BioSig Announces Closing of Public Offering of Common Stock

News and Market Data on BioSig Technologies

 

Westport, CT, March 23, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced the completion of its previously announced underwritten public offering of 2,611,739 shares of its common stock, $0.001 par value per share, at a price to the public of $1.15 per share. The proceeds to BioSig from this offering were $3 million.  The Company also issued a cash warrant at $1.40. Fully exercised the Company will receive another $3m of cash proceeds.

BioSig intends to use the net proceeds from the offering for the continuation of full commercialization activities related to the PURE EP™ System.

A shelf registration statement on Form S-3 (Registration No. 333-251859) relating to the public offering of the shares of common stock described above was previously filed with the Securities and Exchange Commission (“SEC”) and declared effective on January 12, 2021. A final prospectus supplement and accompanying prospectus describing the terms of the offering were filed with the SEC on July 6, 2021, and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from BioSig Technologies, Inc. 55 Greens Farms Road Westport, CT 06880 Attention: Vice President Administration.; email: lmikolaitis@biosigtech.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement. 

About BioSig Technologies 

BioSig Technologies is a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 

Andrew Ballou
Vice President, Investor Relations
BioSig Technologies, Inc.
55 Greens Farms Road
Westport, CT 06880
203 409-5444, x 133
aballou@biosigtech.com

Source: BioSig Technologies, Inc.

Ocugen Announces Appointment Of Marna C. Whittington, PhD, To Board Of Directors

Research, News, and Market Data on Ocugen

 

MALVERN, Pa., March 23, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines, today announced the appointment of Marna C. Whittington, PhD, to the Board of Directors. Her term became effective March 21, 2022.

“We’re extremely pleased to welcome Dr. Marna Whittington to the Ocugen board,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen. “Her experiences will be exceedingly important to our growth strategy as we progress our modifier gene therapies and vaccine candidate. I also want to thank Manish Potti for his significant contributions to the Board and the Company.”

Mr. Potti made the personal decision not to seek another term of service on the Board of Directors, commenting, “Ocugen is uniquely positioned for a bright future. Its pipeline and clinical programs for COVID-19 and ophthalmology are going to be valuable additions for patients. Shankar and the management team are well-prepared to handle the road ahead of them, and I wish the company nothing but continued success.”

Dr. Whittington is a renowned leader within the financial sector and a sought-after expert serving on numerous boards. She was the Chief Executive Officer of Allianz Global Investors Capital from 2001 until her retirement in January 2012. Before that, Dr. Whittington was a corporate officer for Morgan Stanley Investment Management and the University of Pennsylvania as well as the Secretary of Finance for the State of Delaware. She currently serves on the boards of the Salk Institute, Tower Hill School, Macy’s Inc., the Philadelphia Contributionship (a company founded by Benjamin Franklin), Phillips 66 and Oaktree Capital Management.

“This team is making discoveries through courageous innovation and positioning itself to make significant contributions to the health of our communities. I appreciate the opportunity to contribute to its continued success,” said Marna Whittington, PhD, newly appointed Director of Ocugen’s Board of Directors.

About Ocugen, Inc.
Ocugen, Inc. is a clinical-stage biotechnology company focused on discovering, developing, and commercializing gene therapies, biologicals and vaccines that improve health and offer hope for people and global communities. We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com

electroCore Announces Dr. Peter Staats to Keynote the Fifth Annual Bioelectronic Medicine Forum in New York

News and Market Data on electroCore

 

ROCKAWAY, N.J., 
March 23, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced its co-founder and Chief Medical Officer, Dr.  Peter Staats, will keynote the Fifth Annual 
Bioelectronic Medicine Forum on 
April 5, 2022.

The event will take place in 
New York City and will cover a range of technologies and indications for bioelectronic medicine, including applications in cardiovascular medicine, inflammation, gastrointestinal disorders, and many other clinical specialties.

