Vafseo® (vadadustat) Dialysis Dependent Patient Post Hoc Data Analysis: Composite of All-Cause Mortality and Hospitalization Outcomes Statistically More Favorable for Patients Receiving Vadadustat vs. ESAs




Vafseo® (vadadustat) Dialysis Dependent Patient Post Hoc Data Analysis: Composite of All-Cause Mortality and Hospitalization Outcomes Statistically More Favorable for Patients Receiving Vadadustat vs. ESAs

Win-Odds Analysis Presented at American Society of Nephrology Kidney Week 2025

CAMBRIDGE, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) — Akebia Therapeutics^®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the presentation of a post-hoc win odds analysis of all-cause mortality and hospitalization from the Phase 3 INNO₂VATE trials of vadadustat at the American Society of Nephrology Kidney Week 2025 (ASN Kidney Week). The presentation entitled, “Win-Odds Analysis of Deaths and Hospitalization in Patients taking Vadadustat or Darbepoetin Alfa for CKD-Related Anemia Undergoing Dialysis,” demonstrated favorable and statistically significant effects of Vafseo relative to the erythropoiesis-stimulating agent (ESA) darbepoetin alfa on the composite endpoint of death or hospitalization.

Vafseo^® (vadadustat) is approved for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo has been available in the U.S. since January 2025.

“The win-odds statistical method is a useful tool to prioritize clinically meaningful endpoints and account for all events in the order of clinical importance,” said Glenn M. Chertow, M.D., M.P.H., Professor of Medicine, Stanford University School of Medicine. “This analysis showed that patients randomized to vadadustat experienced a lower risk of death or hospitalization compared with patients randomized to darbepoetin alfa. Physicians can consider these findings when selecting medications for the treatment of anemia in patients receiving maintenance dialysis.”

“As we work toward our goal to make Vafseo standard of care for the treatment of CKD-related anemia in patients receiving dialysis, we recognize the value of sharing new analysis of data on well-accepted outcomes like all-cause mortality and hospitalization that can inform care decisions,” said Steven Burke, MD, Senior Vice President and Chief Research & Development Officer at Akebia. “We are also actively advancing multiple trials of Vafseo in real-world clinical settings, including VOICE, a collaborative clinical trial of Vafseo, also designed to measure mortality and hospitalizations. We are grateful to our partners within dialysis organizations and various academic settings, including Dr. Chertow and his team, who clearly share our commitment to persons living with kidney disease.”

Study Details:

The post-hoc win-odds analysis was based on data from two global Phase 3, open-label, randomized (1:1), noninferiority trials (INNO₂VATE) comparing vadadustat treatment vs darbepoetin alfa in adults with anemia associated with incident or prevalent dialysis-dependent chronic kidney disease. The primary safety endpoint in the primary analysis was time to first adjudicated MACE (a composite endpoint of death from any cause, non-fatal myocardial infarction, or non-fatal stroke).

In this post-hoc win-odds analysis of INNO₂VATE data, the hierarchical composite of 1) all-cause mortality and 2) hospitalizations was statistically significantly lower for those patients receiving vadadustat compared to darbepoetin alfa.

Study Analysis:

• On study analysis: Inverted win-odds 0.93, 95% CI (0.87-0.99); P=0.03 (vada loss count+ 0.5*ties)/ (vada win count + 0.5*ties)
• On treatment + 28 days post last dose: Inverted win-odds ratio 0.86, 95% CI (0.81, 0.95); p <0.0001

A win-odds analysis is a statistical method used to analyze clinical trial data to evaluate the effectiveness of treatments. It provides a novel way to measure treatment effect by comparing the number of wins and losses for the treatment and control groups, which can be easily used in studies with prioritized multiple outcomes.

About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.

About Vafseo^® (vadadustat) tablets
Vafseo^® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries.

INDICATION

VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

Limitations of Use

• VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.
• VAFSEO is not indicated for use:
  • As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
  • In patients with anemia due to CKD not on dialysis.

IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets

WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS.

VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE).

Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels.

No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks.

Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions.

CONTRAINDICATIONS

• Known hypersensitivity to VAFSEO or any of its components
• Uncontrolled hypertension

WARNINGS AND PRECAUTIONS

• Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access
  A rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis.

• Hepatotoxicity
  Hepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease.

• Hypertension
  Worsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed.

• Seizures
  Seizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency.

• Gastrointestinal (GI) Erosion
  Gastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present.

• Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis
  The safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa.

• Malignancy
  VAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies.

ADVERSE REACTIONS

• The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea.

DRUG INTERACTIONS

• Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.
• Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.
• BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.
• Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg.

USE IN SPECIFIC POPULATIONS

• Pregnancy: May cause fetal harm.
• Lactation: Breastfeeding not recommended until two days after the final dose.
• Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease.

Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide.

Forward-Looking Statements

Statements in this press release regarding Akebia Therapeutics, Inc.’s (“Akebia’s”) strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia’s expectations about a win odds analysis of all-cause mortality and hospitalization from the Phase 3 INNO₂VATE trials of vadadustat, including that such analysis demonstrates favorable and statistically significant effects of Vafseo relative to the ESA darbepoetin alfa on the composite endpoint of death or hospitalization; Akebia’s beliefs that physicians can consider these findings when selecting medications for the treatment of anemia in patients receiving maintenance dialysis; Akebia’s plans to work toward its goal to make Vafseo standard of care for the treatment of CKD-related anemia in patients receiving dialysis; Akebia’s beliefs that sharing new analysis of data can inform care decisions; and Akebia’s plans to actively advance multiple trials of Vafseo in real-world clinical settings, including VOICE. The terms “intend,” “believe,” “plan,” “goal,” “potential,” “anticipate, “estimate,” “expect,” “future,” “will,” “continue,” derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the results of preclinical and clinical research; decisions made by health authorities, such as the FDA, with respect to regulatory filings and other interactions; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Vafseo, including generic entrants and the timing thereof; the ability of Akebia to attract and retain qualified personnel; Akebia’s ability to achieve and maintain profitability and to maintain operating expenses consistent with its operating plan; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; early termination of any of Akebia’s collaborations; and changes in the geopolitical environment and uncertainty surrounding U.S. trade policy on tariffs. Other risks and uncertainties include those identified under the heading “Risk Factors” in Akebia’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.

Akebia Therapeutics^® and Vafseo^® are registered trademarks of Akebia Therapeutics, Inc.

Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com

Eledon Presents Phase 2 BESTOW Trial Results for Tegoprubart for the Prevention of Rejection in Kidney Transplantation at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting




Eledon Presents Phase 2 BESTOW Trial Results for Tegoprubart for the Prevention of Rejection in Kidney Transplantation at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting

Data from patients who remained on tegoprubart for a year post transplant showed an overall mean 12-month estimated glomerular filtration rate (eGFR) of approximately 69 mL/min/1.73 m² 

Tegoprubart demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus

Supports advancement into Phase 3 development as a potential new standard for the prevention of kidney transplant rejection

Conference call to be held Friday, November 7 at 8:00 a.m. ET

IRVINE, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced results from its Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo kidney transplant. Results from the Phase 2 BESTOW clinical trial were presented today as a late breaking oral presentation titled “Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial,” at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting in Houston, TX.

“The Phase 2 BESTOW data results demonstrate tegoprubart’s potential to maintain excellent kidney function while reducing the chronic metabolic, neurologic, and cardiovascular toxicities that burden patients on tacrolimus,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “By pairing strong immunosuppressive efficacy with a differentiated safety profile, including dramatically lower rates of new-onset diabetes, tremor, and dialysis-requiring delayed graft function, tegoprubart represents a promising next-generation option for kidney transplant immunosuppression as we advance into Phase 3.”

“There remains a significant unmet need for safer alternatives to traditional tacrolimus-based immunosuppression regimens—options that can reduce harmful side effects without compromising efficacy. The Phase 2 results presented at ASN Kidney Week highlight the potential of tegoprubart to deliver strong graft function after kidney transplantation, while avoiding the long-term toxicities often associated with current standard of care,” said Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief, Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota. “It’s been more than a decade since we’ve seen true innovation in transplant immunosuppression. These data offer real hope that patients may soon have a transformative therapy that improves their health outcomes and overall quality of life.”

Study Design

The 12-month, randomized, head-to-head, Phase 2 study enrolled 127 kidney transplant recipients (63 receiving tegoprubart and 64 receiving tacrolimus) across 44 global sites. The study directly compared tegoprubart-based immunosuppression with a tacrolimus-based regimen. All patients also received rabbit antithymocyte globulin (rATG) induction and maintenance therapy with mycophenolate mofetil (MMF/MPA) and corticosteroids.

The study’s primary efficacy endpoint was the change in eGFR at 12 months post-transplant. Secondary endpoints included biopsy-proven acute rejection (BPAR), patient and graft survival, composite efficacy failure, iBox score, donor-specific antibodies (DSAs), delayed graft function (DGF), and new-onset diabetes after transplantation (NODAT).

Safety Results

Safety findings underscore tegoprubart’s potential to maintain effective immunosuppression while minimizing the metabolic, neurologic, and cardiovascular toxicities characteristic of tacrolimus-based therapy.

