Supernus Pharmaceuticals to Participate in March Investor Conferences

Supernus Pharmaceuticals to Participate in March Investor Conferences




Supernus Pharmaceuticals to Participate in March Investor Conferences

ROCKVILLE, Md., Feb. 23, 2026 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that management will participate in the following March investor conferences:

TD Cowen 46th Annual Health Care Conference
Date:
Fireside chat:
Place:
Webcast Link:
Monday, March 2, 2026
2:30 p.m. ET
Boston Marriott Copley Place, Boston, Mass.
Here

Jefferies Biotech on the Beach Summit
Date:
Place:
Tuesday, March 10, 2026
1 Hotel South Beach, Miami Beach, Fla.

Barclays 28th Annual Global Healthcare Conference
Date:
Fireside chat: 
Place: 
Webcast Link:
Wednesday, March 11, 2026
2:00 p.m. ET
Loews Miami Beach, Miami Beach, Fla.
Here

Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinators.

A live audio webcast of the TD Cowen and Barclays Conference presentations can also be accessed on the Events & Presentations section of the Supernus Pharmaceuticals website at www.supernus.com. Archived replays of these webcasts will be available for 60 days on the Company’s website following the conference.

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson’s disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, postpartum depression (PPD), epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel product candidates for CNS disorders.

For more information, please visit www.supernus.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management’s current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products, and the products of its subsidiaries; the Company’s ability to increase its net revenue from its products, and the products of its subsidiaries; the Company’s ability to commercialize its products, and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; changes to laws and regulations applicable to our industry, the impact of macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

CONTACTS:

Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
(301) 838-2591

or

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

MacroGenics Announces Pausing of Enrollment of New Study Participants in LINNET Trial

MacroGenics Announces Pausing of Enrollment of New Study Participants in LINNET Trial




MacroGenics Announces Pausing of Enrollment of New Study Participants in LINNET Trial

FDA has placed partial clinical hold on LINNET study of lorigerlimab in gynecologic cancer

ROCKVILLE, MD, Feb. 23, 2026 (GLOBE NEWSWIRE) —  MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today announced that the U. S. Food and Drug Administration (FDA) has placed a partial clinical hold on its Phase 2 LINNET study of lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4, in patients with gynecologic cancers. Under the partial clinical hold, no new patients will be enrolled in the LINNET study until the partial hold is lifted by the FDA. Current study participants may continue to receive study drug.

The FDA’s partial clinical hold was initiated following the Company’s recent notification to the FDA of a temporary pause in enrollment of new participants in the LINNET trial due to the occurrence of recent safety events. The safety events that prompted the enrollment pause occurred across four patients and included Grade 4 thrombocytopenia (N=2), Grade 4 myocarditis (N=1), and Grade 4 neutropenia and concurrent septic shock (N=1) which led to a Grade 5 event. To date, 41 study participants have been dosed at 6 mg/kg every 3 weeks across the platinum-resistant ovarian cancer (PROC) and clear cell gynecologic cancer (CCGC) cohorts.

“At MacroGenics, our top priority is patient safety,” said Eric Risser, President and CEO. “MacroGenics is fully committed to working closely with the FDA to resolve the partial clinical hold and we intend to resume study enrollment as soon as possible.”

About the LINNET Study

The LINNET study is evaluating lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4, as monotherapy in a Simon two-stage trial in eligible patients with PROC who have received up to three prior lines of therapy. If a predefined activity threshold is met in the first stage — based on approximately 20 patients — the study may expand to enroll an additional 20 patients. The study was also designed to enroll up to 20 patients with CCGC who have received at least one prior line of therapy. The primary endpoint is objective response rate (ORR), with multiple secondary endpoints.

About MacroGenics, Inc.

MacroGenics (the Company) is a biopharmaceutical company focused on developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, expected timing of the release of clinical updates and safety and efficacy data for the Company’s ongoing clinical trials and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy, including our ability to execute on our key strategic priorities for 2025 and 2026, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the risk of delays or failure in reaching an agreement with the FDA regarding the release of a clinical hold, risks that TZIELD, lorigerlimab, ZYNYZ, or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, lorigerlimab, ZYNYZ, or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, including timing and results of efficacy and safety data with respect to product candidates in ongoing clinical trials; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company’s product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.  

CONTACT: CONTACTS

Jim Karrels, Senior Vice President, CFO 
1-301-251-5172 
info@macrogenics.com 

Argot Partners
1-212-600-1902
macrogenics@argotpartners.com

Kyntra Bio Announces Positive Data from the Investigator-Sponsored Phase 1b/2 Study of FG-3246 in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer to Be Presented at ASCO GU 2026

Kyntra Bio Announces Positive Data from the Investigator-Sponsored Phase 1b/2 Study of FG-3246 in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer to Be Presented at ASCO GU 2026




Kyntra Bio Announces Positive Data from the Investigator-Sponsored Phase 1b/2 Study of FG-3246 in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer to Be Presented at ASCO GU 2026

  • FG-3246 and enzalutamide combination therapy, in biomarker unselected patients with androgen receptor pathway inhibitor (ARPI)-treated, taxane-naïve metastatic castration-resistant prostate cancer (mCRPC), led to a median radiographic progression free survival (rPFS) of 7.0 months in the overall study cohort, with median rPFS of 10.1 months observed in patients who progressed on only one prior ARPI
  • Higher tumor uptake of FG-3180, a CD46 directed PET imaging agent, demonstrated a trend towards higher probability of PSA50 response, highlighting its potential for patient selection
  • Combination therapy had a similar safety and exposure profile to the previous FG-3246 Phase 1 monotherapy trial
  • Results further validate key FG-3246 Phase 2 monotherapy design elements, most importantly the inclusion of patients who have progressed on only one prior ARPI and integration of baseline FG-3180 PET for all enrolled patients
  • FG-3246 Phase 2 monotherapy trial on track for interim analysis in 2H 2026

SAN FRANCISCO, Feb. 23, 2026 (GLOBE NEWSWIRE) — Kyntra Bio (Nasdaq: KYNB), formerly FibroGen (Nasdaq: FGEN), today announced that the data on anti-tumor activity of FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) from the investigator-sponsored Phase 1b/2 study will be presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026 in San Francisco, CA.

“The results from this Phase 1b/2 investigator-initiated study demonstrate encouraging preliminary anti-tumor activity of FG-3246 in combination with enzalutamide in patients with mCRPC. Notably, the 10.1 months of rPFS in patients with only one prior ARPI underscores the potential of FG-3246 in earlier lines of therapy,” commented Dr. Rahul Aggarwal, Professor of Medicine at the University of California San Francisco, and Principal Investigator of the study. “The positive trend observed in the association between tumor uptake of FG-3180 (CD46-targeting PET) and PSA50 response, though from a small number of patients, is especially intriguing and I’m excited to see the potential utility of this biomarker further explored in the Phase 2 monotherapy study.”

“These data from the investigator sponsored trial expand on the clinically meaningful results previously observed with FG-3246,” said Thane Wettig, Chief Executive Officer of Kyntra Bio. “The 10.1 months of median rPFS observed in patients progressing on only one prior ARPI, and the mitigation of neutropenia related adverse events with prophylactic G-CSF are especially encouraging as they further validate our Phase 2 monotherapy trial design. We look forward to sharing the interim analysis of the Phase 2 monotherapy trial in the second half of 2026 as well as further characterizing the potential utility of FG-3180 as a patient selection biomarker.”

The presentation includes data from 44 biomarker unselected patients with progressive metastatic castration-resistant prostate cancer, 17 of which were enrolled in the Phase 1b dose escalation portion of the study. Eligibility criteria for the trial included patients who progressed on at least one prior ARPI while patients who were treated with prior chemotherapy in the castration-resistant setting were excluded. Over 60% of the patients progressed on two or more prior ARPIs, which included prior enzalutamide treatment. The primary endpoint of the escalation phase was assessment of dose-limiting toxicities (DLT) and determination of the maximum tolerated dose and recommended dose for the Phase 2 portion of the study – which was determined to be 2.1 mg/kg of FG-3246 and 160 mg/day of enzalutamide. The primary endpoint of the Phase 2 expansion portion of the study was composite response rate (PSA50 response and/or objective response per RECIST v1.1). Secondary endpoints were PSA50 response rate, objective response rate, radiographic progression free survival (rPFS), overall survival, and treatment-related adverse events (TRAEs).

FG-3246 combined with enzalutamide demonstrated anti-tumor activity with a composite response rate of 21% in the overall cohort and 40% in patients who had progressed on only one prior ARPI. Median rPFS of 7.0 months was observed in the overall cohort. Notably, median rPFS of 10.1 months was observed in patients who had progressed on only one prior ARPI, a result which was consistent across the different prior ARPIs administered. Additionally, higher tumor uptake of FG-3180 demonstrated a trend towards higher probability of PSA50 response (p=0.053), highlighting the potential of FG-3180 as a biomarker for patient selection.

Combination therapy of FG-3246 and enzalutamide demonstrated a similar safety profile as was observed in the previous Phase 1 monotherapy trial of FG-3246. Neutropenia risk was successfully mitigated with use of G-CSF prophylaxis. The most frequent TRAEs with the combination therapy included fatigue, peripheral neuropathy, anorexia, and dysgeusia. Cumulative toxicities, including peripheral neuropathy, led to treatment discontinuation for some patients.

The poster presentation, titled “A phase 1b/2 study of FOR46 (FG-3246) in combination with enzalutamide (enza) in patients with metastatic castration resistant prostate cancer (mCRPC)”, is scheduled for the poster session taking place on February 26, 2026 from 11:30 AM to 12:45 PM PT.

FG-3246 is currently being evaluated in a Phase 2 monotherapy trial with interim data expected in the second half of 2026. The trial also includes treatment with FG-3180, a CD46-directed PET imaging agent, which will measure expression levels of CD46 positive lesions. This will enable further assessment of the correlation between CD46 expression and response to FG-3246 and the potential of FG-3180 to serve as a biomarker to aid in patient selection in future trials of FG-3246.

About FG-3246 and FG-3180
FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by Kyntra Bio for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3180 is a companion diagnostic PET imaging agent, using the same CD46-targeting antibody together with an 89Zr tracker. To date, FG-3180 demonstrated specific uptake in CD46 positive tumors and is currently being evaluated as a biomarker for its potential to inform patient selection.

