Novocure Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Company Update

On February 26, 2026 Novocure (NASDAQ: NVCR) reported financial results for the quarter and full year ended December 31, 2025. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2025, a record number of patients received treatment with Novocure’s Tumor Treating Fields therapy, a milestone that reflects our growth and commitment to advancing the treatment of cancer with our technology," said Frank Leonard, CEO, Novocure. "This momentum continues in 2026 with the U.S. FDA approval of Optune Pax for pancreatic cancer, an achievement we are incredibly proud of given the exceptional challenge of developing treatment for this disease. We are well-positioned to continue to drive our patient-forward mission while prioritizing our goal of achieving profitability."

Financial updates for the year and fourth quarter ended December 31, 2025:

Total net revenues for the year were $655.4 million, an increase of 8% year-over-year.
Total net revenues for the fourth quarter were $174.4 million, an increase of 8% year-over-year, primarily driven by an increase in active patients on therapy.
The U.S., Germany, France and Japan contributed $101.6 million, $21.3 million, $20.3 million and $10.2 million in quarterly net revenues, respectively, with our other active markets contributing $16.3 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.6 million.
Recognized revenue from Optune Lua in the fourth quarter was $3.5 million, including $2.4 million from non-small cell lung cancer (NSCLC) and $1.1 million from malignant pleural mesothelioma (MPM).
Gross margin for the quarter was 76%, compared to 79% in the same period in 2024. The reduction was primarily driven by the continued roll out of our Head Flexible Electrode (HFE) array for use with Optune Gio, costs associated with treating NSCLC patients prior to establishing reimbursement and increased tariffs.
Research, development and clinical studies expenses for the quarter were $60.9 million, an increase of 19% from the same period in 2024, primarily driven by higher clinical trial costs associated with the KEYNOTE D58 and LUNAR-2 trials, as well as higher regulatory affairs expenses.
Sales and marketing expenses for the quarter were $68.7 million, an increase of 2% from the same period in 2024, primarily driven by higher marketing expenses in preparation for the U.S. launch of Optune Pax.
General and administrative expenses for the quarter were $43.0 million, a decrease of 41% from the same period in 2024. This was primarily driven by a decrease in share-based compensation expenses.
Net loss for the quarter was $24.5 million with loss per share of $0.22.
Adjusted EBITDA* for the quarter was $(16.4) million.
Cash, cash equivalents and short-term investments were $447.7 million as of December 31, 2025.
Operational updates for the year and fourth quarter ended December 31, 2025:

As of December 31, 2025, there were 4,620 total active patients on TTFields therapy globally.
Optune Gio
1,609 Optune Gio prescriptions for the treatment of glioblastoma (GBM) were received in the quarter, an increase of 6% from the same period in 2024. The U.S., Germany, France and Japan contributed 950; 178; 197 and 139 prescriptions, respectively, with the remaining 145 prescriptions contributed by other active markets.
As of December 31, 2025, there were 4,464 active Optune Gio patients on therapy. The U.S., Germany, France and Japan contributed 2,251; 623; 509 and 542 Optune Gio active patients, respectively, with the remaining 539 active patients contributed by other active markets.
Optune Lua
145 total prescriptions for Optune Lua were received in the quarter.
118 Optune Lua prescriptions were received for the treatment of NSCLC. The U.S., Germany and France contributed 87; 29 and 1 prescriptions, respectively, with the remaining 1 prescription received from other active markets.
27 Optune Lua prescriptions were received for the treatment of MPM. The U.S. and Germany contributed 10 and 16 prescriptions, respectively, with the remaining 1 prescription received from other active markets.
As of December 31, 2025, there were 122 active Optune Lua patients on therapy for the treatment of NSCLC. The U.S. and Germany contributed 102 and 19 active patients, respectively, with the remaining 1 active patient contributed by other active markets.
As of December 31, 2025, there were 34 active Optune Lua patients on therapy for the treatment of MPM. The U.S. and Germany contributed 8 and 24 active patients, respectively, with the remaining 2 active patients contributed by other active markets.
In its Q1 2026 financial reporting, Novocure intends to stop reporting new prescriptions received in indications which have been commercially available for more than one year (GBM, MPM and NSCLC). Prescriptions received for the treatment of pancreatic cancer will be provided for a one-year period following launch. Novocure will continue to report active patients on therapy separated by product (Optune Gio, Optune Lua, Optune Pax) and material market.
Fourth quarter and recent updates:

