Palvella Therapeutics Announces Pricing of Upsized Public Offering




Palvella Therapeutics Announces Pricing of Upsized Public Offering

WAYNE, Pa., Feb. 25, 2026 (GLOBE NEWSWIRE) — Palvella Therapeutics, Inc. (“Palvella”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced the pricing of its upsized public offering of 1,600,000 shares of its common stock at a price to the public of $125.00 per share. In addition, Palvella has granted the underwriters a 30-day option to purchase up to an additional 240,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The aggregate gross proceeds to Palvella from this offering are expected to be $200 million, before deducting underwriting discounts and commissions and other offering expenses, assuming no exercise of the underwriters’ option to purchase additional shares. All shares of common stock are being offered by Palvella. The offering is expected to close on or about February 27, 2026, subject to the satisfaction of customary closing conditions.

TD Cowen, Cantor, Stifel, Mizuho, LifeSci Capital, Oppenheimer & Co., Canaccord Genuity and H.C. Wainwright & Co. are acting as joint bookrunning managers for the offering. Lucid Capital Markets, Jones, Clear Street and Craig-Hallum are acting as co-managers for the offering.

Palvella intends to use the net proceeds from this offering to support the development of its programs, including QTORIN rapamycin and QTORIN pitavastatin, and for working capital and other general corporate purposes, including research and development expenses.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-292544) that was declared effective by the Securities and Exchange Commission (“SEC”) on January 29, 2026. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available for free on the SEC’s website at www.sec.gov. A final prospectus supplement with the final terms of the offering and accompanying prospectus will be filed with the SEC and will be available for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59^th Street, 6^th Floor, New York, NY 10022 or by email at prospectus@cantor.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364‐2720 or by email at syndprospectus@stifel.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

About Palvella Therapeutics

Founded and led by rare disease drug development veterans, Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare skin diseases, many of which are lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being developed for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas. Palvella’s second product candidate, QTORIN™ pitavastatin, is currently being developed for the topical treatment of disseminated superficial actinic porokeratosis.

QTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use only and neither has been approved by the FDA or by any other regulatory agency for any indication.

Caution Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend,” or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of Palvella’s management. Such forward-looking statements include, without limitation, statements relating to the completion, use of proceeds and anticipated total gross proceeds from the offering. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: risks and uncertainties related to market conditions and the satisfaction of customary closing conditions related to the public offering, and other risks and uncertainties related to the public offering, as well as the risks and uncertainties set forth in the “Risk Factors” section and elsewhere in the prospectus supplement related to the public offering filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission and available at www.sec.gov, including but not limited to Palvella’s periodic reports, including Palvella’s most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q and current reports on Form 8-K. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Palvella assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.

Contact Information:
Wesley H. Kaupinen
Founder and CEO, Palvella Therapeutics
wes.kaupinen@palvellatx.com

Media:
Marcy Nanus
Managing Partner, Trilon Advisors LLC
mnanus@trilonadvisors.com

Considering MEDVi QUAD in 2026? Read This Before Enrolling in Any Compounded ED Telehealth Program




Considering MEDVi QUAD in 2026? Read This Before Enrolling in Any Compounded ED Telehealth Program

An informational overview of publicly available disclosures, regulatory context, and verification steps consumers commonly review before starting compounded erectile dysfunction treatment through telehealth.

NEWARK, DE, Feb. 25, 2026 (GLOBE NEWSWIRE) — Disclaimer: This article is for informational purposes only. It is not medical advice. Erectile dysfunction concerns should be evaluated by a qualified healthcare professional. MEDVi QUAD is a compounded prescription medication that requires evaluation by a licensed clinician. Prescription approval is not guaranteed. This content does not diagnose, treat, cure, or prevent any disease. If you purchase through links in this article, a commission may be earned at no additional cost to you. The publisher maintains a separate commercial relationship with the brand. This compensation does not influence the accuracy or integrity of the information presented.

As interest in prescription erectile dysfunction treatment through telehealth platforms continues to expand in 2026, many consumers encounter multi-ingredient compounded options alongside traditional single-ingredient prescriptions. One formulation that comes up frequently in that research process is MEDVi QUAD — a compounded prescription combining four active pharmaceutical ingredients into a single sublingual liquid.

Before enrolling in any compounded ED telehealth program, there are regulatory, clinical, and platform-level details worth understanding clearly. This article covers those details — not as a recommendation, but as the kind of informed overview that helps you ask the right questions and verify the right information before making a decision that involves your health.

This article is independently prepared based on publicly available information and does not represent official statements issued by MEDVi, LLC.

View the current MEDVi QUAD offer (official MEDVi page)

What This Product Is: Regulatory Classification First

This is the most important starting point, and it deserves careful reading regardless of which compounded ED product you may be considering.

MEDVi QUAD is a compounded prescription medication prepared by a licensed pharmacy based on an individual prescription. Compounded medications are not reviewed or approved by the FDA as finished products. They are prepared using active ingredients sourced from FDA-registered facilities under the direction of a prescribing clinician.

The individual active ingredients in the QUAD formulation — sildenafil, tadalafil, and vardenafil — are each FDA-approved as standalone medications for erectile dysfunction. You would recognize them by their brand names: Viagra, Cialis, and Levitra. The fourth ingredient, apomorphine, is FDA-approved for other indications and is commonly prescribed off-label in the context of sexual health, where clinical research has explored its effects on arousal through central nervous system pathways.

Here is the key distinction: while each ingredient carries its own body of FDA-approved research, the specific 4-in-1 compounded combination has not been individually reviewed or approved by the FDA as a finished product. This is how compounding works across the pharmaceutical industry — it is a long-established, regulated practice, but it operates under a different regulatory framework than FDA-approved drugs. Understanding this distinction is essential before evaluating any compounded formulation.

What Compounded Medication Means Under FDA Framework

If you are researching compounded ED treatments for the first time, you probably have questions about what “compounded” actually means in a regulatory context. Here is the straightforward explanation.

Pharmacy compounding is the practice of creating customized medications tailored to individual patient needs. Compounding pharmacies operate under federal and state regulations, and the practice is overseen by state pharmacy boards. Compounded medications are legally prescribed and dispensed in the United States when prepared by licensed pharmacies under the direction of a licensed prescriber.

The regulatory difference from FDA-approved drugs is specific: FDA-approved medications undergo clinical trials evaluating the finished product’s safety and efficacy as a complete formulation. Compounded medications use FDA-approved active ingredients but are not required to undergo separate clinical trials for the specific compounded combination.

This does not mean compounded medications are unregulated or unsafe. It means the regulatory pathway is different, and consumers should be aware of that difference when making informed decisions about their treatment options. For additional context on how the QUAD prescription model and compounded medication protocols work within MEDVi’s telehealth framework, a previously published informational overview examining QUAD’s service disclosures provides further background.

How the Telehealth Structure Works: Platform, Clinician, and Pharmacy

One of the most common points of confusion with telehealth prescription services is understanding who actually does what. With MEDVi QUAD — and with most telehealth prescription platforms — there are three separate entities involved, and knowing the distinction between them matters more than most people realize.

MEDVi (MEDVi, LLC) operates as the telehealth platform. According to the company’s published terms of use, MEDVi itself is not a healthcare provider. The platform provides the technology infrastructure, customer service, and coordination that facilitates the telehealth experience. MEDVi does not diagnose conditions, write prescriptions, or make clinical treatment decisions.

Licensed Medical Providers are independent healthcare professionals who review patient-submitted medical information and independently determine whether a prescription is clinically appropriate. According to the company, these are US-licensed physicians. The platform cannot guarantee that any individual will receive a prescription — that determination rests entirely with the evaluating clinician based on individual medical history, current medications, and contraindications.

Licensed Partner Pharmacies compound and dispense medications based on prescriptions written by the independent medical providers. According to the company’s disclosures, MEDVi is partnered with multiple USA certified pharmacies. The company also states that its team meets regularly with pharmacy partners to discuss product quality, shipping timelines, and medication testing.

This three-entity structure — platform, prescriber, pharmacy — is standard across telehealth prescription services. It exists to maintain appropriate separation between technology facilitation, clinical judgment, and pharmaceutical dispensing.

What the Formulation Contains

According to the official MEDVi QUAD website, the formulation combines four active pharmaceutical ingredients:

Sildenafil — the active ingredient in Viagra, FDA-approved for erectile dysfunction. The company describes this component as providing peak erectile response strength within the formulation.

Tadalafil — the active ingredient in Cialis, FDA-approved for erectile dysfunction. The company describes this component as providing an extended response window.

Vardenafil — the active ingredient in Levitra, FDA-approved for erectile dysfunction. The company describes this component as providing rapid onset characteristics.

Apomorphine — a dopamine agonist FDA-approved for other indications. The company describes this component as addressing the desire and arousal dimension of sexual function through central nervous system pathways. Apomorphine is commonly prescribed off-label in this context.

Important research boundary: Each of these active ingredients has its own published clinical research base as a standalone medication. However, the specific 4-in-1 compounded combination that constitutes QUAD as a finished product has not been clinically studied as a combined formulation. Individual ingredient research does not automatically transfer to the combined product. The evaluating clinician determines whether this combination approach is appropriate based on individual health factors.

Delivery Method Claims

According to the company, QUAD is formulated as a sublingual liquid — meaning you place it under the tongue rather than swallowing a traditional pill. The company states this delivery method bypasses the digestive system and liver (first-pass metabolism), which they describe as allowing the medication to reach the bloodstream faster than traditional oral pills.

