Author: aweinsoff@channelchek.com

Release – Beasley Broadcast Group Reports First Quarter Revenue of $54.4 Million

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Research News and Market Data on BBGI

May 08, 2024 07:00 ET| Source: Beasley Broadcast Group, Inc.Follow

 Conference Call and Webcast
Today, May 8, 2024 at 11:00 a.m. ET
877-407-4018 or 201-689-8471, conference ID 13746158 or www.bbgi.com

Replay information provided below		 
   

NAPLES, Fla., May 08, 2024 (GLOBE NEWSWIRE) — Beasley Broadcast Group, Inc. (Nasdaq: BBGI) (“Beasley” or the “Company”), a multi-platform media company, today announced operating results for the three-month period ended March 31, 2024. For further information, the Company has posted a presentation to its website regarding the first quarter highlights and accomplishments that management will review on today’s conference call.

First Quarter Financial Highlights

In millions, except per share dataThree Months Ended
March 31,
 20242023
Net revenue$54.4 $57.8 
Operating income (loss) (1.1) 0.4 
Net income (loss)1 0.0  (3.5)
Net income (loss) per diluted share1$0.00 ($0.12)
Adjusted EBITDA (non-GAAP) 0.7  2.6 

1 Net income (loss) and net income (loss) per diluted share in the three months ended March 31, 2024 include a $6.0 million gain on sale of an investment in Broadcast Music, Inc.

Net revenue during the three months ended March 31, 2024 decreased 5.9% to $54.4 million, primarily reflecting a year-over-year decline in audio advertising and other revenue due to Beasley’s Wilmington station and esports divestitures as well as ongoing softness in the commercial advertising business, partially offset by growth in digital and political advertising revenue.

Beasley reported an operating loss of $1.1 million in the first quarter of 2024 compared to operating income of $0.4 million in the first quarter of 2023, largely reflecting the year-over-year decrease in net revenue.

Beasley reported net income of approximately $8,000, or $0.00 per diluted share, in the three months ended March 31, 2024, compared to a net loss of $3.5 million, or $0.12 per diluted share, in the three months ended March 31, 2023. The year-over-year improvement was primarily due to the $6.0 million gain on sale of an investment in Broadcast Music, Inc. holdings and lower interest expense.

Adjusted EBITDA (a non-GAAP financial measure) was $0.7 million in the first quarter of 2024 compared to $2.6 million in the first quarter of 2023. The year-over-year decrease is primarily attributable to lower net revenue compared to the prior year period.

Please refer to the “Calculation of Adjusted EBITDA” and “Reconciliation of Net Income (Loss) to Adjusted EBITDA” tables at the end of this release.

Commenting on the financial results, Caroline Beasley, Chief Executive Officer, said, “Beasley continues to advance our core initiatives, which are focused on driving revenue and cash flow, including our digital transformation, revenue diversification and expense management initiatives. We expect digital to account for between 20% and 25% of total revenue in 2024, driven by the ongoing growth and success of our premium content creation and digital services. On the new business front, our dedicated sales teams are leveraging the tremendous audience reach and engagement of our platform to attract new advertisers.

“In summary, Beasley’s underlying fundamentals—mainly, our local audio and digital platforms and audience engagement—remain strong. We are proud of our teams’ steadfast commitment to delivering exceptional content and services to our listeners, advertisers, online users and sports fans, and remain confident that the actions we are taking to transform our company and strengthen our balance sheet, are laying the foundation for future growth and success.”

First Quarter 2024 Highlights

  • Revenue from new customers grew 53% year over year
  • Generated $548,000 in political revenue
  • Local revenue, including digital packages sold locally, accounted for 69% of Total Revenue
  • Digital revenue grew 10% year-over-year, or 20% year-over-year on a same station basis, to $11,000,000
  • Digital revenue accounted for 20% of total company revenue
  • 38% of our total audience listens via the company’s digital platforms

Conference Call and Webcast Information
The Company will host a conference call and webcast today, May 8, 2024, at 11:00 a.m. ET to discuss its financial results and operations. To access the conference call, interested parties may dial 877-407-4018 or 201-689-8471, conference ID 13746158 (domestic and international callers). Participants can also listen to a live webcast of the call at the Company’s website at www.bbgi.com. Please allow 15 minutes to register and download and install any necessary software. Following its completion, a replay of the webcast can be accessed for five days on the Company’s website, www.bbgi.com.

