Category: Health

MustGrow Biologics Corp. (MGROF) – A Step Towards Revenue Generation

Posted on by cpereira@noblefcm.com


Friday, May 03, 2024

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

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

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

A Distribution Agreement. Yesterday, MustGrow Biologics announced an exclusive distribution agreement with G.S. Long Co., Inc. for MustGrow’s TerraSante biofertility product in Oregon and Washington State. We view this as the next step in revenue generation for the Company, with meaningful revenue now on the horizon for 2025.

Who Is G.S. Long? G.S. Long is a family-owned and operated agricultural chemical and fertilizer retailer headquartered in Central Washington with additional branches located in both Washington and Oregon State. The firm has deep crop consultant capabilities, including experience with biologics, representing generational grower relationships. G.S. Long has over 40 state-licensed Crop Advisors providing a variety of full-service consulting to its farming customers.


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Release – PDS Biotech Appoints Stephan Toutain as Chief Operating Officer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

PRINCETON, N.J., May 02, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced the appointment of Stephan Toutain, MS, MBA, as Chief Operating Officer (COO), effective as of May 1, 2024.

“We are thrilled to welcome Stephan to the PDS Biotech team as Chief Operating Officer. His invaluable experience spans many aspects of the life sciences industry, from drug development to commercialization, providing a wealth of knowledge to our team,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Stephan’s strategic vision, proven ability to drive operational excellence, and distinguished track record, particularly in oncology, will be instrumental as we advance our lead program into a pivotal clinical trial.”

Mr. Toutain brings more than 30 years of operational experience in the pharmaceutical industry from drug development, general management, operations, commercial development, market access and sales and marketing leadership with prior global expertise in the oncology and orphan drugs markets. Before joining PDS Biotech, he served as COO at Anavex Life Sciences from May 2018 to April 2024 and Chief Commercial Officer at Interleukin Genetics from July 2016 to August 2017. Mr. Toutain also worked with Alnylam Pharmaceuticals to build its early access program. In addition, he led Global Commercial Development for Sarepta Therapeutics and served as General Manager for Alexion Pharmaceuticals in Europe. Mr. Toutain has also held various U.S. commercial, marketing and product management positions with Celgene Corporation and Johnson & Johnson. He received a Master of Business Administration from the University of North Carolina Kenan-Flagler Business School and a Master of Engineering in Biotechnology from the University of Nancy II in France.

“I am excited to join the PDS Biotech team during this pivotal time as the company hones its late-stage clinical strategy on the novel triple combination,” said Mr. Toutain. “I am eager to contribute my experience and insights to drive forward our mission of transforming how the immune system targets and fights cancer.”

The Company also announced today that on May 1, 2024, PDS Biotech granted a nonstatutory stock option to Mr. Toutain to purchase 200,000 shares of PDS Biotech common stock as a material inducement to Mr. Toutain’s employment with PDS Biotech and in accordance with Nasdaq Listing Rule 5635(c)(4) and PDS Biotech’s 2019 Inducement Plan, as amended, which was adopted on June 17, 2019 and provides for the granting of equity awards to new employees of PDS Biotech.

The stock option has an exercise price of $3.61, the closing price of PDS Biotech’s common stock on May 1, 2024. The stock option vests over a four-year period, with one-quarter of the shares vesting on the first anniversary of the grant date and the remaining shares vesting monthly over the 36-month period thereafter, subject to continued employment with the Company through the applicable vesting dates.

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC). PDS Biotech’s lead program is a proprietary dual-acting combination of IL-12 fused antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune® HPV in regimen with a standard-of-care immune checkpoint inhibitor. We believe that proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.

We believe that with a novel investigational “inside-outside” mechanism, the PDS01ADC and Versamune® HPV immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. We believe that data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility.

Our Infectimune® based vaccines have 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. For more information, please visit www.pdsbiotech.com.

