Neovasc Announces New Appointments in Regulatory and Clinical Leadership

 

Neovasc Team Grows with Addition of Industry Veterans Lisa Becker as VP, Regulatory Affairs, Global Angina Therapies and Sarah Gallagher as VP of Clinical Affairs

VANCOUVER and MINNEAPOLIS – (NewMediaWire) – July 13, 2021 – Neovasc Inc. (Neovasc or the Company) (Nasdaq, TSX: NVCN) announced today that it has appointed Lisa Becker as Vice President, Regulatory Affairs, Global Angina Therapies and Sarah Gallagher as Vice President, Clinical Affairs.

“Neovasc’s Regulatory and Clinical teams will be well strengthened with the additions of Lisa and Sarah, who bring tremendous experience in regulatory and clinical affairs to the overall Neovasc team,” said Fred Colen, President and Chief Executive Officer of Neovasc. “We look forward to leveraging their industry expertise as we pursue our own development goals in North America and Europe.”

Ms. Becker has more than 20 years of experience in medical device regulatory affairs. Her product and therapy experience has spanned medical devices from cardiac rhythm management, to vascular support, pulmonary artery pressure monitoring, cardiac occluders, heart valves and most recently, structural heart products, previously working at Abbott, St. Jude Medical, Boston Scientific and Guidant. She possesses regulatory experience on a global scale, with responsibility for multiple geographies, including US and EU Class III approvals. Ms. Becker earned a Bachelor of Science in Organizational Behavior with a General Engineering minor from the United States Air Force Academy and a Masters of Science from Chapman University. She served nearly ten years on active duty as an officer in the US Air Force. A highlight of Ms. Beckers career includes the approval of the world’s smallest mechanical heart valve and a duct occluder for premature infants, which was approved in four major geographies within a six-month period.

I view my regulatory work as a continuation of my service toward improving lives. As a member of the Neovasc team, I will bring my professional passion for driving medical device development through creative and collaborative regulatory approval strategies to the Company’s efforts to expand approval and acceptance of the Reducer device, said Ms. Becker.

Ms. Gallagher brings 20 years of medical device clinical research experience to the Neovasc team.Prior to joining Neovasc, she held leadership roles at Medtronic in Interventional Pain, Neuromodulation, and Cardiac Rhythm Management, as well as St. Jude Medical in Structural Heart.During her tenure she held roles with increasing responsibility in clinical research and clinical operations, and she has developed and executed both pre- and post-market clinical trials and supported regulatory approvals globally. Ms. Gallagher holds a Bachelor of Applied Arts in Exercise Science and a Bachelor of Arts in Psychology from the University of Minnesota, and Master of Science in Technology Management from the University of St. Thomas.

I am excited to be joining the Neovasc Clinical Affairs team at this critical point in the Company’s corporate and clinical journey, said Ms. Gallagher. I am eager to engage in the ongoing and new studies and data supporting the Reducer and Tiara programs, as we seek to bring these important treatment options to more patients.

Neovasc also announces the departure of Vicki Bebeau, former Vice President of Clinical and Regulatory affairs who is assisting with transitioning activities to Sarah and Lisa until August 30, 2021.

 

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.

 

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact.When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the Company’s regulatory and clinical team being strengthened with the additions of Ms. Becker and Ms. Gallagher, leveraging the industry experience of Ms. Becker and Ms. Gallagher to pursue the Company’s development goals in North America and Europe, Ms. Beckers plans of bringing collaborative regulatory approval strategies to the Company’s efforts to expand approval and acceptance of the Reducer device, Ms. Gallaghers plans to engage in ongoing and new studies and data supporting the Reducer and Tiara programs and seeking to bring these treatment options to more patients and the growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, market and other conditions as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three months ended March 30, 2021 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investors

Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
[email protected]

 

Media

Sean Leous
Westwicke/ICR
Phone: +1.646.866.4012
[email protected]

Namaste Technologies Subsidiary CannMart Signs Master Distribution Agreement with Rapid Dose Therapeutics Corp.

CannMart Receives its First Purchase Orders for its Consumer-Focused Recreational House Brand “Roilty” Vape Carts

TORONTO, July 09, 2021 (GLOBE NEWSWIRE) — Namaste Technologies Inc. (“Namaste” or the “Company”) (TSXV: N) (FRANKFURT: M5BQ) (OTCMKTS:
NXTTF) a marketplace platform for cannabis and wellness products, is very pleased to announce that its subsidiary, CannMart Inc. has signed a Master Distribution Agreement with Rapid Dose Therapeutics Corp. (“RDT”) (CSE: DOSE). As part of this agreement and subject to certain criteria, CannMart will be the exclusive distributor of their innovative RDT branded products across Canada including:

1. QuickStrip™, a 10 mg THC sublingual oral dissolving strip, infused with cannabis that is delivered quickly into the bloodstream bypassing first-pass metabolism resulting in rapid onset of the active ingredient and;

2. QuickSips™, a 10 mg THC lined drinking straw that is 100% biodegradable made from sugarcane fibres which is easily used in hot or cold beverages lined with a precise dose that dissolves quickly and is taken up with your beverage in a few sips.

“We are excited to enter into this agreement with RDT to distribute their innovative cannabis products,” said Meni Morim, CEO of Namaste. “As we continue to build a wide spectrum of cannabis products that offer both traditional and newer delivery platforms, and we are pleased to be entering a new category with the addition of the QuickStrip™ and QuickSips™ line of products. CannMart continues to rapidly increase its SKU count which now stands at approximately 700 and receives a record number of requests from vendors across North America to list their products onto our innovative marketplace platform. We are confident this will be a successful partnership with RDT and we look forward to achieving our growth objectives.”

