Thursday, March 11, 2021

PDS Biotechnology Corp (PDSB)
Versamune-based COVID-19 Vaccine Consortium Received Brazilian Government Grant

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

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

Supporting funding of $US60 million for the coronavirus program. PDS Biotech, Farmacore, and Blanver consortium received a commitment from the Secretary for Research and Scientific Training of the Ministry of Science, Technology, and Innovation of Brazil (MCTI). The funding of approximately US$60 million will be used to support the clinical development and commercialization of a novel, Versamune-based, second-generation COVID-19 vaccine in Brazil.


Near-term value-generating catalysts.  We believe the company has multiple inflection points to generate value including a) PDS0101 preliminary efficacy data anticipated in Q2 2021 and b) PDS0203 safety and immunogenicity data projected in Q4 2021/Q1 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. 

 

PDS Biotech Announces that its COVID-19 Vaccine Consortium Received a Commitment from The Ministry of Science, Technology and Innovation of Brazil (MCTI) to fund Clinical Development and Commercialization of PDS0203 with an Award of up to ~US$60 Million

 

Development and
commercialization of novel T-cell activating vaccine to be performed in Brazil
by consortium of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica

FLORHAM PARK, N.J., March 11, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on PDS Biotech’s proprietary Versamune^® T-cell activating technology, today announced that its COVID-19 vaccine consortium consisting of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica, has received a commitment from the Secretary for Research and Scientific Training of the MCTI to fund up to approximately US$60 million to support the clinical development and commercialization of a novel, Versamune^®-based, second generation COVID-19 vaccine in Brazil.

MCTI intends to start making the funds available to prepare to perform a combined Phase 1/2 clinical trial, upon authorization by the Brazilian regulatory agency, Agência Nacional de Vigilância Sanitária (Anvisa) to initiate the proposed Versamune^®-based COVID-19 vaccine clinical program in Brazil.

The pre-IMPD package for the Phase 1/2 trial is currently under review by Anvisa and the trial is anticipated to begin by Q2/3 2021. The majority of the capital provided by MCTI will fund the manufacturing process scale up, production and the Phase 3 trial, pending the results of the Phase 1/2 trial. The consortium members will work under a mutually agreed work plan to guide the vaccine efficiently through development in compliance with regulatory standards. The consortium anticipates working to initiate manufacturing scale up activities in the second quarter.

This award is based on the preclinical studies of the Versamune^®-based COVID-19 vaccine. The vaccine combines PDS Biotech’s Versamune^® T-cell activating platform technology with a SARS-CoV-2 recombinant protein derived from the spike (S) protein. Notably, the protein in this fully synthetic vaccine includes conserved and non-mutating regions of the virus. The vaccine has demonstrated strong potential in preclinical studies to efficiently promote the induction of killer (CD8+) and helper (CD4+) T-cells that recognize and induce immune responses against such non-mutating regions of the virus. The protein also includes regions of the spike protein that result in the induction of neutralizing antibodies.

The Phase 1 and 2 trials, which will be run together, are anticipated to enroll approximately 360 patients and will assess the safety and efficacy of the vaccine as well as both the antibody and killer T-cell responses induced by the vaccine to the novel coronavirus. The clinical trials are planned to be conducted in Brazil.

“PDS Biotech and Farmacore Biotechnology have taken the important step of advancing our Versamune^®-based COVID-19 vaccine into the clinic,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech.“ The preclinical results demonstrate the vaccine’s potential to induce a broad range of robust anti SARS-CoV-2 immune responses. The rapidly increasing number of SARS-CoV-2 mutations highlights the need for novel, second generation vaccines capable of generating both killer and helper T-cells that can recognize and attack conserved and non-mutating regions of the virus. We applaud Farmacore Biotechnology and Blanver Farmoquímica for reaching this important milestone and look forward to the results of the planned human clinical trials and hopefully a rapid advancement towards commercialization of the product. These clinical trials will also advance our understanding of the potential for novel Versamune^®-based vaccines to provide long-term protection against infection with viruses with pandemic potential such as SARS-CoV-2.”

