Tuesday, May 18, 2021

Helius Medical Technologies (HSDT)(HSM:CA)
First Quarter Results; Moving Forward with U.S. Commercialization

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

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

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

1Q21 Results. Helius reported first quarter 2021 revenue of $84,000, down from $207,000 in the same period last year. Net loss for the quarter was $3.4 million, or $1.65 per share, compared to a net loss of $4.8 million, or $5.38 per share in the first quarter last year. We had forecast revenue of $87,000 and a net loss of $2.8 million, or $1.22 per share.


U.S.  Commercialization. Following FDA approval in March, Helius is developing a plan for U.S. commercialization of the PoNS Treatment. The Company is well on it way of obtaining state approvals, currently approved in 24 states. A team is being assembled to develop and implement a “go to market strategy.” Helius will initially focus on early adopters in the neurologist community and …

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

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

Onconova Therapeutics Reports First Quarter 2021 Financial Results And Provides Business Update

 

NEWTOWN, Pa., May 17, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended March 31, 2021 and provided a business update.

Highlights for the first quarter of 2021 and subsequent weeks include:

• The Phase 1 solid tumor study with ON 123300 in China is ongoing with no dose-limiting toxicities observed in the first two cohorts. Enrollment to the third cohort (120 mg) will now proceed.
• The Phase 1 study with ON 123300 in the United States is open for enrollment, and actively screening patients.
• The first patient has been dosed in an investigator-initiated Phase 2 study designed to assess the efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC).
• The investigator-initiated Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer has progressed nicely and has reached the maximum dose of oral rigosertib per the current protocol.
• The Company strengthened its balance sheet with net proceeds of $35.2 million from two equity offerings; cash and cash equivalents as of March 31, 2021 were $48.0 million. The Company believes it has more than 18 months of cash runway.
  

Management Commentary

“We are off to a strong start in 2021 and remain focused on advancing our clinical programs, in particular with our lead product candidate ON 123300, a multi-kinase inhibitor that potently targets CDK 4 and 6, which are overexpressed in a number of cancers, including HR+ HER 2- metastatic breast cancer, a potential blockbuster commercial opportunity,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “We are delighted that our partner in China, HanX Biopharmaceuticals, is expected to begin the third cohort of their Phase 1 study at 120 mg per dose and that ON 123300 appears to be well tolerated with no dose-limiting toxicities observed to date. Notably, the HanX study is dosing patients on days 1 to 21 of 28-day cycles, while the U.S. Phase 1 study will be investigating a continuous daily dosing regimen. Collectively, we expect these complementary studies to generate important safety data that will inform the design of subsequent trials and potentially provide preliminary signals of efficacy in patients with advanced cancer.”

Dr. Fruchtman continued, “Alongside the progress made with our lead product candidate, we have also seen advancements in several investigator-initiated trials evaluating rigosertib. The first patient was recently dosed in a Phase 2 trial evaluating rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa, a disease with a critical unmet medical need. Additionally, the Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer continues to progress and has reached the highest dose per the current protocol. We expect to continue leveraging our relationships with leading cancer centers and industry collaborators to advance these trials and commence additional investigator initiated studies in RAS-driven cancers in combination with checkpoint inhibitors. We expect such an approach to facilitate our near- and long-term growth by allowing us to preserve our primary focus and resources on ON 123300 while simultaneously pursuing opportunities to develop rigosertib in high unmet need indications.”

First Quarter Financial Results

Cash and cash equivalents as of March 31, 2021 were $48.0 million, compared with $19.0 million as of December 31, 2020. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for more than 18 months.

Research and development expenses were $1.9 million for the first quarter of 2021, compared with $3.4 million for the first quarter of 2020. The decrease was primarily related to lower expenses for the oral rigosertib combination program and the completed Phase 3 INSPIRE study in the 2021 period.

General and administrative expenses were $2.2 million for the first quarter of 2021, compared with $1.8 million for the first quarter of 2020. The increase was primarily related to higher special stockholder meeting by proxy expenses and insurance costs in the 2021 period.

Net loss for the first quarter of 2021 was $4.7 million, or $0.02 per share on 219.2 million weighted average shares outstanding, compared with a net loss for the first quarter of 2020 of $5.1 million, or $0.03 per share on 160.3 million weighted average shares outstanding.

Conference Call and Webcast

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is planned to begin a dose-escalation and expansion Phase 1 trial in the U.S. in 2Q21, and a dose-escalation and expansion Phase 1 trial is currently underway in China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19.

