Ceapro Inc. Reports 2021 Second Quarter and Six-Month Financial Results and Operational Highlights

 

– Company continues to increase R&D activities to advance clinical and preclinical programs –

– Second quarter sales of $4,409,000 compared to $4,666,000 for second quarter 2020 –

– Cash generated from operations of $2,128,000 in Q2 2021 compared to $2,195,000 in Q2 2020 –

– Maintained production operations during COVID-19 pandemic, providing customers with essential products while ensuring the health and safety of our employees –

EDMONTON, Alberta, Aug. 26, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced financial results and operational highlights for the second quarter and six months ended June 30, 2021.

“Progress continues on all fronts from production operations to research and development, allowing us to advance our pipeline while expanding our business model. With our newly formed network of highly renowned experts from University of Alberta, McMaster University, the Montreal Heart Institute, and the Angiogenesis Foundation, we have implemented a comprehensive strategic research plan that we believe enables us to address immune/inflammation-based and lifestyle diseases at various stages and from all angles. Additionally, with upcoming results expected in the fourth quarter of this year for Ceapro’s very first clinical trial, I believe we are well positioned for the next steps in becoming a premier life sciences company. The Company has exciting things on the horizon and we are committed to building on momentum,” stated Gilles Gagnon, M.Sc., MBA, President and CEO.

Corporate and Operational Highlights

Pipeline Development:

• Announced successful completion of collaborative research and development program with University of Alberta. The program developed several new chemical complexes as potential delivery systems and demonstrated the possibility of drying peptides using Pressurized Gas eXpanded (PGX) Technology.
• Initiated bioavailability studies with University of Alberta for new chemical complexes yeast beta glucan-CoQ10 and alginate-CoQ10.
• Resumed research activities with McMaster University to develop an inhalable therapeutic for COVID-19 using yeast beta glucan.
• Completed patient enrollment in clinical study evaluating beta glucan as a cholesterol-lowering agent. Last patient last visit is expected by end of September 2021, followed by locking of data base, unblinding of the study and topline results expected in Q4 2021.

Technology:

• Pursued technical upgrades of PGX demo plant in Edmonton including initiation of commercial scale up of impregnation unit to produce chemical complexes.
• Initiated engineering design for PGX commercial scale unit. Final decision on the type and location of future commercial scale PGX unit to be announced during Q4 2021.

Production Operations:

• Successfully passed thorough audits conducted by two major customers for the Edmonton facility, which is now housing all production operations for the Company.
  

Corporate:

• Pursued out-licensing discussions for PGX-processed new chemical complexes.
  

Subsequent to Quarter:

• Announced research agreement with Montreal Heart Institute for a Phase 1 clinical trial assessing safety and tolerability of pharmaceutical grade avenanthramides.
• Announced research agreement with Boston-based Angiogenesis Foundation to assess in vivo bioefficacy of oat beta glucan and avenanthramides in angiogenesis, blood vessel repairs, wound healing and tissue regeneration in various inflammation-based diseases and conditions like COVID-19 presenting damages of the lung blood vessels.

Financial Highlights for the Second Quarter and the Six-Month Period Ended June 30, 2021

• Total sales of $4,409,000 for the second quarter of 2021 and $9,110,000 for the first six months of 2021 compared to $4,666,000 and $8,939,000 for the comparative periods in 2020.
  
  Sales being made in USA dollars and then reported in CDN dollars, it is noteworthy to look at the impact of the exchange rate (USD/CDN) from year to year. In fact, the Company has recorded respective sales in USD of $3.6M and USD $7.3M for the second quarter and the first six months of 2021 as compared to USD $3.4M and USD $6.5M for the comparative periods of 2020, representing a year-to-date effective increase of 12% in 2021.

• Net profit of $676,000 for the second quarter of 2021 and $1,191,000 for the first six months of 2021 compared to a net profit of $1,077,000 and $2,203,000 for the comparative periods in 2020.
  
  
• Cash flows generated from operations of $2,433,000 for the first six months of 2021 vs $2,727,000 in 2020.
  
  
• Positive working capital balance of $9,303,000 as of June 30, 2021.
  

“The ability of our business to successfully navigate through the challenging second quarter business environment is a testament to the commitment and hard work of our dedicated employees, and a measurable indication of the operational improvements generated by our strategic investments of the past few years,” continued Mr. Gagnon. “Looking ahead, while considering the ongoing potential economic impact related to the new surge of COVID-19, we believe Ceapro is well-positioned to once again deliver solid growth in 2021. With a strong and very clean balance sheet, a group of dedicated people, and a solid base business coupled with the innovative technologies and products that we have developed to enable us to expand, Ceapro is poised to emerge as a successful life science company.”

