Xenetic Biosciences, Inc. Announces Positive Data from Partner’s Pivotal Phase 3 Clinical Trial Utilizing PolyXen(R) Platform Technology

 

• Xenetic leverages its proprietary drug delivery platform, PolyXen, through partnerships with biotechnology and pharmaceutical companies to improve the half-life and other pharmacological properties of next-generation biologic drugs
• Epolong, a polysialylated form of recombinant human erythropoietin that leverages PolyXen, has been shown to be effective and generally well tolerated in Pharmsynthez-conducted trial as a treatment for anemia in patients with chronic kidney disease

FRAMINGHAM, MA / ACCESSWIRE / December 9, 2020 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) (“Xenetic” or the “Company”), a biopharmaceutical company focused on advancing XCART™, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, today announced its partner, PJSC Pharmsynthez, has reported in a press release positive data from its pivotal Phase 3 clinical study leveraging PolyXen® to develop a treatment for anemia in patients with chronic kidney disease (CKD).

PolyXen is Xenetic’s patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties. The PolyXen technology platform was used by Pharmsynthez to develop Epolong (also known as ErepoXen™ or PSA-EPO), a polysialylated form of recombinant human erythropoietin, a hormone produced by the kidneys to promote blood cell production. Pharmsynthez reported in its press release that Epolong is under investigation with the goal of reducing the required dosing frequency and reducing potential side effects, as compared to existing EPO products.

As reported in the press release issued by Pharmsynthez, the pivotal Phase 3 multi-center randomized study was conducted in Russia by Pharmsynthez and was designed to study the efficacy, safety and tolerability of Epolong in comparison with Aranesp® (darbepoetin alfa), the current leader in the long-acting erythropoietin segment. The study enrolled approximately 150 patients with CKD across 36 medical institutions. The results of the study indicated that Epolong was non-inferior to Aranesp with respect to primary and secondary endpoints. Furthermore, the proportion of patients who achieved the target hemoglobin range (10.0-12.0 g/dL inclusive) during the evaluation period was 74% in the Epolong group versus 52% in the Aranesp group. Pharmsynthez also reported that the study revealed that the proportion of patients who exceeded the target threshold level of hemoglobin (12.0 g/dL) was 3.5 times greater in the Aranesp group than in the Epolong group (34.7% versus 10.0%, respectively).

“The PolyXen platform continues to demonstrate broad utility and ability to modulate the pharmacokinetic and pharmacodynamic profiles of protein drugs. We are pleased with the positive results Pharmsynthez has reported and we look forward to the outcome of their registration filing in Russia for Epolong, which they expect to submit in 2021,” commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

In clinical and preclinical settings, therapeutic proteins polysialylated with the PolyXen platform have been shown to have extended circulating half-life, improved thermodynamic stability and resistance to proteases, while retaining pharmacological activity. PolyXen has been demonstrated in human clinical trials to confer prolonged half-life on biotherapeutics such as recombinant human erythropoietin and recombinant Factor VIII (“rFVIII”). PolyXen has potential utility in other molecule classes such as peptides and small molecules. The Company is leveraging its PolyXen technology through an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement.

About Pharmsynthez

Pharmsynthez PJSC (MOEX: LIFE) is a Russian pharmaceutical company that develops new medicines, drug technologies for organ-specific delivery, and innovative methods of manufacturing pharmaceutical ingredients. The company is engaged in production and sale of both medicines for the treatment of respiratory diseases (original OM) and active pharmaceutical ingredients (API). The company has a research and production complex in Kapitolovo, commissioned in 2001. Pharmsynthez actively cooperates with North American, Canadian and European companies in the field of chemical compounds and API production.

About Xenetic Biosciences

Xenetic Biosciences, Inc. is a biopharmaceutical company focused on progressing XCART™, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens. The Company is initially advancing cell-based therapeutics targeting the unique B-cell receptor on the surface of an individual patient’s malignant tumor cells for the treatment of B-cell lymphomas. XCART™ has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications.

