 14, 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 coronaviruses, influenza, hepatitis C viruses and noroviruses, announces that management will present at the Dawson James 2021 Small Cap Growth Conference on Thursday, October 21, 2021 at 2:00 p.m. Eastern time (10:00 a.m. Pacific time). The conference is being held at the Wyndham Grand Hotel in Jupiter, Fla.

“We are excited about recently receiving regulatory clearance from an Australian Human Research Ethics Committee (HREC) to initiate our Phase 1 trial in healthy volunteers with orally administered CC-42344 as a treatment for pandemic and seasonal influenza A, which remains a major global health concern,” said James Martin, CFO and interim co-CEO of Cocrystal. “We also look forward to discussing milestones with our COVID-19 antiviral programs during the presentation at this conference.”

A webcast of the presentation will be available live and archived on the IR Calendar of the company website.

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 virus 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.

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

Source: Cocrystal Pharma, Inc.

electroCore Announces Regulatory Approval in Canada to Treat Adolescent Migraine

 

Health Canada expands gammaCore label to include the acute and preventive treatment of migraine in adolescents

ROCKAWAY, NJ, 
Oct. 14, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that the company received an amended Medical Device License from 
Health Canada to expand the label of gammaCore nVNS to include the acute and preventive treatment of migraine in adolescents between 12 and 17 years of age. gammaCore is now cleared for most forms of primary headache including the acute and preventive treatment of migraine in adolescents and adults, as well as the acute and preventive treatment of cluster headache in adults.

“Migraine affects approximately 1 in 10 adolescents and is one of the most disabling diseases worldwide. Despite this, evidence-based treatment options for adolescents with migraine are limited. It is exciting to see a new treatment option for Canadian adolescents with migraine, particularly as gammaCore offers a non-medication option to families,” said Dr.  Serena Orr,
headache specialist, pediatric neurologist, and researcher at the 
Cumming School of Medicine, University of 
Calgary, Canada. “There is supportive efficacy and safety data in adults for the acute and preventive treatment of migraine and promising pediatric safety data. As adoption increases within the adolescent population, additional data will be generated which will be helpful in understanding how effective it is for adolescents.”

“Prescribers and the parents of adolescent migraine sufferers now have a non-drug treatment option, that is approved for the acute and preventive management of migraine in adolescents,” said  Iain Strickland, Vice President of Global Sales and Strategy at electroCore, Inc. “gammaCore represents a unique treatment for adolescents with migraine, who along with their families would often prefer to avoid the use of prescription drugs.”

The label expansion was based on previously reported randomized controlled trials of gammaCore for the acute and preventive treatment of migraine and was supported by a small study (n=9) in adolescents where 46.8% of all treated attacks were successfully resolved without the use of any acute rescue medication.¹

gammaCore Sapphire™ is available in 
Canada through our exclusive distributor, 
RSK Medical Inc., for patients suffering with primary headache disorders.

For more information, visit https://rskmedical.com.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults. For more information, visit www.electrocore.com.

About gammaCore™

gammaCore™ (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 if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• 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 (less 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 potential of nVNS generally and gammaCore in particular for the acute and preventative treatment of migraine in adolescence in the Unites States and 
Canada 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 Grazzi L, Egeo G, Liebler E, Padovan AM, Barbanti P. Non-invasive vagus nerve stimulation (nVNS) as symptomatic treatment of migraine in young patients: a preliminary safety study. Neurol Sci. 2017 May;38(Suppl 1):197-199. doi: 10.1007/s10072-017-2942-5. PMID: 28527086.

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

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

electroCore Announces Regulatory Approval in Canada to Treat Adolescent Migraine

 

Health Canada expands gammaCore label to include the acute and preventive treatment of migraine in adolescents

ROCKAWAY, NJ, 
Oct. 14, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that the company received an amended Medical Device License from 
Health Canada to expand the label of gammaCore nVNS to include the acute and preventive treatment of migraine in adolescents between 12 and 17 years of age. gammaCore is now cleared for most forms of primary headache including the acute and preventive treatment of migraine in adolescents and adults, as well as the acute and preventive treatment of cluster headache in adults.

“Migraine affects approximately 1 in 10 adolescents and is one of the most disabling diseases worldwide. Despite this, evidence-based treatment options for adolescents with migraine are limited. It is exciting to see a new treatment option for Canadian adolescents with migraine, particularly as gammaCore offers a non-medication option to families,” said Dr.  Serena Orr,
headache specialist, pediatric neurologist, and researcher at the 
Cumming School of Medicine, University of 
Calgary, Canada. “There is supportive efficacy and safety data in adults for the acute and preventive treatment of migraine and promising pediatric safety data. As adoption increases within the adolescent population, additional data will be generated which will be helpful in understanding how effective it is for adolescents.”