• Metabolic effects: New-onset diabetes developed in approximately 1 in 6 patients receiving tacrolimus versus 1 in 47 receiving tegoprubart.
• Neurologic effects: Tremor was markedly higher in the tacrolimus group (25.0% vs. 1.6%).
• Cardiovascular effects: Hypertension (15.9% vs. 25.0%), hypertensive crisis (1.6% vs. 7.8%), and heart failure (0% vs. 4.7%) all favored tegoprubart.
• Renal recovery: Delayed graft function occurred less often with tegoprubart and required shorter dialysis (14.3% vs. 25.0%; 4.6 days vs. 6.1 days), suggesting potential reductions of 115 days on dialysis post-transplant per 100 deceased donor kidney recipients on tegoprubart vs. tacrolimus.
• Infections: Sepsis or bacteremia occurred more frequently in the tacrolimus arm (17.2% vs. 4.8%). Viral infection rates (CMV, BK, EBV, fungal) were similar across groups, with no cases of Post-Transplant Lymphoproliferative Disorder (PTLD) or Progressive Multifocal Leukoencephalopathy (PML).
• Overall rates of serious adverse events were comparable between treatment arms.

Efficacy Results

• eGFR on tegoprubart treatment was 69 mL/min/1.73 m² (n=51) at 12 months vs. 66 mL/min/1.73 m² for tacrolimus (n=56). Although the primary endpoint did not reach statistical significance, tegoprubart maintained strong renal function, delivering what the Company believes is the highest mean eGFR level reported to date in kidney transplant clinical trials evaluating rejection prevention.
  • Subgroup analyses demonstrated higher eGFRs in nearly all tegoprubart subgroups compared with tacrolimus, particularly among living-related donor recipients (~72 mL/min/1.73 m² vs. 62 mL/min/1.73 m²) and high Kidney Donor Profile Index (KDPI > 35) transplants (~62 mL/min/1.73 m² vs. 53 mL/min/1.73 m²).
  • In the deceased donor subgroup, tegoprubart achieved a mean eGFR of approximately 68 mL/min/1.73 m² at 12 months.
• The efficacy failure composite endpoint, comprising death, graft loss and biopsy proven acute rejection, is the approval endpoint currently recognized by the U.S. Food and Drug Administration. Efficacy failure composite endpoint was 22% in the tegoprubart group vs. 17% in the tacrolimus group, demonstrating non-inferiority for tegoprubart vs. tacrolimus, using a 20% non-inferiority margin. The Company believes these results, if replicated in a Phase 3 study, would be sufficient to support tegoprubart’s approvability.
  • The rate of acute rejection in all biopsies was 20.6% in the tegoprubart group compared with 14.1% in the tacrolimus group.
  • Among patients in the tegoprubart group who experienced acute rejection and remained on treatment through month 12, mean eGFR was 73 mL/min/1.73 m², compared with 50 mL/min/1.73 m² in those who switched to tacrolimus.
• There was 1 case of donor-specific antibodies (DSA) in the tegoprubart arm vs. 2 in the tacrolimus arm.

Next Steps

Based on these results, Eledon plans to advance tegoprubart into Phase 3 development following discussions with regulators on study design and data requirements. Insights from the Phase 2 BESTOW data set and the ongoing long-term extension study will be incorporated to optimize the Phase 3 protocol and strengthen the regulatory package.

Estimated cash, cash equivalents and short-term investments totaled approximately $93.4 million as of September 30, 2025. The company expects current cash, cash equivalents and short-term investments to fund operations to late 2026.

Conference Call

Eledon will hold a conference call on November 7, 2025, at 8:00 a.m. Eastern Time to discuss the Phase 2 BESTOW trial results presented at Kidney Week. The dial-in numbers are 1-800-717-1738 for domestic callers and 1-646-307-1865 for international callers. The conference ID is 92427. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call and a copy of the presentation for the conference call will be posted on the Company’s website at https://ir.eledon.com/investor-relations prior to the conference call.

Full details of the oral presentation are below:

Title: Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial
Session Title: Late-Breaking Research Orals – 1
Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota
Session Date and Time: November 6, 2025, from 4:30 p.m. to 6:00 p.m. CT

Eledon is also conducting an ongoing open label Phase 1b study (NCT05027906) and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Participants who complete 12 months of treatment in the Phase 1b and Phase 2 BESTOW trials are eligible to enroll into the long-term extension study.

About Eledon Pharmaceuticals and tegoprubart

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

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Statement Regarding Preliminary Financial Information

The cash, cash equivalents and short-term investments presented in this press release is unaudited and preliminary and is subject to completion of financial closing procedures, including the completion of management’s review. The preliminary financial information is based on information currently available to management, and may vary from the amounts that will be reported in Eledon’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 that the Company will file with the U.S. Securities and Exchange Commission.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about ongoing, planned and future clinical trials, the development of product candidates, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, submissions to regulators, our expected cash, cash equivalents and short-term investments as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and uncertainties relating to the completion of our quarter-end closing procedures for our financial statements for the quarter ended September 30, 2025. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

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

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com

Source: Eledon Pharmaceuticals

MediciNova Wins Contract Research and Development Innovation Award at 2025 BioTech Breakthrough Awards




MediciNova Wins Contract Research and Development Innovation Award at 2025 BioTech Breakthrough Awards

LA JOLLA, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), announces that the company has been selected as a winner of the “Contract Research and Development Innovation Award” at the Fifth Annual BioTech Breakthrough Awards.

MediciNova earned this recognition for its innovative work advancing MN-166 (ibudilast), the company’s lead small molecule drug candidate, currently in development for several neurological diseases, including amyotrophic lateral sclerosis (ALS), one of the fatal neurodegenerative diseases. MN-166 is designed to inhibit neuroinflammation and promote neuroprotection by modulating multiple mechanisms involved in disease progression, representing a promising therapeutic approach for conditions with few effective treatment options.

“This recognition underscores our mission to develop truly disease-modifying therapies for devastating conditions like ALS, and it celebrates the dedication of our team and collaborators working to deliver meaningful breakthroughs for patients,” said Yuichi Iwaki, M.D., Ph.D., MediciNova President and Chief Executive Officer. “Our ongoing Phase 2/3 COMBAT-ALS trial of MN-166 in patients with ALS represents our continued commitment to addressing a serious unmet medical need. We are encouraged by the progress to date and look forward to sharing results as the study advances over the coming year.”

The BioTech Breakthrough Awards program recognizes the most innovative companies, technologies, and products in the global life sciences and biotechnology industries. Conducted annually by BioTech Breakthrough, a leading independent market intelligence organization, the awards celebrate excellence across biopharma, therapeutics, genomics, diagnostics, and research tools.

About MediciNova

MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

Forward-Looking Statements

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166 and MN-001. These forward-looking statements may be preceded by, followed by, or otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “will,” “would,” “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166 and MN-001, and risks of raising sufficient capital when needed to fund MediciNova’s operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2024 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

INVESTOR CONTACT:

David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com

VitalHub Reports Third Quarter 2025 Results




VitalHub Reports Third Quarter 2025 Results

Annual Recurring Revenue (ARR)⁽¹⁾ up 75% YoY to $93.7 million
Total Revenue up 94% YoY to $32.0 million
Adjusted EBITDA⁽¹⁾ up 58% YoY to $7.2 million

TORONTO, Nov. 06, 2025 (GLOBE NEWSWIRE) — Vitalhub Corp. (TSX:VHI) (OTCQX:VHIBF) (the “Company” or “VitalHub”) announced today it has filed its Interim Condensed Consolidated Financial Statements and Management’s Discussion and Analysis report for the three and nine months ended September 30, 2025 with the Canadian securities authorities. These documents may be viewed under the Company’s profile at www.sedarplus.com.

“In the third quarter, we achieved annual organic ARR⁽¹⁾ growth of 15% and 22% adjusted EBITDA⁽¹⁾ as a percent of revenue,” said Dan Matlow, CEO of VitalHub. “Completed project deliveries exceeded our expectations from a services revenue perspective, while recurring revenue trends continued to track positively. We are optimizing the commercial and operational alignment of Novari and Induction. Our primary focus is integrating our most recent acquisitions and enhancing margins while continuing to pursue new opportunities.”

VitalHub’s quarterly investor conference call will take place on Friday, November 7, 2025, at 9:00AM EST. To register for the conference call please visit: https://us06web.zoom.us/webinar/register/WN_CDYke6WeQXGh1QeEQ4xrqg

Third Quarter 2025 Highlights

• ARR⁽¹⁾ as at September 30, 2025 was $93,693,789 as compared to $79,589,081 at June 30, 2025, an increase of $14,104,708 or 18%.
  Over the previous quarter, ARR⁽¹⁾ movement in Q3 2025 from Q2 2025 was attributable to the following:
  • Organic growth of $1,711,335 or 2%.
  • Acquisition growth of $12,000,000 or 15%.
  • Gain of $393,373 due to fluctuations in foreign exchange rates.
• Revenue of $32,044,030 as compared to $16,509,135 in the equivalent prior year period, an increase of $15,534,895 or 94%.
• Gross profit as a percentage of revenue was 81% in Q3 2025 and Q3 2024.
• Net income before income taxes of $1,586,383 as compared to $2,360,258 in the equivalent prior year period, a decrease of $773,875 or 33%.
• EBITDA⁽¹⁾ of $4,777,351 as compared to $3,004,034 in the equivalent prior year period, an increase of $1,773,317 or 59%.
• Adjusted EBITDA⁽¹⁾ of $7,206,257 or 22% of revenue, as compared to $4,554,597 or 28% of revenue in the equivalent prior year period, an increase of $2,651,660 or 58%.

