Category: Health

Release – Tonix Pharmaceuticals Announces Appointment of Joseph Hand, Esq., as General Counsel and Executive Vice President of Operations

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 14, 2025 7:00am EDT Download as PDF

Mr. Hand brings more than 20 years of strategic legal and business leadership experience across multiple functions in the biopharmaceutical industry, including nearly a decade in senior executive positions at Celgene

Served on Celgene’s Executive Committee and played a key leadership role in the BMS transaction, the integration of Celgene into BMS, and the divestiture of Otezla® to Amgen

Appointment marks a key addition as Tonix readies for the potential approval of TNX-102 SL for the management of fibromyalgia next quarter

CHATHAM, N.J., May 14, 2025 (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, today announced the appointment of Joseph Hand, Esq., as General Counsel and Executive Vice President of Operations, effective immediately. Mr. Hand brings significant leadership experience across multiple functions, including legal, business development, human resources and information technology operations.   

“Joe’s strong track record of delivering company growth, driving transformative initiatives, and negotiating complex transactions makes him an important strategic addition to the Tonix team at a pivotal inflection point in the Company’s history,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The breadth of Joe’s expertise and his focus on operational excellence will serve our mission as we prepare for the launch of TNX-102 SL for the management of fibromyalgia, upon receiving FDA marketing authorization.”

Prior to joining Tonix, Mr. Hand’s experience includes nearly a decade at Celgene Corporation, concluding his tenure as Executive Vice President, Global Human Resources and Corporate Services and a member of the Executive Committee. In that capacity, Mr. Hand was responsible for all employee-related activities including talent development, recruiting, and compensation and benefits. He was also responsible for the management of Celgene’s global facilities footprint and played a key strategic role in various transactions, including the $74 billion acquisition of Celgene by Bristol Myers Squibb and subsequent integration, and the $13.4 billion divestiture of Otezla® to Amgen. Subsequent to Celgene, Mr. Hand was Chief Administrative Officer at Phathom Pharmaceuticals, responsible for recruiting over 300 employees into various functions, including the build-out of the company’s commercial sales force. Mr. Hand has previously practiced as a litigation attorney at the international law firm of Jones Day. Mr. Hand holds a BBA from the University of Notre Dame and a JD from New York University School of Law.

“I’m honored to join Tonix at such an exciting time and grateful for the opportunity to work alongside an incredibly talented and dedicated leadership team and group of employees,” said Mr. Hand. “I look forward to contributing to the Company’s momentum and helping to position Tonix for long-term growth while advancing our mission to deliver meaningful therapies to patients.”

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also 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 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 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, Maryland. 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 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, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, 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) 799-8599

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

Media Contact

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

About Zembrace SymTouch and Tosymra

Indication and Usage

Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace or Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released May 14, 2025

Release – Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

May 14, 2025 7:15am EDT Download as PDF

– Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in chronic kidney disease patients on dialysis under review by FDA with PDUFA target action date of June 28, 2025; ongoing commercial planning in preparation for anticipated commercial launch in late 2025

– New data from patient surveys and patient-reported outcomes studies highlight adherence challenges for patients with hyperphosphatemia on dialysis and emphasize the market potential of OLC

LOS ALTOS, Calif., May 14, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended March 31, 2025, and provided a business update.

“We are making incredible strides as we prepare for the potential FDA approval of oxylanthanum carbonate (OLC) so we can bring this treatment to people with chronic kidney disease (CKD) on dialysis as efficiently as possible,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The need for our differentiated treatment, which offers high potency and a significantly reduced pill burden for people struggling to control hyperphosphatemia, has been further validated by new patient survey findings and patient-reported outcomes data. We remain dedicated to bolstering our commercial infrastructure as we strive to deliver a much-needed solution to patients and healthcare providers.”

Key Highlights & Upcoming Milestones

  • The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for OLC. Unicycive continues to prepare for the potential launch of OLC by building key functions, engaging directly with prescribers and other stakeholders, and supporting market access.
  • Expanded awareness of OLC and its potential to address significant needs for CKD patients by publishing data and presentations at medical meetings.
    • Recently, findings were presented at the National Kidney Foundation (NKF) Spring Clinical Meetings and the 2025 American Nephrology Nurses Association (ANNA) National Symposium from a patient survey conducted in partnership with the NKF. The survey included a total of 200 dialysis patients who identified excessive pill numbers, large pill sizes, and forgetfulness as the primary barriers to phosphate binder adherence. Patients also expressed a strong preference for medication regimens with fewer and smaller pills.
    • New patient-reported outcomes data from the pivotal Phase 2 study of OLC were presented at the 2025 American Dialysis Conference (ADC) and the NKF Spring Clinical Meeting, which demonstrated that patients preferred OLC in comparison to their pre-trial phosphate binder medications and significantly enhanced patient satisfaction.  

Financial Results for the Quarter Ended March 31, 2025

Research and Development (R&D) expenses were $2.2 million for the three months ended March 31, 2025, compared to $6.8 million for the three months ended March 31, 2024. The decrease in research and development expenses was primarily due to decreased drug development costs.

General and Administrative (G&A) expenses were $5.8 million for the three months ended March 31, 2025, compared to $2.4 million for the three months ended March 31, 2024. The increase was primarily due to increased consulting and professional services related to our commercial launch preparation.

In addition to the above launch expenses, we continue to focus on the manufacturing of commercial supplies, as reflected in prepaid expenses and other current assets on our balance sheet which increased from $4.8 million as of December 31, 2024 to $7.6 million as of March 31, 2025.

Other income was $8.6 million for the three months ended March 31, 2025, compared to an expense of $11.8 million for the three months ended March 31, 2024, primarily due to a decrease in the fair value of our warrant liability.

Net income attributable to common stockholders for the three months ended March 31, 2025, was $0.5 million, compared to a net loss attributable to common stockholders of $21.2 million for the three months ended March 31, 2024. The net income for the three-month period ended March 31, 2025, was primarily due to a decrease in the fair value of our warrant liability.

As of March 31, 2025, cash and cash equivalents totaled $19.8 million.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:

Rachel Visi
Real Chemistry
redery@realchemistry.com

SOURCE: Unicycive Therapeutics, Inc.

View full release here.

Release – MAIA Biotechnology Announces Director Participation in Recent Private Placement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

May 14, 2025 10:15am EDT

Download as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that two of the Company’s independent directors, Stan V. Smith, Ph.D. and Ramiro Guerrero, JD, LL.M., purchased common stock and warrants in the Company’s private placement offering which closed on May 8, 2025. Gross proceeds from the offering across all investors totaled $1.08 million.

Dr. Smith purchased a total of 66,666 shares and 66,666 warrants for an aggregate purchase price of approximately $100,000. Mr. Guerrero purchased a total of 20,000 shares and 20,000 warrants for an aggregate purchase price of $30,000.

“Stan, Ramiro and our other independent directors have been consistent investors in the Company’s financings, which I believe signals the Board’s confidence in our strategic direction and future market prospects for our novel cancer immunotherapies,” said MAIA Chairman and CEO Vlad Vitoc, M.D.

Dr. Smith commented, “I have participated in nearly all of MAIA’s financings since its founding, and my conviction in the Company is stronger than ever. In my opinion, the clinical and regulatory strategies are thorough, and, as a potential first-in-class cancer telomere targeting treatment, the commercial opportunity for ateganosine is substantial.”

“Based on ateganosine’s clinical results to date, I continue to believe that MAIA’s telomere targeting science could eventually become the standard of care for several high-mortality cancer types,” said Mr. Guerrero.

Additional details on the private placement can be found in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 6, 2025, at www.sec.gov.

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 Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

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

Source: MAIA Biotechnology, Inc.

Released May 14, 2025

Release – Tonix Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Highlights

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 12, 2025 4:30pm EDT

FDA PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years

Announced positive topline results from Phase 1 study of TNX-1500, a next generation anti-CD40L mAb candidate in development for prevention of kidney transplant rejection and treatment of autoimmune disorders

Cash and cash equivalents of $131.7 million reported as of March 31, 2025; Current cash sufficient to fund operations into the second quarter of 2026

CHATHAM, N.J., May 12, 2025 (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, today announced financial results for the first quarter ended March 31, 2025, and provided an overview of recent operational highlights.

“We believe TNX-102 SL (cyclobenzaprine HCl sublingual tablets)* is on track to become a new therapeutic option for patients suffering with fibromyalgia,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “TNX-102 SL would be the first member of a new class of FDA approved drugs for fibromyalgia. TNX-102 SL is a non-opioid analgesic that targets fibromyalgia’s characteristic disturbed sleep to improve the widespread pain of fibromyalgia, while also being well tolerated. Our focus continues to be on the upcoming U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on the market authorization on TNX-102 SL for the management of fibromyalgia. We are building out our commercial team for the anticipated product launch in the fourth quarter of this year. Tonix believes it has sufficient cash to fund operations beyond these key milestones.”