CEAPRO INC.
Consolidated Balance Sheets
Unaudited
	June 30,	December 31,
	2021	2020
	$	$
ASSETS
Current Assets
Cash and cash equivalents	7,269,428	5,369,029
Trade receivables	1,801,568	2,019,723
Other receivables	45,913	102,224
Inventories (note 3)	1,168,163	1,210,079
Prepaid expenses and deposits	236,932	348,845
	10,522,004	9,049,900
Non-Current Assets
Investment tax credits receivable	607,700	607,700
Deposits	82,124	82,124
Licences (note 4)	17,032	18,514
Property and equipment (note 5)	18,029,316	18,591,189
Deferred tax assets	874,304	874,304
	19,610,476	20,173,831
TOTAL ASSETS	30,132,480	29,223,731
LIABILITIES AND EQUITY
Current Liabilities
Accounts payable and accrued liabilities	857,731	1,067,622
Current portion of lease liabilities (note 6)	283,204	250,658
Current portion of CAAP loan (note 8)	77,855	72,263
	1,218,790	1,390,543
Non-Current Liabilities
Long-term lease liabilities (note 6)	2,505,623	2,648,917
Deferred tax liabilities	874,304	874,304
	3,379,927	3,523,221
TOTAL LIABILITIES	4,598,717	4,913,764
Equity
Share capital (note 7 (b))	16,555,619	16,511,067
Contributed surplus (note 7 (e))	4,670,289	4,682,393
Retained earnings	4,307,855	3,116,507
	25,533,763	24,309,967
TOTAL LIABILITIES AND EQUITY	30,132,480	29,223,731

CEAPRO INC.
Consolidated Statements of Net Income and Comprehensive Income
Unaudited
	Quarters Ended June 30,				Six Months Ended June 30,
	2021		2020		2021		2020
	$		$		$		$
Revenue (note 14)	4,408,631		4,665,971		9,110,374		8,939,345
Cost of goods sold	1,770,153		2,079,270		4,213,953		3,980,493
Gross margin	2,638,478		2,586,701		4,896,421		4,958,852
Research and product development	830,511		399,797		1,647,358		902,339
General and administration	952,847		838,263		1,665,054		1,703,297
Sales and marketing	16,362		29,207		29,600		77,435
Finance costs (note 11)	38,344		44,583		132,254		146,192
Income from operations	800,414		1,274,851		1,422,155		2,129,589
Other (expenses) income (note 10)	(123,942	)	(197,812	)	(230,807	)	73,505
Income before tax	676,472		1,077,039		1,191,348		2,203,094
Income taxes	–		–		–		–
Total comprehensive income for the period	676,472		1,077,039		1,191,348		2,203,094
Net income per common share (note 17):
Basic	0.01		0.01		0.02		0.03
Diluted	0.01		0.01		0.02		0.03
Weighted average number of common shares outstanding (note 17):
Basic	77,673,832		77,608,341		77,662,495		77,573,327
Diluted	78,684,303		77,980,876		78,684,344		77,930,529

CEAPRO INC.
Consolidated Statements of Cash Flows
Unaudited
	2021		2020
Six Months Ended June 30,	$		$
OPERATING ACTIVITIES
Net income for the period	1,191,348		2,203,094
Adjustments for items not involving cash
Finance costs	71,662		79,674
Transaction costs	–		1,108
Depreciation and amortization	937,356		920,521
Accretion	5,592		10,410
Share-based payments	6,828		108,147
Net income for the period adjusted for non-cash items	2,212,786		3,322,954
CHANGES IN NON-CASH WORKING CAPITAL ITEMS
Trade receivables	218,155		600,990
Other receivables	56,311		(43,599	)
Inventories	41,916		(592,489	)
Prepaid expenses and deposits	51,179		(33,088	)
Accounts payable and accrued liabilities relating to operating activities	(75,337	)	(448,200	)
Total changes in non-cash working capital items	292,224		(516,386	)
Net income for the period adjusted for non-cash and working capital items	2,505,010		2,806,568
Interest paid	(71,662	)	(79,674	)
CASH GENERATED FROM OPERATIONS	2,433,348		2,726,894
INVESTING ACTIVITIES
Purchase of property and equipment	(277,062	)	(38,230	)
Purchase of leasehold improvements	(19,472	)	–
Deposits relating to investment in equipment	(16,733	)	(50,203	)
Accounts payable and accrued liabilities relating to investing activities	(134,554	)	–
CASH USED IN INVESTING ACTIVITIES	(447,821	)	(88,433	)
FINANCING ACTIVITIES
Stock options exercised	25,620		–
Repayment of long-term debt	–		(97,507	)
Repayment of lease liabilities	(110,748	)	(130,829	)
CASH USED IN FINANCING ACTIVITIES	(85,128	)	(228,336	)
Increase in cash and cash equivalents	1,900,399		2,410,125
Cash and cash equivalents at beginning of the period	5,369,029		1,857,195
Cash and cash equivalents at end of the period	7,269,428		4,267,320

The complete financial statements are available for review on SEDAR at https://sedar.com/Ceapro and on the Company’s website at www.ceapro.com.

About Ceapro Inc.

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

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: [email protected]

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

Source: Ceapro Inc.

Wednesday, August 25, 2021

Helius Medical Technologies (HSDT)(HSM:CA)
$32 Million Market Cap With A Multi-Billion TAM – What’s The Disconnect?

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 (PoNSTM). For more information, visit www.heliusmedical.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

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

Can’t See the Forest For the Trees? We believe investors are missing the big picture at Helius Medical Technologies. Last week the Company received its second Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for its PoNS device, this time for treatment of stroke patients with dynamic gait and balance deficits. Investors are missing the importance of the announcement, in our view.