“Prescribers and the parents of adolescent migraine sufferers now have a non-drug treatment option, that is approved for the acute and preventive management of migraine in adolescents,” said  Iain Strickland, Vice President of Global Sales and Strategy at electroCore, Inc. “gammaCore represents a unique treatment for adolescents with migraine, who along with their families would often prefer to avoid the use of prescription drugs.”

The label expansion was based on previously reported randomized controlled trials of gammaCore for the acute and preventive treatment of migraine and was supported by a small study (n=9) in adolescents where 46.8% of all treated attacks were successfully resolved without the use of any acute rescue medication.¹

gammaCore Sapphire™ is available in 
Canada through our exclusive distributor, 
RSK Medical Inc., for patients suffering with primary headache disorders.

For more information, visit https://rskmedical.com.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults. For more information, visit www.electrocore.com.

About gammaCore™

gammaCore™ (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 if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• 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 (less 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 potential of nVNS generally and gammaCore in particular for the acute and preventative treatment of migraine in adolescence in the Unites States and 
Canada 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 Grazzi L, Egeo G, Liebler E, Padovan AM, Barbanti P. Non-invasive vagus nerve stimulation (nVNS) as symptomatic treatment of migraine in young patients: a preliminary safety study. Neurol Sci. 2017 May;38(Suppl 1):197-199. doi: 10.1007/s10072-017-2942-5. PMID: 28527086.

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

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

Cocrystal Pharma to Present at the Dawson James 2021 Small Cap Growth Conference on October 21, 2021

 

BOTHELL, Wash., Oct. 14, 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 coronaviruses, influenza, hepatitis C viruses and noroviruses, announces that management will present at the Dawson James 2021 Small Cap Growth Conference on Thursday, October 21, 2021 at 2:00 p.m. Eastern time (10:00 a.m. Pacific time). The conference is being held at the Wyndham Grand Hotel in Jupiter, Fla.

“We are excited about recently receiving regulatory clearance from an Australian Human Research Ethics Committee (HREC) to initiate our Phase 1 trial in healthy volunteers with orally administered CC-42344 as a treatment for pandemic and seasonal influenza A, which remains a major global health concern,” said James Martin, CFO and interim co-CEO of Cocrystal. “We also look forward to discussing milestones with our COVID-19 antiviral programs during the presentation at this conference.”

A webcast of the presentation will be available live and archived on the IR Calendar of the company website.

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 virus 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.

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

Source: Cocrystal Pharma, Inc.

Thursday, October 14, 2021

PsyBio Therapeutics (PSYBF)(PSYB:CA)
PsyBio Continues To Report Development Milestones

PsyBio Therapeutics is developing biosynthetic psychoactive compounds which offer a new paradigm of treatment to reverse the course of mental health issues. Psychoactive medications treat the illness by rewiring the brain through contemplation and a change of perception in combination with psychotherapy vs. Standard of care (SSRI’s, SNRI’s, MAOI’s, NDRI’s, etc…) which just chemically treat symptoms. Working in partnership with Miami University utilizing a proprietary platform technology to biologically synthesize psilocybin and other targeted next generation active compounds in Psilocybe Cubensis and other fungi and plants.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

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

PsyBio Has Made Significant Progress.  PsyBio is developing psychedelic compounds for psychiatric disorders.  This field has received recent interest due to clinical efficacy data and the large unmet need for new psychiatric medications. In the past several years, cannabis-derived products have received FDA approval, its legal status has changed, and start-up companies have risen to multi-billion dollar valuations. Many companies have entered the field of psychedelics, yet PsyBio is one of the few that is building a pharmaceutical business around them.


The Company Met A Significant Manufacturing Milestone.  PsyBio has developed proprietary biosysthesis technologies to produce the compounds that are found in psychedelic mushrooms. Its processes avoid the potency and yield variations that result from extracting the compounds from agriculturally produced mushrooms. The company recently announced that it can manufacture psilocybin, now known as its …

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. 

Tuesday, October 12, 2021

Axcella Health Inc. (AXLA)
Fifty Ways To Love Your Liver

Axcella Health Inc. is a clinical-stage biotechnology company focused on treating complex diseases and improvinge health using endogenous metabolic modulator, or EMM, compositions. Its product candidates are comprised of multiple EMMs that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. The company’s pipeline includes two lead therapeutic candidates:, AXA1665 for the reduction in risk of recurrent overt hepatic encephalopathy (OHE) , and AXA1125 for the treatment of non-alcoholic steatohepatitis (NASH).

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

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

Initiating Coverage of AXLA.  Axcella Health is developing drugs based on endogenous metabolic modulators (EMMs), naturally occurring molecules that act as regulators and control mechanisms for metabolic pathways. Its two lead products are AXA1655, in a Phase 2 trial for overt hepatic encephalopathy (OHE), and AXA1125 in a Phase 2b trial for non-alcoholic steatohepatitis (NASH). Additional pipeline developments are expected before year end.


