Cocrystal Pharma Reports First Quarter 2021 Financial Results and Provides Business Update

 

BOTHELL, Wash., May 17, 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, reports financial results for the three months ended March 31, 2021 and provides updates on its antiviral pipeline and business activities.  

“We believe Cocrystal is well-positioned to advance the discovery and development of novel antiviral compounds to address major global medical concerns and create significant market opportunities for our company,” said Gary Wilcox, Ph.D., Chairman and Chief Executive Officer of Cocrystal. “Following the successful financing completed earlier this month, we believe we have sufficient capital to fund our currently planned operations and product development programs through 2024.”

“We remain on track to achieve key milestones this year with our coronavirus, norovirus and influenza A antiviral programs,” said Sam Lee, Ph.D., President of Cocrystal. “As discussed in our coronavirus update release earlier this month, we continue developing novel SARS-CoV-2 oral protease inhibitors and are rapidly advancing lead compounds. We recently demonstrated strong in vitro synergistic effect between remdesivir and our protease inhibitor CDI-45205 and are currently examining in vitro activity of our SARS-CoV-2 3CL protease inhibitors against emerging SARS-CoV-2 variants.

“We also expect to report initial proof-of-concept mouse-model read-out with our norovirus protease inhibitors next month,” added Dr. Lee. “We believe that by targeting viral protease we may develop an effective treatment for norovirus gastroenteritis. This is a significant opportunity for Cocrystal given the lack of any effective antiviral treatment or vaccine for norovirus gastroenteritis, and the limited ability to curtail outbreaks of this highly contagious virus that causes symptoms of acute gastroenteritis.

“With our program for the treatment of seasonal and pandemic influenza, we are completing the remaining IND-enabling studies with CC-42344 with preparations underway to initiate a Phase 1 study in the third quarter of this year. We look forward to providing additional details about this program including announcing our clinical strategy,” Dr. Lee concluded.

Antiviral Development Pipeline Milestones and Updates

COVID-19 Programs

• In December 2020 we announced the selection of CDI-45205 as the lead compound for further development against coronaviruses including SARS-CoV-2, that causes COVID-19. CDI-45205 was one of the broad-spectrum protease inhibitors that were obtained from Kansas State University Research Foundation (“KSURF”) under an exclusive license agreement announced in April 2020. That agreement provides Cocrystal with an exclusive, royalty-bearing license to develop and commercialize therapeutic, diagnostic and prophylactic products against coronaviruses, caliciviruses and picornaviruses based on antivirals discovered by KSURF. The Company believes the 3CL protease has the ability to convert the inactive SARS-CoV-2 replication enzymes into the active form. CDI-45205 showed good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and also no cytotoxicity against a variety of human cell lines.
  

The Company recently demonstrated a strong in vitro synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV-2 infected mice. The Company has initiated scale-up synthesis and process chemistry development and is working toward pre-IND status with CDI-45205.

• Cocrystal has leveraged its antiviral development expertise by using its proprietary technology and drug discovery platform to launch two additional COVID-19 programs, novel SARS-CoV-2 3CL protease inhibitors and replication inhibitors. The Company anticipates identifying another SARS-CoV-2 preclinical 3CL lead for oral administration this year.
  

By targeting the viral replication enzymes and proteases, Cocrystal believes it is possible to develop effective treatments for all coronaviruses that cause COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).

Influenza A Program

• Completing IND-enabling activities with CC-42344 with planned Phase 1 study initiation during the third quarter of 2021. CC-42344 showed excellent antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu-resistant strains, and has a favorable pharmacokinetic profile.
  

Influenza remains a major global concern. The World Health Organization (WHO) estimates 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. Approved influenza therapies have major limitations due to drug resistance and viral mutation. Cocrystal is designing influenza drug candidates to be active against drug-resistant strains, effective against future mutations and available through multiple routes of administration including oral, inhalation and injection.

Hepatitis C Program

• We have been seeking a partner to advance the development of CC-31244 since completing Phase 2a trials. 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 treatment of individuals infected with the hepatitis C virus (HCV). To date, no other company has developed a short-duration HCV treatment of 4 weeks or less with a high (>95%) sustained virologic response (SVR) at week 12.
  

HCV is a viral infection of the liver that causes both acute and chronic infection. According to the WHO, in 2017 HCV chronically affected an estimated 71 million people worldwide, 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.

Norovirus Program

• Completion of a proof-of-concept animal study is expected in the second quarter of 2021 with a broad-spectrum norovirus protease polymerase inhibitor. Cocrystal is further 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. Norovirus is a very common and highly contagious virus that causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea. 

First Quarter 2021 and Recent Highlights

Licensing and Collaboration Agreements

• Completed all research obligations under the Merck exclusive worldwide license and collaboration agreement for influenza A/B antiviral compounds. As of mid-January 2021, Merck assumed all responsibility for further program development.
• Extended a drug discovery collaboration with HitGen and InterX, combining three independent platforms to discover and optimize molecules that may lead to novel antiviral drug candidates.

Research and Development

• Continued IND-enabling studies with influenza PB2 inhibitor CC-42344 in preparation for initiating a Phase 1 clinical study in the third quarter of 2021.
• Developed scale-up synthesis of SARS-CoV-2 3CL protease inhibitor CDI-45205.
• Initiated SARS-CoV-2 3CL oral protease inhibitor program.
• Initiated SARS-CoV-2 replication inhibitor program.
• Continued proof-of-concept mouse norovirus model study with expected initial read-out in June 2021.
  

Scientific Presentation

• Presented an overview of Cocrystal’s drug discovery platform technology, including its unique ability to develop broad-spectrum antiviral therapeutics and its advantages compared with the traditional drug discovery and development process, at the “reimagine Health Research Symposium” in January 2021.
  

Financial Developments

• In May 2021, completed raise of $36.4 million in net proceeds from a public offering of common stock.
  

First 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 mid-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 first quarter of 2021 compared with $461,000 in revenues for the first 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 development, regulatory and sales milestones, as well as royalties on product sales.

R&D expenses for the first quarter of 2021 were $1.6 million compared with $1.3 million for the first quarter of 2020, with the increase primarily related to increased spending on our COVID-19 and influenza programs. General and administrative expenses for the first quarter of 2021 were $1.2 million versus $1.1 million for the prior-year quarter, with the increase primarily due to insurance and professional fees.

