Month: November 2020

Cocrystal Pharma Reports Third Quarter 2020 Financial Results and Provides Update on Antiviral Programs

BOTHELL, WA, Nov. 16, 2020 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the “Company”), a clinical stage biotechnology company discovering and developing novel antiviral therapeutics, today announced its financial results for the quarter ended September 30, 2020 and provided program updates.

Recent Highlights

• Announced promising in vitro and 7-day toxicity data for its influenza A preclinical lead molecule, CC-42344.
• Announced new in vitro data demonstrating antiviral activity with lead compound CC-42344 against major Xofluza (baloxavir)-resistant H1N1 strain (I38T).
• Presented at the virtual World Antiviral Conference held on November 12, 2020.
• Closed $17.2 million bought deal including partial exercise of underwriter’s overallotment option.
• Publication by collaborators of data demonstrating potent in vitro inhibition against Coronavirus in Science Translational Medicine Journal (August 3, 2020).

“We have made significant progress since initiating our COVID-19 program this year by strengthening our patent portfolio around these molecules, conducting a proof of concept animal study, initiating preclinical studies and identifying additional inhibitors using our proprietary platform. Over the course of the last quarter we continued to make progress on multiple fronts. We are pleased with the promising new data we recently announced for our wholly owned influenza A development program and continue to work towards finalizing the Phase 1 study protocol in preparation to initiate the Phase 1 study in 2021,” commented Dr. Gary Wilcox, Chairman and Chief Executive Officer of Cocrystal. “In addition to advancing our development programs, we closed the quarter with $31.8 million cash, which provides funding for the expansion of our COVID-19 and influenza A programs. Our team remains keenly focused on executing our milestones to drive shareholder value.”

Development Programs Overview

COVID-19 Coronavirus Programs:
We have two programs that are aggressively pursuing the development of novel antiviral compounds for the treatment of coronavirus infections.

Our first program is with compounds licensed from Kansas State University Research Foundation (“KSURF”) that have demonstrated in vitro anti-SARS-CoV-2 (responsible for the COVID-19 pandemic) activity, and in vivo efficacy in MERS-CoV-infected animal models. Cocrystal continued preclinical studies of these COVID-19 inhibitors during the third quarter. We anticipate the selection of a lead preclinical molecule by the end of 2020.

Our second program in Covid-19 has identified additional inhibitors using Cocrystal’s proprietary platform technology.

We are evaluating multiple routes of administration of COVID-19 antivirals.

Influenza A/B Inhibitors: Merck Collaboration
We have an exclusive license and collaboration agreement with Merck to discover and develop proprietary influenza A/B antiviral agents.

Cocrystal’s exclusive license and collaboration agreement with Merck Sharp & Dohme Corp. (“Merck”) to discover and develop proprietary influenza A/B antiviral agents is ongoing. Merck has funded the collaborative influenza A/B program and could potentially provide up to $156 million in milestone payments through clinical and commercial development, plus royalties following commercialization.

The collaboration operates under a Research Operating Plan which includes goals for both organizations. The Company has achieved its anticipated goals through the third quarter of 2020.

CC-42344: Influenza A Program:
Novel, broad spectrum influenza antivirals that are specifically designed to be effective against pandemic and seasonal influenza A strains of the influenza virus and to have a high barrier to resistance due to its novel mechanism of action.

The Company’s fully owned drug candidate CC-42344 is a potent, broad spectrum inhibitor of the influenza replication enzyme targeting the PB2 subunit, and has strong synergistic effects when combined with approved influenza antiviral drugs including Tamiflu (oseltamivir) and Xofluza (baloxavir). Cocrystal has data showing that CC-42344 retained single digit nanomolar potency (EC50 = 0.5 nM) against a Xofluza (baloxavir) resistant influenza A strain (H1N1, I38T). This data can potentially show CC-42344 drug superiority when seeking FDA approval.

The Company plans to complete the ongoing IND-enabling studies and enter into clinical trials in 2021.

CC-31244: Hepatitis C Program:
Potential best-in-class pan-genotypic inhibitor of NS5B polymerase for the ultra-short combination treatment of hepatitis C infection.

The Company is pursuing partnering opportunities for CC-31244. The final study report of Cocrystal’s U.S. Phase 2a clinical trial evaluating CC-31244 combination therapy for the ultrashort treatment of hepatitis C virus (“HCV”) infected individuals has been completed and filed with the FDA. The Company has published with its collaborators from the University of Maryland the results of the Phase 2a study (Journal of Medical Virology, November 5, 2020).

Norovirus Program:
Developing inhibitors targeting Norovirus RNA-dependent RNA polymerase and protease.

Cocrystal continues to identify and develop non-nucleoside polymerase and protease inhibitors using its proprietary structure-based drug design technology platform. Cocrystal recently entered into license agreements with KSURF to further develop proprietary broad-spectrum protease inhibitors to treat Norovirus and Coronavirus infections.

Summary of Financial Results for Q3 2020

As of September 30, 2020, Cocrystal had approximately $31,781,000 cash on hand.

Revenue recorded for the three and nine months ended September 30, 2020 was $489,000 and $1,504,000, respectively, compared with $492,000 and $6,162,000 for the three and nine months ended September 30, 2019, respectively. The revenue difference for the nine months ended September 30, 2019 is because that period included $4,368,000 in initial revenue of intellectual property rights conveyed at the signing of the Merck Collaboration Agreement executed on January 2, 2019.