Dr. Lederman continued, “Beyond TNX-102 SL for fibromyalgia, we are encouraged by the continued achievements in our pipeline, including positive Phase 1 results for TNX-1500, a next generation anti-CD40L Fc-modified humanized monoclonal antibody (mAb) in development for prevention of kidney transplant rejection and pre-clinical results for TNX-801, a live-virus vaccine in development for preventing mpox and smallpox. We look forward to providing additional updates to each of these promising programs in 2025.”

Key Investigational Product Candidates* — Recent Highlights

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual tablets): 5.6 mg, once-daily at bedtime small molecule for the management of fibromyalgia (FM) – a centrally-acting, non-opioid analgesic.

  • In March 2025, Tonix announced that FDA will not require an Advisory Committee meeting to discuss the Company’s New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia. The FDA previously granted Fast Track designation to TNX-102 SL for the management of fibromyalgia in 2024, a designation intended to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.
  • In December 2024, the NDA for TNX-102 SL for fibromyalgia was accepted by FDA with a PDUFA goal date of August 15, 2025. The NDA was based upon two Phase 3 studies of TNX-102 SL in fibromyalgia that showed statically significant reduction in the chronic, widespread pain associated with fibromyalgia. TNX-102 SL was generally well tolerated and has no known addictive properties. If approved by the FDA, TNX-102 SL would be the first member of a new class of tertiary amine tricyclic (TAT) non-opioid analgesic drugs for fibromyalgia and the first new drug available for treating fibromyalgia in more than 15 years. Fibromyalgia affects more than 10 million adults in the U.S., most of whom are women.
  • In April 2025, Tonix presented data and analyses of TNX-102 SL treatment and effects on fibromyalgia at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting, held in Austin, Texas, in a poster presentation titled, “Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials.”
  • In March 2025, the Company presented data and analyses of TNX-102 SL treatment and effects on fibromyalgia at the 7th International Congress on Controversies in Fibromyalgia, held in Vienna, Austria, in an oral presentation titled, “Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL) Treatment of Fibromyalgia at Bedtime to Target Non-Restorative Sleep Showed Durable Pain Reduction in Two Double-Blind Randomized Phase 3 Studies.”

TNX-102 SL in development for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)

  • The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial will be conducted by the University of North Carolina under an investigator-initiated investigational new drug (IND) application. The OASIS trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department (ED) after a motor vehicle collision. Fourteen days of bedtime TNX-102 SL will be dosed and tested in the immediate aftermath of motor vehicle collision. The study will test the potential for TNX-102 SL to target trauma-related sleep disturbance and its ability to facilitate recovery from ASR and to prevent PTSD. The program has the potential to provide military personnel with a new treatment option that improves warfighter performance and resilience when administered in the early aftermath of traumatic events in the war theater. The study is expected to be initiated in the second quarter of 2025.

TNX-1300 (recombinant double mutant cocaine esterase): under investigation for biologic for cocaine intoxication

  • The National Institutes of Health (NIH)’s National Institute of Drug Abuse (NIDA) previously awarded Tonix a Cooperative Agreement grant for approximately $5 million to support development of TNX-1300.
  • TNX-1300 has been granted Breakthrough Therapy designation by the FDA.
  • The Company discontinued enrollment and terminated the Phase 2 CATALYST study of its TNX-1300 double-mutant cocaine esterase 200 mg, i.v. solution product candidate for the treatment of cocaine intoxication because enrollment in this emergency department-based study was slower than projected. The Company is evaluating new study designs and new endpoints for further development of TNX-1300. The CATALYST study was not discontinued for safety or efficacy reasons.

Immunology Pipeline

TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody under investigation for prophylaxis for organ transplant rejection and treatment of autoimmune disorders.

  • In February 2025, Tonix announced positive topline results from its Phase 1, single ascending dose (SAD) first-in-human trial of TNX-1500 in healthy participants. The objectives of the Phase 1 trial were to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500, as well as to support dosing in a planned Phase 2 trial in kidney transplant recipients, pending alignment with the FDA. All objectives were met and support proceeding to a Phase 2 trial. TNX-1500 blocked the primary and secondary antibody responses to a test antigen at the 10 mg/kg and 30 mg/kg i.v. doses, showed mean half-life of 34-38 days for the 10 mg/kg and 30 mg/kg doses (supporting monthly dosing for future efficacy trials) and was generally well-tolerated with a favorable safety profile.
  • The first proposed indication for TNX-1500 is prophylaxis of organ rejection in adult patients receiving a kidney transplant; but multiple additional indications are possible, including the treatment of autoimmune diseases. Preclinical studies have shown that TNX-1500 maintains the activity of first-generation monoclonal antibodies (mAbs), yet with reduced risk of thrombotic complications.   Pharmacokinetic data support a monthly i.v. dosing regimen. This analysis together with TNX-1500’s activity and tolerability in animal models, suggests that the protein engineering of TNX-1500’s Fc region has achieved its design goals.

Infectious Disease Pipeline

TNX-801 (recombinant horsepox virus, minimally replicative live vaccine): potential vaccine to protect against mpox and smallpox.

  • In April 2025, the company presented data on TNX-801 in an oral presentation at the World Vaccine Congress Washington 2025, held in Washington, D.C. The presentation titled “A Novel Single-Dose, Attenuated Live, Minimally Replicative Mpox Vaccine” highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected animals from mpox and rabbitpox and was well tolerated, even in immunocompromised animals. Durable protection of rabbits from lethal rabbitpox infection was present six months after vaccination. In September 2024, Tonix announced that the WHO’s preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference, aligns with the characteristics of TNX-801.
  • In March 2025, Tonix announced it was awarded a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of TNX-801. The grant will allow Tonix to develop a commercialization plan for TNX-801.

Corporate and Partnerships – Recent Highlights*

  • In April 2025, the Company announced it has entered into a collaborative research agreement with Makana Therapeutics, a global leader in the field of xenotransplantation, to study Tonix’s anti-CD40L (CD40 ligand, also called CD154) monoclonal antibody candidate, TNX-1500, in combination with Makana’s human-compatible pig organs and cells for the treatment of organ failure. TNX-1500 is an investigational, humanized Fc-modified IgG4 anti-CD40L antibody with high affinity for CD40L. The preclinical research and development collaboration has the potential to span multiple Makana programs including kidney, heart and islet cell xenotransplant.
  • In April 2025, Tonix announced the launch of TONIX ONE™, a fully-integrated digital platform designed to provide resources to help patients better understand and manage their migraine condition. TONIX ONE provides an intuitive, comprehensive journey for patients by offering educational resources about migraine and the limitations of oral medications which can sometimes lead to delayed or ineffective symptom relief. The platform also connects patients directly to independent migraine specialists via telehealth services and e-prescription requests, simplifying and accelerating access to treatment.  
  • During the first quarter of 2025, the Company announced the promotion of Siobhan Fogarty to Chief Technical Officer and the appointment of Gary Ainsworth as its new Vice President, Market Access.

      Financial – Recent Highlight

As of March 31, 2025, Tonix had $131.7 million of cash and cash equivalents, compared to $98.8 million as of December 31, 2024. Net cash used in operations was approximately $16.6 million for first quarter 2025, compared to net cash used in operations of $17.6 for the same period in 2024.

On July 30, 2024, the Company entered into a Sales Agreement with AGP pursuant to which the Company may issue and sell, from time to time, shares of the Company’s common stock having an aggregate offering price of up to $250.0 million in at-the-market sales. During the three months ended March 31, 2025, the Company sold approximately 2.7 million shares of common stock for net proceeds of approximately $59.8 million. Subsequent to March 31, 2025, the Company sold 0.6 million shares of common stock under the Sales Agreement, for net proceeds of approximately $9.9 million.

The Company believes that its cash resources at March 31, 2025, along with the net proceeds of $9.9 million raised from equity offerings in the second quarter of 2025, will meet its planned operating and capital expenditure requirements into the second quarter of 2026.

Subsequent to March 31, 2025, the Company repurchased 150,000 of its shares of common stock outstanding under a share repurchase program, for a gross aggregate cost of approximately $2.9 million.


First Quarter 2025 Financial Results

Net product revenue for the first quarter 2025 was approximately $2.4 million compared to $2.5 million for the same period in 2024. Net product revenue consisted of combined net sales of Zembrace® SymTouch® and Tosymra®. Cost of Sales for the first quarter 2025 was approximately $0.9 million compared to $1.7 million for the same period in 2024.

Research and development expenses for the first quarter 2025 were $7.4 million, compared to $12.9 million for the same period in 2024. This decrease is predominantly due to decreased clinical, non-clinical, manufacturing and employee-related expenses.

Selling, general and administrative expenses for the first quarter 2025 were $10.1 million, compared to $9.3 for the same period in 2024. The increase was primarily due to an increase in sales and marketing expenses offset by a decrease in employee-related expenses resulting from a reduction in workforce in earlier 2024.

