Tag: Biotechnology

Release – Lineage Cell Therapeutics Reports Third Quarter 2022 Financial Results And Provides Business Update

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on LCTX

November 10, 2022 at 4:05 PM EST

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  • Appointed Jill Howe as Chief Financial Officer
  • Established New R&D Facility and Expanded Existing cGMP Manufacturing Facility
  • Received Notice of Allowance for Patent Applications Covering Directed Differentiation Methods for Retinal Pigmented Epithelium and Oligodendrocyte Progenitor Cells
  • Cash, Cash Equivalents, and Marketable Securities of $66.4 Million as of September 30, 2022 Expected to Provide Capital Into Q3 2024

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 10, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the third quarter of 2022. Lineage management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2022 financial and operating results and to provide a business update.

“A single administration of RG6501 (OpRegen®), a proprietary retinal pigment epithelial cell transplant, across an area of atrophy in advanced AMD patients has shown the potential to slow, stop, or reverse the progression of GA in our phase 1/2a clinical trial. To our knowledge, this is the first intervention that has reported anatomical changes of this magnitude in the field of GA, so we are pleased with the continued progress on RG6501 and the efforts which have been made to initiate its next clinical trial,” stated Brian M. Culley, Lineage CEO. “Looking ahead, our focus turns increasingly to planned regulatory interactions for OPC1 and VAC2, from which we expect to inform and enable their next phases of clinical development in spinal cord injury and oncology, respectively. In parallel, we are advancing our newly launched cell transplant programs in photoreceptors for vision disorders and auditory neurons for hearing loss, with initial preclinical studies from our photoreceptor program currently ongoing and the start of preclinical testing of our auditory neuron program anticipated prior to year-end. We believe that completing these efforts while maintaining our commitment to disciplined spending will help Lineage create shareholder value in the coming year.”

Recent milestones and activities included:

– Announced appointment of Jill Howe as Chief Financial Officer effective November 14, 2022

  • Ms. Howe brings more than 20 years of significant strategic, financial, and operational experience to Lineage, with an emphasis on capital strategy, corporate finance, treasury management, global infrastructure, and operational excellence. Ms. Howe has successfully built biotechnology organizations and implemented operational infrastructures alongside the execution of over $1.66 billion of capital raising transactions and will bring extensive strategic experience to the role.

– Established new U.S. R&D facility and expanded current GMP manufacturing facility in Israel

  • New Carlsbad facility will allow us to broaden R&D capabilities in the U.S. and facilitate the advancement of current and future allogeneic cell transplant programs and partnerships; the expansion of the Israel-based facility is expected to increase infrastructure, including development and optimization of larger-scale clinical manufacturing processes, and continued execution under the ongoing collaboration with Roche and Genentech for RG6501 (OpRegen).

– Strengthened intellectual property portfolio

  • Company announced notice of allowance of two patents covering processes for manufacturing allogeneic oligodendrocyte progenitor and retinal pigmented epithelium cells.

– OPC1

  • Completed verification and validation and preclinical testing activities for the novel parenchymal spinal delivery (PSD) system to support an upcoming regulatory submission.

– VAC2

  • Pre-Investigational New Drug (IND) application briefing package submitted to the U.S. Food and Drug Administration (FDA) to support U.S. clinical development for immuno-oncology.

– ANP1 & PNC1

  • Continued process development and activities in support of ongoing and planned preclinical testing.

Some of the key upcoming milestones and activities anticipated by Lineage include:

– Planned Regenerative Medicine Advanced Therapy (RMAT) submission to FDA before year-end regarding an OPC1 IND amendment to enable clinical testing of a novel spinal cord delivery system.

– Response to a pre-IND regulatory submission which should provide clarity on a VAC2 CMC, nonclinical, and clinical information package to inform future U.S. clinical development, expected around year-end.

– Completion of an R&D manufacturing process sufficient to support initiation of preclinical testing and the initiation of such testing with ANP1 for the treatment of hearing loss, anticipated prior to year-end.

– An additional OPC1 manuscript from a Phase 1/2a clinical study in subacute cervical spinal cord injury.