December 2025
Novocure announced the appointment of Frank Leonard as Chief Executive Officer. Mr. Leonard previously served as Novocure’s President.
Novocure submitted the final module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for TTFields therapy use for the treatment of brain metastases from NSCLC.
January 2026
Public health insurers in Czechia announced coverage for Optune Gio for the treatment of adult patients with newly diagnosed GBM.
February 2026
The U.S. FDA approved Optune Pax for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel.
British Columbia (BC) Cancer announced coverage for Optune Gio for adult patients with newly diagnosed GBM.
Chief Medical Officer Nicolas Leupin, M.D., Ph.D., resigned effective February 25, 2026. Chief Innovation Officer Uri Weinberg, M.D., Ph.D. will lead the organization that reported to Dr. Leupin.
In January 2026, Novocure’s billing privileges for its products with the U.S. Centers for Medicare & Medicaid Services (CMS) were revoked retroactive to December 17, 2025 due to an administrative process issue identified during Novocure’s DME supplier re-validation. On February 24, 2026, Novocure received notification from CMS rescinding the revocation of billing privileges and reinstating Novocure’s billing privileges retroactively to December 17, 2025. Novocure does not believe there will be any impact to its ability to recognize revenue for services provided during the period of ineligibility.
William Vernon stepped down as Lead Independent Director and Chairperson of Novocure’s Compensation Committee, effective February 25, 2026. Martin Madden, current member of the board, assumed the roles of Lead Independent Director and Chairperson of the Compensation Committee. Mr. Vernon continues to serve as a director of Novocure’s board.

(Press release, NovoCure, FEB 26, 2026, View Source [SID1234663098])

Crescent Biopharma Reports Fourth Quarter and Full Year 2025 Financial Results
and Recent Business Highlights

On February 26, 2026 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported financial results for the fourth quarter and full year ended December 31, 2025, and recent business highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2025 was a transformational year for Crescent and our efforts to deliver next generation therapies that can improve outcomes for people living with cancer. We expanded our pipeline and accelerated our efforts to deliver best-in-class novel combinations through our exciting partnership with Kelun-Biotech," said Joshua Brumm, chief executive officer of Crescent. "We now have our Phase 1/2 ASCEND clinical trial underway for CR-001, which is positioned to be an immuno-oncology backbone in the treatment of solid tumors. Three more trials are on track to initiate this year, including the first Phase 1/2 ADC combination trial with CR-001. We are rapidly advancing toward multiple clinical data readouts beginning in the first quarter of 2027 and with our recent private placement, we are well funded to deliver on these milestones."

Recent Business Highlights & Anticipated Milestones

Corporate
•In December 2025, Crescent announced a strategic partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech") to develop and commercialize next generation oncology therapeutics, including novel combinations. Under the terms of the collaboration, Crescent granted Kelun-Biotech exclusive rights to research, develop, and commercialize CR-001 (also known as SKB118), an investigational PD-1 x VEGF bispecific antibody, in Greater China (including mainland China, Hong Kong, Macau and Taiwan). In addition, Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (also known as SKB105), an investigational integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload, in the United States, Europe and all markets outside of Greater China. The collaboration includes the development of these candidates as monotherapies, and also the evaluation of CR-001 in combination with CR-003 and with additional ADCs.

•In December 2025, Crescent completed a $185 million private placement with support from leading healthcare investors.
Pipeline
CR-001, PD-1 x VEGF bispecific antibody
•CR-001 is a tetravalent bispecific antibody that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF.

•In January 2026, Crescent announced that the U.S. Food and Drug Administration (FDA) cleared Crescent’s Investigational New Drug (IND) application for CR-001 for the treatment of advanced solid tumors.
•In February 2026, Crescent announced the dosing of the first patient in ASCEND, a global, open-label Phase 1/2 clinical trial evaluating CR-001 in multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological cancers, in both treatment-naïve and previously treated patients. Crescent anticipates reporting proof-of-concept clinical data from the ASCEND trial in the first quarter of 2027, including initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity from dose escalation and backfill cohorts in first-line and previously treated patients.