Net loss available to common stockholders was $16.8 million, or $2.84 per share, basic and diluted, for the first quarter 2025, compared to net loss of $14.9 million, or $535.72 per share, basic and diluted, for the same period in 2024. The basic and diluted weighted average common shares outstanding for the first quarter 2025 was 5,927,231 compared to 27,886 shares for the same period in 2024.

About Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. In March 2025 the FDA guided that no Advisory Committee Meeting will be required for this NDA. The FDA has also 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 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’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. Department of Defense’s (DoD’s) Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent 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, Tosymra and TONIX ONE are 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, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, 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.

View full release here.

Release – SelectQuote, Inc. Reports Third Quarter of Fiscal Year 2025 Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SLQT

05/12/2025

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Third Quarter of Fiscal Year 2025 – Consolidated Earnings Highlights

  • Revenue of $408.2 million
  • Net income of $26.0 million
  • Adjusted EBITDA* of $37.7 million

Fiscal Year 2025 Guidance Ranges:

  • Revenue expected in a range of $1.500 billion to $1.575 billion
  • Net income (loss) expected in a range of $(1) million to $28 million
  • Adjusted EBITDA* expected in a range of $115 million to $140 million

Third Quarter Fiscal Year 2025 – Segment Highlights

Senior

  • Revenue of $169.4 million
  • Adjusted EBITDA* of $45.7 million
  • Approved Medicare Advantage policies of 168,001

Healthcare Services

  • Revenue of $189.6 million
  • Adjusted EBITDA* of $6.4 million
  • 105,523 SelectRx members

Life

  • Revenue of $45.8 million
  • Adjusted EBITDA* of $6.4 million

OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) reported consolidated revenue for the third quarter of fiscal year 2025 of $408.2 million compared to consolidated revenue for the third quarter of fiscal year 2024 of $376.4 million. Consolidated net income for the third quarter of fiscal year 2025 was $26.0 million compared to consolidated net income for the third quarter of fiscal year 2024 of $8.6 million. Finally, consolidated Adjusted EBITDA* for the third quarter of fiscal year 2025 was $37.7 million compared to consolidated Adjusted EBITDA* for the third quarter of fiscal year 2024 of $46.6 million.

SelectQuote Chief Executive Officer, Tim Danker, remarked, “We are very proud of the service and value we delivered to America’s seniors over this past year’s highly unique Medicare Advantage season. SelectQuote’s agent-led model paired with our technology-enabled information advantage made our platform more valuable than ever to participants in the healthcare ecosystem. Policy features changed materially and plan termination activity from carriers was significantly higher than historical averages. Through that volatility and confusion, SelectQuote’s agents again delivered remarkable and efficient service, highlighted by a 15% increase in year-over-year policy close rates. SelectQuote is organized to help each and every customer as an individual and despite significant change, our agents were able to help a higher percentage of them this year than last. Strong execution in our Senior business paired with continued performance in Healthcare Services and our Life division all contributed to successful consolidated results for our fiscal 3rd quarter.”

* See “Non-GAAP Financial Measures” below.

Segment Results

We currently have three reportable segments: 1) Senior, 2) Healthcare Services and 3) Life. The performance measures of the segments include total revenue and Adjusted EBITDA.* Costs of commissions and other services revenue, cost of goods sold-pharmacy revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses that are directly attributable to a segment are reported within the applicable segment. Indirect costs of revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses are allocated to each segment based on varying metrics such as headcount. Adjusted EBITDA is our segment profit measure to evaluate the operating performance of our business. We define Adjusted EBITDA as income (loss) before income tax expense (benefit) plus: (i) interest expense, net; (ii) depreciation and amortization; (iii) share-based compensation; (iv) goodwill, long-lived asset, and intangible assets impairments; (v) transaction costs; (vi) loss on disposal of property, equipment and software, net; (vii) other non-recurring expenses and income; (viii) changes in fair value of warrant liabilities. Adjusted EBITDA Margin is calculated as Adjusted EBITDA divided by revenue.

Senior

Financial Results

The following table provides the financial results for the Senior segment for the periods presented:

Operating Metrics

Submitted Policies

Submitted policies are counted when an individual completes an application with our licensed agent and provides authorization to the agent to submit the application to the insurance carrier partner. The applicant may have additional actions to take before the application will be reviewed by the insurance carrier.

The following table shows the number of submitted policies for the periods presented:

Approved Policies

Approved policies represents the number of submitted policies that were approved by our insurance carrier partners for the identified product during the indicated period. Not all approved policies will go in force.

* See “Non-GAAP Financial Measures” below.

The following table shows the number of approved policies for the periods presented:

Lifetime Value of Commissions per Approved Policy

Lifetime value of commissions per approved policy represents commissions estimated to be collected over the estimated life of an approved policy based on multiple factors, including but not limited to, contracted commission rates, carrier mix and expected policy persistency with applied constraints. The lifetime value of commissions per approved policy is equal to the sum of the commission revenue due upon the initial sale of a policy, and when applicable, an estimate of future renewal commissions.

The following table shows the lifetime value of commissions per approved policy for the periods presented:

Healthcare Services

Financial Results

The following table provides the financial results for the Healthcare Services segment for the periods presented:

Operating Metrics

Members

The total number of SelectRx members represents the amount of active customers to which an order has been shipped and the prescriptions per day represents the total average prescriptions shipped per business day. These two metrics are the primary drivers of revenue for Healthcare Services.

* See “Non-GAAP Financial Measures” below.

The following table shows the total number of SelectRx members as of the periods presented:

The total number of SelectRx members increased by 41% as of March 31, 2025, compared to March 31, 2024, due to our strategy to grow SelectRx membership.

The following table shows the average prescriptions shipped per day for the periods presented:

Combined Senior and Healthcare Services – Consumer Per Unit Economics

The opportunity to leverage our existing database and distribution model to improve access to healthcare services for our consumers has created a need for us to review our key metrics related to our per unit economics. As we think about the revenue and expenses for Healthcare Services, we note that they are primarily driven by the marketing acquisition costs associated with the sale of an MA or MS policy, some of which costs are allocated directly to Healthcare Services, and therefore determined that our per unit economics measure should include components from both Senior and Healthcare Services. See details of revenue and expense items included in the calculation below.

Combined Senior and Healthcare Services consumer per unit economics represents total MA and MS commissions; other product commissions; other revenues, including revenues from Healthcare Services; and operating expenses associated with Senior and Healthcare Services, each shown per number of approved MA and MS policies over a given time period. Management assesses the business on a per-unit basis to help ensure that the revenue opportunity associated with a successful policy sale is attractive relative to the marketing acquisition cost. Because not all acquired leads result in a successful policy sale, all per-policy metrics are based on approved policies, which is the measure that triggers revenue recognition.

The MA and MS commission per MA/MS policy represents the LTV for policies sold in the period. Other commission per MA/MS policy represents the LTV for other products sold in the period, including DVH prescription drug plan, and other products, which management views as additional commission revenue on our agents’ core function of MA/MS policy sales. Pharmacy revenue per MA/MS policy represents revenue from SelectRx, and other revenue per MA/MS policy represents revenue from Population Health, production bonuses, marketing development funds, lead generation revenue, and adjustments from the Company’s reassessment of its cohorts’ transaction prices. Total operating expenses per MA/MS policy represents all of the operating expenses within Senior and Healthcare Services. The revenue to customer acquisition cost (“CAC”) multiple represents total revenue as a multiple of total marketing acquisition cost, which represents the direct costs of acquiring leads. These costs are included in marketing and advertising expense within the total operating expenses per MA/MS policy.

The following table shows combined Senior and Healthcare Services consumer per unit economics for the periods presented. Based on the seasonality of Senior and the fluctuations between quarters, we believe that the most relevant view of per unit economics is on a rolling 12-month basis. All per MA/MS policy metrics below are based on the sum of approved MA/MS policies, as both products have similar commission profiles.

Total revenue per MA/MS policy increased 23% for the twelve months ended March 31, 2025, compared to the twelve months ended March 31, 2024, primarily due to the increase in pharmacy revenue. Total operating expenses per MA/MS policy increased 26% for the twelve months ended March 31, 2025, compared to the twelve months ended March 31, 2024, driven by an increase in cost of goods sold-pharmacy revenue for Healthcare Services due to the growth of the business.

Life

Financial Results

The following table provides the financial results for the Life segment for the periods presented:

Operating Metrics

Life premium represents the total premium value for all policies that were approved by the relevant insurance carrier partner and for which the policy document was sent to the policyholder and payment information was received by the relevant insurance carrier partner during the indicated period. Because our commissions are earned based on a percentage of total premium, total premium volume for a given period is the key driver of revenue for our Life segment.

The following table shows term and final expense premiums for the periods presented:

* See “Non-GAAP Financial Measures” below.