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 PDS01ADC, 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 PDS01ADC, 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 the Company’s 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; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. 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 other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

Release – Ocugen Announces CSO To Present On Modifier Gene Therapy At Retina World Congress

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 2, 2024

MALVERN, Pa., May 02, 2024 (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 announced that Arun Upadhyay, PhD, Chief Scientific Officer, Head of Research & Development, Ocugen will speak at the Retina World Congress (RWC) being held May 9-12, 2024 in Ft. Lauderdale, FL.

“This is a terrific opportunity to share the most recent developments in modifier gene therapy with my peers and learn more about their discoveries to fight retinal disease,” said Dr. Upadhyay. “Opportunities like these are critical as we work together to address unmet medical needs for patients with blindness diseases.”

RWC is one of the largest retina meetings in the world and is leading the advancement of science in retina. This annual meeting brings together retina specialists from every continent to achieve a global scientific and clinical exchange in retinal health. 

Details on Dr. Upadhyay’s presentation are as follows:

RWC Unplugged Panel Session: Gene Therapy, Pharmacotherapy and Optogenetics for IRD
Date: Thursday, May 9, 2024
Time: 9:05 – 9:35 a.m. (ET)
Location: Marriott Harbor Beach Resort

Additionally, Ocugen’s abstract, “Safety and Efficacy Results from a Phase 1/2 Clinical Trial of OCU400 Modifier Gene Therapy for Treatment of Retinitis Pigmentosa,” has been accepted as an e-poster/video presentation and will be showcased in a video display during the conference.

The OCU400 Phase 3 liMeliGhT clinical trial is currently underway and on track to meet the Company’s 2026 BLA and MAA approval targets. OCU400 is the first gene therapy program to enter Phase 3 with a broad retinitis pigmentosa (RP) indication.

About OCU400
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on nuclear hormone receptor (NHR) gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with RP. Between the U.S. and EU, nearly 300,000 people are affected by RP.

About Modifier Gene Therapy
Modifier gene therapy is designed to fulfill unmet medical needs related to retinal diseases, including IRDs, such as RP, Leber congenital amaurosis and Stargardt disease, as well as multifactorial diseases like dry age-related macular degeneration (dAMD). Our modifier gene therapy platform is based on the use of NHRs, master gene regulators, which have the potential to restore homeostasis — the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, we believe that our modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential to address multiple retinal diseases caused by mutations in multiple genes with one product, and to address complex diseases that are potentially caused by imbalances in multiple gene networks. Currently, Ocugen has three modifier gene therapy programs in the clinic: OCU400, OCU410, and OCU410ST. In addition to the OCU400 Phase 3 liMeliGhT clinical trial, the OCU410 Phase 1/2 ArMaDa clinical trial for geographic atrophy (GA) secondary to dAMD and the OCU410ST Phase 1/2 GARDian clinical trial for Stargardt disease are currently underway. GA affects approximately two to three million people between the U.S. and EU and Stargardt disease affects nearly 100,000 people between the U.S. and EU.

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 X 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, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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
Tiffany.Hamilton@ocugen.com

Release – Enrollment Completed in Phase 2a Study with Cocrystal Pharma’s Oral Antiviral Candidate CC-42344 for Pandemic and Seasonal Influenza

Posted on by aweinsoff@channelchek.com

MAY 01, 2024

BOTHELL, Wash., May 01, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces completion of enrollment of 78 subjects who were infected with influenza A in a randomized, double-blind, placebo-controlled Phase 2a human challenge clinical study evaluating the safety, tolerability, antiviral and clinical measurements of its novel, broad-spectrum, oral PB2 inhibitor CC-42344. CC-42344 is a new class of antiviral treatment designed to effectively block an essential step in the viral replication and transcription of pandemic and seasonal influenza A, and was discovered using the Company’s proprietary structure-based drug discovery platform technology.

“There is an urgent need for new influenza antivirals targeting highly pathogenic avian pandemic and seasonal influenza strains. It’s gratifying to report the timely completion of enrollment in this important study, keeping us on track to announce topline results later this year. This human challenge study was conducted in the United Kingdom and was designed to evaluate a favorable safety profile, virological effects, and an improvement in clinical symptom for CC-42344 as a potential oral treatment for avian pandemic and seasonal influenza A,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are pleased to advance our robust pipeline with achievement of this important clinical development milestone as we continue to build our leadership in influenza therapeutics.”