MEDVi markets an onset window as fast as 10–15 minutes for some users; individual response may vary based on physiology, dosage, and other individual factors. The company also states that sublingual absorption may be less affected by food intake compared to traditional oral ED medications, which often carry empty-stomach recommendations.

The company references tadalafil’s extended response window of up to 36 hours in certain patients, which is consistent with the known pharmacokinetic profile of tadalafil as an individual ingredient. Whether this timeline applies equivalently within the QUAD compounded formulation has not been separately studied; prescribing clinicians determine appropriateness based on individual patient factors.

These are the company’s stated characteristics of their delivery format. Individual absorption rates, onset times, and duration may vary. The prescribing clinician determines whether this delivery method is appropriate for each patient.

Pricing Disclosures

According to the official MEDVi QUAD website at the time of this publication, here is what the pricing looks like:

QUAD is listed at a starting price of $119 per month. The company also lists a previous or reference price of $199 per month. According to the company, this pricing includes the physician consultation, shipping, and access to 24/7 medical support.

The company also states that multi-month options are available. Pricing, terms, and promotional offers are subject to change. Always verify current pricing directly on the official website before making any enrollment decision.

Insurance and payment context: According to MEDVi’s published terms, the platform operates as a cash-pay service outside insurance networks. The company’s terms state that MEDVi-affiliated medical professional entities are not contracted healthcare providers with any health insurance plans. Many direct-to-consumer prescription products are not covered by traditional insurance plans, but coverage policies vary. Always confirm benefits directly with your insurer. Some HSA/FSA plans may reimburse qualifying expenses; check your specific plan rules.

Refund terms: According to the company’s published terms, medical consult fees are not subject to refund. The company states that prescription products cannot be returned for reuse or resale, and all sales are final. The company also references a conditional refund policy related to their weight loss program; verify whether similar terms apply to QUAD specifically by reviewing current terms on the official website or contacting customer support before enrolling.

Safety and Contraindications Overview

MEDVi QUAD contains prescription-strength active pharmaceutical ingredients. Like all prescription medications, these ingredients have known risks, contraindications, and potential side effects, and appropriateness must be determined by a licensed clinician. The following points are a high-level overview, not a complete list of risks or precautions.

Multiple PDE5 Inhibitors: Sildenafil, tadalafil, and vardenafil are all PDE5 inhibitors. The decision to combine three PDE5 inhibitors in a single formulation is a clinical determination made by the prescribing physician based on individual patient factors. This combination approach requires careful dose calibration and physician oversight.

Cardiovascular Considerations: PDE5 inhibitors affect vascular function and blood pressure. Patients with cardiovascular conditions, those taking blood pressure medications, or those with a history of heart disease should disclose this information fully during intake. PDE5 inhibitors are contraindicated with nitrate medications — this is an absolute contraindication that applies to all PDE5 inhibitors individually and would apply to any combination.

Apomorphine Considerations: Apomorphine may cause nausea, dizziness, or drowsiness in some individuals. These effects are typically dose-dependent and may be more noticeable during initial use.

Common Side Effects: Based on the known profiles of the individual ingredients, potential side effects may include headache, flushing, nasal congestion, dizziness, visual changes, and digestive discomfort. Side effects may vary by individual and are influenced by dosing as determined by the prescribing clinician.

Eligibility: According to the company’s terms, the platform is intended for adults 18 and older. Individuals currently taking nitrate medications, those with certain cardiovascular conditions, and those with contraindications to any of the four active ingredients should not use this formulation. The medical evaluation process is designed to screen for these contraindications — but patients must provide complete and accurate medical history for this screening to be effective.

This overview is not exhaustive and does not replace the Patient Drug Education or official prescribing information. Always review the full safety information that comes with your prescription and consult your prescriber or pharmacist with any questions.

What Consumers Commonly Verify Before Enrolling

For any telehealth platform offering compounded prescription medications, independent verification is a reasonable step before enrolling. Here is what consumers commonly check — and how to do it:

Business Registration: MEDVi, LLC is registered as a limited liability company in Delaware, according to the company’s published disclosures. Registration status can be confirmed through the Delaware Division of Corporations public database.

Physical Business Address: According to the company, MEDVi operates from 131 Continental Dr. Ste 305, Newark, DE 19713. A verifiable physical address is a baseline legitimacy indicator.

Prescriber Licensing: Patients have the right to verify that their prescribing clinician holds an active medical license in the relevant state. State medical board licensing databases are publicly accessible and searchable.

Pharmacy Licensing: According to the company’s disclosures, MEDVi is partnered with multiple USA certified pharmacies. Consumers can request the names of dispensing pharmacies and verify their licensing status through the relevant state pharmacy board databases.

Published Reviews: According to the company’s website, MEDVi references customer ratings on TrustPilot. Consumers can verify the current rating directly on TrustPilot’s independent platform. As with all published reviews, readers should be aware that review platforms reflect self-selected feedback — satisfied customers are typically more likely to post reviews than those with neutral or negative experiences.

Terms and Refund Policies: Before submitting any personal health information or payment, review the company’s published Terms and Conditions, Refund Policy, and Medical Consent documents. These are available on the official website.

Contraindication Disclosure: Verify that the intake process asks about nitrate use, cardiovascular history, current medications, and other relevant contraindications. A thorough medical screening process is a positive indicator of clinical rigor.

View the current MEDVi QUAD offer (official MEDVi page)

How This Category Compares to Other ED Treatment Models

Telehealth ED services generally fall into three models. Knowing the differences helps you evaluate which approach fits your medical needs, preferences, and comfort level:

Single-Ingredient Telehealth Prescriptions: Many telehealth platforms prescribe individual FDA-approved ED medications — sildenafil alone, tadalafil alone, or vardenafil alone. These are typically FDA-approved generics dispensed through traditional pharmacy channels. The regulatory framework is FDA approval of the finished product. The limitation is that each addresses erectile function through a single mechanism.

Multi-Ingredient Compounded Prescriptions: Platforms offering compounded formulations combine multiple active ingredients into a single dose. The regulatory framework is pharmacy compounding under state and federal rules, using FDA-approved active ingredients. The finished combination is not separately FDA-approved. This model requires physician determination that the combination approach is appropriate for the individual patient.

Traditional In-Person Prescribing: Urologists and primary care physicians prescribe ED medications after in-person physical examination, diagnostic testing, and face-to-face consultation. This provides the most comprehensive clinical evaluation and direct physician-patient relationship. The tradeoffs include scheduling requirements, travel, and in-person pharmacy interaction.

Each model involves different tradeoffs around regulatory framework, clinical oversight intensity, convenience, cost, and the nature of the physician-patient interaction. People evaluating compounded ED telehealth services often weigh these factors based on their individual medical situation, personal preferences, and treatment goals. For broader context on how MEDVi’s telehealth platform operates across prescription categories, a separate informational analysis examining MEDVi’s GLP-1 telehealth model provides additional platform-level background.

Evidence Boundaries: What Has and Has Not Been Studied

Being transparent about what the evidence does and does not support is part of making an informed decision. Here is where the research boundaries stand:

What has been studied: Each of the four active ingredients in QUAD — sildenafil, tadalafil, vardenafil, and apomorphine — has its own body of published clinical research. PDE5 inhibitors are among the most extensively studied classes of medications for erectile dysfunction. Apomorphine has been studied for its effects on sexual arousal through dopaminergic pathways.

What has not been studied: The specific 4-in-1 combination of sildenafil + tadalafil + vardenafil + apomorphine as a single compounded formulation has not been evaluated in published clinical trials as a combined product. There are no published studies comparing the QUAD combination against individual PDE5 inhibitors or against other compounded ED formulations.

What this means practically: The prescribing clinician is making a clinical judgment that combining these ingredients at the prescribed dosages is appropriate for the individual patient, based on the ingredient-level research, the patient’s medical profile, and established compounding practices. This is a standard aspect of prescription compounding — but consumers should be aware of the evidence boundaries.

Summary of Key Considerations

For anyone evaluating MEDVi QUAD or any compounded ED telehealth program in 2026, here is a summary of the key factors this article has covered:

Regulatory framework: QUAD is a compounded prescription medication. Compounded medications are legal and regulated but are not FDA-approved as finished products. Understanding this distinction is essential.

Clinical structure: The platform, prescribing clinicians, and dispensing pharmacies are three separate entities. Prescription approval is not guaranteed and depends entirely on the independent clinician’s medical judgment.

Evidence boundaries: Individual ingredients are well-researched. The specific 4-in-1 combination has not been studied as a combined formulation.

Safety profile: Multiple PDE5 inhibitors in a single formulation require careful physician oversight and accurate patient disclosure. Nitrate medications are a known contraindication for all PDE5 inhibitors and should be disclosed during medical screening.

Verification steps: Business registration, prescriber licensing, pharmacy licensing, published terms, and review platform ratings are all independently verifiable before enrolling.

Important Note: The prescription telehealth and compounded medication industries have been under increased regulatory scrutiny in recent years. Patients should review the most current information about any platform’s compliance, regulatory standing, and pharmacy partnerships before proceeding with treatment.

View the current MEDVi QUAD offer (official MEDVi page)

Contact Information

For questions before or during the enrollment process, according to the company’s website, MEDVi offers the following contact options:

Email: hello@medvi.org

Phone: (585) 312-4226

Address: 131 Continental Dr. Ste 305, Newark, DE 19713

Official product page: Available via link referenced above.