Second Breakthrough Designation.  To put last week’s announcement in perspective, there are over 400 companies with a Breakthrough Device Designation. Only 5.65% have FDA clearance, which Helius is one of them. For a company to have a second BDD puts Helius in rare air …

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

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

Wednesday, August 25, 2021

Helius Medical Technologies (HSDT)(HSM:CA)
$32 Million Market Cap With A Multi-Billion TAM – What’s The Disconnect?

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 (PoNSTM). For more information, visit www.heliusmedical.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

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

Can’t See the Forest For the Trees? We believe investors are missing the big picture at Helius Medical Technologies. Last week the Company received its second Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for its PoNS device, this time for treatment of stroke patients with dynamic gait and balance deficits. Investors are missing the importance of the announcement, in our view.


Second Breakthrough Designation.  To put last week’s announcement in perspective, there are over 400 companies with a Breakthrough Device Designation. Only 5.65% have FDA clearance, which Helius is one of them. For a company to have a second BDD puts Helius in rare air …

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

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

electroCore Announces New Reseller Agreement with Red One Medical Devices, LLC

 

ROCKAWAY, NJ, 
Aug. 24, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced a reseller agreement with 
Red One Medical Devices, LLC. (Red One). The partnership will further expand availability of electroCore’s gammaCore platform in the federal marketplace.

Red One is a Service-Disabled Veteran-Owned Small Business (SDVOSB) offering medical and pharmaceutical goods and services to the 
U.S. Department of Veterans Affairs (VA) and 
Department of Defense (
DoD) hospitals, ensuring compliance with contracting regulations, and providing logistical solutions connected directly into government contracting portals such as ECAT, 
GSA, DAPA, BPA, and DIBBS.

“As a 
VA and 
DoD private sector partner for medical innovation, we are excited to partner with electroCore,” said  Charles Pollak, President of Red One. “Their gammaCore therapy may help thousands of military personnel, family and veterans suffering from primary headache. Painful and disabling headaches torment more than 20% of former service members, especially those from the post-9/11 combat veteran cohort. We look forward to partnering with electroCore to make the therapy more easily accessible in the federal marketplace.”

“Partnering with Red One will help accelerate adoption of electroCore’s therapy within the government channel,” commented  Dan Goldberger, Chief Executive Officer of electroCore. “Our partnership gives electroCore access to a variety of contracting portals enabling easier procurement of gammaCore therapy across veteran and active military channels. We have just begun to scratch the surface of the help we can provide to our veterans, troops, and family members in 
VA and 
DoD, and we are honored to partner with an SDVOSB to make gammaCore more widely available to those veterans and active-duty military who can benefit from our therapy.”

About Red One Medical Devices, LLC
Red One is transforming healthcare for America’s military service members and veterans. Red One identifies and delivers advanced medical and pharmaceutical technologies to the federal government. These products meet the unique needs of military surgeons and patients. They are clinically proven to improve treatment outcomes in both the 
DoD and 
VA. Red One accelerates the procurement process, oftentimes making products available to the government before they’re offered in the private sector. Their team is on a mission to provide veterans with top quality care.

With over 90 combined years of experience in medical sales and government contracting, Red One provides medical and pharmaceutical companies access to the federal marketplace. Red One is a government certified Service-Disabled Veteran Owned Small Business (SDVOSB) and Disability-Owned Business Enterprise (DOBE). Red One connects leading medical and pharmaceutical manufacturers to 
US Department of Veterans Affairs (VA) and 
Department of Defense (
DoD) hospitals.

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

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

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

gammaCore is contraindicated for patients if they:

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

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

• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
  
  

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

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

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

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
[email protected]

electroCore Announces New Reseller Agreement with Red One Medical Devices, LLC

 

ROCKAWAY, NJ, 
Aug. 24, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced a reseller agreement with 
Red One Medical Devices, LLC. (Red One). The partnership will further expand availability of electroCore’s gammaCore platform in the federal marketplace.

Red One is a Service-Disabled Veteran-Owned Small Business (SDVOSB) offering medical and pharmaceutical goods and services to the 
U.S. Department of Veterans Affairs (VA) and 
Department of Defense (
DoD) hospitals, ensuring compliance with contracting regulations, and providing logistical solutions connected directly into government contracting portals such as ECAT, 
GSA, DAPA, BPA, and DIBBS.

“As a 
VA and 
DoD private sector partner for medical innovation, we are excited to partner with electroCore,” said  Charles Pollak, President of Red One. “Their gammaCore therapy may help thousands of military personnel, family and veterans suffering from primary headache. Painful and disabling headaches torment more than 20% of former service members, especially those from the post-9/11 combat veteran cohort. We look forward to partnering with electroCore to make the therapy more easily accessible in the federal marketplace.”

“Partnering with Red One will help accelerate adoption of electroCore’s therapy within the government channel,” commented  Dan Goldberger, Chief Executive Officer of electroCore. “Our partnership gives electroCore access to a variety of contracting portals enabling easier procurement of gammaCore therapy across veteran and active military channels. We have just begun to scratch the surface of the help we can provide to our veterans, troops, and family members in 
VA and 
DoD, and we are honored to partner with an SDVOSB to make gammaCore more widely available to those veterans and active-duty military who can benefit from our therapy.”