“We are excited to continue advancing the program with PDS Biotech, and we are thrilled to have had the continued support of the Brazilian government as we finalize clinical study protocols with Anvisa for human testing of the novel vaccine combining the Versamune^® T-cell activating technology with the SARS-CoV-2 recombinant protein antigen. We are proud to advance this promising medicine in Brazil in the fight against this global pandemic,” said Helena Faccioli, CEO of Farmacore Biotechnology.

As the license holder of PDS0203 in Latin America, Farmacore Biotechnology will continue to lead the regulatory and clinical trial efforts in Brazil and has selected a top clinical research organization, to conduct clinical trials in Brazil. PDS Biotech will continue to contribute scientific expertise and operational support and oversee scale up of the manufacturing process. Blanver Farmoquímica will manufacture, promote, distribute, and commercialize the Versamune^®-based COVID-19 vaccine in Latin America.

All funding is contingent on the availability of financial resources within the MCTI, and The Secretary for Research and Scientific Training of the MCTI has committed to making every effort to finance all clinical and development stages of the program.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Versamune^® effectively delivers disease-specific antigens for
in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About Farmacore Biotechnology

Farmacore Biotechnology is a biotechnology company, founded in 2005, focusing on R&D of innovative immunobiological products for use in the human and veterinary health sectors. It is a technology-based company that conducts research and development of biotechnological products and processes for the human and veterinary sectors. It develops innovative biotechnological and immunobiological products and adds value to them in all stages of development, from project design to biomolecule production www.farmacore.com.br.

About Blanver Farmoquímica

Blanver Farmoquímica e Farmacêutica S.A. is a Brazilian company, founded in 1984, focused on R&D, manufacture and sale of innovative medicines and active pharmaceutical ingredients. The company plays in the segments of HIV, Hepatitis, Oncology and Hematology, providing high quality products for expanding the population’s access to medicines through partnerships with the Ministry of Health and official laboratories. Blanver Farmoquímica is committed in always looking for innovations that will improve people’s health and quality of life.

About PDS0203

PDS0203 is an investigational vaccine designed for the prevention of COVID-19 being jointly developed for Latin America by a consortium that includes PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica. The vaccine combines the utility of PDS Biotech’s Versamune^® platform with a recombinant native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein recognizable by our immune system (antigen). The Versamune^® platform, due to its unique ability to induce both antibody and polyfunctional CD8+ killer and CD4+ helper T-cell responses is being utilized to develop a next generation vaccine that may more effectively prevent COVID-19.

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 and PDS0203 ; 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 and PDS0203 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 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 the COVID-19 pandemic. 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]

Jacob Goldberger
CG Capital
Phone: +1 (404) 736-3841
Email: [email protected]

SOURCE: PDS Biotechnology

Helius Medical Technologies, Inc. Reports Fourth Quarter and Full Year 2020 Financial Results

NEWTOWN, Pa., March 10, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today reported financial results for the quarter and full year ended December 31, 2020.

Fourth Quarter and Recent Business Updates

• The Company closed a private placement for total net proceeds of approximately $3.2 million and an underwritten public offering of units for net proceeds of approximately $9.6 million.
  • Helius expects its existing capital, including net proceeds from the public offering that closed and net proceeds raised through the exercise of warrants in the first quarter of 2021, will be sufficient to fund the Company’s operations into the first quarter of 2022.
• The Company announced on January 11, 2021 that it submitted its formal response to the U.S. Food and Drug Administration’s (the “FDA”) request for additional information, related to Helius’ request for de novo classification and clearance of the PoNS device.
• The Company received written notice from The Nasdaq Stock Market LLC on January 19, 2021 that Helius is in compliance with all applicable listing standards.
• The Centers for Medicare & Medicaid Services (“CMS”) announced that it is finalizing a new coverage pathway, Medicare Coverage of Innovative Technology, or “MCIT,” for FDA-designated breakthrough medical devices cleared by FDA.
  • The MCIT rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices and coverage would last for four years.

Fourth Quarter 2020 Financial Summary

• Revenue of $191 thousand, compared to revenue of $152 thousand in fourth quarter of 2019.
• Operating loss of $3.0 million, compared to operating loss of $5.6 million in fourth quarter of 2019.
• Net loss of $2.5 million, compared to net loss of $5.3 million in fourth quarter of 2019.
  