•Crescent also plans to evaluate CR-001 in combination with multiple ADCs, including CR-002 and CR-003. Initiation of the first Phase 1/2 ADC combination trial with CR-001 is expected in the second half of 2026, with initial data anticipated by year-end 2027.
CR-002, topoisomerase inhibitor ADC targeting PD-L1
•CR-002 is a topoisomerase inhibitor ADC directed to PD-L1, a validated target known to have high expression in multiple solid tumors. CR-002 incorporates a PD-L1 antibody selected for high internalization to facilitate payload release in target cells and a linker designed for intracellular cleavage and high stability in circulation.
•Crescent is on track to submit an IND to the FDA for CR-002 in mid-2026 to support the initiation of a Phase 1/2 trial in solid tumors in the second half of 2026, with proof-of-concept data expected in the second half of 2027.
CR-003, topoisomerase inhibitor ADC targeting integrin beta-6
•CR-003 is a topoisomerase inhibitor ADC directed to ITGB6, which is overexpressed in many solid tumors with minimal expression in most normal tissues. CR-003 consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker.
•In January 2026, Kelun-Biotech received IND approval for CR-003 for the treatment of advanced solid tumors from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.
•Kelun-Biotech plans to initiate a Phase 1/2 trial of CR-003 in Greater China in the first quarter of 2026, with proof-of-concept data expected in the first quarter of 2027. A Phase 1/2 combination trial of CR-003 and CR-001 is expected to initiate in the first half of 2027, with initial data anticipated by year-end 2027.
Fourth Quarter and Full Year 2025 Financial Results
Cash position: Cash and cash equivalents were $213.2 million as of December 31, 2025, which is anticipated to fund operations into 2028.

Revenue: Revenue for the three and twelve months ended December 31, 2025 was $10.8 million compared to no revenue in 2024. The revenue recognized in 2025 is the result of the $20.0 million upfront payment received from Kelun-Biotech pursuant to the license agreement for CR-001.

Research and development (R&D) expenses: R&D expenses were $95.0 million and $11.6 million for the three months ended December 31, 2025 and 2024, respectively. R&D expenses were $138.1 million and $14.0 million for the twelve months ended December 31, 2025 and the period from September 19, 2024 (inception) through December 31, 2024, respectively. The increase in R&D expenses is the result of continued development of CR-001 and CR-002 as well as the $80.0 million upfront payment made to Kelun-Biotech pursuant to the license agreement for CR-003.

General and administrative (G&A) expenses: G&A expenses were $7.3 million and $3.0 million for the three months ended December 31, 2025 and 2024, respectively. G&A expenses were $25.4 million and $3.2 million for the twelve months ended December 31, 2025 and the period from September 19, 2024 (inception) through December 31, 2024, respectively. The increase in G&A expenses is the result of personnel costs, including share-based compensation, and professional services associated with operating as a public company.

Net loss: Net loss was $92.4 million and $15.2 million, or $4.01 and $19.74 per basic and diluted share, for the three months ended December 31, 2025 and 2024, respectively. Net loss was $153.9 million and $17.9 million, or $12.81 and $23.28 per basic and diluted share, for the twelve months ended December 31, 2025 and the period from September 19, 2024 (inception) through December 31, 2024, respectively.

Shares outstanding: As of December 31, 2025, Crescent had approximately 33.3 million shares of the Company’s ordinary shares and ordinary share equivalents issued and outstanding, including ordinary shares underlying pre-funded warrants and non-voting convertible preferred stock.