This informational overview was prepared by an independent digital publisher specializing in regulatory-focused telehealth content analysis.

Disclaimers

Content and Medical Disclaimer: This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. The descriptions of potential benefits are not guarantees and are not a substitute for an individualized medical evaluation. MEDVi QUAD is a compounded prescription medication that requires evaluation by a licensed clinician. The information provided here does not replace the professional judgment of your healthcare provider.

Professional Medical Disclaimer: This article is educational and does not constitute medical advice. MEDVi QUAD is not a substitute for prescribed medical treatment. If you are currently taking medications, have existing health conditions, or are considering any major changes to your health regimen, consult your physician before starting any new prescription treatment. Do not change, adjust, or discontinue any medications or prescribed treatments without your physician’s guidance and approval.

Compounded Medication Notice: MEDVi QUAD is a compounded prescription medication prepared by a licensed pharmacy based on an individual prescription. Compounded medications are not reviewed or approved by the FDA as finished products. They are prepared using active ingredients sourced from FDA-registered facilities under the direction of a prescribing clinician.

Results May Vary: Individual results will vary based on factors including age, baseline health condition, cardiovascular status, lifestyle factors, consistency of use, current medications, and other individual variables. While some patients report improvements, results are not guaranteed. People who share feedback are self-selected — those with positive experiences are typically more likely to leave reviews than those with neutral or negative outcomes.

FTC Affiliate Disclosure: This article contains affiliate links. If you purchase through these links, a commission may be earned at no additional cost to you. The publisher maintains a separate commercial relationship with the brand. This compensation does not influence the accuracy, neutrality, or integrity of the information presented. All descriptions are based on publicly available information from the company’s official website and general regulatory context.

Pricing Disclaimer: All prices, promotional offers, and program terms mentioned were accurate based on MEDVi’s official website at the time of publication (February 2026) but are subject to change without notice. Always verify current pricing and terms on the official MEDVi website before making any enrollment decision.

Publisher Responsibility: The publisher of this article has made every effort to ensure accuracy at the time of publication based on publicly available information. We do not accept responsibility for errors, omissions, or outcomes resulting from the use of the information provided. Readers are encouraged to verify all details directly with MEDVi and their healthcare provider before making decisions.

Insurance Coverage Note: According to MEDVi’s published terms, the platform operates as a cash-pay service outside insurance networks. Many direct-to-consumer prescription products are not covered by traditional insurance plans, but coverage policies vary. Always confirm benefits directly with your insurer. Some HSA/FSA plans may reimburse qualifying expenses; check your specific plan rules.

View the current MEDVi QUAD offer (official MEDVi page)

CONTACT: Email: hello@medvi.org
Phone: (585) 312-4226

ACTG Announces Publication of STOMP Results in the New England Journal of Medicine




ACTG Announces Publication of STOMP Results in the New England Journal of Medicine

Study findings do not support routine use of tecovirimat in people with mpox

CHAPEL HILL, N.C., Feb. 25, 2026 (GLOBE NEWSWIRE) — ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the publication of “Tecovirimat for the Treatment of Mpox (STOMP)” in the New England Journal of Medicine (NEJM). The publication reports on results from STOMP (Study of Tecovirimat for Mpox, also known as A5418) that demonstrated that tecovirimat did not improve mpox resolution. STOMP stopped enrolling participants in December 2024 after an interim analysis showed that the treatment did not reduce the time to lesion resolution or have an effect on pain among outpatient adults with clade II mpox.

“This publication reminds us of the importance of randomized clinical trials – tecovirimat was widely expected by the scientific community to be an effective treatment for mpox and it was only through STOMP that we were able to conclusively demonstrate that it is not,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “Given that mpox continues to be a global health issue, these findings highlight the urgent need to conduct randomized controlled trials to identify safe and effective therapeutics for mpox and other orthopoxviruses.”

STOMP was a phase 3, randomized, placebo-controlled, double-blind trial evaluating the safety and efficacy of tecovirimat for the treatment of mpox. The U.S. Food and Drug Administration (FDA) has approved tecovirimat (SIGA Technologies, Inc.) to treat smallpox, based on its activity in animal models (since smallpox has been eradicated), but prior to STOMP it was not known if it could effectively or safely treat mpox in humans. ACTG launched STOMP in September 2022 in response to a global outbreak of mpox that was characterized by increased person-to-person transmission. STOMP enrolled participants who had symptoms of mpox for less than 14 days and randomized them to receive either tecovirimat (600 mg) or a placebo twice daily for 14 days. Participants with or at risk for severe disease, pregnant women, and children were enrolled in an open-label arm in which everyone received tecovirimat.

STOMP randomized 412 eligible participants to tecovirimat (275) or placebo (137) at 49 sites in seven countries (United States, Peru, Mexico, Thailand, Argentina, Japan, and Brazil). A total of 344 participants had laboratory-confirmed mpox and 336 had at least one active skin or mucosal lesion and were included in the primary analysis. Those participating in STOMP broadly represented the population of people who were most affected by mpox during the 2022-2023 outbreak; the median age was 34 years, 99 percent were male, 52 percent were White, 13 percent were Black, 44 percent were Hispanic, and 23 percent had received at least one dose of an mpox vaccine. Of 337 participants whose HIV status was known, 35 percent were living with HIV.

By day 29, 79 percent of participants in the tecovirimat group had experienced clinical resolution of their symptoms (defined as the first day all skin lesions were scabbed or healed and visible mucosal lesions were healed), compared to 81 percent in the placebo group. There were no differences in pain reduction among those with severe pain, complete lesion healing, or clearance of viral DNA. Adverse events were similar between arms.

“STOMP was designed by ACTG to rapidly assess the efficacy of tecovirimat for clade II mpox in the face of a growing public health emergency,” said Protocol Chair Timothy Wilkin, M.D., M.P.H., University of California San Diego. “While the results may not be what the community had hoped for, they provide important insights into our understanding of mpox and its treatment and encourage us to continue looking for a safe and effective treatment.”

STOMP was led by Dr. Wilkin and William Fischer, M.D., UNC and Jason Zucker, M.D., Columbia University (Vice Chairs). ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice Chair). It is sponsored by the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID, which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634.

About ACTG
ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve.

Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH.

Media Contact:
Jenna Conley, ACTG
jenna@conleycommunications.net

Premier Health Reports 2026 First Quarter Results




Premier Health Reports 2026 First Quarter Results

MONTRÉAL, Feb. 25, 2026 (GLOBE NEWSWIRE) — Premier Health of America Inc. (TSX-V: PHA) (the “Company”), a leading Canadian Healthtech company, announces it has filed its unaudited Quarterly Consolidated Financial Statements and MD&A for its first quarter ended December 31, 2025.

⁽¹⁾  See the Company’s MD&A for details on these non-GAAP measures.

Summary

• Adjusted EBITDA for the quarter was $5K ($0.7M for the same period last year), mainly driven by a decline in the British Columbia market.
• Net Loss for the quarter was $2.5M (loss of $2.3M for the same period last year).

The travel nurse and northern communities services are generally performing well, except in British Columbia, where the Company experienced a reduction in volume. This decline is attributable to a service acquisition centralization initiative undertaken by the health authorities, which is expected to ultimately favour the most competitive service providers such as SSI. During the quarter, the Company formally discontinued its Per Diem and Transportation operations, as these lines of business were no longer profitable, and has since focused its resources on its Travel Nurse operations across Canada.

“Our cost reduction plan is still progressing, and additional efforts were deployed in the current quarter. The Per Diem and transportation operations were abandoned this quarter, and our focus has fully shifted to Travel Nurses. In the short term, we remain committed to cost reduction, debt management, operational efficiency, and pursuing organic growth opportunities,” said Guy D’Aoust, Interim CEO of Premier Health.

More information can be found in the Company’s Quarterly Consolidated Financial Statements and MD&A as available on SEDAR+ at sedarplus.ca.

About Premier Health

Premier Health is a leading Canadian Healthtech company that provides a comprehensive range of outsourced services solutions for healthcare needs to governments, companies, and individuals. Premier Health uses its proprietary LiPHe^® platform to lead the digital transformation of the healthcare services sector, providing patients with faster, more affordable, and more accessible care.

Non-GAAP Measures

Earnings before interest, taxes, depreciation, and amortization (“EBITDA”), is calculated as the net profit (loss), before non-recurring items excluding acquisition and transaction costs, non-cash expenses (including loss from disposal of assets, impairments, amortization, and depreciation), change in fair values, interest expense, and income tax expense (recovery). Adjusted EBITDA excludes Share-based compensation and unusual items, as determined from time to time. Gross margin is either used as a number or a percentage. As a number, it means Revenues minus Direct Costs. When used as a percentage, it means the ratio of Revenues minus Direct Costs to Revenues. More detail can be found in PHA’s Management Discussion and Analysis.