Additionally, Xenetic is leveraging PolyXen®, its proprietary drug delivery platform, by partnering with biotechnology and pharmaceutical companies. PolyXen® has demonstrated its ability to improve the half-life and other pharmacological properties of next-generation biologic drugs. The Company has an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement.

For more information, please visit the Company’s website at www.xeneticbio.com and connect on Twitter, LinkedIn, and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including, but not limited to, statements regarding: expectations regarding Epolong’s investigation and goal of reducing the required dosing frequency and reducing potential side effects compared to existing EPO products; our belief that the PolyXen platform continues to demonstrate broad utility and ability to modulate the pharmacokinetic and pharmacodynamic profiles of protein drugs; expectations regarding the outcome of Pharmsynthez’s registration filing in Russia for Epolong and timing of such registration filing, which is expected to be submitted in 2021; our plans to initially apply the XCART technology to advance cell-based therapeutics by targeting the unique B-cell receptor on the surface of an individual patient’s malignant tumor cells for the treatment of B-cell lymphomas; our expectations that XCART has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications; our plans to leverage PolyXen® by partnering with biotechnology and pharmaceutical companies; and our expectation regarding receipt of royalty payments under the exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance, achievements, or results to differ materially from such plans, estimates or expectations include, among others, (1) unexpected costs, charges or expenses resulting from the acquisition of XCART; (2) uncertainty of the expected financial performance of the Company following completion of the acquisition of XCART; (3) failure to realize the anticipated potential of the XCART or PolyXen technology; (4) the ability of the Company to implement its business strategy; (5) failure of the Pharmsynthez to timely register Epolong in Russia, or at all; and (6) other risk factors as detailed from time to time in the Company’s reports filed with the SEC, including its annual report on Form 10-K, periodic quarterly reports on Form 10-Q, periodic current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions, including potential adverse effects of public health issues, such as the COVID-19 outbreak on economic activity, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.

Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
xbio@jtcir.com

SOURCE: Xenetic Biosciences, Inc.

 

Ceapro Inc. Reports 2020 Third Quarter and Nine-Month Financial Results and Operational Highlights

 

EDMONTON, Alberta, Nov. 27, 2020 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced financial results and operational highlights for the third quarter and the first nine months ended September 30, 2020.

– R&D activities focused on advancing the development of innovative delivery systems and yeast beta glucan as a potential inhalable therapeutic for COVID-19 –
– Q3 2020 sales of $3,476,000 compared to $2,908,000 for Q3 2019, representing a 20% increase –
– Net profit of $192,000 for Q3 2020 vs. net loss of $104,000 for Q3 2019 –
– Cash generated from operations of $4,777,000 in 2020 vs. $1,321,000 in 2019 –
– Maintained production operations during COVID-19 pandemic and completed integration of manufacturing sites –

“Over the course of the third quarter, our operations executed and adapted well, delivering significantly improved year over year results even during the final phase of integration of the production operations and despite the COVID-19 pandemic situation. We successfully completed the full integration of manufacturing operations under one roof in Edmonton, resumed the clinical trial for beta glucan as a cholesterol reducer, as well as the development and optimization of new products developed through the use of our PGX disruptive technology. Additionally, we are extremely proud of our employees who worked tirelessly since the beginning of the year to maintain operations and deliver these solid results despite the COVID-19 pandemic. As we continue to move forward, our focus remains on the health and safety of our associates, followed by business continuity,” stated Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro.

Corporate and Operational Highlights

Pipeline Development:

• Announced publication of positive results from study evaluating avenanthramides in exercise-induced inflammation in the international, peer-reviewed Journal of the International Society of Sports Nutrition.
• Achieved the first milestones in successful development of PGX-processed yeast beta glucan product as a potential inhalable therapeutic for COVID-19 and other fibrotic endpoint diseases of the lung.
• Confirmed capability of PGX Technology to optimize and standardize the size and morphology of yeast beta-glucan (PGX-YBG) suitable for lung inhalation.
• Conducted in-vitro study with human cell lines demonstrating that PGX-YBG obtained from different sources exhibited significant stimulatory effect on human immune response through activation of beta glucan specific Dectin 1 receptors.
• Ongoing PGX-YBG project with McMaster University conducted in parallel for naïve and preclinical animal models. To-date, no safety issues have been encountered. The preclinical phase has been extended to identify the maximum tolerated dose. Progress update on this exciting project to be issued in the near future.
• Conducting additional in vitro PGX-YBG dose response study to correlate with upcoming McMaster animal study results.
• Resumed enrollment of patients for the clinical trial with beta glucan as a cholesterol reducing natural pharmaceutical product. 191 patients have been screened and 65 randomized during the last three months.
• Pursued the development of new PGX-dried chemical complexes for potential applications under various forms like pills, capsules, fast dissolving strips and face masks. Yeast beta glucan to become a key product of Ceapro’s portfolio.

Technology:

• Made significant technical upgrades of PGX demo plant to allow production of yeast beta glucan for a potential human clinical trial with COVID-19.
• Acquired pieces of equipment suitable for the assembling of a commercial scale PGX unit. Timelines to initiate building of the customized large scale unit to be defined due to COVID-19 travel restrictions and resulting availability of expert personnel.
• Initiated installment of a commercial scale unit for impregnation of bioactives with PGX-processed biopolymers.
• Pursued research collaboration projects with University of Alberta and McMaster University for the impregnation of various bioactives using PGX-processed biopolymers as potential delivery systems for multiple applications in healthcare.

Production Operations:

• Completed the decommissioning of Leduc manufacturing site and the moving of all production operations to the Edmonton based facility.

Corporate:

• Fully repaid loan with Alberta Financial Service Corporation.
• Advanced conversations with interested potential partners to utilize Ceapro’s innovative technologies.
• Pursued out-licensing discussions for PGX-processed new chemical complexes.

Subsequent to Quarter:

• Announced expansion of a grant from National Research Council of Canada for the optimization and mass production of yeast beta glucan as a potential inhalable therapeutic for COVID-19 and other fibrotic end-point disease of the lung.

Financial Highlights for the Third Quarter and Nine-Month Period Ended September 30, 2020

• Total sales of $3,476,000 for the third quarter of 2020 and $12,415,000 for the first nine months of 2020 compared to $2,908,000 and $9,159,000 for the comparative periods in 2019. The 36% increase in sales for the first nine months is mainly due to a significant increase in sales of avenanthramides in the USA compared to the same period in 2019.
• Net profit of $192,000 for the third quarter of 2020 and $2,395,000 for the first nine months of 2020 compared to a net loss of $104,000 and $1,299,000 for the comparative periods in 2019. An improvement of $3,694,000 for the nine-month period.
• Excluding non-cash items, mainly amortization, adjusted net profit for the first nine months in 2020 is $ 4,035,000 versus adjusted net profit of $414,000 for the first nine months of 2019.
• Cash flows generated from operations of $4,777,000 in 2020 vs $1,321,000 in 2019.
• Positive working capital balance of $8,151,000 as of September 30, 2020.

“Looking ahead, while taking into account the ongoing potential economic impact related to COVID-19 and evolving consumption trends, we believe Ceapro is well-positioned to once again deliver a double-digit growth in sales well in line with the positive trend achieved over the last years. With a strong balance sheet, a group of dedicated people, and a solid base business, coupled with the innovative technologies and products that we have developed to enable us to expand, Ceapro is poised to emerge as a successful life science company,” concluded Mr. Gagnon.

The complete financial statements are available for review on SEDAR at https://sedar.com/Ceapro and on the Company’s website at www.ceapro.com.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions.

For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: czo@jtcir.com

This press release does not express or imply that the Company claims its product has the ability to eliminate, cure or contain the SARS-2-CoV-2 (COVID-19) at this time.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Source: Ceapro Inc.

Noble Capital Markets, Inc. Announces Type-1 Diabetes Day- The Beginning of the End; Close to a Cure?