“Roilty” Brand Vape Carts First Purchase Orders:

CannMart is pleased to announce that it has received its first purchase orders from the provinces of Manitoba, and Saskatechewan for its 2.0 consumer-focused, recreational house brand 
“Roilty” Concentrates. Under the “Roilty” brand, we will launch new products such as distillate vapes followed by live resin, shatter, crumble and wax in the coming quarters and with many more provinces across Canada. The distillate vapes will be manufactured in bulk by a third party to be packaged at the CannMart facility. This will be a great step to get products into the market as the CannMart Labs team dials in its processes for new and exciting 2.0 products coming in the near future. “Roilty” will be positioned as a premium, accessible and legacy inspired brand. This launch of the “Roilty” Concentrate Vapes is in conjunction with July 10th (“710” / “OIL”) International Oil Day.

About Rapid Dose Therapeutics Corp:

Rapid Dose Therapeutics Corp. is a publicly-traded Canadian life sciences company providing innovative, proprietary drug delivery technologies designed to improve outcomes and quality of lives. RDT offers Quick, Convenient, Precise and Discreet™ choices to consumers. RDT is focused and committed to clinical research and product development for the healthcare manufacturing industry — including nutraceutical, pharmaceutical and cannabis industries. RDT is committed to continually create innovative solutions for humans, animals, and plants.

About Namaste Technologies Inc.

Namaste Technologies is a marketplace platform for cannabis and wellness products. At CannMart.com, the Company provides Canadian medical customers with a diverse selection of hand-picked products from a multitude of federally licensed cultivators and US customers with access to hemp-derived CBD and smoking accessories. The Company also distributes licensed and in-house branded cannabis and cannabis derived products in Canada through a number of provincial government control boards and retailing bodies and facilitates licensed cannabis retailer sales online in Saskatchewan. Namaste’s global technology and continuous innovation address local needs in a burgeoning cannabis industry requiring smart solutions.

Information on the Company and its many products can be accessed through the links below:

NamasteTechnologies.com

NamasteMD.com

Cannmart.com

For more information please contact:
Namaste Technologies Inc.
Meni Morim, CEO
Edward Miller, VP Investor Relations
Ph: 647-362-0390
Email: 
[email protected]

Source: Namaste Technologies Inc

FORWARD-LOOKING INFORMATION – This news release contains “forward-looking information” within the meaning of applicable securities laws. All statements contained herein that are not historical in nature contain forward-looking information. Forward-looking information can be identified by words or phrases such as “may”, “expect”, “likely”, “should”, “would”, “plan”, “anticipate”, “intend”, “potential”, “proposed”, “estimate”, “believe” or the negative of these terms, or other similar words, expressions and grammatical variations thereof, or statements that certain events or conditions “may” or “will” happen.

The forward-looking information contained herein, including, without limitation, statements related to distribution of cannabis products including Roilty products through CannMart provincial buyers are made as of the date of this press release and is based on assumptions management believed to be reasonable at the time such statements were made, including, without limitation, Namaste’s ability to maintain momentum of expanding the CannMart Inc. business, as well as other considerations that are believed to be appropriate in the circumstances. While we consider these assumptions to be reasonable based on information currently available to management, there is no assurance that such expectations will prove to be correct. By its nature, forward-looking information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this press release. Such factors include, without limitation: regulatory risk, risks relating to the Company’s ability to execute its business strategy and the benefits realizable therefrom and risks specifically related to the Company’s operations. Additional risk factors can also be found in the Company’s current MD&A and annual information form, both of which have been filed under the Company’s SEDAR profile at www.sedar.com. Readers are cautioned not to put undue reliance on forward-looking information. The Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

Neither the 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 or has in any way approved or disapproved of the contents of this press release.

Helius Medical Technologies, Inc. Appoints Antonella Favit-Van Pelt, M.D., Ph.D. as Chief Medical Officer

 

NEWTOWN, Pa., July 08, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the appointment of Antonella Favit-Van Pelt, M.D., Ph.D. to the position of Chief Medical Officer.

“I am very pleased to welcome Dr. Favit-Van Pelt to Helius, who joins our team with a clinical and academic background in Neurology, as well as 20 years of experience advising and leading medical programs for healthcare companies – including both large, globally-diversified corporations and smaller, earlier-stage companies,” said Helius CEO, Dane Andreeff. “I look forward to her future contributions as we continue our efforts to raise awareness of PoNS technology and its therapeutic benefits among clinicians, patients and payors in the U.S. market, while planning to enter the next phase of our clinical and regulatory strategy.”

“Helius is breaking new ground in the field of neurology with its PoNS technology, which has great potential as a non-invasive, non-drug therapy for patients suffering from a variety of chronic and debilitating neurological conditions,” said Dr. Favit-Van Pelt. “I am excited to join Helius on the heels of its first U.S. regulatory clearance in multiple sclerosis and look forward to continuing the Company’s recent market development, clinical and regulatory progress.”

Prior to joining Helius, Dr. Favit-Van Pelt led U.S. Medical Strategy for the Neurology program of H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY), a global pharmaceutical company that specializes in the treatment of brain diseases, from 2018 to 2021. In this position, she oversaw the U.S. medical and life-cycle program activities related to therapies for movement disorders and epilepsy.

In 2013, Dr. Favit-Van Pelt founded Synaerion Therapeutics (“Synaerion”) and, in 2016, its affiliate Thera Neuropharma, Inc. (“Thera”), two privately-held biotechnology companies developing a small molecule regenerative therapy and RNAi-based integrated technology platform for ALS and traumatic brain injury (“TBI”). She oversaw all aspects of Synaerion’s and Thera’s management and strategy as Chief Executive Officer, President & Chairwoman of the Board from 2014 to 2017 and she continues to serve as President & Chairwoman. In 2009, she founded StratMedica, LLC, a privately-held company designed to provide corporate clients with contract senior management support. As Principal of StratMedica from 2009 to 2016, she directed clinical development and medical programs for eight healthcare companies, including Johnson & Johnson (NYSE: JNJ) and Teva (NYSE: TEVA). Dr. Favit-Van Pelt served as Senior Director and Global Medical Lead at Shire Pharmaceuticals (Nasdaq: SPHG) from 2007 to 2008, as Director of Medical Strategy at Bristol-Myers Squibb (NYSE: BMY) from 2005 to 2007, and as Global Clinical Development Lead at GE Healthcare (formerly Amersham Health) from 2001 to 2005.