For Further Information Please Contact:

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:

This press release contains forward-looking information within the meaning of applicable securities legislation which reflects the current plans and expectations of the Company with respect to future events and financial performance. All statements other than statements of historical or current facts may be forward-looking information. Forward-looking information includes statements that are predictive in nature, depend upon or refer to future events or conditions, or include words such as ‘believes’, ‘continues’, ‘expects’, ‘projects’, ‘anticipates’, ‘plans’, ‘estimates’, ‘seeks’, ‘intends’, ‘targets’, ‘forecasts’, or negative or grammatical versions thereof and other similar expressions, or future or conditional verbs such as ‘may’, ‘will’, ‘should’, ‘would’ and ‘could’. Forward-looking information in this press release includes, but is not limited to, statements with respect to the execution of the Company’s growth strategy. Forward-looking information is based on management’s plans, estimates, projections, beliefs and opinions as at the date of this release, and the assumptions related to those plans, estimates, projections, beliefs and opinions may change; therefore, they are presented for the purpose of assisting the Company’s security holders in understanding management’s views at such time regarding those future outcomes and may not be appropriate for other purposes. Although the forward-looking information contained in this release is based on assumptions which the Company believes are reasonable, there can be no assurance that actual results will be consistent with such forward-looking information. The forward-looking information in this release relate only to events or information as of the date on which the statements are made and, except as specifically required by applicable securities laws, the Company undertakes no obligation to update or revise publicly any forward-looking information, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. There can be no assurance that the forward-looking information will prove to be accurate. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, or achievements to be materially different from those implied by such statements. The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances unless required by law. These factors and others are more fully discussed in the filings of the Company with Canadian securities regulatory authorities available on SEDAR+ at www.sedarplus.ca

LENSAR® Provides Update on Pending Acquisition by Alcon




LENSAR® Provides Update on Pending Acquisition by Alcon

ORLANDO, Fla., Feb. 25, 2026 (GLOBE NEWSWIRE) — LENSAR, Inc. (Nasdaq: LNSR) (“LENSAR” or the “Company”), a global medical technology company focused on advanced robotic laser solutions for the treatment of cataracts, today provided an update on the status of its pending acquisition by Alcon Research, LLC (“Alcon”).

The Company and Alcon continue to cooperate with the U.S. Federal Trade Commission (the “FTC”) staff in connection with its Request for Additional Information and Documentary Material (the “Second Request”) and related review of the proposed acquisition of the Company by Alcon (the “Alcon Transaction”). In light of this continued review process, the Company currently expects to close the transaction in the first half of 2026, subject to satisfaction of the applicable closing conditions, including receipt of regulatory approval from the FTC.

About LENSAR

LENSAR is a commercial-stage medical device company focused on designing, developing, and marketing advanced systems for the treatment of cataracts and the management of astigmatism as an integral aspect of the procedure. LENSAR has developed its ALLY Robotic Cataract Laser System™ as a compact, highly ergonomic system utilizing an extremely fast dual-modality laser and integrating AI into proprietary imaging and software. ALLY is designed to transform premium cataract surgery by utilizing LENSAR’s advanced robotic technologies with the ability to perform the entire procedure in a sterile operating room or in-office surgical suite, delivering operational efficiencies and reduced overhead. ALLY includes LENSAR’s proprietary Streamline^® software technology, designed to guide surgeons to achieve better outcomes.

Forward-looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Alcon Transaction, regulatory review of the Alcon Transaction and the expected timing of the closing of the Alcon Transaction. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “target,” “will,” “would,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: (i) the Alcon Transaction may not be completed in a timely manner or at all, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the Company; (ii) the possibility that any or all of the various conditions to the consummation of the Alcon Transaction may not be satisfied or waived; (iii) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement related to the Alcon Transaction, including in circumstances which would require the Company to pay a termination fee or other expenses; (iv) the effect of the announcement or pendency of the merger on the Company’s ability to retain and hire key personnel, (v) the incurrence of transaction costs or adverse effects on its operating results and business generally; (vi) adverse consequences of legal proceedings instituted against the Company following the announcement of the Alcon Transaction; and (vii) the Company’s stock price may decline significantly if the Alcon Transaction is not consummated. In addition, a number of other important factors could cause the Company’s actual future results and other future circumstances to differ materially from those expressed in any forward-looking statements, including but not limited to the other important factors that are disclosed under the heading “Risk Factors” contained in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025 filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in its other filings with the SEC, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, to be filed with the SEC, each accessible on the SEC’s website at www.sec.gov and the Investor Relations section of the Company’s website at https://ir.lensar.com.

All forward-looking statements are expressly qualified in their entirety by such factors. Except as required by law, the Company undertakes no obligation to publicly update or review any forward-looking statement, whether because of new information, future developments or otherwise. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Revolution Medicines Reports Fourth Quarter and Full Year 2025 Financial Results and Update on Corporate Progress




Revolution Medicines Reports Fourth Quarter and Full Year 2025 Financial Results and Update on Corporate Progress

• On track for readout of RASolute 302, a Phase 3 trial of daraxonrasib in second line metastatic PDAC, in first half of 2026
• Continues to advance broad late-stage pipeline, with five ongoing Phase 3 trials and three additional Phase 3 trials planned to initiate in 2026
• Expects to substantially complete enrollment in RASolve 301, a Phase 3 trial of daraxonrasib in previously treated NSCLC, this year
• Initiated RASolute 305, the first Phase 3 trial for zoldonrasib, in first line metastatic PDAC harboring a RAS G12D mutation
• Revolution Medicines to hold webcast today at 4:30 p.m. Eastern Time

REDWOOD CITY, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced its financial results for the quarter and full year ended December 31, 2025, and provided an update on corporate progress.

“We made substantial clinical progress over the past year continuing to advance our broad portfolio of RAS(ON) inhibitors across multiple tumor types and disease settings,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “Our focus remains on executing high-quality clinical programs and leveraging our innovation platform to discover and develop potentially groundbreaking approaches aimed at improving outcomes for patients with RAS-addicted cancers. We expect a pivotal readout from RASolute 302 in the first half of 2026, which represents an important milestone for daraxonrasib, for patients with pancreatic cancer, and for our RAS(ON)-targeting strategy overall.”

Recent Clinical Highlights

Pancreatic Ductal Adenocarcinoma (PDAC)

Daraxonrasib in PDAC

Daraxonrasib, a pioneering RAS(ON) multi-selective inhibitor, has shown an unprecedented clinical profile as monotherapy and in various combinations, including a RAS(ON) inhibitor doublet. The company is currently evaluating daraxonrasib in three randomized Phase 3 studies in PDAC:

• RASolute 302: Global enrollment is complete in the randomized registrational trial evaluating daraxonrasib monotherapy in patients with second line (2L) metastatic disease. A readout is expected in the first half of 2026.
• RASolute 303: Initiation is underway for the registrational trial evaluating daraxonrasib both as monotherapy and in combination with chemotherapy in patients with first line (1L) metastatic disease.
• RASolute 304: Enrollment is ongoing in the registrational trial evaluating daraxonrasib monotherapy in the adjuvant setting in patients with resectable disease following surgery and conventional perioperative chemotherapy.

Zoldonrasib in PDAC

Zoldonrasib, an innovative RAS(ON) G12D-selective covalent inhibitor, has shown a highly differentiated safety and tolerability profile as monotherapy and is also being evaluated in a range of combinations.

In January, the company disclosed encouraging initial data from the combination of zoldonrasib plus FOLFIRINOX in patients with 1L metastatic PDAC. Nineteen patients were available for evaluation as of the December 1 data cutoff date. The initial safety and tolerability profile of the combination was largely consistent with the well-known profile of modified FOLFIRINOX alone, with high zoldonrasib dose intensity maintained. With a median follow-up of 3.9 months (2.7 – 8.0 months), 63% of patients achieved a partial response, either confirmed or pending confirmation. The disease control rate was 95% and most patients remained on treatment as of the data cutoff date. The company plans to share initial clinical data evaluating the combinations of zoldonrasib plus gemcitabine nab-paclitaxel and the RAS(ON) inhibitor doublet of zoldonrasib plus daraxonrasib at one or more medical meetings this year.

The company is advancing two 1L Phase 3 combination studies incorporating zoldonrasib this year:

• RASolute 305: The randomized, double-blind, placebo-controlled registrational trial, evaluating zoldonrasib in combination with investigator’s choice of either gemcitabine nab-paclitaxel or modified FOLFIRINOX compared to investigator’s choice of the chemotherapies with placebo, has been initiated.
• RASolute 309: The company plans to initiate, in the second half of 2026, a registrational trial evaluating the RAS(ON) inhibitor doublet combination of zoldonrasib plus daraxonrasib.

Non-Small Cell Lung Cancer (NSCLC)

Daraxonrasib in NSCLC

RASolve 301, a global, randomized Phase 3 trial evaluating daraxonrasib monotherapy in patients with previously treated NSCLC, continues enrolling patients in the U.S. and globally; the company anticipates substantially completing enrollment this year.

The company also expects to disclose its plans for advancing daraxonrasib combination therapy in 1L NSCLC this year.

Zoldonrasib in NSCLC

The company has reported highly encouraging safety/tolerability and antitumor activity with zoldonrasib in patients with previously treated NSCLC harboring a RAS G12D mutation. A zoldonrasib monotherapy expansion cohort of 2L and beyond patients has fully enrolled, and earlier this year zoldonrasib was awarded FDA Breakthrough Therapy designation in this setting, making it the company’s third RAS(ON) inhibitor to have received this distinction.

The company is preparing to initiate, in the first half of 2026, RASolve 308, a randomized, placebo-controlled Phase 3 trial of zoldonrasib in combination with standard of care as a 1L treatment for patients with metastatic RAS G12D NSCLC.

Elironrasib in NSCLC

For elironrasib, the company has reported a differentiated clinical profile in both RAS G12C inhibitor-naïve and G12C inhibitor-experienced NSCLC patients. Elironrasib has demonstrated encouraging results as monotherapy and in combination with either pembrolizumab or as part of a RAS(ON) inhibitor doublet with daraxonrasib.