Other panelists and presenters at the 2022 event include Marom Biksom, Professor of Biomedical Engineering at 
City College of New York;  Imran Eba, partner at 
Action Potential Venture Capital; and  Eric Van Gieson, Ph.D., Program Manager at DARPA Biological Technologies Office; and prior keynote speakers include  Murthy Simhambhatla, the President and CEO of 
SetPoint Medical.

Dr. Staats is the former President of the 
North American Neuromodulation Society, 
American Society of Interventional Pain Physicians, 
New Jersey Society of Interventional Pain Physicians, and the 
Southern Pain Society. He is currently President of the 
World Institute of Pain and continues to serve as Chief Medical Officer for National Spine and Pain Centers, the largest pain practice in 
the United States, and electroCore, Inc.

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

For more information, visit www.electrocore.com.

Investors:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital

Cocrystal Pharma Reports 2021 Financial Results and Provides Updates on Development Programs and Milestones

Research, News, and Market Data on Cocrystal Pharma

 

• Commenced enrollment in Phase 1 trial with orally administered, broad-spectrum antiviral agent CC-42344 for the treatment of pandemic and seasonal influenza A
• Advanced COVID-19 programs with the goal of initiating two Phase 1 trials in 2022 with the intranasal/pulmonary antiviral CDI-45205 and an orally administered antiviral agents
• Selected two promising COVID-19 oral antiviral leads for further evaluation, with both demonstrating activity against SARS-CoV-2 and variants of concern
• Merck continues development of influenza A/B compounds under an exclusive worldwide license and collaboration agreement

BOTHELL, Wash., March 23, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) reports financial results for the 12 months ended December 31, 2021, and provides updates on its antiviral pipeline, upcoming milestones and business activities.

“This is an eventful time at Cocrystal as we thoughtfully advance our antiviral programs for the treatment of influenza and COVID-19,” said Sam Lee, Ph.D., co-interim CEO and President of Cocrystal. “Enrollment is underway in our Phase 1 trial in Australia with our antiviral compound CC-42344 for pandemic and seasonal influenza A, keeping us on track for data readout later this year.

“We affirm plans to initiate first-in-human clinical studies as soon as possible in 2022 with two SARS-CoV-2 protease inhibitors, including our inhalation/pulmonary compound CDI-45205 and an orally administered compound,” Dr. Lee added. “Early this year, we received extensive comments from the U.S. Food and Drug Administration (FDA) on our pre-IND briefing package for CDI-45205 that provide valuable information in designing Phase 1 and Phase 2 studies for both CDI-45205 and our orally administered program.”

“We continue advancing multiple high-value antiviral compounds into clinical development and remain opportunistic,” said James Martin, co-interim CEO and CFO. “Importantly, given current markets and world economic stability conditions, we continue to be well positioned to execute on our strategy with a clean capital structure and a cash balance we believe is sufficient to fund planned operations through 2023.”

Antiviral Pipeline Overview
Many antiviral drugs are effective only against certain strains of a virus and are less effective or not effective at all against other strains. Cocrystal is developing drug candidates that specifically target proteins involved in viral replication. Despite the various strains of virus that may exist or emerge, these enzymes are required for viral replication and are essentially similar (highly conserved) among all strains. By targeting these highly conserved regions of the replication enzymes, our antiviral compounds are designed and tested to be effective against major virus strains.

COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and protease, we believe it is possible to develop an effective treatment for all coronavirus diseases including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Our main SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses that frequently cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis.

• Intranasal/Pulmonary Protease Inhibitor CDI-45205
  • We received guidance from the FDA regarding further development of CDI-45205, our novel SARS-CoV-2 main protease inhibitor as a potential treatment for COVID-19 and its variant via intranasal/pulmonary delivery. The guidance provides a clearer pathway for our planned Phase 1 single-ascending-dose and multiple-ascending-dose study that we expect to initiate in 2022, as well as directives for designing a subsequent Phase 2 study.
  • CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Omicron (Botswana and South Africa/BA.1), Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South Africa/B.1.351) variants, surpassing the activity observed with the original (wild-type) Wuhan strain.
  • CDI-45205 demonstrated good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. CDI-45205 also demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir.
  • CDI-45205 was among the broad-spectrum viral protease inhibitors obtained from Kansas State University Research Foundation (KSURF) under an exclusive license agreement announced in 2020. We believe the protease inhibitors obtained from KSURF have the ability to inhibit the inactive SARS-CoV-2 polymerase replication enzymes into an active form.
    