Dr. Favit-Van Pelt is a Board-certified neurologist who began clinical practice activity in 1994, with a focus on patients with rare neuromuscular disorders. She holds a graduate degree in Medicine and Surgery and a Ph.D. in Pharmacology from the School of Medicine and Surgery at the University of Catania, Italy.        

As a material inducement to entering into employment with Helius, Dr. Favit-Van Pelt, who was not previously an employee or director of Helius, received options to purchase 18,000 shares of the Company’s Class A common stock under Helius’ Inducement Plan. The equity award under Helius’ Inducement Plan was approved by the Company’s independent directors in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.

The options awards have an exercise price of $16.45 per share, the closing price of Helius’ Class A common stock on July 7, 2021, the date of the grant. The options have a ten-year term and vest over a period of four years, with 25% vesting per year on the anniversary date of grant, provided Dr. Favit-Van Pelt’s employment is continuing on each such date, and subject to acceleration or forfeiture upon the occurrence of certain events as set forth in Dr. Favit-Van Pelt’s option agreement.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. PoNS is an investigational medical device in the European Union (“EU”) and Australia (“AUS”). It is currently under premarket review by the AUS Therapeutic Goods Administration.

Cautionary Disclaimer Statement: 

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “looking ahead,” “will,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future strategic and operational execution, the next phase of the Company’s market development activities, the Company’s ability to spread awareness of of PoNS technology, clinical and regulatory development plans for the PoNS device, and the timing and success of the Company’s commercialization efforts in the United States.

These statements involve substantial known and unknown risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, potential changes to the MCIT program, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release. 

CONTACT: Investor Relations Contact: Westwicke on behalf of Helius Medical Technologies, Inc. Jack Powell, Vice President [email protected]

Helius Medical Technologies, Inc. to Participate in the Annual World Congress of the Society for Brain Mapping and Therapeutics

 

NEWTOWN, Pa., July 07, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced it will participate in the Annual World Congress of the Society for Brain Mapping and Therapeutics, which will be held from July 8-11^th in Los Angeles, California.

The Company has been selected to receive the Pioneer in Technology Award during the event, an award presented by the Society to trail blazing companies who have facilitated the development of pioneering technologies through interdisciplinary approaches that have impacted diagnostics, treatment and healthcare delivery in unprecedented ways.

Dr. Jonathan Sackier, Helius’ Co-Founder and Medical Advisor, will host a presentation during the event titled: From porpoise to PoNS™: the bridge of Varolio and translingual neuromodulation to address balance and gait symptoms. The presentation will include a discussion of the history of neuromodulation, the science behind Helius’ PoNS technology, data from trials in experimental and clinical settings – including trials focused on multiple sclerosis, traumatic brain injury, stroke and cerebral palsy – and the PoNS device’s recent regulatory clearances. The presentation will be held on July 11^th at 10 a.m. Pacific Time.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS^TM). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS^TM) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. PoNS is an investigational medical device in the European Union (“EU”) and Australia (“AUS”). It is currently under premarket review by the AUS Therapeutic Goods Administration.

Cautionary Disclaimer Statement: 

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “looking ahead,” “will,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future strategic and operational execution, the next phase of the Company’s market development activities, clinical and regulatory development plans for the PoNS device, and the timing and success of the Company’s commercialization efforts in the United States.

These statements involve substantial known and unknown risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, potential changes to the MCIT program, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

CONTACT: Investor Relations Contact: Westwicke on behalf of Helius Medical Technologies, Inc. Jack Powell, Vice President [email protected]

Helius Medical Technologies, Inc. to Participate in the Annual World Congress of the Society for Brain Mapping and Therapeutics

 

NEWTOWN, Pa., July 07, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced it will participate in the Annual World Congress of the Society for Brain Mapping and Therapeutics, which will be held from July 8-11^th in Los Angeles, California.

The Company has been selected to receive the Pioneer in Technology Award during the event, an award presented by the Society to trail blazing companies who have facilitated the development of pioneering technologies through interdisciplinary approaches that have impacted diagnostics, treatment and healthcare delivery in unprecedented ways.

Dr. Jonathan Sackier, Helius’ Co-Founder and Medical Advisor, will host a presentation during the event titled: From porpoise to PoNS™: the bridge of Varolio and translingual neuromodulation to address balance and gait symptoms. The presentation will include a discussion of the history of neuromodulation, the science behind Helius’ PoNS technology, data from trials in experimental and clinical settings – including trials focused on multiple sclerosis, traumatic brain injury, stroke and cerebral palsy – and the PoNS device’s recent regulatory clearances. The presentation will be held on July 11^th at 10 a.m. Pacific Time.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS^TM). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS^TM) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. PoNS is an investigational medical device in the European Union (“EU”) and Australia (“AUS”). It is currently under premarket review by the AUS Therapeutic Goods Administration.

Cautionary Disclaimer Statement: 

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “looking ahead,” “will,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future strategic and operational execution, the next phase of the Company’s market development activities, clinical and regulatory development plans for the PoNS device, and the timing and success of the Company’s commercialization efforts in the United States.

These statements involve substantial known and unknown risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, potential changes to the MCIT program, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

CONTACT: Investor Relations Contact: Westwicke on behalf of Helius Medical Technologies, Inc. Jack Powell, Vice President [email protected]

Helius Medical Technologies, Inc. Appoints Antonella Favit-Van Pelt, M.D., Ph.D. as Chief Medical Officer

 

NEWTOWN, Pa., July 08, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the appointment of Antonella Favit-Van Pelt, M.D., Ph.D. to the position of Chief Medical Officer.