Nine Month 2025 Highlights

• ARR⁽¹⁾ as at September 30, 2025 was $93,693,789 as compared to $53,452,108 at September 30, 2024, an increase of $40,241,681 or 75%.
  Over the previous year, ARR⁽¹⁾ movement in Q3 2025 from Q3 2024 was attributable to the following:
  • Organic growth of $7,959,283 or 15%.
  • Acquisition growth of $30,470,000 or 57%.
  • Gain of $1,812,398 due to fluctuations in foreign exchange rates.
• Revenue of $77,576,544 as compared to $48,003,531 in the equivalent prior year period, an increase of $29,573,013 or 62%.
• Gross profit as a percentage of revenue was 81% in the first nine months of 2025 and 2024.
• Net income before income taxes of $5,329,022 as compared to net income before income taxes of $5,722,758 in the equivalent prior year period, a decrease of $393,736 or 7%.
• EBITDA⁽¹⁾ of $11,527,408 compared to $8,075,502 in the prior year, an increase of $3,451,906 or 43%.
• Adjusted EBITDA⁽¹⁾ of $19,125,590 or 25% of revenue, compared to $12,793,514 or 27% of revenue in the equivalent prior year period, an increase of $6,332,076 or 49%.
• Cash on hand as at September 30, 2025 was $123,684,500 compared to $56,574,904 as at December 31, 2024.

(1) Non-IFRS measure. Disclaimers and reconciliations can be found in SEDAR filings.

Selected Financial Information

About VitalHub

VitalHub is a leading software company dedicated to empowering health and human services providers globally. VitalHub’s comprehensive product suite includes electronic health records, operational intelligence, and workforce automation solutions that serve over 1,000 clients across the UK, Canada, and other geographies. The Company has a robust two-pronged growth strategy, targeting organic opportunities within its product suite and pursuing an aggressive M&A plan. VitalHub is headquartered in Toronto with over 500 employees globally, across key regions and the VitalHub Innovations Lab in Sri Lanka. For more information about VitalHub (TSX:VHI) (OTCQX:VHIBF), please visit www.vitalhub.com and LinkedIn.

Contact Information

Christian Sgro, CPA, CA, CFA
Head of IR and M&A Specialist
(365) 363-6433
christian.sgro@vitalhub.com

Dan Matlow
Chief Executive Officer, Director
(416) 727-9061
dan.matlow@vitalhub.com

Cautionary Statement

Certain statements contained in this news release may constitute “forward-looking information” or “financial outlook” within the meaning of applicable securities laws that involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information or financial outlook. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of each entity and are based on assumptions and subject to risks and uncertainties. Although the management of each entity believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

Cidara Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results




Cidara Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results

• Announced expanded and accelerated Phase 3 Plan for CD388, its non-vaccine influenza preventative therapeutic
• Enrolled and dosed first patients in Phase 3 ANCHOR study; target enrollment on track for completion in the Northern Hemisphere by December 2025; Phase 3 initiation triggered $45.0 million milestone payment to Janssen
• BARDA award to support expanded manufacturing and clinical development of CD388
• FDA granted Breakthrough Therapy designation to CD388
• Conference call and webcast today at 5:00 PM Eastern Time

SAN DIEGO, Nov. 06, 2025 (GLOBE NEWSWIRE) — Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company or Cidara), a biotechnology company using its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) therapeutics, today reported financial results for the third quarter ended September 30, 2025, and provided recent business updates.

“With our Phase 3 ANCHOR study now over 50 percent enrolled, we expect to achieve target enrollment of 6,000 participants by December 2025 and thereby advance CD388 as a potential universal preventative for people at increased risk of complications from influenza as well as those seeking alternatives to flu vaccines,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Based on constructive feedback from the FDA, the ANCHOR study population has been expanded to include generally healthy adults over the age of 65 in addition to individuals with certain comorbidities or compromised immune status. This change more than doubles the target population potentially eligible to receive CD388. Our successful financing this summer has provided us with a strong balance sheet that we expect to be sufficient to fully fund our Phase 3 development program through completion.”

Recent and Expected Corporate Highlights

• Expanded and accelerated Phase 3 plan for CD388 in influenza. Cidara is proceeding with an expanded and accelerated development plan to seek biologics license application (BLA) approval based on a single Phase 3 study, following an End-of-Phase 2 (EOP2) meeting with the United States (U.S.) Food and Drug Administration (FDA). The Phase 3 study is evaluating the safety and efficacy of CD388 in populations at high-risk for complications from influenza (ANCHOR study). Based on FDA feedback, the ANCHOR study population was expanded to include adults over 65 years of age with no specific comorbidities in addition to subjects over 12 years of age with high-risk comorbidities or immune-compromised status. This increases the initial number of patients that would be potentially eligible to receive CD388 from approximately 50 million to well over 100 million people in the U.S.
• Enrolled and dosed the first patients in the Phase 3 ANCHOR study. The ANCHOR study has a target enrollment of 6,000 participants. Cidara dosed the first patients in the U.S. at the end of September 2025 and enrollment is ongoing in 150 sites in the Northern Hemisphere across the U.S. and the United Kingdom (UK). The ANCHOR study will include an interim analysis in the first quarter of 2026 to assess the trial size and powering assumptions and determine the potential need for additional enrollment during the subsequent Southern Hemisphere flu season.
• BARDA award for CD388. The award from Biomedical Advanced Research and Development Authority (BARDA) is valued at up to $339.2 million in total. The base period funding of $58.1 million over the initial 24 months will support the onshoring of CD388 manufacturing to the U.S. as an addition to the initial commercial supply chain. This project is being supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50125C0017.
• Breakthrough Therapy designation of CD388. The Breakthrough Therapy designation is based on positive results from the Phase 2b study (NAVIGATE study) which showed that CD388 was well-tolerated and that all primary and secondary endpoints were met in connection with preventing seasonal influenza in healthy unvaccinated adults aged 18-64. This designation comes in addition to the previously awarded Fast Track designation and is intended to expedite the review of medicines that treat a serious or life-threatening condition and have shown preliminary clinical evidence indicating the potential for substantial improvement over available therapies.
• Highlighted CD388 in presentations at various medical conferences. During September 2025 and October 2025, Cidara gave presentations at various medical conferences including the International Society for Respiratory Viruses 8th Antiviral Group Meeting and 3rd International Meeting on Respiratory Pathogens in Singapore, ID Week 2025 in Atlanta, Georgia, and the European Scientific Working Group on Influenza’s 10th Influenza Conference in Valencia, Spain. These oral presentations included late-breaking Phase 2b clinical data from Cidara’s successful NAVIGATE study that showed CD388 to be well-tolerated with all primary and secondary endpoints met in connection with preventing influenza illness in healthy adults.

Third Quarter 2025 Financial Results

• Cash, cash equivalents, restricted cash and available-for-sale investments totaled $476.5 million as of September 30, 2025, compared with $196.2 million as of December 31, 2024.
• Collaboration revenue was zero for each of the three and nine months ended September 30, 2025, compared to zero and $1.3 million for the same periods in 2024, respectively. Collaboration revenue related to research and development (R&D) and clinical supply services provided to J&J Innovative Medicine, previously Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), under our license and collaboration agreement with Janssen (the Janssen Collaboration Agreement), which was terminated upon the effectiveness of our license and technology transfer agreement with Janssen (the Janssen License Agreement) on April 24, 2024.
• Acquired in-process research and development (IPR&D) expenses were $45.0 million for each of the three and nine months ended September 30, 2025, compared to zero and $84.9 million for the same periods in 2024, respectively. Acquired IPR&D in 2025 related to a $45.0 million milestone incurred under the Janssen License Agreement, upon dosing the first five subjects in our ANCHOR study, which will be paid to Janssen in the fourth quarter of 2025. Acquired IPR&D in 2024 related to an upfront payment of $85.0 million paid to Janssen under the Janssen License Agreement on April 24, 2024, in connection with the re-acquisition of CD388, plus $0.4 million in direct transaction costs, offset by a gain of $0.5 million to settle the preexisting Janssen Collaboration Agreement relationship.
• R&D expenses were $35.5 million and $84.9 million for the three and nine months ended September 30, 2025, respectively, compared to $12.4 million and $25.0 million for the same periods in 2024, respectively. The increase in R&D expenses for the three months ended September 30, 2025 is primarily due to higher expenses associated with CD388 manufacturing related costs and the preparation and initiation of our ANCHOR study. The increase in R&D expenses for the nine months ended September 30, 2025 is primarily due to higher expenses associated with our NAVIGATE study, CD388 manufacturing related costs, and the preparation and initiation of our ANCHOR study, offset by lower nonclinical expenses associated with our Cloudbreak platform.
• General and administrative (G&A) expenses were $8.1 million and $20.8 million for the three and nine months ended September 30, 2025, respectively, compared to $5.0 million and $13.3 million for the same periods in 2024, respectively. The increase in G&A expenses is primarily due to higher personnel costs, driven by higher stock-based compensation, offset by lower audit fees.
• During the nine months ended September 30, 2025, the Company determined that accrued indirect taxes relating to shipments of our former rezafungin assets totaling $9.4 million were not due and payable upon voluntary disclosure and full compliance in certain jurisdictions and the associated liabilities and operating expenses were reversed as part of continuing operations. No indirect tax reversals were recorded during the three months ended September 30, 2025, or during the three and nine months ended September 30, 2024.
• Other income, net was $5.4 million and $8.9 million for the three and nine months ended September 30, 2025, respectively, compared to $1.9 million and $4.0 million for the same periods in 2024, respectively. Other income, net related primarily to interest income generated from cash held in interest-bearing accounts and available-for-sale investments.
• Income/loss from discontinued operations for each of the three and nine months ended September 30, 2025 was zero, compared to a loss of $0.5 million and income of $0.4 million for the same periods in 2024, respectively. On April 24, 2024, the Company entered into an asset purchase agreement with Napp Pharmaceutical Group Limited (Napp), an affiliate of Mundipharma Medical Company, pursuant to which all rezafungin assets and related contracts were sold to Napp. All conditions of the sale were completed on April 24, 2024, and the financial results of rezafungin have been reported separately as discontinued operations.
• Net loss for the three and nine months ended September 30, 2025 was $83.2 million and $132.4 million, respectively, compared to a net loss of $16.0 million and $117.5 million for the same periods in 2024, respectively.