 

A Panel of World Experts Breaks it all Down in a Virtual Presentation

 

Boca Raton, Fla., Nov. 23, 2020 (VIA NEWSWIRE)  — Noble Capital Markets, Inc. (“Noble”) announced today that it will host Type-1 Diabetes Day where Dr. Camillo Ricordi and a world-class panel of T1D experts will discuss progress toward a functional cure. The virtual event “Type-1 Diabetes – The Beginning of the End; Close to a Cure?” is investor focused but will have broad appeal among all interested in the progress toward a functional cure for T1D. It is to be held November 24, 2020, at 12:30 online to all who register here.

Dr. Camillo Ricordi revolutionized a method of transplantation of islet cells (cells that produce insulin) 32 years ago. His method remains the gold standard today. The promise of overcoming one of the most challenging problems with any transplantation occurred when an anti-rejection antibody being explored for ALS was coupled with the transplantation. New islet cells had previously been rejected by the host. The anti-rejection antibody was key to this procedure jumping several steps closer to success.

The Panel will be moderated by Noble’s Nathan Cali, Managing Director, Head of Healthcare Investment and Merchant Banking, with a primary focus on the Novus Therapeutics, Inc. (NASDAQ:NVUS) – CD40/CD40L – FDA Phase II toxicity and efficacy trials and ongoing progress toward a functional cure with islet cell transplantation. The world-renowned panelists include:

• Dr. Camillo Ricordi, Director of the Diabetes Research Institute at the University of Miami School of Medicine – Ranked as the World Leader in Islet Cell Transplant.
• Dr. James Markmann, Chief of the Division of Transplant Surgery and Director of Clinical Operations at the Transplant Center at Massachusetts General Hospital, and the Claude Welch Professor of Surgery at Harvard Medical School.
• Dr. Norma Sue Kenyon, Martin Kleiman Professor of Surgery, Microbiology and Immunology and Biomedical Engineering at the Diabetes research Institute.
• Dr. David Gros, Chief Executive Officer Novus Therapeutics; Dr. Steven Perrin, President & CSO, Novus Therapeutics.
• Eric Paslay, two-time Grammy award nominee country recording artist, & owner of The Country Note, a podcast featuring patients who battle diabetes.

November is Diabetes Awareness Month; this expert panel presentation will elevate awareness for investors and others interested in promising progress toward a functional cure for T1D.  The presentation is expected to last two hours and will be held at 12:30 PM (register to attend) on November 24, 2020. Attendance is open and at no cost to all who register for T1D-Day. As conference time is limited, Noble requests that only investment focused attendees participate by asking questions of the panelists. 

Who should attend Type-1 Diabetes Day?

Investors, including institutions, family offices, investment advisors, hedge funds, equity analysts, private equity & venture capital firms, independent brokers, wealth managers, and self-directed investors, will benefit from attending.

The subject is of interest to those within the investment community, medical practitioners and  others interested in the future of T1D. “Noble is proud of its part in the progression toward a cure,” said Nico Pronk, CEO/President of Noble, he added, “Although we had hoped to have an in-person conference featuring this panel, we’re taking advantage of the online platform and making sure many more who are interested in this subject can attend without the need to travel farther than their desktop.”

About Noble Capital Markets, Inc.

Noble Capital Markets  is a research-driven boutique investment bank that has supported small & micro-cap companies since 1984. As a FINRA and SEC licensed, broker-dealer Noble provides institutional-quality equity research, merchant and investment banking, wealth management, and order execution services. Noble launched channelchek.vercel.app – an investment community dedicated exclusively to small and micro-cap companies and their industries in 2018. Channelchek is tailored to meet the needs of self-directed investors and financial professionals. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 6,000 public emerging growth companies are listed on the site, with growing content including research, webcasts, podcasts, and balanced news.

Registration: 

 https://register.gotowebinar.com/register/3215566146913039884

 

Contact:

Email: info@noblecapitalmarkets.com

 

General Information:

www.noblecapitalmarkets.com

channelchek.vercel.app

 

FORCE Webinar: Lineage Cell Therapeutics

 

Lineage CEO, Brian Culley and CFO, Brandi Roberts, talk about how their OPC1 Cell Therapy improves mobility after a severe spinal cord injury.