About Red One Medical Devices, LLC
Red One is transforming healthcare for America’s military service members and veterans. Red One identifies and delivers advanced medical and pharmaceutical technologies to the federal government. These products meet the unique needs of military surgeons and patients. They are clinically proven to improve treatment outcomes in both the 
DoD and 
VA. Red One accelerates the procurement process, oftentimes making products available to the government before they’re offered in the private sector. Their team is on a mission to provide veterans with top quality care.

With over 90 combined years of experience in medical sales and government contracting, Red One provides medical and pharmaceutical companies access to the federal marketplace. Red One is a government certified Service-Disabled Veteran Owned Small Business (SDVOSB) and Disability-Owned Business Enterprise (DOBE). Red One connects leading medical and pharmaceutical manufacturers to 
US Department of Veterans Affairs (VA) and 
Department of Defense (
DoD) hospitals.

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

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

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

gammaCore is contraindicated for patients if they:

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

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

• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
  
  

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

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

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

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
[email protected]

Ceapro Inc. Enters into Research Collaboration with the Angiogenesis Foundation for Beta Glucan and Avenanthramides

 

– Research focused on addressing root cause of disease and tissue damage for diseases such as COVID-19 –

– Leveraging the unique expertise and methods developed by the Angiogenesis Foundation to conduct pre-clinical studies to characterize the in vivo bioactivity of Ceapro’s oat-derived bioactive products on angiogenesis, wound healing and tissue regeneration –

EDMONTON, Alberta, Aug. 23, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, announced today it has established a formal research collaboration with the Boston-based Angiogenesis Foundation, a prestigious independent scientific organization focused on driving innovations in health promotion, disease prevention, and disease treatment.

This research collaboration has been established based on preliminary in vitro results showing that Ceapro’s pharmaceutical grade formulations of beta-glucan and avenanthramides stimulate the proliferation and migration of vascular endothelial cells in a dose-dependent manner. Under the collaboration, pre-clinical studies using methods developed by the Angiogenesis Foundation will be conducted to characterize the in vivo bioactivity of Ceapro’s oat-derived bioactive products, beta glucan and avenanthramides, on angiogenesis, blood vessels repair, wound healing and tissue regeneration.

“Endothelial cell stimulation is a hallmark of, and a requirement for, wound healing,” commented Dr. Vincent W. Li, Chief Scientific Officer of the Angiogenesis Foundation. “Given that Ceapro products have demonstrated in vitro activity that may impact healing at the cellular level, we expect to further characterize this biological activity using well-established in vivo models and assess their potential applications to a variety of functional health benefits. These benefits include tissue regeneration and repair as well as disease conditions such as COVID-19 and post-COVID-19, which are associated with severe blood vessel damage leading to thrombosis in the lungs and other organs. We believe this has the potential to address a root cause of such complications.”

“The establishment of this research collaboration represents a noteworthy milestone for Ceapro. As we continue our evolution from a contract manufacturer to a life sciences company involved in inflammation, immune based and life-style diseases, expanding the potential of our technology and bioactive products remains a key driver. We are honored to have garnered the interest of the expert team at the Angiogenesis Foundation, and their associated network of worldwide renowned researchers who pioneered the development of various therapies to treat angiogenesis-based conditions. We will strongly benefit from their invaluable and unique expertise in contributing to the implementation of the comprehensive strategic research plan that we are putting in place with a newly bolstered network of experts committed to addressing disease through an integrated approach, which we believe has a significant potential to bring benefit to patients and healthcare professionals and to unlock value for shareholders,” commented Gilles R. Gagnon, M.Sc., MBA, President and CEO of Ceapro.

About the Angiogenesis Foundation & Disclosure

The Angiogenesis Foundation was founded in 1994 by a group of physicians, including Dr. William Li who is currently the CEO of the Foundation and a board member of Ceapro Inc. The Foundation is an independent 501(c)(3) scientific organization that drives innovations in health promotion, disease prevention, and disease treatment through research, education, and advocacy. The Foundation has experience in developing rigorous, high-impact scientific studies, including in the vascular and immuno-inflammatory arenas that underlie chronic diseases in oncology, cardiovascular diseases, wound healing, and now COVID-19 and has presented its results at national and international meetings, and published in top tier scientific and clinical journals, including Science, Nature, Lancet, and New England Journal of Medicine. For more information or to support the Foundation’s research and programs, visit angio.org.

About Ceapro Inc.

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

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

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: [email protected]

Issuer:

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

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

Source: Ceapro Inc.

Monday, August 23, 2021

Cocrystal Pharma Inc. (COCP)
2Q21 Reported With Clinical Milestones For 2021-22

Cocrystal Pharma Inc is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, hepatitis C viruses, and noroviruses. The company employs structure-based technologies and Nobel Prize-winning expertise to create first-and best-in-class antiviral drugs. It is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks.

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

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

Cocrystal Reports 2Q21 With Clinical Trial Milestones. Cocrystal Pharmaceuticals reported 2Q21 results of a loss of $3.8 million or $(0.04) per share, compared with our expected loss of $3.1 million or (0.04) per share. Differences from our estimates were largely due to higher Research expenses for product development and lower General Expenses. The company ended the quarter with $67.1 million in cash. Based on our estimates for research programs and net losses, we expect this cash to last into 2024.