Third Quarter 2025 Conference Call and Webcast Details

Cidara Therapeutics management will host a conference call and webcast beginning at 5:00 pm ET / 2:00 pm PT today, November 6, 2025. A live webcast may be accessed here. The conference call can be accessed by dialing toll-free 1-844-825-9789 or 1-412-317-5180 (international). The passcode for the conference call is 10203589.

A replay of the webcast will be archived on www.cidara.com for one year under the “Events & Presentations” tab in the Investors section of the company’s website.

About Cidara Therapeutics

Cidara Therapeutics is using its proprietary Cloudbreak^® platform to develop novel DFCs comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment. Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track designation and in October 2025, CD388 was granted Breakthrough Therapy designation, by the FDA. Cidara announced positive top-line results from its NAVIGATE study in June 2025 and initiated its ANCHOR study in September 2025. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “intends,” “believes,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to the potential benefits of and future plans for CD388, the target enrollment and expected timing of the Phase 3 ANCHOR study of CD388 and the interim analysis, the initial number of patients in the U.S. and UK potentially eligible to receive CD388, the potential to obtain approval based on a single Phase 3 study and for a broader patient population including otherwise healthy adults, the potential benefits and accelerated review resulting from Breakthrough Therapy designation, the potential amounts available and uses of funds under the BARDA award, including the onshoring of CD388 manufacturing to the U.S., the timing of the milestone payment to Janssen, and the strength of Cidara’s balance sheet and ability to fully fund the planned Phase 3 development program through completion. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s clinical studies and other risks related to clinical development, delays in or unanticipated action by regulatory authorities, other obstacles associated with the enrollment of participants or other aspects of CD388 or other DFC development, risks related to government contracts, having to use cash in ways other than as expected and other risks and uncertainties associated with Cidara’s business in general. These and other risks are identified under the caption “Risk Factors” in Cidara’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025 and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com 

MEDIA CONTACT:
Michael Fitzhugh
LifeSci Communications
(628) 234-3889
mfitzhugh@lifescicomms.com 

Sight Sciences Appoints Ali Bauerlein as Chief Operating Officer and Jim Rodberg as Chief Financial Officer




Sight Sciences Appoints Ali Bauerlein as Chief Operating Officer and Jim Rodberg as Chief Financial Officer

New leadership appointments strengthen Sight Sciences’ commitment to advancing our interventional dry eye initiatives and driving scalable operations and growth

MENLO PARK, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT) (Sight Sciences, or the Company), an eyecare technology company focused on developing and commercializing innovative, interventional technologies that elevate the standard of care, announced today the appointment of Alison (Ali) Bauerlein as its Chief Operating Officer (COO) and James (Jim) Rodberg as its Chief Financial Officer (CFO), effective November 5, 2025.

“We are very excited to promote both Ali and Jim into new roles at Sight Sciences as we continue to elevate our market leadership position in MIGS and begin to scale the reimbursed interventional dry eye category. We believe the many contributions they each have made over their tenure at Sight Sciences as well as their unique skill sets directly align with our vision of the future of eyecare and the needs of the organization. Ali has a proven track record of leading a rapidly growing medtech organization through multiple phases of growth, and Jim has a strong finance background from a leading medtech organization, which will be critical to our execution in the coming years,” said Paul Badawi, Founder and Chief Executive Officer of Sight Sciences. “We are confident the addition of the COO role will accelerate our growth across the business with enhanced focus and leadership. We are looking forward to both Ali and Jim advancing our strategic plans and ensuring we have the appropriate infrastructure to support profitable growth over time.”

Mrs. Bauerlein, Chief Operating Officer of Sight Sciences, commented, “I am delighted to be moving into the COO role at Sight Sciences at this critical juncture as we look to scale our business. I am excited to leverage my background in high growth medtech to help Sight Sciences achieve its fullest potential. I look forward to working with Paul, the rest of the Sight Sciences team, and the ophthalmic community as we shift towards earlier procedural intervention and improve the lives of our patients.”

Mr. Rodberg, Chief Financial Officer of Sight Sciences, added, “It’s an exciting time at Sight Sciences given the significant patient impact we are positioned to make over the coming years by enabling our customers to treat two major obstructive ophthalmic diseases with proven procedural interventions. I look forward to supporting our growth and profitability goals, while striving to create significant value for the ophthalmic community, our patients, and our shareholders.”

Board of Directors Update

Erica Rogers and Brenda Becker have stepped down from the Sight Sciences Board of Directors. “I would like to thank both Erica and Brenda for their contributions to our vision and mission over the last six and three years, respectively. Erica’s high-growth medtech leadership experience was invaluable as we scaled our business from early commercialization, and Brenda’s decades of public service and private sector expertise helped support our execution in both glaucoma and dry eye with steadfast advice and support,” said Staffan Encrantz, Chairman of the Board of Directors of Sight Sciences.

Mrs. Bauerlein Biography

Mrs. Bauerlein was appointed Chief Operating Officer of Sight Sciences effective November 2025, prior to which she served as Sight Sciences’ Chief Financial Officer since joining the Company in April 2023. She brings experience leading global finance and accounting functions, including revenue management, reporting, investor relations and business development. She joined Sight Sciences from Inogen, a medical technology company offering innovative respiratory products for use in the homecare setting. She cofounded Inogen in 2001 and served as its Chief Financial Officer from 2009 through 2021, as Inogen scaled from start-up operations to over $350 million in annual sales. She also serves as member of the board of directors of Koya Medical since January 2021 and Balance Ophthalmics since July 2024. She received a B.A. in economics/mathematics with high honors from the University of California, Santa Barbara.

Mr. Rodberg Biography

Mr. Rodberg was appointed Chief Financial Officer of Sight Sciences effective November 2025. Previously, he served as Sight Sciences’ Vice President of Finance and Corporate Controller since joining the Company in early 2021 prior to its IPO. He also served as interim CFO at Sight Sciences in 2023. Mr. Rodberg has 20 years of public accounting and company finance leadership experience. Prior to joining Sight Sciences, he served as VP, FP&A at nVent Electric, Director of Finance at Abbott Laboratories and had several progressive finance and accounting roles at St. Jude Medical (prior to its acquisition by Abbott). He began his career at Deloitte in the audit and assurance practice. He received a B.S. in Accounting from the University of Minnesota and is a Certified Public Accountant (inactive).

About Sight Sciences

Sight Sciences is an eyecare technology company focused on developing and commercializing innovative and interventional solutions intended to transform care and improve patients’ lives. Using minimally invasive or non-invasive approaches to target the underlying causes of the world’s most prevalent eye diseases, Sight Sciences seeks to create more effective treatment paradigms that enhance patient care and supplant conventional outdated approaches. The Company’s OMNI® Surgical System and OMNI® Edge Surgical System are implant-free, minimally invasive glaucoma surgery technologies indicated in the United States to reduce intraocular pressure in adult patients with primary open-angle glaucoma. The OMNI Surgical System is CE Marked for the catheterization and transluminal viscodilation of Schlemm’s canal and cutting of the trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma. Glaucoma is the world’s leading cause of irreversible blindness. The SION® Surgical System is a bladeless, manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork. The Company’s TearCare® System is 510(k) cleared in the United States for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland disease (MGD), enabling clearance of gland obstructions by physicians to address the leading cause of dry eye disease.

Visit www.sightsciences.com for more information. 

Sight Sciences and TearCare are trademarks of Sight Sciences registered in the United States. OMNI and SION are trademarks of Sight Sciences registered in the United States, European Union and other territories.

© 2025 Sight Sciences. All rights reserved.

Forward-Looking Statements

This press release, together with other statements and information publicly disseminated by the Company, contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and includes this statement for purposes of complying with these safe harbor provisions. Any statements made in this press release that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements and should be evaluated as such. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “will,” “forecast” and other similar expressions. We base these forward-looking statements on our current expectations, plans and assumptions that we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at such time. Although we believe that these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our business, results of operations and financial condition and could cause actual results to differ materially from those expressed in the forward-looking statements. These statements are not guarantees of future performance or results. These forward-looking statements include, but are not limited to, statements concerning the following: the scaling of the Company’s operations; the advancement of the Company’s strategic plans; anticipated benefits arising out of our recent executive management restructuring, including with respect to the Company’s ability to accelerate and achieve its growth and profitability objectives; and the Company’s ability to elevate the standard of care, deliver best in class solutions and improve the lives of its patients. These forward-looking statements are subject to and involve numerous risks, uncertainties and assumptions, including those discussed under the caption “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, as may be updated from time to time in subsequent filings, and you should not place undue reliance on these statements. These cautionary statements are made only as of the date of this press release. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Media contact:
pr@SightSciences.com

Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
Investor.Relations@Sightsciences.com

OnKure Therapeutics Reports Third Quarter 2025 Financial Results and Provides a Business Update




OnKure Therapeutics Reports Third Quarter 2025 Financial Results and Provides a Business Update

— First patients dosed in triplet expansion arms of the PIKture-01 trial evaluating OKI-219 in combination with fulvestrant and ribociclib, and in combination with trastuzumab and tucatinib in patients with metastatic breast cancer

— Clinical data from OKI-219 PIKture-01 single agent and fulvestrant combination arms are maturing and is now expected to be reported together with initial data from the triplet expansion arms in the first quarter of 2026

— Significant progress in next-generation PI3Kα pan-mutant inhibitor program; multiple candidates identified – announcement planned for the first quarter of 2026

— Expansion into Vascular Malformations – additional information to be provided in 2026

BOULDER, Colo., Nov. 06, 2025 (GLOBE NEWSWIRE) — OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, today reported financial results for the third quarter ended September 30, 2025 and provided a business update.

