Category: Health

Release – Eledon Pharmaceuticals Reports First Quarter 2024 Operating and Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

May 9, 2024

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Completed oversubscribed $50 million private placement

First participant dosed in clinical trial at University of Chicago Medicine assessing the use of tegoprubart to prevent islet cell transplant rejection in patients with type 1 diabetes

Reported updated data from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation

Tegoprubart used as part of immunosuppressive treatment following the first-ever kidney xenotransplant

IRVINE, Calif., May 09, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its first quarter 2024 operating and financial results and reviewed recent business highlights.

“We are pleased with the significant progress made so far this year in the development of tegoprubart for use both in kidney transplantation and in the emerging fields of xenotransplantation and islet cell transplantation. This progress reinforces tegoprubart’s potential to become the first-line immunosuppressive treatment option of choice for a broad range of transplant procedures,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon.

First Quarter 2024 and Recent Corporate Developments

  • First participant in an investigator-led clinical trial has received an islet cell transplant and is being treated with a novel immunosuppression regimen including tegoprubart, the company’s novel anti-CD40L antibody, which is in development for the prevention of pancreatic islet cell transplant rejection in patients with type 1 diabetes. The study is being conducted by the research team at the University of Chicago’s Pancreatic and Islet Transplant Program in collaboration with Eledon, the Juvenile Diabetes Research Foundation, and The Cure Alliance.
  • Announced the use of tegoprubart as part of the immunosuppressive treatment regimen used following the first-ever kidney xenotransplant procedure of a genetically modified kidney from a pig to a human.
  • Enrolled the 12th participant in March 2024 in the ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
  • Completed a private placement financing for total gross proceeds of $50.0 million, before deducting any offering related expenses, to a select group of institutional and accredited investors at a price per share of $2.37.

Anticipated 2024 Milestones

  • June 2024: Report updated interim clinical data from the ongoing Phase 1b trial and open-label extension study of tegoprubart in kidney transplantation at the American Transplant Congress in Philadelphia, PA.
  • End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.

First Quarter 2024 Financial Results

The Company reported a net loss of $10.3 million, or $0.34 per share, for the three months ended March 31, 2024, compared to a net loss of $10.8 million, or $0.75 per share, for the same period in 2023.

Research and development expenses were $7.4 million for the three months ended March 31, 2024, compared to $8.1 million for the comparable period in 2023, a decrease of $0.7 million.

General and administrative expenses were $3.5 million for the three months ended March 31, 2024, compared to $3.0 million for the comparable period in 2023, an increase of $0.5 million.

Eledon ended the first quarter with approximately $42.9 million in cash, cash equivalents and short-term investments, which excludes the $50.0 million in gross proceeds received in the recently completed private placement.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Qs, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

View full release here.

Release – Eledon Pharmaceuticals to Present Updated Data from Ongoing Phase 1b Trial of Tegoprubart in Patients Undergoing Kidney Transplantation at the American Transplant Congress

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

May 9, 2024

PDF Version

IRVINE, Calif., May 09, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that the Company will participate in the American Transplant Congress (ATC) taking place in Philadelphia, PA from June 1-5, 2024. The Company will present a poster that features updated data from Eledon’s ongoing open-label Phase 1b trial and open-label extension study evaluating tegoprubart for the prevention of rejection in patients undergoing kidney transplantation.

Details on the poster presentation are below:

Title: Biomarkers of Inflammation and eGFR in an Ongoing Phase 1B Study of an Anti-CD40L Antibody Tegoprubart, for the Prevention of Rejection in Kidney Transplant
Presenter: Steve Perrin, Ph.D., President and Chief Scientific Officer, Eledon Pharmaceuticals
Poster Number: 6647

Session Date and Time: Monday, June 3, 9:15-10:00 A.M. ET & 2:30-3:15 P.M. ET

Following the poster presentation, a copy of the poster can be found on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations.

The Company will also sponsor a satellite symposium at ATC titled: Blazing a path towards “Total Success” in Solid Organ Transplantation, to be held on Sunday, June 2, at 12:15pm ET. Faculty include, Flavio Vincenti, M.D., University of California San Francisco, Diane Cibrik, M.D., University of Kansas Health System, Allan Kirk, M.D., Duke University School of Medicine, Jay Fishman, M.D., Massachusetts General Hospital, Klemens Budde, M.D., Charité Universitätsmedizin Berlin and Roslyn Mannon, M.D., University of Nebraska Medical Center.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Source: Eledon Pharmaceuticals, Inc.

