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.

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"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])

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.

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"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])

On February 26, 2026 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported its fourth quarter and full fiscal year 2025 financial results.

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Fourth Quarter Highlights:
Appointment of Jon Resnick as Chief Executive Officer and Member of the Board of Directors, effective January 1st, 2026.
Revenue was $103.6 million, compared to $100.4 million in the fourth quarter of 2024, representing growth of 3%.
Software revenue was $46.4 million, compared to $42.3 million in the fourth quarter of 2024, representing growth of 10%.
Services revenue was $57.3 million, compared to $58.1 million in the fourth quarter of 2024, representing a decrease of 1%.
Net loss was $5.9 million, compared to a net income of $6.6 million in the fourth quarter of 2024, representing a decrease of 190%.
Adjusted EBITDA was $32.5 million, compared to $33.5 million in the fourth quarter of 2024, representing a decrease of 3%.
"I am excited to join Certara, the market leader in the fast‑growing, high‑impact fields of AI-enabled biosimulation and model‑informed drug development," said Jon Resnick, Chief Executive Officer. "In my first 60 days, I have been genuinely impressed by the power of our technology, the depth of our customer relationships, and the strength of our people. It’s clear that this company – and this market opportunity – have the foundation required for long‑term success."

"To fully realize our potential, over the course of 2026 we will sharpen our strategic focus, accelerate innovation across our product portfolio, and elevate our commercial execution. It will be a year of transition and investment as we put the right people, processes, and structure in place to position the company to better capture the significant market opportunities and enable the company to drive stronger and sustainable growth."

"Our full year and fourth quarter revenue performance was in-line with our expectations on both a reported and organic basis. Adjusted EBITDA margin was 32% for the year, at the high end of our plan, driven by operating efficiencies while maintaining investment in R&D," said John Gallagher, Chief Financial Officer. "As we look forward into 2026, we expect end markets to remain stable, and we anticipate a number of changes and initiatives over the course of 2026 to drive improving revenue growth through the year, and to better position us for sustained long term growth."

Fourth Quarter 2025 Results
Total revenue for the fourth quarter of 2025 was $103.6 million, representing year-over-year growth of 3% on a reported basis and 2% on a constant currency basis. The overall increase in revenue was primarily driven by the growth in our biosimulation software and services portfolio. Please see note (1) in the section titled "A Note on Non-GAAP Financial Measures" below for more information on constant currency revenue.

Software revenue for the fourth quarter of 2025 was $46.4 million, representing year-over-year growth of 10% on a reported basis and 8% on a constant currency basis. Software growth was driven by contribution from biosimulation software.

Services revenue for the fourth quarter of 2025 was $57.3 million, representing a year-over-year decrease of 1% on a reported basis and 2% on a constant currency basis. Service revenue declined modestly, reflecting normal seasonal fluctuations, while service bookings increased significantly, supporting continued revenue momentum.

Total Bookings for the fourth quarter of 2025 were $155.2 million representing year-over-year growth of 7%.

Software Bookings for the fourth quarter of 2025 were $56.1 million, representing a year-over-year decrease of 6%. The decrease in software bookings was mainly attributable to external factors and execution challenges.

Services Bookings for the fourth quarter of 2025 were $99.1 million, representing year-over-year growth of 17%. The increase in service bookings was primarily driven by growth across all customer tiers, including large, mid-sized, and small customers.

Total cost of revenues for the fourth quarter of 2025 was $39.2 million, an increase of $0.9 million from $38.3 million in the fourth quarter of 2024, primarily attributable to higher software amortization expense and increased professional and consulting costs.

Total operating expenses for the fourth quarter of 2025 were $63.6 million, which increased by $7.5 million from $56.1 million in the fourth quarter of 2024. Higher operating expenses were primarily due to a $7.0 million increase in employee-related costs, a $0.8 million increase in equipment and software expenses, a $0.8 million increase in professional and consulting expenses, and a $0.7 million increase in transaction expenses, primarily related to refinancing of our term loan, partially offset by lower state business taxes, higher capitalized R&D costs, and a lower provision for credit allowance.

Net loss for the fourth quarter of 2025 was $5.9 million, compared to a net income of $6.6 million in the fourth quarter of 2024. The $12.5 million decrease in net income was primarily driven by higher operating expenses, increased tax expenses, and increased cost of revenues, partially offset by higher revenues.