The company plans to share an update on its registrational vision for elironrasib in 2026.

Colorectal Cancer (CRC)

Given the genetically complex and heterogeneous nature of colorectal cancer, the company believes combinatorial approaches are key to maximizing clinical impact. The company has a range of combination trials underway, including evaluating RAS(ON) inhibitor doublets and combinations with current standards of care and other novel investigational approaches.

The company plans to share updated combination data in CRC this year as it looks toward potential pivotal trial opportunities.

Clinical Collaborations

The company’s development efforts include several clinical collaborations studying its RAS(ON) inhibitors with other targeted therapies:

• Under a collaboration with Summit Therapeutics, Inc., the APEX-103 trial is evaluating Revolution Medicines’ RAS(ON) inhibitors with ivonescimab, Summit’s PD-1/VEGF bispecific antibody, across multiple solid tumor settings. The first patient was recently dosed in this clinical trial.
• A collaborative trial with Tango Therapeutics, Inc. is evaluating Revolution Medicines’ RAS(ON) inhibitors in combination with vopimetostat, Tango’s MTA-cooperative PRMT5 inhibitor, in patients with tumors carrying both a RAS mutation and MTAP deletion.
• The company also recently entered into a clinical collaboration with Bristol Myers Squibb to evaluate daraxonrasib in combination with navlimetostat, Bristol Myers Squibb’s MTA-cooperative PRMT5 inhibitor, in patients with pancreatic cancer whose tumors carry both a RAS mutation and MTAP deletion. This collaboration extends Revolution Medicines’ commitment to evaluating novel targeted agents, such as PRMT5 inhibitors, that may be appropriate to combine with RAS(ON) inhibitors in some settings.

Early-Stage Programs

RMC-5127

The company recently advanced its fourth RAS(ON) inhibitor, the RAS(ON) G12V-selective inhibitor RMC-5127, into the clinic and announced that the first patient was dosed in a first-in-human trial.

The company expects to identify a recommended monotherapy Phase 2 dose for this compound in the second half of 2026.

Innovative New Class of RAS(ON) Inhibitors

The company continues to discover novel approaches that have the potential to further transform treatment paradigms for patients living with RAS-addicted cancers.

In January, the company introduced an innovative new class of RAS(ON) inhibitors designed to overcome RAS-driven acquired drug resistance and extend the clinical benefit of its RAS(ON) portfolio. A compound from this class of RAS(ON) inhibitors, RM-055, was shown to drive deep and durable tumor regressions in preclinical PDAC and NSCLC models that had developed resistance to a RAS multi-selective inhibitor.

The company plans to share more information about this new class of compounds at an upcoming scientific meeting, and plans to initiate a Phase 1 trial with the first compound from this class of RAS(ON) inhibitors in the fourth quarter of this year.

Financial Highlights

Fourth Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $2.0 billion as of December 31, 2025. This balance includes the receipt of the first royalty monetization tranche of $250 million in June 2025 from the company’s partnership with Royalty Pharma, and there remains an additional $1.75 billion in future committed capital under this arrangement.

R&D Expenses: Research and development expenses were $294.9 million for the quarter ended December 31, 2025, compared to $188.1 million for the quarter ended December 31, 2024. The increase was primarily due to an increase in clinical trial and manufacturing expenses for daraxonrasib, zoldonrasib, and elironrasib, and an increase in personnel-related expenses and stock-based compensation expense related to additional headcount.

G&A Expenses: General and administrative expenses were $66.7 million for the quarter ended December 31, 2025, compared to $28.2 million for the quarter ended December 31, 2024. The increase in G&A expenses was primarily due to increases in commercial preparation activities, and personnel-related expenses and stock-based compensation related to additional headcount.

Net Loss: Net loss was $364.9 million for the quarter ended December 31, 2025, compared to net loss of $194.6 million for the quarter ended December 31, 2024.

Full Year 2025 Financial Highlights

R&D Expenses: Research and development expenses were $987.3 million for the year ended December 31, 2025, compared to $592.2 million for the year ended December 31, 2024. The increase was primarily due to an increase in clinical trial and manufacturing expenses for daraxonrasib, zoldonrasib, and elironrasib, and an increase in personnel-related expenses and stock-based compensation related to additional headcount.

G&A Expenses: General and administrative expenses were $195.0 million for the year ended December 31, 2025 compared to $97.3 million for the year ended December 31, 2024. The increase in G&A expenses was primarily due to increases in commercial preparation activities, and personnel-related expenses and stock-based compensation related to additional headcount.

Net Loss: Net loss was $1.1 billion for the year ended December 31, 2025, compared to net loss of $600.1 million for the year ended December 31, 2024.

2026 Financial Guidance

Revolution Medicines expects full year 2026 GAAP operating expenses to be between $1.6 and $1.7 billion, which includes estimated non-cash stock-based compensation expense of between $180 and $200 million.

Webcast
Revolution Medicines will host a webcast this afternoon, February 25, 2026, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: https://ir.revmed.com/events-and-presentations. Following the live webcast, a replay will be available on the company’s website for at least 14 days.

About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the company’s financial projections and guidance; the company’s development opportunities, plans and timelines and its ability to build or advance its portfolio and R&D pipeline; progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied; the company’s expectations regarding timing of clinical trial strategies, initiation, enrollment and data readouts or disclosures and clinical trial designs; the company’s ability discover and develop approaches that improve outcomes for patients with RAS-addicted cancers; collaborations, including the aims and expected benefits of the company’s collaborations with Summit, Tango, and Bristol Myers Squibb; plans for developing any of the company’s product candidates as part of a combination treatment; sources of capital, including the availability of capital under the Royalty Pharma arrangement and whether the company achieves the milestones associated with certain payments thereunder.

Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” “believe,” “estimate,” “expect,” “plan,” “potential,” “project,” “up to,” “will” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 25, 2026, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.

Revolution Medicines Media & Investor Contact:
media@revmed.com
investors@revmed.com

(1) Working capital is defined as current assets less current liabilities.

Revolution Medicines Reports Fourth Quarter and Full Year 2025 Financial Results and Update on Corporate Progress




Revolution Medicines Reports Fourth Quarter and Full Year 2025 Financial Results and Update on Corporate Progress

• On track for readout of RASolute 302, a Phase 3 trial of daraxonrasib in second line metastatic PDAC, in first half of 2026
• Continues to advance broad late-stage pipeline, with five ongoing Phase 3 trials and three additional Phase 3 trials planned to initiate in 2026
• Expects to substantially complete enrollment in RASolve 301, a Phase 3 trial of daraxonrasib in previously treated NSCLC, this year
• Initiated RASolute 305, the first Phase 3 trial for zoldonrasib, in first line metastatic PDAC harboring a RAS G12D mutation
• Revolution Medicines to hold webcast today at 4:30 p.m. Eastern Time

REDWOOD CITY, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced its financial results for the quarter and full year ended December 31, 2025, and provided an update on corporate progress.

“We made substantial clinical progress over the past year continuing to advance our broad portfolio of RAS(ON) inhibitors across multiple tumor types and disease settings,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “Our focus remains on executing high-quality clinical programs and leveraging our innovation platform to discover and develop potentially groundbreaking approaches aimed at improving outcomes for patients with RAS-addicted cancers. We expect a pivotal readout from RASolute 302 in the first half of 2026, which represents an important milestone for daraxonrasib, for patients with pancreatic cancer, and for our RAS(ON)-targeting strategy overall.”

Recent Clinical Highlights

Pancreatic Ductal Adenocarcinoma (PDAC)

Daraxonrasib in PDAC

Daraxonrasib, a pioneering RAS(ON) multi-selective inhibitor, has shown an unprecedented clinical profile as monotherapy and in various combinations, including a RAS(ON) inhibitor doublet. The company is currently evaluating daraxonrasib in three randomized Phase 3 studies in PDAC:

• RASolute 302: Global enrollment is complete in the randomized registrational trial evaluating daraxonrasib monotherapy in patients with second line (2L) metastatic disease. A readout is expected in the first half of 2026.
• RASolute 303: Initiation is underway for the registrational trial evaluating daraxonrasib both as monotherapy and in combination with chemotherapy in patients with first line (1L) metastatic disease.
• RASolute 304: Enrollment is ongoing in the registrational trial evaluating daraxonrasib monotherapy in the adjuvant setting in patients with resectable disease following surgery and conventional perioperative chemotherapy.

Zoldonrasib in PDAC

Zoldonrasib, an innovative RAS(ON) G12D-selective covalent inhibitor, has shown a highly differentiated safety and tolerability profile as monotherapy and is also being evaluated in a range of combinations.

In January, the company disclosed encouraging initial data from the combination of zoldonrasib plus FOLFIRINOX in patients with 1L metastatic PDAC. Nineteen patients were available for evaluation as of the December 1 data cutoff date. The initial safety and tolerability profile of the combination was largely consistent with the well-known profile of modified FOLFIRINOX alone, with high zoldonrasib dose intensity maintained. With a median follow-up of 3.9 months (2.7 – 8.0 months), 63% of patients achieved a partial response, either confirmed or pending confirmation. The disease control rate was 95% and most patients remained on treatment as of the data cutoff date. The company plans to share initial clinical data evaluating the combinations of zoldonrasib plus gemcitabine nab-paclitaxel and the RAS(ON) inhibitor doublet of zoldonrasib plus daraxonrasib at one or more medical meetings this year.

The company is advancing two 1L Phase 3 combination studies incorporating zoldonrasib this year:

• RASolute 305: The randomized, double-blind, placebo-controlled registrational trial, evaluating zoldonrasib in combination with investigator’s choice of either gemcitabine nab-paclitaxel or modified FOLFIRINOX compared to investigator’s choice of the chemotherapies with placebo, has been initiated.
• RASolute 309: The company plans to initiate, in the second half of 2026, a registrational trial evaluating the RAS(ON) inhibitor doublet combination of zoldonrasib plus daraxonrasib.

Non-Small Cell Lung Cancer (NSCLC)

Daraxonrasib in NSCLC

RASolve 301, a global, randomized Phase 3 trial evaluating daraxonrasib monotherapy in patients with previously treated NSCLC, continues enrolling patients in the U.S. and globally; the company anticipates substantially completing enrollment this year.

The company also expects to disclose its plans for advancing daraxonrasib combination therapy in 1L NSCLC this year.

Zoldonrasib in NSCLC

The company has reported highly encouraging safety/tolerability and antitumor activity with zoldonrasib in patients with previously treated NSCLC harboring a RAS G12D mutation. A zoldonrasib monotherapy expansion cohort of 2L and beyond patients has fully enrolled, and earlier this year zoldonrasib was awarded FDA Breakthrough Therapy designation in this setting, making it the company’s third RAS(ON) inhibitor to have received this distinction.

The company is preparing to initiate, in the first half of 2026, RASolve 308, a randomized, placebo-controlled Phase 3 trial of zoldonrasib in combination with standard of care as a 1L treatment for patients with metastatic RAS G12D NSCLC.

Elironrasib in NSCLC

For elironrasib, the company has reported a differentiated clinical profile in both RAS G12C inhibitor-naïve and G12C inhibitor-experienced NSCLC patients. Elironrasib has demonstrated encouraging results as monotherapy and in combination with either pembrolizumab or as part of a RAS(ON) inhibitor doublet with daraxonrasib.

The company plans to share an update on its registrational vision for elironrasib in 2026.

Colorectal Cancer (CRC)

Given the genetically complex and heterogeneous nature of colorectal cancer, the company believes combinatorial approaches are key to maximizing clinical impact. The company has a range of combination trials underway, including evaluating RAS(ON) inhibitor doublets and combinations with current standards of care and other novel investigational approaches.

The company plans to share updated combination data in CRC this year as it looks toward potential pivotal trial opportunities.

Clinical Collaborations

The company’s development efforts include several clinical collaborations studying its RAS(ON) inhibitors with other targeted therapies:

• Under a collaboration with Summit Therapeutics, Inc., the APEX-103 trial is evaluating Revolution Medicines’ RAS(ON) inhibitors with ivonescimab, Summit’s PD-1/VEGF bispecific antibody, across multiple solid tumor settings. The first patient was recently dosed in this clinical trial.
• A collaborative trial with Tango Therapeutics, Inc. is evaluating Revolution Medicines’ RAS(ON) inhibitors in combination with vopimetostat, Tango’s MTA-cooperative PRMT5 inhibitor, in patients with tumors carrying both a RAS mutation and MTAP deletion.
• The company also recently entered into a clinical collaboration with Bristol Myers Squibb to evaluate daraxonrasib in combination with navlimetostat, Bristol Myers Squibb’s MTA-cooperative PRMT5 inhibitor, in patients with pancreatic cancer whose tumors carry both a RAS mutation and MTAP deletion. This collaboration extends Revolution Medicines’ commitment to evaluating novel targeted agents, such as PRMT5 inhibitors, that may be appropriate to combine with RAS(ON) inhibitors in some settings.

Early-Stage Programs

RMC-5127

The company recently advanced its fourth RAS(ON) inhibitor, the RAS(ON) G12V-selective inhibitor RMC-5127, into the clinic and announced that the first patient was dosed in a first-in-human trial.

The company expects to identify a recommended monotherapy Phase 2 dose for this compound in the second half of 2026.

Innovative New Class of RAS(ON) Inhibitors

The company continues to discover novel approaches that have the potential to further transform treatment paradigms for patients living with RAS-addicted cancers.

In January, the company introduced an innovative new class of RAS(ON) inhibitors designed to overcome RAS-driven acquired drug resistance and extend the clinical benefit of its RAS(ON) portfolio. A compound from this class of RAS(ON) inhibitors, RM-055, was shown to drive deep and durable tumor regressions in preclinical PDAC and NSCLC models that had developed resistance to a RAS multi-selective inhibitor.

The company plans to share more information about this new class of compounds at an upcoming scientific meeting, and plans to initiate a Phase 1 trial with the first compound from this class of RAS(ON) inhibitors in the fourth quarter of this year.

Financial Highlights

Fourth Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $2.0 billion as of December 31, 2025. This balance includes the receipt of the first royalty monetization tranche of $250 million in June 2025 from the company’s partnership with Royalty Pharma, and there remains an additional $1.75 billion in future committed capital under this arrangement.

R&D Expenses: Research and development expenses were $294.9 million for the quarter ended December 31, 2025, compared to $188.1 million for the quarter ended December 31, 2024. The increase was primarily due to an increase in clinical trial and manufacturing expenses for daraxonrasib, zoldonrasib, and elironrasib, and an increase in personnel-related expenses and stock-based compensation expense related to additional headcount.

G&A Expenses: General and administrative expenses were $66.7 million for the quarter ended December 31, 2025, compared to $28.2 million for the quarter ended December 31, 2024. The increase in G&A expenses was primarily due to increases in commercial preparation activities, and personnel-related expenses and stock-based compensation related to additional headcount.

Net Loss: Net loss was $364.9 million for the quarter ended December 31, 2025, compared to net loss of $194.6 million for the quarter ended December 31, 2024.

Full Year 2025 Financial Highlights

R&D Expenses: Research and development expenses were $987.3 million for the year ended December 31, 2025, compared to $592.2 million for the year ended December 31, 2024. The increase was primarily due to an increase in clinical trial and manufacturing expenses for daraxonrasib, zoldonrasib, and elironrasib, and an increase in personnel-related expenses and stock-based compensation related to additional headcount.

G&A Expenses: General and administrative expenses were $195.0 million for the year ended December 31, 2025 compared to $97.3 million for the year ended December 31, 2024. The increase in G&A expenses was primarily due to increases in commercial preparation activities, and personnel-related expenses and stock-based compensation related to additional headcount.

Net Loss: Net loss was $1.1 billion for the year ended December 31, 2025, compared to net loss of $600.1 million for the year ended December 31, 2024.

2026 Financial Guidance

Revolution Medicines expects full year 2026 GAAP operating expenses to be between $1.6 and $1.7 billion, which includes estimated non-cash stock-based compensation expense of between $180 and $200 million.

Webcast
Revolution Medicines will host a webcast this afternoon, February 25, 2026, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: https://ir.revmed.com/events-and-presentations. Following the live webcast, a replay will be available on the company’s website for at least 14 days.

About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the company’s financial projections and guidance; the company’s development opportunities, plans and timelines and its ability to build or advance its portfolio and R&D pipeline; progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied; the company’s expectations regarding timing of clinical trial strategies, initiation, enrollment and data readouts or disclosures and clinical trial designs; the company’s ability discover and develop approaches that improve outcomes for patients with RAS-addicted cancers; collaborations, including the aims and expected benefits of the company’s collaborations with Summit, Tango, and Bristol Myers Squibb; plans for developing any of the company’s product candidates as part of a combination treatment; sources of capital, including the availability of capital under the Royalty Pharma arrangement and whether the company achieves the milestones associated with certain payments thereunder.

Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” “believe,” “estimate,” “expect,” “plan,” “potential,” “project,” “up to,” “will” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 25, 2026, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.

Revolution Medicines Media & Investor Contact:
media@revmed.com
investors@revmed.com

(1) Working capital is defined as current assets less current liabilities.

PROCEPT BioRobotics Reports Fourth Quarter 2025 Financial Results and Updates 2026 Revenue Guidance




PROCEPT BioRobotics Reports Fourth Quarter 2025 Financial Results and Updates 2026 Revenue Guidance

SAN JOSE, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) — PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today reported unaudited financial results for the quarter ended December 31, 2025.

“In the fourth quarter, we delivered our highest procedure volume to date—approximately 12,200—and sold 65 new systems, marking our strongest capital quarter,” said Larry Wood, Chief Executive Officer. “At the same time, we took meaningful steps to position the Company for its next phase of growth. To sharpen our focus on delivering durable procedure growth, we realigned our commercial organization, established a dedicated launch team to reduce activation variability, and implemented a more disciplined handpiece pricing strategy. Furthermore, we successfully reduced field inventory levels and eliminated end-of-quarter purchasing incentives, which led to a fourth quarter revenue shortfall but improved handpiece average selling price by approximately 5%.”