“I am very pleased to welcome Dr. Favit-Van Pelt to Helius, who joins our team with a clinical and academic background in Neurology, as well as 20 years of experience advising and leading medical programs for healthcare companies – including both large, globally-diversified corporations and smaller, earlier-stage companies,” said Helius CEO, Dane Andreeff. “I look forward to her future contributions as we continue our efforts to raise awareness of PoNS technology and its therapeutic benefits among clinicians, patients and payors in the U.S. market, while planning to enter the next phase of our clinical and regulatory strategy.”

“Helius is breaking new ground in the field of neurology with its PoNS technology, which has great potential as a non-invasive, non-drug therapy for patients suffering from a variety of chronic and debilitating neurological conditions,” said Dr. Favit-Van Pelt. “I am excited to join Helius on the heels of its first U.S. regulatory clearance in multiple sclerosis and look forward to continuing the Company’s recent market development, clinical and regulatory progress.”

Prior to joining Helius, Dr. Favit-Van Pelt led U.S. Medical Strategy for the Neurology program of H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY), a global pharmaceutical company that specializes in the treatment of brain diseases, from 2018 to 2021. In this position, she oversaw the U.S. medical and life-cycle program activities related to therapies for movement disorders and epilepsy.

In 2013, Dr. Favit-Van Pelt founded Synaerion Therapeutics (“Synaerion”) and, in 2016, its affiliate Thera Neuropharma, Inc. (“Thera”), two privately-held biotechnology companies developing a small molecule regenerative therapy and RNAi-based integrated technology platform for ALS and traumatic brain injury (“TBI”). She oversaw all aspects of Synaerion’s and Thera’s management and strategy as Chief Executive Officer, President & Chairwoman of the Board from 2014 to 2017 and she continues to serve as President & Chairwoman. In 2009, she founded StratMedica, LLC, a privately-held company designed to provide corporate clients with contract senior management support. As Principal of StratMedica from 2009 to 2016, she directed clinical development and medical programs for eight healthcare companies, including Johnson & Johnson (NYSE: JNJ) and Teva (NYSE: TEVA). Dr. Favit-Van Pelt served as Senior Director and Global Medical Lead at Shire Pharmaceuticals (Nasdaq: SPHG) from 2007 to 2008, as Director of Medical Strategy at Bristol-Myers Squibb (NYSE: BMY) from 2005 to 2007, and as Global Clinical Development Lead at GE Healthcare (formerly Amersham Health) from 2001 to 2005.

Dr. Favit-Van Pelt is a Board-certified neurologist who began clinical practice activity in 1994, with a focus on patients with rare neuromuscular disorders. She holds a graduate degree in Medicine and Surgery and a Ph.D. in Pharmacology from the School of Medicine and Surgery at the University of Catania, Italy.        

As a material inducement to entering into employment with Helius, Dr. Favit-Van Pelt, who was not previously an employee or director of Helius, received options to purchase 18,000 shares of the Company’s Class A common stock under Helius’ Inducement Plan. The equity award under Helius’ Inducement Plan was approved by the Company’s independent directors in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.

The options awards have an exercise price of $16.45 per share, the closing price of Helius’ Class A common stock on July 7, 2021, the date of the grant. The options have a ten-year term and vest over a period of four years, with 25% vesting per year on the anniversary date of grant, provided Dr. Favit-Van Pelt’s employment is continuing on each such date, and subject to acceleration or forfeiture upon the occurrence of certain events as set forth in Dr. Favit-Van Pelt’s option agreement.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. PoNS is an investigational medical device in the European Union (“EU”) and Australia (“AUS”). It is currently under premarket review by the AUS Therapeutic Goods Administration.

Cautionary Disclaimer Statement: 

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “looking ahead,” “will,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future strategic and operational execution, the next phase of the Company’s market development activities, the Company’s ability to spread awareness of of PoNS technology, clinical and regulatory development plans for the PoNS device, and the timing and success of the Company’s commercialization efforts in the United States.

These statements involve substantial known and unknown risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, potential changes to the MCIT program, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release. 

CONTACT: Investor Relations Contact: Westwicke on behalf of Helius Medical Technologies, Inc. Jack Powell, Vice President [email protected]

	Image Credit: pudgeefeet (flickr)

Stem Cell-Derived Epithelium Cells May Reveal Light at the End of the Tunnel

 

Human retinal pigment epithelium cells made from stem cells in the lab hold promise in restoring
vision

 

Blindness, eye diseases, and vision impairment

As part of the Global Burden of Disease study, epidemiologists estimated that in 2020, 43.3 million people worldwide were blind¹. The leading global causes of blindness in individuals aged 50 years and older in 2020 were:

• Cataracts
• Glaucoma
• Undercorrected refractive error
• Age-related macular degeneration
• Diabetic retinopathy

In the U.S. (2015), about 1.02 million people were blind, and roughly 3.22 million people had impaired vision². According to data from the CDC’s Disability and Health Data System (2019), the nationwide prevalence of ‘vision disability’ was 5%³. The CDC predicts that the population of adults with blindness and vision impairment will double due to the rapidly aging population, coupled with the increasing incidence of diabetes and other chronic diseases that contributes to vision loss⁴.

Vision loss is a debilitating condition that affects both patients and family members. Loss of sight negatively impacts one’s quality of life, independence, mobility, emotional wellbeing, social function, and even cognitive capabilities⁵. The economic burden of blindness and vision impairment is also significant – the total economic cost was estimated to be about $139 billion (2013) in the U.S⁶. Vision impairment does not only affect visual health; it also correlates with poorer physical (falls, injury, worsening of other chronic conditions) and mental health (depression, anxiety⁷). Vision loss alone resulted in the loss of 283 000 disability-adjusted life years (DALYs)⁶. Therefore, the disease burden⁸ of blindness and vision impairment remains to be a public health concern.