– Submission of a grant application to California Institute for Regenerative Medicine (CIRM) for the continued support of the clinical development of OPC1.

– Clinical data update from the ongoing VAC2 Phase 1 non-small cell lung cancer (NSCLC) study, pending release from Cancer Research UK (CRUK).

– Evaluation of new partnership opportunities and/or expansion of existing collaborations.

– Continued participation in investor and partnering meetings and medical and industry conferences to broaden awareness of our mission, programs, and accomplishments.

Balance Sheet Highlights

Cash, cash equivalents, and marketable securities totaled $66.4 million as of September 30, 2022, which is expected to support planned operations into Q3 2024.

Third Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from licensing fees, royalties, collaboration revenues, and research grants. Total revenues for the three months ended September 30, 2022 were approximately $3.0 million, a net increase of $0.7 million as compared to $2.3 million for the same period in 2021. The increase was driven by collaboration and licensing revenue recognized from deferred revenues from the Roche Agreement, partially offset by less royalty revenues.

Operating Expenses: Operating expenses are comprised of research and development (“R&D”) expenses and general and administrative (“G&A”) expenses. Total operating expenses for the three months ended September 30, 2022 were $8.0 million, a decrease of $0.1 million as compared to $8.1 million for the same period in 2021.

R&D Expenses: R&D expenses for the three months ended September 30, 2022 were $3.6 million, a net increase of $0.8 million as compared to $2.8 million for the same period in 2021. The net increase was primarily driven by higher OpRegen related expenses to support the Roche collaboration.

G&A Expenses: G&A expenses for the three months ended September 30, 2022 were $4.4 million, a net decrease of approximately $0.9 million as compared to $5.3 million for the same period in 2021. The decrease was primarily driven by $1.1 million in lower litigation and legal expenses and $0.3 million in lower investor relations expense, partially offset by a $0.5 million increase in payroll and related benefits expense.

Loss from Operations: Loss from operations for the three months ended September 30, 2022 was $5.2 million, a decrease of $1.6 million as compared to $6.8 million for the same period in 2021.

Other Expenses, Net: Other expenses, net for the three months ended September 30, 2022 reflected other expense, net of $0.3 million, compared to other expense, net of $2.0 million for the same period in 2021. The net change was primarily driven by a decrease in the value of marketable equity securities and exchange rate fluctuations related to Lineage’s international subsidiaries.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended September 30, 2022 was $6.1 million, or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $7.8 million, or $0.05 per share (basic and diluted), for the same period in 2021.

Conference Call and Webcast

Interested parties may access today’s conference call by dialing (800) 715-9871 from the U.S. and Canada and should request the “Lineage Cell Therapeutics Call” or provide conference ID number 5262180. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through November 17, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 5262180.

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 and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. 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,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “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: our ability to support our planned operations into the third quarter of 2024 with our existing cash, cash equivalents and marketable securities; Ms. Howe’s employment with Lineage and the anticipated or implied benefits thereof to Lineage and Lineage’s continued growth and ability to exhibit greater productivity in the future; plans and expectations regarding our products in development and our ability to advance our product candidates into their next phases of clinical or preclinical testing; our ability to create shareholder value in the future; the potential benefits to us and our operations of our new and expanded facilities, including the broadening of our R&D capabilities, advancing our programs and partnerships, and increasing our infrastructure; our ability to support multiple years of progress and achieve important milestones; our collaboration and license agreement with Roche and Genentech and the potential to receive milestone and other consideration thereunder; the potential benefits of treatment with OpRegen; the potential future achievements of our clinical and preclinical programs; the timing of anticipated FDA interactions, preclinical activities, clinical trials, and clinical data updates related to our programs, and the submission of a grant application to the CIRM; plans and expectations regarding publications relating to our programs; plans and expectations regarding potential new partnership opportunities and existing collaborations; and our ability to broaden awareness of our mission and accomplishments. 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, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to use our cash more quickly than expected; that potential benefits of the new and expanded facilities to the Company and its operations may not be realized as quickly as expected or at all; that potential benefits of newly developed intellectual property to the Company may not be realized as quickly as expected or at all; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that we may not establish new partnerships or expand existing collaborations; that we do not successfully broaden awareness of our mission or accomplishments; that we may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (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 most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221110005260/en/

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

LifeSci Advisors
Daniel Ferry
(daniel@lifesciadvisors.com)
(617) 430-7576

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.