“We have made steady progress advancing our lead clinical development program, OKI-219, and are committed to leading the advancement of selective PI3Kα inhibitors for the treatment of patients with breast cancer and rare diseases. Based on its selectivity and safety profile, the differentiated value of OKI-219 is best demonstrated in early lines of therapy. This fact is at the heart of our clinical strategy. It is important to note that the single agent and fulvestrant dose ranging combination arms of our PIKture-01 trial have supported the expanded development of OKI-219 with the recent initiation of two triplet arms of the trial, including an evaluation of OKI-219 in combination with fulvestrant and ribociclib.   We are at an exciting time in our company’s history, and we look forward to sharing clinical data from several arms of our ongoing PIKture-01 trial of OKI-219 in the first quarter of 2026,” said Nick Saccomano, Ph.D., President and Chief Executive Officer of OnKure.

“While the team has been hard at work advancing the development of OKI-219, we have also continued to fuel the future growth of OnKure, with important advancements in our next-generation PI3Kα pan-mutant inhibitor program and the beginnings of an expansion program in vascular malformations. We look forward to offering additional details on these programs as our activities ramp up over the next several months.”

Program Highlights

OKI-219

OnKure’s lead product candidate, OKI-219, is a highly selective PI3kα^H1047 mutant specific inhibitor. OKI-219 is being evaluated in the PIKture-01 phase 1 clinical trial for the treatment of patients with HR+ and HER2+ metastatic breast cancer.

• In August 2025, the Company announced that it had completed and closed enrollment in the monotherapy and fulvestrant combination dose escalation arms of the PIKture-01 trial. As of October 14, 2025, a total of 71 patients have been dosed across both arms: 37 in monotherapy and 34 in combination with fulvestrant. The last patient in the monotherapy arm was dosed in September 2025 and the last patient in the fulvestrant combination arm was dosed in July 2025. The Company expects to announce initial data from these two arms of the trial in the first quarter of 2026.
• In September 2025, the first patient was dosed in a triplet expansion arm of PIKture-01 evaluating OKI-219 in combination with fulvestrant and ribociclib in patients with PI3Kα^H1047R mutated, HR+ metastatic breast cancer. The 600 and 900 mg BID cohorts are enrolled. Initial data is expected in the first quarter of 2026.
• In October 2025, the first patient was dosed in a triplet expansion arm of PIKture-01 evaluating OKI-219 in combination with trastuzumab and tucatinib in patients with PI3Kα^H1047R mutated, HER2+ breast cancer. Initial data is expected in the first quarter of 2026.

Next-Generation PI3Kα^PAN Mutant Selective Program

OnKure has identified a series of next-generation PI3Kα pan-mutant inhibitors. OnKure believes that to be truly “pan-mutant,” a candidate should be highly selective against each of the most common PI3Kα mutations (PI3Kα^H1047X, PI3Kα^E542K, and PI3Kα^E545K), with a favorable safety and tolerability profile that enables combinability with other agents.

• The Company is evaluating a series of PI3Kα pan-mutant inhibitor development candidates shown preclinically to have an overall selectivity profile, combinability, and pharmaceutical attributes that the Company believes will produce best-in-class pan-mutant PI3Kα inhibitors.
• The Company plans to announce additional details in the first quarter of 2026.

Vascular Malformations Expansion

PI3Kα mutations are the most common driver mutations for specific sub-types of vascular malformations. These mutations in the PI3KCA gene lead to overactivation of the pathway, which controls cell growth, proliferation, and survival.

• OnKure believes its portfolio of PI3kα inhibitors have great potential to serve patients in this large, underserved population. The Company plans to announce additional information on its vascular malformations program in 2026.

Financial Results

• Cash and cash equivalents were approximately $70.3 million as of September 30, 2025. The Company believes its current cash and cash equivalents will be sufficient to fund its planned clinical activities and corporate operations into the fourth quarter of 2026.
• Research and development (R&D) expenses were $11.9 million for the third quarter of 2025, compared with $10.1 million for the third quarter of 2024. The increase in R&D expenses was primarily due to increased personnel-related costs, including share-based compensation charges.
• General and Administrative (G&A) expenses were $3.6 million for the third quarter of 2025, compared with $1.4 million for the third quarter of 2024. The increase in G&A expenses was primarily due to increased personnel-related costs, including share-based compensation charges, and increases in director compensation, consulting, filing fees, franchise taxes, and other professional service fees.
• Net loss and net loss per share for the third quarter of 2025 were $14.7 million and $1.09 per share, compared with $11.6 million and $36.55 per share for the third quarter of 2024.

About OnKure Therapeutics

OnKure Therapeutics, Inc. (Nasdaq: OKUR) is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of diseases that are underserved by available therapies. Using a structure-based drug design platform, OnKure is building a pipeline of tumor-agnostic candidates that are designed to achieve optimal efficacy and tolerability. OnKure is currently developing OKI-219, a selective PI3Kα^H1047R inhibitor, as its lead program. OnKure aims to become a leader in targeting oncogenic or pathologically activated PI3Kα and has multiple programs designed to enable best-in-class targeting of this key disease creating gene.

For more information about OnKure, visit us at www.onkure.com and follow us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, OnKure’s current and potential future product candidates and programs, including OKI-219 and the pan-mutant program; OnKure’s ability to advance additional programs; OnKure’s ability to advance and expected timing of additional programs in vascular malformations; expected milestones and timing of such milestones, including additional data for OKI-219 from the PIKture-01 trial and an anticipated development candidate announcement; and statements regarding OnKure’s cash runway. In some cases, you can identify forward-looking statements by terminology such as “estimate”, “intend”, “expect”, “may”, “plan”, “potentially”, “will” or the negative of these terms or other similar expressions.

We based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things, OnKure’s limited operating history; the significant net losses incurred since inception; the ability to raise additional capital to finance operations; the risk that actual uses of cash and cash equivalents differ from the assumptions underlying our expected cash runway; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, OnKure’s product candidates; the outcome of preclinical testing and early clinical trials for OnKure’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements, timing of regulatory reviews and approvals, and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; OnKure’s limited resources; the risk of adverse events, toxicities or other undesirable side effects; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; the decision to develop or seek strategic collaborations to develop OnKure’s current or future product candidates in combination with other therapies and the cost of combination therapies; OnKure’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; the substantial competition OnKure faces in discovering, developing, or commercializing products; OnKure’s ability to protect its intellectual property and proprietary technologies; developments relating to OnKure’s competitors and its industry, including competing product candidates and therapies; reliance on third parties, contract manufacturers, and contract research organizations; legislative, regulatory, political and economic developments and general market conditions; and those risks described in the section entitled “Risk Factors” in documents that OnKure files from time to time with the Securities and Exchange Commission (“SEC”), including our Quarterly Report on Form 10-Q filed with the SEC on November 6, 2025 and any subsequent filings with the SEC. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release.

Contact:

Dan Ferry
LifeSci Advisors
daniel@lifesciadvisors.com

Clearmind Medicine Receives Nasdaq Notification Regarding Minimum Stockholders’ Equity Deficiency




Clearmind Medicine Receives Nasdaq Notification Regarding Minimum Stockholders’ Equity Deficiency

The Notification Letter has no immediate effect on the Company’s listing on the Nasdaq Capital Market at this time, nor are the Company’s business operations affected by receipt of the Notification Letter

Vancouver, Canada, Nov. 06, 2025 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced that the Company received a written notification (the “Notification Letter”) from the Listing Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”) dated November 3, 2025, notifying the Company that it is no longer in compliance with Nasdaq Listing Rule 5550(b)(1) (the “Rule”).

The Rule requires companies listed on the Nasdaq Capital Market to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing. However, based on the Company’s Form 6-K filed on September 11, 2025, where the Company filed its unaudited condensed interim consolidated financial statements for the three and nine months ended July 31, 2025, the Company reported a stockholders’ equity of $1,065,668, and does not meet the alternatives of market value of listed securities or net income from continuing operations, and is thus non-compliant with the Rule.

The Notification Letter has no immediate effect on the Company’s listing on the Nasdaq Capital Market at this time and the Company’s common shares continue to trade on Nasdaq Capital Market under the symbol “CMND”, nor are the Company’s business operations affected by receipt of the Notification Letter. In accordance with the Nasdaq Listing Rules, the Company has 45 calendar days, or until December 18, 2025, to submit a plan to regain compliance. If the plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from receipt of the Notification Letter to evidence compliance.

The Company is looking into various options available to regain compliance and maintain its continued listing on the Nasdaq Capital Market. The Company intends to submit the compliance plan as soon as practicable. There can be no assurance that the Company’s plan will be accepted or the Company will be able to regain compliance with the Rule.

As previously announced, on September 17, 2025, the Company entered into securities purchase agreements with investors pursuant to which the Company shall issue and sell, from time to time, convertible promissory notes (the “Notes”) in the aggregate principal amount of up to $10,000,000. On October 30, 2025 and October 31, 2025, an aggregate of $1,045,062 of outstanding amounts due under the Notes were converted into 885,000 of the Company’s common shares. The Company expects that it will be able to demonstrate compliance with the Nasdaq stockholders’ equity requirement if additional portions of the Notes are converted.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The Company’s intellectual portfolio currently consists of nineteen patent families including 31 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on Nasdaq under the symbol “CMND” and the Frankfurt Stock Exchange under the symbol “CWY0.”

