Category: Health

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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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

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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

MustGrow Biologics Corp. (MGROF) – Releases Fiscal Year 2023 Results

Posted on by cpereira@noblefcm.com


Thursday, April 25, 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.

Fiscal Year Results. Management reported revenue of CAD$4.7 million for the year from CAD$6,479 last year. This is due to fees earned from technology license, evaluation, and collaboration agreements. The Company had a net loss of CAD$676,940, or a loss of $0.01 per share, from a loss of CAD$5.6 million or $0.11 last year, with the improvement from the increased revenue.

Balance Sheet and Cash Flow. MustGrow ended the year with CAD$6.8 million in cash, slightly down from CAD$7.0 million last year. The Company used CAD$294,764 in CFFO, an improvement from a use of CAD$3.3 million last year. The improvement was due to the revenue from fees earned. Barring any additional revenue, we estimate that the Company currently has an approximate 15-month runaway before needing new capital.


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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. 

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  • Emerging Growth Public Healthcare Company Executive Presentations
  • Q&A Sessions Moderated by Noble’s Analysts and Bankers
  • Scheduled 1×1 Meetings with Qualified Investors

Noble Capital Markets, a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving emerging growth companies, is pleased to present the Emerging Growth Virtual Healthcare Conference, taking place April 17th and 18th, 2024. This virtual gathering is set to be an immersive experience, bringing together a unique blend of investors, industry leaders, and experts in the life sciences, healthcare, and medical device sectors.

Part of Noble’s Robust 2024 Events Calendar

The Emerging Growth Virtual Healthcare Conference is part of Noble’s 2024 event programming, featuring a range of c-suite interviews, in-person non-deal roadshows throughout the United States, two more sector-specific virtual equity conferences, and culminating in Noble’s preeminent in-person investor conference, NobleCon20, to be held at Florida Atlantic University in Boca Raton, Florida December 3-4. Keep an eye out for the official press release on NobleCon20 coming soon.

Check out the calendar of upcoming in-person non-deal roadshows here.

Sign up to receive more information on Noble’s other virtual conferences here.

What to Expect

The Emerging Growth Virtual Healthcare Conference will feature 2 days of corporate presentations from up to 50 innovative public healthcare, biotech, and medical device companies, showcasing their latest advancements and investment opportunities. Each presentation will be followed by a fireside-style Q&A session proctored by one of Noble’s analyst or bankers, with questions taken from the audience during the presentation. Panel presentations are planned, featuring key opinion leaders in the healthcare sector, providing valuable insights on emerging trends. Scheduled one-on-one meetings with public company executives, coordinated by Noble’s dedicated Investor Outreach team, are also available to qualified investors.

Why Your Company Should Present

Looking to increase awareness in your company and increase liquidity? Paid participation in Noble’s investor conferences, both virtual and in-person, provides that opportunity, with a tailored experience aimed at delivering substantial value. After 40 years of serving emerging growth companies, and the investors who follow them, Noble has built an investor base eager to discover where the next success story lies.

Noble’s investor base is relevant and, in many cases, new to your company. Noble’s dedicated Investor Outreach team provides unmatched exposure to investors that can invest in your company, including small money managers, family offices, RIAs, wealth managers, self-directed investors, and institutions. Most of Noble’s investors specifically seek undervalued, overlooked, emerging investment opportunities.

The cost to present includes your corporate presentation with a Q&A session proctored by one of Noble’s analysts or bankers, a webcast recording, scheduled 1×1 meetings with qualified investors, and marketing on Channelchek.

Benefits for Investors

The emerging growth healthcare space may be poised for a breakout year.  The recent dislocation in the healthcare and biotech spaces has created compelling valuation profiles for many companies. Hear directly from the c-suite of the next innovators in this space and learn about new investment opportunities. The Q&A portion of each presentation gives you the opportunity to have your questions answered during or after the proctored session. The planned panel presentations are sure to provide expert insight on growing trends in the healthcare space. And, for qualified investors, one-on-one meetings are available with company executives; scheduled by Noble’s dedicated Investor Outreach team. All from the comfort of your own desk, and at no cost.

How to Register

Limited presenting slots are available

Publicly traded companies in the healthcare space can submit their registration details here.

If you have any questions about presenting, please contact events@noblecapitalmarkets.com

Investor / Guest attendees can register here

Interested in becoming a sponsor of Noble’s virtual and in-person investor conferences?

Contact events@noblecapitalmarkets.com for sponsorship information.

Release – MAIA Biotechnology Announces $1.00 Million Private Placement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

April 23, 2024 8:51am EDT

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 it has 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 is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.26 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The securities being sold to the Company directors participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about April 25, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $1.00 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund research and development activities, such as to fund the first third of the pivotal accelerated approval Part C of the THIO-101 trial in non-small cell lung cancer (NSCLC).

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

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/20240423249584/en/

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

Source: MAIA Biotechnology, Inc.