 

Age-related macular degeneration

Macular degeneration, also known as age-related macular degeneration (AMD), is a neurodegenerative disease that is one of the leading causes of blindness and vision impairment. Advanced age is a major risk factor of AMD; therefore, AMD primarily affects elderly individuals. About 11 million individuals are affected with AMD in the U.S, and by 2050, the number is expected to increase to 22 million⁹. Patients with AMD have damage to the macula, a part of the retina, resulting in a progressive loss of central vision. There are two types of AMD – dry and wet AMD. Dry AMD is characterized by the thinning of the macula over time, gradually resulting in vision loss. Dry AMD is the more common, accounting for 70-90% of AMD cases¹⁰. Wet AMD is a late-stage AMD where abnormal blood vessels grow in the back of the eye, causing damage to the macula. Currently, there are several treatment options for wet AMD, such as anti-VEGF drugs and photodynamic therapy¹¹. However, the main goal of those treatment options is to prevent the growth of blood vessels or to seal abnormal blood vessels underneath the macula in order to preserve existing vision and prevent further deterioration of vision. Those treatments are not designed to restore vision. In addition, there are no treatments for early or late dry AMD.

 

Retinal
cell therapy for treating retinal diseases

The use of retinal cell replacement therapy has recently been explored as a feasible treatment option for retinal diseases that underly vision loss, such as AMD and even glaucoma. Human retinal pigment epithelium (RPE) is a layer of pigmented cells that play several critical roles in supporting photoreceptor function and maintaining visual function¹². Retinal degeneration seen in retinal diseases, such as in the case of AMD, results in vision impairment. Therefore, retinal cell replacement therapy aims to replace damaged or diseased RPE cells with healthy, functioning ones in order to improve or even restore visual function.

 

Sources of
human retinal pigment
epithelium cells

There are a few sources of human RPE cells that could be used for retinal cell replacement therapy:

• Adult RPE isolated from cadaveric donors¹³
• Fetal RPE or retinal progenitor cells (RPCs) isolated from fetal eyes¹⁴
• Immortalized adult RPE cells that are manipulated such that the cells are able to proliferate and grow continuously. 

However, there are disadvantages to using these cells. It is difficult to culture adult RPE cells in the lab as they readily lose their functional properties and molecular signatures. Fetal RPE cells were able to better preserve their function when cultured in vitro; they were pigmented, uniform in size and shape, and retained their molecular signatures¹⁵. Lastly, both adult RPE cells and fetal RPE cells are limited in numbers and largely depend on the availability of donors. Although immortalized adult RPE can be easily cultured in vitro and be generated in large numbers, they do not physiologically represent actual RPE cells and may pose cancer risks when used for replacement therapy. Most importantly, experiments involving the use of these cells for retinal cell replacement therapy did not result in vision recovery¹⁶.

 

Generating human retinal pigment epithelium cells from human pluripotent stem cells (hPSCs) in the lab

Human pluripotent stem cells (hPSCs) such as human embryonic stem cells (hESCs) and human-induced pluripotent stem cells (iPSCs) have emerged to be a viable and sustainable source of human RPE cells. hPSCs are, by definition, capable of differentiating into any cell type in the body and are self-renewal, which means that they are able to proliferate while retaining their pluripotency. This essentially means that hPSCs could be used to generate an unlimited supply of human RPE cells for retinal cell replacement therapy.

Over the past decade, efforts have been channeled into developing a differentiation protocol to generate human retinal pigment epithelium (RPE) cells from hPSCs. Masayo Takahashi, a pioneer in stem cell-derived RPE cells from Japan’s RIKEN Institute, came up with ways to generate RPE cells as well as RPE sheets from human iPSCs. The RPE sheets were shown to express molecular signatures and exhibit characteristics similar to native RPE. They also showed upon transplantation of iPSC-derived RPE sheets into nonhuman primates, no adverse effects were reported. Earlier this year, researchers from Singapore also showed that stem cell-derived RPE cells (monolayers) that were transplanted under the macula of nonhuman primates were able to survive and maintain healthy photoreceptors¹⁷. In another study, when human iPSCs-derived RPE cells were transplanted in a rat model of retinal degeneration, visual function in these rats was rescued¹⁸. Recently, researchers have even developed methods to generate 3-D retina organoids that improve visual function when transplanted into animal models of RPE dysfunction¹⁹.

 

Clinical trials

There are already several past and ongoing clinical trials for retinal cell replacement therapy, conducted by biotech companies, research institutions, and even big pharmas^16,20. More recently, the National Eye Institute (NEI) of the National Institute of Health (NIH) launched the first U.S. clinical trial of iPSC-derived RPE cells for the treatment of dry AMD²¹. They will be reprogramming patients’ blood cells into iPSCs before differentiating the iPSCs into RPE cells. The cells will then be grown in one-cell thick sheets (on a biodegradable biological scaffold) before transplantation into the eyes of the patients.

However, the first-ever retinal cell replacement therapy was performed in Japan on a 70—year old Japanese woman²². This experiment was conducted by a group of researchers led by Takahashi. The patient’s skin cells were first reprogrammed into iPSCs, and the iPSCs were then differentiated into RPE cells and transplanted into the patient’s eyes. Takahashi and colleagues performed a similar experiment in 2017 where they transplanted patient iPSC-derived RPE cells into a patient with wet AMD²³.

 

Moving forward

There is light at the end of the tunnel – stem cell-derived RPE holds great promise in treating retinal diseases and restoring vision caused by underlying retinal dysfunctions. With the NIH, biotech companies, and pharmaceutical giants pouring in large amounts of resources into performing research and clinical trials to test the efficacy and safety of stem cell-derived RPE cells for retinal cell replacement therapy, stem cell-derived RPE as a treatment option will soon be a reality. 

 

About the Author:  Nicole Pek is a stem cell biologist and enthusiastic science communicator. She has worked on using human pluripotent stem cells to study cellular development in multiple organ systems, to model complex human diseases, and screen for therapeutics that could treat the diseases. Outside of
the lab, Nicole plays a pro-active role in communicating to the public through her science blog ‘Two Cells’ and her education podcast ‘The Diploid Duo’.