The net loss for the first quarter of 2021 was $2.7 million, or $0.04 per share, compared with a net loss for the first quarter of 2020 of $2.0 million, or $0.05 per share.

The Company reported cash and cash equivalents of $33.3 million as of March 31, 2021, compared with $33.0 million as of December 31, 2020. The Company reported working capital of $32.2 million as of March 31, 2021.

In May 2021, Cocrystal closed an underwritten public offering of 26,000,000 shares of common stock at a price to the public of $1.54 per share, and received net proceeds of approximately $36.4 million less underwriting discounts and commissions.

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 future success of our discovery and development activities in addressing major global medical concerns, the expected achievement of key milestones in our antiviral programs and the anticipated timing of achieving such milestones, including reporting proof-of-concept mouse-model read-out with our norovirus protease inhibitors in June 2021, the planned initiation of the influenza A Phase 1 study during the third quarter of 2021, identifying another SARS-CoV-2 preclinical 3CL lead for oral administration in 2021, and our plans regarding the expected completion of a norovirus proof-of-concept animal study in the second quarter of 2021; our expectations and estimates regarding the future applications and effectiveness of, and the market opportunities for, our product candidates; the expected results of Cocrystal’s extended collaboration with HitGen and InterX; 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 and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, HitGen’s DNA Encoded Library technology and InterX’s software performing as expected, the results of future preclinical and clinical studies, 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
jcain@lhai.com

COCRYSTAL PHARMA, INC. 
CONSOLIDATED BALANCE SHEETS
(in thousands)

		March 31, 2021				December 31, 2020
			(unaudited)
Assets
Current assets:
Cash		$	33,278			$	33,010
Restricted cash			50				50
Accounts receivable			–				556
Prepaid expenses and other current assets			363				399
Total current assets			33,691				34,015
Property and equipment, net			571				591
Deposits			46				46
Operating lease right-of-use assets, net (including $25 and $39 to related party)			451				498
Goodwill			19,092				19,092
Total assets		$	53,851			$	54,242
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses		$	1,194			$	1,080
Current maturities of finance lease liabilities			36				39
Current maturities of operating lease liabilities (including $25 and $39 to related party)			167				178
Derivative liabilities			60				61
Total current liabilities			1,457				1,358
Long-term liabilities:
Finance lease liabilities			28				34
Operating lease liabilities			308				345
Total long-term liabilities			336				379
Total liabilities			1,793				1,737
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 100,000 shares authorized as of March 31, 2021 and December 31, 2020; 71,469,000 and 70,439 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively			72				71
Additional paid-in capital			299,632				297,342
Accumulated deficit			(247,646	)			(244,908	)
Total stockholders’ equity			52,058				52,505
Total liabilities and stockholders’ equity		$	53,851			$	54,242

COCRYSTAL PHARMA, INC. 
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)

		Three months ended March 31,
		2021				2020
Revenues:
Collaboration revenue		$	–			$	461
Operating expenses:
Research and development			1,577				1,283
General and administrative			1,161				1,139
Total operating expenses			2,738				2,422
Loss from operations			(2,738	)			(1,961	)
Other (expense) income:
Interest expense, net			(1	)			(2	)
Change in fair value of derivative liabilities			1				(27	)
Total other expense, net			–				(29	)
Net loss		$	(2,738	)		$	(1,990	)
Net loss per common share, basic and diluted		$	(0.04	)		$	(0.05	)
Weighted average number of common shares outstanding, basic and diluted			71,248				41,662

Source: Cocrystal Pharma, Inc.

 

PDS Biotech Receives $4.5M After Selling Its Net Operating Loss Tax Benefits Through The New Jersey Economic Development Program

 

FLORHAM PARK, N.J., May 17, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the receipt of $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020.

“We are pleased to receive an allocation from the New Jersey NOL program,” said Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “The funding will be beneficial to us as we continue to efficiently utilize our resources to advance our immuno-oncology pipeline through development.”

The NOL program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 U.S. employees (including parent company and all subsidiaries) to sell a percentage of net operating losses and research and development (R&D) tax credits to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development or other allowable expenditures. PDS Biotech is one of 49 early-stage companies to share in approximately $54.5 million of tax credit transfers approved by NJEDA for the 2020 period.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

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

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

 

PDS Biotech Receives $4.5M After Selling Its Net Operating Loss Tax Benefits Through The New Jersey Economic Development Program

 

FLORHAM PARK, N.J., May 17, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the receipt of $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020.

“We are pleased to receive an allocation from the New Jersey NOL program,” said Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “The funding will be beneficial to us as we continue to efficiently utilize our resources to advance our immuno-oncology pipeline through development.”

The NOL program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 U.S. employees (including parent company and all subsidiaries) to sell a percentage of net operating losses and research and development (R&D) tax credits to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development or other allowable expenditures. PDS Biotech is one of 49 early-stage companies to share in approximately $54.5 million of tax credit transfers approved by NJEDA for the 2020 period.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

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

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

Cocrystal Pharma Reports First Quarter 2021 Financial Results and Provides Business Update

 

BOTHELL, Wash., May 17, 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, reports financial results for the three months ended March 31, 2021 and provides updates on its antiviral pipeline and business activities.  

“We believe Cocrystal is well-positioned to advance the discovery and development of novel antiviral compounds to address major global medical concerns and create significant market opportunities for our company,” said Gary Wilcox, Ph.D., Chairman and Chief Executive Officer of Cocrystal. “Following the successful financing completed earlier this month, we believe we have sufficient capital to fund our currently planned operations and product development programs through 2024.”

“We remain on track to achieve key milestones this year with our coronavirus, norovirus and influenza A antiviral programs,” said Sam Lee, Ph.D., President of Cocrystal. “As discussed in our coronavirus update release earlier this month, we continue developing novel SARS-CoV-2 oral protease inhibitors and are rapidly advancing lead compounds. We recently demonstrated strong in vitro synergistic effect between remdesivir and our protease inhibitor CDI-45205 and are currently examining in vitro activity of our SARS-CoV-2 3CL protease inhibitors against emerging SARS-CoV-2 variants.

“We also expect to report initial proof-of-concept mouse-model read-out with our norovirus protease inhibitors next month,” added Dr. Lee. “We believe that by targeting viral protease we may develop an effective treatment for norovirus gastroenteritis. This is a significant opportunity for Cocrystal given the lack of any effective antiviral treatment or vaccine for norovirus gastroenteritis, and the limited ability to curtail outbreaks of this highly contagious virus that causes symptoms of acute gastroenteritis.