Telomeres and New Findings on Cancer Mortality

Posted on by phoffman@channelchek.com
Image Credit: Steve Jurvetson (Flickr)

How Cancer Cells can Become Immortal – New Research Finds a Mutated Gene that Helps Melanoma Defeat the Normal Limits on Repeated Replication

A defining characteristic of cancer cells is their immortality. Usually, normal cells are limited in the number of times they can divide before they stop growing. Cancer cells, however, can overcome this limitation to form tumors and bypass “mortality” by continuing to replicate.

Telomeres play an essential role in determining how many times a cell can divide. These repetitive sequences of DNA are located at the ends of chromosomes, structures that contain genetic information. In normal cells, continued rounds of replication shorten telomeres until they become so short that they eventually trigger the cell to stop replicating. In contrast, tumor cells can maintain the lengths of their telomeres by activating an enzyme called telomerase that rebuilds telomeres during each replication.

Telomeres are protective caps at the ends of chromosomes

Telomerase is encoded by a gene called TERT, one of the most frequently mutated genes in cancer. TERT mutations cause cells to make a little too much telomerase and are thought to help cancer cells keep their telomeres long even though they replicate at high rates. Melanoma, an aggressive form of skin cancer, is highly dependent on telomerase to grow, and three-quarters of all melanomas acquire mutations in telomerase. These same TERT mutations also occur across other cancer types.

Unexpectedly, researchers found that TERT mutations could only partially explain the longevity of telomeres in melanoma. While TERT mutations did indeed extend the life span of cells, they did not make them immortal. That meant there must be something else that helps telomerase allow cells to grow uncontrollably. But what that “second hit” might be has been unclear.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Pattra Chun-On Ph.D. Candidate in Environmental and Occupational Health, University of Pittsburgh Health Sciences and Jonathan Alder Assistant Professor of Medicine, University of Pittsburgh Health Sciences.

We are researchers who study the role telomeres play in human health and diseases like cancer in the Alder Lab at the University of Pittsburgh. While investigating the ways that tumors maintain their telomeres, we and our colleagues found another piece to the puzzle: another telomere-associated gene in melanoma.

Cell Immortality Gets a Boost

Our team focused on melanoma because this type of cancer is linked to people with long telomeres. We examined DNA sequencing data from hundreds of melanomas, looking for mutations in genes related to telomere length.

We identified a cluster of mutations in a gene called TPP1. This gene codes for one of the six proteins that form a molecular complex called shelterin that coats and protects telomeres. Even more interesting is the fact that TPP1 is known to activate telomerase. Identifying the TPP1 gene’s connection to cancer telomeres was, in a way, obvious. After all, it was more than a decade ago that researchers showed that TPP1 would increase telomerase activity.

We tested whether having an excess of TPP1 could make cells immortal. When we introduced just TPP1 proteins into cells, there was no change in cell mortality or telomere length. But when we introduced TERT and TPP1 proteins at the same time, we found that they worked synergistically to cause significant telomere lengthening.

To confirm our hypothesis, we then inserted TPP1 mutations into melanoma cells using CRISPR-Cas9 genome editing. We saw an increase in the amount of TPP1 protein the cells made, and a subsequent increase in telomerase activity. Finally, we returned to the DNA sequencing data and found that 5% of all melanomas have a mutation in both TERT and TPP1. While this is still a significant proportion of melanomas, there are likely other factors that contribute to telomere maintenance in this cancer.

Our findings imply that TPP1 is likely one of the missing puzzle pieces that boost telomerase’s capacity to maintain telomeres and support tumor growth and immortality.

Making Cancer Mortal

Knowing that cancer use these genes in their replication and growth means that researchers could also block them and potentially stop telomeres from lengthening and make cancer cells mortal. This discovery not only gives scientists another potential avenue for cancer treatment but also draws attention to an underappreciated class of mutations outside the traditional boundaries of genes that can play a role in cancer diagnostics.