Full Year 2020 Financial Summary

• Revenue of $0.7 million, compared to revenue of $1.5 million in 2019.
• Operating loss of $14.4 million, compared operating loss of $24.0 million in 2019.
• Net loss of $14.1 million, compared to net loss of $9.8 million in 2019.
• As of December 31, 2020, the Company had cash of $3.3 million, compared to $5.5 million at December 31, 2019. The Company had no debt outstanding at December 31, 2020.

“During the fourth quarter, we were pleased with our pace of progress and the commitment our employees have shown in view of the continued headwinds created by the COVID-19 pandemic,” said Dane Andreeff, Interim President and Chief Executive Officer of Helius. “Our regulatory team focused on preparing a thorough response to FDA’s request for additional information related to our request for U.S. de novo classification and clearance in MS. As a result of their efforts, we were pleased to announce the submission of our response on January 11th, and we hope to receive de novo classification and clearance during the first half of 2021. In Canada, while we continued to see the impacts of COVID on the clinics we serve and their patients, our commercial team successfully expanded our network of authorized PoNS clinics from 7 to 31 locations by year-end, exceeding our goal. Subsequent to quarter-end, we also secured approximately $11 million to strengthen our balance sheet and support our operations going forward.”

“As we enter 2021, Helius is focused on securing regulatory clearance and coverage for our breakthrough PoNS device in the U.S. while supporting our recently expanded network of Canadian clinics. With our U.S. de novo submission in MS under review, a network of 31 clinics in Canada and an enhanced balance sheet, we believe we are well-positioned to weather the continued effects of the pandemic and expand the availability of our PoNS Treatment going forward. We remain committed to executing on our regulatory and commercial strategies as effectively and efficiently with the ultimate goal of bringing our innovative PoNS Treatment to the aid of as many patients as possible.”

Fourth Quarter 2020 Financial Results

Total revenue for the fourth quarter of 2020 was $191 thousand, compared to $152 thousand in the fourth quarter of 2019. Product sales represented approximately 96% of total revenue in the fourth quarter of 2020 compared to 100% of total revenue in the fourth quarter of 2019. Product sales in both periods were generated through sales of the PoNS device pursuant to supply agreements with PoNS Authorized clinic locations in Canada. License and fee revenue represented 4% of sales in the fourth quarter of 2020, compared to 0% of sales in the fourth quarter of 2019.

Gross loss for the fourth quarter of 2020 was $10 thousand, compared to gross loss of $156 thousand in the fourth quarter of 2019. Operating expenses for the fourth quarter of 2020 decreased $2.5 million, or 45% year-over-year, to $3 million, compared to $5.5 million in the fourth quarter of 2019.

Operating loss for the fourth quarter of 2020 decreased $2.6 million, or 47% year-over-year, to $3.0 million, compared to $5.6 million in the fourth quarter of 2019.

Total other income for the fourth quarter of 2020 was $468 thousand, compared to $294 thousand in the fourth quarter of 2019.

Net loss for the fourth quarter of 2020 was $2.5 million, or $(1.77) per basic and diluted common share, compared to a net loss of $5.3 million, or $(6.71) per basic and diluted common share, in the fourth quarter of 2019. Weighted average shares used to compute basic and diluted net loss per common share were 1.4 million and 0.8 million for the fourth quarter of 2020 and 2019, respectively.

Full Year 2020 Financial Results

Total revenue for the full year 2020 was $0.7 million, compared to $1.5 million for full year 2019. Product sales represented 95% of total revenue for full year 2020, compared to 97% of total for full year 2019. Product sales in both periods were generated through sales of the PoNS device pursuant to supply agreements with PoNS Authorized clinic locations in Canada. License and fee revenue represented 5% of total revenue for full year 2020, compared to 3% of total revenue for the full year 2019.

Gross profit for full year 2020 was $0.3 million, compared to gross profit of $0.7 million for full year 2019. Operating expenses for full year 2020 decreased $9.9 million, or 41% year-over-year, to $14.7 million, compared to $24.6 million for full year 2019.