Release – GoHealth Reports First Quarter 2024 Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

May 09, 2024 at 6:01 AM EDT

CHICAGO, May 09, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (NASDAQ: GOCO) (“GoHealth” or the “Company”), a leading health insurance marketplace and Medicare-focused digital health company, today announced financial results for the three months ended March 31, 2024.

First Quarter Highlights

  • First quarter 2024 net revenues of $185.6 million, a slight increase compared to $183.2 million in the prior year period.
  • First quarter 2024 Submissions of 216,148, a 2,503 increase compared to 213,645 Submissions in the prior year period.
  • First quarter 2024 net loss of $21.3 million, an improvement of $1.2 million compared to $22.5 million in the prior year period.
  • First quarter 2024 Adjusted EBITDA(1) of $26.9 million, a decrease of $1.9 million compared to $28.8 million in the prior year period.
  • First quarter 2024 trailing twelve months (“TTM”) cash flow from operations was $101.2 million, compared to TTM cash flow from operations of $26.9 million in the prior year period.

Regulatory Updates

  • We are gaining insight into the Centers for Medicare and Medicaid Services (“CMS”) Final 2025 Marketing Rule and are confident that the CMS guidelines align with our Encompass model and our strategic plans.
  • Based on health plans’ reactions to the CMS Final 2025 Rate Notice we expect greater demand for the GoHealth personalized Encompass shopping and enrollment experience this fall.

“Our first quarter results exceeded our expectations and highlight our team’s ability to be innovative and resilient amongst market conditions. The proactive work we have done to drive consumer centricity has been instrumental in our ability to navigate the ever-evolving regulatory landscape. Our model is aligned with CMS’s intentions to protect consumers, and the work we have done has prepared us well for the current regulations and those likely to come,” said Vijay Kotte, CEO of GoHealth. “Looking ahead, we remain committed to leveraging our insights and technology to further improve the healthcare journey for consumers, ensuring they have the support they need to make informed decisions.”

“While we realize that rewarding agents for doing the right thing may not maximize revenue in the short term, we stand by our belief that PlanFit is an investment in the consumer that will pay off long-term,” said Jason Schulz, CFO of GoHealth. “This alignment of improved financial outcomes with our consumer-first philosophy supports our strategic direction. We remain committed to leveraging technology for better healthcare decisions, as we are poised to drive both sustained profitability and positive consumer impact in the years to come.

(1) Adjusted EBITDA is a non-GAAP measure. For a definition of Adjusted EBITDA and a reconciliation to the most comparable GAAP measure, please see below.

Conference Call Details

The Company will host a conference call today, Thursday, May 9, 2024 at 8:00 a.m. (ET) to discuss its financial results. Participants can pre-register for the conference call at the following link: https://register.vevent.com/register/BI3893cf432a644987bbaaed690971a174. A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.

Investor Relations:
John Shave
JShave@gohealth.com

Media Relations:
Pressinquiries@gohealth.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements are made in reliance upon the safe harbor provision of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, future capital expenditures and debt service obligations, are forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “aims,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “likely,” “future” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions, projections and other statements about future events that are based on current expectations and assumptions. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.

These forward-looking statements speak only as of the date of this press release and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described in the sections titled “Summary Risk Factors,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (“2023 Annual Report on Form 10-K”) and in our other filings with the Securities and Exchange Commission. The factors described in our 2023 Annual Report on Form 10-K should not be construed as exhaustive and should be read together with the other cautionary statements included in this press release, as well as the cautionary statements and other risk factors set forth in the forthcoming Quarterly Report on Form 10-Q for the first quarter ended March 31, 2024 and our other filings with the Securities and Exchange Commission.

You should read this press release and the documents that we reference in this press release completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

To view full release, click here.