Diluted earnings per share for the fourth quarter of 2025 was $(0.04), as compared to diluted earnings per share of $0.04 in the fourth quarter of 2024.

Adjusted EBITDA for the fourth quarter of 2025 was $32.5 million compared to $33.5 million for the fourth quarter of 2024, a decrease of $1.1 million. See note (2) in the section titled "A Note on Non-GAAP Financial Measures" below for more information on adjusted EBITDA.

Adjusted net income for the fourth quarter of 2025 was $14.9 million compared to $24.7 million for the fourth quarter of 2024, a decrease of $9.8 million. Adjusted diluted earnings per share for the fourth quarter of 2025 was $0.09, compared to $0.15 for the fourth quarter of 2024. See note (3) in the section titled "A Note on Non-GAAP Financial Measures" below for more information on adjusted net income and adjusted diluted earnings per share.

THREE MONTHS ENDED DECEMBER 31, TWELVE MONTHS ENDED DECEMBER 31,
2025 2024
2025 2024
Key Financials (in millions, except per share data)
Revenue $ 103.6 $ 100.4 $ 418.8 $ 385.1
Software revenue $ 46.4 $ 42.3 $ 183.3 $ 155.7
Service revenue $ 57.3 $ 58.1 $ 235.6 $ 229.5
Total bookings $ 155.2 $ 144.5 $ 482.1 $ 445.3
Software bookings $ 56.1 $ 59.7 $ 184.3 $ 169.4
Service bookings $ 99.1 $ 84.8 $ 297.7 $ 275.9
Net income (loss) $ (5.9 ) $ 6.6 $ (1.6 ) $ (12.1 )
Diluted earnings per share $ (0.04 ) $ 0.04 $ (0.01 ) $ (0.08 )
Adjusted EBITDA $ 32.5 $ 33.5 $ 134.5 $ 122.0
Adjusted net income $ 14.9 $ 24.7 $ 70.9 $ 72.9
Adjusted diluted earnings per share $ 0.09 $ 0.15 $ 0.44 $ 0.45
Cash and cash equivalents $ 189.4 $ 179.2

2026 Financial Outlook
Certara is providing its guidance for the full year 2026:

Full year 2026 revenue is expected to grow in the range of 0-4%.
Full year adjusted EBITDA margin to be approximately 30-32%.
Full year adjusted diluted earnings per share is expected to be in the range of $0.44- $0.48.
Fully diluted shares are expected to be in the range of 160 million to 162 million.
Please note that the Company has not reconciled adjusted EBITDA, adjusted EBITDA margin or adjusted diluted earnings per share forward-looking guidance included in this press release to the most directly comparable GAAP measures because this cannot be done without unreasonable effort due to the variability and low visibility with respect to costs related to acquisitions, financings, and employee stock compensation programs, which are potential adjustments to future earnings. We expect the variability of these items to have a potentially unpredictable, and a potentially significant, impact on our future GAAP financial results.

Webcast and Conference Call Details
Certara will host a conference call today, February 26, 2026, at 8:30 a.m. ET to discuss its fourth quarter and full fiscal year 2025 financial results. Investors interested in listening to the conference call are required to register online in advance of the call. A live and archived webcast of the event will be available on the "Investors" section of the Certara website at View Source

(Press release, Certara, FEB 26, 2026, View Source [SID1234663063])

On February 26, 2026 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science, reported financial results for the year ended December 31, 2025, as well as business updates.

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"We made significant progress in 2025, notably demonstrating cemsidomide’s best-in-class potential, establishing an efficient and differentiated regulatory path for cemsidomide, and extending our cash runway beyond key value‑inflection milestones, further positioning us to become a fully integrated biopharmaceutical company," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "As cemsidomide progresses into later-stage clinical trials across multiple lines of therapy in multiple myeloma, we believe it is well positioned to become the IKZF1/3 degrader of choice. We continue to advance our discovery strategy, focused on targets that have a strong degrader rationale with first-in-class potential in inflammation, neuroinflammation and neurodegeneration diseases. Together, these achievements will bring us closer to delivering transformative TPD medicines for patients with significant unmet needs."