 

References

1.   Bourne, R. et al. Trends in prevalence of blindness and distance and near vision impairment over 30 years: an analysis for the Global Burden of Disease Study. The Lancet Global Health
9, e130–e143 (2021).

2.   Varma, R. et al. Visual Impairment and Blindness in Adults in the United States: Demographic and Geographic Variations From 2015 to 2050. JAMA Ophthalmol 134, 802–809 (2016).

3.   CDC. Disability and Health Data System (DHDS) | CDC. Centers for Disease Control and Prevention https://www.cdc.gov/ncbddd/disabilityandhealth/dhds/index.html (2021).

4.   Burden of Vision Loss | CDC. https://www.cdc.gov/visionhealth/risk/burden.htm (2020).

5.   National Academies of Sciences, E. et al. The Impact of Vision Loss. Making Eye
Health a Population Health Imperative: Vision for Tomorrow (National Academies Press (U.S.), 2016).

6.   Witteborn, John, R., David. The Future of Vision: Forecasting the Prevalence and Cost of Vision Problems. (2014).

7.   Demmin, D. L. & Silverstein, S. M. Visual Impairment and Mental Health: Unmet Needs and Treatment Options. Clin Ophthalmol 14, 4229–4251 (2020).

8.   Gordois, A. et al. An estimation of the worldwide economic and health burden of visual impairment.
Global Public Health 7, 465–481 (2012).

9.   Pennington, K. L. & DeAngelis, M. M. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye
Vis (Lond) 3, 34 (2016).

10.   Common Eye Disorders and Diseases | CDC. https://www.cdc.gov/visionhealth/basics/ced/index.html (2020).

11.   Age-related macular degeneration (AMD) – Treatments. nhs.uk https://www.nhs.uk/conditions/age-related-macular-degeneration-amd/treatment/ (2017).

12.   Strauss, O. The Retinal Pigment Epithelium in Visual Function. Physiological Reviews 85, 845–881 (2005).

13.   Akrami, H. et al. Retinal Pigment Epithelium Culture;a Potential Source of Retinal Stem Cells. J
Ophthalmic Vis Res 4, 134–141 (2009).

14.   Maminishkis, A. et
al. Confluent monolayers of cultured human fetal retinal pigment epithelium exhibit morphology and physiology of native tissue. Invest Ophthalmol Vis
Sci 47, 3612–3624 (2006).

15.   Ablonczy, Z. et al. Human Retinal Pigment Epithelium Cells as Functional Models for the RPE In Vivo. Invest. Ophthalmol. Vis. Sci. 52, 8614–8620 (2011).

16.   Oswald, J. & Baranov, P. Regenerative medicine in the retina: from stem cells to cell replacement therapy. Ther Adv Ophthalmol 10, 2515841418774433 (2018).

17.   Liu, Z. et al. Surgical Transplantation of Human RPE Stem Cell-Derived RPE Monolayers into Non-Human Primates with Immunosuppression. Stem Cell Reports 16, 237–251 (2021).

18.   Surendran, H. et
al. Transplantation of retinal pigment epithelium and photoreceptors generated concomitantly via small molecule-mediated differentiation rescues visual function in rodent models of retinal degeneration. Stem Cell Research
& Therapy 12, 70 (2021).

19.   Lin, B. et al. Retina Organoid Transplants Develop Photoreceptors and Improve Visual Function in RCS Rats With RPE Dysfunction. Invest Ophthalmol Vis Sci 61, 34 (2020).

20.   Zarbin, M., Sugino, I. & Townes-Anderson, E. Concise Review: Update on Retinal Pigment Epithelium Transplantation for Age-Related Macular Degeneration. STEM CELLS Translational
Medicine 8, 466–477 (2019).

21.   NIH launches first U.S. clinical trial of patient-derived stem cell therapy to replace and repair dying cells in retina | National Eye Institute. https://www.nei.nih.gov/about/news-and-events/news/nih-launches-first-us-clinical-trial-patient-derived-stem-cell-therapy-replace-and-repair-dying.

22.   Cyranoski, D. Japanese woman is first recipient of next-generation stem cells. Nature (2014) doi:10.1038/nature.2014.15915.

23.   First donor iPSC-derived RPE cell transplantation in AMD patient Center for Developmental Biology | RIKEN CDB. http://www.cdb.riken.jp/en/news/2017/topics/0404_10343.html.

 

Suggested Reading

The Investor Forum at the World Stem Cell Summit	Stem Cells Role in the Anti Aging Business

Therapeutic Research Advanced by Stem Cell Science	Why Stem Cell Stocks in 2021 Make Sense

 

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Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech, Shares Phase 3 Results Demonstrating 77.8% Protection against Overall Disease

• Efficacy analysis demonstrates COVAXIN™ to be 93.4%
  protective against severe symptomatic COVID-19

• Efficacy data demonstrates 65.2% protection against the
  SARS-CoV-2, B.1.617.2 Delta variant

• Adverse events reported were similar to placebo, with
  12.4% of subjects experiencing commonly known side effects and less than
  0.5% of subjects feeling serious adverse events

MALVERN, Pa., and HYDERABAD, India, July 02, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ:
OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that its co-development partner, Bharat Biotech, shared positive results of its Phase 3 study of COVAXIN™, a whole virion inactivated COVID-19 vaccine candidate.  COVAXIN™ demonstrated a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 77.8% with efficacy against severe COVID-19 disease alone of 93.4%. 

“As we brace ourselves for the potential next wave of COVID-19 outbreaks from the Delta variant, reporting of the final efficacy analysis from this Phase 3 study comes at a crucial time.  We expect these efficacy and safety outcomes, along with demonstrated efficacy against emerging variants of concern, will support our initiatives to bring COVAXIN™ to the US and Canadian markets,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen. 