PDS Biotechnology (PDSB) – PDS Holds KOL Event and Announces New Trial Design

Posted on by cpereira@noblefcm.com


Thursday, May 09, 2024

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

Robert LeBoyer, 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 Trial Design Will Test Two Drugs Against Standard Of Care. PDS Biotech held a KOL event featuring two prominent oncologists to discuss head and neck cancer and its clinical program data. The presentations included a review of current treatments and its two Phase 2 studies. The new Phase 3 study design was announced, now planned with three arms to test Versamune HPV with Keytruda, Versamune HPV and PDS01ADC with Keytruda, and Keytruda alone.

Phase 2 Trials Greatly Improved Patient Outcomes. The Phase 2 VERSATILE-002 trial testing Versamune HPV with Keytruda had strong improvements over current treatments in several clinical endpoints. During 2023, PDS discussed the path to approval for Versamune with the FDA. This led to design of the Phase 3 VERSATILE-003 trial testing the two-drug combination, similar to VERSATILE-002.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

MustGrow Biologics Corp. (MGROF) – California Joins the TerraSante Approved List

Posted on by cpereira@noblefcm.com


Thursday, May 09, 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.

Another Approval. The Company announced receipt of the California Department of Food Agriculture registration approval for its TerraSante product. MustGrow also received organic certification from California’s Organic Input Material (OIM) Program, specific certification for California. The certification is a requirement for organic products to be sold in California and goes beyond MustGrow’s existing Organic OMRI Listed certifications. California now joins Washington and Oregon as states to authorize product sales of TerraSante.

OIM Program. According to the California Department of Food Agriculture, the OIM program registers materials used for fertilization of organic crops and food production. The material is either bulk or packaged and excludes pesticides. The program is mandated by the Legislature with support from the industry.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Eledon Pharmaceuticals (ELDN) – Islet Cell Transplant Patient Treated As Kidney Data Presentation Is Announced

Posted on by cpereira@noblefcm.com


Wednesday, May 08, 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 IIT Study Has Started, With Phase 1b Data Kidney Trial Update In June.  An Investigator-Initiated Trial (IIT) testing tegoprubart in islet cell transplantation has treated its first patient. Interim data from the Phase 1b trial testing tegoprubart in kidney transplantation was announced, with presentation at a medical meeting scheduled for June 1 to June 5, 2024.

Tegoprubart Is Currently In Two Kidney Transplant Trials. Eledon continues to report follow-up data from its Phase 1b open-label trial for tacrolimus as it enrolls patients in the double-blind Phase 2 BESTOW trial. Tegoprubart acts through a different mechanism than tacrolimus (the current standard treatment), with potential to have greater protection against rejection with improved function. 


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – PDS Biotech to Announce First Quarter 2024 Financial Results on May 15, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., May 07, 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 that the Company will report financial results for the first quarter of 2024 and provide a business update on Wednesday, May 15, 2024, before the market opens. The press release will be available in the Investor Relations section of the Company’s website at www.pdsbiotech.com.

Additionally, the Company will host a Key Opinion Leader (“KOL”) Event on Wednesday, May 8, 2024, at 1:30 pm ET 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 KOL event 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

The event will be moderated by Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer who will also present the next steps on the clinical path forward to registration for the Versamune® HPV and PDS01ADC based triple combination.

To register for the KOL 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. 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.

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

Eledon Pharmaceutical’s Novel Transplant Drug Delivering Promising Early Results

Posted on by slightbourne@noblecapitalmarkets.com

Eledon Pharmaceuticals (NASDAQ:ELDN) is making exciting progress with its lead drug candidate tegoprubart, potentially ushering in a new era of safer and more effective immunosuppression for transplant recipients. The clinical-stage biotech recently achieved two major milestones that increase confidence in tegoprubart’s best-in-class prospects as a next-generation solution for preventing organ rejection.

First, the first participant has successfully received an islet cell transplant and treatment with tegoprubart in a pioneering trial at the University of Chicago. The study is evaluating tegoprubart as part of a novel immunosuppressive regimen aimed at reversing type 1 diabetes by allowing insulin independence after an islet cell transplant. Currently, toxic side effects from standard anti-rejection drugs limit broader utilization of this potential cure.

Tegoprubart’s selective mechanism of action blocking the CD40L pathway could open up islet transplantation to many more patients by avoiding the nephrotoxicity, neurotoxicity, hypertension and other issues seen with calcineurin inhibitors like tacrolimus. Reversing type 1 diabetes through a safe, functional islet cell transplant would provide transformative benefits for patient quality of life.