For further information visit: https://www.clearmindmedicine.com or contact:

Investor Relations
invest@clearmindmedicine.com

Telephone: (604) 260-1566
US: CMND@crescendo-ir.com

General Inquiries
Info@Clearmindmedicine.com
www.Clearmindmedicine.com

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses regaining compliance with Nasdaq’s continued listing requirements, timing and effect thereof and Company’s expectation that if additional portions of the convertible promissory notes that the Company shall issue and sell, from time to time, will be converted, the Company will be able to demonstrate compliance with the Nasdaq stockholders’ equity requirement. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2024 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

Ventyx Biosciences Reports Third Quarter 2025 Financial Results and Highlights Recent Corporate Progress




Ventyx Biosciences Reports Third Quarter 2025 Financial Results and Highlights Recent Corporate Progress

• Data from the recent Phase 2 study position Ventyx’s NLRP3 inhibitor VTX3232 as a next generation, oral anti-inflammatory therapy, for cardiovascular disease
• Positive topline data from Phase 2a biomarker trial support the potential use of VTX3232 as a disease-modifying therapy for patients with Parkinson’s disease
• Topline data from Phase 2 study of VTX2735 in patients with recurrent pericarditis expected in Q4 2025
• Cash, cash equivalents and marketable securities balance of $192.6M as of
  September 30, 2025, expected to fund planned operations into at least H2 2026

SAN DIEGO, Nov. 06, 2025 (GLOBE NEWSWIRE) — Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”, “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oral therapies for patients with autoimmune, inflammatory, and neurodegenerative diseases, today reported third quarter financial results and highlighted recent pipeline and business progress.

“I am proud of the Ventyx team for achieving two key milestones this year, generating data from the Phase 2a study with our CNS penetrant NLRP3 inhibitor VTX3232 in patients with early Parkinson’s disease and, more recently, data from the VTX3232 Phase 2 study in participants with obesity and cardiovascular risk factors. Key takeaways from the latter study were hsCRP levels were reduced by nearly 80% and, additionally, we saw significant reductions in IL-6, hsCRP, Lp(a) and other markers of systemic inflammation,” said Raju Mohan, PhD, Chief Executive Officer. “Earlier in the year, we reported data showing that treatment with VTX3232 yields significant reductions in NLRP3-mediated biomarkers in the plasma and CSF of patients with early Parkinson’s disease. These results position VTX3232 as a next generation, oral therapy, targeting inflammation in cardiovascular, neuroinflammatory and neurodegenerative diseases.   We are looking forward to achieving our third major milestone of 2025 by reporting topline data from our Phase 2 study of VTX2735 in recurrent pericarditis during the fourth quarter.”

Pipeline Updates and Anticipated Milestones

Promising NLRP3 Inhibitor Portfolio: Ventyx’s portfolio of potential best-in-class oral NLRP3 inhibitors in clinical development include VTX2735, a peripherally restricted NLRP3 inhibitor, and VTX3232, a central nervous system (CNS)-penetrant NLRP3 inhibitor.

• Phase 2 Study of VTX3232 in Subjects with Obesity and Cardiovascular Risk Factors (Positive topline Phase 2 data, Oct 2025): The Phase 2, multicenter, double-blind, placebo-controlled trial evaluated VTX3232 versus placebo, alone or in combination with semaglutide. The study met its primary endpoint of safety with VTX3232 adverse event rates comparable to placebo over the 12-week study. In the study VTX3232 also demonstrated significant reductions in cardiovascular risk factors, with additional benefits when combined with semaglutide.

  VTX3232 monotherapy achieved ~80% reduction in hsCRP within the first week that was sustained through week 12.   Moreover, approximately 70% of patients on VTX3232 monotherapy achieved target hsCRP levels of 2 mg/L or lower. Participants treated with VTX3232 monotherapy also showed statistically significant reductions in IL-6 to levels associated with reduced cardiovascular risk (IL-6 ≤1.65ng/L). Statistically significant reductions in Lp(a), fibrinogen, and ESR were also demonstrated with VTX3232.   Furthermore, the combination of VTX3232 and semaglutide demonstrated significant reductions in hsCRP, IL-6, fibrinogen, ESR, Lp(a) and liver inflammation relative to semaglutide alone.

• VTX2735 in Recurrent Pericarditis (Data Expected Q4 2025): The multicenter, Phase 2, open-label trial is evaluating VTX2735 in patients with recurrent pericarditis over a 6-week primary treatment period, followed by a 7-week extension. Key endpoints include safety, change in the numerical rating scale (NRS) pain score, and change in hsCRP. Ventyx expects to report interim topline results from this ongoing study in Q4 2025.
• VTX3232 in Parkinson’s Disease (Positive topline Phase 2a data, June 2025): The Phase 2a trial met its goal of successfully establishing safety and tolerability of VTX3232 in patients with early stage Parkinson’s disease. Once-daily dosing with VTX3232 achieved high drug exposures with steady state concentrations in CSF and plasma exceeding the IC₉₀ for NLRP3 inhibition by ≥3-fold for 24-hours. VTX3232 also showed clear evidence of target engagement in plasma and CSF with robust reductions in downstream biomarkers of NLRP3 inhibition, such as IL-1β, IL-6 and high-sensitivity C-reactive protein (hsCRP). In addition, VTX3232 treatment was associated with improved motor and non-motor symptoms of Parkinson’s disease, as measured by the MDS-UPDRS. No drug-related treatment emergent adverse events were observed in this study.

Inflammatory Bowel Disease (IBD) Portfolio:

• Tamuzimod (S1P1R Modulator, ulcerative colitis): Phase 2 induction data published in The Lancet (January 2025, doi:10.1016/S2468-1253(24)00386-8) showed that patients treated with tamuzimod experienced robust clinical and endoscopic remission rates compared to placebo. We believe combination treatment has the potential to overcome modest remission seen with Inflammatory bowel disease (IBD) monotherapies today. Tamuzimod’s efficacy and safety profile could position it as the backbone of future combination regimens with another oral or biologic agent. The Company is exploring partnership opportunities.
• VTX958 (TYK2 Inhibitor, Crohn’s disease): Phase 2 data suggest that VTX958 may have disease-modifying benefits in Crohn’s disease. Presentation of results in Crohn’s disease (the Journal of Crohn’s and Colitis, (February, 2025, doi.org/10.1093/ecco-jcc/jjae190.1175) showed that VTX958 demonstrated a robust, dose-dependent endoscopic response at Week 12 compared to placebo, with a greater magnitude of reduction in two key biomarkers of inflammation, CRP and fecal calprotectin. Ventyx is exploring multiple options for continued development, including partnership opportunities.

Third Quarter Financial Results

• Cash Position: Cash, cash equivalents and marketable securities were $192.6 million as of September 30, 2025. We believe our current cash, cash equivalents and marketable securities are sufficient to fund our planned operations into at least H2 2026.
• Research and Development (R&D) expenses: R&D expenses were $17.7 million for the third quarter of 2025, compared to $30.6 million for the third quarter of 2024.
• General and Administrative (G&A) expenses: G&A expenses were $7.2 million for the third quarter of 2025, compared to $7.9 million for the third quarter of 2024.
• Net loss: Net loss was $22.8 million for the third quarter of 2025, compared to $35.2 million for the third quarter of 2024.

About Ventyx Biosciences

Ventyx Biosciences is a clinical-stage biopharmaceutical company developing innovative oral therapies for patients with autoimmune, inflammatory, and neurodegenerative diseases. Our expertise in medicinal chemistry, structural biology, and immunology enables the discovery of differentiated oral small molecule therapeutics for conditions with high unmet medical need, and our extensive experience in clinical development allows the rapid progression of these drug candidates through clinical trials.

Our portfolio of NLRP3 inhibitors includes VTX2735, a peripherally restricted NLRP3 inhibitor in Phase 2 development for recurrent pericarditis, and VTX3232, a CNS-penetrant NLRP3 inhibitor that recently completed a Phase 2 study in participants with obesity and cardiovascular risk factors and a Phase 2a study in Parkinson’s disease. Our inflammatory bowel disease portfolio includes two Phase 2 compounds: tamuzimod (VTX002), an S1P1R modulator, and VTX958, a TYK2 inhibitor.

For more information on Ventyx, please visit our website at https://ventyxbio.com.

Forward-Looking Statements

Ventyx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Ventyx’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential of each of Ventyx’s product candidates, including the potential of VTX2735 and VTX3232, to emerge as best-in-class NLRP3 inhibitors and produce safe, effective or disease modifying results for the treatment of inflammation associated with cardiovascular, neurodegenerative or neuroinflammatory diseases; the ability of VTX3232 to become a next generation of oral anti-inflammatory therapy for cardiovascular disease; the timing of reporting data from the Phase 2 trial in recurrent pericarditis in Q4 2025; management’s plans with respect to the commitment of internal resources toward further analysis, or development, including future studies, partnerships or other source of non-dilutive financing for tamuzimod in ulcerative colitis and VTX958 in Crohn’s disease; and, the expected timeframe for funding Ventyx’s operating plan with current cash, cash equivalents and marketable securities.

The inclusion of forward-looking statements should not be regarded as a representation by Ventyx that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Ventyx’s business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; Ventyx’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; disruptions in the supply chain, including raw materials needed for manufacturing and animals used in research, delays in site activations and enrollment of clinical trials; the results of preclinical studies and clinical trials; early clinical trials not necessarily being predictive of future results; interim results not necessarily being predictive of final results; the potential of one or more outcomes to materially change as a trial continues and more patient data become available and following more comprehensive audit and verification procedures; regulatory developments in the United States and foreign countries; economic uncertainty in global markets caused by, among other things, geopolitical conditions, tariffs, military conflicts, and inflation volatility; unexpected adverse side effects or inadequate efficacy of Ventyx’s product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Ventyx’s ability to obtain and maintain intellectual property protection for its product candidates; the use of capital resources by Ventyx sooner than expected; and other risks described in Ventyx’s prior press releases and Ventyx’s filings with the Securities and Exchange Commission (SEC), including in Part II, Item 1A (Risk Factors) of Ventyx’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed on or about the date hereof, and Ventyx’s subsequent filings with the SEC.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Ventyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor Relations Contact:
Alex Schwartz
Vice President, Investor Relations and FP&A
Ventyx Biosciences, Inc.
IR@ventyxbio.com

Financial Tables

Progyny, Inc. Announces Third Quarter 2025 Results




Progyny, Inc. Announces Third Quarter 2025 Results

Reports Revenue of $313.3 Million, Reflecting 9.3% Growth
Raises Full Year Guidance to Reflect Continued Strength in Member Engagement
Selling Season Yields Over 80 New Clients, 900,000 New Lives, and Near 100% Retention of Existing Base
Record $156.0 Million in Operating Cash Flow Generated over the First Nine Months of 2025
Board Authorizes Up to $200 Million in Share Repurchase Program

NEW YORK, Nov. 06, 2025 (GLOBE NEWSWIRE) — Progyny, Inc. (Nasdaq: PGNY) (“Progyny” or the “Company”), a global leader in women’s health and family building solutions, today announced its financial results for the three-month period ended September 30, 2025 (“the third quarter of 2025”), as compared to the three-month period ended September 30, 2024 (“the third quarter of 2024” or “the prior year period”).