Operating loss full year 2020 decreased $9.6 million, or 40% year-over-year, to $14.4 million, compared to operating loss of $24.0 million for full year 2019.

Total other income for full year 2020 was $0.3 million, compared to $14.2 million of other income for full year 2019. The year-over-year change is driven primarily by the change in fair value of derivative instruments which is primarily attributable to the change in our stock price, volatility and the number of derivative financial instruments being measured during the period.

Net loss for full year 2020 was $14.1 million, or $(11.80) per basic and diluted common share, compared to net loss of $9.8 million, or $(12.99) per basic and diluted common share, for full year 2019. Weighted average shares used to compute basic and diluted net loss per share were 1.2 million and 0.8 million for full year 2020 and full year 2019, respectively.

Net cash provided by financing activities during the twelve months ended December 31, 2020 was $9.6 million.

As of December 31, 2020, the Company had cash of $3.3 million, compared to $5.5 million at December 31, 2019. The Company had no debt outstanding at December 31, 2020.

Full Year 2021 Outlook

The Company is not providing a formal financial outlook for the full year 2021 at this time, given the continued uncertainty on the duration and impact of the COVID-19 pandemic on its financial and operating results.

Conference Call

Management will host a conference call at 5:00 p.m. Eastern Time on March 10, 2021 to discuss the results of the quarter and business outlook. Those who would like to participate may dial 877-407-2988 (201-389-0923 for international callers) and provide access code 13715793. A live webcast of the call will also be provided on the Events section of the Company’s investor relations website at:

https://heliusmedical.com/index.php/investor-relations/events/upcoming-events.

For those unable to participate, a replay of the call will be available for two weeks at 877-660-6853 (201-612-7415 for international callers); access code 13715793. The webcast will be archived on the Events section of the Company’s investor relations website.

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 authorized class II, non-implantable, medical device in Canada intended for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (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 the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for de novo classification and clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ is currently not commercially available in the United States, the European Union or Australia.

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,” “expect,” “look forward,” “will” and similar expressions. Such forward-looking statements include, among others, statements regarding the COVID-19 pandemic, including its impact on the Company, the Company’s future growth and operational progress, including clinical and regulatory development plans for the PoNS device, the Company’s expectations regarding the sufficiency of funds for anticipated future operations, potential receipt of regulatory clearance of the PoNS device in the United States, the success of the Company’s planned study, business and commercialization initiatives and objectives, and expectations for full year 2021.

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 the clinical development process and FDA regulatory submission and approval process, including that the Company’s request for de novo classification and clearance may be declined by the FDA, that the FDA is not required to and may not respond to the Company’s request in the timeframe indicated by its de novo review goals or in the time the Company expects, whether the Company’s response will be satisfactory to the FDA, whether the FDA will require additional information, whether the Company will be able to provide it in a timely manner and whether such additional information will be satisfactory to the FDA, the impact of the COVID-19 pandemic, uncertainties associated with clinical trial enrollments and the results of the planned study, uncertainties associated with the clinical development process and FDA regulatory submission and approval process, including the Company’s capital requirements to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators, and including the risks and uncertainties about the Company’s business described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 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.

Helius Medical Technologies, Inc.
Unaudited Consolidated Balance Sheets
(Except for share data, amounts in thousands)

		December 31, 2020				December 31, 2019
ASSETS
Current assets
Cash		$	3,331			$	5,459
Accounts receivable, net			74				210
Other receivables			156				364
Inventory, net			389				598
Prepaid expenses			735				610
Total current assets			4,685				7,241
Property and equipment, net			486				712
Other assets
Goodwill			759				1,242
Intangible assets, net			527				582
Operating lease right-of-use asset, net			90				552
Other assets			—				18
Total other assets			1,376				2,394
TOTAL ASSETS		$	6,547			$	10,347
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable		$	747			$	1,676
Accrued liabilities			1,337				1,519
Operating lease liability			59				172
Derivative financial instruments			—				5
Deferred revenue			281				430
Total current liabilities			2,424				3,802
Non-current liabilities
Operating lease liability			32				465
Deferred revenue			220				245
TOTAL LIABILITIES			2,676				4,512
STOCKHOLDERS’ EQUITY
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of December 31, 2020 and December 31, 2019			—				—
Class A Common stock, $0.001 par value; 150,000,000 shares authorized; 1,484,362 and 877,672 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively			1				1
Additional paid-in capital			123,872				111,509
Accumulated other comprehensive loss			(1,099	)			(902	)
Accumulated deficit			(118,903	)			(104,773	)
TOTAL STOCKHOLDERS’ EQUITY			3,871				5,835
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	6,547			$	10,347