In March 2024 Cocrystal announced receipt of positive Pre-Investigational New Drug (Pre-IND) feedback from the FDA providing guidance and clarification on critical steps including designing a proposed Phase 2b study protocol for CC-42344 as a potential oral treatment for pandemic and seasonal influenza A.

Cocrystal also plans to begin a Phase 1 study in Australia with an inhaled formulation of CC-42344 as a potential influenza A treatment and post-exposure prophylaxis. Recent preclinical data showed that inhaled CC-42344 exhibited highly effective delivery into the lung, superior lung exposure, efficacy in influenza-infected human lung epithelia and a favorable safety profile.

CC-42344 Influenza A PB2 Inhibitor

In December 2023, Cocrystal announced the achievement of first-patient-in for the Phase 2a human challenge clinical trial with CC-42344, an investigational new oral antiviral inhibitor for the treatment of pandemic and seasonal influenza A. The randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, viral and clinical measurements of influenza A infection in subjects dosed with oral CC-42344 treatment. The study enrolled 78 healthy subjects.

In late 2022 Cocrystal reported favorable safety and tolerability results in the single-ascending and multiple-ascending dose portions of the healthy volunteer Phase 1 trial conducted in Australia. Preclinical data showed that CC-42344 is highly active against seasonal and pandemic influenza A strains.

About Seasonal Influenza

Each year there are approximately 1 billion cases of seasonal influenza worldwide, with 3-5 million severe illnesses and up to 650,000 deaths, according to the World Health Organization. On average about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually.

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), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and results of the Phase 2a trial for CC-42344 for the oral treatment of influenza A in 2024, an anticipated Phase 2b trial for oral treatment of influenza A following the Phase 2a trial, plans to begin a Phase 1 study in Australia for an inhaled formulation of CC-42344 as a potential influenza A treatment and prophylaxis, and the potential efficacy and clinical benefits of, and market for, such product candidates. 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, risks relating to our ability to proceed with the studies including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, the results of such studies and our ability to obtain FDA approval to initiate the Phase 2b study. 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, 2023. 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

# # #

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Source: Cocrystal Pharma, Inc.

Released May 1, 2024

Release – MAIA Biotechnology Announces Share Purchase By Director Adelina Louie In Private Placement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

April 30, 2024 8:08am EDT

  • Original seed investor has remained top MAIA stockholder

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that independent director Ms. Adelina Louie Ngar Yee made an individual purchase of 19,665 shares, and warrants for 19,665 shares, of MAIA’s common stock as part of the Company’s recent private placement of common stock and warrants to accredited investors and certain Company directors. The securities sold to the Company directors participating in the offering were issued pursuant to the Company’s 2021 Equity Incentive Plan.

Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer, commented, “As a top investor in MAIA, we extend our deep appreciation to Adelina for both her longstanding support as director and for her participation in this offering alongside director Stan Smith and other long-term stockholders.”

In previous public remarks, Ms. Louie stated her belief that MAIA is at the critical point of bringing life-changing therapies to large populations of cancer sufferers.

Ms. Louie has 30 years of service with HSBC Group in a variety of functions, principally with businesses of Global Banking and Markets including investment and securities management, asset management, and global research. Most recently she was the Chief Operating Officer of Internal Audit at HSBC Group.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240430225198/en/

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released April 30, 2024

ZyVersa Therapeutics, Inc. (ZVSA) – Inflammation Study Links Alzheimer’s Disease With Chronic Heart Disease

Posted on by cpereira@noblefcm.com


Tuesday, April 30, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

New Study On Inflammasomes Connects Alzheimer’s Disease With Cardiovascular Disease. Research published in a peer-reviewed journal has shown that Alzheimer’s disease produces inflammasome components that can lead a systemic response, including chronic heart disease and stroke. This study links inflammasomes in the brain to inflammation in distant organs, worsening cardiovascular and other chronic diseases.