• Oral Protease Inhibitors
  
  • We selected investigational novel antiviral drug candidates CDI-988 and CDI-873 for further development as potential oral treatments for COVID-19. Both candidates were designed and developed using our proprietary structure-based drug discovery platform technology. These agents are chemically differentiated and exhibit superior in vitro potency again SARS-CoV-2, with activity maintained against current variants of concern. Both candidates demonstrated a favorable safety profile and pharmacokinetic properties that are supportive of daily oral dosing.
  • We plan to initiate a Phase 1 trial as soon as possible in 2022 with one of these candidates. We believe the FDA’s guidance for further development of CDI-45205 provides us with a clearer pathway for the clinical development of our oral COVID-19 program.
    
• Replication Inhibitors
  
  • We are using our proprietary structure-based drug discovery platform technology to discover replication inhibitors as orally administered therapeutic and prophylactic treatments for SARS-CoV-2. Replication inhibitors hold potential to work with protease inhibitors in a combination therapy regimen.

Influenza Programs
The global market for influenza therapeutics is expected to reach nearly $6.5 billion by 2022, according to a report published by BCC Research in May 2018.

• Pandemic and Seasonal Influenza A
  • Earlier this month we announced dosing of the first subjects in the Phase 1 clinical trial with CC-42344. A novel PB2 inhibitor, CC-42344 has shown excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as strains resistant to Tamiflu and Xofluza. CC-42344 also has favorable pharmacokinetic and drug-resistance profiles. We expect to report data on the Phase 1 clinical trial in 2022.

• Pandemic and Seasonal Influenza A/B program
  • In January 2019 we entered into an Exclusive License and Research Collaboration Agreement with Merck Sharp & Dohme Corp. to discover and develop certain proprietary influenza antiviral agents that are effective against both influenza A and B strains. This agreement includes milestone payments of up to $156 million plus royalties on sales of products discovered under the agreement.
  • In January 2021 we announced completion of all research obligations under the agreement. Merck is now solely responsible for further preclinical and clinical development of the influenza A/B antiviral compounds discovered under this agreement.
  • Merck continues development activities with the antiviral influenza A/B compounds discovered under this agreement.

Norovirus Program

• We are developing certain proprietary broad-spectrum antiviral compounds to treat norovirus infections.
• Norovirus is a global public health problem responsible for nearly 90% of epidemic, non-bacterial outbreaks of gastroenteritis around the world.

Hepatitis C Program

• We are seeking a partner to advance the development of CC-31244 following completion of a Phase 2a trial. This compound has shown favorable safety and preliminary efficacy in a triple-regimen Phase 2a study in combination with Epclusa (sofosbuvir/velpatasvir) for the ultra-short duration treatment of individuals infected with the hepatitis C virus (HCV).
• HCV is a viral infection of the liver that causes both acute and chronic infection. The 2017 World Health Organization Global Hepatitis Report estimates that 71 million people worldwide have chronic HCV infections.

2021 Financial Results
Throughout 2020 Cocrystal reported revenues under an influenza A/B collaboration with Merck consisting of research and development (R&D) services performed by Cocrystal and reimbursed by Merck. As discussed above, in January 2021 Merck assumed all activities and expenses associated with the continued development of the influenza A/B compounds discovered under this collaboration. As anticipated, Cocrystal reported no revenues for 2021 compared with $2.0 million in revenues for 2020. Under the terms of the Merck collaboration, Cocrystal is eligible to receive up to $156 million in payments related to designated developments, regulatory and sales milestones, as well as royalties on product sales.