Fourth Quarter 2025 Financial Results

• Total revenue of $76.4 million for the fourth quarter of 2025, an increase of 12% compared to the prior year period in 2024
• U.S. procedures of approximately 12,200 for the fourth quarter of 2025, an increase of approximately 69% compared to the prior year period
• U.S. handpieces sold of approximately 9,400 for the fourth quarter of 2025, an increase of approximately 7% compared to the prior year period
• Fourth quarter of 2025 handpiece average selling price increased 5% sequentially to $3,340
• 2025 ending U.S. install base of 718 systems, representing a 42% increase compared to the prior year period
• International revenue of $9.8 million for the fourth quarter of 2025, an increase of 25% compared to the prior year period in 2024

Total revenue for the fourth quarter of 2025 was $76.4 million, an increase of 12% compared to the prior year period. U.S. revenue was $66.6 million, representing growth of 10% compared to the prior year period. The increase was primarily driven by increased handpiece revenue. U.S. handpiece and consumable revenue for the fourth quarter of 2025 was $34.0 million, an increase of 16% compared to the prior year period. U.S. system revenue for the fourth quarter of 2025 was $27.6 million, which was flat compared to the prior year period. As of December 31, 2025, the install base of robotic systems in the U.S. was 718 systems, an increase of 42% compared to the prior year period. International revenue was $9.8 million for the quarter, an increase of 25% compared to the prior year period.

Gross margin for the fourth quarter 2025 was 61% compared to 64% in the prior year period. Gross margin decline in the fourth quarter was primarily driven by lower-than-expected U.S. consumable revenue, as well as a one-time cost associated with a voluntary field action.

Operating expenses in the fourth quarter of 2025 were $77.4 million, compared with $63.4 million in the prior year period. The increase in operating expenses reflects continued investment to support commercial expansion, innovation across our BPH platform technology and increased funding for our Water IV Prostate Cancer trial.

Net loss was $29.8 million for the fourth quarter of 2025, compared to a loss of $18.9 million in the prior year period. Adjusted EBITDA* was a loss of $19.0 million for the fourth quarter of 2025, compared to a loss of $10.3 million in the prior year period.

Cash, cash equivalents and restricted cash balances as of December 31, 2025, totaled $289.5 million.

Full Year 2025 Financial Results
Revenue for the full year 2025 was $308.1 million, an increase of 37% compared to the prior year period. The growth was primarily driven by increases in U.S. revenue attributable to system placements and increased handpieces sold.

Gross margin for full year 2025 was 64%, compared to 61% for the full year 2024. Gross margin improvement was primarily due to improved overhead absorption and favorable revenue mix of U.S. handpieces sold.

Operating expenses were $300.1 million for the full year 2025, compared to $233.7 million for the full year 2024, an increase of 28%. The increase was driven by increased sales and marketing expenses primarily to expand the commercial organization, and increased research and development and general and administrative expenses.

Net loss was $95.6 million for the full year 2025, compared to $91.4 million for the full year 2024. Adjusted EBITDA was a loss of $50.2 million for full year 2024, compared to a loss of $61.1 million for the full year 2024.

Full Year 2026 Financial Guidance
“Historically, handpiece unit sales exceeded procedure volumes by approximately 8% to 16%. Going forward, we expect handpiece unit sales and procedure volumes to be closely aligned,” said Larry Wood. “While annual U.S. procedure growth will be in the range of 39% to 48%, our decision to forecast procedure and handpiece volumes in close alignment has reduced our projected 2026 handpiece revenue guidance; however, this impact is meaningfully offset by higher handpiece prices of $3,500 per unit. Considering these factors, together with the short-term disruption associated with the sales force realignment, we are resetting our 2026 guidance to $390 to $410 million, representing annual growth of 27% to 33%. We believe these actions are essential to our long-term goals of sustained high growth and establishing a favorable financial profile.”

• The Company expects revenue for the full year 2026 to be in the range of $390 million to $410 million, which represents growth of 27% to 33% compared to the prior year period
• The Company expects full year 2026 U.S. procedure growth to be in the range of 39% to 48% compared to the prior year period
• The Company expects full year 2026 gross margin to be approximately 65%
• The Company expects full year 2026 operating expenses to be approximately $350 million
• The Company expects full year 2026 adjusted EBITDA* loss to be in the range of $30 million to $17 million

First Quarter 2026 Financial Guidance

• The Company expects total procedures for the first quarter of 2026 to be in the range of 12,000 to 12,800, which represents growth of 31% to 36% compared to the prior year period.
• Total revenue for the first quarter of 2026 is expected to be in the range of $79 million to $82 million dollars, which represents growth of 14% to 19% to the prior year period.

*Adjusted EBITDA is a financial measure that is not prepared in accordance with generally accepted accounting principles in the United States (GAAP). For more information about the Company’s use of non-GAAP financial measures, please see the section below titled “Use of Non-GAAP Financial Measures (Unaudited).

Webcast and Conference Call Information
PROCEPT BioRobotics will host a conference call to discuss the fourth quarter 2025 financial results on Wednesday, February 25, 2026, at 4:30 p.m. Eastern Time.

Investors interested in listening to the conference call may do so by following one of the links below:

• Webcast link for interested listeners:
  • https://edge.media-server.com/mmc/p/mej8z6sd/
• Dial-in registration for sell-side research analysts:
  • https://register-conf.media-server.com/register/BIf439042f85a64a1f98d8f534e4d10fcb

Investor Day in New York and Webcast
The Company will also host an in-person investor day event on Thursday, February 26, 2026, at the NASDAQ Headquarters in New York City beginning at 8:00am Eastern Time. A live, as well as an archived recording, will be available on the “Investors” section of the Company’s website at https://ir.procept-biorobotics.com.

About PROCEPT BioRobotics Corporation
PROCEPT BioRobotics’ mission is to revolutionize BPH treatment globally in partnership with urologists by delivering best-in-class robotic solutions that positively impact patients and drive value. PROCEPT BioRobotics manufactures the AQUABEAM® and HYDROS® Robotic Systems. The HYDROS Robotic System is the only AI-Powered, robotic technology that delivers Aquablation® therapy. PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe, and durable outcomes for males suffering from lower urinary tract symptoms or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. The Company has developed a significant and growing body of clinical evidence with over 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy.

Use of Non-GAAP Financial Measures (Unaudited)
This press release references Adjusted EBITDA, a financial measure that is not prepared in accordance with generally accepted accounting principles in the United States (GAAP). The Company defines Adjusted EBITDA as earnings before interest expense, taxes, depreciation and amortization and stock-based compensation. Non-GAAP financial measures are not a substitute for or superior to measures of financial performance prepared in accordance with GAAP and should not be considered as an alternative to any other performance measures derived in accordance with GAAP.

The Company believes that presenting Adjusted EBITDA provides useful supplemental information to investors about the Company in understanding and evaluating its operating results, enhancing the overall understanding of its past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by its management in financial and operational decision making. However, there are a number of limitations related to the use of non-GAAP measures and their nearest GAAP equivalents. For example, other companies may calculate non-GAAP measures differently, or may use other measures to calculate their financial performance, and therefore any non-GAAP measures the Company uses may not be directly comparable to similarly titled measures of other companies.

Forward Looking Statements
This release contains forward‐looking statements within the meaning of federal securities laws, including with respect to the Company’s projected financial performance for full year 2026, statements regarding the potential utilities, values, benefits and advantages of Aquablation therapy performed using PROCEPT BioRobotics’ products, including AquaBeam or Hydros Robotic Systems, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on the Company’s current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which the Company is not currently aware.   Forward-looking statements may include statements regarding financial guidance, market opportunity and penetration, procedure growth, the Company’s possible or assumed future results of operations, including descriptions of the Company’s revenues, gross margins, profitability, operating expenses, installed base growth, commercial momentum and overall business strategy. Forward‐looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward‐looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward‐looking statements as a result of these risks and uncertainties. These risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s annual report on Form 10-K filed with the SEC on February 27, 2025, and amended on April 11, 2025, and subsequent quarterly reports on Form 10-Q. PROCEPT BioRobotics does not undertake any obligation to update forward‐looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward‐looking statements contained herein. These forward-looking statements should not be relied upon as representing PROCEPT BioRobotics’ views as of any date subsequent to the date of this press release.

Important Safety Information
All surgical treatments have inherent and associated side effects. For a list of potential side effects visit https://aquablation.com/safety-information/

Investor Contact:
Matt Bacso
VP, Investor Relations and Business Operations
m.bacso@procept-biorobotics.com

PROCEPT BioRobotics Reports Fourth Quarter 2025 Financial Results and Updates 2026 Revenue Guidance




PROCEPT BioRobotics Reports Fourth Quarter 2025 Financial Results and Updates 2026 Revenue Guidance

SAN JOSE, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) — PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today reported unaudited financial results for the quarter ended December 31, 2025.

“In the fourth quarter, we delivered our highest procedure volume to date—approximately 12,200—and sold 65 new systems, marking our strongest capital quarter,” said Larry Wood, Chief Executive Officer. “At the same time, we took meaningful steps to position the Company for its next phase of growth. To sharpen our focus on delivering durable procedure growth, we realigned our commercial organization, established a dedicated launch team to reduce activation variability, and implemented a more disciplined handpiece pricing strategy. Furthermore, we successfully reduced field inventory levels and eliminated end-of-quarter purchasing incentives, which led to a fourth quarter revenue shortfall but improved handpiece average selling price by approximately 5%.”