FOURTH QUARTER 2025 HIGHLIGHTS AND RECENT ACHIEVEMENTS

In February 2026, the first patient was dosed in the Phase 2 MOMENTUM trial evaluating cemsidomide in combination with dexamethasone in the fourth line or later MM setting. The MOMENTUM trial was designed for potential accelerated approval with a recommended Phase 2 dose of 100 µg. The trial will enroll approximately 100 patients with enrollment expected to be completed in Q1 2027.
In October 2025, C4T entered into a clinical trial collaboration and supply agreement with Pfizer Inc. Under the terms of the agreement, Pfizer will supply elranatamab (ELREXFIO), a B-cell maturation antigen CD3 targeted bispecific antibody, for the upcoming Phase 1b trial of cemsidomide in combination with elranatamab in earlier lines of MM treatment. C4T has continued to execute operational steps necessary for the initiation of the Phase 1b trial, which is expected in Q2 2026.
In October 2025, C4T raised $125 million in gross proceeds through an underwritten offering with the potential to earn up to $225 million in additional proceeds if the outstanding warrants are exercised.
In January 2026, C4T earned a $2 million milestone payment from Biogen related to BIIB145, a BTK degrader, designed by C4T and delivered to Biogen for clinical development. This is the second degrader that Biogen has advanced into the clinic under the Biogen and C4T collaboration.
KEY UPCOMING MILESTONES

Cemsidomide: IKZF1/3 Degrader for Relapsed Refractory Multiple Myeloma (RRMM)

On track to initiate the Phase 1b trial of cemsidomide in combination with elranatamab in Q2 2026 with plans to provide incremental progress throughout 2026.
Present further analysis of the data from the completed Phase 1 trial of cemsidomide in combination with dexamethasone in mid-2026.
Share the plan to initiate an additional Phase 1b trial to evaluate cemsidomide in combination with other anti-myeloma agents in mid-2026.
CFT8919: EGFR L858R Degrader for Non-Small-Cell Lung Cancer (NSCLC)

By end of Q1 2026, utilize data from the Phase 1 dose escalation trial conducted by Betta Pharmaceuticals to inform potential ex-China clinical development.
Research & Discovery: Internal Discovery Efforts Focused on Inflammation, Neuroinflammation & Neurodegeneration (INN) with Collaboration Efforts Focused on Oncology & Non-oncology

Optimize indication selection for multiple targets across discovery portfolio focused on INN in 2026.
Deliver at least one development candidate to a collaboration partner by year-end 2026.
Advance existing collaborations toward key milestones by year-end 2026.
UPCOMING INVESTOR EVENTS

March 3, 2026, at 11:50 AM ET: Management will participate in a presentation and fireside chat at the TD Cowen 46th Annual Health Care Conference taking place in Boston, Massachusetts.
March 10, 2026, at 8:00 AM ET: Management will participate in a fireside chat at the Barclays 28th Annual Global Healthcare Conference taking place in Miami, Florida.
FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS

Revenue: Total revenue for the fourth quarter and full year ended December 31, 2025, was $11.0 million and $35.9 million, respectively, compared to $5.2 million and $35.6 million for the prior year periods. The increase in revenue for the fourth quarter of 2025, as compared to the prior year period, reflects the prioritization of one KRAS project under the collaboration with Merck KGaA, Darmstadt, Germany.

Research and Development (R&D) Expense: R&D expense for the fourth quarter and full year ended December 31, 2025, was $25.0 million and $104.2 million, respectively, compared to $32.5 million and $110.6 million for the prior year periods. The decrease in R&D expense for the fourth quarter of 2025, as compared to the prior year period, was primarily related to the completion of the CFT1946 Phase 1 clinical trial.

General and Administrative (G&A) Expense: G&A expense for the fourth quarter and full year ended December 31, 2025, was $9.2 million and $36.2 million, respectively, compared to $10.4 million and $42.1 million for the prior year periods. The decrease in G&A expense for the fourth quarter of 2025, as compared to the prior year period, was primarily related to lower stock-based compensation expense.