“With our program for the treatment of seasonal and pandemic influenza, we are completing the remaining IND-enabling studies with CC-42344 with preparations underway to initiate a Phase 1 study in the third quarter of this year. We look forward to providing additional details about this program including announcing our clinical strategy,” Dr. Lee concluded.

Antiviral Development Pipeline Milestones and Updates

COVID-19 Programs

• In December 2020 we announced the selection of CDI-45205 as the lead compound for further development against coronaviruses including SARS-CoV-2, that causes COVID-19. CDI-45205 was one of the broad-spectrum protease inhibitors that were obtained from Kansas State University Research Foundation (“KSURF”) under an exclusive license agreement announced in April 2020. That agreement provides Cocrystal with an exclusive, royalty-bearing license to develop and commercialize therapeutic, diagnostic and prophylactic products against coronaviruses, caliciviruses and picornaviruses based on antivirals discovered by KSURF. The Company believes the 3CL protease has the ability to convert the inactive SARS-CoV-2 replication enzymes into the active form. CDI-45205 showed good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and also no cytotoxicity against a variety of human cell lines.
  

The Company recently demonstrated a strong in vitro synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV-2 infected mice. The Company has initiated scale-up synthesis and process chemistry development and is working toward pre-IND status with CDI-45205.

• Cocrystal has leveraged its antiviral development expertise by using its proprietary technology and drug discovery platform to launch two additional COVID-19 programs, novel SARS-CoV-2 3CL protease inhibitors and replication inhibitors. The Company anticipates identifying another SARS-CoV-2 preclinical 3CL lead for oral administration this year.
  

By targeting the viral replication enzymes and proteases, Cocrystal believes it is possible to develop effective treatments for all coronaviruses that cause COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).

Influenza A Program

• Completing IND-enabling activities with CC-42344 with planned Phase 1 study initiation during the third quarter of 2021. CC-42344 showed excellent antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu-resistant strains, and has a favorable pharmacokinetic profile.
  

Influenza remains a major global concern. The World Health Organization (WHO) estimates 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. Approved influenza therapies have major limitations due to drug resistance and viral mutation. Cocrystal is designing influenza drug candidates to be active against drug-resistant strains, effective against future mutations and available through multiple routes of administration including oral, inhalation and injection.

Hepatitis C Program

• We have been seeking a partner to advance the development of CC-31244 since completing Phase 2a trials. 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 treatment of individuals infected with the hepatitis C virus (HCV). To date, no other company has developed a short-duration HCV treatment of 4 weeks or less with a high (>95%) sustained virologic response (SVR) at week 12.
  

HCV is a viral infection of the liver that causes both acute and chronic infection. According to the WHO, in 2017 HCV chronically affected an estimated 71 million people worldwide, 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.

Norovirus Program

• Completion of a proof-of-concept animal study is expected in the second quarter of 2021 with a broad-spectrum norovirus protease polymerase inhibitor. Cocrystal is further 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. Norovirus is a very common and highly contagious virus that causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea. 

First Quarter 2021 and Recent Highlights

Licensing and Collaboration Agreements

• Completed all research obligations under the Merck exclusive worldwide license and collaboration agreement for influenza A/B antiviral compounds. As of mid-January 2021, Merck assumed all responsibility for further program development.
• Extended a drug discovery collaboration with HitGen and InterX, combining three independent platforms to discover and optimize molecules that may lead to novel antiviral drug candidates.

Research and Development

• Continued IND-enabling studies with influenza PB2 inhibitor CC-42344 in preparation for initiating a Phase 1 clinical study in the third quarter of 2021.
• Developed scale-up synthesis of SARS-CoV-2 3CL protease inhibitor CDI-45205.
• Initiated SARS-CoV-2 3CL oral protease inhibitor program.
• Initiated SARS-CoV-2 replication inhibitor program.
• Continued proof-of-concept mouse norovirus model study with expected initial read-out in June 2021.
  

Scientific Presentation

• Presented an overview of Cocrystal’s drug discovery platform technology, including its unique ability to develop broad-spectrum antiviral therapeutics and its advantages compared with the traditional drug discovery and development process, at the “reimagine Health Research Symposium” in January 2021.
  

Financial Developments

• In May 2021, completed raise of $36.4 million in net proceeds from a public offering of common stock.
  

First 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 mid-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 first quarter of 2021 compared with $461,000 in revenues for the first 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 development, regulatory and sales milestones, as well as royalties on product sales.

R&D expenses for the first quarter of 2021 were $1.6 million compared with $1.3 million for the first quarter of 2020, with the increase primarily related to increased spending on our COVID-19 and influenza programs. General and administrative expenses for the first quarter of 2021 were $1.2 million versus $1.1 million for the prior-year quarter, with the increase primarily due to insurance and professional fees.

The net loss for the first quarter of 2021 was $2.7 million, or $0.04 per share, compared with a net loss for the first quarter of 2020 of $2.0 million, or $0.05 per share.

The Company reported cash and cash equivalents of $33.3 million as of March 31, 2021, compared with $33.0 million as of December 31, 2020. The Company reported working capital of $32.2 million as of March 31, 2021.

In May 2021, Cocrystal closed an underwritten public offering of 26,000,000 shares of common stock at a price to the public of $1.54 per share, and received net proceeds of approximately $36.4 million less underwriting discounts and commissions.