COVID-19 Program Has Two Preclinical Studies.   Cocrystal has two programs developing protease inhibitors against the virus that causes COVID-19, SARS-CoV-2.  The company plans to hold a pre-IND meeting with the FDA for CDI-45205 later this year, with an IND enabling study in 1H22 using intranasal/pulmonary delivery. A pre-IND for an oral inhibitor in is expected in 1H22, followed by an IND-enabling …

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

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

Ceapro Inc. Enters into Research Collaboration with the Angiogenesis Foundation for Beta Glucan and Avenanthramides

 

– Research focused on addressing root cause of disease and tissue damage for diseases such as COVID-19 –

– Leveraging the unique expertise and methods developed by the Angiogenesis Foundation to conduct pre-clinical studies to characterize the in vivo bioactivity of Ceapro’s oat-derived bioactive products on angiogenesis, wound healing and tissue regeneration –

EDMONTON, Alberta, Aug. 23, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, announced today it has established a formal research collaboration with the Boston-based Angiogenesis Foundation, a prestigious independent scientific organization focused on driving innovations in health promotion, disease prevention, and disease treatment.

This research collaboration has been established based on preliminary in vitro results showing that Ceapro’s pharmaceutical grade formulations of beta-glucan and avenanthramides stimulate the proliferation and migration of vascular endothelial cells in a dose-dependent manner. Under the collaboration, pre-clinical studies using methods developed by the Angiogenesis Foundation will be conducted to characterize the in vivo bioactivity of Ceapro’s oat-derived bioactive products, beta glucan and avenanthramides, on angiogenesis, blood vessels repair, wound healing and tissue regeneration.

“Endothelial cell stimulation is a hallmark of, and a requirement for, wound healing,” commented Dr. Vincent W. Li, Chief Scientific Officer of the Angiogenesis Foundation. “Given that Ceapro products have demonstrated in vitro activity that may impact healing at the cellular level, we expect to further characterize this biological activity using well-established in vivo models and assess their potential applications to a variety of functional health benefits. These benefits include tissue regeneration and repair as well as disease conditions such as COVID-19 and post-COVID-19, which are associated with severe blood vessel damage leading to thrombosis in the lungs and other organs. We believe this has the potential to address a root cause of such complications.”

“The establishment of this research collaboration represents a noteworthy milestone for Ceapro. As we continue our evolution from a contract manufacturer to a life sciences company involved in inflammation, immune based and life-style diseases, expanding the potential of our technology and bioactive products remains a key driver. We are honored to have garnered the interest of the expert team at the Angiogenesis Foundation, and their associated network of worldwide renowned researchers who pioneered the development of various therapies to treat angiogenesis-based conditions. We will strongly benefit from their invaluable and unique expertise in contributing to the implementation of the comprehensive strategic research plan that we are putting in place with a newly bolstered network of experts committed to addressing disease through an integrated approach, which we believe has a significant potential to bring benefit to patients and healthcare professionals and to unlock value for shareholders,” commented Gilles R. Gagnon, M.Sc., MBA, President and CEO of Ceapro.

About the Angiogenesis Foundation & Disclosure

The Angiogenesis Foundation was founded in 1994 by a group of physicians, including Dr. William Li who is currently the CEO of the Foundation and a board member of Ceapro Inc. The Foundation is an independent 501(c)(3) scientific organization that drives innovations in health promotion, disease prevention, and disease treatment through research, education, and advocacy. The Foundation has experience in developing rigorous, high-impact scientific studies, including in the vascular and immuno-inflammatory arenas that underlie chronic diseases in oncology, cardiovascular diseases, wound healing, and now COVID-19 and has presented its results at national and international meetings, and published in top tier scientific and clinical journals, including Science, Nature, Lancet, and New England Journal of Medicine. For more information or to support the Foundation’s research and programs, visit angio.org.

About Ceapro Inc.

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

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

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: [email protected]

Issuer:

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

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

Source: Ceapro Inc.

Thursday, August 19, 2021

Lineage Cell Therapeutics (LCTX)
Treating Diseases By Transplanting New Cells

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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

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

Initiating Coverage of LCTX.  Lineage Cell Therapeutics is developing cellular-based therapies for use as standardized, “off-the-shelf” products to restore tissue damaged by disease processes. The company has developed a proprietary technology for growing early cells into mature cell lines of differentiated, functional tissue components. These cells are then implanted to restore areas of dead or damaged cells.


Lead Product is In Dry AMD.  The company’s technology directs cells to differentiate along specific cell lines, guiding them to mature into functional tissue components.  Its lead product, OpRegen, is in development for dry age-related macular degeneration, or dry AMD. Interim results from a Phase 1/2a trial RPE were updated in July 2021, with the next clinical trial planned in late 2021-early 2022 …

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

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

Wednesday, August 18, 2021

Helius Medical Technologies (HSDT)(HSM:CA)
FDA Breakthrough Device Designation for Stroke

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 (PoNSTM). For more information, visit www.heliusmedical.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

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

FDA Breakthrough Designation. Yesterday, Helius announced that it received Breakthrough Designation from the U.S. Food and Drug Administration (“FDA”) for its PoNS device with the proposed indication for use as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke. It is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over. Helius will utilize the Breakthrough Devices Program to facilitate its pursuit of U.S. regulatory clearance for treatment of stroke-induced symptoms.


