ProMIS Neurosciences to Present at the 10th Annual Neurodegenerative Drug Development Summit

News and Market Data on ProMIS Neurosciences

 

TORONTO, Ontario and CAMBRIDGE, MA , March 24, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of therapeutics targeting misfolded proteins such as toxic oligomers implicated in the development of neurodegenerative diseases, announced today that it will be presenting at the upcoming 10^th Annual Neurodegenerative Drug Development Summit, to be held in Boston, MA, March 28-30, 2022.

ProMIS Chief Scientific Officer, Dr. Neil Cashman, will deliver an oral presentation entitled: “Abeta oligomers in Alzheimer Disease: Target Engagement and Target Distraction”, on Tuesday, March 29, 2022, at 3 PM local time at the Boston Park Plaza Hotel.

Much scientific data has implicated misfolded oligomers as the toxic molecular species of amyloid beta (Abeta) relevant to Alzheimer’s disease. However, using conventional methods, it has proven difficult to selectively target oligomers while sparing other species – including monomers and fibrils – which “distract” a therapeutic antibody from its primary target. Immune recognition of Abeta fibrils can also lead to dose-limiting adverse effects. In his presentation, Dr. Cashman will discuss the use of Collective Coordinates^TM, a proprietary computational algorithm, to design conformational epitopes that specifically target oligomers, while sparing monomers and fibrils from immune recognition.

Dr. Cashman’s presentation will be available on the ProMIS website (www.promisneurosciences.com) at the conclusion of the meeting. For more information about the meeting please consult the organizer’s website here.

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

To learn more, visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: ProMIS Neurosciences Inc.

Neovasc Announces Consolidation and Extension of Convertible Debt

Research, News, and Market Data on Neovasc

 

VANCOUVER – ( NewMediaWire ) – March 24, 2022 – Neovasc Inc. (NASDAQ: NVCN) (TSX: NVCN) (“Neovasc” or the “Company”), a leader in the development of minimally invasive devices for the treatment of refractory angina, and in the development of minimally invasive transcatheter mitral valve replacement technologies, announced today that, pursuant to a Restated Securities Purchase Agreement with Strul Medical Group LLC (“SMG”), on a private placement basis (the “Private Placement”), it has issued an amended and restated convertible note (the “2022 Restated Note”).

The 2022 Restated Note was issued in an aggregate principal amount of $13,000,000 and consolidates the amount owed by the Company under certain convertible notes the Company issued to SMG in 2019 and 2020. The Company paid out in cash an additional amount of $290,961 that was owed under the 2019 and 2020 notes.

The 2022 Restated Note matures on December 31, 2025 (the “Maturity Date”) and bears interest at a rate of 9% per annum, compounded quarterly, a portion of which is payable in cash at the end of June and December annually and the rest due on the Maturity Date. The 2022 Restated Note is convertible into common shares of the Company (the “Common Shares”) at a price of $1.00 per Common Share for up to 15,674,184 Common Shares comprised of the principal amount and accrued and unpaid interest. The 2022 Restated Note is subject to a four month and one day hold period.

The transaction was conducted in accordance with Section 602.1 of the TSX Company Manual, which provides that the Toronto Stock Exchange will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as the Nasdaq Capital Market (the “Nasdaq”).

“We are very pleased to continue with our support of Neovasc as they advance their development strategies for both Reducer and Tiara,” said Aubrey Strul, a Principal of SMG. “We continue to have confidence in Fred and the Neovasc team to achieve critical milestones during the term of the Note.”

“This is an important development for our cash requirements in the coming years. It combines and extends the terms of our current notes with the SMG beyond our targeted date for the readout of our COSIRA II clinical study and an anticipated decision from the FDA on our application for approval to commercialize the Reducer in the United States,” stated Fred Colen, President and Chief Executive Officer of Neovasc. “We have reviewed opportunities, that might generally be available to us in the debt market, and given our company status and market conditions, we came to the conclusion that this debt restructuring agreement with the SMG is the best option available to Neovasc.”

This announcement is neither an offer to sell nor a solicitation of an offer to buy any securities and shall not constitute an offer, solicitation, or sale in any jurisdiction in which such offer, solicitation, or sale is unlawful. The securities have not been and will not be registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is under clinical investigation in the United States and has been commercially available in Europe since 2015, and Tiara^TMfor the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com .

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to SMG’s belief in the Company’s management to achieve critical milestones, the importance of the Private Placement on the Company’s cash requirements in the future, the targeted date timeline for the COSIRA-II study, the anticipated timeline of the FDA decision and the growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate in the circumstances. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, risks around the Company’s ability to continue as a going concern; risks around the Company’s history of losses and significant accumulated deficit; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2021 and 2020 but not at December 31, 2019; risks relating to the Common Share price being volatile; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to the influence of significant shareholders of the Company over our business operations and share price; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; risks relating to future issuances of equity securities by the Company, or sales of common shares or conversions of convertible notes, and exercise of warrants, options and restricted stock units by our existing security holders, causing the price of the Company’s securities to fall; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Report on Form 20-F and 40-F for the years ended December 31, 2021 and 2020 (copies of which may be obtained at www.sec.gov ). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators (copies of which may be obtained at www.sedar.com or www.sec.gov ), whether because of new information, future events or otherwise, except as required by law.