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 future success of our discovery and development activities in addressing major global medical concerns, the expected achievement of key milestones in our antiviral programs and the anticipated timing of achieving such milestones, including reporting proof-of-concept mouse-model read-out with our norovirus protease inhibitors in June 2021, the planned initiation of the influenza A Phase 1 study during the third quarter of 2021, identifying another SARS-CoV-2 preclinical 3CL lead for oral administration in 2021, and our plans regarding the expected completion of a norovirus proof-of-concept animal study in the second quarter of 2021; our expectations and estimates regarding the future applications and effectiveness of, and the market opportunities for, our product candidates; the expected results of Cocrystal’s extended collaboration with HitGen and InterX; 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 and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, HitGen’s DNA Encoded Library technology and InterX’s software performing as expected, the results of future preclinical and clinical studies, 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
jcain@lhai.com

COCRYSTAL PHARMA, INC. 
CONSOLIDATED BALANCE SHEETS
(in thousands)

		March 31, 2021				December 31, 2020
			(unaudited)
Assets
Current assets:
Cash		$	33,278			$	33,010
Restricted cash			50				50
Accounts receivable			–				556
Prepaid expenses and other current assets			363				399
Total current assets			33,691				34,015
Property and equipment, net			571				591
Deposits			46				46
Operating lease right-of-use assets, net (including $25 and $39 to related party)			451				498
Goodwill			19,092				19,092
Total assets		$	53,851			$	54,242
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses		$	1,194			$	1,080
Current maturities of finance lease liabilities			36				39
Current maturities of operating lease liabilities (including $25 and $39 to related party)			167				178
Derivative liabilities			60				61
Total current liabilities			1,457				1,358
Long-term liabilities:
Finance lease liabilities			28				34
Operating lease liabilities			308				345
Total long-term liabilities			336				379
Total liabilities			1,793				1,737
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 100,000 shares authorized as of March 31, 2021 and December 31, 2020; 71,469,000 and 70,439 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively			72				71
Additional paid-in capital			299,632				297,342
Accumulated deficit			(247,646	)			(244,908	)
Total stockholders’ equity			52,058				52,505
Total liabilities and stockholders’ equity		$	53,851			$	54,242

COCRYSTAL PHARMA, INC. 
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)

		Three months ended March 31,
		2021				2020
Revenues:
Collaboration revenue		$	–			$	461
Operating expenses:
Research and development			1,577				1,283
General and administrative			1,161				1,139
Total operating expenses			2,738				2,422
Loss from operations			(2,738	)			(1,961	)
Other (expense) income:
Interest expense, net			(1	)			(2	)
Change in fair value of derivative liabilities			1				(27	)
Total other expense, net			–				(29	)
Net loss		$	(2,738	)		$	(1,990	)
Net loss per common share, basic and diluted		$	(0.04	)		$	(0.05	)
Weighted average number of common shares outstanding, basic and diluted			71,248				41,662

Source: Cocrystal Pharma, Inc.

Ayala Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update

 

Ayala Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update

 

 

PDS Biotech Provides Business Update and Reports First Quarter 2021 Financial Results

FLORHAM PARK, N.J., May 13, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, will discuss its financial results for the quarter ended March 31, 2021 and provide a business update on its conference call today.

Recent Business Highlights:

• National Cancer Institute to present interim efficacy and safety data of PDS0101 Phase 2 clinical trial in an oral presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting on June 7, 2021. This trial is evaluating PDS0101 with two clinical stage immunotherapies from EMD Serono, a first in class bifunctional checkpoint inhibitor Bintrafusp Alfa (M7824) and an antibody conjugated cytokine M9241 (NHS-IL12), in patients with all types of advanced HPV-associated cancers, whose cancer has returned or spread after treatment.

• COVID-19 consortium received a commitment from the Secretary for Research and Scientific Training of The Ministry of Science, Technology and Innovation of Brazil (MCTI) to fund up to approximately US$60 million to support the clinical development and commercialization of a Versamune^®-based COVID-19 vaccine by Farmacore in Brazil. 

“We look forward to the presentation of preliminary efficacy and safety data from the National Cancer Institute (NCI)-led Phase 2 combination study of PDS0101 at the ASCO conference in early June.  ASCO provides an important opportunity to present the potential of PDS0101 and the Versamune^® platform in oncology to the research and medical community,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech, “The presentation of the human clinical efficacy data at ASCO is an important milestone both for PDS0101 and our entire Versamune^®-based oncology pipeline.”

First Quarter 2021 Financial Results
PDS Biotech reported a net loss of approximately $3.0 million, or $0.14 per basic share and diluted share, for the three months ended March 31, 2021 compared to a net loss of approximately $4.0 million, or $0.39 per basic share and diluted share, for the three months ended March 31, 2020.

Research and development (R&D) expenses decreased 28% to approximately $1.4 million for the three months ended March 31, 2021 from approximately $2.0 million for the three months ended March 31, 2020. The decrease of approximately $0.6 million in 2021 was primarily attributable to a decrease of $0.3 million in professional services and $0.3 million in clinical studies.

General and administrative expenses decreased 21% to approximately $1.6 million for the three months ended March 31, 2021 from approximately $2.1 million for the three months ended March 31, 2020. The decrease of approximately $0.5 million is primarily attributable to a decrease in professional services of approximately $0.7 million which includes legal fees of approximately $0.2 million, offset by an increase of approximately $0.2 million in personnel costs.

Total operating expenses decreased 24% to approximately $3.0 million for the three months ended March 31, 2021 from approximately $4.0 million for the three months ended March 31, 2020. 

PDS Biotech’s cash balance as of March 31, 2021 was approximately $25.0 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am ET on Thursday, May 13, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotech. Participants can also access the conference call via webcast on the investor relations page of the Company’s corporate website (link).

The event will be archived in the investor relations section of PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13716518.

About PDS Biotech

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional  tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune
^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The Company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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

Media & Investor Relations Contact:
Deanne Randolph
PDS Biotechnology
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838 
Email: pdsb@cg.capital

 

PDS BIOTECHNOLOGY
CORPORATION AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and
Comprehensive Loss

(Unaudited)

 

Neovasc to Sponsor Symposium on Reducer at EuroPCR

VANCOUVER and MINNEAPOLIS – (NewMediaWire) – May 13, 2021 – Neovasc Inc. (Neovasc or the Company) (NASDAQ,TSX: NVCN) today announced that it will sponsor a symposium presenting the latest long-term clinical data on the Reducer(TM) (Reducer), highlighting its easy integration into current cardiovascular and microvascular disease treatments. The symposium titled, Latest clinical evidence and practical aspects to start Reducer therapy in your center, will be presented at the 2021 EuroPCR, taking place digitally from May 18-20, 2021. EuroPCR is a leading opportunity for cardiologists to exchange ideas and latest best practices.

The session will be available for registered participants via a global livestream, from 1:00 to 2:00 PM EDT, Thursday, May 20, 2021 on the Valvular channel, and via replay for three months.