Axcella’s Products Target Multiple Pathways of Disease. The company’s EMM products are amino acid compositions in proprietary ratios that act through metabolic pathways. The indications in clinical trials are conditions in which liver disease or injury has starting a cycle of injury, repair, compromised function, and further injury. Axcella’s products work through the biological pathways to restore …

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. 

electroCore Provides Business Update and Select Third Quarter 2021 Financial Guidance

 

• Third quarter 2021 revenue expected to be approximately $1.5 million
  
• Net cash used to fund operations in the third quarter 2021 of approximately $3.5 million

ROCKAWAY, NJ, 
Oct. 12, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today provided an operating and business update as well as select unaudited preliminary financial guidance for the third quarter of 2021.

“We are pleased to announce preliminary third quarter results, which continued to show sequential growth in our revenue generating channels.,” stated  Dan Goldberger, Chief Executive Officer of electroCore. “Revenue for the quarter ended 
September 30, 2021, is expected to be approximately 
$1.5 million. Our headache markets in the US and 
UK were impacted somewhat by the pandemic and we look forward to accelerating revenue in the future.”

Government Channels: During the third quarter of 2021, the company expects to recognize revenue of approximately 
$946,000 pursuant to the 
Department of Veterans Affairs (“VA”) and 
Department of Defense (“DoD”) originating prescriptions, compared to 
$779,000 during the second quarter of 2021 and 
$646,000 third quarter of 2020. 96 
VA and 
DoD military treatment facilities have purchased gammaCore products through 
September 30, 2021, as compared to 85 through the second quarter 2021 and 67 through the third quarter of 2020. 

Outside of the U.S.: During the third quarter of 2021, electroCore expects to recognize revenue of approximately 
$371,000 outside of 
the United States through direct channels, as compared to 
$369,000 during the second quarter of 2021 and 
$278,000 during the third quarter of 2020. These figures do not include new global stocking distributors which contributed revenues from 
Australia, 
Canada, and 
Qatar.

The company continued to expand its distributor relationships internationally, entering into an agreement with 
Kromax South Asia Ptd Ltd. to serve as the exclusive distributor of the gammaCore Sapphire^TM non-invasive vagus nerve stimulator (nVNS) in 
Malaysia, 
Singapore, and 
Indonesia.

Commercial: The company continues to make targeted investments in its Commercial channel. In 
January 2021, CMS published its Level II Healthcare Common Procedure Coding System, commonly known as HCPCS, including a unique code “K1020” for “Non-invasive vagus nerve stimulator,” which went into effect on 
April 1, 2021. During the third quarter, the company received a favorable coverage determination from a second regional payor and continues to work on obtaining additional positive medical benefit coverage decisions.

The company continues to develop cash pay business models for commercial patients with high deductible benefit plans or whose insurance does not yet cover nVNS therapy. More than 40 physicians’ offices in the US are currently offering the cash pay alternative contributing approximately 
$75,000 of revenue in the quarter ended 
September 30, 2021.

Financial Guidance: electroCore today announced the following preliminary unaudited financial guidance for the third quarter of 2021:

Third Quarter Revenue: electroCore anticipates that third quarter 2021 revenue will be approximately 
$1.5 million. This represents a 15% increase over second quarter 2021 revenue of 
$1.3 million and 36% growth over third quarter 2020 revenue of 
$1.1 million.

September 30, 2021 Cash: The company ended the third quarter of 2021 with approximately 
$39.0 million of cash, cash equivalents and marketable securities, compared to 
$23.7million as of the end of the second quarter 2021. Net cash used from operations in the third quarter was approximately 
$3.5 million. During the third quarter, the company raised net proceeds of approximately 
$18.8 million through a public offering of its common stock.

Mr. Goldberger commented further, “We continue to be enthusiastic about the prospects of the business.  We have a strong balance sheet which will support our continued efforts to educate and improve physician and patient awareness, which we believe will ultimately lead to the successful adoption of gammaCore globally.” 

The company intends to provide a detailed operational and financial update during its third quarter 2021 earnings call in 
November 2021.

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

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 (nVNS) 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 if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• 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 (less 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.