(Press release, Crescent Biopharma, FEB 26, 2026, View Source [SID1234663064])

Nuvalent Outlines Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2025 Financial Results

On February 26, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress, reiterated key anticipated milestones, and announced fourth quarter and full year 2025 financial results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As we advance toward the culmination of our OnTarget 2026 operating plan with a first potential FDA approval targeted for later this year, our focus remains on applying the disciplined, patient-centric approach that has enabled rapid progress in discovery and development across our pipeline towards building the capabilities needed to effectively deliver new medicines to patients," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We are executing against our initial registration paths for zidesamtinib and neladalkib in TKI pre-treated patients and are well underway with launch readiness efforts to ensure we have the commercial infrastructure in place to deliver these medicines to patients, if approved. In parallel, we continue to pursue label expansion opportunities for TKI-naïve patients towards our goal of bringing new therapies to all patients with ROS1-positive or ALK-positive NSCLC, and advance our earlier-stage and discovery programs. With a steady cadence of anticipated milestones across our pipeline in 2026 and a strong balance sheet, we believe we are positioned to become an enduring leader in precision oncology across the full continuum of discovery, development, and delivery, built to serve patients for years to come."

Recent Pipeline Achievements and Anticipated 2026 Milestones

ROS1 Program


The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI), and assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Pending FDA review, Nuvalent anticipates U.S. commercial launch of zidesamtinib in 2026.

Nuvalent plans to submit data to the FDA to support a potential label expansion of zidesamtinib in TKI-naïve patients with advanced ROS1-positive NSCLC in the second half of 2026.

ALK Program


Nuvalent completed its pre-NDA meeting with the FDA and aligned on a submission strategy for neladalkib in TKI pre-treated ALK-positive NSCLC. The company plans to move forward with an NDA submission of the data for TKI pre-treated patients with advanced ALK-positive NSCLC from the ALKOVE-1 study of neladalkib in the first half of 2026.

Enrollment is ongoing in ALKAZAR, the company’s global Phase 3 randomized, controlled trial designed to evaluate neladalkib for the treatment of TKI-naïve patients with advanced ALK-positive NSCLC. Patients are randomized 1:1 to receive neladalkib or alectinib, a front-line standard of care, reflecting input from collaborating physician-scientists and alignment with global regulatory agencies. The company expects to continue to progress the ALKAZAR trial throughout 2026.

HER2 Program


Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2026.

Discovery Research Programs


Nuvalent continues to advance its discovery research programs and expects to disclose a new development candidate by year-end 2026.

Business Highlights


Completed Successful Public Offering of Common Stock Raising $500.0 Million in Gross Proceeds: On November 20, 2025, Nuvalent closed an underwritten public offering of 4,950,496 shares of Class A common stock at a price to the public of $101.00 per share. The gross proceeds to Nuvalent from the offering were approximately $500.0 million, before deducting underwriting discounts and commissions and other offering expenses.

Ron Squarer Appointed to Board of Directors: Nuvalent appointed Ron Squarer to its board of directors in December 2025. Mr. Squarer brings more than 30 years of proven leadership in oncology drug development and commercialization to the Nuvalent Board.

Upcoming Events


TD Cowen 46thAnnual Health Care Conference in Boston: Management will be participating in a fireside chat on Wednesday, March 4, 2026, at 9:45 a.m. ET.

Leerink Global Healthcare Conference 2026 in Miami: Management will be participating in a fireside chat on Monday, March 9, 2026, at 2:20 p.m. ET.
Live webcasts of the fireside chats will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following each conference.

Fourth Quarter and Full Year 2025 Financial Results


Cash Position: Cash, cash equivalents and marketable securities were $1.4 billion as of December 31, 2025. Nuvalent continues to believe that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into 2029.

R&D Expenses: Research and development (R&D) expenses were $67.8 million for the fourth quarter of 2025 and $307.0 million for the year ended December 31, 2025.

G&A Expenses: General and administrative (G&A) expenses were $34.4 million for the fourth quarter of 2025 and $107.3 million for the year ended December 31, 2025.

Net Loss: Net loss was $118.7 million for the fourth quarter of 2025 and $425.4 million for the year ended December 31, 2025.