Research and development expenses for the three and nine months ended September 30, 2020 were $2,077,000 and $5,336,000, respectively, compared with $1,077,000 and $3,046,000 for the three and nine months ended September 30, 2019, respectively. The increase for the three and nine months ended September 30, 2020 compared to the three and nine months ended September 30, 2019 was primarily due to initiating our COVID-19 program and advancing our Influenza A program in preparation for clinical trials in 2021.

General and administrative expenses for the three and nine months ended September 30, 2020 were $1,121,000 and $4,288,000, respectively, compared with $1,223,000 and $3,597,000 for the three and nine months ended September 30, 2019, respectively. The decrease for the three months ended September 30, 2020 compared to the three months ended September 30, 2019 was primarily due to decreased litigation costs during the 2020 three-month period. The increase for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019 was primarily due to higher litigation costs, insurance increases and employee compensation in the first half of 2020.

Net loss for the three and nine months ended September 30, 2020 was $2,670,000 and $8,155,000, respectively, compared with a net loss of $1,780,000 and $324,000 for the three and nine months ended September 30, 2019, respectively, as a result of revenue and expenses described above.

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, SARS-CoV-2 virus, hepatitis C viruses, and norovirus. Cocrystal employs unique, proprietary, 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 related to the expected progress of, and the anticipated timing of achieving the value-driving milestones in, our coronavirus program, including the selection of a preclinical lead molecule in Q4 2020; the expected progress of, and the anticipated timing of achieving the value-driving milestones in, our Influenza A program, including the completion of the ongoing IND-enabling studies and commencement of Phase 1 clinical study in 2021; our expectations with respect to CC-42344 drug superiority; and the expected results of our collaboration with Merck, including the potential future milestone payments of up to $156,000,000 and royalties in connection with the collaboration. The words “believe,” “proceeds,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from the impact of the COVID-19 pandemic on the national and global economy and on our Company, including supply chain disruptions, our continued ability to proceed with our programs, our reliance on certain third parties, our reliance on continuing with Merck under the license and collaboration agreement, the future results of preclinical and clinical studies, general risks arising from clinical trials, receipt of regulatory approvals, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2019, as updated and supplemented by the Quarterly Reports on Form 10-Q for the quarters ended September 30, 2020 and June 30, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Additional 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 and Media Contact:

JTC Team, LLC
(833) 475-8247
COCP@jtcir.com

Source: Cocrystal Pharma, Inc.

Lineage Cell Therapeutics Proudly Supports Patients’ Access To Innovative Cell Therapy Treatments And Research Through Passage Of Proposition 14

Voters Authorize California Institute for Regenerative Medicine to Fund $5.5 Billion in Grants for Stem Cell Research and Development

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 13, 2020– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, strongly endorses the recent passing of Proposition 14 in California. This bill will enhance patients’ access to groundbreaking stem cell therapy treatments by authorizing the California Institute for Regenerative Medicine (CIRM) the ability to fund up to $5.5 billion in grants to support therapeutic development, medical research, and facilities based on stem cell technologies. This initiative builds upon the success of Proposition 71, which issued approximately $3 billion for the funding of stem cell research and led to important medical advances, including functional cures in some patients receiving cell therapy treatments. The development of Lineage’s OPC1 oligodendrocyte progenitor cell therapy for the treatment of acute spinal cord injury (SCI), was one of the first clinical trials supported by CIRM and has showed durable and encouraging results in some patients.

“At Lineage, the patients and their families inspire us to advance cell therapy products and this recent approval of Proposition 14 ensures that access to cutting edge cell-based therapies can continue from companies like ours,” stated Brian M. Culley, Lineage CEO. “Cell therapy has the ability to make a profound impact on millions of lives and the passage of Proposition 14 reflects California’s serious commitment to supporting innovative local companies through the expensive and time-consuming process required to discover and test new cell-based therapies and will drive further innovation in stem cell development and research. Of note, our clinical study of OPC1 for the treatment of acute spinal cord injury was one of the first cell therapy clinical trials supported by CIRM under Prop 71. It was tremendously meaningful for some of our patients’ success stories to be featured in the Prop 14 campaign this year, along with others who have experienced life-changing benefits from stem cell therapy innovation in California. We are extremely thankful to CIRM for their partnership and valuable contributions, not only to Lineage, but also for other companies working in this exciting and rapidly growing field. We believe that all three of our clinical-stage programs could be considered for future grant funding under this new initiative.”

About OPC1

OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements to motor recovery in individuals with acute spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. SCI occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. and there currently are no FDA-approved drugs specifically for the treatment of SCI. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

About the OPC1 Clinical Study

The SCiStar Study of OPC1 is an open-label, 25-patient, single-arm trial testing three sequential escalating doses of OPC1 which was administered 21 to 42 days post-injury, at up to 20 million OPC1 cells in patients with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI). These individuals had experienced severe paralysis of the upper and lower limbs. The primary endpoint in the SCiStar study was safety as assessed by the frequency and severity of adverse events related to OPC1, the injection procedure, and immunosuppression with short-term, low-dose tacrolimus. Secondary outcome measures included neurological functions measured by upper extremity motor scores (UEMS) and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations through 365 days post-treatment. Enrollment is complete in this study; patients will continue to be evaluated on a long-term basis.

About Lineage Cell Therapeutics, Inc.

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

Forward-Looking Statements

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

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@troutgroup.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.