In addition to this groundbreaking study, Eledon also reported very promising interim Phase 1b results demonstrating tegoprubart’s ability to preserve kidney function with a well-tolerated safety profile following kidney transplantation. Through 1 year of treatment, participants averaged estimated glomerular filtration rates (eGFRs) greater than 60 mL/min/1.73m2 at all timepoints after day 30. This is substantially higher than the typical eGFRs in the low 50s seen in kidney transplant recipients on standard immunosuppressants during the first year.

These eGFR results highlight tegoprubart’s potential to protect transplanted kidneys from the nephrotoxic effects of current anti-rejection medications over the long-term. With similarly impressive 1-year eGFR data north of 90 mL/min/1.73m2 in two subjects, the drug could potentially enable kidney transplants to last significantly longer before failure versus what is currently possible.

From a safety perspective, tegoprubart was very well-tolerated in the Phase 1b trial. Only 3 out of 13 participants discontinued treatment due to manageable side effects like hair loss and fatigue, with no reports of graft loss or death. This clean profile contrasts starkly with the harsh toxicities of current calcineurin inhibitor regimens that often lead to treatment discontinuations.

With its unique mechanism avoiding general immunosuppression, tegoprubart represents a paradigm shift in preventing transplant rejection that could finally break the tradeoff between organ rejection and drug toxicity. Eledon plans to showcase the full Phase 1b kidney transplant dataset at an upcoming medical conference, setting the stage for additional catalysts from the ongoing Phase 2 BESTOW trial expected to read out in the coming months.

Analysts forecast peak sales for tegoprubart well into potential blockbuster territory above $1 billion across multiple transplant indications and autoimmune diseases like lupus that also involve the CD40/CD40L pathway. With its excellent early efficacy and safety results, tegoprubart is steadily derisking its path to becoming the next standard of care in immunosuppression for transplantation.

At a modest $50 million market cap, Eledon is currently an undervalued opportunity for investors considering tegoprubart’s multi-billion dollar commercial prospects. As the drug continues to make strides in the clinic, the company’s shares have tremendous upside potential. Eledon is definitively a clinical-stage biotech to keep high on the watchlist.

Take a moment to take a look at Eledon’s company presentation at NobleCon19.

Release – Traws Pharma Completes First Cohort Dosed In Phase 1 Trial For Covid Therapy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ONTX

May 07, 2024

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Investigational travatrelvir demonstrated preclinical activity against multiple SARS-CoV-2 variants

Orally administered novel protease inhibitor does not require ritonavir co-administration

First-in-Human study to evaluate safety, tolerability and pharmacokinetics in healthy volunteers

Topline Phase 1 data and Phase 2 initiation expected in H2 2024

NEWTOWN, Pa., May 07, 2024 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (“Traws” or “Traws Pharma”), a clinical stage biopharmaceutical company developing oral small molecules for respiratory viral diseases and cancer, today announced that it completed dosing in the first cohort of the first-in-human Phase 1 study to evaluate travatrelvir (TRX01), an orally-available protease inhibitor, in development for treatment of COVID19. There have been no safety observations reported.

“COVID-19 remains a significant global health concern, with SARS-CoV-2 infections posing a leading cause of mortality, especially among individuals aged 65 and above,” stated Werner Cautreels, Ph.D., Chief Executive Officer of Traws Pharma. “Our mission at Traws is to develop novel agents to treat respiratory viral diseases. Subject to future study results, we believe that travatrelvir may represent a major potential advance in the treatment of SARS-CoV-2 and are thrilled to advance this program into the first human clinical studies. We expect to report topline data from the Phase 1 study in H2 2024, followed by the initiation of an international Phase 2 safety and efficacy study.”

Robert R. Redfield, M.D., Chief Medical Officer of Traws Pharma and former director of the US Centers for Disease Control (CDC) added, “Travatrelvir has an exciting and unique profile. In preclinical trials, it is active against multiple SARS-CoV-2 variants, does not require ritonavir co-administration and has a pharmacokinetic profile that may enable a dosing regimen that reduces the likelihood of viral rebound. These qualities may enable travatrelvir to overcome some of the limitations reported with other treatments and position travatrelvir as a potential best-in-class agent. We are grateful for the collaboration of the clinical investigators, human volunteers, and study sites and hope that travatrelvir will represent a new treatment option for this deadly viral disease.”

About Travatrelvir, the Phase 1 Program and Planned Next Steps

Travatrelvir was designed as an inhibitor of the SARS-CoV-2 Mpro (3CL protease). It has demonstrated in vitro activity against the original strain of the virus as well as the delta and omicron variants and is more active than nirmatrelvir (Pfizer’s Mpro inhibitor) in preclinical studies. Also in preclinical studies, travatrelvir did not require co-administration with a human cytochrome P450 (CYP) inhibitor, such as ritonavir, and so it is expected to avoid associated drug:drug interactions, potentially permitting wider patient use. The drug candidate’s pharmacokinetic (PK) profile may enable a once daily, 10-day treatment regimen to reduce the likelihood of viral rebound. GLP toxicology studies did not identify adverse events (AEs) in animals at the doses being studied in the Phase 1 clinical trial.

The Phase 1 study will evaluate single and multiple ascending doses of travatrelvir in a double-blinded, placebo-controlled study to assess safety, tolerability, and pharmacokinetics. Subjects will be randomized 3:1 in five fasted and one fed single ascending dosing (SAD) cohorts and two multiple ascending dosing (MAD) cohorts. Topline data from the study, which is being conducted in Australia (ACTRN12624000220561p), and the initiation of an international Phase 2 study in subjects with moderate to severe COVID19, are expected to take place in H2 2024.

About Traws Pharma, Inc.

Traws Pharma is a clinical stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes an oral inhibitor of the SARS-CoV-2 Mpro (3CL protease), and a new oral antiviral drug candidate for influenza which targets the influenza cap-dependent endonuclease and has shown activity in cell-based assays against drug resistant viruses as well as against avian flu.

In the cancer program, Traws is developing the novel, proprietary multi-kinase CDK2/4/6 inhibitor narazaciclib for refractory endometrial cancer and potentially other cancers. Narazaciclib targets pathways involved in the development of resistance to CDK inhibitors.

Traws Pharma is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need or that are specifically vulnerable, we build solutions for important medical challenges, aiming to alleviate the burden of viral infections and cancer.

Forward-Looking Statements

Some of the statements in this release are 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, and involve risks and uncertainties including statements regarding the Phase 1 study of travatrelvir in Australia and its design, timing and potential results and the timing of a planned Phase 2 study. Traws has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Traws Pharma, Inc. Contact:
Mark Guerin
Traws Pharma, Inc.
267-759-3680
www.trawspharma.com

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Release – Eledon Announces Clinical Progress with Tegoprubart in the Prevention of Transplant Rejection

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

May 7, 2024

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First participant dosed in clinical trial at University of Chicago Medicine assessing the use of tegoprubart to prevent islet cell transplant rejection in patients with type 1 diabetes

Company reports updated data from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation

IRVINE, Calif., May 07, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that the first participant in an investigator-led clinical trial has received an islet cell transplant and is being treated with a novel immunosuppression regimen including tegoprubart, the company’s novel anti-CD40L antibody, which is in development for the prevention of pancreatic islet cell transplant rejection in patients with type 1 diabetes. The study is being conducted by the research team at University of Chicago Medicine’s Pancreatic and Islet Transplant Program. Separately, the company reported updated data from its ongoing Phase 1b trial demonstrating tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated.

In January 2024, Eledon announced a collaboration with the University of Chicago Transplant Institute for an investigator sponsored trial in pancreatic islet cell transplantation in patients with type 1 diabetes (NCT06305286). Eledon is supplying tegoprubart as a cornerstone component of the immunosuppressive regimen for trial participants and tegoprubart is being evaluated for the prevention of transplant rejection in the trial. Funding for the study includes grants from the Juvenile Diabetes Research Foundation (JDRF) and the Cure Alliance.