The session will be facilitated by Prof. Stefan Verheye, MD, PhD, Antwerp Cardiovascular Center, Middelheim, Antwerp, Belgium, and include presentations by:

Prof. Martine Gilard, MD, Director of Interventional Cardiology, Brest University Hospital, France

Dr. Romain Didier, Interventional Cardiologist, Brest University Hospital, France

Prof. Jonathan Hill, MD, Consultant Interventional Cardiologist at Royal Brompton & Harefield NHS Foundation Trust, London, U.K.

Prof. Tommaso Gori, MD, PhD, University Medical Center, Mainz, Germany

Dr. Francesco Giannini, Interventional Cardiologist, Maria Cecilia Hospital, Cotignola, Italy

Reducer therapy is an important tool for the interventional cardiologist to treat patients with the challenging diagnosis of refractory angina, said Prof. Gilard. We are at the forefront of emerging treatments that offer new hope for patients that, until now, have had no other options.

 

About Reducer

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that issimilar toimplanting a coronary stent and is completed in approximately 20 minutes.

While the Reducer is not approved for commercial use in the United States, the FDA granted Breakthrough Device designation to the Reducer in October 2018. This designation is granted by the FDA in order to expedite the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.

Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.

 

About Neovasc Inc.

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

For more information on and to register for EuroPCR, please visit: https://www.pcronline.com/Courses/EuroPCR

Investors

Mike Cavanaugh
Westwicke/ICR

Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com

 

Media

Sean Leous
Westwicke/ICR

Phone: +1.646.866.4012
Sean.Leous@westwicke.com

 

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the Company’s plans to sponsor the symposium and expectations as to the growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward looking statements, including those described in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three months endedMarch 31, 2021 (copies of which may be obtained atwww.sedar.comorwww.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise

Lineage Reports First Quarter 2021 Financial Results and Highlights Significant Progress With All Three Clinical Programs

• OpRegen^® Clinical
  Data Continued to Demonstrate Improvements in Dry Age-Related Macular
  Degeneration (AMD) with Geographic Atrophy (GA)
• Worldwide License Agreement Secured for a
  Cancer Immunotherapy Candidate Based on the Lineage VAC Platform
• Exclusive Agreement Secured to Evaluate a
  Novel System for Enhanced Delivery of OPC1
• Board of Directors Enhanced with Appointments
  of Healthcare Leaders, Drs. Anula Jayasuriya and Dipti Amin
• Current Cash and Marketable Securities
  Expected to Support Operations Well Into 2023

CARLSBAD, Calif.–(BUSINESS WIRE)–May 13, 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 financial and operating results for the first quarter 2021. Lineage will host a conference call today at 4:30 p.m. Eastern Time to discuss its first quarter 2021 financial results and to provide a business update.

“Lineage reported significant operational progress with each of its three clinical programs during the first quarter and beyond, delivering not only continued positive clinical results with OpRegen for the treatment of dry-AMD with GA, but also validating partnerships to support our OPC1 and VAC programs,” stated Brian M. Culley, Lineage CEO. “We remain encouraged by the totality of the OpRegen clinical data presented to date, which is suggestive of clinically meaningful benefits, especially in earlier stage disease dry-AMD patients. Moreover, the strategic collaborations we announced for OPC1 and VAC reflect our commitment to a comprehensive asset management approach and add external validation to the potential of our platform to create positive outcomes for patients. Additionally, the capital we brought in during the first quarter ensures that we not only are well funded to reach additional milestones, but also provide us with optionality with respect to partnership discussions.”

Some of the significant events and milestones achieved to date
this year include:

– Presented a positive interim clinical update from the ongoing Phase 1/2a study of OpRegen for the treatment of dry-AMD with GA at the 2021 Association for Research in Vision and Ophthalmology Meeting: 83% of all Cohort 4 patients exhibited stable or improved Best Corrected Visual Acuity (BCVA) while visual acuity declined in the majority of untreated eyes;

– Reported that the first known finding of retinal tissue restoration in a patient who received a retinal pigment epithelium (RPE) cell transplant continues to demonstrate areas of retinal restoration as of their last assessment, approximately 3 years after treatment;

– Treated a vitelliform maculopathy patient with OpRegen under named patient compassionate use: the delivery of OpRegen RPE cells via pars plana vitrectomy (PPV) was successful, with no complications arising during the procedure and the patient remains in follow-up;

– Entered into a worldwide license agreement with Immunomic Therapeutics for an allogeneic cell-based cancer immunotherapy based on Lineage’s VAC platform with a total of $2 million in upfront payments anticipated in the first year and the potential for $67 million in development and commercial milestones;

– Entered into an exclusive agreement with Neurgain Technologies to evaluate a novel delivery system for OPC1 for treatment of spinal cord injury;

– Announced the appointment of Anula Jayasuriya, M.D., Ph.D., M.B.A., a successful healthcare private equity executive and venture capitalist with extensive clinical, industry, entrepreneurial, and investment experience, to the Company’s Board of Directors; and

– Announced the appointment of Dr. Dipti Amin, MBBS, a medically trained senior executive with broad expertise in medicine, pharmacology, healthcare, research, and product development, to the Company’s Board of Directors.

Some of the events and milestones to look forward to during the
remainder of 2021 include:

– OpRegen Program

• Presentation of additional interim data from the Phase 1/2a study, anticipated during the second quarter of 2021;
• Meeting with the U.S. Food and Drug Administration (FDA) to discuss further clinical development, anticipated in the third quarter of 2021.

– OPC1 Program

• FDA Regenerative Medicine Advanced Therapy interaction to assess plans to evaluate the Neurgain Parenchymal Spinal Delivery (PSD) system, scheduled in June 2021;
• Evaluation of the Neurgain PSD system;
• Completion of improved manufacturing process, GMP production, and comparability testing to support a late-stage clinical trial;
• FDA interaction to discuss manufacturing improvements, anticipated around the end of 2021.

– VAC Program

• Completion of enrollment in the ongoing VAC2 Phase 1 non-small cell lung cancer study, anticipated in mid 2021;
• Introduction of manufacturing enhancements to the VAC platform;
• Reporting of results from the ongoing VAC2 Phase 1 study, anticipated in the fourth quarter of 2021;
• Evaluation of opportunities for new VAC product candidates based on internally-identified or partnered tumor antigens.

– Continued evaluation of partnership opportunities and expansion of existing external collaborations and identification of new collaborations.