Questions from analysts, institutional investors and debt holders may be e-mailed to ir@bbgi.com at any time up until 9:00 a.m. ET on Wednesday, May 8, 2024. Management will answer as many questions as possible during the conference call and webcast (provided the questions are not addressed in their prepared remarks).

About Beasley Broadcast Group
Beasley Broadcast Group, Inc. (www.bbgi.com) was founded in 1961 by George G. Beasley and owns 57 AM and FM stations in 13 large- and mid-size markets in the United States. Beasley radio stations reach over 30 million unique consumers weekly over-the-air, online and on smartphones and tablets, and millions regularly engage with the Company’s brands and personalities through digital platforms such as Facebook, Twitter, text, apps and email. For more information, please visit www.bbgi.com.

For further information, or to receive future Beasley Broadcast Group news announcements via e-mail, please contact Beasley Broadcast Group, at 239-263-5000 or email@bbgi.com, or Joseph Jaffoni, JCIR, at 212-835-8500 or bbgi@jcir.com.

Definitions
EBITDA is defined as net income (loss) before interest income or expense, income tax expense or benefit, depreciation, and amortization.

Adjusted EBITDA is defined as EBITDA further adjusted to exclude certain, non-operating or other items that we believe are not indicative of the performance of our ongoing operations, such as impairment losses, other income or expense, or equity in earnings of unconsolidated affiliates. See “Reconciliation of Net Income (Loss) to Adjusted EBITDA” for additional information.

Adjusted EBITDA can also be calculated as net revenue less operating and corporate expenses. We define operating expenses as cost of services and selling, general and administrative expenses. Corporate expenses include general and administrative expenses and certain other income and expense items not allocated to the operating segments.

Adjusted EBITDA is a measure widely used in the media industry. The Company recognizes that because Adjusted EBITDA is not calculated in accordance with GAAP, it is not necessarily comparable to similarly titled measures employed by other companies. However, management believes that Adjusted EBITDA provides meaningful information to investors because it is an important measure of how effectively we operate our business and assists investors in comparing our operating performance with that of other media companies.

Same station revenue excludes revenue from all divestitures and other operations that were exited in the prior 12 months.

New business revenue is defined as revenue from an advertiser that has not advertised in the prior 13 months before the start of the current quarter.

Note Regarding Forward-Looking Statements
Statements in this release that are “forward-looking statements” are based upon current expectations and assumptions and involve certain risks and uncertainties within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Words or expressions such as “looking ahead,” “intends,” “believes,” “expects,” “seek,” “will,” “should” or variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements, by their nature, address matters that are, to different degrees, uncertain. Key risks are described in the Company’s reports filed with the Securities and Exchange Commission (“SEC”) including its annual report on Form 10-K and quarterly reports on Form 10-Q. Readers should note that forward-looking statements are subject to change and to inherent risks and uncertainties and may be impacted by several factors, including:

  • our ability to comply with the continued listing standards of the Nasdaq Capital Market;
  • risk from social and natural catastrophic events;
  • external economic forces and conditions that could have a material adverse impact on our advertising revenues and results of operations;
  • the ability of our stations to compete effectively in their respective markets for advertising revenues;
  • our ability to develop compelling and differentiated digital content, products and services;
  • audience acceptance of our content, particularly our audio programs;
  • our ability to respond to changes in technology, standards and services that affect the audio industry;
  • our dependence on federally issued licenses subject to extensive federal regulation;
  • actions by the FCC or new legislation affecting the audio industry;
  • increases to royalties we pay to copyright owners or the adoption of legislation requiring royalties to be paid to record labels and recording artists;
  • our dependence on selected market clusters of stations for a material portion of our net revenue;
  • credit risk on our accounts receivable;
  • the risk that our FCC licenses and/or goodwill could become impaired;
  • our substantial debt levels and the potential effect of restrictive debt covenants on our operational flexibility and ability to pay dividends;
  • the potential effects of hurricanes on our corporate offices and stations;
  • the failure or destruction of the internet, satellite systems and transmitter facilities that we depend upon to distribute our programming;
  • disruptions or security breaches of our information technology infrastructure and information systems;
  • the loss of key personnel;
  • our ability to integrate acquired businesses and achieve fully the strategic and financial objectives related thereto and their impact on our financial condition and results of operations;
  • the fact that our Company is controlled by the Beasley family, which creates difficulties for any attempt to gain control of our Company; and
  • other economic, business, competitive, and regulatory factors affecting our businesses, including those set forth in our filings with the SEC.