 

 

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

 

– Continued progress of COVID-19 development programs with additional preclinical studies of coronavirus protease inhibitors (3CL) underway and lead preclinical molecule selection expected by year end –

– Ongoing Merck collaboration to discover and develop influenza A/B antiviral agents –

– Continued advancement of wholly owned Influenza A development program and IND enabling studies towards Phase 1 clinical study in 2021–

– Successful completion of strategic financing fuels expansion of COVID-19 and Influenza A development 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 Presents New Opregen® Data For Dry Amd With Ga At 2020 American Academy Of Ophthalmology Annual Meeting

 

• Improved Visual Acuity Continues to be Observed in Cohort 4 Patients
• First Known Clinical Report of Retinal Tissue Regeneration Persisted to 23 Months with Further Improvement in Visual Acuity
• Patient Enrollment Recently Completed
• Therapeutic Expert Call with Principal Investigator Christopher D. Riemann, M.D. Scheduled for November 17, 2020 at 4:00 pm Eastern Time

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 16, 2020– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing three novel cell therapies for serious medical conditions, today announced positive interim results from the ongoing 24-patient Phase 1/2a clinical study of Lineage’s lead product candidate, OpRegen®. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). At AAO, new data were presented on 20 patients, including 8 patients treated in Cohort 4, which feature better baseline vision and smaller areas of GA. All 8 of these patients were treated with a new “thaw-and-inject” formulation of OpRegen and 4 were treated using the Gyroscope Orbit Subretinal Delivery System (Gyroscope SDS). Data presented at AAO showed improvements in visual acuity in Cohort 4 patients, with treated versus fellow eye comparisons reaching statistical significance at 9 and 12 months following OpRegen administration. These improvements were maintained for up to 24 months in some patients. A trend towards slower GA growth was observed in the first 6 Cohort 4 patients, a trend maintained for as long as 24 months in patients with 24-month data available. Previously reported structural improvements in the retina and decreases in drusen density have continued with evidence of durable engraftment of OpRegen cells in treated patients, some more than 4 years following administration, with no immunosuppression utilized beyond the perioperative period. Overall, OpRegen appears to be well-tolerated in all patients treated to date. The final four patients in the study were treated during November and will provide additional visual acuity data in the coming months.

“These new data increasingly suggest to us that treatment with OpRegen can provide clinically meaningful outcomes in dry AMD patients with GA, particularly for those with earlier-stage disease,” stated Brian M. Culley, Lineage CEO. “According to a recent survey published in Investigative Ophthalmology & Visual Science, only 27% percent of retinal specialists believed patients with visual acuity of 20/200 or worse could benefit from treatment with an agent which slows the growth of GA, while 93-99% of them believed patients with visual acuity of 20/200 or better could benefit from this approach. This is consistent with our belief that recent data from our Cohort 4 patients, which have less advanced disease and better baseline vision, are more exciting and provide a better surrogate for the potential clinical and commercial opportunity for OpRegen.”

Mr. Culley added, “In addition to reporting the first known finding of anatomical restoration of retinal tissue, which has persisted below baseline for 23 months and counting, treatment with OpRegen continues to demonstrate other benefits in some patients, including increases in visual acuity, reductions in the growth rate of GA and increases in reading speed. These are additive to the improvements we previously reported in retinal architecture and drusen reduction. Further, the multi-year durability of transplants without rejection is notable for our allogeneic cell therapy approach, especially as patients did not require long-term immunosuppression. With enrollment recently completed, our focus turns next toward collecting safety and efficacy data on the most recently treated patients, advancing partnership and investor discussions we’ve been having, exploring our options for later-stage clinical development, and speaking with the FDA about next steps. Our objective is to position the OpRegen program as a front-runner in the race to address an unmet need in what is widely expected to be a multi-billion-dollar dry AMD therapeutic market and to drive Lineage forward as the pre-eminent allogeneic cell therapy company.”