Baudax Bio (BXRX) – Feeling the Pain; Focus on NMBs

Posted on by cpereira@noblefcm.com


Thursday, November 10, 2022

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Baudax reported 3Q 2022 results. 3Q revenues reported of $0.238 million were well below our expectation of $0.965 million.  While vials sold increased year-over-year approximately 16%, much of the 3Q volume was discounted into 340B hospitals causing revenues to decline 15% from the prior year.

Feeling the pain. In the Covid environment that doesn’t seem to go away, hospitals face financial pressures as they struggle to curtail costs. For a single product company like Baudax Bio, the hospital issues have inflicted continued pain that is difficult to overcome. Hospitals look for less expensive alternatives in pain management. Recognizing that Covid-related issues facing hospitals now could continue into and through 2023, the Company eliminated the remaining commercial team in September 2022.


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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. 

Release – MustGrow Receives Final Approval to List on the TSX Venture Exchange

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on MGROF

SASKATOON, Saskatchewan, Canada, November 9, 2022 – MustGrow Biologics Corp. (CSE: MGRO; OTCQB: MGROF; FRA: 0C0) (the “Company” or “MustGrow”), is pleased to announce that the TSX Venture Exchange (“TSXV“) has approved the Company’s application to list its common shares (the “Shares“) on the TSXV. The Shares will commence trading on the TSXV under the ticker symbol “MGRO” at the opening of the Market on November 11, 2022. Shareholders will not be required to take any action in connection with MustGrow’s listing on the TSXV. The Shares will also continue to be listed on the OTCQB Marketplace in the United States under the symbol “MGROF” and on the Frankfurt Stock Exchange under the symbol “0C0”.

In connection with the listing of the Shares on the TSXV, the Company has submitted a request to voluntarily delist the Shares from the Canadian Securities Exchange (“CSE“). The last day of trading of the Company’s shares on the CSE will be November 10, 2022.

For further details, please refer to the Listing Application on the Company’s SEDAR profile available at www.sedar.com.

———

About MustGrow

MustGrow is an agriculture biotech company developing organic biopesticides and bioherbicides by harnessing the natural defense mechanism of the mustard plant to protect the global food supply from diseases, insect pests, and weeds. MustGrow and its leading global partners –  Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg – are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection. Pending regulatory approval, MustGrow’s patented liquid products could be applied through injection, standard drip, or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation. MustGrow has approximately 49.7 million basic common shares issued and outstanding and 55.6 million shares fully diluted. For further details, please visit www.mustgrow.ca.

ON BEHALF OF THE BOARD

“Corey Giasson”

Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include statements MustGrow makes regarding the anticipated date of the commencement of trading of the Company’s Shares on the TSXV.

Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) the preferences and choices of agricultural regulators with respect to product approval timelines; (ii) the ability of MustGrow’s partners to meet obligations under their respective agreements; and (iii) other risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2021 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the CSE, the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the CSE and TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2022 MustGrow Biologics Corp. All rights reserved.

Ocugen (OCGN) – 3Q22 Reported With Pipeline Updates

Posted on by cpereira@noblefcm.com


Wednesday, November 09, 2022

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Financial Results Met Expectations. Ocugen reported a 3Q loss of $21.9 million or $(0.10) per share, close to our estimates of $21.2 million and $(0.10) for the quarter. Cash on hand at September 30, 2022 was $101.6 million, which the company expects to last through 2023. 

COVID-19 Programs Are Moving Forward. The Phase 2/3 immuno-bridging study for COVAXIN has completed enrollment with data release expected in early 2023. This study is testing COVAXIN to determine the immune response in the current US population, providing a “bridge” for comparability with the Phase 3 trial conducted in India. The study enrolled patients who were unvaccinated and patients that received mRNA vaccines to determine both initial and booster efficacy. Once completed, Ocugen plans to work with government agencies for support and funding for regulatory approval of its COVID-19 products.


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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. 