About the Phase 1b/2 Study of FG-3246 in Combination with Enzalutamide
This Phase 1b/2 study is an investigator-sponsored trial being conducted at the University of California San Francisco to evaluate FG-3246 (FOR46) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) after prior progression on at least one androgen receptor pathway inhibitor. The primary objective for the Phase 1b portion of the study is to determine the maximally tolerated dose (MTD) and recommended Phase 2 dose of FG-3246 in combination with enzalutamide in patients with mCRPC. The objectives of the Phase 2 portion of the study are to determine the composite response rate (CRR), proportion of participants with a greater than or equal to 50% change in prostate specific antigen (PSA50), objective response rate (ORR), median duration of response, median radiographic progression free survival (rPFS), and median overall survival (OS) of patients treated with FG-3246 in combination with enzalutamide. For more information about this study, which is currently enrolling, please visit www.clinicaltrials.gov (NCT05011188).

About Kyntra Bio
Kyntra Bio is a biopharmaceutical company focused on development of novel therapies in oncology and rare disease. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.kyntrabio.com.

Forward-Looking Statements
This release contains forward-looking statements regarding Kyntra Bio’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of Kyntra Bio products and product candidates, statements regarding the potential effectiveness of FG-3180 as a biomarker or predictor of response rate, and any forward looking statements regarding the design, efficacy or safety results of our ongoing Phase 2 monotherapy trial of FG-3246. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Kyntra Bio’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in Kyntra Bio’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Kyntra Bio undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

For Investor Inquiries:
David DeLucia, CFA
Senior Vice President and Chief Financial Officer
ir@kyntrabio.com

TARA-002 Demonstrates 68% Complete Response Rate at Six Months in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

TARA-002 Demonstrates 68% Complete Response Rate at Six Months in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer




TARA-002 Demonstrates 68% Complete Response Rate at Six Months in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events

Company expects to complete enrollment of the BCG-Unresponsive cohort of the ADVANCED-2 trial in 2H 2026

Company to host conference call and webcast tomorrow at 8:00 a.m. ET

NEW YORK, Feb. 23, 2026 (GLOBE NEWSWIRE) — Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced updated interim results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company’s investigational cell-based therapy, in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve. These results will be featured on Friday, February 27, 2026 during poster sessions at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco.

“These interim data are highly encouraging with respect to TARA-002’s efficacy and safety,” said Raj Satkunasivam, MD, MS, FRCSC, Urologic Oncologist, Associate Professor at Houston Methodist Hospital and ADVANCED-2 study investigator. “The results in the BCG-Unresponsive cohort demonstrate compelling six-month response rates with maturing 12-month data showing promising signals of durability. These clinically meaningful response rates and favorable tolerability profile make TARA-002 a potentially promising treatment option.”

“TARA-002 continues to demonstrate impressive and durable response rates with excellent safety and tolerability,” said Neal Shore, MD, FACS, Medical Director of the START Carolinas/Carolina Urologic Research Center. “These results, coupled with a clean safety profile and a simple, streamlined administration for both physicians and patients, make TARA-002 a potentially innovative new therapy for urologists, particularly those in busy community practices.”

Updated Interim Results

BCG-Unresponsive Cohort

The interim analysis of the BCG-Unresponsive cohort includes 35 evaluable participants, of whom, 22 were evaluable at six months and 15 were evaluable at 12 months as of a January 28, 2026 data cutoff.

  • The CR rate at any time was 65.7% (23 of 35)
  • The CR rate was 68.2% (15 of 22) at six months and 33.3% (5 of 15) at 12 months
  • Among responders:
    • The Kaplan-Meier (KM) estimated probability of maintaining a CR for six months was 71.1% (95% CI: 46.7, 95.5)
    • 100% (5 of 5) maintained their CR from nine to 12 months
  • 61.5% (8 of 13) of re-induced patients converted to a CR at six months

BCG-Naïve Cohort

The interim analysis of the BCG-Naïve cohort includes 29 evaluable participants, 27 of whom, were evaluable at six months and 19 were evaluable at 12 months as of a January 28, 2026 data cutoff.

  • The CR rate at any time was 72.4% (21 of 29)
  • The CR rate was 66.7% (18 of 27) at six months and 57.9% (11 of 19) at 12 months
  • Among responders:
    • The KM estimated probability of maintaining a CR for six months was 73.1% (95% CI: 52.9, 93.4)
    • 100% (11 of 11) maintained their CR from nine to 12 months
  • 66.7% (4 of 6) of re-induced patients converted to a CR at six months

Safety and Tolerability

The majority of treatment-related adverse events (TRAEs) were Grade 1 and transient with no Grade 3 or greater TRAEs and no related serious adverse events as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most common TRAEs were dysuria, bladder spasm, fatigue and micturition urgency. Most bladder irritations resolved shortly after administration or within a few hours to a few days.

“The data generated to date in these high-risk NMIBC patient populations highlight TARA-002’s potential as a meaningful addition to the treatment landscape,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “In addition to demonstrating impressive efficacy and safety, TARA-002 overcomes the limitations of existing NMIBC treatments that burden patients as well as urologists and their practices. We look forward to continuing to advance TARA-002’s clinical development as we work to bring this treatment to patients.”

Next Steps

Protara expects to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in the second half of 2026. Enrollment is complete in the BCG-Naïve cohort of the ADVANCED-2 trial with 31 patients, and the Company remains on track to initiate the ADVANCED-3 registrational trial in BCG-Naïve patients in the second half of 2026.

Conference Call and Webcast

Protara will host a conference call and webcast tomorrow at 8:00 a.m. ET to review the data reported this evening. Neal Shore, MD, FACS, Medical Director of the Carolina Urologic Research Center will join management for the discussion. The live event and accompanying slides can be accessed by visiting https://protara-therapeutics-asco-gu-update-call.open-exchange.net/, or via the Events and Presentations section of the Company’s website: https://ir.protaratx.com. A replay of the webcast will be archived for a limited time following the event.

About ADVANCED-2

ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive (Cohort B N=75-100) or BCG-Naïve (Cohort A N=31). Trial subjects receive an induction course, with or without a reinduction, of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease, Breakthrough and Fast Track Designations by the U.S. Food and Drug Administration. TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, IL-6, IL-10 and IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil® in Japan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the sixth most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses, representing approximately 65,000 patients in the U.S. each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

About Protara Therapeutics, Inc.

Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin, as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visit www.protaratx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “designed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include but are not limited to, statements regarding Protara’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: Protara’s business strategy, including its development plans for its product candidates and plans regarding the timing or outcome of existing or future clinical trials (including the timing of any particular phases of such trials and the timing of the announcement of any data produced during such trials or phases thereof); statements related to expectations regarding interactions with the U.S. Food and Drug Administration (FDA); Protara’s financial position; statements regarding the anticipated safety or efficacy of Protara’s product candidates; and Protara’s outlook for the remainder of the year and future periods. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that contribute to the uncertain nature of the forward-looking statements include: risks that Protara’s financial guidance may not be as expected, as well as risks and uncertainties associated with: Protara’s development programs, including the initiation and completion of non-clinical studies and clinical trials and the timing of required filings with the FDA and other regulatory agencies; general market conditions; changes in the competitive landscape; changes in Protara’s strategic and commercial plans; Protara’s ability to obtain sufficient financing to fund its strategic plans and commercialization efforts; having to use cash in ways or on timing other than expected; the impact of market volatility on cash reserves; failure to attract and retain management and key personnel; the impact of general U.S. and foreign, economic, industry, market, regulatory, political or public health conditions; and the risks and uncertainties associated with Protara’s business and financial condition in general, including the risks and uncertainties described more fully under the caption “Risk Factors” and elsewhere in Protara’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Protara undertakes no obligation to update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as required by law.

Company Contact:

Justine O’Malley
Protara Therapeutics
Justine.OMalley@protaratx.com
646-817-2836

Palvella Therapeutics to Host Conference Call to Discuss Topline Results from Phase 3 SELVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) in Microcystic Lymphatic Malformations 

Palvella Therapeutics to Host Conference Call to Discuss Topline Results from Phase 3 SELVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) in Microcystic Lymphatic Malformations 




Palvella Therapeutics to Host Conference Call to Discuss Topline Results from Phase 3 SELVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) in Microcystic Lymphatic Malformations 

Webcast conference call to take place tomorrow, Tuesday, February 24, 2026, at 8:00am ET

WAYNE, Pa., Feb. 23, 2026 (GLOBE NEWSWIRE) — (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), 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 that it will host a conference call and webcast tomorrow, Tuesday, February 24, 2026, at 8:00am ET to discuss topline results from the Phase 3 SELVA clinical trial assessing the efficacy and safety of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations. The Company plans to issue a press release sharing the topline results at approximately 6:30am ET tomorrow, prior to the start of the call.

Conference Call

To access the live webcast of the call with slides, please click here or visit the “Events & Presentations” section of Palvella’s website. To access the call by phone, please use this registration link, and you will be provided with dial in details. A replay of the webcast will be available approximately 2 hours after the conclusion of the call and archived for 90 days under the “Events & Presentations” section of the Company’s website at www.palvellatx.com.

About Palvella Therapeutics

Founded and led by rare disease drug development veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) 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. For more information, please visit www.palvellatx.com or follow Palvella on LinkedIn or X (formerly known as Twitter).

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.

Contact Information

Investors
Wesley H. Kaupinen
Founder and CEO, Palvella Therapeutics
wes.kaupinen@palvellatx.com

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

SI-BONE, Inc. Reports Record Financial Results for the Fourth Quarter 2025 and Issues 2026 Guidance

SI-BONE, Inc. Reports Record Financial Results for the Fourth Quarter 2025 and Issues 2026 Guidance




SI-BONE, Inc. Reports Record Financial Results for the Fourth Quarter 2025 and Issues 2026 Guidance

Achieves 20% worldwide revenue growth and positive adjusted EBITDA for Fiscal Year 2025
Generates free cash flow in the Fourth Quarter 2025

SANTA CLARA, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) — SI-BONE, Inc. (Nasdaq: SIBN), the global leader in developing procedural solutions to address clinical challenges associated with compromised bone, today reported financial results for the fourth quarter and full year ended December 31, 2025.