OpRegen Data Update & Highlights from the AAO Presentation (data presented on 20 patients, dosed through October 5, 2020):

• Continued progressive functional improvement.
• In Cohort 4, 6 out of 7 (86%) of patients’ treated eyes measured above their baseline vision (Best Corrected Visual Acuity, or BCVA) at 12 months, a clinically relevant timeframe, or as of the longest available timepoint less than 12 months (data collection continues for more recently-treated patients).
• Data to date demonstrate a localized slowing of GA progression in the treated areas with a trend towards slower GA growth in treated versus fellow eyes in pooled analyses.

• Long-term engraftment is supported with imaging observations up to more than 4 years, even with a short immunosuppression regimen.
• In all Cohort 4 patients receiving OpRegen TAI formulation, per protocol, immunosuppressants have been discontinued as scheduled, typically within 90 days post-operatively, and no cases of acute or delayed rejection or inflammation have been reported.
• One Cohort 4 patient was treated only with mycophenolate mofetil and received no tacrolimus for immunosuppression.

• Anatomical restoration of retinal tissue.
• A Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, which was first reported at 9 months, continues at month 23 to have an area of GA smaller than at baseline.
• This patient also experienced additional improvement in BCVA from 9 to 23 months post-treatment, while the untreated eye has experienced further reduction in visual acuity.
• Long-term monitoring on this patient is expected to continue.

• Treatment overview.
• As of October 5, 2020, 16 patients were treated via pars planar vitrectomy (PPV), while 4 were treated with the Gyroscope SDS.
• As of November 10, 2020, 17 patients were treated via PPV, while 7 were treated with the Gyroscope SDS.
• Enrollment in the phase 1/2a study is complete; follow-up continues for safety and efficacy.

• Safety and tolerability.
• The primary objective of the study is to evaluate the safety and tolerability of OpRegen at 12 months, and in patients which have reached this time point OpRegen appears well tolerated.
• There have been no unexpected adverse events (AEs) or treatment-related systemic serious AEs reported in enrolled patients.
• The most common and expected ocular AEs were the formation or exacerbation of mild to moderate epiretinal membranes (ERMs) and a single report of a retinal detachment, with cause unknown (all occurring in patients receiving OpRegen via the PPV route of administration).
• The Gyroscope SDS is an alternative to the PPV route and is designed to avoid ERM formation.
• Through October 2020, 16 patients were treated via PPV while 4 were treated with the Gyroscope SDS. ERMs were observed in 13 PPV patients.
• One patient treated with the Gyroscope SDS developed a mild choroidal neovascularization (CNV) at the site of needle penetration 6 months post-treatment which was successfully treated with a single dose of an approved anti-VEGF agent. The cause was unknown.
• One patient treated via PPV developed a mild CNV at > 24 months post-treatment.
• Other changes observed following OpRegen treatment persisted through the last time point examined (> 4 years in some patients), including subretinal pigmentation and hyper-reflective areas seen on optical coherence tomography (OCT).

The results were presented at the 2020 American Academy of Ophthalmology Annual Meeting (AAO 2020). The presentation, “Phase 1/2a Study of Subretinally Transplanted hESC-Derived RPE Cells in Advanced Dry-Form AMD Patients” was featured as part of the Original Paper Session, OP02V Retina, Vitreous Original Papers on November 15, 2020 and was presented by Christopher Riemann, M.D.

KOL Call and Webcast

Lineage will host a therapeutic area expert call with Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute and University of Cincinnati School of Medicine, to discuss the interim results on November 17, 2020 at 4:00 pm Eastern Time / 1:00 p.m. Pacific Time. Interested parties can access the event on the Events and Presentations section of Lineage’s website.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (vision from 20/65 to 20/250 with smaller areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. In total, 17 patients were treated via PPV, while 7 were treated with the Gyroscope SDS. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additionally, for the patients in Cohort 4 that receive subretinal delivery of OpRegen utilizing the Gyroscope SDS, objectives will include the evaluation of the safety of delivery of OpRegen using the Gyroscope SDS.

OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics, Inc.

About Dry AMD

Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with dry AMD.

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.