Earnings Conference Call

SelectQuote, Inc. will host a conference call with the investment community on May 12, 2025, beginning at 8:30 a.m. ET. To register for this conference call, please use this link: https://registrations.events/direct/Q4I54780976. 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 at least 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.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures intended to supplement, not substitute for, comparable GAAP measures. To supplement our financial statements presented in accordance with GAAP and to provide investors with additional information regarding our GAAP financial results, we have presented in this release Adjusted EBITDA and Adjusted EBITDA Margin, which are non-GAAP financial measures. These non-GAAP financial measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similarly titled measures presented by other companies. We define Adjusted EBITDA as net income (loss) before income tax expense (benefit), plus interest expense, depreciation and amortization, changes in fair value of warrant liabilities, and certain add-backs for non-cash or non-recurring expenses, including restructuring and share-based compensation expenses. The most directly comparable GAAP measure is income (loss) before tax expense (benefit). We define Adjusted EBITDA Margin as Adjusted EBITDA divided by revenue. The most directly comparable GAAP measure is net income margin. We monitor and have presented in this release Adjusted EBITDA and Adjusted EBITDA Margin because they are key measures used by our management and Board of Directors to understand and evaluate our operating performance, to establish budgets, and to develop operational goals for managing our business. In particular, we believe that excluding the impact of these expenses in calculating Adjusted EBITDA can provide a useful measure for period-to-period comparisons of our core operating performance. We believe that these non-GAAP financial measures help identify underlying trends in our business that could otherwise be masked by the effect of the expenses that we exclude in the calculations of these non-GAAP financial measures. Accordingly, we believe that these financial measures provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects. Reconciliations of net income (loss) before income tax expense (benefit) to Adjusted EBITDA are presented below beginning on page 12.

Forward Looking Statements

This release contains forward-looking statements. These forward-looking statements reflect our current views with respect to, among other things, future events and our financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “should,” “could,” “predict,” “potential,” “believe,” “will likely result,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “projection,” “would” and “outlook,” or the negative version of those words or other comparable words or phrases of a future or forward-looking nature. These forward-looking statements are not historical facts, and are based on current expectations, estimates and projections about our industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.

There are or will be important factors that could cause our actual results to differ materially from those indicated in these forward-looking statements, including, but not limited to, the following: our reliance on a limited number of insurance carrier partners and any potential termination of those relationships or failure to develop new relationships; existing and future laws and regulations affecting the health insurance market; changes in health insurance products offered by our insurance carrier partners and the health insurance market generally; insurance carriers offering products and services directly to consumers; changes to commissions paid by insurance carriers and underwriting practices; competition with brokers, exclusively online brokers and carriers who opt to sell policies directly to consumers; competition from government-run health insurance exchanges; developments in the U.S. health insurance system; our dependence on revenue from carriers in our senior segment and downturns in the senior health as well as life, automotive and home insurance industries; our ability to develop new offerings and penetrate new vertical markets; risks from third-party products; failure to enroll individuals during the Medicare annual enrollment period; our ability to attract, integrate and retain qualified personnel; our dependence on lead providers and ability to compete for leads; failure to obtain and/or convert sales leads to actual sales of insurance policies; access to data from consumers and insurance carriers; accuracy of information provided from and to consumers during the insurance shopping process; cost-effective advertisement through internet search engines; ability to contact consumers and market products by telephone; global economic conditions, including inflation; disruption to operations as a result of future acquisitions; significant estimates and assumptions in the preparation of our financial statements; impairment of goodwill; potential litigation and other legal proceedings or inquiries; our existing and future indebtedness; our ability to maintain compliance with our debt covenants; access to additional capital; failure to protect our intellectual property and our brand; fluctuations in our financial results caused by seasonality; accuracy and timeliness of commissions reports from insurance carriers; timing of insurance carriers’ approval and payment practices; factors that impact our estimate of the constrained lifetime value of commissions per policyholder; changes in accounting rules, tax legislation and other legislation; disruptions or failures of our technological infrastructure and platform; failure to maintain relationships with third-party service providers; cybersecurity breaches or other attacks involving our systems or those of our insurance carrier partners or third-party service providers; our ability to protect consumer information and other data; failure to market and sell Medicare plans effectively or in compliance with laws; and and other factors related to our pharmacy business, including manufacturing or supply chain disruptions, access to and demand for prescription drugs, and regulatory changes or other industry developments that may affect our pharmacy operations. For a further discussion of these and other risk factors that could impact our future results and performance, see the section entitled “Risk Factors” in the most recent Annual Report on Form 10-K (the “Annual Report”) and subsequent periodic reports filed by us with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

About SelectQuote:

Founded in 1985, SelectQuote (NYSE: SLQT) 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. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.

With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. 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, SelectPatient Management, a provider of chronic care management services, and Healthcare Select which proactively connects consumers with a wide breadth of healthcare services supporting their needs.

Source: SelectQuote, Inc.

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Release – Gyre Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GYRE

May 9, 2025

PDF Version

Net Income of $3.7 million; reaffirms Full-Year Revenue Guidance of $118–$128 million

  • Q1 2025 revenue of $22.1 million; GAAP basic EPS: $0.03
  • Completed data collection and achieved database lock for the pivotal Phase 3 trial of Hydronidone in Chronic Hepatitis B (“CHB”)-associated liver fibrosis; currently reviewing data and on track to report topline results in Q2 2025
  • Received IND approval from China’s National Medical Products Administration (“NMPA”) for a new indication of pirfenidone to treat radiation-induced lung injury (“RILI”), with or without immune-related pneumonitis (“CIP”), marking Gyre’s first entry into oncology supportive care space
  • Initiated commercialization of avatrombopag in China in March 2025, building a strategic presence with liver disease specialists
  • Nintedanib remains on track for commercialization in May 2025, expanding IPF treatment options across our physician network
  • $51.3 million in cash, cash equivalents, and short and long-term deposits as of March 31, 2025

SAN DIEGO, May 09, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced financial results for the first quarter ended March 31, 2025 and provided a business update.

“This quarter marked a meaningful step forward in expanding our market presence, particularly in the liver space,” said Han Ying, Ph.D., CEO of Gyre Therapeutics. “The successful launch of avatrombopag and our growing commercial footprint with hepatology and hematology specialists provide a strong foundation for our future growth. In addition, the recent NMPA approval to initiate a clinical trial of pirfenidone in radiation-induced lung injury, including with or without immune-related pneumonitis, supports our ability to enter the oncology supportive care space with a novel, lung-protective therapy. We plan to initiate an adaptive Phase 2/3 trial in the second half of 2025 to advance this program through development.”

First Quarter 2025 Business Highlights and Upcoming Milestones

Commercial Portfolio Expansion

ETUARY® (pirfenidone): Delivered $21.7 million in Q1 sales. While sales declined year-over-year due to relatively high sales in the first quarter of 2024, ETUARY remains the market leader for idiopathic pulmonary fibrosis (IPF) in the PRC.

Nintedanib: Gyre remains on track to commercially launch nintedanib in May 2025, targeting multiple forms of fibrosing interstitial lung disease (“ILD”), including IPF, systemic sclerosis-associated ILD, and progressive fibrosing ILD. This is expected to expand Gyre’s share of the pulmonary fibrosis treatment landscape and support second-half 2025 revenue growth.

Avatrombopag: Commercialization of avatrombopag was initiated in March 2025, expanding Gyre’s footprint in hepatology and hematology. Approved for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, the launch aligns with Gyre’s strategy to deepen clinical engagement with liver disease specialists and diversify the market of available products.

Indication Expansion: Oncology Supportive Care

Pirfenidone New Indication: In March 2025, Gyre received NMPA approval to initiate a clinical trial of pirfenidone for RILI, including cases complicated by CIP. This development positions pirfenidone for potential entry into oncology supportive care, with plans to begin an adaptive Phase 2/3 trial in the second half of 2025 across top oncology centers in China.

Pipeline Development Updates

F573:

  • F573 is a caspase inhibitor and potential Category 1 new drug for the treatment of acute/acute on-chronic liver failure (“ALF/ACLF”). Completion of the Phase 2 clinical trial of F573 for ALF/ACLF is expected by the end of 2026.

F230:

  • F230, a selective endothelin receptor agonist for the treatment of pulmonary arterial hypertension (“PAH”), is expected to begin a Phase 1 trial in Q2 2025.

F528:

  • F528, a novel anti-inflammation agent with the potential to modify the progression of chronic obstructive pulmonary disease (“COPD”), is undergoing preclinical studies as a potential first-line therapy for the treatment of COPD. Gyre Pharmaceuticals plans to submit an IND application in 2026.

Corporate Updates

  • In March 2025, Gyre appointed Ping Zhang as Executive Chairman of the Company’s Board of Directors; he remains a member of the Nominating and Corporate Governance Committee.

Financial Results

Cash Position

As of March 31, 2025, Gyre Therapeutics held $15.0 million in cash and cash equivalents, $14.8 million in short-term bank deposits, and $21.4 million in long-term certificates of deposit, totaling $51.3 million.

Gyre believes that its existing cash resources, combined with anticipated cash flow from commercial operations, will be sufficient to fund its operating and capital requirements for the next 12 months.