Fourth Quarter 2025 Financial Highlights (all comparisons are to the prior year period)

  • Worldwide revenue of $56.3 million, representing growth of 15.0%
  • U.S. revenue of $53.5 million, representing growth of 13.9%
  • Gross margin of 79.0%
  • Net loss of $1.6 million, representing an improvement of 63.3%
  • Positive adjusted EBITDA of $5.1 million, representing an improvement of 176.2%
  • Positive cashflow from operations of $1.7 million and positive free cash flow of $0.4 million
  • Ended the quarter with $147.8 million in cash and equivalents

Fiscal Year 2025 Highlights (all comparisons are to the prior year period)

  • Worldwide revenue of $200.9 million, representing growth of 20.2%
  • U.S. revenue of $191.1 million, representing growth of 20.6%
  • Gross margin of 79.6%
  • Net loss of $18.9 million, representing an improvement of 38.8%
  • Positive adjusted EBITDA of $8.9 million, representing an improvement of $14.0 million

Recent Operational (all comparisons are to the prior year period)

  • ~1,640 U.S. physicians performed a procedure in the fourth quarter, representing an increase of 18%
  • Entered into a strategic partnership with Smith+Nephew, an orthopedics industry leader, to distribute iFuse TORQ and iFuse TORQ TNT across Level 1 and Level 2 trauma centers nationwide for pelvic trauma
  • Expanded INTRA platform with the launch of INTRA Ti in February, our newest SI joint fusion solution that provides physicians procedural flexibility and workflow efficiency in ambulatory surgery centers
  • U.S. patent portfolio covering the original iFuse, including the triangular shape, extended to August 2028

Organizational Update

  • Anshul Maheshwari promoted to Chief Operating Officer in addition to his role as Chief Financial Officer
  • As previously announced, Nikolas Kerr was promoted to the role of Chief Commercial Officer
  • Jeff Zigler promoted to Senior Vice President of Market Access and Reimbursement

“In 2025, we demonstrated the strength and scalability of our business model, delivering another year of worldwide revenue growth that exceeded 20% while expanding margins and exiting the year with positive free cash flow. These results reflect disciplined execution, a differentiated platform, and durability of demand across our portfolio,” said Laura Francis, Chief Executive Officer. “As we enter 2026, we have a compelling set of growth catalysts, including favorable reimbursement dynamics, expanding commercial footprint and upcoming product launches designed to deepen physician engagement and expand our reach into a sizable new market. Together, these factors reinforce our confidence in SI-BONE’s ability to sustain strong, profitable growth over the long term.”

Fourth Quarter 2025 Financial Results

Worldwide revenue was $56.3 million in the fourth quarter 2025, a 15.0% increase from $49.0 million in the corresponding period in 2024. U.S. revenue for the fourth quarter 2025 was $53.5 million, a 13.9% increase from $46.9 million in the corresponding period in 2024. International revenue for the fourth quarter 2025 was $2.9 million, a 38.8% increase from $2.1 million in the corresponding period in 2024.

Gross profit was $44.5 million in the fourth quarter 2025, an increase of 14.8% from $38.8 million in the corresponding period in 2024. Gross margin was stable at 79.0% for the fourth quarter 2025 compared to 79.1% in the corresponding period in 2024.

Operating expenses increased 6.2% to $47.0 million in the fourth quarter 2025, as compared to $44.3 million in the corresponding period in 2024. The change in operating expenses was primarily driven by general commercial activity related to higher revenue and research and development investments related to future products.

Operating loss improved by 55.2% to $2.5 million in the fourth quarter 2025, as compared to an operating loss of $5.5 million in the corresponding period in 2024.

Net loss improved by 63.3%, to $1.6 million, or $0.04 per diluted share in the fourth quarter 2025, as compared to a net loss of $4.5 million, or $0.11 per diluted share in the corresponding period in 2024.

Adjusted EBITDA improved by 176.2% to positive $5.1 million in the fourth quarter 2025, as compared to a positive adjusted EBITDA of $1.9 million in the corresponding period in 2024.

Fiscal Year 2025 Financial Results

Worldwide revenue was $200.9 million for 2025, a 20.2% increase from $167.2 million in 2024. U.S. revenue for 2025 was $191.1 million, a 20.6% increase from $158.4 million in 2024. International revenue was $9.8 million in 2025, a 12.4% increase from $8.8 million in 2024.

Gross profit was $159.9 million in 2025, a 21.0% increase from $132.1 million in 2024. Gross margin was 79.6% in 2025 and 79.0% in 2024.

Operating expenses increased 8.9% to $182.2 million in 2025, as compared to $167.4 million in 2024. The change in operating expenses was primarily driven by general commercial activity related to higher revenue and research and development investments related to future products.

Operating loss improved by 36.6% to $22.3 million in 2025, as compared to an operating loss of $35.2 million in 2024.

Net loss improved by 38.8%, to $18.9 million, or $0.44 per diluted share in 2025, as compared to a net loss of $30.9 million, or $0.75 per diluted share in 2024.

Adjusted EBITDA improved to positive $8.9 million in 2025, as compared to a loss of $5.1 million in 2024, representing and improvement of $14.0 million.

Cash and equivalents were $147.8 million, representing a sequential improvement of $2.1 million, and borrowings were $35.6 million as of December 31, 2025.

2026 Financial Guidance

SI-BONE expects 2026 worldwide revenue to be in the range of $228.5 million to $232.5 million, implying year-over-year growth of ~14% to ~16%. SI-BONE estimates fiscal year 2026 gross margin to be approximately 78%, and operating expenses growth to be ~12.5% at the mid-point of the revenue guidance. Based on these assumptions, SI-BONE expects to deliver increased positive adjusted EBITDA for the full year 2026.

Webcast Information
SI-BONE will host a conference call to discuss the fourth quarter 2025 financial results after market close on Monday, February 23, 2026 at 4:30 P.M. Eastern Time. The conference call can be accessed live over webcast at https://edge.media-server.com/mmc/p/zfxy6yox. Live audio of the webcast will be available on the “Investors” section of the company’s website at: www.si-bone.com. The webcast will be archived and available for replay for at least 90 days after the event.

About SI-BONE, Inc.

SI-BONE (NASDAQ: SIBN) is a global leader in developing procedural solutions to address clinical challenges associated with compromised bone. With expertise in biomechanical design and anatomy specific innovation, SI-BONE has built a technology platform with market-leading applications centered on the spinopelvic anatomy. SI-BONE continues to leverage the deep experience in addressing the challenges of low-density bone in the sacrum to develop unique technologies that are targeting new clinical adjacencies to help improve outcomes for patients with compromised bone. Since 2009, SI-BONE has supported physicians in performing a total of over 140,000 procedures. A unique body of clinical evidence supports the use of SI-BONE’s technologies, including four randomized controlled trials and over 180 peer reviewed publications.

SI-BONE® is a registered trademark of SI-BONE, Inc. ©2026 SI-BONE, Inc. All Rights Reserved.

Forward-Looking Statements

The statements in this press release regarding expectations of future events or results, including SI-BONE’s expectations of continued revenue and procedure growth and financial outlook, contained in this press release are “forward-looking” statements. These forward-looking statements are based on SI-BONE’s current expectations and inherently involve significant risks and uncertainties. These risks include SI-BONE’s ability to introduce and commercialize new products and indications, SI-BONE’s ability to maintain favorable reimbursement for procedures using its products, the impact of any future economic weakness on the ability and desire of patients to undergo elective procedures including those using SI-BONE’s devices, SI-BONE’s ability to manage risks to its supply chain, future capital requirements driven by new surgical systems requiring instrument tray and implant inventory investment, and the pace of the re-normalization of the healthcare operating environment including the ability and desire of patients and physicians to undergo and perform procedures using SI-BONE’s devices. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these and other risks and uncertainties, many of which are described in the company’s most recent filing on Form 10-K, and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov), especially under the caption “Risk Factors.” SI-BONE does not undertake any obligation to update forward-looking statements and expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.

Use of Non-GAAP Financial Measures

To supplement our condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (“GAAP”), SI-BONE uses two non-GAAP financial measures: Adjusted EBITDA and free cash flow. Non-GAAP measures should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP. Adjusted EBITDA excludes the effect of items that increase or decrease SI-BONE’s reported results of operations. Free cash flow is not intended to represent our residual cash flow available for discretionary expenditures. Management strongly encourages investors to review, when they become available, the company’s consolidated financial statements and publicly filed reports in their entirety. The company’s definition of adjusted EBITDA and free cash flow may differ from similarly titled measures used by others.

Adjusted EBITDA excludes from net loss the effects of interest income, interest expense, depreciation and amortization, and stock-based compensation. Free cash flow is defined as net cash provided by operating activities less purchases of property and equipment. SI-BONE believes the presentation of these financial measures is useful to management because it allows management to more consistently analyze period-to-period financial performance and provides meaningful supplemental information with respect to core operational activities used to evaluate management’s performance. SI-BONE also believes the presentation of non-GAAP financial measures is useful to investors and other interested persons as it enables these persons to use this additional information to assess the company’s performance in using this additional metric that management uses to assess the company’s performance.

Investor Contact

Saqib Iqbal
VP, FP&A and Investor Relations
investors@SI-BONE.com

SI-BONE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
       
  Three Months Ended
December 31
  Twelve Months Ended
December 31
    2025       2024       2025       2024  
Revenue $ 56,350     $ 49,002     $ 200,925     $ 167,178  
Cost of goods sold   11,818       10,225       41,046       35,057  
Gross profit   44,531       38,777       159,879       132,121  
Operating expenses:              
Sales and marketing   32,806       31,249       124,224       117,054  
Research and development   4,363       3,870       17,448       16,560  
General and administrative   9,825       9,152       40,537       33,755  
Total operating expenses   46,994       44,271       182,209       167,369  
Loss from operations   (2,463 )     (5,494 )     (22,330 )     (35,248 )
Interest and other income (expense), net:              
Interest income   1,446       1,784       6,074       7,848  
Interest expense   (629 )     (795 )     (2,628 )     (3,440 )
Other income (expense), net   (2 )     10       (20 )     (73 )
Net loss $ (1,648 )   $ (4,495 )   $ (18,904 )   $ (30,913 )
               
Net loss per share, basic and diluted $ (0.04 )   $ (0.11 )   $ (0.44 )   $ (0.75 )
Weighted-average number of common shares used to compute basic and diluted net loss per share   43,507,786       41,994,284       42,959,856       41,466,564  
                               

SI-BONE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(unaudited)
       
  December 31,
2025
  December 31,
2024
ASSETS      
Current assets:      
Cash and cash equivalents $ 42,240     $ 34,948  
Short-term investments   105,583       115,094  
Accounts receivable, net   29,915       27,459  
Inventory   33,897       27,074  
Prepaid expenses and other current assets   4,480       3,204  
Total current assets   216,115       207,779  
Property and equipment, net   21,298       20,374  
Operating lease right-of-use assets   1,087       1,984  
Other non-current assets   55       300  
TOTAL ASSETS $ 238,555     $ 230,437  
       
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:      
Accounts payable $ 4,631     $ 6,488  
Accrued liabilities and other   19,704       19,492  
Operating lease liabilities, current portion   944       1,152  
Total current liabilities   25,279       27,132  
Long-term borrowings   35,569       35,452  
Operating lease liabilities, net of current portion   175       879  
Other long-term liabilities   —       10  
TOTAL LIABILITIES   61,023       63,473  
       
