Release – Tonix Pharmaceuticals Announces Oral Presentation at the World Vaccine Congress Europe 2024

Research News and Market Data on TNXP

October 24, 2024 8:00am EDT

CHATHAM, N.J., Oct. 24, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Zeil Rosenberg, M.D., M.P.H., Executive Vice President, Medical, Tonix Pharmaceuticals, will deliver an oral presentation at the World Vaccine Congress Europe, which will be held in Barcelona, Spain, October 28-31, 2024. A copy of the Company’s presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the World Vaccine Congress Europe website here.

Presentation Details
  
Presenter:Zeil Rosenberg, M.D., M.P.H.
Title:A Novel, Single-dose, Live, Attenuated, Minimally Replicating Mpox Vaccine
Location:Fira de Barcelona – Montjuïc – Hall 2
Date:Wednesday, October 30, 2024
Time:2:10 p.m. GMT
 

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institute of Drug Abuse and Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Healthcare
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released October 24, 2024

Release – Beasley Broadcast Group, Inc. Appoints Lauren Burrows Coleman as Chief Financial Officer

Research News and Market Data on BBGI

Marie Tedesco to Retire as CFO Following Three Decades of Service

October 24, 2024 07:00 ET

    NAPLES, Fla., Oct. 24, 2024 (GLOBE NEWSWIRE) — Beasley Broadcast Group, Inc. (Nasdaq: BBGI), a multi-platform media company, today announced the appointment of Lauren Burrows Coleman as Chief Financial Officer, effective Friday, November 1, 2024. Longtime CFO Marie Tedesco will retire from Beasley after 33 years of dedicated service to the company.

    Before joining Beasley, Ms. Burrows Coleman served as Global Head of Strategic Corporate and Commercial Finance at Wayfair (NYSE: W), where she led a global team of 50 across Financial Planning & Analysis, Commercial Finance, Capital Markets, Corporate Development, and Global Tax functions.

    Ms. Burrows Coleman’s impressive career also includes leadership positions at WindSail Capital Group and Wind Point Partners, both private equity firms, as well as GE Capital, where she managed equity and debt investments across various industries. She began her career as an investment banker in the Communications & Media group at Lehman Brothers.

    “We are absolutely thrilled to welcome Lauren into the Beasley family,” said Caroline Beasley, Chief Executive Officer of Beasley Broadcast Group, Inc. “Her extensive and diverse experience, combined with her leadership skills, are exactly what we need to drive the company forward as we evolve into the future.”

    Ms. Burrows Coleman holds an MBA from Harvard Business School and an A.B. cum laude from Dartmouth College.

    She will succeed Marie Tedesco, who is retiring on November 1st after more than three decades with the organization.

    “Marie has been an integral part of our success and her contributions have shaped the organization into what it is today,” said Caroline Beasley. “It has been a privilege to work alongside her, and we are deeply grateful for her unwavering commitment, hard work, and leadership. We will greatly miss Marie’s wisdom and guidance, and we wish her nothing but the very best!”

    About Beasley Broadcast Group:
    Beasley Broadcast Group, Inc. (NASDAQ: BBGI) is a multi-platform media company whose primary business is operating radio stations throughout the United States. The Company offers local and national advertisers integrated marketing solutions across audio, digital and event platforms. The Company owns and operates stations in the following markets: Atlanta, GA, Augusta, GA, Boston, MA, Charlotte, NC, Detroit, MI, Fayetteville, NC, Fort Myers-Naples, FL, Las Vegas, NV, Middlesex, NJ, Monmouth, NJ, Morristown, NJ, Philadelphia, PA, and Tampa-Saint Petersburg, FL. Approximately 20 million consumers listen to the Company’s radio stations 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.

    Contact

    Joseph Jaffoni, Jennifer Neuman JCIR
    (212) 835-8500
    bbgi@jcir.com

    Heidi Raphael, BBGI
    (239) 263-5000

    Release – Cadrenal Therapeutics Joins Corporate Council Of Anticoagulation Forum

    Research News and Market Data on CVKD

    Participation Reinforces Cadrenal’s Commitment to Innovation, Education and Improved Patient Outcomes with Anticoagulation Therapy

    PONTE VEDRA, Fla., Oct. 23, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to improve anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions, today announced its membership in the Corporate Council of the Anticoagulation Forum (AC Forum).