What is Breakthrough Designation? The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.  The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to …

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

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

Helius Medical Technologies, Inc. Announces FDA Breakthrough Device Designation for the Treatment of Dynamic Gait and Balance Deficits Following a Stroke

 

NEWTOWN, Pa., Aug. 17, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has received Breakthrough Designation from the U.S. Food and Drug Administration (“FDA”) for its PoNS™ device with the proposed indication for use as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke, to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over.

“We are very pleased to announce the receipt of Breakthrough Designation for our PoNS device to treat stroke-induced gait and balance deficits,” said Helius CEO, Dane Andreeff. “Strokes are a large and growing cause of long-term disability in the United States. An estimated 7 million Americans are living with stroke-related complications, and more than 80% of stroke survivors are estimated to develop gait impairment.¹”

Mr. Andreeff continued: “Obtaining Breakthrough Designation represents an important milestone in our path to providing this underserved patient population with a non-drug, non-implantable treatment option that has the potential to significantly improve their gait and balance, their ability to walk and perform daily tasks. We look forward to building on this achievement by utilizing the Breakthrough Devices Program to facilitate our pursuit of U.S. regulatory clearance for treatment of stroke-induced symptoms in close collaboration with the FDA.”

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.

The Breakthrough Devices Program offers manufacturers such as Helius an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission.

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 including 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. The PoNS™ is an investigational medical device in Australia (“AUS”) and is currently under premarket review by the AUS Therapeutic Goods Administration.

Investor Relations Contact:

Westwicke on behalf of Helius Medical Technologies, Inc.
Jack Powell, Vice President
[email protected]

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,” “will,” “goal,” “aim to,” “look forward” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s regulatory plans and pursuit of U.S. regulatory clearance for treatment of stroke-related symptoms.

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 associated with future clinical trials and the clinical development process, the product development process and FDA regulatory submission review and approval process, other development activities, 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, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, manufacturing and supply chain risks, potential changes to the MCIT program resulting from the 60-day deferral of the program implementation, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section 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 June 30, 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.

¹ Carmen M. Cirstea. Gait Rehabilitation After Stroke, Should we re-evaluate our practice? Stroke 2020;51(10):2892-94.

Helius Medical Technologies, Inc. Announces FDA Breakthrough Device Designation for the Treatment of Dynamic Gait and Balance Deficits Following a Stroke

 

NEWTOWN, Pa., Aug. 17, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has received Breakthrough Designation from the U.S. Food and Drug Administration (“FDA”) for its PoNS™ device with the proposed indication for use as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke, to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over.

“We are very pleased to announce the receipt of Breakthrough Designation for our PoNS device to treat stroke-induced gait and balance deficits,” said Helius CEO, Dane Andreeff. “Strokes are a large and growing cause of long-term disability in the United States. An estimated 7 million Americans are living with stroke-related complications, and more than 80% of stroke survivors are estimated to develop gait impairment.¹”

Mr. Andreeff continued: “Obtaining Breakthrough Designation represents an important milestone in our path to providing this underserved patient population with a non-drug, non-implantable treatment option that has the potential to significantly improve their gait and balance, their ability to walk and perform daily tasks. We look forward to building on this achievement by utilizing the Breakthrough Devices Program to facilitate our pursuit of U.S. regulatory clearance for treatment of stroke-induced symptoms in close collaboration with the FDA.”

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.

The Breakthrough Devices Program offers manufacturers such as Helius an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission.

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 including 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. The PoNS™ is an investigational medical device in Australia (“AUS”) and is currently under premarket review by the AUS Therapeutic Goods Administration.

Investor Relations Contact:

Westwicke on behalf of Helius Medical Technologies, Inc.
Jack Powell, Vice President
[email protected]

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,” “will,” “goal,” “aim to,” “look forward” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s regulatory plans and pursuit of U.S. regulatory clearance for treatment of stroke-related symptoms.

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 associated with future clinical trials and the clinical development process, the product development process and FDA regulatory submission review and approval process, other development activities, 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, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, manufacturing and supply chain risks, potential changes to the MCIT program resulting from the 60-day deferral of the program implementation, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section 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 June 30, 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.

¹ Carmen M. Cirstea. Gait Rehabilitation After Stroke, Should we re-evaluate our practice? Stroke 2020;51(10):2892-94.

Cocrystal Pharma Reports Second Quarter 2021 Financial Results and Provides Antiviral Program and Milestone Updates

 

• Influenza program Phase 1 clinical trial with CC-42344 on track to begin in the third quarter of 2021
  
• COVID-19 program preclinical development with the novel oral SARS-CoV-2 protease inhibitors is advancing
• Two IND-enabling studies in the COVID-19 program expected to begin in the first half of 2022 prior to Phase 1 clinical trials
• $67 million in cash at quarter-end is expected to fund current operations beyond 2024

BOTHELL, Wash., Aug. 16, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”), a clinical-stage biotechnology company, reports financial results for the three and six months ended June 30, 2021, and provides updates on its antiviral pipeline, milestones and business activities.