Stockholders’ Equity:      
Common stock and additional paid-in capital   626,974       598,074  
Accumulated other comprehensive income   816       244  
Accumulated deficit   (450,258 )     (431,354 )
TOTAL STOCKHOLDERS’ EQUITY   177,532       166,964  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 238,555     $ 230,437  
               

SI-BONE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
   
  Twelve Months Ended
December 31,
    2025       2024  
Cash flows from operating activities      
Net loss $ (18,904 )   $ (30,913 )
Adjustments to reconcile net loss to net cash used in operating activities      
Stock-based compensation   25,524       25,869  
Depreciation and amortization   5,770       4,379  
Accounts receivable credit losses   570       470  
Inventory reserve   1,997       1,300  
Amortization of discount and premium on marketable securities   (3,051 )     (5,440 )
Amortization of debt issuance costs   117       153  
Loss on disposal of property and equipment   1,627       1,877  
Changes in operating assets and liabilities      
Accounts receivable   (3,027 )     (5,840 )
Inventory   (8,684 )     (8,047 )
Prepaid expenses and other assets   (1,030 )     (2 )
Accounts payable   (1,763 )     1,861  
Accrued liabilities and other   179       1,908  
Net cash used in operating activities   (675 )     (12,425 )
Cash flows from investing activities      
Maturities of marketable securities   205,100       228,500  
Purchases of marketable securities   (192,526 )     (205,380 )
Purchases of property and equipment   (8,414 )     (10,497 )
Net cash provided by (used in) investing activities   4,160       12,623  
Cash flows from financing activities      
Proceeds from debt financing, net of debt issuance cost   —       35,954  
Repayments of debt financing   —       (36,000 )
Final payment fee related to debt   —       (720 )
Proceeds from the exercise of common stock options   1,169       570  
Proceeds from issuance of common stock under employee stock purchase plan   2,207       2,154  
Net cash provided by financing activities   3,376       1,958  
Effect of exchange rate changes on cash and cash equivalents   431       (479 )
Net increase in cash and cash equivalents   7,292       1,677  
Cash and cash equivalents at      
Beginning of year   34,948       33,271  
End of year $ 42,240     $ 34,948  
               

SI-BONE, INC.
RECONCILIATION OF NET LOSS TO NON-GAAP ADJUSTED EBITDA
(In thousands)
(unaudited)
         
    Three Months Ended December 31,   Twelve Months Ended December 31,
      2025       2024       2025       2024  
Net loss   $ (1,648 )   $ (4,495 )   $ (18,904 )   $ (30,913 )
Interest income     (1,446 )     (1,784 )     (6,074 )     (7,848 )
Interest expense     629       795       2,628       3,440  
Depreciation and amortization     1,638       1,213       5,770       4,379  
Stock-based compensation     5,976       6,135       25,524       25,868  
Adjusted EBITDA   $ 5,150     $ 1,864     $ 8,944     $ (5,074 )
                 

SI-BONE, INC.
RECONCILIATION OF FREE CASH FLOW
(In thousands)
(unaudited)
     
    Twelve Months Ended December 31,
      2025       2024  
Net cash used in operating activities   $ (675 )   $ (12,425 )
Less:        
Purchases of property and equipment     (8,414 )     (10,497 )
Free cash flow   $ (9,089 )   $ (22,922 )

Relay Therapeutics to Participate in Two Upcoming Investor Conferences in March

Relay Therapeutics to Participate in Two Upcoming Investor Conferences in March




Relay Therapeutics to Participate in Two Upcoming Investor Conferences in March

CAMBRIDGE, Mass., Feb. 23, 2026 (GLOBE NEWSWIRE) — Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, today announced that management will participate in two upcoming fireside chats in March:

  • TD Cowen 46th Annual Health Care Conference on Monday, March 2, 2026 at 3:10 p.m. ET
  • Barclays 28th Annual Global Healthcare Conference on Wednesday, March 11, 2026 at 10:30 a.m. ET

The fireside chats will be webcast live and may be accessed through Relay Therapeutics’ website under Events in the News & Events section through the following link: https://ir.relaytx.com/news-events/events-presentations. An archived replay of the webcast will be available for up to 30 days following the event.

About Relay Therapeutics

Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease. Relay’s Dynamo® platform integrates an array of leading-edge computational and experimental approaches designed to drug protein targets that have previously been intractable or inadequately addressed. The company’s lead clinical asset, zovegalisib, is the first pan-mutant selective PI3Kα inhibitor to enter clinical development and is currently in a Phase 3 clinical trial (ReDiscover-2) in HR+/HER2- metastatic breast cancer. Zovegalisib is also being investigated in a group of genetic disease indications called PI3Kα-driven vascular anomalies. Relay’s pipeline also includes programs for NRAS-driven solid tumors and Fabry disease. For more information, please visit www.relaytx.com or follow us on LinkedIn.

Contact:
Pete Rahmer
prahmer@relaytx.com

Media:
Dan Budwick
1AB
973-271-6085
dan@1abmedia.com

Mangoceuticals’ Patented MGX-0024 Achieves Zero Respiratory-Related Mortality in 29,000-Bird Field Trials and Demonstrates Prophylactic Benefit Against H5N1 in Controlled Government Study

Mangoceuticals’ Patented MGX-0024 Achieves Zero Respiratory-Related Mortality in 29,000-Bird Field Trials and Demonstrates Prophylactic Benefit Against H5N1 in Controlled Government Study




Mangoceuticals’ Patented MGX-0024 Achieves Zero Respiratory-Related Mortality in 29,000-Bird Field Trials and Demonstrates Prophylactic Benefit Against H5N1 in Controlled Government Study

Dallas, TX, Feb. 23, 2026 (GLOBE NEWSWIRE) — Mangoceuticals, Inc. (NASDAQ: MGRX), a company focused on developing, marketing, and selling a variety of health and wellness products via a secure telemedicine platform under the brands MangoRx and PeachesRx, and a pioneer in innovative wellness solutions, today announced new data from its proprietary antiviral compound MGX-0024. A technical report issued by partner IntraMont Technologies in late 2025, combined with the final signed report from the ICAR-National Institute of High Security Animal Diseases (NIHSAD), Bhopal, supports MGX-0024’s potential to reduce respiratory disease impacts in commercial poultry settings and provide meaningful early protection against highly pathogenic avian influenza (HPAI) H5N1 and other respiratory illnesses like Newcastle’s disease, IBH, ILT, etc. in birds.

In three independent commercial field trials conducted on farms in Tamil Nadu, India (Duraiswamy and Raghupati Farms), a total of approximately 29,000 broiler chicken received MGX-0024-infused drinking water starting around day 14 of life through market age (37–48 days), with no concurrent antibiotics or antivirals used. Across all flocks, zero mortality was attributed to respiratory pathogens, including viral or bacterial causes such as suspected avian influenza and Mycoplasma infections. Historical farm data and simultaneous neighboring untreated flocks indicated expected respiratory-related mortality of approximately 50%, or roughly 14,500 birds. All recorded deaths, which were minimal in number, were linked to non-respiratory causes, primarily heat stress.

These outcomes build on and expand the earlier May 2025 field studies, which reported zero respiratory-related deaths in treated groups of approximately 8,000–10,000 birds. The current results replicate that performance across a significantly larger population and multiple independent sites. Diagnostic confirmation in the field trials relied on clinical observation and farm records; additional PCR or serology testing was not uniformly applied across all birds due to real-world commercial constraints.

Complementing the field data, a rigorously controlled challenge study by Vipragen Biosciences and conducted at ICAR-NIHSAD under BSL-3 lab conditions evaluated MGX-0024 in specific-pathogen-free layered chicks using the highly pathogenic clade 2.3.4.4b H5N1 strain (A/duck/India/11TR05/2021). Chicks received MGX-0024 via drinking water for 24–48 hours prior to intranasal challenge at a dose of 10⁵ EID₅₀ in the revised Phase II protocol. In the 48-hour pre-treatment group, mortality was reduced by up to 60% compared to untreated controls (2 out of 7 deaths versus 5 out of 7 in controls). The mean time to death was extended significantly, up to 10.71 days versus 5.86 days in controls. Surviving birds exhibited only intermittent, low-level viral shedding and remained seronegative for H5 antibodies at day 14, suggesting effective early interference with infection establishment. This small-scale, controlled laboratory study (n=7 per group) provides encouraging preliminary evidence of prophylactic activity but is not a direct substitute for larger field validation against natural exposure.

“These results represent meaningful progress,” said Jim Intrater, President of IntraMont Technologies. “Eliminating observed respiratory-related mortality in real-world commercial flocks, alongside a clear prophylactic signal in a controlled H5N1 challenge, positions MGX-0024 as a promising tool for managing endemic respiratory challenges and supporting biosecurity against avian influenza threats.”

MGX-0024 is a GRAS-classified formulation of select polyphenols and zinc, administered through standard farm drinking-water systems. It forms a persistent physical-chemical barrier in the respiratory tract to inhibit viral attachment and replication, offering a non-vaccine, non-antibiotic approach. Intellectual property is protected under U.S. Patent No. 11,517,523 and corresponding patents in the EU, Canada, China, India, Australia, and Japan, with additional applications pending.

Jacob Cohen, CEO of Mangoceuticals, added: “We continue to advance this program with strong interest from distributors, farms, and agencies in key markets like India. We are scaling production, refining pricing and logistics, while our partner IntraMont Technologies is actively engaging in regulatory discussions in the United States, Australia, UK, Canada, and elsewhere. This aligns well with global trends toward reduced antibiotic use and sustainable poultry production.”

Mangoceuticals and IntraMont are planning further multi-farm studies in India and pursuing grant opportunities through USDA, BARDA, and international equivalents. Commercial discussions and potential rollout activities are underway, with targeted availability in select markets anticipated in the coming periods.

For inquiries, contact info@mangorxipholdings.com or visit www.MangoRxIPHoldings.com.

Study Disclaimer

The field trial results for MGX-0024 described herein are based on commercial studies commissioned and funded by Mangoceuticals, Inc., in collaboration with partners including Solice International and IntraMont Technologies. The controlled H5N1 challenge study was conducted at ICAR-NIHSAD under BSL-3 conditions, sponsored by Vipragen Biosciences. While the Company believes these results are accurate and represent meaningful advancements, they remain preliminary in certain aspects—particularly the small sample size in the H5N1 lab study—and are subject to further independent validation, larger-scale field trials, and regulatory review. Efficacy against natural outbreaks or specific pathogens (including HPAI H5N1) may vary by environment, flock conditions, diagnostic methods, and other factors. No claims of approved veterinary use or broad-spectrum efficacy have been authorized by regulatory authorities.