Alzheimer’s Brains Produces Inflammasome Components That Travel Through the Circulation.  Using models of AD, the study found that parts of the brain had elevated levels of the inflammasome-signaling proteins. When heart ventricles were tested, they also showed significant elevations inflammasome components. Next, serum extracts were administered to cardiovascular cells in culture, resulting in inflammasome activation and significant increases of inflammatory mediators.


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*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. 

X4 Pharmaceuticals Hits Jackpot With Xolremdi Approval, Unlocking M&A Potential

Posted on by slightbourne@noblecapitalmarkets.com

In a significant value-creating event, X4 Pharmaceuticals has secured FDA approval for its lead drug Xolremdi, ushering the biotech into the commercial realm and positioning it as an attractive M&A target in the hot rare disease space.

Xolremdi (mavorixafor) nabbed approval to treat WHIM (warts, hypogammaglobulinemia, infections and myelokathexis) syndrome, an ultra-rare primary immunodeficiency disorder. As the first approved therapy tackling WHIM’s genetic root cause, the CXCR4 inhibitor fills a massive unmet need where treatment options were previously limited to symptom management.

With its novel mechanism mobilizing infection-fighting white blood cells out of the bone marrow, Xolremdi demonstrated impressive clinical benefits in Phase 3. These included slashing rates of severe infections and boosting critical white blood cell levels like neutrophils and lymphocytes in WHIM patients.

While WHIM’s prevalence is difficult to pinpoint given its rarity, X4 estimates around 1,000 cases in the U.S. However, the commercial opportunity could be larger if the company successfully identifies underdiagnosed patients through its genetic screening initiatives and physician education efforts.

Xolremdi isn’t a curevbut holds potential to bolster long-term immune defenses for WHIM patients who chronically suffer from infections, warts, and abnormally low antibody levels. This positions the drug as a high-value therapy that can command premium pricing despite the tiny patient population.

Indeed, X4 has set an eyebrow-raising $496,400 annual list price for Xolremdi in patients over 50 kg, and $372,300 for smaller individuals. While pricey, these kinds of ultra-orphan drug costs are typical and highlight the blockbuster revenue potential if X4 can rapidly build out its U.S. presence and strike reimbursement wins with payers.

With its first FDA approval in hand, X4 is kicking its commercial launch into high gear. The company has deployed and trained a 24-person field force blanketing the country, established distribution channels, and stockpiled launch supplies ahead of the Xolremdi decision. Smooth execution out of the gate will be crucial.

This pivotal milestone transforms X4 from a clinical-stage biotech into a fully integrated rare disease player with an approved therapy, commercial infrastructure, and revenue stream. That fresh commercial status boosts X4’s profile considerably, increasing the odds it could become an enticing buyout target.

Big Pharma has been extremely hungry to expand rare disease franchises through M&A, driven by high unmet needs, accelerated regulatory pathways, and lucrative pricing opportunities in niche markets. Potential suitors could view X4’s new orphan disease platform as complementary.

Further underlining X4’s M&A appeal, the Xolremdi approval came with a priority review voucher as a bonus. These valuable vouchers can be redeemed to fast-track another regulatory filing or sold to other drugmakers for hundreds of millions.

Additionally, X4 believes mavorixafor has therapeutic potential beyond WHIM. The biotech aims to rapidly initiate a Phase 3 program testing the drug in chronic neutropenia, expanding its pipeline.

While the ultra-rare WHIM population limits how much a solo acquirer could value Xolremdi’s revenue stream, the drug’s approval derisks X4’s pipeline and corporate strategy. With its first FDA win and voucher under its belt, X4 stands as an intriguing M&A target that could fetch a premium from buyers seeking a rare disease foothold.

Release – MAIA Biotechnology Announces Share Purchase By Director Stan Smith, PH.D. In Private Placement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

April 29, 2024 8:08 am EDTDownload as PDF

  • Dr. Smith has participated in every MAIA funding round

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that independent director Stan V. Smith, Ph.D. made an individual purchase of 147,492 shares, and warrants for 147,492 shares, of MAIA’s common stock as part of the Company’s recent private placement of common stock and warrants.

On April 23, 2024, MAIA entered into definitive agreements for the purchase and sale of an aggregate of 494,096 shares of common stock at a purchase price of $2.034 per share, in a private placement to accredited investors and certain Company directors. Each share of common stock was offered together with a warrant to purchase one share of common stock at an exercise price of $2.26 per share. The gross proceeds from the offering are approximately $1.0 million, prior to offering expenses payable by the Company. The securities sold to the Company directors participating in the offering were issued pursuant to the Company’s 2021 Equity Incentive Plan.

“Our independent directors continue to show their support and conviction for our new science which utilizes a novel dual mechanism of action for cancer therapy: telomere targeting and immunogenicity,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “We especially thank Stan for his unwavering participation in every round of MAIA’s financing dating back to 2022.”

Dr. Smith recently spoke about his confidence in MAIA, stating in part, “I am a big believer in MAIA’s telomere-targeting approach to cancer and its potential to disrupt the field of research and development for cancer therapies.”

Dr. Smith is president of Smith Economics Group, Ltd. in Chicago, providing economic and financial consulting nationwide. Trained at the University of Chicago and specializing in litigation economics, Dr. Smith co-authored the first textbook on the subject of economic damages. Dr. Smith has served as an adjunct professor at the University of Chicago and at DePaul University College of Law where he created the first course in the United States in forensic economics.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240429771977/en/

Investor Relations
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released April 29, 2024

Release – YS Biopharma Receives Additional 180 Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Rule

Posted on by aweinsoff@channelchek.com

Research News and Market Data on YS

 Download this Press Release

GAITHERSBURG, Md., April 29, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (Nasdaq: YS) (“YS Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that it received an extension of 180 calendar days (the “Extension Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”) to regain compliance with the Nasdaq’s minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the “Bid Price Requirement”), following the expiration of the initial 180 calendar days period to regain compliance on April 22, 2024.

   

As previously announced, the Company received a written notification from Nasdaq dated October 24, 2023, indicating that because the closing bid price of the Company’s ordinary shares for the last 31 consecutive business days was below $1.00 per share, the Company was not in compliance with the Bid Price Requirement, and Nasdaq granted the Company a period of 180 calendar days, or until April 22, 2024, to regain compliance with the Bid Price Requirement.

 As of the date hereof, the Company has not regained compliance with the Bid Price Requirement. That being said, pursuant to the Extension Notice, the Company is eligible for an additional 180 calendar day period, or until October 21, 2024, to regain compliance with the Bid Price Requirement. To regain compliance, the Company’s ordinary shares must have a closing bid price of at least US$1.00 per share for a minimum of 10 consecutive business days, at which point the matter will be closed. In the event that the compliance cannot be demonstrated by October 25, 2024, the staff of Nasdaq will provide written notification that the Company’s securities will be delisted.

The Company intends to monitor the closing bid price of its ordinary shares between now and October 21, 2024 and is considering its options in order to regain compliance with the Bid Price Requirement. The Extension Notice does not affect the Company’s business operations, its U.S. Securities and Exchange Commission reporting requirements, or its contractual obligations.

About YS Group

YS Group is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. YS Biopharma operates in China, the United States, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit investor.ysbiopharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of YS Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, YS Biopharma’s ability to source and retain talent, and the cash position of YS Biopharma. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of YS Biopharma’s management and are not predictions of actual performance.

YS Biopharma cannot assure you the forward-looking statements in this press release will be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading “Risk Factors” in the Post-effective Amendment No. 2 to the Company’s Registration Statement on Form F-1 filed with the SEC on January 23, 2024, and other filings with the SEC. There may be additional risks that YS Biopharma does not presently know or that YS Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of YS Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while YS Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of YS Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, YS Biopharma does not undertake any duty to update these forward-looking statements.

Investor Relations Contact

Alyssa Li
Director of Investor Relations
Email: ir@yishengbio.com

Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/ys-biopharma-receives-additional-180-day-extension-by-nasdaq-to-regain-compliance-with-minimum-bid-price-rule-302129986.html

SOURCE YS Biopharma Co., Ltd.

Release – ZyVersa Therapeutics Announces Publication Reinforcing the Rationale for Inhibiting ASC with IC 100 to Potentially Attenuate Cardiac Comorbidities in Patients with Alzheimer’s Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Apr 29, 2024

  • This publication, authored by leading experts in inflammasome-mediated inflammation and neurology at University of Miami Miller School of Medicine, demonstrates that multiple inflammasome triggers (NLRP1 and pyrin) govern the inflammatory response in Alzheimer’s Disease (AD), and that release of inflammasome laden extracellular vesicles (EV) into the blood induce significant inflammation in cardiovascular cells.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes, including NLRP1 and pyrin, and their associated ASC specks that trigger damaging inflammation and its spread to surrounding tissues.
  • AD, a progressive neurodegenerative disease affecting 6.7 million people in the US, is associated with many comorbidities, especially heart disease and stroke, resulting in increased morbidity and mortality.

WESTON, Fla., April 29, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that acclaimed inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100, have published a scientific paper in the peer-reviewed journal, Frontiers in Molecular Neuroscience, highlighting how inflammasome-mediated inflammation in Alzheimer’s disease can trigger inflammation in the heart.

The paper titled, “Extracellular vesicles mediate inflammasome signaling in the brain and heart of Alzheimer’s disease mice,” summarizes research evaluating serum and tissue cultures from an AD mouse model, and experiments of adoptive transfer of EV from AD patients into cardiovascular cells. Following is a summary of key findings:

  • NLRP1, pyrin, caspase-1, and ASC were significantly elevated in the cortex of AD mice.
  • In AD mice, there was a heightened level of inflammatory proteins circulating in the body via EVs containing an inflammasome protein cargo.
  • Inflammasome activation was demonstrated in the heart of AD mice, associated with an increase in ASC oligomerization into specks.
  • In adoptive transfer experiments, EVs released from AD patients induced significant inflammation in cardiovascular cells when compared to EVs from healthy individuals.

“Our data provide evidence that there is a neural-cardiac axis mediated by EVs in AD. Therefore, inflammasomes may provide a novel therapeutic target for the treatment of cardiac comorbidities in AD and beyond,” said Juan Pablo de Rivero Vaccari, Associated Professor of Neurological Surgery and The Miami Project to Cure Paralysis at the University of Miami.

“This research reinforces the importance of attenuating activation of multiple types of inflammasomes that govern the inflammatory response in AD and mediating systemic inflammatory signals in EVs to control the spread of damaging inflammation to cardiovascular and other cells,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “ZyVersa’s Inflammasome ASC inhibitor IC 100 is designed to inhibit formation of multiple types of inflammasomes to attenuate initiation of the inflammatory cascade and to inhibit their associated ASC specks to reduce spread and perpetuation of damaging inflammation.”

To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641     

Release – Ocugen Announces OCU400—Modifier Gene Therapy—Phase 1/2 Data Presentation At Retinal Cell And Gene Therapy Innovation Summit 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

April 29, 2024

MALVERN, Pa., April 29, 2024 (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 announced that Benjamin Bakall, MD, PhD, Director of Clinical Research at Associated Retina Consultants and Clinical Assistant Professor at the University of Arizona, College of Medicine—Phoenix will present data from the OCU400 Phase 1/2 clinical trial at the Retinal Cell and Gene Therapy Innovation Summit being held May 3, 2024 in Seattle, WA.

“I look forward to sharing more about my clinical experience with this novel modifier gene therapy with my peers and industry leadership during the summit,” said Dr. Bakall. “There remains a significant unmet need for patients with retinitis pigmentosa (RP) and I believe that this approach can offer a new therapeutic option to address the disease itself.”

The Retinal Cell and Gene Therapy Innovation Summit 2024 is jointly organized by the Foundation Fighting Blindness and the Oregon Health and Science University Casey Eye Institute. The Summit brings together representatives from the biotech and pharma industries, along with members of the medical and research communities, to discuss rapidly emerging ocular gene and cell therapies and strategize how to move the most advanced retinal disease therapies toward clinical utility.