For more information, please visit www.onconova.com.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the registered direct offering, its patents and clinical development plans including patient enrollment timelines and indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
(929) 469-3859
[email protected]

(Tables to follow)

ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands)
	March 31,				December 31,
	2021				2020
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	48,005			$	19,025
Receivables		38				37
Prepaid expenses and other current assets		607				722
Total current assets		48,650				19,784
Property and equipment, net		49				52
Other non-current assets		150				150
Total assets	$	48,849			$	19,986
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	3,988			$	4,833
Accrued expenses and other current liabilities		3,112				4,962
Deferred revenue		226				226
Total current liabilities		7,326				10,021
Warrant liability		957				321
Deferred revenue, non-current		3,413				3,469
Total liabilities		11,696				13,811
Stockholders’ equity:
Preferred stock		–				–
Common stock		2,367				1,859
Additional paid in capital		468,059				432,858
Accumulated other comprehensive (loss) income		(2	)			14
Accumulated deficit		(433,271	)			(428,556	)
Total stockholders’ equity		37,153				6,175
Total liabilities and stockholders’ equity	$	48,849			$	19,986

ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
	Three months ended March 31,
	2021				2020
Revenue	$	56			$	52
Operating expenses:
General and administrative		2,217				1,807
Research and development		1,937				3,370
Total operating expenses		4,154				5,177
Loss from operations		(4,098	)			(5,125	)
Change in fair value of warrant liability		(636	)			(63	)
Other income, net		19				96
Net loss		(4,715	)			(5,092	)
Net loss per share of common stock, basic and diluted	$	(0.02	)		$	(0.03	)
Basic and diluted weighted average shares outstanding		219,242,077				160,346,087

 

PDS Biotechnology Appoints Immuno-Oncology Experts Dr. Olivera Finn and Dr. Mark Frohlich to Scientific Advisory Board

 

Preeminent translational cancer immunotherapy researcher and renowned clinical/commercial cancer immunotherapy expert join the advisory board

FLORHAM PARK, N.J., May 18, 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 appointment of Dr. Olivera Finn and Dr. Mark Frohlich to its Scientific Advisory Board.

Dr. Olivera Finn is a Distinguished Professor of Immunology at the University of Pittsburgh, School of Medicine. Dr. Finn brings over three decades of expertise in translational research in immunology and oncology, including the discovery of the first tumor-associated protein (antigen) recognized by T-cells, called MUC-1. In 2016, she received the National Cancer Institute’s Outstanding Investigator Award for her pioneering and extensive ground-breaking research in cancer immunotherapy. Previously, Dr. Finn served as the Director of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute and is a Distinguished Fellow of the American Association of Immunologists. Dr. Finn obtained a Ph.D. in Immunology, and subsequently completed her postdoctoral fellowship at Stanford University.

Dr. Mark Frohlich is a renowned medical oncologist and biopharma executive who brings over 20 years of experience in developing immunotherapies for cancer. Dr. Frohlich has extensive clinical drug development and translational research expertise. As the Chief Medical Officer and Executive VP of R&D at Dendreon Corporation, he led the clinical team responsible for the development and approval of Provenge^® for the treatment of advanced prostate cancer. Provenge^® was the first therapeutic cancer vaccine to gain FDA approval. He subsequently served as Executive VP of Portfolio Strategy at Juno Therapeutics. Dr. Frohlich received his Doctor of Medicine degree from Harvard Medical School and completed his internal medicine residency and oncology fellowship at University of California San Francisco.

“We are excited to add Dr. Olivera Finn, Ph.D. and Dr. Mark Frohlich, M.D., two world-renowned immunotherapy experts, to our Scientific Advisory Board,” commented Dr. Lauren V. Wood, M.D., Chief Medical Officer of PDS Biotech. “These appointments further strengthen our translational research expertise in immuno-oncology as we prepare to progress clinical development of PDS0102 and PDS0103 for prostate and MUC-1 associated cancers respectively, and continue to advance our lead cancer immunotherapy PDS0101 through Phase 2 clinical testing. We very much look forward to adding their experience and guidance to our team of accomplished advisors.”

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. PDS Biotech is also collaborating with the National Cancer Institute to develop PDS0102 for prostate and breast cancers and to develop PDS0103, a MUC-1 targeting immunotherapy for breast, colon, lung and ovarian cancers. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. 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: [email protected]

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

 

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: [email protected]

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

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
[email protected]

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.

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
[email protected]

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: [email protected]

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

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

 

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

 

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
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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

[email protected]

www.noblecapitalmarkets.com

channelchek.vercel.app

worldstemcellsummit.com

 

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: [email protected]

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

 

PDS BIOTECHNOLOGY
CORPORATION AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and
Comprehensive Loss

(Unaudited)