(Press release, Nuvalent, FEB 26, 2026, View Source [SID1234663083])

Synthekine Announces Clinical Trial Collaboration with Merck to Evaluate STK-012 In Combination with Keytruda® (Pembrolizumab) and Chemotherapy in Ongoing Randomized Phase 2 Trial in First-Line, PD-L1 Negative Nonsquamous Non-Small Cell Lung Cancer

On February 26, 2026 Synthekine Inc., an engineered cytokine therapeutics company, reported that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada). STK-012, a first-in-class α/β-IL-2 receptor biased partial agonist, will be evaluated in combination with standard of care chemotherapy and Keytruda (pembrolizumab), Merck’s anti-PD-1 (programmed cell death receptor-1) therapy, in the ongoing SYNERGY-101 randomized Phase 2 study in first-line, PD-L1 negative nonsquamous (NSQ) non-small cell lung cancer (NSCLC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In our Phase 1b study, STK-012 in combination with pembrolizumab and chemotherapy has shown promising efficacy in first-line PD-L1 negative NSQ NSCLC patients, with a 50% response rate in this population presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025," said Debanjan Ray, Chief Executive Officer of Synthekine. "We are excited to collaborate with Merck on our randomized Phase 2 study to further demonstrate the potential of this combination to deliver improved clinical outcomes for these patients, who receive limited benefit from current standard of care therapies."

STK-012 is a first-in-class α/β-IL-2 receptor biased partial agonist engineered to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid broad stimulation of other lymphocytes, such as natural killer (NK) cells, which are associated with IL-2 toxicity.

Under the terms of the agreement, Merck will provide its anti-PD-1 therapy, Keytruda, to be used in combination with STK-012 and standard of care chemotherapy in the SYNERGY-101 trial. SYNERGY-101 is a global, randomized Phase 2 study that has already begun enrollment, with the first patient dosed in November 2025. This study will investigate the safety and efficacy of STK-012 in combination with standard dose pembrolizumab and chemotherapy vs. the safety and efficacy of standard dose pembrolizumab and chemotherapy in patients with first-line, PD-L1 negative NSQ NSCLC. Synthekine and Merck will each retain all commercial rights to their respective compounds for use as monotherapies or in combination regimens.

For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05098132.

(Press release, Synthekine, FEB 26, 2026, View Source [SID1234663099])

Crinetics Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

On February 26, 2026 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the fourth quarter and full year ended December 31, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2025 was a breakout year for Crinetics, as the approval and launch of Palsonify demonstrated our ability to bring an innovative therapy from concept to the patients who need it most," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "With strong launch dynamics, we are now focused on building a business capable of scaling that success. We have the commercial infrastructure, the pipeline depth and the capital to build a premier, multi-product company that will define the future of endocrinology."

Full Year 2025 and Recent Highlights:

Secured FDA approval on September 25, 2025 for PALSONIFY as the first and only once-daily oral somatostatin receptor ligand for the treatment of acromegaly. The subsequent U.S. commercial launch in Q4 2025 demonstrated strong early execution, generating $5.4 million in net product revenue and over 200 enrollment forms at the end of December 2025. In addition, over 125 unique HCPs prescribed PALSONIFY in Q4 2025.
Today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of PALSONIFY (paltusotine) for the medical treatment of adult patients with acromegaly. The positive opinion is now referred to the European Commission (EC) for an approval decision. PALSONIFY was previously granted Orphan Designation by the EMA in February of 2025.

Reported positive data from the Phase 2 open-label study of atumelnant in patients with congenital adrenal hyperplasia (CAH), with 88% of participants in Cohort 4 reducing glucocorticoid doses to physiologic replacement levels by week 12, while maintaining androstenedione (A4) reductions similar to those observed in earlier cohorts. Across all cohorts of the Phase 2 open-label study, atumelnant administration has resulted in rapid, substantial and sustained statistically significant reduction in A4 levels. Atumelnant has been well-tolerated and treatment with atumelnant has been associated with significant clinical improvements. These results reinforce the strong clinical rationale for the ongoing pivotal Phase 3 development program and highlight atumelnant’s potential as a best-in-class oral ACTH antagonist.