Balance Sheet Highlights

Cash, cash equivalents and marketable securities totaled $62.4 million as of March 31, 2021. Marketable securities of $6.2 million as of March 31, 2021 include our remaining ownership of 1,122,401 shares of common stock in OncoCyte and 169,167 shares of common stock in Hadasit Bio-Holdings Ltd.

We added to our cash position in the first quarter of 2021 with net proceeds of $19.3 million received from sales of our common shares under our ATM offering and net proceeds of $10.1 million received from selling a portion of our marketable securities.

No sales were conducted under our ATM offering from March 6, 2021 through May 12, 2021.

First Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from research grants, royalties, and licensing fees. Total revenues for the three months ended March 31, 2021 were approximately $0.4 million, a decrease of $0.1 million as compared to $0.5 million for the same period in 2020. The decrease was primarily related to an approximate $0.2 million decrease in grant income, which was primarily driven by the completion of SBIR grant-related activities, offset by a $0.1 million increase in royalty-related revenues.

Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses for the three months ended March 31, 2021 were $7.3 million, a decrease of $0.6 million as compared to $7.9 million for the same period in 2020.

R&D Expenses: R&D expenses for the three months ended March 31, 2021 were $3.4 million, an increase of approximately $0.1 million as compared to $3.3 million for the same period in 2020. The overall increase was primarily related to increases of $0.5 million and $0.4 million in VAC and OPC1 program expenses, respectively, and a net decrease of $0.8 million in OpRegen and other ophthalmic application expenses, primarily driven by fluctuations in the timing of manufacturing activities.

G&A Expenses: G&A expenses for the three months ended March 31, 2021 were $3.9 million, a decrease of approximately $0.6 million as compared to $4.5 million for the same period in 2020. The decrease was primarily attributable to decreases of $0.4 million in expenses related to our merger with Asterias Biotherapeutics, Inc., $0.2 million in rent expense and utilities, $0.1 million in legal and patent expenses, and $0.1 million in compensation expense, offset by a $0.2 million increase in investor and public relations expenses.

Loss from Operations: Loss from operations for the three months ended March 31, 2021 was approximately $7.0 million, a decrease of $0.4 million as compared to $7.4 million for the same period in 2020.

Other Income/(Expenses), Net: Other income/(expenses), net for the three months ended March 31, 2021 reflected other income, net of $5.6 million, compared to other expense, net of ($1.0) million for the same period in 2020. The variance was primarily related to the gain on sale of marketable securities and changes in the value of marketable equity securities for the applicable periods, as well as exchange rate fluctuations related to Lineage’s international subsidiaries. The increase in the value of Lineage’s OncoCyte shares and subsequent sales during the first quarter 2021 contributed significantly to the overall net increase in other income.

Net loss attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2021 was $1.4 million, or $0.01 per share (basic and diluted), compared to a net loss attributable to Lineage of $8.4 million, or $0.06 per share (basic and diluted), for the same period in 2020.

Conference Call and Webcast

Lineage will host a conference call and webcast today, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2021 financial results and to provide a business update. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the “Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 21, 2021, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 4996965.

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 three allogeneic (“off-the-shelf”) clinical programs are in markets with billion dollar opportunities: (i) OpRegen^®, an investigational 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 investigational 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, with investigational immunotherapy VAC2 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,” “look forward to” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s anticipated funding runway, data presentations, clinical trial advancement, meetings and interactions with the FDA, evaluation of the Neurgain PSD system, manufacturing improvements, enrollment in the VAC2 Phase 1 study, announcement of clinical study results, payments under the license agreement with Immunomic Therapeutics, partnership evaluations and opportunities, and market opportunity and potential for its product candidates. 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 most recent Annual Report on Form 10-K filed with the SEC and Quarterly Report on Form 10-Q 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.

Noble Capital Markets and Channelchek to Host Investor Forum C-Suite Interviews During Prestigious 16th Annual World Stem Cell Summit

View the Investor Forum Presentations Here

View the Official Investor Forum Book Here

PRESS RELEASE – Noble Capital Markets (“Noble”), a research-driven investment bank, today announces its platinum-level sponsorship of, and collaboration with, the 16th World Stem Cell Summit, to be held virtually June 14-18, 2021. Noble will also provide significant content through its small and microcap investor portal, Channelchek.com.

Produced by the nonprofit Regenerative Medicine Foundation (RMF), the 2021 Summit is the most inclusive and expansive interdisciplinary networking and partnering meeting in the stem cell translation and regenerative medicine field. With the overarching purpose of fostering biomedical research, funding and investments targeting cures, the Summit is the single conference serving the diverse ecosystem of regenerative medicine stakeholders. Combined with the WFIRM & RMF Regenerative Medicine Essentials Course, the Summit provides distinctive educational and futuristic experiences through which all participants collect opportunities, become inspired and flourish…  CLICK
HERE FOR FULL RELEASE

World Stem Cell Summit Website  |  Channelchek
Free Access to the
Investor Forum at
the World Stem
Cell Summit

Noble Capital Markets and Channelchek to Host Investor Forum C-Suite Interviews During Prestigious 16th Annual World Stem Cell Summit

View the Investor Forum Presentations Here

View the Official Investor Forum Book Here

Boca Raton, FL– Noble Capital Markets (Noble), a research-driven investment bank, today announces its platinum-level sponsorship of, and collaboration with, the 16^th World Stem Cell Summit, to be held virtually June 14-18, 2021. Noble will also provide significant content through its small and microcap investor portal, Channelchek.com.

Produced by the nonprofit Regenerative Medicine Foundation (RMF), the 2021 Summit is the most inclusive and expansive interdisciplinary networking and partnering meeting in the stem cell translation and regenerative medicine field. With the overarching purpose of fostering biomedical research, funding and investments targeting cures, the Summit is the single conference serving the diverse ecosystem of regenerative medicine stakeholders. Combined with the WFIRM & RMF Regenerative Medicine Essentials Course, the Summit provides distinctive educational and futuristic experiences through which all participants collect opportunities, become inspired and flourish.  

“This segment of life sciences represents an exciting opportunity for investors and, more importantly, breakthroughs in terms of disease control and the overall quality and longevity of life,” said Nico Pronk, Noble’s president and CEO. “It is our passion at Noble, and we’re extremely excited to serve as the principal partner of the Investor Forum track at the Summit.”