Net Loss and Net Loss per Share: Net loss for the fourth quarter and full year ended December 31, 2025, was $20.5 million and $105.0 million, respectively, compared to $34.6 million and $105.3 million for the prior year periods. Net loss per share for the fourth quarter and full year ended December 31, 2025, was $0.18 and $1.27, respectively, compared to $0.49 and $1.52 for the prior year periods.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of December 31, 2025, was $297.1 million, compared to $199.8 million as of September 30, 2025, and $267.3 million as of December 31, 2024. The increase in cash, cash equivalents and marketable securities during 2025 was primarily the result of the net proceeds from the October equity offering partially offset by the cash used to fund operations and advance our programs. The company expects that its current cash, cash equivalents and marketable securities will enable it to fund its operating plan to the end of 2028.

About Cemsidomide
Cemsidomide is an investigational, orally bioavailable molecular glue degrader (MonoDAC degrader) of IKZF1/3, transcription factors foundational to multiple myeloma biology. Data from the Phase 1 trial, which has completed enrollment, show cemsidomide’s differentiated safety and tolerability profile and potentially class-leading anti-myeloma activity that support the potential for durable outcomes.

About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. Data from the Phase 1 trial identified 100 µg as the recommended Phase 2 dose. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior anti-myeloma regimens that must have included an IKZF1/3 degrader, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy will be enrolled in the trial. More information is available at clinicaltrials.gov (NCT07284758).

About Cemsidomide in Combination With Elranatamab (ELREXFIO)
The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader. Exclusion criteria for patients include those who have received prior treatment with a BCMA-directed T-cell engager or BCMA-directed CAR-T therapy. More information is available at clinicaltrials.gov (NCT07280013).

About Multiple Myeloma
Multiple myeloma (MM) is a rare blood cancer affecting plasma cells. Approximately 36,000 people in the United States are diagnosed with MM each year. Approved IKZF1/3 degraders remain foundational therapies across lines of MM treatment. Despite advances, including immune-directed approaches, most patients ultimately relapse, underscoring a growing need for new therapeutics options that continue to leverage IKZF1/3 degradation to drive myeloma cell death and T-cell activation.

(Press release, C4 Therapeutics, FEB 26, 2026, View Source [SID1234663062])

On February 26, 2026 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) reported that SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), reported positive topline results from a pre-specified interim analysis of a Phase III study (BL-B01D1-307) evaluating izalontamab brengitecan (iza-bren), an EGFR×HER3 bispecific antibody-drug conjugate (ADC), in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose disease progressed following prior taxane therapy.

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In the pre-specified interim analysis, topline results showed that iza-bren demonstrated statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy of physician’s choice, meeting both dual primary endpoints.

This Phase III study represents the third Phase III trial in which iza-bren has achieved its primary endpoint(s). It is the first bispecific ADC in a Phase III study to report dual positive PFS/OS results in the treatment of triple-negative breast cancer.

"Patients with advanced triple-negative breast cancer who progress after standard therapies face an urgent need for more effective options," said Dr. Yi Zhu, Chief Executive Officer of Biokin "These topline results further strengthen our confidence in iza-bren’s potential to deliver meaningful clinical benefit across multiple cancers."

"These results underscore the potential of bispecific ADC technology targeting both EGFR and HER3 to meaningfully change outcomes in difficult‑to‑treat cancers," said Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb. "We look forward to advancing the science and development of ADCs, with the hope of uncovering new options for people living with cancer."

These data will be presented at an upcoming medical meeting.

The BL-B01D1-307 study is sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), in Mainland China. Outside of China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb (BMS) under a collaboration and exclusive license agreement.

The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation (BTD) to iza-bren for the treatment of seven indications, and the U.S. FDA has granted BTD to iza-bren for previously treated NSCLC patients with an EGFR mutation. The New Drug Applications (NDAs) for two indications of iza-bren, for the treatment of locally advanced or metastatic nasopharyngeal carcinoma and for the treatment of recurrent or metastatic esophageal squamous cell carcinoma, have been accepted by the CDE and included in the priority review process.

About BL-B01D1-307
BL-B01D1-307 is a Phase III, randomized, open-label, multi-center clinical study in China, evaluating iza-bren in patients with unresectable locally advanced or metastatic triple-negative breast cancer whose disease progressed following prior taxane therapy. The study includes dual primary endpoints of progression-free survival (PFS) and overall survival (OS). For more detailed information, please visit clinical.trials.gov (NCT06382142).

About iza-bren
SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death.

(Press release, Bristol-Myers Squibb, FEB 26, 2026, View Source [SID1234663061])