“Our scientific team is rapidly advancing the discovery and development of novel antiviral compounds that are aimed at addressing unmet medical needs for antiviral therapeutics,” said Sam Lee, Ph.D., President and co-interim CEO of Cocrystal. “Our novel antivirals are intended to halt the replication of viruses that cause serious human diseases.

“We plan to initiate IND-enabling studies in the first half of 2022 with our SARS-CoV-2 protease inhibitor, CDI-45205, for intranasal/pulmonary delivery, as well as with a novel oral SARS-CoV-2 protease inhibitor that we discovered with our proprietary structure-based drug discovery technology. Our plan is to hold a pre-IND meeting with the FDA with CDI-45205 this year, followed by a pre-IND meeting with our novel oral inhibitor in the first half of 2022,” he added. “We are encouraged by recent in vitro laboratory data indicating CDI-45205 is highly active against the SARS-CoV-2 (Wuhan strain) as well as four variants of concern, including the Delta variant. We are also very excited by recent preclinical data with our SARS-CoV-2 oral inhibitors. We plan to initiate drug substance and drug product manufacturing with these oral inhibitors this year.

“We are on track this quarter to initiate a Phase 1 clinical trial in healthy volunteers with CC-42344, our lead compound being developed for the treatment of seasonal and pandemic influenza,” Dr. Lee concluded.

“We are in a good financial position at the second quarter with more than $67 million in cash and a clean balance sheet consisting of common stock only with no debt,” said James Martin, CFO and Co-Interim CEO. “We believe our capital is sufficient to fund planned operations beyond 2024, including clinical trials, as we advance toward commercialization.”

Antiviral Pipeline Overview

COVID-19 Programs

• By targeting viral replication enzymes and proteases, Cocrystal believes it is possible to develop effective treatments for all coronaviruses including SARS-CoV-2, SARS-CoV and MERS-CoV.
• CDI-45205 was among the broad-spectrum viral protease inhibitors obtained from Kansas State University Research Foundation (KSURF) under an exclusive license agreement announced in 2020. Cocrystal entered into the KSURF agreements to enable the rapid advancement of COVID-19 programs.
• CDI-45205 has demonstrated a strong in vitro synergistic effect with the FDA-approved COVID-19 medicine remdesivir.
• Proof-of-concept data demonstrated that daily injections of CDI-45205 exhibited favorable in vivo efficacy in mice infected with MERS-CoV-2.

Influenza A Program

• The Phase 1 clinical study with CC-42344 is expected to be conducted in Australia, which offers favorable regulatory policies and a clinical trial environment that aligns with the Company’s strategy for rapid, cost-efficient and high-quality clinical development.
• CC-42344 showed broad-spectrum and potent antiviral activity against influenza A strains, including avian pandemic strains, Tamiflu- and Xofluza-resistant strains, along with a favorable pharmacokinetic profile.
• Influenza remains a major global concern. An influenza pandemic is a global outbreak of new influenza A virus. According to the World Health Organization (WHO) there are approximately 1 billion cases of influenza annually worldwide, resulting in 3 million to 5 million cases of severe illness and 250,000 to 500,000 deaths.
  

Norovirus Program

• Cocrystal is developing certain proprietary broad-spectrum antiviral compounds to treat norovirus infections under its license agreement with KSURF.
• Norovirus is a public health problem responsible for nearly 90% of epidemic, non-bacterial outbreaks of gastroenteritis around the world.

Hepatitis C Program

• Cocrystal is seeking a partner to advance the development of CC-31244 following completion of a Phase 2a trial. This compound showed favorable safety and preliminary efficacy in a triple regimen Phase 2a study in combination with Epclusa (sofosbuvir/velpatasvir) for the ultra-short duration treatment of individuals infected with the hepatitis C virus (HCV). To date, no other company has developed an HCV treatment of 4 weeks or less with a high (>95%) sustained virologic response at Week 12.
• HCV is a viral infection of the liver that causes both acute and chronic infection. According to the WHO, in 2017 an estimated 71 million people worldwide had chronic HCV infection, including 3.5 million in the U.S. Approximately 399,000 people die each year from hepatitis C infection, mostly from cirrhosis and hepatocellular carcinoma.

Second Quarter 2021 and Recent Corporate Highlights

• Designated President Dr. Lee and CFO Martin as Co-Interim CEOs, following the unexpected passing of Chairman, CEO and co-founder Dr. Gary Wilcox. Roger Kornberg, Ph.D., co-founder, Chief Scientist, Director and Chairman of the Scientific Advisory Board, was named Chairman of the Board, and Steve Rubin, Director of Cocrystal and its predecessor company since 2008, was named Vice Chairman.
• Raised $36.4 million in net proceeds from a public offering of common stock in May 2021.
• Cocrystal common stock was added to the Russell Microcap^® Index, a broadly used performance measure for smaller growth stocks in the U.S.
  

Second Quarter Financial Results

Throughout 2020 Cocrystal reported quarterly revenues under an influenza A/B collaboration with Merck consisting of research and development (R&D) services performed by Cocrystal and reimbursed by Merck. In January 2021 Merck assumed all activities and expenses associated with the continued development of the influenza A/B compounds discovered under this collaboration. As anticipated, Cocrystal reported no revenues for the second quarter of 2021 compared with $554,000 in revenues for the second quarter of 2020. Under the terms of the Merck collaboration, Cocrystal is eligible to receive up to $156 million in future payments related to designated developments, regulatory and sales milestones, as well as royalties on product sales.