Initiated three pivotal trials including the CAREFNDR Phase 3 trial evaluating paltusotine for carcinoid syndrome, the CALM-CAH Phase 3 trial evaluating atumelnant in adults with congenital adrenal hyperplasia (CAH), and the BALANCE-CAH Phase 2/3 trial addressing the critical unmet need in pediatric CAH patients.
Finalized protocol for the pivotal seamless Phase 2/3 EQUILIBRIUM study of atumelnant in patients with ACTH-dependent Cushing’s Syndrome with the first patient expected to enroll in the first half of 2026.
Brought the first candidate from our proprietary nonpeptide drug conjugate (NDC) platform, CRN09682, into clinical development with the initiation of the BRAVESST2 Phase 1/2 trial. The study is evaluating CRN09682 in patients with SST2-expressing neuroendocrine tumors (NETs) and other solid tumors, validating the company’s intent to extend its endocrine expertise into GPCR-targeted oncology indications.

Fourth Quarter and Full Year 2025 Financial Results:

Revenue was $6.2 million and $7.7 million for the quarter and year ended December 31, 2025, compared to $0.0 million and $1.0 million for the same periods in 2024. Revenue for the quarter and year ended December 31, 2025 includes $5.4 million in net product revenue from the U.S. commercial launch of PALSONIFY.
Cost of product revenue was $1.1 million for the quarter and year ended December 31, 2025, primarily related to costs in expanding our commercial manufacturing capacity.

Research and development expenses were $85.1 million and $332.1 million for the quarter and year ended December 31, 2025, compared to $66.6 million and $240.2 million for the same periods in 2024, and compared to $90.5 million in the quarter ended September 30, 2025. The increase compared to the prior year period reflects our continued commitment and investments in paltusotine, atumelnant, and other research and development programs. The sequential decline compared to the prior quarter was primarily due to pre-approval and launch costs, as well as startup costs associated with our ongoing Phase 3 trials, which were recognized in the third quarter but not the fourth quarter.

Selling, general and administrative expenses were $53.7 million and $191.3 million for the quarter and year ended December 31, 2025, compared to $28.2 million and $99.7 million for the same periods in 2024, and compared to $52.3 million in the quarter ended September 30, 2025. The increase compared to the prior year period is related to our commercial organization build-out and investment in our overall infrastructure as a commercialized company. The stability compared to the prior quarter reflects the company’s strategic decision to put in place key investments for commercialization, including field force, commercial team and corporate functions, prior to approval of PALSONIFY.
Net loss was $122.8 million and $465.3 million for the quarter and year ended December 31, 2025, compared to net loss of $80.6 million and $298.4 million for the same periods in 2024.

Crinetics used $326.2 million of net total cash, cash equivalents, and investment securities in 2025, which was below our guidance range of $340 million to $370 million.

Cash, cash equivalents, and investment securities totaled $1.0 billion as of December 31, 2025, compared to $1.4 billion as of December 31, 2024. On January 8, 2026, Crinetics completed an underwritten public offering of 8,763,000 shares of its common stock at a price to the public of $45.95 per share, which included 1,143,000 shares of common stock issued pursuant to the underwriters’ option to purchase additional shares. Net proceeds from the offering were approximately $380.0 million, after underwriting discounts and commissions and other offering costs. Immediately after the completion of this public offering, Crinetics had approximately $1.4 billion in cash, cash equivalents, and investment securities.

Guidance and Outlook:

Crinetics expects 2026 operating expenses presented in accordance with U.S. generally accepted accounting principles ("GAAP") to be between $600 million to $650 million and non-GAAP operating expenses – which exclude cost of product revenue, stock-based compensation, depreciation and amortization – to be between $480 million to $520 million.

Crinetics is unable to reconcile forward-looking non-GAAP operating expenses to the most directly comparable GAAP measure without unreasonable effort because the items that are being excluded are difficult to predict or a range of results could lead to disclosure that would be imprecise or potentially misleading. Material changes to any one of the exclusions could have a significant effect on our forward-looking estimates and GAAP results. Such items include cost of product revenue, stock-based compensation, depreciation and amortization. See "Use of Non-GAAP Financial Measures".

Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, February 26 at 4:30 p.m. ET. To participate, please dial 1-833-470-1428 (domestic) or 1-646-844-6383 (international) and refer to Access Code 027322. To access the webcast, the direct link (here) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

(Press release, Crinetics Pharmaceuticals, FEB 26, 2026, View Source [SID1234663065])