Release – Ocugen Provides Business Update & Third Quarter 2022 Financial Results

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on OCGN

November 8, 2022

Conference Call and Webcast Today at 8:30 a.m. ET

  • Initiated dosing in the third and final cohort of U.S. Phase 1/2 OCU400 gene therapy clinical trial
  • Expanded product pipeline with OCU500—Ocugen’s mucosal COVID-19 vaccine and OCU410ST for Stargardt disease
  • Completed enrollment of U.S. Phase 2/3 COVAXIN™ (BBV152) clinical trial

MALVERN, Pa., Nov. 08, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today reported financial results for the quarter ended September 30, 2022, and provided a general business update.

“We achieved several important milestones in the third quarter of 2022,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “We expanded our vaccines pipeline by adding a second asset to combat COVID-19, OCU500, through our exclusive license agreement with Washington University to develop, manufacture, and commercialize a mucosal vaccine in the United States, Europe, and Japan.”

“Our modifier gene therapy platform has significant potential to address multiple blindness diseases,” said Dr. Musunuri. “The OCU400 clinical trial is on track, and we are also pleased to announce the addition of OCU410ST to our pipeline as a potential therapy for Stargardt disease—an orphan disease.”

“We continue to deliver on our near-term commitments as we advance our longer-term strategy and goal of bringing solutions to patients with debilitating diseases for whom no appropriate treatment options exist. We are passionate about this goal and anticipate achieving multiple milestones across our programs next year,” Dr. Musunuri concluded.

Business Updates

Vaccines

  • COVAXIN™ – enrollment was completed, and dosing continues, in the Phase 2/3 immuno-bridging and broadening clinical trial. No safety concerns have been identified to date and efficacy is being continuously monitored. Top line data is expected in early 2023.
  • OCU500 – a novel adenovirus-vectored mucosal vaccine, specifically designed to block COVID-19 infection at the portal of virus entry and that could prevent transmission as well as provide protection against new variants. This approach represents a potential universal booster, regardless of previous COVID-19 vaccination. Obtaining mucosal immunity has been published as a potential way to prevent infection and transmission, thus limiting the origin of new variants. Mucosal vaccines similar to the Company’s approach are already authorized in China and India. Ocugen intends to work closely with government agencies tasked with pandemic preparedness and response to initiate clinical trials.

Gene Therapies

  • OCU400
    • Dosing of subjects with NR2E3 and RHO-related retinitis pigmentosa in Cohort 2 was completed. Based on a review of safety data by the independent Data and Safety Monitoring Board for the clinical trial, dosing has begun in Cohort 3, and enrollment is expected to be completed by the end of the year.
    • The current clinical trial will also start enrolling patients with Leber congenital amaurosis associated with CEP290 mutations.

  • OCU410 and OCU410ST – Filings of Investigational New Drug (IND) applications for both dry age-related macular degeneration and Stargardt disease are planned for Q2 2023.

Biologicals

  • OCU200 – Ocugen is currently executing IND-enabling studies. The filing of an IND application targeting DME is planned for Q1 2023.

Cell Therapies

  • NeoCart® – Ocugen continues to work with the U.S. Food and Drug Administration to finalize the Phase 3 protocol necessary for the clinical development program of NeoCart®. Ocugen is building its own manufacturing suites to prepare for a NeoCart® clinical trial and as part of an overall research and development expansion.

Third Quarter 2022 Financial Results

  • The Company’s cash, cash equivalents, and restricted cash totaled $101.6 million as of September 30, 2022, compared to $95.1 million as of December 31, 2021. The Company believes that its current cash and cash equivalents balance will enable it to fund its operations into Q4 2023. The Company had 216.7 million shares of common stock outstanding as of September 30, 2022.
  • Research and development expenses for the three months ended September 30, 2022, were $15.6 million compared to $6.3 million for the three months ended September 30, 2021. General and administrative expenses for the three months ended September 30, 2022, were $7.5 million compared to $4.5 million for the three months ended September 30, 2021.
  • Ocugen reported a $0.10 net loss per share for the three months ended September 30, 2022, compared to a $0.05 net loss per share for the three months ended September 30, 2021.

Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers

Conference ID: 3481499

Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address 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.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com

PDS Biotechnology Corp (PDSB) – SITC Abstracts Released For Two Studies

Posted on by cpereira@noblefcm.com


Tuesday, November 08, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Data To Be Presented At SITC.  PDS Biotechnology released two PDS0101 abstracts to be presented at the SITC (Society for Immunotherapy of Cancer) meeting later this week. Data will be from the Phase 2 IMMUNOCERV trial in cervical cancer in combination with chemotherapy and radiation and the trial known as the Triple Combination Study or NCI Study, testing PDS0101 in combination with two immunomodulating agents. We believe both studies show positive results that are consistent with our expectations. 

IMMUNOCERV Trial Highlights. The Phase 2 IMMUNOCERV trial is testing PDS0101 in combination with standard-of-care chemotherapy in advanced cervical cancer. Out of 17 patients enrolled in the study, 8 had been reached the 170-day status evaluation for by PET CT. Complete responses (CR) were seen in 7 out of 8 (87.5%) of the patients. One year survival was all 8 out of 8 (100%), with 7 out of 8 disease free (87.5%). One patient who only received 3 out of 5 doses showed signs of residual disease. The study is still ongoing.


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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. 

Release – PDS Biotech Announces Presentation of Preliminary PDS0101 Efficacy, Safety, and Immunology Data at Society for Immunotherapy of Cancer (SITC 2022)

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on PDSB

Patients with high-risk, locally advanced cervical cancer on IMMUNOCERV demonstrated increased tumor-infiltrating polyfunctional CD8+ (killer) T cells, and 1-year overall survival of 100%

Data from study across several checkpoint inhibitor refractory HPV-positive cancers demonstrate an increase in HPV-specific T cells following treatment with PDS0101-based triple combination

FLORHAM PARK, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced upcoming poster presentations of clinical data from two Phase 2 clinical trials of PDS0101 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2022) being held November 8-12, 2022 in Boston. PDS0101 is PDS Biotech’s lead candidate being developed as a potential treatment for HPV-positive cancers.

The first abstract accepted for presentation, titled, “IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers,” highlights data from The University of Texas MD Anderson Cancer Center-led IMMUNOCERV Phase 2 clinical trial (NCT04580771). The study is investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the potential treatment of cervical cancer in patients with large tumors over 5cm in size and/or cancer that has spread to the lymph nodes (lymph node metastasis). Highlights from the study being presented at SITC 2022 include:

  • 17 patients have been enrolled in the trial.
  • 8 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer.
  • 87.5% (7/8) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease.
  • In comparison, 74.1% (40/54) of locally advanced patients who received CRT alone and were monitored at The University of Texas MD Anderson Cancer Center on a prospective protocol independent of IMMUNOCERV had a CR on PET CT at Day 170.   
  • The 1-year overall survival is 100% (8/8) in patients treated with the combination of PDS0101 and CRT.
  • The observed 1-year disease-free survival rate for IMMUNOCERV patients is 87.5% (7/8).
  • Patients treated with the combination of PDS0101 and CRT had a 71% increase in multi-cytokine-inducing (polyfunctional) killer (CD8+) T cells within the tumors from baseline to end of treatment (38% to 65%). This increase in activated T cells was not seen in patients receiving standard-of-care CRT.
  • Toxicity of PDS0101 was limited to low-grade local injection site reactions.

The second abstract, titled “Immune Correlates Associated with Clinical Benefit in Patients with Checkpoint Refractory HPV-Associated Malignancies Treated with Triple Combination Immunotherapy,” reports data from the Phase 2 triple combination trial (NCT04287868), which is being led by the Center for Cancer Research at the National Cancer Institute (NCI), part of the National Institutes of Health. The study is investigating PDS0101 in combination with two investigational immune-modulating agents: M9241, a tumor-targeting IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/ TGF-β). The triple combination is being studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy. For most patients who are CPI refractory, there is no effective therapy. The immune correlates before and after treatment in the CPI refractory patient population were studied. Highlights from the study being presented at SITC 2022 include:

  • A more than two-fold increase in HPV16-specific T cells in the blood of 79% (11/14 tested) of the evaluated patients.
  • Immune responses were associated with increases in natural killer cells, soluble granzyme B (associated with active killer T cells), IFN-γ, TNF-α, etc., two weeks after the first treatment cycle thus signaling a pro-inflammatory response.
  • These immunogenicity findings highlight the potential role of the combination in altering immune suppressive forces, and support previously announced results documenting promising clinical outcomes in the CPI-refractory population receiving the triple combination.