Bernard Siegel, executive director of RMF and founder of the World Stem Cell Summit said, “There is huge investor interest in the regenerative medicine and longevity space. I’ve attended Noble’s superbly organized, large-scale NobleCon investor conference. Their meetings deliver the critical content and context investors need. We are delighted to have Noble and Channelchek as our partners, providing expertise and unsurpassed connectivity.”

Bernard Siegel, executive director of RMF and founder of the World Stem Cell Summit said, “There is huge investor interest in the regenerative medicine and longevity space. I’ve attended Noble’s superbly organized, large-scale NobleCon investor conference. Their meetings deliver the critical content and context investors need. We are delighted to have Noble and Channelchek as our partners, providing expertise and unsurpassed connectivity.”

For more than 35 years, Noble has supported small and microcap companies – many in the life sciences space – through investment banking activities and institutional-quality equity research. In 2018, the company launched Channelchek.com, a website that offers the free distribution of news, advanced market data, extensive video content and equity research to every level of investor, ranging from novice through to institutional. There are more than 6,000 companies listed on the site that fit the small/microcap definition.

For the Summit, Noble will produce a track of interviews (“ChannelCasts”) with executives from participating life sciences companies. As many as 12 are expected, with three – Celularity, Longeveron and Avalon GloboCare – among the first to register. Each of these C-Suite interviews will consist of a detailed explanation of the company business and financial plan, followed by an investor-oriented Q&A session moderated by a FINRA-licensed senior research analyst from Noble. Channelchek will be the platform used to build awareness of the Summit and the participating companies to its user base of 50,000+, as well as for the rebroadcast of the C-Suite Series Interviews (the recordings will also be available on the Channelchek YouTube Channel.) As with all other content on Channelchek, there will be no cost to access these ChannelCasts.

World Stem Cell Summit Website  |  Channelchek
Free Access to the
Investor Forum at
the World Stem
Cell Summit

 

About
Noble Capital Markets, Inc. / Channlechek.com

Noble Capital Markets (“Noble”) www.noblecapitalmarkets.com  is a research driven boutique investment bank that has supported small & microcap companies since 1984. As a FINRA and SEC licensed and registered broker-dealer Noble provides institutional-quality equity research, merchant and investment banking, wealth management and order execution services. In 2005, Noble established NobleCon, an investor conference that has grown substantially over the last decade and a half. In 2018 Noble launched channelchek.vercel.app – an investment community dedicated exclusively to small and micro-cap companies and their industries. Channelchek is tailored to meet the needs of self-directed investors and financial professionals and is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 6,000 emerging growth companies are listed on the site, with growing content including webcasts, industry sector reports, advanced market data and balanced news.

 

Contact & Info:

Mark Pinvidic

mpinvidic@noblecapitalmarkets.com

www.noblecapitalmarkets.com

channelchek.vercel.app

worldstemcellsummit.com

ProMIS Neurosciences appoints renowned neuroscientist, Dr. Rudolph Tanzi, as Chair of Scientific Advisory Board

TORONTO, Ontario and CAMBRIDGE, Massachusetts – May 12, 2021 – ProMIS Neurosciences, Inc. (TSX: PMN); (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics selectively targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced the appointment of Rudolph Tanzi, Ph.D, as Chair of the  Company’s scientific advisory board (SAB). Dr. Tanzi is the Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard University and Vice-Chair of Neurology, Director of the Genetics and Aging Research Unit, and Co-Director of the Henry and Allison McCance Center for Brain Health at Massachusetts General Hospital.

“Dr. Rudy Tanzi has been a valuable member of our scientific advisory board for years, and we are thrilled that he has agreed to accept the Chairman’s role as we work to expand our portfolio of potential best in class products,” stated Eugene Williams, ProMIS Executive Chairman. “As an expert neuroscientist in the field of neurodegenerative disorders, with over three decades of outstanding research accomplishments in Alzheimer’s, ALS, and other diseases, Dr. Tanzi can help us fully develop the potential of our portfolio, capitalizing on the recent strong financial support from a Boston-based group of investors.” 

Commenting on the appointment, Dr. Tanzi stated: “I am delighted to take on this new role with  the ProMIS SAB.  I have been impressed with the progress of the scientific portfolio, based on ProMIS’ unique technology platform, that continues to create potential antibody therapies highly selective for the toxic forms of proteins.  I look forward to advising ProMIS Neurosciences as the Company progresses its innovative programs into the clinic, including PMN310 in Alzheimer’s disease.”

Dr. Rudolph Tanzi is a neuroscientist and geneticist with scientific expertise in Alzheimer’s disease (AD) and brain health. He is one of the world’s leading scientists in research aimed at preventing and treating Alzheimer’s disease. His research studies and books have also focused on preserving and promoting brain health. In his research achievements, Dr. Tanzi served on the team that was the first to find a disease gene (Huntington’s disease) using human genetic markers, helping to launch the field of neurogenetics. Dr. Tanzi went on to identify all three early-onset familial AD genes: the amyloid precursor protein and presenilins 1 and 2. As leader of the Cure Alzheimer’s Fund Alzheimer’s Genome Project, he has identified several other AD-related genes, including the first shown to causing neuroinflammation in AD (CD33). Dr. Tanzi also uncovered the Wilson’s disease gene and several other neurological disease-related genes.

Dr. Tanzi and his team have used AD genes and human stem cells to create “Alzheimer’s-in-a-Dish” – a three-dimensional human stem cell-derived neural culture system that was the first to recapitulate both pathological hallmarks of AD: plaques and tangles. This model has made drug screening for AD considerably faster and more efficient. Using this system, Dr. Tanzi has developed several promising therapeutic candidates for AD including gamma secretase modulators aimed at beta-amyloid pathology. Most recently, Dr. Tanzi and his team have discovered that beta-amyloid may play a role in the innate immune system of the brain operating as an anti-microbial peptide, suggesting a possible role for infection in the etiology and pathogenesis of AD. 

Dr. Tanzi has published over 600 research papers and has received the highest awards in his field, including the Metropolitan Life Foundation Award, Potamkin Prize, Ronald Reagan Award, Silver Innovator Award, and the Smithsonian American Ingenuity Award, the top national award for invention and innovation. He serves on dozens of editorial boards and scientific advisory boards and was named to TIME magazine’s list of TIME100 Most Influential People in the World. He also co-authored the books Decoding
Darkness, and the three international bestsellers, Super Brain, Super
Genes, and The Healing Self. Dr. Tanzi is also a musician who professionally records and performs (keyboards), most recently with Joe Perry and Aerosmith.