“Our strong results this quarter reflect that members have continued to pursue the care and services they need in order to best address both their family building goals and their overall health, and did so at levels that exceeded our expectations,” said Pete Anevski, Chief Executive Officer of Progyny.  

“We’re equally pleased with the results of our latest selling season, which resulted in commitments from over 80 new clients representing approximately 900,000 new lives, as well as a near 100% client retention rate for 2026, in addition to strong expansions of services across existing accounts,” continued Anevski. “Our newest programs – including pregnancy-postpartum, menopause, and leave and benefit navigation – continue to resonate in the market, further demonstrating both the underlying need for these services, as well as the measurable value that our solutions deliver. More than 2.7 million lives will have access to one or more of those solutions next year, or an incremental 1.2 million lives above 2025.”

“The third quarter results reflect both strong revenue growth and margin expansion, and through our continuing focus on prudent management of our business operations, we’ve maintained a high conversion of Adjusted EBITDA to cash flow, yielding a record $156 million in operating cash flow over the first nine months of the year,” said Mark Livingston, Chief Financial Officer of Progyny. “Given our balance sheet strength and solid cash position, we’re pleased to be in a position to return value to our shareholders through our latest share repurchase program, which we’ll pursue while also maintaining the ability to continue investing in our business for future growth.”

Third Quarter 2025 Highlights:

1. Net income per diluted share reflects weighted-average shares outstanding as adjusted for potential dilutive securities, including options, restricted stock units, warrants to purchase common stock, and shares issuable under the employee stock purchase plan.
2. Adjusted Earnings per Diluted Share, Adjusted EBITDA, and Adjusted EBITDA margin are financial measures that are not required by, or presented in accordance with, U.S. generally accepted accounting principles (“GAAP”). Please see Annex A of this press release for a reconciliation of Adjusted Earnings per Diluted Share to earnings per share, and Adjusted EBITDA to net income, the most directly comparable financial measures stated in accordance with GAAP for each of the periods presented. We calculate Adjusted Earnings per Diluted Share as net income per diluted share excluding the impact of stock-based compensation, adjusted for the impact of taxes. We calculate Adjusted EBITDA margin as Adjusted EBITDA divided by revenue.

Financial Highlights
Revenue was $313.3 million, a 9.3% increase as compared to the $286.6 million reported in the third quarter of 2024, primarily as a result of the increase in our number of clients and covered lives. As previously disclosed, a large client did not renew its services agreement for 2025, though it provided for an extended transition period over the first half of 2025 for members meeting certain criteria. There was no contribution from this client in the third quarter of 2025, and excluding the $32.8 million of revenue from this client in the third quarter of 2024, revenue increased 23%.

• Fertility benefit services revenue was $201.9 million, a 13% increase from the $178.8 million reported in the third quarter of 2024.
• Pharmacy benefit services revenue was $111.4 million, a 3% increase as compared to the $107.9 million reported in the third quarter of 2024.

Gross profit was $72.8 million, an increase of 23% from the $59.2 million reported in the third quarter of 2024, primarily due to the higher revenue. Gross margin was 23.2%, as compared to the 20.7% reported in the prior year period primarily due to ongoing efficiencies realized in the delivery of our care management services.

Net income was $13.9 million, or $0.15 income per diluted share, as compared to the $10.4 million, or $0.11 income per diluted share, reported in the third quarter of 2024. The higher net income was due primarily to the higher operating profit, which was partially offset by lower interest and other income, net, and a higher provision for income taxes driven by the discrete tax impacts of equity compensation.

Adjusted EBITDA was $55.0 million, an increase of 18% as compared to the $46.5 million reported in the third quarter of 2024, as the higher gross profit more than offset increased investments to expand the platform and integrate recent acquisitions. Adjusted EBITDA margin was 17.5% as compared to the 16.2% Adjusted EBITDA margin in the third quarter of 2024. Refer to Annex A for a reconciliation of Adjusted EBITDA to net income.

Cash Flow
Net cash provided by operating activities in the third quarter of 2025 was $50.7 million, as compared to $44.5 million provided by operating activities in the prior year period. Cash flow reflects the timing impact of certain working capital items in both periods.

Balance Sheet and Financial Position
As of September 30, 2025, the Company had total working capital of approximately $411.5 million and no debt. This included cash and cash equivalents and marketable securities of $345.2 million, an increase of $117.3 million from the balances as of December 31, 2024. During the quarter, the Company entered into a revolving credit facility which makes available a maximum aggregate amount of $200 million, subject to customary borrowing conditions, until its maturity on July 1, 2030. The revolver, which is expected to further enhance the Company’s operational and financial flexibility, is undrawn and the Company has no planned use for the facility at this time.

Key Metrics
The Company had 553 fertility and family building clients as of September 30, 2025, as compared to 468 clients as of September 30, 2024.

^{* Represents the number of ART cycles performed, including IVF with a fresh embryo transfer, IVF freeze all cycles/embryo banking, frozen embryo transfers, and egg freezing. Includes ART cycles performed in the first half of 2025 under the extended transition of care agreement with the large client who did not renew its services agreement.
** Represents the member utilization rate for all fertility and family building services, including, but not limited to, ART cycles, initial consultations, IUIs, and genetic testing. The utilization rate for all members includes all unique members (female and male) who utilize the benefit during that period, while the utilization rate for female only includes only unique females who utilize the benefit during that period. For purposes of calculating utilization rates in any given period, the results reflect the number of unique members utilizing the benefit for that period. Individual periods cannot be combined as member treatments may span multiple periods. Utilization for 2025 excludes activity under the extended transition of care agreement ending June 30, 2025 with the large client who did not renew its services agreement, as only members meeting certain criteria were eligible to use the benefit.
*** Includes approximately 300,000 members from a single client who are not reflected in utilization as a result of the client’s chosen benefit design. 2025 excludes the limited number of members who were eligible to use the benefit under the extended transition of care agreement ending June 30, 2025 with the large client who did not renew its services agreement.}

Financial Outlook
“As the fourth quarter begins, member activity continues to remain healthy. In light of our strong results over the first nine months of the year, as well as our expectations for member engagement over the remainder of the year, we’re pleased to raise our full year guidance,” said Mr. Anevski.

Given the variability in member engagement experienced in prior periods, as well as the potential for any impact from ongoing macroeconomic uncertainty, the guidance issued today reflects a range of member engagement. The ranges also reflect the impact of the Company’s previously announced investments in member experience and acquisition integration. Lastly, as the extended transition of care agreement with the large client expired on June 30th, the guidance reflects no further contribution from that client in the second half of the year.

The majority of the clients added in the most recent selling season are expected to go live in the first quarter of 2026, though a number of the newest clients have already or will launch their benefit in 2025. Once all new clients are live in 2026, the Company anticipates having over 600 clients, representing approximately 7.6 million covered lives, compared to the 530 clients and 6.7 million covered lives that were under commitment before the commencement of the latest selling season. As it relates to 2026, consistent with past practice, the Company anticipates providing financial guidance when it reports its year-end results in February.  

The Company is providing the following financial guidance for both the three-month and full year periods ending December 31, 2025. The guidance ranges presented do not reflect any impact from the share repurchase program announced today.

• Full Year 2025 Outlook:
  • Revenue is now projected to be $1.263 billion to $1.278 billion, reflecting growth of 8.2% to 9.5%; excluding the $48.5 million and $136.1 million of revenue in 2025 and 2024, respectively, from the large client who was under a transition agreement in the first half of 2025, revenue is expected to increase by 17.8% to 19.2%
  • Net income is projected to be $58.5 million to $61.5 million, or $0.65 to $0.68 per diluted share, on the basis of approximately 90 million assumed weighted-average fully diluted-shares outstanding
  • Adjusted EBITDA¹ is projected to be $216.0 million to $220.0 million
  • Adjusted earnings per diluted share¹ is projected to be $1.79 to $1.82

• Fourth Quarter of 2025 Outlook:
  • Revenue is projected to be $292.7 million to $307.7 million, reflecting a change of (1.9)% to 3.1%; excluding the $35.9 million of revenue in 2024 from the large client who was under a transition agreement in the first half of 2025, revenue is expected to increase by 11.5% to 17.2%
  • Net income is projected to be $12.5 million to $15.5 million, or $0.14 to $0.17 per diluted share, on the basis of approximately 91 million assumed weighted-average fully diluted-shares outstanding
  • Adjusted EBITDA¹ is projected to be $45.3 million to $49.3 million
  • Adjusted earnings per diluted share¹ is projected to be $0.37 to $0.40

1. Adjusted EBITDA and Adjusted earnings per diluted share are financial measures that are not required by, or presented in accordance with, GAAP. Please see Annex A of this press release for a reconciliation of forward-looking Adjusted EBITDA to forward-looking net income and Adjusted net income to net income, the most directly comparable financial measures stated in accordance with GAAP, for the period presented.