This press release contains forward-looking statements, including but not limited to statements about the potential efficacy, commercial rollout, and regulatory approval of MGX-0024, as well as its impact on poultry farming and biosecurity. These statements are subject to risks and uncertainties, including the outcomes of ongoing and future studies, regulatory approvals, market acceptance, and the ability to scale production and distribution. There is no guarantee that MGX-0024 will achieve the same results in other settings or receive regulatory approval in key markets. The Company’s plans to engage with regulatory authorities, secure funding, and expand studies are aspirational and may not materialize as anticipated. See also “Cautionary Note Regarding Forward-Looking Statements”, below.

Mangoceuticals, Inc. has not independently verified the data provided by Solice International, and investors and stakeholders are cautioned not to place undue reliance on these preliminary results. For further details on the study methodologies and results, please contact info@mangorxipholdings.com. The Company undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.

A link to the complete study can be found here or by visiting the website at www.MangoRxIPHoldings.com.

About Mangoceuticals, Inc.

MangoRx is focused on developing a variety of men’s health and wellness products and services via a secure telemedicine platform. To date, the Company currently offers pharmaceutical-based products specifically related to the treatments of erectile dysfunction, hair growth, hormone replacement therapies, and weight management. Interested consumers can use MangoRx’s telemedicine platform for a smooth experience. Prescription requests will be reviewed by a licensed medical provider and, if approved, fulfilled and discreetly shipped through MangoRx’s partner compounding pharmacy and right to the patient’s doorstep. To learn more about MangoRx’s mission and other products, please visit www.MangoRx.com.

Cautionary Note Regarding Forward-Looking Statements

Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws, including within the meaning of the Private Securities Litigation Reform Act of 1995 (“forward-looking statements”). These forward-looking statements represent the Company’s current expectations or beliefs concerning future events and can generally be identified using statements that include words such as “estimate,” “expects,” “project,” “believe,” “anticipate,” “intend,” “plan,” “foresee,” “forecast,” “likely,” “will,” “target” “up to” or similar words or phrases. These forward-looking statements include, but are not limited to, the review and evaluation of strategic transactions and their impact on shareholder value; the process by which the Company engages in evaluation of strategic transactions; the outcome of potential future strategic transactions and the terms thereof; macroeconomic, industry and market conditions, including inflation, interest rate volatility, recessionary trends, financial market disruptions, changes in regulatory or political environments, and other factors beyond the Company’s control that could adversely affect its business, financial condition and results of operations; our ability to meet the continued listing requirements of Nasdaq and maintain the listing of our common stock on Nasdaq, including as a result of our current non-compliance with certain listing standards relating to our stock price; our ability to successfully undertake a crypto treasury strategy in the future; risks related to the significant number of shares in the public float, our share volume, the effect of sales of a significant number of shares in the marketplace; dilution caused by offerings; conversion of outstanding shares of preferred stock and the rights and preferences thereof, the fact that we have a significant number of outstanding warrants to purchase shares of common stock and other convertible securities, the resale of which underlying shares have been registered under the Securities Act of 1933, as amended, dilution caused by exercises/conversions thereof, overhang related thereto, and decreases in the trading price of our common stock caused by sales thereof; our ability to build and maintain our brands; cybersecurity, information systems, fraud and website risks; compliance with applicable laws and regulations affecting our operations, products, marketing, manufacturing, labeling and distribution; shipping, production and supply chain delays; reliance on third parties for prescribing, compounding and other key services; product safety risks; macroeconomic and geopolitical conditions, including inflation, interest rates, recessions, pandemics, acts of war, tariffs and trade disruptions; protection of intellectual property; our ability to attract and retain key personnel; potential stock overhang and volatility in the trading price of our common stock; and consumer sentiment and discretionary spending trends. Although we believe that our plans, intentions and expectations reflected in or suggested by the forward-looking statements we make in this release are reasonable, we provide no assurance that these plans, intentions or expectations will be achieved. Consequently, you should not consider any such list to be a complete set of all potential risks and uncertainties.

More information on potential factors that could affect the Company’s financial results is included from time to time in the “Cautionary Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and subsequent reports. These filings are available at www.sec.gov and at our website at https://www.mangoceuticals.com/sec-filings . All subsequent written and oral forward-looking statements attributable to the Company or any person acting on behalf of the Company are expressly qualified in their entirety by the cautionary statements referenced above. Other unknown or unpredictable factors also could have material adverse effects on the Company’s future results. The forward-looking statements included in this press release are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and takes no obligation to update or correct information prepared by third parties that are not paid for by the Company. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.

FOR INVESTOR RELATIONS
Mangoceuticals Investor Relations
Email: investors@mangorx.com

Metagenomi Therapeutics, Inc. to Present at the 46th Annual TD Cowen Healthcare Conference

Metagenomi Therapeutics, Inc. to Present at the 46th Annual TD Cowen Healthcare Conference




Metagenomi Therapeutics, Inc. to Present at the 46th Annual TD Cowen Healthcare Conference

EMERYVILLE, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) — Metagenomi Therapeutics, Inc. (Nasdaq: MGX) (the “Company”), an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients, today announced that Jian Irish, Ph.D., M.B.A., President and Chief Executive Officer of the Company, will participate in a fireside chat at the 46th Annual TD Cowen Healthcare Conference, being held in Boston, MA, on Monday, March 2, 2026 at 11:10 a.m. ET.

The fireside chat presentation will be made available on the “News & Events” page in the Investors section of the Company’s website at https://ir.metagenomi.co/news-events/events.

About Metagenomi Therapeutics, Inc.

Metagenomi Therapeutics, Inc. is an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients. The Company was founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel editing tools potentially capable of correcting any type of genetic mutation found anywhere in the human genome. The Company focuses on high value programs in disease indications with well-understood biology and clearly defined clinical development and regulatory pathways. Going forward, the Company intends to continue to expand its pipeline by leveraging its proprietary genetic editing capabilities in site specific deletion, integration and correction.

MGX-001, the Company’s lead, wholly-owned development program in hemophilia A, has demonstrated a preclinical profile potentially competitive with best-in-class treatment options, including targeted genome editing and durable gene expression in a one-time treatment. MGX-001 is designed to provide curative, life-long protection from bleeding events and joint damage in adults and children with hemophilia A. The Company is also currently pursuing other secreted protein deficiencies leveraging the MGX-001 site-specific genome integration system and partnered assets targeting cardiometabolic diseases. For more information, please visit https://metagenomi.co.

Cautionary Note Regarding Forward-Looking Statements
This press release contains ​“forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” ​“expect,” ​“goal,” ​“intend,” ​“look forward to,” ​“may,” ​“plan,” ​“potential,” ​“predict,” ​“project,” ​“should,” ​“will,” ​“would” and similar expressions include, but are not limited to, any statements relating to our product development programs, including the timing of and our ability to conduct IND-enabling studies and make regulatory filings such as INDs, expectations regarding MGX-001, including the preclinical profile being potentially competitive with best-in-class treatment options and timing to submit the IND/CTA package, statements regarding the Company’s plans to prioritize its preclinical pipeline and potential for value creation and sustainable growth, statements regarding upcoming milestones including the nomination of development candidates, statements concerning the potential of therapies and product candidates, statements concerning the impact of the organizational restructuring, statements concerning our anticipated cash runway, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of IND submissions and starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation and the current regulatory environment; patent and intellectual property matters; competition; the volatility of capital markets and other adverse macroeconomic factors; as well as other risks described in ​“Risk Factors,” in our most recent Form 10-K and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Investor Contacts:

Stephen Jasper
Gilmartin Group
stephen@gilmartinir.com

Myriad Genetics Reports Fourth Quarter and Full-Year 2025 Financial Results; Reiterates 2026 Financial Guidance Reflecting Strengthened Execution

Myriad Genetics Reports Fourth Quarter and Full-Year 2025 Financial Results; Reiterates 2026 Financial Guidance Reflecting Strengthened Execution




Myriad Genetics Reports Fourth Quarter and Full-Year 2025 Financial Results; Reiterates 2026 Financial Guidance Reflecting Strengthened Execution

Highlights

  • Fourth quarter 2025 revenue of $209.8 million was consistent with fourth quarter 2024 revenue, but grew 4% year-over-year when excluding the previously discussed headwind1 of $8.1 million.
  • Full year 2025 revenue of $824.5 million decreased 2% year-over-year. Excluding headwinds2, full year 2025 revenue grew 2% year-over-year.
  • Drivers of fourth quarter 2025 test volume growth year-over-year include Prolaris prostate cancer test at 12%, Hereditary cancer testing at 9%, and GeneSight at 9%.
  • Fourth quarter 2025 gross margin was 70.0% and in-line with third quarter 2025.
  • Fourth quarter 2025 GAAP net loss of $7.9 million, or $0.08 per share, while adjusted EPS was $0.04 per share and adjusted EBITDA was $14.3 million.

SALT LAKE CITY, Feb. 23, 2026 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, today announced financial results for its fourth quarter ended December 31, 2025, and reaffirmed its financial guidance on business performance for the full-year 2026.

“We ended 2025 with positive momentum in a number of key areas, including within the Cancer Care Continuum where we drove another quarter of high single-digit volume growth in Hereditary cancer testing year-over-year and recognized improving volume growth for our Prolaris prostate cancer test. I’m also pleased to report improving volume growth in our GeneSight mental health test. We attribute this momentum to strengthened execution across the commercial team and the enterprise overall. Prenatal testing has been uneven through 2025 but we continue to make progress and expect growth to reaccelerate in the coming quarters,” said Sam Raha, President and CEO, of Myriad Genetics. “2026 is a milestone year for Myriad Genetics, with three significant new test launches, including Precise MRD, starting with a targeted alpha launch for breast cancer expected in March 2026, and full commercial launches of our AI-enabled Prolaris prostate cancer test in partnership with PATHOMIQ expected in the second quarter of 2026, and the multiple prenatal screen test, FirstGene, expected in the second half of 2026. We are looking forward to these tests supporting clinical decisions starting in 2026 and being important components of our growth in 2027 and beyond.”

_________________________________

1 Attributable to UNH discontinuation of coverage (commercial and managed Medicaid) of GeneSight.
2 Attributable to UNH discontinuation of coverage (commercial and managed Medicaid) of GeneSight and the divestiture of the European EndoPredict business.  