Investors:
Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com 

Media:
Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.Leous@westwicke.com 

Thursday, March 24, 2022

Avivagen Inc. (VIVXF)(VIV:CA)
A Debt for a Debt

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

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

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

The New Offering. Avivagen’s management announced yesterday the intention to complete a private placement financing of secured debentures. The gross proceeds of this financing will total up to CAD$6.5 million and will close on March 28, 2022. Bloom Burton Securities is acting as the agent in the offering.

Details on the Offering.  The debentures will have an annual interest rate of 9%, payable semi annually, and the purchasers will be paid a maintenance fee of 3%. Purchasers of the debentures will also receive common shares equal to 20% of the principal amount of the debentures divided by the market price of the shares on the TSX Venture Exchange on the last trading day prior to closing. These are …

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. 

 

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

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 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.

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

  Image: Agency for Healthcare Research and Quality (DHHS) 

Ongoing Federal Review on Cannabis and Pain Shows Some Relief

 

Does medical marijuana have the potential to help reduce opioid use in chronic pain patients? Late in 2020, a U.S. Government agency set out to answer two questions related to cannabis and pain. First, what if any benefits there are in using cannabinoids for chronic pain, and second, what are the harms of cannabinoids? This week they released results from this round of testing.

 

The Test

The Agency for Health and Research Quality (AHRQ) is one of many agencies under the Department of Health and Human Services. Their cannabis ‘living’ systematic review (continually updated) assesses the effectiveness and harms of cannabis and other plant-based treatments for chronic pain conditions. This first review used plant-based compounds (PBCs) similar to opioids with potential for addiction, misuse, and serious adverse effects and measured them against other PBCs such as cannabis derivatives. The findings are intended for policymakers, financiers, chronic pain researchers, and clinicians who treat pain.

The report for the living systemic review will be updated quarterly.

 

The Review

This was the AHRQ’s first study for the ongoing living systematic review on cannabis and other plant-based treatments for chronic pain. Researchers grouped cannabis-related products based on their tetrahydrocannabinol (THC) to cannabidiol (CBD) ratio using the categories: high-THC to CBD, comparable THC to CBD, and low-THC to CBD (including CBD only). Not included in this study, a new placebo-controlled randomized controlled trial (RCT) of oral CBD1 and an observational study of plant-based comparable THC to CBD versus synthetic CBD. This added to a total of 21 RCTs and 8 observational studies. In patients with chronic (mainly neuropathic) pain with short-term treatment (4 weeks to <6 months).

 

The Results (Small, Medium, Large)

The AHRQ review suggests comparable THC to CBD ratio oral spray is associated with small improvements in pain severity and overall function versus a placebo. There was no increase in the risk of serious adverse events or withdrawal due to any events. Potentially, there is a high increased risk of dizziness and sedation and a moderately increased risk of nausea.

Results measured after testing synthetic THC to CBD suggest moderate improvement in pain severity, no effect on overall function and increased risk of sedation, as well as a large increased risk of nausea versus a placebo. The synthetic THC is probably associated with the large increased risk of dizziness, according to the reported results.

The extracted whole-plant high THC to CBD ratio combination while offering some relief, may be associated with large increases in the risk of study withdrawal due to adverse events and dizziness versus placebo.

Whole plant and “patient’s choice” choice products low in THC to CBD produced insufficient findings to draw any conclusion.

Not reported in the report were other adverse outcomes such as psychosis, cannabis use disorder, cognitive deficits, and outcomes on the impact cannabinoid use has on the use of opioids.

 

Take-Away

One of the many potential medical uses of marijuana is pain relief. This has become particularly important as it’s desirable to have safer alternatives to opioid-based pain relievers. Taxpayer-funded research on pain relief is ongoing at the AHRQ. The agency will be reporting its findings quarterly. The most recent review, albeit a very small sample size, found various THC:CBD ratios provided different levels of relief and different risk levels.

 

Paul
Hoffman

Managing Editor, Channelchek

 

Suggested Reading

Opportunities in the Rapidly Growing Pain Management Sector

The NFL is Providing Funds for a Marijuana Study Related to Injured Athlete Use

The Future of Cannabis Crosses Many Industries

Federal Law Questions Still Loom for the Cannabis Industry

Sources

https://effectivehealthcare.ahrq.gov/products/plant-based-chronic-pain-treatment-annual-update/draft-comment

https://effectivehealthcare.ahrq.gov/products/plant-based-chronic-pain-treatment/living-review

https://effectivehealthcare.ahrq.gov/products/plant-based-chronic-pain-treatment/protocol

https://effectivehealthcare.ahrq.gov/products/form/plant-based-chronic-pain-treatment-annual-update

 

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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