Helius Medical Technologies, Inc.
Unaudited Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands except share and per share data)

		Three Months Ended								Year Ended
		December 31,								December 31,
		2020				2019				2020				2019
Revenue:
Product sales, net		$	184			$	159			$	625			$	1,454
Fee revenue			—				(12	)			9				37
License revenue			7				5				27				5
Total operating revenue			191				152				661				1,496
Cost of sales:
Cost of product sales			201				308				388				846
Gross profit			(10	)			(156	)			273				650
Operating expenses:
Research and development			827				1,599				4,582				8,061
Selling, general and administrative			2,089				3,806				9,714				16,521
Amortization expense			76				64				363				64
Total operating expenses			2,992				5,469				14,659				24,646
Operating loss			(3,002	)			(5,625	)			(14,386	)			(23,996	)
Other income:
Other income			—				60				63				95
Change in fair value of derivative financial instruments			—				80				4				14,113
Foreign exchange gain			468				154				189				7
Total other income			468				294				256				14,215
Net loss			(2,534	)			(5,331	)			(14,130	)			(9,781	)
Other comprehensive loss:
Foreign currency translation adjustments			(406	)			(143	)			(197	)			(311	)
Comprehensive loss		$	(2,940	)		$	(5,474	)		$	(14,327	)		$	(10,092	)
Net loss per share
Basic		$	(1.77	)		$	(6.71	)		$	(11.80	)		$	(12.99	)
Diluted		$	(1.77	)		$	(6.71	)		$	(11.80	)		$	(12.99	)
Weighted average shares outstanding
Basic			1,430,504				793,934				1,197,774				752,932
Diluted			1,430,504				793,934				1,197,774				752,932

Helius Medical Technologies, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows
(Amounts in thousands)

		Year Ended
		December 31,
		2020				2019
Cash flows from operating activities:
Net loss		$	(14,130	)		$	(9,781	)
Adjustments to reconcile net loss to net cash used in operating activities:
Change in fair value of derivative financial instruments			(4	)			(14,113	)
Stock-based compensation expense			2,529				4,691
Unrealized foreign exchange (gain) loss			(182	)			70
Depreciation expense			119				127
Amortization expense			363				64
Provision for doubtful accounts			140				220
Provision for inventory reserve			205				50
Intangible asset impairment			184				—
Loss from disposal of property and equipment			110				—
Gain from lease modification			(56	)			—
Changes in operating assets and liabilities:
Accounts receivable			(4	)			(438	)
Other receivables			226				(278	)
Inventory			4				(256	)
Prepaid expenses			(125	)			(163	)
Other current assets			—				264
Operating lease liability			(28	)			(13	)
Accounts payable			(635	)			(1,116	)
Accrued liabilities			(280	)			(327	)
Deferred revenue			(174	)			—
Net cash used in operating activities			(11,738	)			(20,999	)
Cash flows from investing activities:
Purchase of property and equipment			(63	)			(278	)
Proceeds from sale of property and equipment			61				—
Business acquisitions, net of cash acquired			—				(416	)
Internally developed software			(7	)			(75	)
Net cash used in investing activities			(9	)			(769	)
Cash flows from financing activities:
Proceeds from the issuance of common stock and accompanying warrants			10,653				1,685
Share issuance costs			(1,015	)			(247	)
Proceeds from the exercise of stock options and warrants			—				215
Proceeds from Paycheck Protection Program Loan			323				—
Repayment of Paycheck Protection Program Loan			(323	)			—
Net cash provided by financing activities			9,638				1,653
Effect of foreign exchange rate changes on cash			(19	)			(9	)
Net decrease in cash			(2,128	)			(20,124	)
Cash at beginning of year			5,459				25,583
Cash at end of year		$	3,331			$	5,459

Investor Relations Contact:

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

SOURCE: Helius Medical Technologies, Inc.