“We are very pleased that research describing PDS0101’s therapeutic potential will be highlighted in two poster presentations at SITC 2022, including encouraging preliminary efficacy results from the ongoing IMMUNOCERV Phase 2 clinical trial,” said Dr. Frank Bedu-Addo, CEO of PDS Biotech. “Taken together, the data being presented at SITC 2022 demonstrate the potential ability of PDS0101 to elicit in patients the right type and quality of therapeutic immune response. This seems to allow PDS0101 to work in combination with a variety of therapeutic agents to generate clinical responses that appear to exceed current standards of care and allow for improved outcomes in patients with HPV-positive cancers. We look forward to continued progression of our Phase 2 clinical trials evaluating the efficacy, safety and tolerability of PDS0101 in combination with other therapies.”

Details of the posters being presented at SITC 2022 are as follows:

Abstract Number: 674
Abstract Title: IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers
Presenting Author: Dr. Ann Klopp, The University of Texas MD Anderson Cancer Center
Session Date: Friday, Nov. 11

Abstract Number: 695
Abstract Title:  Immune correlates associated with clinical benefit in patients with checkpoint refractory HPV-associated malignancies treated with triple combination immunotherapy
Presenting Author: Dr. Meg Goswami, National Cancer Institute
Session Date: Thursday, Nov. 10 

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A National Cancer Institute-supported Phase 2 clinical study of PDS0101 in a triple combination therapy is also being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers. A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being led by The University of Texas MD Anderson Cancer Center. A final Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients HPV16+ head and neck cancer patients is being conducted at the Mayo Clinic.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contact:
Bill Borden/Dave Schemelia
Tiberend Strategic Advisors, Inc.
Phone: +1 (732) 910-1620/+1 (609) 468-9325
Email: bborden@tiberend.com /dschemelia@tiberend.com

Release – Lineage Cell Therapeutics to Report Third Quarter 2022 Financial Results and Provide Business Update On November 10, 2022

Posted on by aweinsoff@channelchek.com

News, Research, and Market Data on LCTX

November 3, 2022 at 8:00 AM EDT

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 3, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its third quarter 2022 financial and operating results on Thursday, November 10, 2022, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, November 10, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2022 financial and operating results and to provide a business update.

Interested parties may access the conference call by dialing (800) 715-9871 from the U.S. and Canada and should request the “Lineage Cell Therapeutics Call” or provide conference ID number 5262180. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through November 17, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 5262180.

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 and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

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

LifeSci Advisors
Daniel Ferry
(daniel@lifesciadvisors.com)
(617) 430-7576

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.

Release – Cocrystal Pharma to Participate in Two Investor Conferences in November

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on COCP

NOVEMBER 02, 2022

BOTHELL, Wash., Nov. 02, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that management will participate in two upcoming investor conferences as follows:

  • 2022 BioFlorida Annual Conference: James Martin, CFO and interim co-CEO, will participate in a panel titled “BioTrends: Learning from the Pandemic: The Fight Against Infectious Diseases” on Thursday, November 3 at 2:05 p.m. Eastern time. The conference is being held at Hyatt Regency Miami. More information about the conference is available here.

  • Q4 Investor Summit: Mr. Martin will present a company overview on Monday, November 14 at 11:30 a.m. Eastern time. The conference is sponsored by the Investor Summit Group and is being held at the Sheraton New York Time Square Hotel. More information about the conference is available here.

A webcast of the Q4 Investor Summit presentation will be posted to the IR Calendar page of the company website.

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

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

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

# # #

Source: Cocrystal Pharma, Inc.