Financial Results for the Three Months Ended March 31, 2025

  • Revenues: Revenues for the three months ended March 31, 2025, were $22.1 million, compared to $27.2 million in the same period last year. The $5.1 million decrease was primarily due to a $5.2 million decline in ETUARY® sales. This was anticipated, as early 2024 revenues were elevated by a one-time marketing campaign focused on rural expansion, which we did not repeat in 2025. The shift in marketing resources was deliberate, with funds reallocated to support the upcoming launches of Nintedanib and avatrombopag. Additionally, weaker economic conditions in China and increased competition in the IPF treatment market also contributed to the decline. Revenues from generic products decreased by $0.2 million, partially offset by $0.3 million in initial revenue from the March 2025 launch of avatrombopag.

Gyre anticipates revenue growth over the remainder of the year, driven by the planned commercial launch of Nintedanib in May 2025 and the continued expansion of avatrombopag. Based on current performance and market outlook, the company is reaffirming its full-year 2025 revenue guidance of $118 to $128 million1, compared to $105.8 million in 2024.

  • Cost of Revenues: For the three months ended March 31, 2025, cost of revenues was $0.9 million, compared to $1.0 million for the same period in 2024. The $0.1 million decrease was in line with the corresponding decline in sales.
  • Selling & Marketing Expense: For the three months ended March 31, 2025, selling and marketing expense was $10.8 million, compared to $12.5 million for the same period in 2024. The $1.7 million decrease was primarily driven by a reduction in commission costs due to the decrease of sales.
  • Research & Development Expense: For the three months ended March 31, 2025, research and development expense was $3.1 million, compared to $2.2 million for the same period in 2024. The increase was primarily attributable to Gyre Pharmaceuticals and was driven by a $1.3 million increase in clinical research expenses, primarily related to data analysis costs for F351. This increase was partially offset by a $0.2 million decrease in materials and utilities and a $0.1 million reduction in staff costs, primarily due to reduction of headcounts. The overall increase was further offset by a $0.1 million decrease from Gyre Therapeutics, due to the reduction in contract services.

[1] 2025 revenue guidance assumes a constant foreign currency exchange rate and no significant economic disruption or downturn.

  • General & Administrative Expense: For the three months ended March 31, 2025, general and administrative expense was $5.0 million, compared to $3.4 million for the same period in 2024. The increase was primarily driven by a $0.6 million increase in functional and administrative department’s personnel and stock compensation costs, a $0.8 million increase in miscellaneous expense, mainly due to the increase in the annual meeting expense.
  • Income from operations: For the three months ended March 31, 2025, income from operations was $2.3 million, compared to $8.1 million for the same period in 2024. The decrease was primarily due to a reduction in revenue.
  • Net Income: For the three months ended March 31, 2025, net income was $3.7 million, compared to $9.9 million in net income for the same period in 2024. The decrease was primarily attributable to lower income from operations and unfavorable change in fair value of warrant liabilities.
  • Non-GAAP Adjusted Net Income: For the three months ended March 31, 2025, non-GAAP adjusted net income was $2.9 million, compared to $8.2 million non-GAAP adjusted net income for the same period in 2024. The decrease was primarily driven by the decline in revenue of $5.1 million and increase in operating expenses of $0.2 million.

Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.

Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.

About F351 (Hydronidone)

F351 is a structural analogue of the approved anti-fibrotic IPF drug pirfenidone and has been shown to inhibit in vitro both p38γ kinase activity and TGF-β1-induced excessive collagen synthesis in hepatic stellate cells (“HSCs”), which are recognized as critical event in the development and progression of fibrosis in the liver. This is further supported by its anti-proliferative effects on the HSCs in the liver. In vitro anti-fibrotic effects of F351 were also confirmed in several established in vivo models of liver fibrosis such as CCI4-induced liver fibrosis mouse model, DMN-induced liver fibrosis rat model, and HSA-induced liver rat model, as well as mouse model of MASH fibrosis (CCI4+Western High Fat Diet).

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to report topline data by Q2 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, DKD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.).

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company’s experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including topline results of the Phase 3 trial of Hydronidone in CHB-associated liver fibrosis, timing of initiation of Gyre’s Phase 2 trial in the U.S. for F351 for the treatment of MASH-associated liver fibrosis, initiation of Gyre Pharmaceuticals’ clinical trial evaluating pirfenidone capsules in oncology-related pulmonary complications, timing of completion of Gyre’s Phase 2 clinical trial in the PRC of F573 for ALF/ACLF, initiation of Phase 1 trial of F230 for the treatment of PAH and IND submission of F528 in COPD, the expectations regarding commercial launch of nintedanib, interactions with regulators, expectations regarding future product sales, and Gyre’s financial position and cash resources. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings with the Securities and Exchange Commission.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

For Investors:

Stephen Jasper

stephen@gilmartinir.com

View full release here.

Release – SelectQuote Responds to Allegations in Department of Justice Complaint

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SLQT

05/09/2025

For over 40 years, SelectQuote has helped millions of Americans find the right insurance coverage to meet their healthcare needs. Our steadfast commitment to integrity, compliance and customer service is foundational to our business.

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, strongly disagrees with the allegations made by the Department of Justice (DoJ) complaint filed against multiple participants in the Medicare Advantage industry last week. SelectQuote believes the allegations are incorrect and lack a clear understanding of the overall industry and SelectQuote’s business model.

As we have previously disclosed, we have cooperated with the DoJ’s inquiries since 2022. We firmly reject these allegations and will defend our reputation as a compliant and fair-dealing standard bearer in the Medicare Advantage industry.

SelectQuote’s mission remains as it always has been: to connect our customers to the best insurance plans to meet their unique needs. We look forward to continuing our 40-year legacy as customer-focused, value-enhancing broker in the Medicare Advantage sector.

Over the past four decades, we have served over 8 million Americans, helping them find the right insurance coverage for their needs. We are particularly proud of our Senior health work, which helps some of the most underserved communities in every corner of our country, including many seniors in small towns, rural areas, and urban areas.

The beneficiary population we serve also skews toward seniors who are both lower income and less healthy than the U.S. average. The percent of our customers who qualify for dual special needs plans based upon their income level is more than twice the national average. Our policy sales also represent a much higher portion of individuals with severe and chronic diseases than the national average.

Throughout our history, we have worked hard to build a culture based on values of integrity and compliance, and we require and prioritize adherence to all applicable laws, rules and regulations.

SelectQuote will defend itself against the allegations in the DoJ’s complaint, and we are confident that once the facts are presented, there will be a positive resolution to this matter.

About SelectQuote:

Founded in 1985, SelectQuote (NYSE: SLQT) 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. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.

With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. 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, SelectPatient Management, a provider of chronic care management services, 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 – Ocugen Provides Business Update with First Quarter 2025 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 9, 2025

PDF Version

Conference Call and Webcast Today at 8:30 a.m. ET

  • OCU400 Phase 3 clinical trial for retinitis pigmentosa (RP) is progressing well and on target for potential BLA/MAA filings by mid-2026
  • Anticipate initiating OCU410ST Phase 2/3 pivotal confirmatory clinical trial for Stargardt disease mid- 2025

MALVERN, Pa., May 09, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported first quarter 2025 financial results along with a general business update.

“All three of our novel modifier gene therapies are advancing through the clinic and we are on track to meet our goal of three Biologics License Application (BLA)/Marketing Authorization Application (MAA) filings in the next three years,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “We remain steadfast in our mission to provide a one-time therapy for life to address considerable unmet medical needs that exist for millions of patients facing the terrifying prospect of losing their vison.”

In January, the Company announced positive two-year long-term safety and efficacy data from the Phase 1/2 clinical trial of OCU400 for RP that demonstrated a durable, clinically meaningful, and statistically significant (p=0.005) improvement in visual function (LLVA) in all evaluable treated subjects at two years when compared to untreated eyes. Additionally, 100% (10/10) of treated evaluable subjects demonstrated improvement or preservation in visual function compared to untreated eyes. This data further supports the gene-agnostic mechanism of action of OCU400, a broad RP treatment not restricted to specific mutations, with durability.

The OCU400 Phase 3 liMeliGhT clinical trial is open to all eligible RP patients—early to advanced stage RP including pediatric subjects age 5+—regardless of gene mutation (syndromic and non-syndromic forms of RP). OCU400 has the potential to treat all 300,000 RP patients in the U.S. and EU.