R&D expenses for 2021 were $8.8 million compared with $6.0 million for 2020, with the increase primarily related to COVID-19 and influenza programs. The Company expects R&D expenses to increase during 2022 due to the advancement of our influenza A program into the clinic and progress with preclinical COVID-19 programs toward clinical development. General and administrative expenses for 2021 were $5.4 million compared with $5.6 million for 2020, with the decrease primarily due to reduced professional fees resulting from the conclusion of certain previously reported legal matters.

The net loss for 2021 was $14.2 million, or $0.16 per share, compared with a net loss for 2020 of $9.6 million, or $0.17 per share.

The Company reported unrestricted cash of $58.7 million as of December 31, 2021, compared with $33.0 million as of December 31, 2020. Net cash used in operating activities for 2021 was $12.7 million. During 2021 the company raised $38.5 million, net of transaction costs, which included net proceeds of approximately $2.1 million from the sale of common stock through an At-The-Market (ATM) facility in January 2021 and $36.4 million in net proceeds from a public offering of common stock May 2021. The Company reported working capital of $57.8 million as of December 31, 2021.

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

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our goals of initiating two Phase 1 studies for our COVID-19 programs in 2022, our expectations of reporting data from the Phase 1 clinical study of our Influenza A product candidate later in 2022, the viability and efficacy of potential treatments for coronavirus and other diseases, expectations for the global market for influenza therapeutics, our attempts to discover replication inhibitors, our development of antiviral treatments for norovirus, our expectations concerning R&D expenses, the expected sufficiency of our cash balance to fund our planned operations through 2023 and our 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 and/or the Ukraine war on our Company, our collaboration partners, and on the national and global economy, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including and adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current Clinical Research Organization (CRO) and any future CROs and Contract Manufacturing Organizations (CMOs), the ability of our current CRO to recruit volunteers for, and to proceed with, clinical trials, possible delays resulting from future lockdowns in Australia, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and any additional costs related to unfavorable future outcome of pending litigation or any unanticipated claims. 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, 2021. 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

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

 COCRYSTAL PHARMA, INC.

CONSOLIDATED BALANCE SHEETS
(in thousands)

		December 31, 2021				December 31, 2020
Assets
Current assets:
Cash		$	58,705			$	33,010
Restricted cash			50				50
Accounts receivable			–				556
Prepaid expenses and other current assets			568				399
Total current assets			59,323				34,015
Property and equipment, net			453				591
Deposits			46				46
Operating lease right-of-use assets, net (including $153 to related party)			478				498
Goodwill			19,092				19,092
Total assets		$	79,392			$	54,242
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses		$	1,297			$	1,080
Current maturities of finance lease liabilities			27				39
Current maturities of operating lease liabilities (including $53 to related party)			209				178
Derivative liabilities			12				61
Total current liabilities			1,545				1,358
Long-term liabilities:
Finance lease liabilities			7				34
Operating lease liabilities (including $101 to related party)			291				345
Total long-term liabilities			298				379
Total liabilities			1,843				1,737
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 150,000 and 100,000 shares authorized as of December 31, 2021 and December 31, 2020, respectively; 97,469 and 70,439 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively			98				71
Additional paid-in capital			336,544				297,342
Accumulated deficit			(259,093	)			(244,908	)
Total stockholders’ equity			77,549				52,505
Total liabilities and stockholders’ equity		$	79,392			$	54,242

COCRYSTAL PHARMA, INC.

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

		December 31,
		2021				2020
Revenues:
Collaboration revenue		$	–			$	2,014
Operating expenses:
Research and development			8,794				6,034
General and administrative			5,427				5,566
Total operating expenses			14,221				11,600
Loss from operations			(14,221	)			(9,586	)
Other (expense) income:
Interest expense, net			(4	)			(8	)
Change in fair value of derivative liabilities			49				(54	)
Foreign exchange loss			(9	)			–
Total other income (expense), net			36				(62	)
Net loss		$	(14,185	)		$	(9,648	)
Net loss per common share:
Loss per share, basic and diluted		$	(0.16	)		$	(0.17	)
Weighted average number of common shares outstanding, basic and diluted			88,368				55,217

# # #

Source: Cocrystal Pharma, Inc.

Cocrystal Pharma Reports 2021 Financial Results and Provides Updates on Development Programs and Milestones

Research, News, and Market Data on Cocrystal Pharma

 

• Commenced enrollment in Phase 1 trial with orally administered, broad-spectrum antiviral agent CC-42344 for the treatment of pandemic and seasonal influenza A
• Advanced COVID-19 programs with the goal of initiating two Phase 1 trials in 2022 with the intranasal/pulmonary antiviral CDI-45205 and an orally administered antiviral agents
• Selected two promising COVID-19 oral antiviral leads for further evaluation, with both demonstrating activity against SARS-CoV-2 and variants of concern
• Merck continues development of influenza A/B compounds under an exclusive worldwide license and collaboration agreement

BOTHELL, Wash., March 23, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) reports financial results for the 12 months ended December 31, 2021, and provides updates on its antiviral pipeline, upcoming milestones and business activities.

“This is an eventful time at Cocrystal as we thoughtfully advance our antiviral programs for the treatment of influenza and COVID-19,” said Sam Lee, Ph.D., co-interim CEO and President of Cocrystal. “Enrollment is underway in our Phase 1 trial in Australia with our antiviral compound CC-42344 for pandemic and seasonal influenza A, keeping us on track for data readout later this year.

“We affirm plans to initiate first-in-human clinical studies as soon as possible in 2022 with two SARS-CoV-2 protease inhibitors, including our inhalation/pulmonary compound CDI-45205 and an orally administered compound,” Dr. Lee added. “Early this year, we received extensive comments from the U.S. Food and Drug Administration (FDA) on our pre-IND briefing package for CDI-45205 that provide valuable information in designing Phase 1 and Phase 2 studies for both CDI-45205 and our orally administered program.”

“We continue advancing multiple high-value antiviral compounds into clinical development and remain opportunistic,” said James Martin, co-interim CEO and CFO. “Importantly, given current markets and world economic stability conditions, we continue to be well positioned to execute on our strategy with a clean capital structure and a cash balance we believe is sufficient to fund planned operations through 2023.”

Antiviral Pipeline Overview
Many antiviral drugs are effective only against certain strains of a virus and are less effective or not effective at all against other strains. Cocrystal is developing drug candidates that specifically target proteins involved in viral replication. Despite the various strains of virus that may exist or emerge, these enzymes are required for viral replication and are essentially similar (highly conserved) among all strains. By targeting these highly conserved regions of the replication enzymes, our antiviral compounds are designed and tested to be effective against major virus strains.

COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and protease, we believe it is possible to develop an effective treatment for all coronavirus diseases including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Our main SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses that frequently cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis.

• Intranasal/Pulmonary Protease Inhibitor CDI-45205
  • We received guidance from the FDA regarding further development of CDI-45205, our novel SARS-CoV-2 main protease inhibitor as a potential treatment for COVID-19 and its variant via intranasal/pulmonary delivery. The guidance provides a clearer pathway for our planned Phase 1 single-ascending-dose and multiple-ascending-dose study that we expect to initiate in 2022, as well as directives for designing a subsequent Phase 2 study.
  • CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Omicron (Botswana and South Africa/BA.1), Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South Africa/B.1.351) variants, surpassing the activity observed with the original (wild-type) Wuhan strain.
  • CDI-45205 demonstrated good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. CDI-45205 also demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir.
  • CDI-45205 was among the broad-spectrum viral protease inhibitors obtained from Kansas State University Research Foundation (KSURF) under an exclusive license agreement announced in 2020. We believe the protease inhibitors obtained from KSURF have the ability to inhibit the inactive SARS-CoV-2 polymerase replication enzymes into an active form.
    
• Oral Protease Inhibitors
  
  • We selected investigational novel antiviral drug candidates CDI-988 and CDI-873 for further development as potential oral treatments for COVID-19. Both candidates were designed and developed using our proprietary structure-based drug discovery platform technology. These agents are chemically differentiated and exhibit superior in vitro potency again SARS-CoV-2, with activity maintained against current variants of concern. Both candidates demonstrated a favorable safety profile and pharmacokinetic properties that are supportive of daily oral dosing.
  • We plan to initiate a Phase 1 trial as soon as possible in 2022 with one of these candidates. We believe the FDA’s guidance for further development of CDI-45205 provides us with a clearer pathway for the clinical development of our oral COVID-19 program.
    
• Replication Inhibitors
  
  • We are using our proprietary structure-based drug discovery platform technology to discover replication inhibitors as orally administered therapeutic and prophylactic treatments for SARS-CoV-2. Replication inhibitors hold potential to work with protease inhibitors in a combination therapy regimen.

Influenza Programs
The global market for influenza therapeutics is expected to reach nearly $6.5 billion by 2022, according to a report published by BCC Research in May 2018.

• Pandemic and Seasonal Influenza A
  • Earlier this month we announced dosing of the first subjects in the Phase 1 clinical trial with CC-42344. A novel PB2 inhibitor, CC-42344 has shown excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as strains resistant to Tamiflu and Xofluza. CC-42344 also has favorable pharmacokinetic and drug-resistance profiles. We expect to report data on the Phase 1 clinical trial in 2022.

• Pandemic and Seasonal Influenza A/B program
  • In January 2019 we entered into an Exclusive License and Research Collaboration Agreement with Merck Sharp & Dohme Corp. to discover and develop certain proprietary influenza antiviral agents that are effective against both influenza A and B strains. This agreement includes milestone payments of up to $156 million plus royalties on sales of products discovered under the agreement.
  • In January 2021 we announced completion of all research obligations under the agreement. Merck is now solely responsible for further preclinical and clinical development of the influenza A/B antiviral compounds discovered under this agreement.
  • Merck continues development activities with the antiviral influenza A/B compounds discovered under this agreement.

Norovirus Program

• We are developing certain proprietary broad-spectrum antiviral compounds to treat norovirus infections.
• Norovirus is a global public health problem responsible for nearly 90% of epidemic, non-bacterial outbreaks of gastroenteritis around the world.

Hepatitis C Program

• We are seeking a partner to advance the development of CC-31244 following completion of a Phase 2a trial. This compound has shown favorable safety and preliminary efficacy in a triple-regimen Phase 2a study in combination with Epclusa (sofosbuvir/velpatasvir) for the ultra-short duration treatment of individuals infected with the hepatitis C virus (HCV).
• HCV is a viral infection of the liver that causes both acute and chronic infection. The 2017 World Health Organization Global Hepatitis Report estimates that 71 million people worldwide have chronic HCV infections.

2021 Financial Results
Throughout 2020 Cocrystal reported revenues under an influenza A/B collaboration with Merck consisting of research and development (R&D) services performed by Cocrystal and reimbursed by Merck. As discussed above, in January 2021 Merck assumed all activities and expenses associated with the continued development of the influenza A/B compounds discovered under this collaboration. As anticipated, Cocrystal reported no revenues for 2021 compared with $2.0 million in revenues for 2020. Under the terms of the Merck collaboration, Cocrystal is eligible to receive up to $156 million in payments related to designated developments, regulatory and sales milestones, as well as royalties on product sales.

R&D expenses for 2021 were $8.8 million compared with $6.0 million for 2020, with the increase primarily related to COVID-19 and influenza programs. The Company expects R&D expenses to increase during 2022 due to the advancement of our influenza A program into the clinic and progress with preclinical COVID-19 programs toward clinical development. General and administrative expenses for 2021 were $5.4 million compared with $5.6 million for 2020, with the decrease primarily due to reduced professional fees resulting from the conclusion of certain previously reported legal matters.