R&D expenses for the second quarter of 2021 were $2.7 million compared with $2.0 million for the second quarter of 2020, with the increase primarily related to higher spending on the COVID-19 and influenza programs. The Company expects R&D expenses to increase in the second half of 2021 with the initiation of a clinical trial in the influenza A program and advancements with the COVID-19 programs toward clinical development. General and administrative (G&A) expenses for the second quarter of 2021 were $1.1 million versus $2.0 million for the prior-year quarter, with the decline primarily due to reduced professional fees.

The net loss for the second quarter of 2021 was $3.8 million, or $0.04 per share, compared with a net loss for the second quarter of 2020 of $3.5 million, or $0.07 per share.

Year to Date Financial Results

The Company did not report revenues for the first six months of 2021 versus $1.0 million for the first six months of 2020. The 2020 revenues were reimbursement for R&D services performed under the influenza A/B program with Merck. In January 2021, the influenza A/B program was advanced for continued development of the antiviral agents at Merck. Merck is responsible for funding continued development of the compounds.

R&D expenses for the first half of 2021 increased 33% to $4.3 million and G&A expenses decreased 29% to $2.2 million, both compared with the first six months of 2020. The increased R&D in 2021 was primarily due to development of COVID-19 programs and preparation to advance our influenza A program into clinical trials.

The net loss for the six months ended June 30, 2021 was $6.6 million, or $0.08 per share, compared with a net loss for the six months ended June 30, 2020 of $5.5 million, or $0.12 per share.

The Company reported cash and cash equivalents of $67.1 million as of June 30, 2021 compared with $33.0 million as of December 31, 2020. The Company reported working capital of $65.0 million as of June 30, 2021.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected advancement of our antiviral programs, including the planned initiation of the influenza A Phase 1 study during the third quarter of 2021, the planned pre-IND meetings with the FDA and the expected initiation of two IND-enabling studies in the COVID-19 program in the first half of 2022 and subsequent Phase 1 clinical trials, the anticipated initiation of SARS-CoV-2 oral inhibitors manufacturing in 2021; our expectations and estimates regarding the future applications and effectiveness of, and the market opportunities for, our product candidates; our expectations related to conducting clinical trials in Australia; our expectations regarding future operating results; the expected results of Cocrystal’s collaboration with Merck, including potential receipt of future milestone payments of up to $156 million and royalties; ; and future liquidity. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from the impact of the COVID-19 pandemic on the national and global economy, on our collaboration partners, CROs, CMOs, and on our Company, including raw material and test animal shortages and other supply chain disruptions, the ability of our CROs to recruit volunteers for, and to proceed with, clinical trials, possible delays resulting from the lockdown in Australia, the cooperation of the FDA in accelerating development in our COVID-19 program, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
[email protected]

Financial Tables to follow

 COCRYSTAL PHARMA, INC.

CONSOLIDATED BALANCE SHEETS
(in thousands)

		June 30, 2021				December 31, 2020
			(unaudited)
Assets
Current assets:
Cash		$	67,062			$	33,010
Restricted cash			50				50
Accounts receivable			–				556
Prepaid expenses and other current assets			225				399
Total current assets			67,337				34,015
Property and equipment, net			539				591
Deposits			46				46
Operating lease right-of-use assets, net (including $10 to related party)			403				498
Goodwill			19,092				19,092
Total assets		$	87,417			$	54,242
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses		$	2,138			$	1,080
Current maturities of finance lease liabilities			33				39
Current maturities of operating lease liabilities (including $10 to related party)			157				178
Derivative liabilities			51				61
Total current liabilities			2,379				1,358
Long-term liabilities:
Finance lease liabilities			21				34
Operating lease liabilities			269				345
Total long-term liabilities			290				379
Total liabilities			2,669				1,737
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 100,000 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 97,469 and 70,439 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively			98				71
Additional paid-in capital			336,117				297,342
Accumulated deficit			(251,467	)			(244,908	)
Total stockholders’ equity			84,748				52,505
Total liabilities and stockholders’ equity		$	87,417			$	54,242

COCRYSTAL PHARMA, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)

		Three months ended June 30,								Six months ended June 30,
		2021				2020				2021				2020
Revenues:
Collaboration revenue		$	–			$	554			$	–			$	1,015
			–				554				–				1,015
Operating expenses:
Research and development			2,747				1,976				4,324				3,259
General and administrative			1,081				2,028				2,242				3,167
Total operating expenses			3,828				4,004				6,566				6,426
Loss from operations			(3,828	)			(3,450	)			(6,566	)			(5,411	)
Other income (expense):
Interest expense, net			(2	)			(2	)			(3	)			(4	)
Change in fair value of derivative liabilities			9				(43	)			10				(70	)
Total other income (expense), net			7				(45	)			7				(74	)
Net loss		$	(3,821	)		$	(3,495	)		$	(6,559	)		$	(5,485	)
Net loss per common share, basic and diluted		$	(0.04	)		$	(0.07	)			(0.08	)			(0.12	)
Weighted average number of common shares outstanding, basic and diluted			87,069				52,141				79,116				46,930

Source: Cocrystal Pharma, Inc.