Fourth Quarter 2025 Financial Results

• Total revenue of $76.4 million for the fourth quarter of 2025, an increase of 12% compared to the prior year period in 2024
• U.S. procedures of approximately 12,200 for the fourth quarter of 2025, an increase of approximately 69% compared to the prior year period
• U.S. handpieces sold of approximately 9,400 for the fourth quarter of 2025, an increase of approximately 7% compared to the prior year period
• Fourth quarter of 2025 handpiece average selling price increased 5% sequentially to $3,340
• 2025 ending U.S. install base of 718 systems, representing a 42% increase compared to the prior year period
• International revenue of $9.8 million for the fourth quarter of 2025, an increase of 25% compared to the prior year period in 2024

Total revenue for the fourth quarter of 2025 was $76.4 million, an increase of 12% compared to the prior year period. U.S. revenue was $66.6 million, representing growth of 10% compared to the prior year period. The increase was primarily driven by increased handpiece revenue. U.S. handpiece and consumable revenue for the fourth quarter of 2025 was $34.0 million, an increase of 16% compared to the prior year period. U.S. system revenue for the fourth quarter of 2025 was $27.6 million, which was flat compared to the prior year period. As of December 31, 2025, the install base of robotic systems in the U.S. was 718 systems, an increase of 42% compared to the prior year period. International revenue was $9.8 million for the quarter, an increase of 25% compared to the prior year period.

Gross margin for the fourth quarter 2025 was 61% compared to 64% in the prior year period. Gross margin decline in the fourth quarter was primarily driven by lower-than-expected U.S. consumable revenue, as well as a one-time cost associated with a voluntary field action.

Operating expenses in the fourth quarter of 2025 were $77.4 million, compared with $63.4 million in the prior year period. The increase in operating expenses reflects continued investment to support commercial expansion, innovation across our BPH platform technology and increased funding for our Water IV Prostate Cancer trial.

Net loss was $29.8 million for the fourth quarter of 2025, compared to a loss of $18.9 million in the prior year period. Adjusted EBITDA* was a loss of $19.0 million for the fourth quarter of 2025, compared to a loss of $10.3 million in the prior year period.

Cash, cash equivalents and restricted cash balances as of December 31, 2025, totaled $289.5 million.

Full Year 2025 Financial Results
Revenue for the full year 2025 was $308.1 million, an increase of 37% compared to the prior year period. The growth was primarily driven by increases in U.S. revenue attributable to system placements and increased handpieces sold.

Gross margin for full year 2025 was 64%, compared to 61% for the full year 2024. Gross margin improvement was primarily due to improved overhead absorption and favorable revenue mix of U.S. handpieces sold.

Operating expenses were $300.1 million for the full year 2025, compared to $233.7 million for the full year 2024, an increase of 28%. The increase was driven by increased sales and marketing expenses primarily to expand the commercial organization, and increased research and development and general and administrative expenses.

Net loss was $95.6 million for the full year 2025, compared to $91.4 million for the full year 2024. Adjusted EBITDA was a loss of $50.2 million for full year 2024, compared to a loss of $61.1 million for the full year 2024.

Full Year 2026 Financial Guidance
“Historically, handpiece unit sales exceeded procedure volumes by approximately 8% to 16%. Going forward, we expect handpiece unit sales and procedure volumes to be closely aligned,” said Larry Wood. “While annual U.S. procedure growth will be in the range of 39% to 48%, our decision to forecast procedure and handpiece volumes in close alignment has reduced our projected 2026 handpiece revenue guidance; however, this impact is meaningfully offset by higher handpiece prices of $3,500 per unit. Considering these factors, together with the short-term disruption associated with the sales force realignment, we are resetting our 2026 guidance to $390 to $410 million, representing annual growth of 27% to 33%. We believe these actions are essential to our long-term goals of sustained high growth and establishing a favorable financial profile.”

• The Company expects revenue for the full year 2026 to be in the range of $390 million to $410 million, which represents growth of 27% to 33% compared to the prior year period
• The Company expects full year 2026 U.S. procedure growth to be in the range of 39% to 48% compared to the prior year period
• The Company expects full year 2026 gross margin to be approximately 65%
• The Company expects full year 2026 operating expenses to be approximately $350 million
• The Company expects full year 2026 adjusted EBITDA* loss to be in the range of $30 million to $17 million

First Quarter 2026 Financial Guidance

• The Company expects total procedures for the first quarter of 2026 to be in the range of 12,000 to 12,800, which represents growth of 31% to 36% compared to the prior year period.
• Total revenue for the first quarter of 2026 is expected to be in the range of $79 million to $82 million dollars, which represents growth of 14% to 19% to the prior year period.

*Adjusted EBITDA is a financial measure that is not prepared in accordance with generally accepted accounting principles in the United States (GAAP). For more information about the Company’s use of non-GAAP financial measures, please see the section below titled “Use of Non-GAAP Financial Measures (Unaudited).

Webcast and Conference Call Information
PROCEPT BioRobotics will host a conference call to discuss the fourth quarter 2025 financial results on Wednesday, February 25, 2026, at 4:30 p.m. Eastern Time.

Investors interested in listening to the conference call may do so by following one of the links below:

• Webcast link for interested listeners:
  • https://edge.media-server.com/mmc/p/mej8z6sd/
• Dial-in registration for sell-side research analysts:
  • https://register-conf.media-server.com/register/BIf439042f85a64a1f98d8f534e4d10fcb

Investor Day in New York and Webcast
The Company will also host an in-person investor day event on Thursday, February 26, 2026, at the NASDAQ Headquarters in New York City beginning at 8:00am Eastern Time. A live, as well as an archived recording, will be available on the “Investors” section of the Company’s website at https://ir.procept-biorobotics.com.

About PROCEPT BioRobotics Corporation
PROCEPT BioRobotics’ mission is to revolutionize BPH treatment globally in partnership with urologists by delivering best-in-class robotic solutions that positively impact patients and drive value. PROCEPT BioRobotics manufactures the AQUABEAM® and HYDROS® Robotic Systems. The HYDROS Robotic System is the only AI-Powered, robotic technology that delivers Aquablation® therapy. PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe, and durable outcomes for males suffering from lower urinary tract symptoms or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. The Company has developed a significant and growing body of clinical evidence with over 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy.

Use of Non-GAAP Financial Measures (Unaudited)
This press release references Adjusted EBITDA, a financial measure that is not prepared in accordance with generally accepted accounting principles in the United States (GAAP). The Company defines Adjusted EBITDA as earnings before interest expense, taxes, depreciation and amortization and stock-based compensation. Non-GAAP financial measures are not a substitute for or superior to measures of financial performance prepared in accordance with GAAP and should not be considered as an alternative to any other performance measures derived in accordance with GAAP.

The Company believes that presenting Adjusted EBITDA provides useful supplemental information to investors about the Company in understanding and evaluating its operating results, enhancing the overall understanding of its past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by its management in financial and operational decision making. However, there are a number of limitations related to the use of non-GAAP measures and their nearest GAAP equivalents. For example, other companies may calculate non-GAAP measures differently, or may use other measures to calculate their financial performance, and therefore any non-GAAP measures the Company uses may not be directly comparable to similarly titled measures of other companies.

Forward Looking Statements
This release contains forward‐looking statements within the meaning of federal securities laws, including with respect to the Company’s projected financial performance for full year 2026, statements regarding the potential utilities, values, benefits and advantages of Aquablation therapy performed using PROCEPT BioRobotics’ products, including AquaBeam or Hydros Robotic Systems, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on the Company’s current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which the Company is not currently aware.   Forward-looking statements may include statements regarding financial guidance, market opportunity and penetration, procedure growth, the Company’s possible or assumed future results of operations, including descriptions of the Company’s revenues, gross margins, profitability, operating expenses, installed base growth, commercial momentum and overall business strategy. Forward‐looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward‐looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward‐looking statements as a result of these risks and uncertainties. These risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s annual report on Form 10-K filed with the SEC on February 27, 2025, and amended on April 11, 2025, and subsequent quarterly reports on Form 10-Q. PROCEPT BioRobotics does not undertake any obligation to update forward‐looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward‐looking statements contained herein. These forward-looking statements should not be relied upon as representing PROCEPT BioRobotics’ views as of any date subsequent to the date of this press release.

Important Safety Information
All surgical treatments have inherent and associated side effects. For a list of potential side effects visit https://aquablation.com/safety-information/

Investor Contact:
Matt Bacso
VP, Investor Relations and Business Operations
m.bacso@procept-biorobotics.com

Celcuity To Participate in Upcoming Investor Conferences




Celcuity To Participate in Upcoming Investor Conferences

MINNEAPOLIS, Feb. 25, 2026 (GLOBE NEWSWIRE) — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences:

• A fireside chat at the TD Cowen 46^th Annual Healthcare Conference at 10:30 a.m. ET on Wednesday, March 4, 2026. A live webcast will be available using this weblink: https://event.summitcast.com/view/9z5g2VrV6e6rbCqQgDRoHA/NYER3h287L9qyxak8BZiq2
• A fireside chat at the Leerink Global Healthcare Conference at 2:20 p.m. ET on Tuesday, March 10, 2026. A live webcast will be available using this weblink: https://event.summitcast.com/view/mT9poctHDNthc6b89WqVjf/VziaefXK3xAkvtByRaxLpT

• Jefferies Biotech on the Beach Summit; Wednesday, March 11, 2026. Management will host one-on-one investor meetings only.

Alternatively, the live webcasts will be accessible from the Investors section of the company’s website at https://ir.celcuity.com/events-presentations/ with a replay available shortly after the live events.

About Celcuity

Celcuity is a clinical-stage biotechnology company pursuing the development of targeted therapies for the treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant, with or without palbociclib, in patients with HR+/HER2- advanced breast cancer (“ABC”), has completed enrollment, and the company has reported detailed results for the PIK3CA wild-type cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC, is ongoing. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Contacts: 

Celcuity Inc. 
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com  
(763) 392-0123  
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924