The net loss for 2021 was $14.2 million, or $0.16 per share, compared with a net loss for 2020 of $9.6 million, or $0.17 per share.

The Company reported unrestricted cash of $58.7 million as of December 31, 2021, compared with $33.0 million as of December 31, 2020. Net cash used in operating activities for 2021 was $12.7 million. During 2021 the company raised $38.5 million, net of transaction costs, which included net proceeds of approximately $2.1 million from the sale of common stock through an At-The-Market (ATM) facility in January 2021 and $36.4 million in net proceeds from a public offering of common stock May 2021. The Company reported working capital of $57.8 million as of December 31, 2021.

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

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our goals of initiating two Phase 1 studies for our COVID-19 programs in 2022, our expectations of reporting data from the Phase 1 clinical study of our Influenza A product candidate later in 2022, the viability and efficacy of potential treatments for coronavirus and other diseases, expectations for the global market for influenza therapeutics, our attempts to discover replication inhibitors, our development of antiviral treatments for norovirus, our expectations concerning R&D expenses, the expected sufficiency of our cash balance to fund our planned operations through 2023 and our 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 and/or the Ukraine war on our Company, our collaboration partners, and on the national and global economy, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including and adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current Clinical Research Organization (CRO) and any future CROs and Contract Manufacturing Organizations (CMOs), the ability of our current CRO to recruit volunteers for, and to proceed with, clinical trials, possible delays resulting from future lockdowns in Australia, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and any additional costs related to unfavorable future outcome of pending litigation or any unanticipated claims. 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, 2021. 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

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

 COCRYSTAL PHARMA, INC.

CONSOLIDATED BALANCE SHEETS
(in thousands)

		December 31, 2021				December 31, 2020
Assets
Current assets:
Cash		$	58,705			$	33,010
Restricted cash			50				50
Accounts receivable			–				556
Prepaid expenses and other current assets			568				399
Total current assets			59,323				34,015
Property and equipment, net			453				591
Deposits			46				46
Operating lease right-of-use assets, net (including $153 to related party)			478				498
Goodwill			19,092				19,092
Total assets		$	79,392			$	54,242
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses		$	1,297			$	1,080
Current maturities of finance lease liabilities			27				39
Current maturities of operating lease liabilities (including $53 to related party)			209				178
Derivative liabilities			12				61
Total current liabilities			1,545				1,358
Long-term liabilities:
Finance lease liabilities			7				34
Operating lease liabilities (including $101 to related party)			291				345
Total long-term liabilities			298				379
Total liabilities			1,843				1,737
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 150,000 and 100,000 shares authorized as of December 31, 2021 and December 31, 2020, respectively; 97,469 and 70,439 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively			98				71
Additional paid-in capital			336,544				297,342
Accumulated deficit			(259,093	)			(244,908	)
Total stockholders’ equity			77,549				52,505
Total liabilities and stockholders’ equity		$	79,392			$	54,242

COCRYSTAL PHARMA, INC.

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

		December 31,
		2021				2020
Revenues:
Collaboration revenue		$	–			$	2,014
Operating expenses:
Research and development			8,794				6,034
General and administrative			5,427				5,566
Total operating expenses			14,221				11,600
Loss from operations			(14,221	)			(9,586	)
Other (expense) income:
Interest expense, net			(4	)			(8	)
Change in fair value of derivative liabilities			49				(54	)
Foreign exchange loss			(9	)			–
Total other income (expense), net			36				(62	)
Net loss		$	(14,185	)		$	(9,648	)
Net loss per common share:
Loss per share, basic and diluted		$	(0.16	)		$	(0.17	)
Weighted average number of common shares outstanding, basic and diluted			88,368				55,217

# # #

Source: Cocrystal Pharma, Inc.