Cocrystal Pharma Extends Drug Discovery Collaboration with HitGen and InterX

 

BOTHELL, Wash, March 10, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, the SARS-CoV-2 virus, hepatitis C viruses and noroviruses, announces an extension of its drug discovery collaboration with HitGen, a biotech company with an innovative DNA Encoded Library technology, and InterX Inc., a computer software company with a biomolecular simulation for drug discovery. The collaboration was initiated in September 2017 and will now continue through August 2023.

Through this collaboration, Cocrystal, HitGen and InterX scientists are applying HitGen’s DNA-encoded library (DEL) technology platform, Cocrystal’s structure-based drug discovery platform technology, and InterX’s computational science to develop novel antiviral lead candidates. The DEL technology combines the power of molecular biology, combinatorial chemistry, high throughput sequencing and advanced informatics to identify potential drug candidates. Cocrystal applies its technology to determine the cocrystal structures of the potential drug candidates identified from the DEL library. This structural information is then combined with InterX’s advanced computer algorithms to predict inhibitor-target interactions. A Joint Steering Committee comprised of representatives from all three companies is overseeing the collaboration.

“This collaboration represents a truly innovative and important approach to drug discovery in which we combine three novel platforms to generate and select molecules that could lead to superior drugs,” said Gary Wilcox, Ph.D., Chairman and Chief Executive Officer of Cocrystal. “We view this collaboration as a long-term relationship with the potential to build Cocrystal’s platform and expand our pipeline with high-value compounds for future development.”

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 term and the results of Cocrystal’s collaboration with HitGen and InterX. 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, HitGen’s DNA Encoded Library technology and InterX software performing as expected, potential disagreements with HitGen or InterX resulting in delays or termination of the collaboration, and the results of future preclinical and clinical studies. The economic and unknown impacts of Covid-19 could result in unanticipated material adverse effects on HitGen, InterX or Cocrystal. Further information on our risk factors is contained in our filings with the SEC, including our Prospectus Supplement dated August 26, 2020 and our Annual Report on Form 10-K for the year ended December 31, 2020, as amended and supplemented by the Quarterly Reports on Form 10-Q for the three months ended June 30, 2020 and the three months ended September 30, 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]

Source: Cocrystal Pharma, Inc.

 

Lineage Cell Therapeutics Raises $35.9 Million From Sales Of Marketable Securities Holdings And An At-The-Market Equity Offering

 

Improved Cash Position Expected to Fund Operations for More Than Two Years

CARLSBAD, Calif.–(BUSINESS WIRE)–Mar. 8, 2021– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported that it raised $11 million in new capital from sales of its holdings of marketable securities, including shares of OncoCyte Corporation (Nasdaq: OCX) and Hadasit Bio-Holdings (TASE: HDST), as well as $25 million in gross proceeds from its at-the-market (“ATM”) offering. Lineage expects its approximately $57 million of cash and cash equivalents as of March 5, 2021 to fund operations well into 2023, by which time the Company expects to have achieved value-creating clinical and product development milestones. Lineage’s strengthened balance sheet also provides it with strategic flexibility in its ongoing partnership discussions.

“During the past six months, appreciation in our share price and that of marketable securities we owned has provided us with opportunities to monetize our investments and raise additional capital through our ATM offering,” stated Brian Culley, Lineage’s CEO. “These sales underscore that Lineage has created substantial value for its shareholders over time not only by advancing our product candidates toward later-stage clinical trials, but also by making and now harvesting significant early investments in OncoCyte and Hadasit and from aggressive and prudent expense reductions we previously reported. We expect that Lineage is now funded well into 2023, by which time we expect to have reached additional significant milestones, explored new areas to deploy our technology, and moved Lineage ever closer to our goal of becoming the preeminent allogeneic cell transplant company. Our stronger balance sheet also can provide us with optionality with respect to our ongoing partnership discussions.”