Released November 2, 2022

Ocugen (OCGN) – R&D Day Highlights Gene Therapy and COVID Programs

Posted on by cpereira@noblefcm.com


Wednesday, November 02, 2022

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Gene Therapy In The Spotlight.  Ocugen held an R&D Day to highlight its programs in gene therapy and COVID-19.  The presentations discussed the novel mechanisms behind its gene therapy products and the nature of the ophthalmic disease indications in development.  While the company has been best known for COVAXIN and COVID-19, we have always seen the gene therapy indications as highly promising and underappreciated.

Modifier Gene Therapy Platform.  The first presentations discussed the company’s novel approach to gene therapy.  In contrast to other approaches that seek to transfer a functional copy of a gene to replace a gene that has mutated or become dysfunctional, Ocugen’s Modifier Gene Therapy targets a “master control gene” that controls the expression of multiple gene pathways, allowing products to be developed for diseases caused by downstream gene pathways and combinations of genetic mutations.


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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. 

Axcella Therapeutics (AXLA) – 3Q22 Reported After An Eventful Quarter

Posted on by cpereira@noblefcm.com


Wednesday, November 02, 2022

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Financial Results.  Axcella reported a 3Q22 loss of $17.8 million or $(0.34) per share, compared with our estimate of a loss of $21.7 million or $(0.43) per share.  The company sold convertible notes raising $6.0 million to end the quarter with $25.4 million in cash and equivalents.  After the quarter ended, it added $28.2 million in cash through a direct offering of common stock.  Based on our 4Q22 estimate of a loss of $18.1 million, we project the cash balance at YE22 to be around $35.5 million.

Long COVID Study Results Were Encouraging.  Results from a Phase 2a study testing AXA1125 in Long COVID were announced in early August, as discussed in our note from August 3. The data showed statistically significant improvements in both physical and mental fatigue symptoms.  We believe this is clinically relevant for an estimated 20% to 30% of the people who have been infected with COVID-19.  Axcella is in currently in discussions with regulatory authorities to design the next study, planned to begin in 2023.


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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. 

Release – Cocrystal Pharma Granted European Patent Covering Oral Antiviral Candidate CC-42344 in Combination with Another Antiviral Agent for the Treatment of Influenza

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on COCP

NOVEMBER 01, 2022

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BOTHELL, Wash., Nov. 01, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces it has been granted European patent EP3866778 titled “Combinations Of Inhibitors of Influenza Virus Replication,” which covers the Company’s broad-spectrum oral PB2 inhibitor CC-42344 in combination with approved influenza antiviral drugs including Tamiflu®, Xofluza® or Favipiravir. Cocrystal recently announced the completion of enrollment in a Phase 1 study with CC-42344 for the treatment of pandemic and seasonal influenza A, with topline study results expected later this year.

“This new patent provides meaningful protection for our PB2 clinical program in the European Union and is the first to be granted as we pursue a similar patent strategy in other jurisdictions,” said James Martin, Cocrystal’s CFO and interim Co-CEO. “The granting of this patent is an important step in our efforts to expand protection of our novel, best-in-class antiviral candidates both in the U.S. and internationally.”

About CC-42344 and Influenza
CC-42344 is an oral PB2 inhibitor discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. It is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®, while also demonstrating favorable PK and safety profiles.

According to a June 2022 report by Precision Reports, the global influenza therapeutics market is projected to reach $9.5 billion by 2027, up from $6.6 billion in 2020 and growing at a 4.8% CAGR between 2021 and 2027.

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.

Cocrystal Pharma 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 the potential design and efficacy of CC-42344, and the demand and potential market size for products designed to treat influenza. 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 possibility that assumptions underlying market projections prove to be incorrect, the availability of federal government funding and budgetary issues that may arise, the risks and uncertainties arising from any future impact of the Russian invasion of Ukraine, and/or inflation and interest rate increases on the global economy, the U.K. and on our Company and collaboration partners, including supply chain disruptions and our continued ability to proceed with our programs such as obtaining the requisite regulatory approvals including from the United Kingdom Medicines and Healthcare Products Regulatory Agency, the ability of the CRO to recruit patients into clinical trials, and the results of the studies for CC-42344. 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

# # #

Source: Cocrystal Pharma, Inc.

Released November 1, 2022