“There is clinical evidence from our studies and others conducted by the National Institute of Health’s Clinical Islet Transplantation Consortium that demonstrate islet cell transplantation may reverse diabetes by eliminating the need for exogenous insulin and reinstating metabolic control in selected patients with difficult to control type 1 diabetes. However, the required use of current standard of care anti-rejection medications, specifically calcineurin inhibitors, has limited the benefit of these procedures due to well-known associated toxicity to the islets, nephrotoxicity, neurotoxicity and risk of hypertension. We hope that tegoprubart will effectively protect islets from rejection without side effects related to current standard therapy,” said Piotr Witkowski, M.D., Ph.D., Director, Pancreatic and Islet Transplant Program, University of Chicago Medicine, and principal investigator of the trial with John Fung, M.D., Ph.D.

“This first islet cell transplant as part of the University of Chicago trial is a significant milestone in our efforts to advance tegoprubart as a novel and much-needed treatment option for transplant patients,” said Steven Perrin, Ph.D., President and Chief Scientific Officer of Eledon. “We look forward to continuing our work with the University of Chicago team and further studying tegoprubart and its potential ability to prevent islet cell transplant rejection that may lead to improved outcomes and quality of life for people living with type 1 diabetes.”

The company also announced updated data as of April 2024 from 13 participants in the ongoing Phase 1b trial evaluating tegoprubart for the prevention of rejection in kidney transplantation. Results demonstrated that tegoprubart is generally safe and well-tolerated and support tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation. Aggregate mean estimated glomerular filtration rate (eGFR) – a measure of kidney function – measured above 60 mL/min/1.73m2 at all reported time points after day 30. Two subjects completed 12 months on therapy post-transplant and both demonstrated mean eGFRs above 90 mL/min/1.73m2 at one year. Historical studies using standard of care immunosuppression therapy have reported average eGFRs generally in the low 50 mL/min/1.73m2 range during the first year after kidney transplant. To date, three subjects discontinued the study because of hair loss and fatigue, viral infection, and rejection, respectively. There have been no cases of graft loss or death. The company plans to present this data at the upcoming American Transplant Congress in Philadelphia, PA, in early June 2024.

Eledon is currently conducting a Phase 1b trial (NCT05027906), the Phase 2 BESTOW trial (NCT05983770), and a Long-Term Safety and Efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with islet cell transplantation or kidney transplantation, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals


Source: Eledon Pharmaceuticals, Inc.

Release – Eledon Pharmaceuticals Announces Oversubscribed $50 Million Private Placement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

May 7, 2024

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IRVINE, Calif., May 07, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it has entered into a securities purchase agreement with certain institutional and accredited healthcare investors for a private investment in public equity financing that is expected to result in gross proceeds of approximately $50 million, before deducting offering expenses. Pursuant to the terms of the securities purchase agreement, Eledon is selling an aggregate of 13,110,484 shares of its common stock (“Common Stock”) at a price of $2.37 per share and pre-funded warrants at a price of $2.369 per underlying share, which are exercisable to purchase 7,989,516 shares of Common Stock at a price of $0.001 per share. The financing is expected to close the week of May 6, 2024, subject to satisfaction of customary closing conditions. The oversubscribed financing was led by BVF Partners LP and includes participation from new and existing investors.

The Company intends to use the net proceeds from the private placement to fund pre-commercial activities for its products and general corporate purposes, which will include the clinical development of its lead asset tegoprubart.

The securities sold in the private placement, including the common shares underlying the pre-funded warrants, are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Concurrently with the execution of the securities purchase agreement, Eledon and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities issued in the private placement.

Leerink Partners is acting as lead placement agent. LifeSci Capital and Noble Capital Markets are acting as co-placement agents in connection with the financing.

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 Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Release – PDS Biotechnology Announces Details of Virtual KOL Event

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Virtual Webinar Updated VERSATILE-002 Phase 2 Trial Results, Unmet Treatment Needs in Advanced Head and Neck Cancer and Planned Triple Combination Trial to be held May 8, 2024

PRINCETON, N.J., May 03, 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 additional details of its virtual Key Opinion Leader (KOL) event to be held on Wednesday, May 8, 2024 at 1:30 PM ET. To register for the event, click here.

The virtual webinar will focus on the positive, updated data from the Company’s VERSATILE-002 Phase 2 clinical trial, current unmet need in HPV-positive head and neck cancer, and next steps for PDS Biotech’s planned triple combination trial including Versamune® HPV and PDS01ADC (IL-12 fused antibody drug conjugate).