“With the Delta variant becoming a dominant strain of COVID-19 in the United States, we believe that the Phase 3 efficacy results reported by Bharat Biotech demonstrate that COVAXIN™ has the potential to become an important option to expand protection against this emerging variant. Combining these data with the only Delta-variant results from a controlled Phase 3 clinical trial, evidence continues to support a favorable benefit-risk profile for COVAXIN™,” said Dr. Bruce Forrest, Acting Chief Medical Officer and a member of the vaccine scientific advisory board of Ocugen. 

Phase 3 Results as
Reported by Bharat Biotech 
Bharat Biotech’s Phase 3 clinical trial enrolled 25,798 participants across 25 sites and between 18-98 years of age in India, including 2,750 over the age of 60 and 7,065 with comorbidities. The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.  

“The safety and efficacy readouts from Phase III clinical trials present a comprehensive data package for COVAXIN™. This has been a great journey of science leading to translational product development to combat this deadly pandemic,” added Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech. “We continue our efforts towards additional studies on variants of concern. Our commitment to data transparency has been sustained with 10 publications within the past year, and we will share our findings with regulators worldwide.”

COVAXIN™ demonstrated overall efficacy of 77.8% (95% CI; 65.2-86.4), achieving its primary endpoint. One hundred and thirty positive COVID-19 cases were observed: 24 in the vaccine group and 106 in the placebo group. Sixteen severe cases were observed: one in the vaccine group and 15 in the placebo group, achieving an efficacy of 93.4% (95% CI; 57.1-99.8) with respect to severe COVID-19 infection.

In the Phase 3 trial conducted by Bharat Biotech, subjects vaccinated with COVAXIN™ achieved greater protection against emerging B.1.617.2 (delta) and B.1.351 (beta) variants than those who had previous natural infections. Results showed an efficacy rate of 65.2% (95% CI; 33.1-83.0).

Adverse events reported were low, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events, side effects that keep many from considering taking current vaccines. Both adverse events and severe adverse events reported in the vaccine group were reported at similar rates to the placebo group.

Ocugen recently announced that it will pursue submission of a Biologics License Application (BLA) for its COVID-19 vaccine candidate, COVAXIN™ in the United States and has initiated discussions with Health Canada for regulatory approval.

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

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

Based on the more than 30 million doses supplied in India and other countries, COVAXIN™ has an excellent safety record. COVAXIN™ is currently being administered under emergency use authorizations in 13 countries, and applications for emergency use authorization are pending in more than 60 additional countries.

About Ocugen,
Inc. 
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to 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. 

About Bharat Biotech 
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. 

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO^®, ROTAVAC^®, and Typbar TCV^® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com. 

Cautionary Note on
Forward-Looking Statements  
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether we will be able to provide the U.S. Food and Drug Administration (FDA) with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA); the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA; any additional chemistry, manufacturing and controls information that we may be required to submit the timing of our BLA filing; whether and when an application for authorization under interim order for emergency use will be filed in Canada; whether and when any such applications may be approved by Health Canada; whether developments with respect to COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release. 

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
[email protected]

Please submit investor-related inquiries to: [email protected]

Media contact for
Bharat Biotech:
Sheela Panicker | +91 9849809594 | [email protected]
Shilpa Suryawanshi | +91 9833738595 | [email protected]

 

 

PDS Biotechnology Joins Russell Microcap® Index

 

FLORHAM PARK, N.J., July 01, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, was added to the Russell Microcap® Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective on June 28, according to the FTSE Russell website.

Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

“Inclusion in the Russell Microcap Index underscores the progress we are making towards potentially improving the effectiveness of cancer therapy and increasing shareholder value by progressing our three (3) Phase 2 clinical programs for our lead HPV-cancer immunotherapy PDS0101,” said Dr. Frank Bedu-Addo, President and CEO of PDS Biotech. “Inclusion in the Index significantly benefits our Company and shareholders by elevating our visibility within the global investment community. We look forward to continuing to progress the clinical development of PDS0101 while also moving additional oncology pipeline products into human testing within the next year.”

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells capable of targeting and killing tumors. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in three (3) Phase 2 clinical studies in HPV-associated cancers. Interim data for the company’s most advanced Phase 2 trial was reported in an oral presentation at the recent American Society of Clinical Oncology (ASCO) on June 7, 2021. The interim results demonstrated strong efficacy in treating the cancer in patients with advanced, treatment-resistant HPV16-positive anal, cervical, head and neck, vaginal and vulvar cancers. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About FTSE Russell

FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.

FTSE Russell is wholly owned by London Stock Exchange Group.

For more information, visit www.ftserussell.com.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

PDS Biotechnology Joins Russell Microcap® Index

 

FLORHAM PARK, N.J., July 01, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, was added to the Russell Microcap® Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective on June 28, according to the FTSE Russell website.

Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

“Inclusion in the Russell Microcap Index underscores the progress we are making towards potentially improving the effectiveness of cancer therapy and increasing shareholder value by progressing our three (3) Phase 2 clinical programs for our lead HPV-cancer immunotherapy PDS0101,” said Dr. Frank Bedu-Addo, President and CEO of PDS Biotech. “Inclusion in the Index significantly benefits our Company and shareholders by elevating our visibility within the global investment community. We look forward to continuing to progress the clinical development of PDS0101 while also moving additional oncology pipeline products into human testing within the next year.”

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells capable of targeting and killing tumors. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in three (3) Phase 2 clinical studies in HPV-associated cancers. Interim data for the company’s most advanced Phase 2 trial was reported in an oral presentation at the recent American Society of Clinical Oncology (ASCO) on June 7, 2021. The interim results demonstrated strong efficacy in treating the cancer in patients with advanced, treatment-resistant HPV16-positive anal, cervical, head and neck, vaginal and vulvar cancers. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About FTSE Russell

FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.

FTSE Russell is wholly owned by London Stock Exchange Group.