    Cadrenal Therapeutics, Inc. is a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation. (PRNewsfoto/Cadrenal Therapeutics, Inc.)


    The AC Forum is the largest professional organization of anticoagulation specialists, committed to advancing the quality and safety of chronic anticoagulation care globally. Through participation in the Corporate Council, Cadrenal Therapeutics will collaborate with the AC Forum as it works to identify and address unmet clinical needs, share cutting-edge research, and promote advocacy and educational initiatives for the organization’s 15,000 healthcare professional members aimed at improving outcomes for patients on anticoagulants.

    “Our membership in the AC Forum’s Corporate Council reflects our shared commitment to transforming anticoagulation care,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “We look forward to partnering with the AC Forum and contributing to programs that advance safer, more effective care and inform about ongoing research and anticoagulation best practice guidelines.”

    Darren Triller, PharmD, Director of Strategic Initiatives at the Anticoagulation Forum, welcomed Cadrenal Therapeutics to the Corporate Council, saying: “We are excited to have Cadrenal Therapeutics join us in our mission to improve the quality of care for patients receiving antithrombotic therapies. We look forward to a productive partnership that will help us address the challenges in the anticoagulation landscape together.”

    About Cadrenal Therapeutics, Inc.

    Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds and deaths than warfarin, the most commonly used anticoagulant for these patients despite its prevalent side effects, drug-to-drug interactions and frequent dosing changes. Tecarfarin received an orphan drug designation for advanced heart failure patients with implanted left ventricular assist devices (LVADs) as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is planning pivotal clinical trials and pursuing clinical and commercial partnerships. The company’s plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. Visit www.cadrenal.com to learn more.

    About the Anticoagulation Forum

    The Anticoagulation Forum has led advancements in thrombosis-related care for over three decades. With more than 15,000 members across 3,000 healthcare institutions, the AC Forum is dedicated to enhancing the safety and quality of care for over 1 million patients annually. Through education, thought leadership, and partnerships with industry leaders, the AC Forum shapes the future of anticoagulation management to ensure the best outcomes for patients.

    For more information, please contact:
    Cadrenal Therapeutics:
    Matthew Szot, CFO
    858-337-0766
    press@cadrenal.com

    Investors:
    Lytham Partners, LLC
    Robert Blum, Managing Partner
    602-889-9700
    CVKD@lythampartners.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-joins-corporate-council-of-anticoagulation-forum-302283944.html

    SOURCE Cadrenal Therapeutics, Inc.

    Release – Conduent to Report Third-Quarter 2024 Financial Results on Nov. 6, 2024

    Research News and Market Data on CNDT

    October 23, 2024

    Earnings/Financial

    FLORHAM PARK, N.J. — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, plans to report its third-quarter 2024 financial results on Wednesday, November 6 before market open. Management will present the results during a conference call and webcast at 9:00 a.m. ET.

    The call will be available by live audio cast along with the news release and online presentation slides at https://investor.conduent.com.

    The conference call will also be available by calling 877-407-4019 toll free. If requested, the conference ID 13748951.

    The international dial-in is +1 201-689-8337. The international conference ID is also 13748951.

    A recording of the conference call will be available by calling 877-660-6853 three hours after the conference call concludes. The access ID for the recording is 13748951.

    The call recording will be available until November 20, 2024.

    We look forward to your participation.

    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 55,000 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.

    Note: To receive RSS news feeds, visit www.news.conduent.com. For open commentary, industry perspectives and views, visit http://twitter.com/Conduenthttp://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.

    Media Contacts

    Sean Collins

    Conduent

    Sean.Collins2@conduent.com

    +1-310-497-9205

    Giles Goodburn

    Conduent

    ir@conduent.com

    +1-203-216-3546

    Release – Travelzoo Announces Share Repurchase Program

    Research News and Market Data on TZOO

    Oct 23, 2024, 08:35 ET

    NEW YORK, Oct. 23, 2024 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO), the club for travel enthusiasts, today announced that its board of directors has authorized a new program to repurchase up to 1,000,000 shares of the Company’s outstanding common stock.

    Purchases may be made, from time to time, in the open market and will be funded from available cash. The number of shares to be purchased and the timing of purchases will be based on the level of Travelzoo’s cash balances, general business and market conditions, and other factors, including alternative investment opportunities.

    About Travelzoo
    We, Travelzoo®, are the club for travel enthusiasts. Our 30 million members receive exclusive offers and one-of-a-kind experiences personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with more than 5,000 top travel suppliers—our long-standing relationships give Travelzoo members access to irresistible deals.

    Investor Relations: 
    ir@travelzoo.com   

    SOURCE Travelzoo

    Release – Bowlero to Report First Quarter 2025 Financial Results on November 4, 2024

    Research News and Market Data on BOWL

    10/22/2024

    RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL) (“Bowlero” or the “Company”), one of the world’s premier operators of location-based entertainment, will report financial results for the first quarter of fiscal 2025 on Monday, November 4, 2024, after the U.S. stock market closes. Management will discuss the results via webcast at 4:30 PM ET on the same day.

    The live webcast, replay, and results presentation will be available in the Events & Presentations section of the Bowlero Investor Relations website at https://ir.bowlerocorp.com/.

    About Bowlero Corp.
    Bowlero Corporation is one of the world’s premier operators of location-based entertainment. With approximately 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.

    IRSupport@BowleroCorp.com

    Source: Bowlero Corp

    Release – SelectQuote to Release Fiscal First Quarter 2025 Earnings on November 4

    Research News and Market Data on SLQT

    10/22/2024

    OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT), a leading distributor of Medicare insurance policies and owner of a rapidly growing Healthcare Services platform, today announced it will release its first quarter 2025 financial results before market open on Monday, November 4, 2024. Chief Executive Officer, Tim Danker, and Chief Financial Officer, Ryan Clement, will host a conference call on the day of the release (November 4, 2024) at 8:30 am ET to discuss the results.

    To register for this conference call, please use this link: https://registrations.events/direct/Q4I1559258472

    After registering, a confirmation will be sent via email, including dial in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx or via this link.

    About SelectQuote:

    Founded in 1985, SelectQuote (NYSE: SLQT) provides solutions that help consumers protect their most valuable assets: their families, health, and property. The company pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads.

    With an ecosystem offering high touchpoints for consumers across insurance, medicare, pharmacy, and value-based care, the company now has four core business lines: SelectQuote Senior, SelectQuote Healthcare Services, SelectQuote Life, and SelectQuote Auto and Home. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, and Healthcare Select which proactively connects consumers with a wide breadth of healthcare services supporting their needs.

    Investor Relations:
    Sloan Bohlen
    877-678-4083
    investorrelations@selectquote.com

    Media:
    Matt Gunter
    913-286-4931
    matt.gunter@selectquote.com

    Source: SelectQuote, Inc.

    Release – Data and Safety Monitoring Board Approves Initiation of Phase 2 of OCU410ST GARDian Clinical Trial for Stargardt Disease

    Research News and Market Data On OCGN

    October 22, 2024

    PDF Version

    • Determined the high dose of OCU410ST to be the maximum tolerated dose
    • No serious adverse events have been reported
    • Approved proceeding to Phase 2 using high and medium doses of OCU410ST

    MALVERN, Pa., Oct. 22, 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, biologics, and vaccines, today announced that the Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian clinical trial recently convened and approved enrollment for the second phase of the Phase 1/2 clinical trial. OCU410ST (AAV5-hRORA) is a novel modifier gene therapy candidate being developed for Stargardt disease.

    “The DSMB has recommended moving forward with Phase 2 enrollment, as safety data indicates that OCU410ST appears to be safe and well-tolerated to date,” said Charles Wykoff, MD, PhD, Director of Research, Retina Consultants of Texas & Retina Consultants of America, and a lead study investigator. “The safety and tolerability profile of OCU410ST remains encouraging as the clinical trial has progressed and continues to bring hope to patients with Stargardt disease, which still has no FDA-approved treatments.”

    The first phase of the Phase 1/2 clinical trial was an open-label, dose-ranging study that enrolled nine patients to receive either a low (3.75 x 1010 vg/mL), medium (7.5 x 1010 vg/mL), or high (2.25 x 1011 vg/mL) dose of OCU410ST administered via subretinal injection. No serious adverse events (SAEs) have been reported, and the DSMB determined the high dose to be the maximum tolerated dose (MTD).

    Stargardt disease is the most common form of inherited macular dystrophy. Symptoms of bilateral central vision loss typically begin in childhood and gradually worsen over time.

    “We are enthusiastic about the potential of OCU410ST to be the first one-time novel modifier gene therapy for Stargardt disease,” said Huma Qamar, MD, MPH, Chief Medical Officer of Ocugen. “We are encouraged by the prospect of addressing a substantial unmet medical need for the estimated 100,000 Stargardt patients in the U.S. and Europe.”

    The GARDian clinical trial is currently being performed at 6 leading retinal surgery centers across the U.S.

    About Stargardt Disease
    Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

    Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

    About OCU410ST
    OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathway links to Stargardt disease such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.

    About Ocugen, Inc.
    Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, 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, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; 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 annual and 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 Announces Presentation of Rationale and Design of First Recurrent Prostate Cancer Trial to Combine an Androgen Receptor Pathway Inhibitor with an Immunocytokine

    Research News and Market Data on PDSB

    Study to evaluate PDS01ADC + Xtandi® (Enzalutamide) versus Xtandi® alone to be presented by Dr. Ravi Madan, National Cancer Institute at Cytokines 2024

    PRINCETON, N.J., Oct. 22, 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 rationale and trial design for a study evaluating PDS01ADC for the treatment of recurrent prostate cancer will be discussed during an oral presentation at the 12th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2024) in Seoul, South Korea. Details of the presentation are as follows:

    Date: Wednesday, October 23, 2024
    Session time: 08:30-10:10 Korean Standard Time (KST)
    Session title: Symposium 20 – Cytokine-mediated Translational Approaches of Human Diseases
    Presentation time: 09:20-09:32 KST
    Presentation title: A Clinical Trial Combining a Tumor Targeting Immunocytokine (PDS01ADC) and Enzalutamide without Testosterone Lowering Therapy in Biochemically Recurrent Prostate Cancer
    Presenter: Ravi A. Madan, M.D., Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, part of the U.S. National Institutes of Health

    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 HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

    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, Versamune® HPV (formerly 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, Versamune® HPV, 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.

    Xtandi® is a registered trademark of Astellas Pharma, Inc.

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

    Media Contact:
    Janine McCargo
    6 Degrees
    Phone +1 (646) 528-4034
    Email: jmccargo@6degreespr.com

    Release – Travelzoo Q3 2024 Earnings Conference Call on October 23 at 11:00 AM ET

    Research News and Market Data on TZOO

    NEW YORK, Oct. 21, 2024 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO):

    WHAT:Travelzoo, the club for travel enthusiasts, will host a conference call to discuss the Company’s financial results for the third quarter ended September 30, 2024. Travelzoo will issue a press release reporting its results before the market opens on October 23, 2024.
    WHEN:October 23, 2024 at 11:00 AM ET
    HOW: A live webcast of Travelzoo’s Q3 2024 earnings conference call can be accessed at http://ir.travelzoo.com/events-presentations. The webcast will be archived within 2 hours of the end of the call and will be available through the same link.
    CONTACT:Travelzoo Investor Relations
    ir@travelzoo.com

    About Travelzoo
    We, Travelzoo®, are the club for travel enthusiasts. Our 30 million members receive exclusive offers and one-of-a-kind experiences personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with more than 5,000 top travel suppliers—our long-standing relationships give us access to irresistible deals.

    SOURCE Travelzoo

    Release – Direct Digital Holdings Announces Strategic $20 Million Equity Reserve Facility to Accelerate Growth Plan

    Research News and Market Data on DRCT

    October 21, 2024 9:00 am EDT Download as PDF

    HOUSTON, Oct. 21, 2024 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Orange142, LLC (“Orange 142”) and Huddled Masses LLC (“Huddled Masses”), today announced the Company has entered into a $20 million Equity Reserve Facility (“ERF”) with New Circle Principal Investments LLC, an affiliate of New Circle Capital LLC (“New Circle”).

    Mark D. Walker, CEO and Co-Founder of Direct Digital Holdings, commented, “We are very pleased to announce this $20 million Equity Reserve Facility with New Circle. The funding will enable the expansion of our technology and strategic capabilities, benefiting both publishers and advertisers. It also opens the door to new growth opportunities and strengthens our commitment to increasing shareholder value.”

    Under the agreement, at our sole election, New Circle will purchase, from time to time, shares of our Class A common stock up to an aggregate of $20 million over a period of 36 months, subject to the conditions in the agreement. The proceeds of these sales may be used for general corporate purposes. The Company anticipates using such proceeds to reduce debt obligations, strengthen the overall balance sheet, and drive key growth initiatives.  Those key initiatives extend across Direct Digital Holdings’ subsidiaries, and include specifically:

    Advancing Innovation for Colossus SSP
    The Company expects to make investments to drive technological advancements for Direct Digital Holdings’ supply-side platform (SSP), Colossus SSP, including the development of new segment-based products in carbon and attention. It will also support direct integrations with leading demand-side platforms (DSPs), optimizing supply path efficiency for advertisers. Additionally, the funding will expand Colossus SSP’s efforts to bring underrepresented publishers into the programmatic ecosystem, with their inventory available through the Company.

    Enhancing Growth on the Demand Side
    On the demand-side, the Company expects that funding will support the unification of Direct Digital Holdings’ advertising consultancy groups, Orange142 and Huddled Masses. This will enable the delivery of new capabilities, particularly in helping clients navigate emerging technologies, such as artificial intelligence (AI) and machine learning (ML), as well as emerging channels such as connected TV (CTV), social media and retail media.

    Keith Smith, President and Co-Founder of Direct Digital Holdings, added, “We are pleased to partner with New Circle on this flexible facility which we expect will enhance our financial liquidity, strengthen our shareholder equity and support a host of growth initiatives across both our supply-side and demand-side platforms.”

    BJ Arnold, Managing Partner of New Circle, commented, “New Circle is pleased to partner with Direct Digital Holdings, helping to fuel the company’s growth and support their innovative technology and industry-leading approaches to advertising.”

    The Company’s right to commence sales of Class A common stock to New Circle are subject to certain conditions, including that a registration statement covering the resale of such shares is declared effective by the SEC. Actual sales of shares of Class A common stock to New Circle under the agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding and the Company’s operations.

    Further information on the financing can be found in the Current Report on Form 8-K filed today with the Securities and Exchange Commission.

    Cautionary Note Regarding Forward Looking Statements
    This press release contains forward-looking statements within the meaning of federal securities laws that are subject to certain risks, trends and uncertainties. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Accordingly, any such statements are qualified in their entirety by reference to the information described under the caption “Risk Factors” and elsewhere in our most recent Annual Report on Form 10 K (the “Form 10-K”) and subsequent periodic and or current reports filed with the Securities and Exchange Commission (the “SEC”).

    The forward-looking statements contained in this press release are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this press release, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties (many of which are beyond our control) and assumptions.

    Although we believe that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements. We believe these factors include, but are not limited to, the following: the conditions to our ability to sell Class A common stock to New Circle, including the effectiveness of the registration statement registering the resale by New Circle of the shares of Class A common stock; the restrictions and covenants imposed upon us by our credit facilities; the substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing; our ability to secure additional financing to meet our capital needs; our ineligibility to file short-form registration statements on Form S-3, which may impair our ability to raise capital; our failure to satisfy applicable listing standards of the Nasdaq Capital Market resulting in a potential delisting of our common stock; failure to remedy any listing deficiencies noted in the deficiency letters from the Listing Qualifications Department of The Nasdaq Stock Market LLC; the risk that the Listing Qualifications Department of The Nasdaq Stock Market LLC does not accept the Company’s plan to regain compliance with applicable rules to maintain its listing on The Nasdaq Capital Market;  costs, risks and uncertainties related to the restatement of certain prior period financial statements;  any significant fluctuations caused by our high customer concentration; risks related to non-payment by our clients; reputational and other harms caused by our failure to detect advertising fraud; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; our failure to manage our growth effectively; the difficulty in identifying and integrating any future acquisitions or strategic investments; any changes or developments in legislative, judicial, regulatory or cultural environments related to information collection, use and processing; challenges related to our buy-side clients that are destination marketing organizations and that operate as public/private partnerships; any strain on our resources or diversion of our management’s attention as a result of being a public company; the intense competition of the digital advertising industry and our ability to effectively compete against current and future competitors; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; as a holding company, we depend on distributions from Direct Digital Holdings, LLC (“DDH LLC”) to pay our taxes, expenses (including payments under the Tax Receivable Agreement) and any amount of any dividends we may pay to the holders of our common stock; the fact that DDH LLC is controlled by DDM, whose interest may differ from those of our public stockholders; any failure by us to maintain or implement effective internal controls or to detect fraud; and other factors and assumptions discussed in our Form 10-K and subsequent periodic and current reports we may file with the SEC.