Financial and Operational Highlights

  • Test volumes of 382,000 in the fourth quarter of 2025 increased 2% year-over-year.
  • The following table summarizes year-over-year testing volume changes in the company’s core product categories:
  Three months ended December 31,   Twelve Months Ended December 31,
(in thousands) 2025   2024   % Change   2025   2024   % Change
Product volumes:                      
Hereditary cancer 82   75   9 %   315   294   7 %
Tumor profiling(1) 12   12   — %   48   53   (9 )%
Prenatal 150   160   (6 )%   637   666   (4 )%
Mental Health 138   127   9 %   537   507   6 %
Total 382   374   2 %   1,537   1,520   1 %
                       
(1) Tumor Profiling decreased for the twelve months ended December 31, 2025 compared to the same period in the prior year due primarily to a decrease in testing volume for EndoPredict due to the sale of the company’s international EndoPredict business in August 2024.
 
  • The following table summarizes year-over-year revenue changes in the company’s core product categories:
  Three months ended December 31,   Twelve Months Ended December 31,
(in millions) 2025   2024   % Change   2025   2024   % Change
Product revenues:                      
Hereditary cancer $ 96.8   $ 94.3   3 %   $ 372.4   $ 364.5   2 %
Tumor profiling(1)   31.5     30.8   2 %     121.7     125.8   (3 )%
Prenatal   44.9     44.9   — %     186.3     177.1   5 %
Mental Health   36.6     40.6   (10 )%     144.1     170.2   (15 )%
Total $ 209.8   $ 210.6   — %   $ 824.5   $ 837.6   (2 )%
             
(1) Tumor Profiling decreased for the twelve months ended December 31, 2025 compared to the same period in the prior year due primarily to a decrease in testing volume for EndoPredict due to the sale of the company’s international EndoPredict business in August 2024.
 
  • Operating expenses in the fourth quarter of 2025 were $152.5 million, decreasing $37.4 million year-over-year. Adjusted operating expenses in the fourth quarter of 2025 decreased $7.0 million year-over-year to $139.0 million, reflecting the company’s commitment to disciplined cost management while maintaining investments in key strategic areas.
  • Operating loss in the fourth quarter of 2025 was $5.7 million.

Cash Flow and Liquidity

Fourth quarter 2025 cash flow provided by operations was $10.6 million; adjusted operating cash flow in the fourth quarter of 2025 was $17.9 million. Capital expenditures and capitalization of internal use software costs totaled $6.0 million in the fourth quarter 2025 resulting in adjusted free cash flow of $11.9 million in the fourth quarter of 2025.

As of the end of the fourth quarter of 2025, the company had cash and cash equivalents of $149.6 million.

Business Performance and Highlights

Oncology

The Oncology business delivered revenue of $84.7 million in the fourth quarter of 2025.

  • Fourth quarter 2025 hereditary cancer testing revenue in Oncology increased 2% year-over-year driven by a 9% year-over-year increase in volume.
  • Fourth quarter 2025 Prolaris testing revenue grew 16% year-over-year. The company continues to make progress and intends to commercially launch its first AI-enabled prostate cancer test, in partnership with PATHOMIQ, in the first half of 2026.
  • The company advanced personalized breast cancer risk assessment through the launch of the first integrated AI and genetic risk platform, developed in partnership with Clairity and MagView. The company believes this solution enhances its leadership in precision breast health.
  • The company showcased nine new oncology and Molecular Residual Disease (MRD) research abstracts at the 2025 San Antonio Breast Cancer Symposium, highlighting continued progress in its precision oncology pipeline. The company believes these data reinforce the scientific strength behind the company’s MRD and hereditary cancer programs and underscore Myriad Genetics’ commitment to advancing clinically meaningful innovations for patients and providers.
  • In January 2026, at the 2026 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, collaborators from the National Cancer Center Hospital East in Japan reported positive interim key outcomes from MONSTAR-SCREEN-3, a multi-center, prospective study of patients with resectable Stage I-IV colorectal cancer that incorporates Precise MRD. These outcomes include 100% baseline sensitivity and highly sensitive detection of residual disease post-surgery.

Women’s Health

The Women’s Health business delivered revenue of $88.5 million in the fourth quarter of 2025.

  • Fourth quarter 2025 hereditary cancer testing revenue and volume for the unaffected population increased 3% and 11% year-over-year, respectively, demonstrating progress with implementing the company’s electronic medical records (EMR) solutions and breast cancer risk assessment programs.
  • Prenatal testing revenue in the fourth quarter of 2025 was stable year-over-year, while volume decreased 6% year-over-year reflecting transition dynamics following the second quarter 2025 implementation of the company’s new order management system.
  • The multi-site CONNECTOR study, using the company’s FirstGene Multiple Prenatal Screen, continues to see meaningful progress in enrollment and the Company expects this study to support future commercial launch activities and expand capabilities in prenatal testing.

Mental Health

GeneSight test revenue was $36.6 million in the fourth quarter of 2025.

  • Fourth quarter 2025 revenue continues to reflect the impact of UnitedHealthcare’s discontinuation of coverage of multi-gene panel pharmacogenetic testing, including GeneSight, effective in the first quarter of 2025.
  • GeneSight test volume in the fourth quarter of 2025 grew 9% year-over-year, reflecting ongoing improvement in the year-over-year volume growth through 2025.

Financial Guidance

Myriad Genetics does not provide forward-looking guidance in accordance with accounting principles generally accepted in the United States (GAAP) for the measures on which it provides forward-looking non-GAAP guidance as the company is unable to provide a quantitative reconciliation of forward-looking non-GAAP measures to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, are dependent on various factors, are out of the company’s control, or cannot be reasonably predicted. Such adjustments include, but are not limited to, strategic realignment, certain litigation charges and loss contingencies, costs related to acquisitions/divestitures and the related amortization, impairment and related charges, depreciation, equity compensation, tax benefits, and other adjustments. For example, stock-based compensation may fluctuate based on the timing of employee stock transactions and unpredictable fluctuations in the company’s stock price. Any associated estimate of these items and their impact on GAAP performance could vary materially.

Below is a table summarizing Myriad Genetics’ full-year 2026 financial guidance*:

(in millions, except percentages) 2026 Guidance   FY 2026  Comments
         
Revenue $860 – $880   Reiterate the full year 2026 revenue range. Q1’26 revenue is expected to be between $200 and $203 million, or 2% to 4% growth over Q1’25. This reflects current business trends offset by an unfavorable YOY comparison for Prenatal testing. 

Expect 2H’26 revenue to be greater than 1H’26

Adjusted Gross Margin %** 68% – 69%   Gross margins expected to fluctuate quarter to quarter given product mix and pricing trends.
Adjusted EBITDA*** $37 – $49   Q1’26 adjusted EBITDA is expected to be near breakeven
         
* Assumes currency rates as of February 23, 2026.
** Adjusted Gross Margin is defined as Gross Margin plus non-cash cost of sales, such as amortization of intangible assets and share-based compensation expense, and non-recurring one-time expenses.
*** Adjusted EBITDA is defined as Net income (loss) plus income tax expense (benefit), total other income (expense), non-cash operating expenses, such as amortization of intangible assets, depreciation, impairment of long-lived assets, and share-based compensation expense, and one-time expenses such as expenses from strategic realignment, legal settlements, and divestitures and acquisitions.
   

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release.

Conference Call and Webcast

A conference call will be held today, Monday, February 23, 2026, at 4:30 p.m. ET to discuss Myriad Genetics’ financial results and business developments for the fourth quarter of 2025. A live webcast of the conference call can be accessed on Myriad Genetics’ Investor Relations website at investor.myriad.com. To participate in the live conference call via telephone, please register at https://register-conf.media-server.com/register/BI5830bb581ca54ea4bd54f619ab018230. Upon registering, a dial-in number and unique PIN will be provided to join the conference call. Following the conference call, an archived webcast of the call will be available at investor.myriad.com.

About Myriad Genetics

Myriad Genetics is a leading molecular diagnostic and precision medicine company committed to advancing health and well-being for all. Myriad Genetics develops and commercializes molecular tests that help patients and providers uncover genetic insights. Our tests assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care, support earlier detection, enable more precise treatment and contribute to lowering healthcare costs. For more information, visit www.myriad.com.

Myriad, the Myriad logo, BRACAnalysis, BRACAnalysis CDx, Colaris, MyRisk, Myriad myRisk, MyRisk Hereditary Cancer, MyChoice, Tumor BRACAnalysis CDx, MyChoice CDx, Prequel, Prequel with Amplify, Amplify, Foresight, Foresight Universal Plus, Precise Tumor, Precise Oncology Solutions, Precise Liquid, Precise MRD, FirstGene, SneakPeek, SneakPeek Early Gender DNA Test, SneakPeek Snap, Urosuite, myGeneHistory, Health.Illuminated., RiskScore, Prolaris, and GeneSight are registered trademarks or trademarks of Myriad Genetics, Inc. All third-party marks—® and ™—are the property of their respective owners. © 2026 Myriad Genetics, Inc. All rights reserved.

Revenue by Product (Unaudited)

  Three months ended December 31,
(in millions) 2025   2024    
  WH ONC MH Total   WH ONC MH Total   % Change
Hereditary Cancer $ 43.6 $ 53.2 $ — $ 96.8   $ 42.3 $ 52.0 $ — $ 94.3   3 %
Tumor Profiling   —   31.5   —   31.5     —   30.8   —   30.8   2 %
Prenatal   44.9   —   —   44.9     44.9   —   —   44.9   — %
Mental Health   —   —   36.6   36.6     —   —   40.6   40.6   (10 )%
Total Revenue $ 88.5 $ 84.7 $ 36.6 $ 209.8   $ 87.2 $ 82.8 $ 40.6 $ 210.6   — %
                                         

  Twelve months ended December 31,
(in millions) 2025   2024    
  WH ONC MH Total   WH ONC MH Total   % Change
Hereditary Cancer $ 164.4 $ 208.0 $ — $ 372.4   $ 163.1 $ 201.4 $ — $ 364.5   2 %
Tumor Profiling   —   121.7   —   121.7     —   125.8   —   125.8   (3 )%
Prenatal   186.3   —   —   186.3     177.1   —   —   177.1   5 %
Mental Health   —   —   144.1   144.1     —   —   170.2   170.2   (15 )%
Total Revenue $ 350.7 $ 329.7 $ 144.1 $ 824.5   $ 340.2 $ 327.2 $ 170.2 $ 837.6   (2 )%
                                       

Business Units:
WH = Women’s Health
ONC = Oncology
MH = Mental Health

Product Categories:
Hereditary Cancer – MyRisk, BRACAnalysis, BRACAnalysis CDx
Tumor Profiling – myChoice CDx, Prolaris, Precise Tumor, EndoPredict
Prenatal – Foresight, Prequel, SneakPeek
Mental Health – GeneSight

MYRIAD GENETICS, INC.
AND SUBSIDIARIES
Condensed Consolidated Statements of Operations (unaudited)
(in millions, except per share amounts)
 
  Three months ended December 31,   Twelve months ended December 31,
  2025   2024   2025   2024
Revenue $ 209.8     $ 210.6     $ 824.5     $ 837.6  
Cost of revenue   63.0       59.7       247.9       252.2  
Gross profit   146.8       150.9       576.6       585.4  
               
Operating expenses:              
Research and development expense   25.5       29.7       106.8       113.4  
Sales and marketing expense   68.7       72.0       280.8       284.1  
General and administrative expense   55.6       66.5       256.8       275.9  
Legal settlements   —       (21.3 )     —       (21.3 )
Goodwill and long-lived asset impairment charges   2.7       43.0       319.4       56.8  
Total operating expenses   152.5       189.9       963.8       708.9  
Operating loss   (5.7 )     (39.0 )     (387.2 )     (123.5 )
Other income (expense):              
Interest income   0.8       0.3       1.8       1.7  
Interest expense   (4.4 )     (0.7 )     (10.5 )     (2.8 )
Other   0.4       0.3       0.8       1.1  
Total other expense   (3.2 )     (0.1 )     (7.9 )     —  
Loss before income tax   (8.9 )     (39.1 )     (395.1 )     (123.5 )
Income tax (benefit) expense   (1.0 )     3.4       (29.2 )     3.8  
Net loss $ (7.9 )   $ (42.5 )   $ (365.9 )   $ (127.3 )
Net loss per share:              
Basic and Diluted $ (0.08 )   $ (0.47 )   $ (3.95 )   $ (1.41 )
Weighted average shares outstanding:              
Basic and Diluted   93.3       91.1       92.6       90.6  
                               

MYRIAD GENETICS, INC.
AND SUBSIDIARIES
Condensed Consolidated Balance Sheets (unaudited)
(in millions, except per share amounts)
 
  December 31,
2025
  December 31,
2024
ASSETS      
Current assets:      
Cash and cash equivalents $ 149.6     $ 102.4  
Trade accounts receivable   115.3       121.2  
Inventory   30.6       27.5  
Prepaid taxes   12.0       16.4  
Prepaid expenses and other current assets   25.1       30.5  
Total current assets   332.6       298.0  
Operating lease right-of-use assets   49.4       55.0  
Property, plant and equipment, net   114.0       117.4  
Intangible assets, net   153.4       262.4  
Goodwill   51.6       286.3  
Other assets   5.6       8.5  
Total assets $ 706.6     $ 1,027.6  
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:      
Accounts payable $ 30.0     $ 32.3  
Accrued liabilities   96.9       119.0  
Current maturities of operating lease liabilities   6.9       12.8  
Total current liabilities   133.8       164.1  
Unrecognized tax benefits   0.2       32.7  
Long-term debt   119.9       39.6  
Noncurrent operating lease liabilities   83.0       87.9  
Other long-term liabilities   1.7       2.2  
Total liabilities   338.6       326.5  
Commitments and contingencies      
Stockholders’ equity:      
Common stock, 93.5 and 91.3 shares outstanding at December 31, 2025 and December 31, 2024, respectively   0.9       0.9  
Additional paid-in capital   1,489.0       1,457.8  
Accumulated other comprehensive income (loss)   0.8       (0.8 )
Accumulated deficit   (1,122.7 )     (756.8 )
Total stockholders’ equity   368.0       701.1  
Total liabilities and stockholders’ equity $ 706.6     $ 1,027.6  
               

MYRIAD GENETICS, INC.
AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows (unaudited)
(in millions)
 
  Three months ended
December 31,
  Twelve months ended
December 31,
  2025   2024   2025   2024
Net cash provided by (used in) operating activities $ 10.6     $ 6.6     $ 1.8     $ (8.7 )
Net cash used in investing activities   (6.0 )     (5.9 )     (27.4 )     (11.9 )
Net cash provided by (used in) financing activities   (8.2 )     2.1       64.2       (7.4 )
Effect of foreign exchange rates on cash, cash equivalents, and restricted cash   0.1       (0.7 )     0.8       (1.0 )
Net increase (decrease) in cash, cash equivalents, and restricted cash   (3.5 )     2.1       39.4       (29.0 )
Cash, cash equivalents, and restricted cash at beginning of the period   154.8       109.8       111.9       140.9  
Cash, cash equivalents, and restricted cash at end of the period $ 151.3     $ 111.9     $ 151.3     $ 111.9  
                               

Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including (i) the company’s full-year 2026 financial guidance, (ii) the company’s continued progress in prenatal testing and expectation that prenatal testing growth will reaccelerate in the coming quarters, (iii) the company’s intention to launch, and the expected timing thereof, three significant new tests, including an alpha phase launch of Precise MRD, full commercial launches of its AI-enabled Prolaris prostate cancer test and the multiple prenatal screen test, FirstGene, and (iv) the expected benefits of the CONNECTOR study. These “forward-looking statements” are management’s present expectations of future events as of the date hereof and are subject to a number of known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated.

These risks include, but are not limited to: the risk that sales and profit margins of the company’s existing tests may decline; the risk that the company may not be able to operate its business on a profitable basis; risks related to the company’s ability to achieve certain revenue growth targets and generate sufficient revenue from its existing product portfolio or in launching and commercializing new tests to be profitable; risks related to recent changes in the company’s senior management team and the successful implementation of the company’s strategic plan; risks related to changes in governmental or private insurers’ coverage and reimbursement levels for the company’s tests or the company’s ability to obtain reimbursement for its new tests at comparable levels to its existing tests; risks related to increased competition and the development of new competing tests; the risk that the company may be unable to develop or achieve commercial success for additional tests in a timely manner, or at all; the risk that the company is not able to secure additional financing to fund its business, if needed, in a timely manner or on favorable terms, if it all; the risk that the company may not successfully develop new markets or channels for its tests; the risk that licenses to the technology underlying the company’s tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating the company’s laboratory testing facilities; risks related to public concern over genetic testing in general or the company’s tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to the company’s ability to obtain new corporate collaborations or licenses and acquire or develop new technologies or businesses on satisfactory terms, if at all; risks related to the company’s ability to successfully integrate and derive benefits from any technologies or businesses that it licenses, acquires or develops; risks related to the company’s projections or estimates about the potential market opportunity for the company’s current and future products; the risk that the company or its licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying the company’s tests; the risk of patent-infringement claims or challenges to the validity of the company’s patents; risks related to changes in intellectual property laws covering the company’s tests, or patents or enforcement, in the United States and foreign countries; risks related to security breaches, loss of data and other disruptions, including from cyberattacks and other cybersecurity incidents; risks of new, changing and competitive technologies in the United States and internationally and that the company may not be able to keep pace with the rapid technology changes in its industry, or properly leverage new technologies to achieve or sustain competitive advantages in its products; the risk that the company may be unable to comply with financial or operating covenants under the company’s credit or lending agreements; the risk that the company may not be able to maintain effective disclosure controls and procedures and internal control over financial reporting; risks related to current and future investigations, claims or lawsuits, including derivative claims, product or professional liability claims, and risks related to the amount of the company’s insurance coverage limits and scope of insurance coverage with respect thereto; and other factors discussed under the heading “Risk Factors” contained in Part I, Item 1A of the company’s Annual Report on Form 10-K filed with the SEC on February 28, 2025, as well as any updates to those risk factors filed from time to time in the company’s subsequent Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. The company is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.

Investor Contact
Matt Scalo
(801) 584-3532
matt.scalo@myriad.com

Media Contact
Kate Schraml        
(224) 875-4493
PR@myriad.com

Statement regarding use of non-GAAP financial measures

In this press release, the company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. Management believes that presentation of operating results using non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the company’s core operating results and comparison of operating results across reporting periods. Management also uses non-GAAP financial measures to establish budgets and to manage the company’s business. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the schedules below and a description of the adjustments made to the GAAP financial measures is included at the end of each schedule.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, if available, to more fully understand its business. Non-GAAP financial results are reported in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.

The company does not forecast GAAP gross margin or GAAP net income (loss) because it cannot predict certain elements that are included in reported GAAP results. Please see above under “Financial Guidance” for a full explanation.

Reconciliation of GAAP to Non-GAAP Financial Measures
for the Three and Twelve Months Ended December 31, 2025 and 2024
(unaudited data in millions, except per share amounts)

    Three months ended
December 31,
  Twelve months ended
December 31,
    2025   2024
  2025   2024
Adjusted Operating Expenses                              
Operating Expenses $ 152.5     $ 189.9     $ 963.8     $ 708.9  
Acquisition – amortization of intangible assets(1)   (6.4 )     (9.6 )     (29.8 )     (40.2 )
Goodwill and long-lived asset impairment(2)   (2.7 )     (43.0 )     (319.4 )     (56.8 )
Equity compensation(3)   (2.6 )     (10.7 )     (34.1 )     (48.3 )
Real estate optimization(4)   —       (1.7 )     (5.2 )     (7.2 )
Transformation initiatives(5)   —       —       —       (6.6 )
Strategic realignment(6)   (2.1 )     —       (12.2 )     —  
Legal settlements(7)   —       21.1       —       20.6  
Other adjustments(8)   0.3       —       0.3       (3.5)  
Adjusted Operating Expenses $ 139.0     $ 146.0     $ 563.4     $ 566.9  
                                 
(1) Represents recurring amortization charges resulting from the acquisition of intangible assets.  
(2) Expense related to goodwill and long-lived asset impairment. For the twelve months ended December 31, 2025, consists of $319.4 million of impairment expense primarily associated with our Mental Health and Women’s Health reporting units and asset groups. For the three months ended December 31, 2024, consists of $43.0 million of impairment expense for a GeneSight developed technology intangible asset. For the twelve months ended December 31, 2024, consists of $43.0 million of impairment expense for a GeneSight developed technology intangible asset and $13.8 million primarily related to the sale of the EndoPredict business to Eurobio Scientific.  
(3) Consists of the non-cash equity-based compensation provided to Myriad Genetics employees and directors.  
(4) Costs related to real estate initiatives. For the twelve months ended December 31, 2025, consists of additional rent as a result of the build-out of our new laboratories in Salt Lake City, Utah and South San Francisco, California, while maintaining our previous facilities in those locations. For the three and twelve months ended December 31, 2024, includes additional rent as a result of the build-out of our new laboratories in Salt Lake City, Utah and South San Francisco, California, while maintaining our previous facilities in those locations, costs associated with the voluntary termination of a lease, testing and set-up costs for equipment in our new facilities, and impairment in connection with the ceased use of one of our facilities.  
(5) Costs related to transformation initiatives including consulting and professional fees for the twelve months ended December 31, 2024.  
(6) Costs related to strategic realignment of the company including severance and consulting fees for the three and twelve months ended December 31, 2025.   
(7) Costs related to one-time legal expenses. For the three and twelve months ended December 31, 2024, primarily includes reversal of $21.3 million related to the contingent settlement for the Ravgen litigation that is no longer considered probable.   
(8) Other one-time non-recurring adjustments for the three and twelve months ended December 31, 2025. For the twelve months ended December 31, 2024, primarily includes a gain recognized on acquisition, changes in the fair value of contingent consideration related to acquisitions from prior years, the reclassifications of cumulative translation adjustments to income upon liquidation of an investment in a foreign entity, and costs incurred in connection with executive personnel changes.  
     
    Three months ended
December 31,
  Twelve months ended
December 31,
    2025
  2024
  2025   2024
Adjusted Net Income(1)                              
Net Loss $ (7.9 )   $ (42.5 )   $ (365.9 )   $ (127.3 )
Acquisition – amortization of intangible assets(2)   6.5       10.0       30.5       41.5  
Goodwill and long-lived asset impairment(3)   2.7       43.0       319.4       56.8  
Equity compensation(4)   2.8       10.9       35.2       49.8  
Real estate optimization(5)   —       1.7       5.2       7.2  
Transformation initiatives(6)   —       —       —       6.6  
Strategic realignment(7)   2.1       —       12.2       —  
Legal settlements(8)   —       (21.1 )     —       (20.6 )
Other adjustments(9)   (0.6 )     0.8       (0.2 )     3.3  
Uncertain tax benefit(10)   (0.4 )     —       (29.4 )     —  
Tax adjustments(11)   (1.3 )     0.4       (1.2 )     (4.8 )
Adjusted Net Income $ 3.9     $ 3.2     $ 5.8     $ 12.5  
                                 
Weighted average shares outstanding:                              
Diluted   94.6       92.1       93.4       92.1  
Adjusted Earnings Per Share                              
Diluted $ 0.04     $ 0.03     $ 0.06     $ 0.14  
                                 
(1) To determine Adjusted Earnings Per Share, or adjusted EPS.  
(2) Represents recurring amortization charges resulting from the acquisition of intangible assets.  
(3) Expense related to goodwill and long-lived asset impairment. For the twelve months ended December 31, 2025, consists of $319.4 million of impairment expense primarily associated with our Mental Health and Women’s Health reporting units and asset groups. For the three months ended December 31, 2024, consists of $43.0 million of impairment expense for a GeneSight developed technology intangible asset. For the twelve months ended December 31, 2024, consists of $43.0 million of impairment expense for a GeneSight developed technology intangible asset and $13.8 million primarily related to the sale of the EndoPredict business to Eurobio Scientific.  
(4) Consists of the non-cash equity-based compensation provided to Myriad Genetics employees and directors.  
(5) Costs related to real estate initiatives. For the twelve months ended December 31, 2025, consists of additional rent as a result of the build-out of our new laboratories in Salt Lake City, Utah and South San Francisco, California, while maintaining our previous facilities in those locations. For the three and twelve months ended December 31, 2024, includes additional rent as a result of the build-out of our new laboratories in Salt Lake City, Utah and South San Francisco, California, while maintaining our previous facilities in those locations, costs associated with the voluntary termination of a lease, testing and set-up costs for equipment in our new facilities, and impairment in connection with the ceased use of one of our facilities.  
(6) Costs related to transformation initiatives including consulting and professional fees for the twelve months ended December 31, 2024.  
(7) Costs related to strategic realignment of the company including severance and consulting fees for the three and twelve months ended December 31, 2025.   
(8) Costs related to one-time legal expenses. For the three and twelve months ended December 31, 2024, primarily includes reversal of $21.3 million related to the contingent settlement for the Ravgen litigation that is no longer considered probable.   
(9) Other one-time non-recurring adjustments for the three and twelve months ended December 31, 2025. For the twelve months ended December 31, 2024, primarily includes a gain recognized on acquisition, changes in the fair value of contingent consideration related to acquisitions from prior years, the reclassifications of cumulative translation adjustments to income upon liquidation of an investment in a foreign entity, and costs incurred in connection with executive personnel changes.  
(10) Consists of the release of unrecognized tax benefits and the recognition of valuation allowances for the three and twelve months ended December 31, 2025. The unrecognized tax benefits released were primarily related to tax years under Joint Committee on Taxation review, which upon conclusion of the review were remeasured or released.  
(11) Tax expense or benefit due to non-GAAP adjustments, differences between stock compensation recorded for book purposes as compared to the allowable tax deductions, and valuation allowance recognized against federal and state deferred tax assets in the United States. As of December 31, 2025, a valuation allowance of $103.6 million was not recognized for non-GAAP purposes given our historical and forecasted positive earnings performance. As of December 31, 2024, a valuation allowance of $64 million was not recognized for non-GAAP purposes given the company’s historical and forecasted positive earnings performance.  
     

    Three months ended
December 31,
  Twelve months ended
December 31,
    2025
  2024
  2025
  2024
Adjusted EBITDA                              
Net Loss $ (7.9 )   $ (42.5 )   $ (365.9 )   $ (127.3 )
Acquisition – amortization of intangible assets(1)   6.5       10.0       30.5       41.5  
Depreciation expense(2)   4.7       4.7       19.5       17.9  
Goodwill and long-lived asset impairment(3)   2.7       43.0       319.4       56.8  
Equity compensation(4)   2.8       10.9       35.2       49.8  
Real estate optimization(5)   —       1.7       5.2       7.2  
Transformation initiatives(6)   —       —       —       6.6  
Strategic realignment(7)   2.1       —       12.2       —  
Legal settlements(8)   —       (21.1 )     —       (20.6 )
Interest expense, net of interest income(9)   3.6       0.4       8.7       1.1  
Other adjustments(10)   0.8       0.1       3.3       3.6  
Uncertain tax benefits(11)   (0.4 )     —       (29.4 )     —  
Income tax (benefit) expense(12)   (0.6 )     3.4       0.2       3.8  
Adjusted EBITDA $ 14.3     $ 10.6     $ 38.9     $ 40.4  
                                 
(1) Represents recurring amortization charges resulting from the acquisition of intangible assets.  
(2) Depreciation expense excludes depreciation included in real estate optimization of $0.3 million and $1.6 million for the three and twelve months ended December 31, 2024, respectively.      
(3) Expense related to goodwill and long-lived asset impairment. For the twelve months ended December 31, 2025, consists of $319.4 million of impairment expense primarily associated with our Mental Health and Women’s Health reporting units and asset groups. For the three months ended December 31, 2024, consists of $43.0 million of impairment expense for a GeneSight developed technology intangible asset. For the twelve months ended December 31, 2024, consists of $43.0 million of impairment expense for a GeneSight developed technology intangible asset and $13.8 million primarily related to the sale of the EndoPredict business to Eurobio Scientific.  
(4) Consists of the non-cash equity-based compensation provided to Myriad Genetics employees and directors.  
(5) Costs related to real estate initiatives. For the twelve months ended December 31, 2025, consists of additional rent as a result of the build-out of our new laboratories in Salt Lake City, Utah and South San Francisco, California, while maintaining our previous facilities in those locations. For the three and twelve months ended December 31, 2024, includes additional rent as a result of the build-out of our new laboratories in Salt Lake City, Utah and South San Francisco, California, while maintaining our previous facilities in those locations, costs associated with the voluntary termination of a lease, testing and set-up costs for equipment in our new facilities, and impairment in connection with the ceased use of one of our facilities.  
(6) Costs related to transformation initiatives including consulting and professional fees for the twelve months ended December 31, 2024.  
(7) Costs related to strategic realignment of the company including severance and consulting fees for the three and twelve months ended December 31, 2025.  
(8) Costs related to one-time legal expenses. For the three and twelve months ended December 31, 2024, primarily includes reversal of $21.3 million related to the contingent settlement for the Ravgen litigation that is no longer considered probable.  
(9) Derived from interest expense and interest income from the Condensed Consolidated Statements of Operations.  
(10) Other one-time non-recurring expenses. For purposes of adjusted EBITDA, this includes Other adjustments described in the Adjusted Net Income table above as well as the amounts reported as Other income (expense) in the Condensed Consolidated Statement of Operations.  
(11) Consists of the release of unrecognized tax benefits and the recognition of valuation allowances for the three and twelve months ended December 31, 2025. The unrecognized tax benefits released were primarily related to tax years under Joint Committee on Taxation review, which upon conclusion of the review were remeasured or released.  
(12) Derived from income tax (benefit) expense from the Condensed Consolidated Statement of Operations, net of the adjustment for unrecognized tax benefits described above in Note 11 above.   
     

    Three months ended
December 31,
  Twelve months ended
December 31,
    2025
  2024
  2025
  2024
Adjusted operating and free cash flow                              
Net cash provided by (used in) operating activities $ 10.6     $ 6.6     $ 1.8     $ (8.7 )
Real estate optimization(1)   0.5       2.7       9.2       14.4  
Transformation initiatives(2)   —       —       —       6.6  
Strategic realignment(3)   6.8       —       10.9       —  
Legal settlements(4)   —       6.1       —       6.7  
Contingent consideration payment(5)   —       —       —       5.8  
Other adjustments(6)   —       —       0.2       3.5  
Adjusted operating cash flow $ 17.9     $ 15.4     $ 22.1     $ 28.3  
Capital expenditures(7)   (4.7 )     (3.6 )     (15.6 )     (19.0 )
Capitalization of internal-use software costs(7)   (1.3 )     (2.3 )     (11.8 )     (10.7 )
Adjusted free cash flow $ 11.9     $ 9.5     $ (5.3 )   $ (1.4 )
                                 
(1) The cash flow effect of real estate optimizations, excluding non-cash items such as accelerated depreciation.  
(2) Transformation initiatives includes the cash paid for those costs in the related periods.  
(3) Strategic realignment includes the cash paid for those costs for the three and twelve months ended December 31, 2025.  
(4) The cash flow effect of legal expense in the related period.  
(5) The payment of contingent consideration related to the previous acquisition of Sividon Diagnostics GmbH.  
(6) The cash flow effect of executive personnel changes and severance for the twelve months ended December 31, 2024.  
(7) Derived from the Condensed Consolidated Statements of Cash Flows.