Details on Dr. Bakall’s presentation are as follows:

Presentation Title: “Nuclear Hormone Receptor-Based Gene Modifier Therapy: Safety and Efficacy from Phase 1/2 Clinical Trials for Retinitis Pigmentosa”
Date: Friday, May 3, 2024
Time: 10:50 – 11:05 a.m. (PT)
Location: Hyatt Regency Seattle

The OCU400 Phase 3 liMeliGhT clinical trial is currently underway and on track to meet the Company’s 2026 BLA and MAA approval targets. Between the U.S. and EU, nearly 300,000 people are affected by RP.

About OCU400
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with RP.

About RP
RP is a group of rare, genetic disorders that involve a breakdown and loss of cells in the retina, leading to vision loss and blindness. Currently, RP is associated with mutations in more than 100 genes. There are no approved treatment options that slow or stop the progression of multiple forms of RP. Proposed treatments for RP include gene replacement therapy, retinal implant devices, retinal transplantation, stem cells, vitamin therapy, and other pharmacological treatments. Current gene replacement therapies are promising but are limited to treating just a single mutation. In addition, while gene therapies may provide a new functional gene, they do not necessarily eliminate the underlying genetic defect, which may still cause stress and toxic effects leading to retina degeneration. Therefore, the development of gene-specific replacement therapy is highly challenging, especially when multiple and unknown genes are involved. Thus, novel therapeutic approaches targeting broader RP disease in a gene-agnostic manner offer greater hope for patients.

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 X 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, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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
Tiffany.Hamilton@ocugen.com

Incyte Shells Out $750M for Escient’s Immunology Assets

Posted on by slightbourne@noblecapitalmarkets.com

In a move that further solidifies its position in the inflammatory disease space, Incyte Corporation has agreed to acquire Escient Pharmaceuticals for $750 million. The deal, announced on Tuesday, will add two promising immunology and inflammation candidates to Incyte’s pipeline, complementing its existing dermatology portfolio.

The star assets in the acquisition are EP262 and EP547, both of which have shown promising early results in clinical trials. EP262, the more advanced of the two, is currently being evaluated for the treatment of various inflammatory skin conditions, including atopic dermatitis, psoriasis, and vitiligo. Preclinical data has demonstrated EP262’s ability to improve atopic dermatitis-like lesions and reduce inflammation, making it a potentially valuable addition to Incyte’s dermatology lineup.

EP547, while in an earlier stage of development, is being studied for the treatment of itching associated with kidney and liver diseases – a condition known as pruritus, which can significantly impact a patient’s quality of life. With two phase 1 trials currently underway, EP547 could address a significant unmet need in these patient populations.

“EP262 and EP547 are complementary additions to our portfolio, providing an opportunity to leverage our expertise, address the needs of patients with inflammatory diseases and additional potential launch opportunities starting in 2029,” said Hervé Hoppenot, Incyte’s CEO.

For Incyte, the acquisition of Escient Pharmaceuticals represents a strategic move to strengthen its position in the lucrative dermatology market. The company already has an approved JAK1/JAK2 inhibitor cream, Opzelura, which is indicated for atopic dermatitis and vitiligo. With EP262 and additional pipeline candidates, Incyte aims to expand its offerings and capture a larger share of the growing inflammatory skin disease market.

The deal also follows Incyte’s recent acquisition of the cancer drug Monjuvi from MorphoSys, further demonstrating the company’s commitment to bolstering its portfolio through strategic partnerships and acquisitions.

Escient Pharmaceuticals, a relatively young company founded in 2018, had already attracted significant investor interest, raising over $200 million in private financing rounds from the likes of Sanofi. The company’s promising early-stage pipeline and expertise in inflammatory diseases likely made it an attractive target for Incyte.

The transaction, which is expected to close in the third quarter of 2024, will provide Incyte with a diverse range of assets spanning multiple inflammatory and immunological indications. As the company continues to expand its offerings, it remains well-positioned to capitalize on the growing demand for innovative treatments in these therapeutic areas.

Take a moment to take a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage list.

Release – Ocugen To Present On Modifier Gene Therapy Platform At Association For Research In Vision And Ophthalmology 2024 Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

April 26, 2024

MALVERN, Pa., April 26, 2024 (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 announced that the Company will present on its innovative modifier gene therapy platform, including OCU400 for the treatment of retinitis pigmentosa (Phase 3 LiMeliGhT clinical trial), OCU410 for the treatment of geographic atrophy (Phase 1/2 ArMaDa clinical trial), and OCU410ST for the treatment of Stargardt disease (Phase 1/2 GARDian clinical trial) at The Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting in Seattle, WA from May 5-9, 2024.

“With three gene therapies to treat blindness diseases currently in the clinic, now is an exciting time for Ocugen and the patients who can potentially benefit from our first-in-class modifier gene therapy platform,” said Dr. Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen. “We look forward to sharing more about the scientific foundation of our programs and providing clinical updates with industry leaders during ARVO.”

Ocugen’s presence at ARVO 2024 includes:

Paper Session (oral presentation)

Title: OCU400 Nuclear Hormone Receptor-Based Gene Modifier Therapy: Safety and Efficacy from Phase 1/2 Clinical Trial for Retinitis Pigmentosa Associated with NR2E3 and RHO Mutations

Authors: Byron L. Lam, Arun K. Upadhyay, Shankar Musunuri, Murthy Chavali, Sahar Matloob, Nalin Mehta, David G. Birch, Paul Yang, Benjamin Bakall, Nieraj Jain, Jose S. Pulido, Borooah Shyamanga

Presenter: Byron Lam, MD, Professor of Ophthalmology, Dr. Mark J. Daily Endowed Chair, University of Miami
Presentation Number: 406
Location: Seattle Convention Center, Arch Building, Room 612
Date: Sunday, May 5, 2024
Time: 1:45-2 p.m. (PT)

Exhibitor Presentations

Title: OCU400—A Gene Agnostic Modifier Gene Therapy for the Treatment of Retinitis Pigmentosa (Phase 1/2 Clinical Study Results and Phase 3 liMeliGhT Study Design) 
Presenter: Arun Upadhyay, PhD, Chief Scientific Officer, Head of Research & Development, Ocugen
Location: Show Floor, Educational Lounge, Booth #4921
Date: Monday, May 6, 2024
Time: 1 p.m. (PT)

Title: OCU410 Gene Therapy—Multifactorial Therapeutic Intervention for Dry Age-Related Macular Degeneration 
Presenter: Huma Qamar, MD, MPH, Chief Medical Officer, Ocugen
Location: Show Floor, Educational Lounge, Booth #4921
Date: Tuesday, May 7, 2024
Time: 2 p.m. (PT)

Title: Nuclear Hormone Receptor RORA as a Novel Modifier Approach for Treatment of Stargardt Disease 
Presenter: Murthy Chavali, PhD, Director, Clinical Development, Ocugen
Location: Show Floor, Educational Lounge, Booth #4921
Date: Wednesday, May 8, 2024
Time: 2 p.m. (PT)

Ocugen is committed to bringing game-changing therapies to treat inherited retinal diseases as well as blindness diseases affecting millions to market and working even harder to provide access to patients globally.

About AAV-hNR2E3 (OCU400)
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with retinitis pigmentosa. Between the U.S. and EU, nearly 300,000 people are affected by retinitis pigmentosa. The OCU400 Phase 3 liMeliGhT clinical trial is currently underway and on track to meet the Company’s 2026 BLA and MAA filing targets.

About AAV-hRORA (OCU410/OCU410ST)
AAV-hRORA utilizes an AAV delivery platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in in-vitro and in-vivo (animal model) studies. These results demonstrate the ability to target multiple pathways linked with dry age-related macular degeneration and Stargardt pathophysiology. Ocugen is developing OCU410 as a one-time gene therapy for the treatment of GA (affecting one million people in the U.S.) and OCU410ST as a one-time gene therapy for the treatment of Stargardt disease (affecting 41,000 people in the U.S.).

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 X 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, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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
Tiffany.Hamilton@ocugen.com