Released April 23, 2024

Release – PDS Biotech to Host Key Opinion Leader Event to Discuss Positive, Updated Data from Phase 2 VERSATILE-002 Clinical Trial with Versamune® HPV in Combination with KEYTRUDA® in Recurrent or Metastatic Head and Neck Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Company to Host Key Opinion Leader Event on May 8 at 1:30pm ET to Discuss Updated Results of VERSATILE-002, Unmet Treatment Needs in Advanced Head and Neck Cancer and planned Triple Combination Trial

PRINCETON, N.J., April 23, 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 a Key Opinion Leader (“KOL”) Event to discuss positive, updated data from its VERSATILE-002 Phase 2 clinical trial with Versamune® HPV in combination with KEYTRUDA® (pembrolizumab) (NCT04260126) and next steps for Versamune® HPV and PDS01ADC. The new data cut-off from VERSATILE-002 clinical trial remains consistent with the update provided by PDS Biotech in October of 2023.

The KOL event will take place on Wednesday, May 8, 2024, at 1:30 pm ET and panel participants will include:

  • Dr. Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at University of North Carolina, and Principal Investigator of the VERSATILE-002 clinical trial who will present and discuss the trial results
  • Dr. Robert Haddad, M.D., Professor of Medicine, Harvard Medical School and Dana-Farber Cancer Institute who will discuss the unmet need in HPV-positive head and neck squamous cell cancer (“HNSCC”)

The VERSATILE-002 trial is evaluating Versamune® HPV (formerly PDS0101) in combination with the immune checkpoint inhibitor (“ICI”) pembrolizumab in patients with unresectable, recurrent, or metastatic HPV16-positive HNSCC. The topline results to be discussed at the upcoming event are based on analysis of the most recent data cut-off.

“Approximately 20% of HPV-related patients with HNSCC will develop recurrent, incurable disease,” said Dr. Weiss. “HPV-related HNSCC that is recurrent or metastatic is a devastating, difficult-to-treat cancer, and a majority of patients do not respond to current treatments, and therefore have a relatively short survival. We believe that the data warrant further investigation in a randomized controlled clinical trial, and we are hopeful about the potential that the unique combination including Versamune® HPV and the IL-12 fused antibody drug conjugate PDS01ADC may represent in the treatment of HPV-related HNSCC.”

To register for the Key Opinion Leader event, click here.

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. Proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.

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. Robust data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated 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.

Keytruda® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

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 – YS Biopharma Granted Phase I Clinical Trial License of Therapeutic Chronic Hepatitis B Virus Vaccine

Posted on by aweinsoff@channelchek.com

Research News and Market Data on YS

GAITHERSBURG, Md., April 18, 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 its YS-HBV-002 immunotherapeutic vaccine, designed to treat patients suffering from chronic hepatitis B virus (“HBV”) infection, has been granted clinical trial approval by the Philippine Food and Drug Administration (“PFDA”). In light of the approval, the Company is preparing to initiate a Phase I clinical trial for YS-HBV-002 in the Philippines, which is expected to begin in June 2024.

Chronic HBV infection is a major global health concern, with an estimated 254 million people suffering from the condition, with 1.2 million new infections each year, according to the World Health Organization (WHO). Those infected are at higher risk for cirrhosis, liver failure, and liver cancer, with between 15%-40% of chronic HBV patients afflicted with one or more of these conditions. In 2022, HBV infection resulted in an estimated 1.1 million deaths, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer). Chronic HBV infections occur in both developing and developed countries, constituting a significant unaddressed public health threat. At present, the efficacy of existing anti-viral treatment paradigms is limited, and no cure for chronic HBV has yet been developed. Despite the availability of preventive vaccines for hepatitis B infection, there remains an urgent need for effective therapies for individuals who are already infected and have progressed to chronic stages of infection.

Dr. David Shao, Director, President, and CEO of YS Biopharma, commented, “The approval of YS-HBV-002 by the Philippines FDA and Ethics Committee represents a significant milestone in our efforts to develop innovative therapies for chronic hepatitis B infection. At present, there is no effective vaccine treatment option for patients suffering from chronic HBV, leaving them at higher risk for other conditions affecting the liver and significantly hampering their quality of life. With our recent approval and upcoming clinical study, we hope to provide these patients with a safe and effective solution to combat this significant unaddressed public health threat. As always, we plan to conduct the clinical trial to the highest safety and ethical standards, and we are eager to take the next step towards delivering these much-needed treatment options to chronic HBV patients.”

The Phase I clinical trial for YS-HBV-002 will mark an important milestone in addressing this unmet medical need. This trial will employ a double-blind, randomized, placebo-controlled, dose-escalation approach, and aims to evaluate the safety, immunogenicity, and efficacy of YS-HBV-002 among adult patients diagnosed with chronic HBV infection. By targeting both humoral and cellular immune responses, YS-HBV-002 has the potential to disrupt immune tolerance mechanisms and facilitate the treatment of chronic HBV infection in patients.

About YS-HBV-002

YS-HBV-002 is a new generation of therapeutic HBV vaccine based on the proprietary technology and clinical results of YS-HBV-001, the first generation of HBV vaccine in the pipeline of YS Biopharma. YS-HBV-002 is formulated with several key components, including recombinant core and surface hepatitis B antigens, and YS Biopharma’s proprietary PIKA adjuvant. This carefully designed set of components has the potential to activate both innate and adaptive immune responses in patients, thereby generating a more robust and targeted response to the virus. The re-establishment of a desirable and comprehensive immune response is the first step towards the eradication of chronic HBV infection from the body.

About YS Biopharma

YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of preventive and therapeutic biologics with a potential for improved Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines. 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 bio-pharmaceutical industry. For more information, please visit www.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 that the forward-looking statements in this press release will prove to 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 

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SOURCE YS Biopharma Co., Ltd.