About the ProMIS Scientific Advisory Board

The ProMIS SAB brings together a multidisciplinary group of specialists in Alzheimer’s disease and neurodegenerative disease along with experts in neurotoxic, prion-like misfolded proteins. In addition to Dr. Tanzi, the current members of the Company’s SAB include:

 

• Neil R. Cashman, MD is Chief Science Officer at ProMIS Neurosciences and Professor of Medicine at the University of British Columbia, where he holds the Canada Research Chair in Neurodegeneration and Protein Misfolding Diseases and serves as the Director of the UBC ALS Centre. Dr. Cashman is recognized as a pioneer in the field of prion-like misfolded proteins and their role in development of neurodegenerative diseases, in particular ALS and AD. Neil Cashman is co-chair of the SAB;
• Sharon Cohen, MD is a trained behavioral neurologist and former speech language pathologist. Her memory clinic and dementia clinical trials program at  Toronto Memory Programme are the largest and most active in Canada and have contributed substantially to patient care and to global clinical trial cohorts. Through her commitment to knowledge translation and her passion for clinically meaningful outcomes, Dr. Cohen provides a valuable perspective which places the patient at the center of Alzheimer’s drug development programs;
• Hans Frykman MD, PhD, is the CEO and medical director of BC Neuroimmunology Lab and Neurocode Labs. BC Neuroimmunology lab has a 35-year history of delivering highly specific clinical neuroimmunology testing to the North American marketplace. The lab is a technology leader and is academically collaborating with several leading centers in Europe and USA. Neurocode labs is Canada’s first and only clinical whole exome sequencing facility. It has a particular focus in seizure disorder, cardiac sequencing and sequencing of the neonate. Dr. Frykman is a clinical assistant professor of medicine at University of British Columbia. Dr. Frykman received his postgraduate medical training at Karolinska University Hospital, Mayo Clinic, University of Minnesota, Memorial Sloan Kettering Cancer Center, and University of British Columbia. Dr Frykman received his medical degree from Karolinska Institute in Stockholm, PhD in Bio-organic chemistry from Royal Institute of Technology in Stockholm and MSc in Chemical Engineering from Chalmers University in Gothenburg;
• Michelle L. Hastings, PhD is Professor of Cell Biology and Anatomy and Director of the Center for Genetic Diseases at the Chicago Medical School, Rosalind Franklin University of Medicine and Science.  Dr. Hastings’ expertise is in RNA biology and antisense technology. Her lab is leading advances in the field of RNA splicing and how the process can be harnessed to treat disease. Dr. Hastings has utilized small molecules and antisense oligonucleotides to modulate aberrant splicing associated with spinal muscular atrophy (SMA), Usher syndrome, Alzheimer’s disease, Parkinson’s disease, Batten disease and cystic fibrosis.  She received her Ph.D. at Marquette University and was a post-doctoral fellow at Cold Spring Harbor Laboratory;  
• William C. Mobley, MD, PhD is Associate Dean for Neurosciences Initiatives, Distinguished Professor of Neurosciences, Florence Riford Chair for Alzheimer Disease at the University of California, San Diego (UCSD), and the university’s Executive Director of the Down Syndrome Center for
  Research and Treatment. Dr. Mobley’s research focuses on the neurobiology of neuronal dysfunction in developmental and age-related disorders of the nervous system; 
• C. Warren Olanow, MD has authored more than 300 publications primarily related to Parkinson’s disease and neurodegeneration. He is the previous Henry P. and Georgette Goldschmidt Professor and Chairman of the Department of Neurology at the Mount Sinai School of Medicine in New York City, and is presently Professor Emeritus in the Department of Neurology and in the Department of Neuroscience. He also serves as Chief Executive Officer of CLINTREX, a pharmaceutical advisory firm that has designed numerous clinical trials in neurodegenerative disease for the pharmaceutical industry;
• Andre Strydom, MD, PhD, is a professor in the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, and Honorary Consultant psychiatrist, South London and the Maudsley NHS Trust. His current projects and collaborations include the LonDownS consortium, funded by the Wellcome Trust/ MRC, to study the neurobiology of Alzheimer’s Disease in Down syndrome to understand the underlying factors that may influence variation in age of onset of symptoms. His research in Down syndrome includes investigation of biomarkers of cognitive decline including those related to excess amyloid production, oxidative stress, and neurodegeneration. His group also conducts neuroimaging studies using high-density EEG, MRI and fNIRS. He has been an investigator on clinical trials of new drug treatment options in Down syndrome, fragile X syndrome and autism;
• Dr. David Wishart is a Distinguished University Professor in the Departments of Biological Sciences and Computing Science at the University of Alberta. He also holds adjunct appointments with the Faculty of Pharmaceutical Sciences and with the Department of Pathology and Laboratory Medicine.  He has been with the University of Alberta since 1995. Dr. Wishart has been studying protein folding and misfolding for more than 30 years using a combination of computational and experimental approaches. These experimental approaches include NMR spectroscopy, circular dichroism, fluorescence spectroscopy, electron microscopy, protein engineering and molecular biology. The computational methods include molecular dynamics, agent-based modeling, bioinformatics and machine learning. Over the course of his career, Dr. Wishart has published more than 430 scientific papers covering many areas of protein science including structural biology, protein metabolism and computational biochemistry. These papers have been cited more than 78,000 times.  Dr. Wishart has been awarded research grants totaling more than $130 million from a number of funding agencies including CIHR, NSERC, NIH, Genome Canada, CFI, NRC, APRI, PrioNET, PENCE and Compute Canada. Dr. Wishart currently co-directs The Metabolomics Innovation Centre (TMIC), Canada’s national metabolomics laboratory.  Dr. Wishart was awarded a Lifetime Honorary Fellowship by the Metabolomics Society in 2014 and elected as a Fellow of the Royal Society of Canada in 2017. Dr. Wishart has been identified as one of the world’s most highly cited scientists for each of the past 7 years.

About ProMIS Neurosciences, Inc.

ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its thermodynamic, computational discovery platform -ProMIS™ and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and PD.  ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

For further information about ProMIS Neurosciences, please consult the Company’s website at:  www.promisneurosciences.com

 

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