Conference Call Information
Progyny will host a conference call at 4:45 P.M. Eastern Time (1:45 P.M. Pacific Time) today, November 6, 2025, to discuss its financial results. Interested participants from the United States may join by calling 1.866.825.7331 and using conference ID 265484. Participants from international locations may join by calling 1.973.413.6106 and using the same conference ID. A replay of the call will be available until November 13, 2025 at 5:00 P.M. Eastern Time by dialing 1.800.332.6854 (U.S. participants) or 1.973.528.0005 (international) and entering passcode 265484. A live audio webcast of the call and subsequent replay will also be available through the Events & Presentations section of the Company’s Investor Relations website at investors.progyny.com.

About Progyny
Progyny (Nasdaq: PGNY) is a global leader in women’s health and family building solutions, trusted by the nation’s leading employers, health plans and benefit purchasers. We envision a world where everyone can realize their dreams of family and ideal health. Our outcomes prove that comprehensive, inclusive and intentionally designed solutions simultaneously benefit employers, patients, and physicians.

Our benefits solution empowers patients with concierge support, coaching, education, and digital tools; provides access to a premier network of fertility and women’s health specialists who use the latest science and technologies; drives optimal clinical outcomes; and reduces healthcare costs.

Headquartered in New York City, Progyny has been recognized for its leadership and growth as a TIME100 Most Influential Company, CNBC Disruptor 50, Modern Healthcare’s Best Places to Work in Healthcare, Forbes’ Best Employers, Financial Times Fastest Growing Companies, INC. 5000, INC. Power Partners and Crain’s Fast 50 for NYC. For more information, visit www.progyny.com. 

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact, including, without limitation, statements regarding our financial outlook for the fourth quarter and full year 2025, including the impact of our sales season and client launches; our anticipated number of clients and covered lives for 2026; our expected utilization rates and mix; the demand for our solutions; our positioning to successfully manage economic uncertainty on our business; the timing of client decisions; our ability to retain existing clients and acquire new clients; and our business strategy, plans, goals and expectations concerning our market position, future operations, and other financial and operating information. The words “anticipates,” “assumes,” “believe,” “contemplate,” “continues,” “could,” “estimates,” “expects,” “future,” “intends,” “may,” “plans,” “predict,” “potential,” “project,” “seeks,” “should,” “target,” “will,” and the negative of these or similar expressions and phrases are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions.

Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, without limitation, failure to meet our publicly announced guidance or other expectations about our business; competition in the market in which we operate; our history of operating losses and ability to sustain profitability; unfavorable conditions in our industry or the United States economy; our limited operating history and the difficulty in predicting our future results of operations; our ability to attract and retain clients and increase the adoption of services within our client base; the loss of any of our largest client accounts; changes in the technology industry; changes or developments in the health insurance market; negative publicity in the health benefits industry; lags, failures or security breaches in our computer systems or those of our vendors; a significant change in the utilization of our solutions; our ability to offer high-quality support; positive references from our existing clients; our ability to develop and expand our marketing and sales capabilities; the rate of growth of our future revenue; the accuracy of the estimates and assumptions we use to determine the size of target markets; our ability to successfully manage our growth; reductions in employee benefits spending; seasonal fluctuations in our sales; the adoption of new solutions and services by our clients or members; our ability to innovate and develop new offerings; our ability to adapt and respond to the changing medical landscape, regulations, and client needs, requirements or preferences; our ability to maintain and enhance our brand; our ability to attract and retain members of our management team, key employees, or other qualified personnel; risks related to any litigation against us; our ability to maintain our Center of Excellence network of healthcare providers; our strategic relationships with and monitoring of third parties; our ability to maintain our pharmacy distribution network if there is a disruption to our network or its associated supply chains; our relationship with key pharmacy program partners or any decline in rebates provided by them; our ability to maintain our relationships with benefits consultants; exposure to credit risk from our members; risks related to government regulation; risks related to our business with government entities; our ability to protect our intellectual property rights; risks related to acquisitions, strategic investments, or partnerships; federal tax reform and changes to our effective tax rate; the imposition of state and local state taxes; our ability to utilize a portion of our net operating loss or research tax credit carryforwards; our ability to develop or maintain effective internal control over financial reporting; and our ability to adapt and respond to the changing SEC or stakeholder expectations regarding environmental, social and governance practices. For a detailed discussion of these and other risk factors, please refer to our filings with the Securities and Exchange Commission (the “SEC”), including in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and subsequent reports that we file with the SEC, which are available at http://investors.progyny.com and on the SEC’s website at https://www.sec.gov. 

Forward-looking statements represent our management’s beliefs and assumptions only as of the date of this press release. Our actual future results could differ materially from what we expect. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons.

Non-GAAP Financial Measures
In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), this press release and the accompanying tables include the non-GAAP financial measures Adjusted EBITDA, Adjusted EBITDA margin, Adjusted EBITDA margin on incremental revenue and Adjusted earnings per diluted share.

Adjusted EBITDA, Adjusted EBITDA margin, Adjusted EBITDA margin on incremental revenue and Adjusted earnings per diluted share are supplemental financial measures that are not required by, or presented in accordance with, GAAP. We believe that these non-GAAP measures, when taken together with our GAAP financial results, provide meaningful supplemental information regarding our operating performance and facilitates internal comparisons of our historical operating performance on a more consistent basis by excluding certain items that may not be indicative of our business, results of operations or outlook. In particular, we believe that the use of Adjusted EBITDA, Adjusted EBITDA margin, Adjusted EBITDA margin on incremental revenue and Adjusted earnings per diluted share are helpful to our investors as they are measures used by management in assessing the health of our business, determining incentive compensation, evaluating our operating performance, and for internal planning and forecasting purposes.

Adjusted EBITDA, Adjusted EBITDA margin, Adjusted EBITDA margin on incremental revenue and Adjusted earnings per diluted share are presented for supplemental informational purposes only, have limitations as analytical tools and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. Some of the limitations of Adjusted EBITDA, Adjusted EBITDA margin, Adjusted EBITDA margin on incremental revenue and Adjusted earnings per diluted share include: (1) it does not properly reflect capital commitments to be paid in the future; (2) although depreciation and amortization are non-cash charges, the underlying assets may need to be replaced and Adjusted EBITDA does not reflect these capital expenditures; (3) it does not consider the impact of stock-based compensation expense; (4) it does not reflect other non-operating income and expenses, including interest and other income, net; and (5) it does not reflect tax payments that may represent a reduction in cash available to us. In addition, our non-GAAP measures may not be comparable to similarly titled measures of other companies because they may not calculate such measures in the same manner as we calculate these measures, limiting their usefulness as comparative measures. Because of these limitations, when evaluating our performance, you should consider Adjusted EBITDA, Adjusted EBITDA margin, Adjusted EBITDA margin on incremental revenue and Adjusted earnings per diluted share alongside other financial performance measures, including our net income, gross margin, and our other GAAP results.

We calculate Adjusted EBITDA as net income, adjusted to exclude depreciation and amortization; stock-based compensation expense; interest and other income, net; and provision for income taxes. We calculate Adjusted EBITDA margin as Adjusted EBITDA divided by revenue. We calculate Adjusted EBITDA margin on incremental revenue as incremental Adjusted EBITDA in 2025 divided by incremental revenue in 2025. We calculate Adjusted earnings per diluted share as net income per diluted share excluding the impact of stock-based compensation, adjusted for the associated impact of taxes. Please see Annex A: “Reconciliation of GAAP to Non-GAAP Financial Measures” elsewhere in this press release.

For Further Information, Please Contact:

Investors:
James Hart
investors@progyny.com 

Media:
Alexis Ford
media@progyny.com 

ANNEX A

PROGYNY, INC.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
(in thousands, except share and per share amounts)

Costs of Services, Gross Margin and Operating Expenses Excluding Stock-Based Compensation Calculation
The following table provides a reconciliation of cost of services, gross profit, sales and marketing and general and administrative expenses to each of these measures excluding the impact of stock-based compensation expense for each of the periods presented:

Note: percentages shown in the table may not cross foot due to rounding.

Adjusted Earnings Per Diluted Share Calculation
The following table provides a reconciliation of net income to Adjusted Earnings Per Diluted Share for each of the periods presented:

Adjusted EBITDA and Adjusted EBITDA Margin on Incremental Revenue Calculation
The following table provides a reconciliation of Net income to Adjusted EBITDA for each of the periods presented:

Reconciliation of Non-GAAP Financial Guidance for the Three Months Ending December 31, 2025 and Year Ending December 31, 2025 

* All of the numbers in the tables above reflect our future outlook as of the date hereof.  Net income, Adjusted Net Income and Adjusted EBITDA ranges do not reflect any estimate for other potential activities and transactions, nor do they contemplate any discrete income tax items, including the income tax impact related to equity compensation activity.

Assisted Reproductive Technology (ART) Cycles per Unique Female Utilizer

The following tables provide historical trend and guidance assumptions for average members, female utilization rate, and ART Cycles per Unique Female Utilizer for the full year and quarterly periods presented:

¹ Calculations for 2024 and 2025 exclude approximately 300,000 members from a single client not reflected in female utilizers as a result of the client’s chosen benefit design.
² Calculations exclude activity from a large client whose program discontinued for 2025, but who allowed for an extended period of transition of care for certain members during the first half of 2025.

Quarterly ART Cycles per Unique Female Utilizer

*Calculations for 2024 and 2025 exclude approximately 300,000 members from a single client not reflected in female utilizers as a result of the client’s chosen benefit design.
E indicates the estimated value assumed.