Panel participants will include:

  • Jared Weiss, MD, 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 updated trial results
  • Robert Haddad, MD, 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 event will be moderated by Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer who will also present the next steps on the clinical path forward to registration for the Versamune® HPV and PDS01ADC based triple combination.

The VERSATILE-002 trial (NCT04260126) is evaluating Versamune® HPV in combination with the immune checkpoint inhibitor (“ICI”) KEYTRUDA® (pembrolizumab) in patients with unresectable, recurrent, or metastatic HPV16-positive HNSCC.

A live Q&A session will follow the formal presentations.

About Jared Weiss, MD
Jared Weiss, MD received his undergraduate degree from Brown University and medical degree from Yale University. He completed residency at Harvard’s Beth Israel Deaconess Medical Center then fellowship at the Hospital of the University of Pennsylvania. He is currently employed as a tenured professor of medicine at UNC’s Lineberger Comprehensive Cancer Center where he also serves as section chief of thoracic and head/neck oncology. Dr. Weiss is proud to volunteer for and serve on the executive board of cancergrace.org and to advocate with the Lung Cancer Initiative of North Carolina. Dr. Weiss has published extensively, including in the New England Journal of Medicine, the Journal of Clinical Oncology and Lancet Oncology. He has played a role in the development of numerous approved agents, most recently including pembrolizumab, durvalumab, selpercatinib, trilaciclib and adagrasib. He has frequently presented at international conferences, including the Presidential Session of the European Society of Medical Oncology and Plenary Session of the Multidisciplinary Head and Neck Cancer Symposium. Dr. Weiss’s clinical practice is focused on lung cancer and head/neck cancer. Dr. Weiss’s research is focused on personalized and adaptive immunotherapy to treat cancer (neo-antigen cancer vaccines and cellular therapeutics). He has particular interest in small-cell lung cancer and in NUT carcinoma.

About Robert Haddad, MD
Robert Haddad, MD is Professor of Medicine, Harvard Medical School, Division Chief and Institute Physician, Center of Head and Neck Oncology Program, and a member of the Department of Adult Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.

Dr. Haddad received his medical degree from Saint Joseph University, French Faculty of Medicine, and served as intern and resident at St. Luke’s Roosevelt Hospital Center, New York, New York. He completed his fellowship in hematology/oncology at Greenbaum Cancer Center, University of Maryland, Baltimore, Maryland. Dr. Haddad is a member of several professional societies, including the American Society of Clinical Oncology, American Association for Cancer Research and the American Society for Therapeutic Radiology and Oncology. Dr Haddad research is focused on identifying innovative forms of treatment in Head and Neck Cancer. His research activities involve the use of induction chemotherapy for patients with locally advanced head and neck cancer and the development of novel immunotherapeutic agents for treating locally advanced disease. He has been instrumental in the development, execution and publication of numerous phase II and III trials in head and neck cancer. These trials have advanced the field of head and neck oncology and have resulted in new therapies for patients.

Dr Haddad is also involved in teaching oncology fellows as well as medical residents, and ENT residents through the Dana-Farber Cancer Institute outpatient clinic and Brigham and Women’s Hospital inpatient service. He lectures extensively on head and neck cancer at the local, regional, national and international levels and has been invited to lecture in prestigious institutions and at national and international forums. He has presented his work at important scientific meetings such as the American Society of Clinical Oncology (ASCO) and the American Head and Neck Society Meeting (AHNS) and has edited two textbooks on head and neck cancer. Dr Haddad has an active role in the national comprehensive cancer network (NCCN) where he participates as a committee member in the head and neck committee and chair of the thyroid cancer committee. In this capacity, He helps write treatment guidelines. He has authored more than 200 publications related to Head and Neck cancer.

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.

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 – Ocugen To Host Conference Call on Tuesday, May 14 At 8:30 a.m. ET To Discuss Business Updates And First Quarter 2024 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 3, 2024

MALVERN, Pa., May 03, 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 it will host a conference call and live webcast to discuss the Company’s first quarter 2024 financial results and provide a business update at 8:30 a.m. ET on Tuesday, May 14, 2024.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 8699924
Webcast: Available on the events section of the Ocugen investor site

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

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

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