Alignment was reached with the FDA to move forward with a Phase 2/3 pivotal confirmatory trial for OCU410ST for Stargardt disease, which includes an adaptive design with a masked interim analysis at 8 months. Stargardt disease affects 100,000 people in the U.S. and EU. The Phase 2/3 clinical trial will randomize 51 subjects, 34 of whom will receive a single, subretinal, injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with worse visual acuity, and 17 of whom will serve as untreated controls. The primary endpoint in the clinical trial is change in atrophic lesion size. Key secondary endpoints include visual acuity as measured by best corrected visual acuity (BCVA) and LLVA compared to untreated controls. One-year data will be utilized for the BLA filing. The latest data from the OCU410ST Phase 1 clinical trial demonstrates atrophic lesions grew slower by 54% at six months in evaluable treated eyes when compared to untreated eyes. In BCVA, treated eyes demonstrated statistically significant (p=0.02) improvement in visual function when compared to untreated fellow eyes. Ocugen plans to initiate the Phase 2/3 study by mid-year with a target BLA filing in 2027.

In February, dosing was complete in the Phase 2 portion of the OCU410 Phase 1/2 ArMaDa clinical trial for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). In evaluable subjects, OCU410 12-month data demonstrates a 4-line (23-letter) gain in visual acuity and 41% slower GA lesion growth in treated eyes versus untreated fellow eyes after a single injection. The unique mechanism of action of OCU410 targets multiple pathways associated with dAMD pathogenesis, in contrast to products currently approved or under development that treat only one cause of GA, require multiple injections per year, and have safety considerations. Approximately 2-3 million patients in the U.S. & EU and 8 million globally suffer from GA.

All of Ocugen’s modifier gene therapies—OCU400 for RP, OCU410ST for Stargardt disease, and OCU410 for GA were granted Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency’s (EMA) Committee for Advanced Therapies. ATMP classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential one-time gene therapy for life. Additionally, this classification allows the Company to interact with the EMA more frequently for scientific advice and protocol assistance.

Relevant to Ocugen’s recent ATMP classifications, Dr. Musunuri participated in a panel addressing the journey of successfully commercializing ATMPs, which focused on the challenges and strategies in achieving commercial success while also ensuring access for the patients who need them, during the 2025 Cell & Gene Meeting on the Mediterranean, hosted by the Alliance for Regenerative Medicine. The Meeting on the Med provided an excellent forum to reach a wide audience about the importance of changing the treatment paradigm by bringing potentially transformative modifier gene therapies to market.

Also in the first quarter of 2025, the first patient was dosed in the Phase 1 clinical trial for OCU200, the Company’s biologic product candidate for diabetic macular edema. Currently, patients are being dosed in the second cohort and Ocugen is planning to complete the Phase 1 clinical trial in the second half of this year. The Company intends to initiate the Phase 3 trial for NeoCart® contingent on adequate availability of funding and/or based on the potential of a future partnership. Finally, the Investigational New Drug application is in effect for OCU500, and the National Institute of Allergy and Infectious Diseases intends to initiate a Phase 1 clinical trial in the second quarter of 2025. Ocugen is continuing discussions with relevant government agencies as well as strategic partners regarding developmental funding for its vaccines technology for flu.

“We have had a strong start to 2025 and are approaching considerable milestones in the next few months,” said Dr. Musunuri. “I am enthusiastic about where we are as a Company, with a clear and precise business strategy to operate efficiently in service of our patients and shareholders.”

Modifier Gene Therapy Platform—a Novel First-in-Class Platform

  • OCU400 for RP – The EMA provided a positive opinion for ATMP classification for OCU400 and granted eligibility to submit the OCU400 MAA via the centralized procedure as an ATMP based on the current study design and statistical analysis plan. Actively recruiting patients in the U.S. and Canada in the Phase 3 liMeliGhT clinical trial and on track to meet BLA/MAA filing targets in mid-2026.
  • OCU410ST for Stargardt Disease – Received FDA alignment to move forward with Phase 2/3 pivotal confirmatory clinical trial, which can be the basis of a BLA submission. ATMP classification granted by the EMA.
  • OCU410 for GA – Announced that dosing was complete, ahead of schedule, in the Phase 2 portion of the Phase 1/2 ArMaDa clinical trial for OCU410. Received ATMP classification from the EMA.

First Quarter 2025 Financial Results

  • The Company’s cash and restricted cash totaled $38.1 million as of March 31, 2025, compared to $58.8 million as of December 31, 2024. The Company had 292.0 million shares of common stock outstanding as of March 31, 2025. The Company expects its cash and restricted cash runway into the first quarter of 2026.
  • Total operating expenses for the three months ended March 31, 2025 were $16.0 million and included research and development expenses of $9.5 million and general and administrative expenses of $6.5 million. This compares to total operating expenses for the three months ended March 31, 2024 of $13.2 million that included research and development expenses of $6.8 million and general and administrative expenses of $6.4 million.
  • Ocugen reported a $0.05 net loss per common share for the three months ended March 31, 2025 compared to a $0.05 net loss per common share for the three months ended March 31, 2024.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 1773288
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 pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us 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; Ocugen’s expected cash runway, 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
IR@ocugen.com 

View full release here.

Release – Zomedica to Report First Quarter 2025 Financial Results with a Business Update on Thursday, May 15, 2025 at 4:30 pm ET

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZOMDF

ANN ARBOR, MI / ACCESS Newswire / May 9, 2025 / Zomedica Corp. (OTCQB:ZOMDF) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostic and therapeutic products for equine and companion animals, will host a conference call and audio-only webcast on Thursday, May 15, 2025, at 4:30 p.m. ET to discuss the Company’s operational and financial highlights for its first quarter ended March 31, 2025. A question-and-answer session will follow management’s prepared remarks.

Event: Zomedica First Quarter 2025 Earnings Call

Date: Thursday, May 15, 2025

Time: 4:30 p.m. Eastern Time

Live Call: +1-800-717-1738 (U.S. Toll-Free) or +1-646-307-1865 (International)

Webcast: LINK

For interested individuals unable to join the conference call, a dial-in replay of the call will be available until Thursday, May 29, 2025 at 11:59 PM ET and can be accessed by dialing +1-844-512-2921 (U.S. Toll-Free) or +1-412-317-6671 (International) and entering replay pin number: 1148151.

About Zomedica

Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices, along with the TRUFORMA® diagnostic platform, TRUVIEW® digital cytology system, VETGuardian® no-touch monitoring system, and VETIGEL® hemostatic gel, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. Zomedica grew revenue 8% in 2024 to $27 million and maintains a strong balance sheet with approximately $71 million in liquidity as of December 31, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

Follow Zomedica

Investor Relations Contact:

Zomedica Investor Relations
investors@zomedica.com
1-734-369-2555

SOURCE: Zomedica Corp.

View the original press release on ACCESS Newswire

Release – Cadrenal Therapeutics Reports First-Quarter 2025 Financial Results and Provides Corporate Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

Leadership appointment strengthens strategic and development capabilities

FDA Type D Meeting provides additional guidance for advancing the clinical development of tecarfarin

Collaboration Agreement with Abbott (NYSE: ABT) validates the need for new anticoagulation options

PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today reported its financial results for the first quarter ended March 31, 2025, and provided an update on the strategic focus of the company and clinical development of tecarfarin.

“In the first quarter of 2025, Cadrenal continued to build on the momentum we achieved during 2024,” said Quang X. Pham, Chairman & CEO. “The appointment of James Ferguson, M.D., FACC, FAHA, as our Chief Medical Officer positions us for success in reviewing potential assets to add to our portfolio and designing and executing our clinical program for tecarfarin. The finalized Collaboration Agreement with Abbott validates the critical need in the market for a new anticoagulant for patients with left ventricular assist devices (LVADs). And our meeting with the FDA provided additional guidance in the design of a pivotal trial.”

Highlights from the Quarter Ended March 31, 2025, and Other Recent Events:

Leadership Advances

In February 2025, Cadrenal appointed James J. Ferguson, M.D., FACC, FAHA, as Chief Medical Officer to lead the review of business development opportunities to expand the Company’s pipeline and drive the late-stage clinical development of tecarfarin for conditions requiring chronic anticoagulation therapy.

Regulatory Update

In February 2025, Cadrenal met with the U.S. Food and Drug Administration (FDA) for a Type D meeting. The FDA provided additional guidance on the appropriate design for a Phase 3 tecarfarin trial and welcomed submission of a final study design for review.

Collaboration Agreement with Abbott

In March 2025, we announced a Collaboration Agreement with Abbott (NYSE: ABT) to support our pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. Under the agreement, Abbott will share insights from recent HeartMate 3™ clinical trials and will support Cadrenal with trial design, site identification, trial awareness, and HeartMate 3™ expertise.

Operational Milestones

During the quarter, Cadrenal successfully completed the technical transfer and manufacturing of its tecarfarin drug substance (API) from a CDMO site located in Asia to a CDMO site in the United States. This initiative was done to support the company’s clinical and regulatory development strategy for tecarfarin and to improve supply chain security.

Cadrenal also conducted strategic market opportunity research for multiple indications, including patients with left ventricular assist devices. This research indicates that tecarfarin is uniquely positioned to provide clinical value to patients in the rapidly growing LVAD market, which is projected to nearly double by 2032. This research also showed that tecarfarin has the potential to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin’s potential value proposition for patients.