PsyBio Therapeutics to Participate in the 2022 Maxim Group Virtual Growth Conference on March 28-30, 2022

Research, News, and Market Data on PsyBio

 

OXFORD, Ohio and COCONUT CREEK, Fla., March 23, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an integrated and intellectual property driven biotechnology company focusing on discovering developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today announces that Evan Levine, Chief Executive Officer and Chairman, will participate in the 2022 Maxim Group Virtual Growth Conference on March 28-30, 2022.

PsyBio’s presentation will be available to view on demand beginning at 9:00 a.m. ET on Monday, March 28th. To attend, please register here. To listen to the presentation, please click here to access the webcast.

To schedule a meeting with the PsyBio management team, please contact KCSA Strategic Communications by emailing PsyBio@kcsa.com.

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders, and other human health conditions. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development activities are currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psycho-targeted compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSX Venture Exchange (“TSXV“) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

Cocrystal Pharma to Participate in the Maxim Group 2022 Virtual Growth Conference

Research, News, and Market Data on Cocrystal Pharma

 

BOTHELL, Wash., March 22, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that management will participate in the 2022 Virtual Growth Conference, presented by Maxim Group and hosted by M-Vest, being held March 28-30, 2022. Those interested in attending the virtual conference can register here.

A pre-recorded company presentation will be available on the M-Vest platform for 72 hours beginning March 28 at 9:00 a.m. Eastern time and can be accessed here. An archived webcast of the presentation will be available on the IR Calendar page of the company website.

Maxim Group LLC is a leading full-service investment bank, securities and wealth management firm headquartered in mid-town Manhattan and is a registered broker-dealer with the SEC and the Municipal Securities Rulemaking Board (MSRB) and is a member of FINRA and SIPC. M-Vest is a division of Maxim Group LLC that serves to allow investors to access investment opportunities online and to provide a digital community built for issuers, investors, and thought leaders to share information.

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.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

Source: Cocrystal Pharma, Inc.

Tonix Pharmaceuticals to Participate in the 2022 Virtual Growth Conference Presented by Maxim Group LLC and Hosted by M-Vest

Research, News, and Market Data on Tonix Pharmaceuticals

 

CHATHAM, N.J., March 22, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, President and Chief Executive Officer of Tonix Pharmaceuticals, has been invited to present at the 2022 Virtual Growth Conference, presented by Maxim Group LLC and hosted by M-Vest.

The conference will take place March 28-30, 2022, with pre-recorded presentations available on-demand through the conference portal at 2022 Virtual Growth Conference and available under the IR Events tab of the Tonix website at www.tonixpharma.com. This conference will be live on M-Vest. To attend, just sign up to become an M-Vest member here: Reserve Your Seat.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, central nervous system (CNS) and infectious disease product candidates. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL², (cyclobenzaprine HCl sublingual tablets), is a small molecule drug in mid-Phase 3 development for the management of fibromyalgia, with a new Phase 3 study expected to start in the first half of 2022. TNX-102 SL is also being developed to treat Long COVID, a chronic post-COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the first half of 2022. TNX-1300³ is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first half of 2022. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer. Tonix’s lead immunology candidate, TNX-1500¹, is a humanized monoclonal antibody targeting CD40 ligand being developed for the prevention of allograft rejection and the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to start in the second half of 2022. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Tonix’s lead vaccine program is TNX-801 (live horsepox virus for percutaneous administration) for preventing smallpox and monkeypox⁴. Horsepox is also the basis for Tonix’s recombinant pox vaccine (RPV) platform. Tonix’s lead vaccine candidates for COVID-19, TNX-1840 and TNX-1850⁵, are live virus vaccines in development based on the RPV platform. Finally, TNX-3500⁶ (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development.

¹TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.

²TNX-102 SL is an investigational new drug and has not been approved for any indication.

³TNX-1300 is an investigational new biologic and has not been approved for any indication.

⁴TNX-801 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.

⁵TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. TNX-1840 and TNX-1850 are designed to express the spike protein of SARS-CoV-2 from omicron and BA.2 variants, respectively, based on the experience from TNX-1800, which expresses the spike protein from the ancestral Wuhan strain.

⁶TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.