For more information, visit www.ftserussell.com.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

electroCore Announces Pricing of $18.0 Million Public Offering of Common Stock

 

ROCKAWAY, NJ, 
June 30, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced the pricing of an underwritten public offering of 18,000,000 shares of its common stock at a public offering price of 
$1.00 per share. The gross proceeds of the offering to the Company are expected to be 
$18.0 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. In addition, the Company granted the underwriters a 45-day option to purchase up to an additional 2,700,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

The closing of the offering is expected to occur on or about 
July 2, 2021, subject to the satisfaction of customary closing conditions.

Ladenburg Thalmann & Co. Inc. is acting as sole book-runner for the offering. 
Paulson Investment Company, LLC is acting as a co-manager for the offering.

The Company intends to use the net proceeds of the offering for sales and marketing, working capital, and general corporate purposes. In addition, it believes that opportunities may exist from time to time to expand its current business through acquisitions or in-licenses of, or investments in, complementary companies, medicines, intellectual property or technologies. While the Company has no current agreements or commitments for any specific acquisitions, in-licenses or investments at this time, it may use a portion of the net proceeds for these purposes.

The securities described above are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-232655) previously filed with the 
Securities and Exchange Commission (“SEC”) on 
July 15, 2019, which registration statement became effective on 
September 5, 2019.

A preliminary prospectus supplement relating to the offering was filed with the 
SEC on 
June 29, 2021 and is available on the SEC’s website at http://www.sec.gov. The final prospectus supplement relating to and describing the terms of the offering will be filed with the 
SEC and also will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that the Company has filed with the 
SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about the Company and the offering. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, from 
Ladenburg Thalmann & Co. Inc., 
640 Fifth Avenue, 4th Floor, 
New York, NY 10017, or by email at [email protected].

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

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

For more information, visit www.electrocore.com.

Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, including those regarding the anticipated and potential use of proceeds for the proposed offering, satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, stock price volatility and the impact of general business and economic conditions are forward-looking statements. electroCore may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading “Risk Factors” in electroCore’s Annual Report on Form 10-K for the fiscal year ended 
December 31, 2020, filed with the 
SEC on 
March 11, 2021 and in subsequent filings with, or submissions to, the 
SEC. Except as otherwise required by law, electroCore disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Investors:
Rich CockrellCG Capital
404-736-3838
[email protected]

electroCore Announces Proposed Public Offering of Common Stock

 

ROCKAWAY, NJ, 
June 29, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (the “Company”), NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. All the shares to be sold in the offering will be offered by the Company. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. In addition, the Company intends to grant the underwriters a 45-day option to purchase up to an additional 15 percent of shares of its common stock offered in the public offering.

Ladenburg Thalmann & Co. Inc. is acting as sole book-runner for the offering. 
Paulson Investment Company, LLC is acting as a co-manager for the offering.

The Company intends to use the net proceeds of the offering for sales and marketing, working capital, and general corporate purposes. In addition, it believes that opportunities may exist from time to time to expand its current business through acquisitions or in-licenses of, or investments in, complementary companies, medicines, intellectual property or technologies. While the Company has no current agreements or commitments for any specific acquisitions, in-licenses or investments at this time, it may use a portion of the net proceeds for these purposes.

The securities described above are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-232655) previously filed with the 
Securities and Exchange Commission (“SEC”) on 
July 15, 2019, which registration statement became effective on 
September 5, 2019. The securities will be offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the 
SEC and will be available on the SEC’s website at http://www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained, when available, from 
Ladenburg Thalmann & Co. Inc., 
640 Fifth Avenue, 4th Floor, 
New York, NY 10017, or by email at [email protected].

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

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

For more information, visit www.electrocore.com.

Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, including those regarding the anticipated use of proceeds for the proposed offering, satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, stock price volatility and the impact of general business and economic conditions are forward-looking statements. electroCore may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading “Risk Factors” in electroCore’s Annual Report on Form 10-K for the fiscal year ended 
December 31, 2020, filed with the 
SEC on 
March 11, 2021 and in subsequent filings with, or submissions to, the 
SEC. Except as otherwise required by law, electroCore disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Investors:
Rich CockrellCG Capital
404-736-3838
[email protected]

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
[email protected]

electroCore Announces Proposed Public Offering of Common Stock

 

ROCKAWAY, NJ, 
June 29, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (the “Company”), NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. All the shares to be sold in the offering will be offered by the Company. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. In addition, the Company intends to grant the underwriters a 45-day option to purchase up to an additional 15 percent of shares of its common stock offered in the public offering.

Ladenburg Thalmann & Co. Inc. is acting as sole book-runner for the offering. 
Paulson Investment Company, LLC is acting as a co-manager for the offering.

The Company intends to use the net proceeds of the offering for sales and marketing, working capital, and general corporate purposes. In addition, it believes that opportunities may exist from time to time to expand its current business through acquisitions or in-licenses of, or investments in, complementary companies, medicines, intellectual property or technologies. While the Company has no current agreements or commitments for any specific acquisitions, in-licenses or investments at this time, it may use a portion of the net proceeds for these purposes.

The securities described above are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-232655) previously filed with the 
Securities and Exchange Commission (“SEC”) on 
July 15, 2019, which registration statement became effective on 
September 5, 2019. The securities will be offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the 
SEC and will be available on the SEC’s website at http://www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained, when available, from 
Ladenburg Thalmann & Co. Inc., 
640 Fifth Avenue, 4th Floor, 
New York, NY 10017, or by email at [email protected].

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

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

For more information, visit www.electrocore.com.

Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, including those regarding the anticipated use of proceeds for the proposed offering, satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, stock price volatility and the impact of general business and economic conditions are forward-looking statements. electroCore may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading “Risk Factors” in electroCore’s Annual Report on Form 10-K for the fiscal year ended 
December 31, 2020, filed with the 
SEC on 
March 11, 2021 and in subsequent filings with, or submissions to, the 
SEC. Except as otherwise required by law, electroCore disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Investors:
Rich CockrellCG Capital
404-736-3838
[email protected]

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
[email protected]