    Should one or more of these risks or uncertainties materialize, or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. New factors that could cause our business not to develop as we expect emerge from time to time, and it is not possible for us to predict all of them. Further, we cannot assess the impact of each currently known or new factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

    About Direct Digital Holdings
    Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions generate billions of impressions per month across display, CTV, in-app and other media channels.

    Contacts:
    Investors:
    Brett Milotte, ICR
    Brett.Milotte@icrinc.com

    Direct Digital Holdings Logo (PRNewsfoto/Direct Digital Holdings)

    View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-announces-strategic-20-million-equity-reserve-facility-to-accelerate-growth-plan-302281770.html

    SOURCE Direct Digital Holdings

    Release – Tonix Pharmaceuticals Receives First Contract Payment from U.S. Department of Defense for Accelerated Development of Broad-Spectrum Antivirals with the Defense Threat Reduction Agency (DTRA)

    Research News and Market Data on TNXP

    October 17, 2024 8:00am EDT Download as PDF

    First payment received under Tonix’s contract with the Defense Threat Reduction Agency (DTRA), for up to $34 million over five years

    CHATHAM, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, received its first payment from the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense (DoD), to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. The previously announced award from DTRA is for up to $34 million over five years.

    “This award provides important validation and substantial non-dilutive funding for our ongoing research to advance our antiviral discovery program,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals “With biological adaptations and mutations happening to viruses rapidly across the globe, this research will be crucial in order to protect lives in the event biological threats are introduced onto the battlefield.”

    The $34.0 million five-year contract will help fund and accelerate the development of the Company’s broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors, specifically compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government with a complete and cost-effective solution for a broad-spectrum medical countermeasure. Tonix’s premise is that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety profile.

    Tonix will utilize its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab at its research and development center (RDC) facility located in Frederick, Md., as well as experienced personnel in-house. The RDC is located in Maryland’s ‘I-270 biotech corridor’ and is close to the center of the U.S. biodefense research community.

    About Defense Threat Reduction Agency (DTRA)
    The Defense Threat Reduction Agency (DTRA), an agency within the United States Department of Defense (DoD) is both a Defense Agency and Combat Support Agency with two distinct yet highly integrated roles countering Weapons of Mass Destruction (WMD) and emerging threats. Its origins stretch back to World War II and the Manhattan Project, but today the agency encompasses a wide variety of strategic and operational functions that deter, prevent, and ultimately prevail against these unique threats. DTRA enables the Department of Defense (DoD), the United States Government and international partners to counter and deter weapons of mass destruction (WMD) and emerging threats. DTRA provides cross-cutting solutions to enable the Department of Defense, the United States Government, and international partners to deter strategic attack against the United States and its allies; prevent, reduce, and counter WMD and emerging threats; and prevail against WMD-armed adversaries in crisis and conflict. DTRA’s continued effort to enhance the combat support mission also advances public health services by developing innovative technologies that protect against biological threats. For more information, visit www.dtra.mil.

    Tonix Pharmaceuticals Holding Corp.**
    Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institude of Drug Abuse and Addiction (NIDA). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

    * Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
    Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements
    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Investor Contact
    Jessica Morris
    Tonix Pharmaceuticals
    investor.relations@tonixpharma.com
    (862) 904-8182

    Peter Vozzo
    ICR Westwicke
    peter.vozzo@westwicke.com
    (443) 213-0505

    Media Contact
    Ray Jordan
    Putnam Insights
    ray@putnaminsights.com
    (949) 245-5432

    Primary Logo

    Source: Tonix Pharmaceuticals Holding Corp.