Participation in Key Investor, Medical, and Business Development Conferences

Cadrenal was active during the first quarter in several significant conferences to build corporate visibility and underscore its commitment to advancing innovation in anticoagulation therapy. Investor interactions included participation at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, a Company presentation at the BIO CEO and Investor Conference in New York, and, after the close of the quarter, a Company presentation at the Centri Capital Conference at Nasdaq headquarters in New York. Shortly after the quarter’s close, Cadrenal participated in the 18th National Conference on Anticoagulation Therapy in Washington, D.C.

Strategic Development Collaborations

Cadrenal continues to explore opportunities to add to the Company’s clinical pipeline and collaborate with potential development partners to advance the development of tecarfarin for patients with LVADs and for other indications requiring chronic anticoagulation.

First Quarter 2025 Financial Highlights

Research and development expenses for the quarter ended March 31, 2025, were $1.7 million compared to $0.6 million for the same period in 2024. General and administrative expenses for the quarter ended March 31, 2025, were $2.3 million compared to $1.1 million for the same period in 2024. Cadrenal reported a net loss of $3.8 million for the quarter ending March 31, 2025, compared to $1.7 million for the same period in 2024.

On March 31, 2025, Cadrenal had cash and cash equivalents of $7.3 million, compared to $10.0 million as of December 31, 2024. The Company had approximately 1.9 million shares of common stock outstanding as of March 31, 2025.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for a number of indications, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of warfarin and capture value in a market with high demand for safer, more manageable treatment options.

Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).

Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/ and connect with us on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the appointment of James Ferguson, M.D., FACC, FAHA, as the Company’s Chief Medical Officer positioning the Company for success in reviewing potential assets to add to its portfolio and designing and executing its clinical program for tecarfarin; the finalized Collaboration Agreement with Abbott validating the critical need in the market for a new anticoagulant for patients with left ventricular assist devices (LVADs); Abbott sharing insights from recent HeartMate 3™ clinical trials and supporting Cadrenal with trial design, site identification, trial awareness, and HeartMate 3™ expertise; the LVAD market projected to nearly double by 2032; and tecarfarin having the potential to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin’s potential value proposition for patients. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to utilize Abbott’s expertise to advance tecarfarin, the ability to successfully collaborate with Abbott, the initiation of the pivotal clinical trial for tecarfarin in LVAD patients by Cadrenal; for tecarfarin to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin’s potential value proposition for patients; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

View full release here.

Corporate and Investor Relations

Paul Sagan

LaVoieHealthScience

(617) 865-0041

psagan@lavoiehealthscience.com

Media

Andrew Korda

LaVoieHealthScience

(617) 865-0043

akorda@lavoiehealthscience.com

Release – MariMed Reports First Quarter 2025 Earnings

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MRMD

May 07, 2025 5:00pm EDT

NORWOOD, Mass., May 07, 2025 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or the “Company”) (CSE: MRMD) (OTCQX: MRMD), a leading multi-state cannabis operator focused on improving lives every day, today announced its financial results for the first quarter ended March 31, 2025.

Management Commentary

“We are executing on our vision to build the best consumer packaged goods company in cannabis, and over the past quarter we continued to penetrate more storefronts and capture more market share for our innovative, high-quality portfolio of brands,” said Jon Levine, MariMed Chief Executive Officer. “Our Betty’s Eddies™ cannabis chews remained the top-selling edible in Massachusetts, Maryland, and Delaware, and moved up to the #5 position in Illinois after its launch there just over a year ago. Our other core brands also achieved strong market share growth as we sold our products into 70 new storefronts. Wholesale sales now account for 44 percent of our revenue mix, an upward trend that we anticipate will continue as we further leverage our brands as the primary growth engine for the Company.”

“We are pleased to report sequential revenue growth in the first quarter of 2025, driven by continued strength in wholesale performance,” said Mario Pinho, MariMed Chief Financial Officer. “Wholesale sales helped to offset the financial impact of a soft quarter at retail as well as ramp-up costs associated with our new assets in Illinois and Missouri. We remain confident in delivering enhanced shareholder value through expanded brand distribution into new storefronts; the pursuit of new revenue streams, including through M&A, brand licensing, and potential entry into the hemp space; and a continued focus on disciplined cost management, operational efficiencies, and improved execution.”

Financial Highlights1

The following table summarizes the Company’s consolidated financial highlights (in millions, except percentage amounts):

1 See the reconciliations of non-GAAP financial measures to the most directly comparable GAAP measures and additional information about non-GAAP measures in the section entitled “Discussion of Non-GAAP Financial Measures” below and in the financials information included herewith.

CONFERENCE CALL

MariMed management will host a conference call on Thursday, May 8, 2025 at 8:00 a.m. Eastern time, to discuss these results. The conference call may be accessed through MariMed’s Investor Relations website, or by clicking the following link: Q125 MRMD Earnings Call.

FIRST QUARTER 2025 OPERATIONAL HIGHLIGHTS

During the first quarter, the Company announced the following development in the implementation of its strategic growth plan:

  • February 28: Completed its acquisition of First State Compassion Center (“FSCC”), the leading cannabis operator in Delaware, in accordance with the terms of the previously announced Omnibus Agreement entered into with FSCC in July 2023. The acquisition integrates FSCC’s cultivation and processing facilities and two dispensaries into MariMed’s fully vertical operations, further enhancing the Company’s revenue and profitability.

OTHER DEVELOPMENTS

Subsequent to the end of the first quarter, the Company announced the following further developments:

  • April 1: Commenced distribution of its Nature’s Heritage™-branded cannabis flower, pre-rolls, and vapes in Illinois, marking the first time the brand’s premium products are available in the state.
  • April 3: Expanded the line-up of its top-selling Betty’s Eddies™-branded cannabis chews with the introduction of a new caramel chew, Betty’s Caramelt Away.
  • April 8: Promoted Ryan Crandall to Chief Commercial Officer to lead the Company’s commercial strategy and activities, including Sales, Marketing, Product Development, and Retail Operations. He had served as the Company’s Chief Revenue Officer since July 2022, and prior was its Chief Products Officer and SVP, Sales for four years.

DISCUSSION OF NON-GAAP FINANCIAL MEASURES

MariMed’s management uses several different financial measures, both GAAP and non-GAAP, in analyzing and assessing the overall performance of its business, making operating decisions, and planning and forecasting future periods. The Company has provided in this release several non-GAAP financial measures: Non-GAAP Adjusted EBITDA and non-GAAP Adjusted EBITDA margin, Non-GAAP Gross margin, Non-GAAP Operating expenses and Non-GAAP Net income (loss), as supplements to Revenue, Gross margin, Operating expenses, Income (loss) from operations, Net income (loss) and other financial measures prepared in accordance with GAAP.

Management believes these non-GAAP financial measures are useful in reviewing and assessing the performance of the Company, and when planning and forecasting future periods, as they provide meaningful operating results by excluding the effects of expenses that are not reflective of its operating business performance. In addition, the Company’s management uses these non-GAAP financial measures to understand and compare operating results across accounting periods and for financial and operational decision-making. The presentation of these non-GAAP measures is not intended to be considered in isolation or as a substitute for the financial information prepared in accordance with GAAP.

Management believes that investors and analysts benefit from considering non-GAAP financial measures in assessing the Company’s financial results and its ongoing business, as it allows for meaningful comparisons and analysis of trends in the business. In particular, non-GAAP adjusted EBITDA is used by many investors and analysts themselves, along with other metrics, to compare financial results across accounting periods and to those of peer companies.

As there are no standardized methods of calculating non-GAAP financial measures, the Company’s calculations may differ from those used by analysts, investors and other companies, even those within the cannabis industry, and therefore may not be directly comparable to similarly titled measures used by others.

Management defines non-GAAP Adjusted EBITDA as income (loss) from operations, determined in accordance with GAAP, excluding the following items:

  • depreciation and amortization of property and equipment;
  • amortization of acquired intangible assets;
  • impairment or write-downs of acquired intangible assets;
  • inventory revaluation;
  • stock-based compensation;
  • severance;
  • legal settlements; and
  • acquisition-related and other expenses.

For further information, please refer to the publicly available financial filings available on MariMed’s Investor Relations website, as filed with the U.S. Securities and Exchange Commission, or as filed with the Canadian securities regulatory authorities on the SEDAR website.

ABOUT MARIMED

MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, Vibations™, InHouse™, and Nature’s Heritage™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.

IMPORTANT CAUTION REGARDING FORWARD-LOOKING STATEMENTS:

The information in this release contains “forward-looking” statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, which are subject to several risks and uncertainties. All statements other than statements of historical facts contained in this release, including without limitation statements regarding projected financial results for 2025, including anticipated openings of dispensaries and facilities, timing of regulatory approvals, plans and objectives of management for future operations, are forward-looking statements. Without limiting the foregoing, the words “anticipates”, “believes”, “estimates”, “expects”, “expectations”, “intends”, “may”, “plans”, and other similar language, whether in the negative or affirmative, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Forward-looking statements are based on our current beliefs and assumptions regarding our business, timing of regulatory approvals, the ability to obtain new licenses, business prospects and strategic growth plan, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated in these forward-looking statements due to various risks, uncertainties, and other important factors, including, among others, reductions in customer spending, our ability to recruit and retain key personnel, and disruptions from the integration efforts of acquired companies.