Cash and cash equivalents as of December 31, 2020 were $32.6 million and reflected $5.1 million in gross proceeds from sales on the ATM (which excluded $0.3 million in cash in transit related to 2020 sales that settled in 2021) and $0.8 million in gross proceeds from sales of Hadasit shares during the fourth quarter. From January 1, 2021 through March 5, 2021, Lineage raised an additional $19.9 million in gross proceeds through the ATM offering (which included $0.3 million in cash in transit related to 2020 sales that settled in 2021), as well as $10.1 million in gross proceeds from sales of OncoCyte shares and $21,000 in gross proceeds from sales of Hadasit shares. Lineage incubated OncoCyte and funded its initial product development before spinning it out as a separate public company in January 2016. As of March 5, 2021, OncoCyte’s market capitalization was over $300 million and Lineage has realized $32.5 million in total sales of its OncoCyte shares over time. The Company continues to hold 1,122,401 shares of OncoCyte stock valued at approximately $4.2 million and 169,167 shares of Hadasit stock valued at approximately $330,000, in each case based on the closing prices of those shares on March 5, 2021. Previously, Lineage also incubated and funded the initial product development of AgeX Therapeutics (NYSE American: AGE), and subsequently spun it out as a separate public company in November 2018, ultimately raising nearly $50 million from sales of its securities. Lineage believes that its broad technology platform and intellectual property portfolio may allow it to create additional value for shareholders through the advancement of its own novel pipeline as well as through the incubation and development of other products and companies, and through strategic corporate partnerships.

About Lineage Cell Therapeutics, Inc.

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

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s expected eligibility for grants. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (the SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
([email protected])
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
([email protected])
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or David Schull
[email protected]
[email protected]
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

Research coverage of Lineage Cell Therapeutics (LCTX) on Channelchek is provided by Noble Capital Markets, Inc. Please refer to the research disclosures on the most recent LCTX report for more information.

Friday, March 05, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
First Quarter 2021 Results

Avivagen Inc is a Canadian based company operating in the healthcare sector. It develops science-based, natural health products for animals. It develops and commercializes products for livestock feeds to replace antibiotics for growth promotion and to help prevent disease by supporting the animal’s own health defenses. Its product range includes OxC-beta, Vivamune health chews, Oximunol chewable tablets, and Carotenoid Oxidation products.

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

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

1Q21 Results. Avivagen reported fiscal first quarter revenue of $261,987 and a net loss of $1.27 million, or $0.03 per share. We had projected revenue of $700,000 and a net loss of $1.25 million, or $0.03 per share. During the quarter, Avivagen shipped 2,325 kg of product to the Philippines, Thailand, and Taiwan. We had expected shipments into Mexico too during the quarter but the shipments moved into the second quarter.


Increasing Volume.  Although 1Q21 fell short of our expectations, so far in fiscal 2021 Avivagen has announced order volumes for fiscal 2021 that are larger than all of fiscal 2020. All shipping arrangements for the 10 tonne Mexican order have been finalized and shipments will commence in 2Q21. The 6 tonne order will begin in April 2021. We expect to see additional orders from UNAHCO, as well as…

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

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

Avivagen Announces Proposed Extension of Warrants

 

Ottawa, ON /Business Wire/ March 5, 2021 / – Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen” or the “Corporation”),a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhance and support immune function, thereby supporting general health and performance, announces that it will be requesting approval from the TSX Venture Exchange for the extension of the expiration date of warrants exercisable to purchase 2,774,992 common shares at $0.90 per share, which were originally issued on June 1, 2016. These warrants currently have an expiration date of March 31, 2021. Subject to TSX Venture Exchange approval, the new date of expiry for such warrants will be June 1, 2021. All other terms of such warrants will remain unchanged.

About Avivagen

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

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

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

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

Forward Looking Statements

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

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

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

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

SOURCE: Avivagen

Avivagen Announces Upcoming Research Publication Highlighting The Benefits Of OxC-betaTM Livestock for Broiler Poultry

 

• Study to be published soon in leading peer-reviewed journal Poultry Science.
• Poultry Science is an internationally renowned journal, known as the authoritative source for a broad range of poultry information and high-caliber research.

Ottawa, ON /Business Wire/ March 4, 2021 / – Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen” or the “Corporation”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that enhance feed intake and safely support immune function, thereby supporting general health and performance, has announced that a manuscript reporting the benefits of OxC-betaTM Livestock (“OxC-beta”) for broiler poultry has been approved for publication by Poultry Science, a leading peer-reviewed journal.

The paper, entitled “Effect of Oxidized ?-Carotene (OxBC) on the Growth and Feed Efficiency of Broilers” reports on the positive results of two dietary supplementation trials in which OxC-beta was used with broiler poultry. In both trials, birds in the OxC-beta groups achieved significantly improved growth performance measures, including average daily weight gain and feed utilization efficiency, when compared to birds in control groups. These findings demonstrate that dietary supplementation with OxC-beta helps broiler poultry achieve their full growth potential under real world commercial conditions without the use of antibiotics.

The first of the two comprehensive studies was conducted in Canada, with birds being reared under typical commercial conditions for broiler production in Ontario. The second study was conducted in Scotland under typical commercial conditions for broiler production in the United Kingdom.

“We are very excited about the publication of the study in a highly credible peer-reviewed journal like Poultry Science,” says Kym Anthony, Chief Executive Officer, Avivagen. “This publication provides an additional level of scientific validation supporting the commercially meaningful benefits of using OxC-beta for broiler poultry, providing additional value to Avivagen’s current and future customers committed to eliminating or reducing antibiotic use in their operations.’

About Avivagen

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

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

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

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

Forward Looking Statements

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

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

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

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

SOURCE: Avivagen

Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech shares Phase 3 Interim Results of COVAXIN, Demonstrates Efficacy of 81%

 

• Data from 25,800 participants in Phase 3 trial in India, received vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated and demonstrated 81% efficacy in preventing COVID-19 in those without prior infection after the second dose.
• Clinical trial to continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of COVAXIN in additional secondary study endpoints.

MALVERN, Pa., March 03, 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, announced the results of the first interim analysis of its Phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN demonstrated a vaccine efficacy of 81%.

“We are thrilled with the interim efficacy results of Bharat Biotech’s Phase 3 trial of COVAXIN in India. These results, which in part suggest significant immunogenicity against the rapidly emerging UK variant, represent an additional step towards outlining the regulatory pathway for EUA and approval in the United States. COVAXIN, a whole virion based vaccine candidate, is designed to fill a significant unmet need in our national arsenal of vaccines against COVID-19,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“Today’s results from the interim analysis of Bharat Biotech’s Phase 3 trial of COVAXIN mark a milestone in the development of another critical vaccine option for the US market. COVAXIN has been shown to induce immune responses against multiple protein antigens of the virus potentially reducing the possibility of mutant virus escape. This breadth of immune responses has been demonstrated by ability of antibodies induced by COVAXIN to neutralize the UK variant of SARS-Cov-2,” said Dr. Bruce Forrest, member of the vaccine scientific advisory board of Ocugen.

Interim Phase 3 Results as Reported by Bharat Biotech

Bharat Biotech’s Phase 3 clinical trial enrolled 25,800 participants between 18-91 years of age, including 2,433 over the age of 60 and 4,500 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 first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the COVAXIN group, resulting in a point estimate of vaccine efficacy of 80.6%.

The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. The trial’s conduct and monitoring are as per Good Clinical Practice guidelines and have been outsourced to IQVIA.

Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains, which has been published in bioRxiv.

Bharat Biotech expects to share further details of the trial results as additional data become available. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication.

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.

In addition to generating strong immune response against multiple antigens, COVAXIN™ is 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 several other vaccines, COVAXIN™ is packaged in multi-dose vials that can be stored at 2-8oC.

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 fight 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 US market. For more information, please visit www.ocugen.com.

About Bharat Biotech:

Bharat Biotech has established an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries, and 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 6 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 the introduction of path breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The recent acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest rabies vaccine manufacturer in the world. 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 Phase 3 interim data that is the subject of this release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; 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 the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, 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:

Ocugen, Inc.
Sanjay Subramanian
Chief Financial Officer and Head of Corporate Development
[email protected]

Media Contact:

For Ocugen:

LaVoieHealthScience
Emmie Twombly
[email protected]
+1 857-389-6042

Lisa DeScenza
[email protected]

+1 978-395-5970

SOURCE: Ocugen