    Released October 17, 2024

    Release – ZyVersa Therapeutics CEO, Stephen C. Glover, Issues Letter to Shareholders Highlighting Obesity Development Plans for Inflammasome ASC Inhibitor IC 100 Over the Next Nine Months

    Research News and Market Data on ZVSA

    Oct 17, 2024

    PDF Version

    • Lead indication for ZyVersa’s Inflammasome ASC Inhibitor IC 100 is obesity with metabolic complications.

    WESTON, Fla., Oct. 17, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, has issued a Letter to Shareholders highlighting obesity development plans for Inflammasome ASC Inhibitor IC 100 with anticipated milestones over the next nine months. The full text of the letter follows.

    A MESSAGE FROM OUR PRESIDENT AND CHIEF EXECUTIVE OFFICER

    To my fellow shareholders,

    As announced in late July, ZyVersa selected obesity with metabolic complications as the lead indication for Inflammasome ASC Inhibitor IC 100. Selection of this indication is consistent with our mission to restore health and transform patient lives through innovation. Although GLP-1 agonist therapy has changed the treatment paradigm for obesity with unsurpassed weight loss, significant unmet medical needs remain. A critical unmet need is for therapies to address the chronic systemic inflammation of obesity that causes life-altering metabolic comorbidities such as cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, and even neurodegenerative diseases such as Parkinson’s and Alzheimer’s diseases. Based on IC 100’s highly differentiated mechanism of action, it is anticipated that IC 100 will control the chronic systemic inflammation of obesity, attenuate development and/or progression of associated metabolic comorbidities, and augment weight loss when added to GLP-1 agonist therapy.

    Selection of obesity with metabolic complications as the lead indication for IC 100 is also consistent with ZyVersa’s goal to drive shareholder value. The obesity drug revolution has led to a 10-fold increase in private venture dollars flowing into the category over the last 5 years and high deal volume. This is expected to continue with investment opportunities in R&D innovation to develop GLP-1 agonist add-on therapies to address unmet needs. This is exemplified by some of the latest transactions:

    • Oct 10, 2024: Lilly announced up to $1.4 billion plus upfront payment and royalties for expanded collaboration with KeyBioscience for rights to dual amylin calcitonin receptor agonists for obesity and complications (e.g., osteoarthritis).
    • September 25, 2024: Bioage announced an upsized $198 Million IPO driven by their APJ agonist in development for muscle preservation and improved metabolism to be used in combination with GLP-1 agonist therapy.
    • September 23, 2024: Sanofi announced a $27 Million strategic investment in Ventyx Biosciences’ NLRP3 inhibitor VTX3232, which is phase 2 for obesity with cardiovascular complications and Parkinson’s disease.
    • September 4, 2024: Lilly announced a collaboration with Haya Therapeutics for up to $1 Billion for drug discovery in obesity and related metabolic conditions.
    • August 10, 2024: Novo Nordisk announced acquisition of Inversago Pharma, valued up to $1.075 Billion. Inversago develops CB1 receptor-based therapies for obesity, diabetes, and complications associated with metabolic disorders.

    We are excited about the potential for Inflammasome ASC Inhibitor IC 100 as an add-on therapy to GLP-1 agonists to help restore health and transform the lives of patients living with obesity and its associated comorbidities. We recently reviewed the preclinical data supporting IC 100 with our newly formed Obesity, Metabolic, and Inflammatory Disease Scientific Advisory Board. Advisory Board members indicated that IC 100’s mechanism of action supports its rationale for use as an add-on treatment to GLP-1 agonists to address the chronic inflammation of obesity and its associated metabolic complications. They also provided excellent input on our planned DIO obesity model studies to strengthen their design and endpoints for proof-of-concept of IC 100’s potential as a treatment for obesity with metabolic complications.

    Following are key IC 100 short-term obesity development milestones that we expect to achieve:

    Q4-2024: Initiate IC 100 monotherapy study using semaglutide as a comparator in DIO mice.

    Q1- 2025: Initiate IC 100 combination study with semaglutide in DIO mice.

    Q2-2025: File IND.

    Q3-2025: Initiate IC 100 phase 1 trial in healthy overweight subjects with a BMI 27 – 30.

    We appreciate your current and ongoing support that enables us to progress IC 100’s development program to drive shareholder value.

    About Inflammasome ASC Inhibitor IC 100

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

    About ZyVersa Therapeutics, Inc.

    ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux Mediator™ VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. For more information, please visit www.zyversa.com.

    Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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