The 
U.S. FDA has cleared the gammaCore Sapphire CV (nVNS) 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 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 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 expectations for revenue and cash used in operations during the third quarter of 2021, its expectations for future performance, as well as electroCore’s business prospects and clinical and product development plans for 2021 and beyond, its pipeline or potential markets for its technologies, additional indications for gammaCore, the timing, outcome and impact of regulatory, clinical and commercial developments (including human trials for the study of headache, PTH, mTBI, Parkinson’s diseases and sleep deprivation stress and the business, operating or financial impact of such studies), further international expansion, and statements about anticipated distribution arrangements, government and payor funding arrangements (including those relating to 
Canada, 
Western Europe, 
Qatar, 
Taiwan, and 
China) 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™, 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:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

electroCore Provides Business Update and Select Third Quarter 2021 Financial Guidance

 

• Third quarter 2021 revenue expected to be approximately $1.5 million
  
• Net cash used to fund operations in the third quarter 2021 of approximately $3.5 million

ROCKAWAY, NJ, 
Oct. 12, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today provided an operating and business update as well as select unaudited preliminary financial guidance for the third quarter of 2021.

“We are pleased to announce preliminary third quarter results, which continued to show sequential growth in our revenue generating channels.,” stated  Dan Goldberger, Chief Executive Officer of electroCore. “Revenue for the quarter ended 
September 30, 2021, is expected to be approximately 
$1.5 million. Our headache markets in the US and 
UK were impacted somewhat by the pandemic and we look forward to accelerating revenue in the future.”

Government Channels: During the third quarter of 2021, the company expects to recognize revenue of approximately 
$946,000 pursuant to the 
Department of Veterans Affairs (“VA”) and 
Department of Defense (“DoD”) originating prescriptions, compared to 
$779,000 during the second quarter of 2021 and 
$646,000 third quarter of 2020. 96 
VA and 
DoD military treatment facilities have purchased gammaCore products through 
September 30, 2021, as compared to 85 through the second quarter 2021 and 67 through the third quarter of 2020. 

Outside of the U.S.: During the third quarter of 2021, electroCore expects to recognize revenue of approximately 
$371,000 outside of 
the United States through direct channels, as compared to 
$369,000 during the second quarter of 2021 and 
$278,000 during the third quarter of 2020. These figures do not include new global stocking distributors which contributed revenues from 
Australia, 
Canada, and 
Qatar.

The company continued to expand its distributor relationships internationally, entering into an agreement with 
Kromax South Asia Ptd Ltd. to serve as the exclusive distributor of the gammaCore Sapphire^TM non-invasive vagus nerve stimulator (nVNS) in 
Malaysia, 
Singapore, and 
Indonesia.

Commercial: The company continues to make targeted investments in its Commercial channel. In 
January 2021, CMS published its Level II Healthcare Common Procedure Coding System, commonly known as HCPCS, including a unique code “K1020” for “Non-invasive vagus nerve stimulator,” which went into effect on 
April 1, 2021. During the third quarter, the company received a favorable coverage determination from a second regional payor and continues to work on obtaining additional positive medical benefit coverage decisions.

The company continues to develop cash pay business models for commercial patients with high deductible benefit plans or whose insurance does not yet cover nVNS therapy. More than 40 physicians’ offices in the US are currently offering the cash pay alternative contributing approximately 
$75,000 of revenue in the quarter ended 
September 30, 2021.

Financial Guidance: electroCore today announced the following preliminary unaudited financial guidance for the third quarter of 2021:

Third Quarter Revenue: electroCore anticipates that third quarter 2021 revenue will be approximately 
$1.5 million. This represents a 15% increase over second quarter 2021 revenue of 
$1.3 million and 36% growth over third quarter 2020 revenue of 
$1.1 million.

September 30, 2021 Cash: The company ended the third quarter of 2021 with approximately 
$39.0 million of cash, cash equivalents and marketable securities, compared to 
$23.7million as of the end of the second quarter 2021. Net cash used from operations in the third quarter was approximately 
$3.5 million. During the third quarter, the company raised net proceeds of approximately 
$18.8 million through a public offering of its common stock.

Mr. Goldberger commented further, “We continue to be enthusiastic about the prospects of the business.  We have a strong balance sheet which will support our continued efforts to educate and improve physician and patient awareness, which we believe will ultimately lead to the successful adoption of gammaCore globally.” 

The company intends to provide a detailed operational and financial update during its third quarter 2021 earnings call in 
November 2021.

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

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 (nVNS) 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 if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• 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 (less 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.

The 
U.S. FDA has cleared the gammaCore Sapphire CV (nVNS) 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 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 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 expectations for revenue and cash used in operations during the third quarter of 2021, its expectations for future performance, as well as electroCore’s business prospects and clinical and product development plans for 2021 and beyond, its pipeline or potential markets for its technologies, additional indications for gammaCore, the timing, outcome and impact of regulatory, clinical and commercial developments (including human trials for the study of headache, PTH, mTBI, Parkinson’s diseases and sleep deprivation stress and the business, operating or financial impact of such studies), further international expansion, and statements about anticipated distribution arrangements, government and payor funding arrangements (including those relating to 
Canada, 
Western Europe, 
Qatar, 
Taiwan, and 
China) 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™, 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:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com