Our actual performance and results could differ materially because of these factors and other factors discussed in our SEC filings, including but not limited to our annual reports on Form 10-K or quarterly reports on Form 10-Q, copies of which can be obtained from the SEC, www.sec.gov, or our website, www.bbgi.com. All information in this release is as of May 8, 2024, and we undertake no obligation to update the information contained herein to actual results or changes to our expectations, except as required by law.

View the full release here.

CONTACT: 
B. Caroline BeasleyJoseph Jaffoni, Jennifer Neuman
Chief Executive OfficerJCIR
Beasley Broadcast Group, Inc.212/835-8500 or bbgi@jcir.com
239/263-5000 or ir@bbgi.com 
  

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

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 – AdTheorent Holding Company, Inc. Announces Expiration of “Go-Shop” Period Contained in Previously Announced Merger Agreement and Receipt of Acquisition Proposal

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ADTH

May 6, 2024

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NEW YORK, May 06, 2024 (GLOBE NEWSWIRE) — AdTheorent Holding Company, Inc. (“AdTheorent” or the “Company”) (Nasdaq: ADTH), a machine learning pioneer delivering measurable value for programmatic advertisers, today announced the expiration of the 33-day “go-shop” period pursuant to the terms of the previously announced definitive merger agreement (the “Merger Agreement”) pursuant to which Cadent, LLC (“Cadent”), a leading provider of platform-based converged TV advertising solutions and a portfolio company of Novacap, one of North America’s established private equity firms, agreed to acquire all outstanding shares of AdTheorent common stock for $3.21 per share in cash, or approximately $324 million. The “go-shop” period expired at 11:59 p.m. Eastern Time on May 4, 2024.

During the go-shop period, AdTheorent received one acquisition proposal (the “Go-Shop Proposal”) from a third-party (the “Go-Shop Party”), pursuant to which the Go-Shop Party proposed to acquire all outstanding shares of AdTheorent common stock for $3.35 per share in cash. The Go-Shop Proposal is non-binding and subject to the completion of confirmatory due diligence, as well as the negotiation of a definitive merger agreement with the Go-Shop Party. On May 6, 2024, AdTheorent’s board of directors determined, in accordance with the Merger Agreement, that the Go-Shop Proposal would reasonably be expected to lead to a Superior Company Proposal (as defined in the Merger Agreement), and provided Cadent with written notice of the Go-Shop Proposal. The Merger Agreement permits AdTheorent, following the delivery of such notice, to engage in further discussions and negotiations with the Go-Shop Party, and to continue to take any other actions that were permitted during the go-shop period, in response to the Go-Shop Proposal.

If and when AdTheorent notifies Cadent that the board of directors has determined that the Go-Shop Proposal constitutes a Superior Company Proposal, and that it intends to terminate the Merger Agreement in favor of the Go-Shop Proposal, Cadent will be entitled to certain “match rights” under the Merger Agreement prior to any such termination. There is no assurance that AdTheorent’s receipt of the Go-Shop Proposal will lead to a Superior Company Proposal or an alternative transaction with the Go-Shop Party in lieu of the existing transaction with Cadent.

At this time, the Company remains subject to the Merger Agreement, the provisions of which will remain in effect unless and until the Merger Agreement is terminated. The Board has not made an “Adverse Recommendation Change” (as defined in the Merger Agreement). The Company does not intend to disclose further developments with respect to this process unless and until it determines it is appropriate to do so, subject to the terms of the Merger Agreement.

About AdTheorent:

AdTheorent uses advanced machine learning technology and privacy-forward solutions to deliver impactful advertising campaigns for marketers. AdTheorent’s advanced machine learning-powered media buying platform powers its predictive targeting, predictive audiences, geo-intelligence, audience extension solutions and in-house creative capability, Studio A\T. Focused on the predictive value of machine learning models, AdTheorent’s product suite and flexible transaction models allow advertisers to identify the most qualified potential consumers coupled with the optimal creative experience to deliver superior results, measured by each advertiser’s real-world business goals. AdTheorent is headquartered in New York, with fourteen locations across the United States and Canada.

AdTheorent is consistently recognized with numerous technology, product, growth and workplace awards. AdTheorent was named “Best Buy-Side Programmatic Platform” in the 2023 Digiday Technology Awards and was honored with an AI Breakthrough Award and “Most Innovative Product” (B.I.G. Innovation Awards) for six consecutive years. Additionally, AdTheorent is the only seven-time recipient of Frost & Sullivan’s “Digital Advertising Leadership Award.” In September 2023, evidencing its continued prioritization of its team, AdTheorent was named a Crain’s Top 100 Best Place to Work in NYC for the tenth consecutive year. AdTheorent ranked tenth in the Large Employer Category and 26th Overall in 2023. For more information, visit adtheorent.com.

Additional Information and Where to Find It:

This release may be deemed to be solicitation material in respect of the transaction contemplated by the Merger Agreement (the “proposed merger”). In connection with the proposed merger, the Company filed its Preliminary Proxy Statement on April 30, 2024. This communication is not a substitute for the Preliminary Proxy Statement or any other document that AdTheorent may file with the SEC or send to its stockholders in connection with the proposed merger. If and when the Company files its proxy statement in definitive form (the “Definitive Proxy Statement”) with the SEC, the Company will mail the Definitive Proxy Statement and a proxy card to each stockholder entitled to vote at the special meeting relating to the proposed merger. INVESTORS AND STOCKHOLDERS OF THE COMPANY ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE COMPANY’S DEFINITIVE PROXY STATEMENT (IF AND WHEN AVAILABLE), BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER. Investors and security holders are or will be able to obtain the documents (if and when available) free of charge at the SEC’s website at www.sec.gov, or free of charge from the Company by directing a request to April Scee, Investor Relations at AdTheorentIR@icrinc.com or (646) 277-1219.

Participants in the Solicitation:

AdTheorent, Cadent, and their respective directors, executive officers and other members of management and employees, under SEC rules, may be deemed to be “participants” in the solicitation of proxies from stockholders of AdTheorent in favor of the proposed merger. Additional information about AdTheorent’s directors and executive officers is set forth in AdTheorent’s Form 10-K/A for the year ended December 31, 2023, which was filed with the SEC on April 25, 2024 (the “Form 10-K/A”). To the extent holdings of AdTheorent’s securities by its directors or executive officers have changed since the amounts set forth in the Form 10-K/A, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC. Additional information concerning the interests of AdTheorent’s participants in the solicitation, which may, in some cases, be different than those of AdTheorent’s stockholders generally, will be set forth in the Definitive Proxy Statement relating to the proposed merger if and when it becomes available.

No Offer or Solicitation:

This release is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made in the United States absent registration under the Securities Act of 1933, as amended, or pursuant to an exemption from, or in a transaction not subject to, such registration requirements.

Forward Looking Statements:

This release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate or imply future results, performance or achievements, and may contain words such as “believe,” “anticipate,” “expect,” “estimate,” “intend,” “project,” “plan,” or words or phrases with similar meaning. Such statements may also include statements regarding the completion of the proposed merger and the expected timing of the completion of the proposed merger, the management of AdTheorent upon completion of the proposed merger and AdTheorent’s plans upon completion of the proposed merger. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on current expectations, forecasts and assumptions that involve risks and uncertainties, including, but not limited to, the market for programmatic advertising developing slower or differently than AdTheorent’s expectations, the demands and expectations of clients and the ability to attract and retain clients and other economic, competitive, governmental and technological factors outside of AdTheorent’s control, that may cause AdTheorent’s business, strategy or actual results to differ materially from the forward-looking statements. Actual future results, performance or achievements may differ materially from historical results or those anticipated depending on a variety of factors, some of which are beyond the control of AdTheorent, including, but not limited to, the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement, including under circumstances that would require the Company to pay a termination fee; the inability to complete the proposed merger due to the failure to obtain stockholder approval for the proposed merger or the failure to satisfy other conditions to completion of the proposed merger; risks related to disruption of management’s attention from AdTheorent’s ongoing business operations due to the proposed merger; unexpected costs, charges or expenses resulting from the proposed merger; AdTheorent’s ability to retain and hire key personnel in light of the proposed merger; certain restrictions during the pendency of the proposed merger that may impact AdTheorent’s ability to pursue certain business opportunities or strategic transactions; the ability of the buyer to obtain the necessary financing arrangements set forth in the commitment letters received in connection with the proposed merger; potential litigation relating to the proposed merger that could be instituted against the parties to the Merger Agreement or their respective directors, managers or officers, including the effects of any outcomes related thereto; the effect of the announcement of the proposed merger on AdTheorent’s relationships with its customers, operating results and business generally; and the risk that the proposed merger will not be consummated in a timely manner, if at all. AdTheorent refers you to the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Form 10-K for the fiscal year ended December 31, 2023, and comparable sections of the Company’s Quarterly Reports on Form 10-Q and other filings, which have been filed with the SEC and are available on the SEC’s website at www.sec.gov. All of the forward-looking statements made in this report are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on AdTheorent or its business or operations. Readers are cautioned not to rely on the forward-looking statements contained in this report. Forward-looking statements speak only as of the date they are made and AdTheorent does not undertake any obligation to update, revise or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by applicable law.

Investor Contact:
David DeStefano, ICR
AdTheorentIR@icrinc.com
(203) 682-8383

Press Contact:
Melanie Berger, AdTheorent
melanie@adtheorent.com
(850) 567-0082

Release – Bowlero Reports Third Quarter Results For Fiscal Year 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BOWL

05/06/2024

RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL) (“Bowlero” or the “Company”), one of the world’s premier operators of location-based entertainment, today provided financial results for the third quarter of the 2024 Fiscal Year, which ended on March 31, 2024.

Quarter Highlights:

  • Revenue increased 7.0% to $337.7 million versus the prior year and increased 64.7% versus 3QFY19 (quarter ended March 31, 2019)
  • Revenue excluding Service Fee Revenue increased 8.8% to $336.4 million versus the prior year and was up 64.1% versus 3QFY19
  • Same Store Revenue declined 2.1% versus the prior year and grew 26.1% versus 3QFY19
  • Net income of $23.8 million versus prior year loss of $32.1 million and income of $27.4 million in 3QFY19
  • Adjusted EBITDA of $122.8 million versus prior year of $127.6 million and $67.4 million in 3QFY19
  • Added 2 locations during the quarter, 1 through acquisitions and 1 new build-out, bringing year-to-date new locations to 23
  • Total locations in operation as of May 6, 2024 is 352

“Third quarter fiscal year 2024 started slowly due to weather. Post the first three weeks of January, we found a stable footing and increased investments to drive traffic. After the first three weeks of the quarter, we achieved a positive same-store-comp and double-digit total growth. Lucky Strike Miami opened in the quarter with exciting results, and we expect to have four more new builds opening in the next nine months with two in the Denver area and two in California. Summer Season Pass returned this year, and we expect that our continued investments in traffic will drive results throughout the spring and fall,” said Thomas Shannon, Founder and Chief Executive Officer of Bowlero.

“Last week, we closed an acquisition in the water park space by acquiring Raging Waves, the largest outdoor water park in Illinois. We bought the park at an attractive price with the opportunity to partner with a strong operator in the space,” followed Thomas Shannon. “We will continue to use internal and external investments to support increasing wallet share from customers in the out-of-home entertainment space, helping grow our industry-leading free cash flow generation.”

Bobby Lavan, Chief Financial Officer, added, “We had a strong cash flow quarter building up cash balances as we focused on investing capital in new builds and acquisitions. We ended the quarter with $212 million of cash and $432 million of total liquidity.”

Positive Update on EEOC Matter

The Company has received positive updates on the status of the age discrimination claims that had been pending with the EEOC. On April 12, 2024, the EEOC issued Closure Notices for the individual age discrimination charges that had been filed, in most cases, many years ago with the EEOC. The notices provide the claimants, as a matter of course, with an individual right to sue. The vast majority of these claims are time-barred. On May 3, 2024, the EEOC issued an additional Closure Notice for the related pattern and practice directed investigation. The notice states that the EEOC has determined not to bring litigation against the Company.

Share Repurchases

From January 1, 2024 through May 6, 2024, the Company repurchased 1.1 million shares of Class A common stock for approximately $13 million, bringing current total repurchases in fiscal year 2024 to approximately 20.8 million. Since 2021, the Company has spent approximately $446 million retiring all SPAC-related warrants, repurchasing 32.1 million shares of common stock, and 5.0 million as-converted preferred shares, reducing common stock outstanding by about 20%.

Dividend

The Board of Directors declared a quarterly cash dividend of $0.055 per share of common stock for the fourth quarter of fiscal year 2024. The dividend will be payable on June 7, 2024, to stockholders of record on May 24, 2024.

Fiscal Year 2024 Guidance

After completing three fiscal quarters, we now expect to be near the low end of our fiscal year 2024 Revenue and Adjusted EBITDA guidance.

Investor Webcast Information

Listeners may access an investor webcast hosted by Bowlero. The webcast and results presentation will be accessible at 10:00 AM ET on May 6, 2024 in the Events & Presentations section of the Bowlero Investor Relations website at https://ir.bowlerocorp.com/overview/default.aspx.

About Bowlero Corp.

Bowlero Corporation is one of the world’s premier operators of location-based entertainment. With over 350 locations across North America, the Company serves more than 40 million guest visits annually through a family of brands that include Lucky Strike, Bowlero and AMF. In 2019, Bowlero acquired the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Bowlero, please visit BowleroCorp.com.

Forward Looking Statements

Some of the statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risk, assumptions and uncertainties, such as statements of our plans, objectives, expectations, intentions and forecasts. These forward-looking statements are generally identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “confident,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on our management’s current expectations, estimates, forecasts, projections, assumptions, beliefs and information. Although management believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will prove to have been correct. All such forward-looking statements are subject to risks and uncertainties, many of which are outside of our control, and could cause future events or results to be materially different from those stated or implied in this document. It is not possible to predict or identify all such risks. These risks include, but are not limited to: our ability to design and execute our business strategy; changes in consumer preferences and buying patterns; our ability to compete in our markets; the occurrence of unfavorable publicity; risks associated with long-term non-cancellable leases for our centers; our ability to retain key managers; risks associated with our substantial indebtedness and limitations on future sources of liquidity; our ability to carry out our expansion plans; our ability to successfully defend litigation brought against us; our ability to adequately obtain, maintain, protect and enforce our intellectual property and proprietary rights and claims of intellectual property and proprietary right infringement, misappropriation or other violation by competitors and third parties; failure to hire and retain qualified employees and personnel; the cost and availability of commodities and other products we need to operate our business; cybersecurity breaches, cyber-attacks and other interruptions to our and our third-party service providers’ technological and physical infrastructures; catastrophic events, including war, terrorism and other conflicts; public health emergencies and pandemics, such as the COVID-19 pandemic, or natural catastrophes and accidents; changes in the regulatory atmosphere and related private sector initiatives; fluctuations in our operating results; economic conditions, including the impact of increasing interest rates, inflation and recession; and other factors described under the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) by the Company on September 11, 2023, as well as other filings that the Company will make, or has made, with the SEC, such as Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this press release and in other filings. We expressly disclaim any obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by applicable law.

Non-GAAP Financial Measures

To provide investors with information in addition to our results as determined under Generally Accepted Accounting Principles (“GAAP”), we disclose Revenue Excluding Service Fee Revenue, Total Bowling Center Revenue, Same Store Revenue and Adjusted EBITDA as “non-GAAP measures”, which management believes provide useful information to investors because each measure assists both investors and management in analyzing and benchmarking the performance and value of our business. Accordingly, management believes that these measurements are useful for comparing general operating performance from period to period, and management relies on these measures for planning and forecasting of future periods. Additionally, these measures allow management to compare our results with those of other companies that have different financing and capital structures. These measures are not financial measures calculated in accordance with GAAP and should not be considered as a substitute for revenue, net income, or any other operating performance or liquidity measure calculated in accordance with GAAP, and may not be comparable to a similarly titled measure reported by other companies. Our fiscal year 2024 guidance measures (other than revenue) are provided on a non-GAAP basis without a reconciliation to the most directly comparable GAAP measure because the Company is unable to predict with a reasonable degree of certainty certain items contained in the GAAP measures without unreasonable efforts. For the same reasons, the Company is unable to address the probable significance of the unavailable information. Such items include, but are not limited to, acquisition related expenses, stock-based compensation and other items not reflective of the company’s ongoing operations.

Revenue Excluding Service Fee Revenue represents Total Revenue less Service Fee Revenue. Total Bowling Center Revenue represents Total Revenue less Non-Center Related Revenue, Revenue from Closed Centers (as defined below), and Service Fee Revenue, if applicable. Same Store Revenue represents Total Revenue less Non-Center Related Revenue, Revenue from Closed Centers, Service Fee Revenue, if applicable, and Acquired Revenue. Adjusted EBITDA represents Net Income (Loss) before Interest Expense, Income Taxes, Depreciation and Amortization, Share-based Compensation, EBITDA from Closed Locations, Foreign Currency Exchange Loss (Gain), Asset Disposition Loss (Gain), Transactional and other advisory costs, changes in the value of earnouts, and other.

The Company considers Revenue Excluding Service Fee Revenue as an important financial measure because provides a financial measure of revenue directly associated with consumer discretionary spending and Total Bowling Center Revenue as an important financial measure because it provides a financial measure of revenue directly associated with bowling center operations. The Company also considers Same Store Revenue as an important financial measure because it provides comparable revenue for centers open for the entire duration of both the current and comparable measurement periods.

The Company considers Adjusted EBITDA as an important financial measure because it provides a financial measure of the quality of the Company’s earnings. Other companies may calculate Adjusted EBITDA differently than we do, which might limit its usefulness as a comparative measure. Adjusted EBITDA is used by management in addition to and in conjunction with the results presented in accordance with GAAP. We have presented Adjusted EBITDA solely as a supplemental disclosure because we believe it allows for a more complete analysis of results of operations and assists investors and analysts in comparing our operating performance across reporting periods on a consistent basis by excluding items that we do not believe are indicative of our core operating performance. Adjusted EBITDA has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. Some of these limitations are that Adjusted EBITDA:

  • do not reflect every expenditure, future requirements for capital expenditures or contractual commitments;
  • do not reflect changes in our working capital needs;
  • do not reflect the interest expense, or the amounts necessary to service interest or principal payments, on our outstanding debt;
  • do not reflect income tax (benefit) expense, and because the payment of taxes is part of our operations, tax expense is a necessary element of our costs and ability to operate;
  • do not reflect non-cash equity compensation, which will remain a key element of our overall equity based compensation package; and
  • do not reflect the impact of earnings or charges resulting from matters we consider not to be indicative of our ongoing operations.

To view full release click here.

Bowlero Corp. Investor Relations

IR@BowleroCorp.comSource: Bowlero Corp

Release – Bitcoin Depot Schedules First Quarter 2024 Conference Call for Tuesday, May 14th at 10:00 am ET

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BTM

May 06, 2024 8:05 AM EDT

ATLANTA, May 06, 2024 (GLOBE NEWSWIRE) — Bitcoin Depot (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, will hold a conference call and live audio webcast on Tuesday, May 14th at 10:00 a.m. Eastern time (7:00 a.m. Pacific Time) to discuss its financial results for the first quarter ended March 31, 2024. Bitcoin Depot plans to release results before the market open on the same day.

Call Date: Tuesday, May 14, 2024  
Time: 10:00 a.m. Eastern time (7:00 a.m. Pacific time)
U.S. dial-in: 646-968-2525
International dial-in: 888-596-4144
Conference ID: 1037410

The conference call will broadcast live and be available for replay here following the call.

Please call the conference telephone number approximately 10 minutes before the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Bitcoin Depot’s investor relations team at 1-949-574-3860.

A replay of the call will be available beginning after 2:00 p.m. Eastern time on May 14, 2024 through May 21, 2024.

U.S. replay number: 609-800-9909
International replay number: 800-770-2030
Conference ID: 1037410

About Bitcoin Depot
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with approximately 7,400 kiosk locations as of April 1, 2024. Learn more at www.bitcoindepot.com. 

Contacts:

Investors 
Cody Slach, Alex Kovtun 
Gateway Group, Inc. 
949-574-3860 
BTM@gateway-grp.com

Media 
Zach Kadletz, Brenlyn Motlagh, Ryan Deloney 
Gateway Group, Inc.
949-574-3860 
BTM@gateway-grp.com

Source: Bitcoin Depot Inc.

Released May 6, 2024

Release – Conduent Announces Agreement to Sell its Casualty Claims Solutions Business to MedRisk

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CNDT

MAY 03, 2024

Transaction expected to close the third quarter of 2024

FLORHAM PARK, N.J. — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, today announced an agreement to sell its Casualty Claims Solutions business to MedRisk, the nation’s largest managed care organization dedicated to the physical rehabilitation of workers’ compensation patients.

The sale, for $240 million in cash, subject to customary adjustments, consists of Conduent’s workers’ compensation and auto casualty bill review solutions and services that includes the processing of medical bills and clinical services, and its portfolio of Strataware bill review software products. In 2023, the business, with approximately 100 clients across multiple markets, processed approximately 29 million medical bills.

As part of this transaction, current Conduent employees in the Casualty Claims Solutions business will join MedRisk. Conduent will continue to provide mailroom services for current casualty claims clients including MedRisk. The transaction is expected to close in the third quarter of 2024, subject to the satisfaction of customary closing conditions and regulatory approvals.

“This transaction is an additional example of the significant progress we have made in our strategy to streamline our portfolio while increasing our focus on core capabilities to fuel Conduent’s growth,” said Cliff Skelton, Conduent President and CEO. “MedRisk is well-established in the workers’ compensation industry, and we are confident in a seamless transition for our associates and clients.”

About Conduent

Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 59,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com .

About MedRisk

Based in King of Prussia, Pennsylvania, MedRisk is the nation’s largest managed care organization dedicated to the physical rehabilitation of workers’ compensation patients. For more information, please visit www.medrisknet.com or call 800-225-9675.

Note: To receive RSS news feeds, visit www.news.conduent.com . For open commentary, industry perspectives and views, visit http://twitter.com/Conduent, http://www.linkedin.com/company/conduent or http://www.facebook.com/Conduent.

Trademarks

Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.

Forward-Looking Statements

This press release may contain “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “estimate,” “expect,” “plan,” “intend,” “will,” “aim,” “should,” “could,” “forecast,” “target,” “may,” “continue to,” “endeavor,” “if,” “growing,” “projected,” “potential,” “likely,” “see,” “ahead,” “further,” “going forward,” “on the horizon,” and similar expressions (including the negative and plural forms of such words and phrases), as they relate to us, are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. All statements other than statements of historical fact included in this press release are forward-looking statements, including, but not limited to, all statements regarding the sale of Conduent’s Casualty Claims Solutions business, including that such transaction will be consummated and the timing of such consummation, expectations regarding our strategy to streamline our portfolio while increasing our focus on core capabilities to fuel Conduent’s growth, expectations regarding continued efforts to be strategic regarding the allocation of capital and any future portfolio rationalization efforts, and our confidence in a seamless transition for our associates and clients. These statements reflect our current views with respect to future events and are subject to certain risks, uncertainties and assumptions, many of which are outside of our control, that could cause actual results to differ materially from those expected or implied by such forward-looking statements contained in this press release, any exhibits to this press release and other public statements we make. Important factors and uncertainties that could cause actual results to differ materially from those in our forward-looking statements include, but are not limited to: Conduent’s ability to realize the benefits anticipated from the sale of its Casualty Claims Solutions business, including as a result of a delay or failure to obtain certain required regulatory approvals or the failure of any other condition to the closing of the transaction such that the closing of the transaction is delayed or does not occur; unexpected costs, liabilities or delays in connection with the proposed transaction; the significant transaction costs associated with the proposed transaction; negative effects of the announcement, pendency or consummation of the transaction on the market price of our common stock or operating results, including as a result of changes in key customer, supplier, employee or other business relationships; the risk of litigation or regulatory actions; our inability to retain and hire key personnel; the risk that certain contractual restrictions contained in the definitive transaction agreement during the pendency of the proposed transaction could adversely affect our ability to pursue business opportunities or strategic transactions; and other factors that are set forth in the “Risk Factors” and other sections of our Annual Report on Form 10-K, as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with or furnished to the Securities and Exchange Commission. Any forward-looking statements made by us in this press release speak only as of the date on which they are made. We are under no obligation to, and expressly disclaim any obligation to, update or alter our forward-looking statements, whether because of new information, subsequent events or otherwise, except as required by law.

Media Contacts

SEAN COLLINS

Conduent

Sean.Collins2@conduent.com

+1-310-497-9205

GILES GOODBURN

Conduent

ir@conduent.com

+1-203-216-3546

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

Release – PDS Biotech Appoints Stephan Toutain as Chief Operating Officer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

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

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

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

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

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

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

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

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

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

Our Infectimune® based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. For more information, please visit www.pdsbiotech.com.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. 

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

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

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

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 2, 2024

MALVERN, Pa., May 02, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that Arun Upadhyay, PhD, Chief Scientific Officer, Head of Research & Development, Ocugen will speak at the Retina World Congress (RWC) being held May 9-12, 2024 in Ft. Lauderdale, FL.

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

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

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

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

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

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

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

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

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

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