These factors are not intended to be an all-encompassing list of risks and uncertainties that may affect our business and results of operations. These statements are not a guarantee of future performance and involve risk and uncertainties that are difficult to predict, including, among other factors, changes in demand for the Company’s services and products, changes in the law and its enforcement, and changes in the economic environment. Additional information regarding these and other factors can be found in our reports filed with the U.S. Securities and Exchange Commission. In providing these forward-looking statements, the Company expressly disclaims any obligation to update these statements publicly or otherwise, whether as a result of new information, future events or otherwise, except as required by law.

All trademarks and service marks are the property of their respective owners.

For More Information Contact:

Howard Schacter, Chief Communications Officer
Email: hschacter@marimedinc.com
Phone: (781) 277-0007

View full release here.

Release – GeoVax Expands Gedeptin(R) Patent Portfolio

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Allowed Patent Claims Cover the Synergistic Combination of Gedeptin® Therapy with Radiation As a Targeted Approach for Solid Tumors

Atlanta, GA – May 7, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against solid tumors and infectious diseases, announced today that the U.S. Patent and Trademark Office has issued a Notice of Allowance related to U.S. patent application 17/502,101 entitled “Enhanced Therapeutic Usage of a Purine Nucleoside Phosphorylase or Nucleoside Hydrolase Prodrug”. The allowed claims further strengthen GeoVax’s intellectual property position in the oncology space.

The allowed claims describe a method for treating solid tumors—including glioblastoma, breast, prostate, head and neck, glioma, and lung cancers—through the direct intratumoral administration of an adenoviral vector encoding purine nucleoside phosphorylase (Ad/PNP), followed by local administration of the prodrug fludarabine phosphate (F-araAMP), and subsequent radiation therapy. This triple-combination strategy is designed to generate local, targeted cytotoxic activity within the tumor microenvironment while minimizing systemic toxicity.

The allowed patent joins the growing Gedeptin intellectual property portfolio, which was exclusively licensed to GeoVax through a prior agreement with PNP Therapeutics, Inc. and the University of Alabama at Birmingham (UAB)/Southern Research. Under the agreement, GeoVax has assumed all licensing rights and IP prosecution responsibilities for the Gedeptin platform.

David Dodd, Chairman and CEO of GeoVax, commented, “This allowed patent underscores the clinical and commercial promise of our Gedeptin platform and demonstrates our commitment to expanding therapeutic options for patients with difficult-to-treat cancers. While the claims do not directly mirror our ongoing clinical programs, they establish a critical foundation for future directions, including potential integration with advanced delivery systems for tumors that are challenging to access.”

Dodd continued, “The USPTO’s recognition of this therapeutic method further validates our approach and underscores the growing value of our wholly owned, co-owned, and in-licensed intellectual property estate, now standing at over 135 granted or pending patent applications spread across 23 distinct patent families”.

Having successfully completed a Phase 1/2a study, as monotherapy in advanced head and Neck cancer patients, Gedeptin is scheduled to begin a Phase 2 trial in combination with an Immune Check Inhibitor (ICI) for patients with first recurrence of head and neck cancer. The newly allowed claims provide further protection as GeoVax explores expanded applications, including novel device-based delivery approaches in potential partnership with interventional oncology companies.

About Gedeptin

Gedeptin is a viral-vectored gene therapy that employs a non-replicating adenoviral vector encoding the E. coli enzyme purine nucleoside phosphorylase (PNP). When injected directly into a tumor and followed by systemic administration of the prodrug fludarabine phosphate, PNP enzymatically converts the prodrug into a cytotoxic metabolite (fluoroadenine), resulting in selective killing of tumor cells by disrupting RNA and protein synthesis.

This tumor-targeted approach offers several key advantages:

  • Localized cytotoxicity with reduced systemic side effects,
  • Potential synergy with immune checkpoint inhibitors (ICIs),
  • Applicability across multiple solid tumor types, particularly those accessible for intratumoral injection.

Gedeptin will soon be evaluated in a Phase 2 clinical trial for patients with first recurrence of head and neck cancer in combination with an approved ICI. It has been granted Orphan Drug Designation by the U.S. FDA for intratumoral treatment of oral and pharyngeal cancers.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Release – Century Lithium Provides Technical Update on Angel Island

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CYDVF

May 6, 2025 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (“Century Lithium” or “the Company”) is pleased to provide an update on its 100%-owned lithium project, Angel Island (“Angel Island”) near Silver Peak, Nevada and the associated Lithium Extraction Facility (“Demonstration Plant”) in Amargosa Valley, Nevada.

“Century Lithium has continued to advance Angel Island through the Company’s Demonstration Plant,” said Bill Willoughby, Century Lithium President and CEO. “Our Demonstration Plant allows us to improve our technology through various avenues of testing, most recently with ARi, where recent results have exceeded our expectations.”

Advancements to the Demonstration Plant

Century Lithium has successfully completed testing at the Demonstration Plant in collaboration with Amalgamated Research, LLC (“ARi”) of Twin Falls, Idaho. This testing focused on new developments within the Direct Lithium Extraction (“DLE”) portion of Century Lithium’s process. These results exceeded expectations for lithium recovery and eluate grade produced from a primary step in the DLE process. The Company believes this could result in a substantial reduction in the estimated capital and operating costs at Angel Island.

Results from DLE Pilot Testing (November 2024–January 2025):

  • 328 milligrams per liter (“mg/L”) lithium feed concentration
  • 91.6% lithium recovery
  • 575 mg/L eluate grade with a low Na:Li ratio of 0.6:1

Additional Technical Progress at the Demonstration Plant

  • An increase of lithium in eluate to 12 to 14 grams per liter (“g/L”) lithium concentration using specialty membranes in the concentration steps following DLE
  • Continued operation of the lithium carbonate (“Li2CO3”) circuit, resulting in 99.87% purity in Li2CO3 samples
  • Third-party evaluation is underway on Li2CO3 samples for use in producing lithium iron phosphate (“LFP”) batteries. LFP batteries have a high energy density and long cycle life and are used in solar, energy storage systems and long-range EV applications
  • Testing is underway for thermal pretreatment of Angel Island clay with the potential to significantly reduce hydrochloric acid use in the leach stage of processing

Qualified Person

Todd Fayram, MMSA-QP and Senior Vice President, Metallurgy of Century Lithium is the qualified person as defined by National Instrument 43-101 and has approved the technical information in this release.

ABOUT CENTURY LITHIUM CORP.

Century Lithium Corp. is an advanced stage lithium company, focused on developing its wholly owned Angel Island project in Esmeralda County, Nevada, which hosts one of the largest sedimentary lithium deposits in the United States. The Company has utilized its patent-pending process for chloride leaching combined with direct lithium extraction to make battery-grade lithium carbonate product samples from Angel Island’s lithium-bearing claystone on-site at its Demonstration Plant in Amargosa Valley, Nevada.

Angel Island is one of the few advanced lithium projects in development in the United States to provide an end-to-end process to produce battery-grade lithium carbonate for the growing electric vehicle and battery storage market. Angel Island is currently in the permitting stage for a three-phase feasibility-level production plan expected to yield an estimated life-of-mine average of 34,000 tonnes per year of carbonate over a 40-year mine-life.

To learn more, please visit centurylithium.com

ON BEHALF OF CENTURY LITHIUM CORP.

WILLIAM WILLOUGHBY, PhD., PE
President & Chief Executive Officer

For further information, please contact:
Spiros Cacos | Vice President, Investor Relations
Direct: +1 604 764 1851
Toll Free: 1 800 567 8181
scacos@centurylithium.com
centurylithium.com

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

Cautionary Note Regarding Forward-Looking Statements

This release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” and similar expressions suggesting future outcomes or statements regarding an outlook.

Forward-looking statements relate to any matters that are not historical facts and statements of our beliefs, intentions and expectations about developments, results and events which will or may occur in the future, without limitation, statements with respect to the potential development and value of the Project and benefits associated therewith, statements with respect to the expected project economics for the Project, such as estimates of life of mine, lithium prices, production and recoveries, capital and operating costs, IRR, NPV and cash flows, any projections outlined in the Feasibility Study in respect of the Project, the permitting status of the Project and the Company’s future development plans.

These and other forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. These risks include those described under the heading “Risk Factors” in the Company’s most recent annual information form and its other public filings, copies of which can be under the Company’s profile at www.sedarplus.com. The Company expressly disclaims any obligation to update-forward-looking information except as required by applicable law. No forward-looking statement can be guaranteed, and actual future results may vary materially. Accordingly, readers are advised not to place reliance on forward-looking statements or information. Furthermore, Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability.