On March 4, 2026 Verastem presented its corporate presentation.

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(Presentation, Verastem, MAR 4, 2026, View Source [SID1234663252])

On March 4, 2026 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the quarter and year ended December 31, 2025, and provided operating and partner program updates.

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"OmniAb exited 2025 with an expanded base of 107 active partners and a growing portfolio of 407 active programs. Our differentiated technologies support our business outlook and allow us to add programs while maintaining a disciplined cost structure. As our partner pipeline continues to advance, several later-stage assets are emerging with potential to generate meaningful milestones and, ultimately, recurring royalty revenue," said Matt Foehr, Chief Executive Officer of OmniAb. "Our focus on innovation was evident in the recent launch of OmniUltra, which strengthens our ability to attract new partners and service new programs. Additionally, we continue to see strong interest in the xPloration partner access program and are excited about its contributions to the business."

Fourth Quarter 2025 Financial Results

Revenue for the fourth quarter of 2025 was $8.4 million, compared with $10.8 million for the same period in 2024, with the decrease primarily related to a decline in license revenue and service revenue, partially offset by an increase in milestone and royalty revenue and the addition of xPloration revenue.

Research and development expense was $13.9 million for the fourth quarter of 2025, compared with $13.3 million for the same period in 2024, with the increase due to a $3.9 million impairment charge primarily related to certain small molecule ion channel property and equipment, partially offset by lower personnel expenses related to reduced headcount and share-based compensation expense, and lower external expenses associated with legacy small molecule ion channel programs. General and administrative expense was $6.8 million for the fourth quarter of 2025, compared with $7.4 million for the same period in 2024, with the decrease primarily due to lower share-based compensation expense.

Net loss for the fourth quarter of 2025 was $14.2 million, or $0.11 per share, compared with a net loss of $13.1 million, or $0.12 per share, for the same period in 2024.

Full Year 2025 Financial Results

Revenue for 2025 was $18.7 million, compared with $26.4 million for 2024. The decline was primarily due to a decrease in license revenue of $2.5 million and milestone revenue of $1.6 million. Service revenue declined as a result of the completion or discontinuation of certain legacy small molecule ion channel programs. These decreases were offset by the addition of $0.8 million in xPloration revenue reflecting the sale of an instrument and related consumables.

Cost of xPloration revenue was $0.3 million for 2025 and consisted of direct costs associated with the sale of the xPloration instrument and associated consumables. Research and development expense was $47.8 million for 2025, compared with $55.1 million for 2024, primarily due to lower personnel expenses related to reduced headcount and share-based compensation expense, lower external expenses associated with legacy small molecule ion channel programs and a decline in contract research costs, partially offset by a $3.9 million impairment charge primarily related to certain small molecule ion channel property and equipment. General and administrative expense was $29.2 million for 2025, compared with $30.7 million for 2024 with the decrease primarily due to lower legal fees and share-based compensation expense. Other operating income, net for 2025 was $2.5 million and reflected a gain of $3.0 million from the sale of a small molecule Kv7.2 program partially offset by a $0.3 million increase in contingent liability expense attributed to changes in certain ion channel programs. Other operating income, net during 2024 was $2.4 million and included a $2.5 million reduction in contingent liabilities primarily attributed to changes in small molecule ion channel programs.

Net loss for 2025 was $64.8 million, or $0.57 per share, compared with a net loss of $62.0 million, or $0.61 per share, for the same period in 2024.

As of December 31, 2025, OmniAb had cash, cash equivalents and short-term investments of $54.0 million.

2026 Financial Guidance

OmniAb expects 2026 revenue to be in the range of $25 million to $30 million, and costs and operating expenses to be in the range of $80 million to $85 million. Cash costs and operating expenses is expected to be in the range of $50 million to $55 million (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure). The Company expects to end the year with cash and cash equivalents in the range of $30 million to $35 million. The 2026 effective tax rate is expected to be approximately 0%.

Fourth Quarter 2025 and Recent Business Highlights

During the fourth quarter of 2025, OmniAb entered into new license agreements including with Dana Farber Cancer Institute, Mabtrx Biosciences and two global pharmaceutical companies. As of December 31, 2025, the Company had 107 active partners and 407 active programs, including 32 OmniAb-derived programs in clinical development or being commercialized.

In December 2025, the Company launched OmniUltra, the industry’s first and only transgenic chicken engineered to express ultralong CDRH3 domains on a human antibody framework. OmniUltra also enables the isolation of picobodies, the smallest known natural antibody-derived binding domain (4–6 kDa), which are approximately one-third the size of a nanobody. OmniUltra is designed to deliver pre-optimized specificity, affinity and structural stability, streamlining hit-to-lead identification. By generating both antibodies and picobodies, it is ideal for applications such as bispecifics, multispecifics, CAR-T, radioligands and stand-alone peptide therapeutics.

OmniAb and GSK published a paper titled "Voltage sensor interaction site for a selective small molecule Nav1.1 sodium channel potentiator that enhances firing of fast-spiking interneurons" in the October 2025 edition of Molecular Pharmacology. The paper highlights the potential for Nav1.1 as a therapeutic target for seizure disorders.

Business and partner highlights from the fourth quarter of 2025 and recent weeks included the following:

IMVT-1402 & batoclimab

The potentially registrational trial with IMVT-1402 in difficult-to-treat rheumatoid arthritis is fully enrolled, with topline data expected in the second half of this year. Topline data from the proof-of-concept trial with IMVT-1402 in cutaneous lupus erythematosus is also expected in the second half of the year.
Potentially registrational studies with IMVT-1402 in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease remain on track with topline data in each of GD and MG expected in 2027.
Immunovant anticipates sharing topline data from its two Phase 3 studies evaluating batoclimab as a treatment for active, moderate-to-severe thyroid eye disease in the first half of this year.
TEV- ‘408

Topline results of the Phase 1b trial evaluating TEV-‘408 for vitiligo are expected in the first half of this year. Topline results of the Phase 2a trial evaluating TEV-‘408 for celiac disease are expected in the second half of this year.
Teva Pharmaceuticals announced a funding agreement with Royalty Pharma of up to $500 million to accelerate the clinical development of Teva’s anti-IL-15 antibody TEV-‘408 for vitiligo.
Precemtabart tocentecan (M9140)

Merck KGaA indicated that based on Phase 1 data, it plans to advance precemtabart tocentecan, a novel anti‑CEACAM5 antibody‑drug conjugate with topoisomerase 1 inhibitor payload, to Phase 3 trials in metastatic colorectal cancer, with the study initiation anticipated in 2026.
RNDO-564

In December 2025, Rondo Therapeutics announced the first patient was dosed in its Phase 1/1b clinical trial evaluating RNDO-564.
Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 549-8228 using the conference ID 62412. Slides, as well as the live and replay webcast, are available at View Source

(Press release, OmniAb, MAR 4, 2026, View Source [SID1234663253])

On March 4, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported financial results for the three months and full year ended December 31, 2025, and highlighted recent progress.

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"2025 was a transformative year for us, highlighted by the landmark FDA approval of AVMAPKI FAKZYNJA CO-PACK, the only medicine approved to specifically treat KRAS-mutated recurrent LGSOC. The launch is off to a strong start, and this novel-novel combination therapy is gaining positive response across the LGSOC community with gynecologic and medical oncologists in both academic and community settings increasingly turning to it when patients experience a first or subsequent recurrence. We also made considerable progress with VS-7375, our oral, KRAS G12D (ON/OFF) inhibitor with best-in-class potential for solid tumor cancers, clearing multiple dose levels across both monotherapy and cetuximab combination cohorts with no DLTs or major toxicities. Building on the insights from the China data, the tolerability profile that is emerging with VS-7375 in the U.S. has shown meaningful improvement and supports continued dose escalation," said Dan Paterson, president and chief executive officer at Verastem Oncology. "In 2026, our priorities are to continue driving a strong launch of AVMAPKI FAKZYNJA CO-PACK to fuel sustainable growth, while we continue to accelerate the clinical development of VS-7375 and breakout Phase 2 registration-directed clinical trials in pancreatic, lung, and colorectal cancers."

Fourth Quarter 2025 and Recent Highlights

AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) U.S. Launch

AVMAPKI FAKZYNJA CO-PACK generated net product revenues of $17.5 million for the fourth quarter of 2025 and $30.9 million for the full year 2025, following accelerated U.S. Food and Drug Administration (FDA) approval in May 2025, approximately two months ahead of its Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025.
On February 4, 2026, the Company announced updated data for RAMP 201J in Japan with a data cutoff of January 30, 2026. Of the 16 patients enrolled with a median follow-up of 10 months, a confirmed overall response rate (ORR) of 38% (6/16) was achieved by investigator assessment. Among patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC), the confirmed ORR was 57% (4/7) and the disease control rate (DCR) was 100% (7/7). Among patients with KRAS wild-type recurrent LGSOC, the confirmed ORR was 22% (2/9) and the DCR was 89% (8/9). Of the 16 patients enrolled, 11 patients remain on treatment. No patients discontinued due to an adverse event. The safety profile was similar to previously reported data outside of Japan. Steady-state exposures of avutometinib and defactinib in the RAMP 201J study were comparable to those seen in RAMP 201.
On February 25, 2026, the annual update of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Ovarian Cancer was released. The Guidelines did not expand the recommendation for avutometinib plus defactinib to include patients with recurrent LGSOC without a KRAS mutation. The Guidelines retained the category 2A recommendation for avutometinib plus defactinib for patients with KRAS-mutated recurrent LGSOC.

"We are disappointed for the patients with KRAS wild-type recurrent LGSOC, who currently have no targeted, FDA-approved treatment options specifically for their disease and face a particularly poor prognosis. Across three separate clinical trials (the FRAME study, RAMP 201, and RAMP 201J) we have observed what we believe are robust objective responses rates for patients with recurrent LGSOC with and without KRAS mutations. We remain committed to advancing the clinical evidence through longer term follow-up analyses from the RAMP 201 study planned for the SGO annual meeting, and completing our ongoing confirmatory RAMP 301 Phase 3 clinical trial, which includes patients with and without KRAS mutations, and look forward to sharing these data with the NCCN and the medical community to support future guideline consideration," said John Hayslip, chief medical officer at Verastem Oncology.
Expected Key Milestones:

Maximize adoption of AVMAPKI FAKZYNJA CO-PACK in the U.S. as the treatment of choice at the earliest recurrence, leveraging its robust clinical data.
Report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027.
Continue to pursue regulatory paths for potential expansion into Europe and Japan.
VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor in Advanced Solid Tumors

The Company reported an update on its progress with the VS-7375-101 Phase 1/2 study:
After clearing the 900 mg daily (QD) dose level with no dose-limiting toxicities (DLTs), the dose escalation phase will continue to 1200 mg QD to further interrogate the dose range and characterize the safety, tolerability, and efficacy profile of VS-7375.
The 600 mg QD dose level of VS-7375 in combination with cetuximab was cleared with no DLTs and higher doses are now being evaluated.
In a pharmacokinetics (PK) analysis, doses of VS-7375 at 600 mg QD and above, with feeding and anti-emetic prophylaxis, yielded similar exposures to fasted patients in China. The exposures achieved cover the exposures in preclinical models necessary for maximal anti-tumor efficacy.
As of the January 30, 2026 data cutoff, VS-7375 demonstrated an encouraging safety profile and was generally well-tolerated across all monotherapy dose levels evaluated to date. Patients (n=23) receiving VS-7375 at either 400 mg QD, 600 mg QD or 900 mg QD with a mean duration of therapy of 1.6 months (0.7-5.6), reported no drug related liver function test abnormalities. There was no drug-related neutropenia greater than Grade 2 and rates of nausea, vomiting and diarrhea remained lower than those reported by the Company’s partner in China. No DLTs have been reported to date, and the maximum tolerated dose has not been reached.
Following recent feedback from the FDA, the Company is amending the VS-7375-101 Phase 1/2 protocol to separate out disease-specific Phase 2 registration-directed trials for KRAS G12D mutated 2L pancreatic ductal adenocarcinoma (PDAC) and 2L/3L non-small cell lung cancer (NSCLC) (monotherapy) and 2L+ colorectal cancer (CRC) in combination with cetuximab.
In January 2026, the Company reported updates on its VS-7375-101 trial including that it had cleared the 400 mg QD, 600 mg QD and 900 mg QD dose levels with no DLTs and no major toxicities. The VS-7375 monotherapy expansion cohorts were initiated, and the cohort sizes were expanded in 2L PDAC, 2L/3L NSCLC, and 2L+ other KRAS G12D-mutated solid tumors. In the VS-7375 dose-escalation combination cohort, the 400 mg QD dose was cleared in combination with cetuximab with no DLTs. The combination dose escalation cohorts were initiated in 1L NSCLC and 2L PDAC at the end of 2025.
In October 2025, the Company announced a preliminary update on the Phase 1/2 monotherapy dose escalation trial of VS-7375 in patients with previously treated advanced KRAS G12D mutant solid tumors. In the study, VS-7375 cleared both the 400 mg QD and the 600 mg QD monotherapy doses with no DLTs observed. At the two dose levels evaluated in the U.S. cohort, no nausea, vomiting, or diarrhea greater than Grade 1 were reported. In addition, no new safety signals have been observed relative to earlier data presentations in both PDAC and NSCLC by GenFleet Therapeutics, the Company’s partner in China. Of the five efficacy evaluable patients in the VS-7375-101 study with at least one scan, four out of five patients have had a tumor reduction and were still on treatment.
The Company shared multiple updates from GenFleet and its ongoing evaluation of VS-7375, known as GFH375, in China:

On March 2, 2026, GenFleet announced that GFH375 was granted its first Breakthrough Therapy Designation in China for patients with KRAS G12D-mutated NSCLC who have received prior systemic therapy.
In December 2025, GenFleet announced the initiation of a registrational Phase 3 study for GFH375 in patients with pretreated KRAS G12D-mutated metastatic pancreatic cancer in China.
In October 2025, the Company announced updated data for GFH375 in PDAC featured in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. GenFleet shared additional analyses of this data set on October 27, 2025:
In a subgroup analysis, 12 patients with 2L PDAC at 600 mg QD achieved an ORR of 58.3% and a DCR of 100%. In the 3L+ setting, 47 PDAC patients receiving 600 mg QD achieved an ORR of 36.2% and a DCR of 95.7%. In the 2L subgroup, the median progression free survival (mPFS) and median overall survival (mOS) have not been reached. An additional analysis of gastrointestinal disorders, hematological toxicities, and liver enzyme abnormalities in 2L+ patients with PDAC (n=66) at 600 mg QD showed no adverse events Grade ≥3 occurred at rates above 8.0%.
In an analysis of pre-treated patients with NSCLC at 600 mg QD, the four-month PFS rate was greater than 75% and the mPFS has not been reached. The median follow-up time was 4.2 months.
In October 2025, GenFleet announced that the first patient has been dosed in a Phase 1b/2 study of GFH375 combined with cetuximab or chemotherapy for advanced solid tumors, including 1L PDAC, in China.
In August 2025, the Company announced data of GFH375 would be featured in a mini oral presentation at the IASLC 2025 World Conference on Lung Cancer (WCLC) on September 8, 2025. At the recommended Phase 2 dose (RP2D) of 600 mg QD, the ORR was 68.8% (11/16) (both confirmed and unconfirmed) and the DCR was 93.8% (15/16). Among the 26 evaluable patients with NSCLC treated across all dose levels, the ORR was 57.7% (15/26) (both confirmed and unconfirmed) and the DCR was 88.5% (23/26).
Expected Key Milestones:

Report early data from the VS-7375-101 trial in 1H 2026.
Select the RP2D with cetuximab and initiate the CRC combination expansion cohort in 1H 2026.
Complete enrollment in combination dose-escalation cohorts in mid-2026.
Complete enrollment in monotherapy expansion cohorts in 2H 2026.
Select the RP2D and plan to initiate the PDAC and NSCLC combination expansion cohorts in 2H 2026.
RAMP 205: Avutometinib Plus Defactinib in Combination with Chemotherapy in 1L Metastatic Pancreatic Cancer

In November 2025, the Company announced that enrollment was completed in the expansion cohort in Q3 2025.
Expected Key Milestone:

Report an update on the safety and efficacy of the RAMP 205 expansion cohort with at least six months of follow-up on all patients in Q2 2026.
Upcoming Presentations

Multiple abstracts were selected for oral and poster presentations at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting on Women’s Cancer on April 10-13 in Puerto Rico. These presentations will include a late-breaking oral presentation on the long-term analysis of the Phase 2 RAMP 201 trial of avutometinib and defactinib combination in recurrent LGSOC.
Corporate Updates

In December 2025, the Company announced John Johnson, current board member, was appointed to chairman of Verastem’s Board of Directors, and Michael Kauffman, M.D., Ph.D., lead director since 2016, was appointed to president of development of Verastem.
In November 2025, the Company announced it had completed a public offering of over $96.9 million of common stock and pre-funded warrants.
Fourth Quarter 2025 Financial Results

Verastem Oncology ended the fourth quarter of 2025 with cash, cash equivalents, and investments of $205 million. On a pro forma basis, taking into account the net proceeds from the exercise of warrants in January 2026 of $29.4 million, cash, cash equivalents, and investments were $234.4 million as of December 31, 2025. These additional sources of capital along with the existing cash, cash equivalents, and investments and ongoing product revenue provide an expected cash runway into first half of 2027.

Net product revenue for the three months ended December 31, 2025 (the "2025 Quarter") was $17.5 million, compared to no revenue recognized for the three months ended December 31, 2024 (the "2024 Quarter"). The Company began commercial sales of the AVMAPKI FAKZYNJA CO-PACK within the U.S. following receipt of FDA approval in May 2025.

Total operating expenses for the 2025 Quarter were $59.0 million, compared to $31.6 million for the 2024 Quarter. Cost of sales associated with product revenue was $2.9 million for the 2025 Quarter, compared to no cost of sales recognized for the 2024 Quarter.

Research & development expenses for the 2025 Quarter were $31.7 million, compared to $20.8 million for the 2024 Quarter. The increase of $10.9 million, or 52.4%, was primarily due to higher costs incurred for drug substance and drug product manufacturing, contract research organizations, and investigator fees.

Selling, general & administrative expenses for the 2025 Quarter were $24.4 million, compared to $10.8 million for the 2024 Quarter. The increase of $13.6 million, or 125.9%, was primarily due to commercialization costs, including consulting, personnel costs, and professional fees, incurred in connection with the launch of AVMAPKI FAKZYNJA CO-PACK in KRAS-mutated recurrent LGSOC.

Net loss (GAAP basis) for the 2025 Quarter was $32.9 million, or $0.39 per share (basic), compared to $64.6 million, or $1.33 per share (basic and diluted) for the 2024 Quarter.

For the 2025 Quarter, non-GAAP adjusted net loss was $39.8 million, or $0.48 per share (basic) compared to non-GAAP adjusted net loss of $29.3 million, or $0.60 per share (basic), for the 2024 Quarter. Please refer to the GAAP to non-GAAP Reconciliation attached to this press release.

Full-Year 2025 Financial Results

Net product revenue for the year ended December 31, 2025 (the "2025 Period") was $30.9 million, compared to no product revenue recognized for the year ended December 31, 2024 (the "2024 Period"). Sale of COPIKTRA license and related assets revenue was $0.0 million for the 2025 Period, compared to $10.0 million for the 2024 Period. Revenue for the 2024 Period was comprised of one sales milestone payment of $10.0 million due upon Secura Bio achieving cumulative worldwide net sales of COPIKTRA exceeding $100.0 million.

Total operating expenses for the 2025 Period were $201.0 million, compared to $125.0 million for the 2024 Period. Cost of sales associated with product revenue was $5.3 million for the 2025 period, compared to no cost of sales recognized for the 2024 Period.

Research & development expenses for the 2025 Period were $114.6 million, compared to $81.3 million for the 2024 Period. The increase of $33.3 million, or 41.0%, was primarily due to higher costs incurred for contract research organizations, investigator fees, and drug substance and drug product manufacturing.

Selling, general & administrative expenses for the 2025 Period were $81.1 million, compared to $43.6 million for the 2024 Period. The increase of $37.5 million, or 86.0%, was primarily due to commercialization costs, including consulting, personnel costs, and professional fees, incurred in connection with the launch of AVMAPKI FAKZYNJA CO-PACK in KRAS-mutated recurrent LGSOC.

Net loss for the 2025 Period was $209.5 million, or $3.02 per share (basic and diluted), compared to $130.6 million, or $3.66 per share (basic and diluted) for the 2024 period.

For the 2025 Period, non-GAAP adjusted net loss was $163.1 million, or $2.35 per share (basic) compared to non-GAAP adjusted net loss of $107.4 million, or $3.01 per share (basic), for the 2024 Period. Please refer to the GAAP to non-GAAP Reconciliation attached to this press release.

Conference Call and Webcast

Verastem will host a conference call and webcast today at 4:30 p.m. ET to review the fourth quarter and full year 2025 financial results and recent business updates. To access the conference call, please dial (888) 596-4144 (U.S.) or (646) 968-2525 (international) and enter the passcode 7321921 at least 10 minutes prior to the event start time. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcast will be archived and available following the event.

(Press release, Verastem, MAR 4, 2026, View Source [SID1234663254])

On March 4, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that new data evaluating DecisionDx-Melanoma’s i31-SLNB test result for prediction of sentinel lymph node (SLN) positivity will be presented at the Society of Surgical Oncology (SSO) 2026 Annual Meeting, being held March 5-7 in Phoenix.

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"The initial reports from the same prospective, multicenter study confirmed the performance of DecisionDx-Melanoma to both (i) impact sentinel lymph node biopsy (SLNB) decision-making and (ii) identify patients at low risk of nodal metastasis," said Rebecca Critchley-Thorne, Ph.D., vice president, research and development, at Castle Biosciences. "The data being presented at SSO 2026 further extend this growing body of evidence supporting the use of DecisionDx-Melanoma to guide risk-aligned management decisions consistent with National Comprehensive Cancer Network guideline risk thresholds, including whether to forgo, consider or pursue SLNB."

Castle will share the following ePoster at SSO: EP49: The integrated 31-gene expression profile test identifies patients with T1b–T2a cutaneous melanoma who can safely avoid sentinel lymph node biopsy.

DecisionDx-Melanoma’s i31-SLNB algorithm integrates the independent 31-GEP score with key clinicopathologic factors, including Breslow thickness, ulceration, mitotic rate and age. This integrated approach was developed and independently validated to provide more precise risk estimation than staging criteria alone. By combining tumor biology with traditional clinical features, the algorithm generates a personalized likelihood of SLN positivity, supporting risk-aligned shared decision-making for SLNB, a surgical staging procedure commonly used to assess nodal metastasis risk.

ePosters will be available for viewing in the SSO 2026 Exhibit Hall, on the SSO Annual Meeting website and within the SSO Mobile App. The ePoster gallery will be accessible to registered attendees.

For more information on DecisionDx-Melanoma and the poster above, please visit Castle at booth #321.

About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile (GEP) test designed to analyze tumor biology to deliver a personalized risk assessment for patients with stage I–III cutaneous melanoma, enhancing risk stratification beyond American Joint Committee on Cancer (AJCC) staging alone. By combining molecular insights with select clinicopathologic features, the test provides two distinct outputs: a personalized risk of sentinel lymph node (SLN) positivity and a personalized risk of recurrence and/or metastasis. This clinically actionable information is designed to help guide risk-aligned patient management decisions, including SLN biopsy consideration, follow-up intensity, imaging and referrals.

DecisionDx-Melanoma is supported by more than 50 peer-reviewed publications, including prospective studies and meta-analyses, and was developed in collaboration with more than 100 leading U.S. institutions. The test has been clinically validated in more than 10,000 patient samples, ordered more than 220,000 times since launch, and has been shown to be associated with improved patient survival. Learn more at www.CastleBiosciences.com.

(Press release, Castle Biosciences, MAR 4, 2026, View Source [SID1234663270])

On March 3, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the fourth quarter and year ended December 31, 2025.

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"Meaningful scientific and operational progress in 2025 has positioned us well to generate human proof-of-concept data over the next 12-18 months for SC451 in type 1 diabetes and SG293 in blood cancers," said Steve Harr, Sana’s President and Chief Executive Officer. "Clinical data for UP421, a study which is now out beyond a year, provide the first known example of transplanting an allogeneic cell therapy for the treatment of type 1 diabetes without any immunosuppression. These results, when combined with progress in the field of transplanting pancreatic islets, make us optimistic that SC451, which incorporates the same hypoimmune gene edits into a more scalable manufacturing platform, can lead to a functional cure for people with type 1 diabetes, meaning normal blood glucose, no more insulin injections, and no immunosuppression. Moving to the fusogen platform, we made improvements to our in vivo CAR T platform with our next‑generation SG293 candidate, offering the potential for a simple, one-time, off-the-shelf treatment without the use of conditioning chemotherapy for the treatment of B cell cancers and B cell-mediated autoimmune diseases. We look forward to beginning clinical trials for both of these therapies this year. With two powerful platforms advancing in parallel, we look to drive meaningful clinical benefit for patients."

Corporate Highlights

Published positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression.

UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) was to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into a type 1 diabetes patient without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator.
Results of the study through one year after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with mixed meal tolerance tests performed over the course of the study, consistent with insulin secretion in response to a meal. PET-MRI scanning performed at week 12 and again at week 52 demonstrated islet cells at the transplant site in the forearm. The study identified no safety issues, and the HIP-modified islet cells evaded immune detection.
The New England Journal of Medicine (NEJM) published a journal article titled "Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression" (DOI: 10.1056/NEJMoa2503822). The article discusses 12-week results from this study. NEJM also published an accompanying editorial that further describes both the Sana technology and progress in the field (DOI: 10.1056/NEJMe2507578).

Advancing our focused pipeline across two platforms:

Hypoimmune Platform – Type 1 diabetes – Sana continues development of SC451, an O-negative, HIP-modified, iPSC-derived pancreatic islet cell therapy, which uses the same HIP technology as UP421. Sana has had multiple interactions with regulators over the last year, including FDA INTERACT and Pre-IND meetings, the results of which increase confidence in its manufacturing process, manufacturing controls, nonclinical testing plan, and clinical trial plan. Sana expects to file an IND and begin a Phase 1 clinical trial for SC451 as early as this year.
Fusogen Platform – In vivo CAR T cells – Sana continues to develop its next-generation in vivo CAR T product candidate, SG293, which uses Sana’s proprietary fusogen delivery-based technology. SG293 is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make CD19-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver. Preclinical data demonstrate that a SG293 surrogate achieves cell-specific delivery and deep B-cell depletion – as measured by depletion in circulating and lymph node B cells as well as a phenotypic reset when B cells return – in non-human primates without the use of any lymphodepleting chemotherapy. Sana intends to explore SG293 in both B-cell cancers and B-cell mediated autoimmune diseases and expects to generate first-in-human data as early as this year.

Published preclinical data in Nature Biotechnology demonstrating potent in vivo gene editing of hematopoietic stem cells (HSCs) in the bone marrow with systemic delivery in preclinical murine models using fusogen technology:

The article describes a study that evaluated a systemically delivered virus-like particle (VLP) using the fusogen technology to target and gene edit HSCs in vivo. Results show potent and cell-specific in vivo delivery and gene editing of HSCs in the bone marrow in several murine models, with stable gene editing of long-term HSCs.
This broadens the application of fusogen technology beyond T cells to a second cell type, HSCs, and underscores the ability to deliver diverse payloads, including CRISPR gene-editing and base-editing machinery.

Raised aggregate gross proceeds of $133.7 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and equity financing in 2025; expected cash runway into late 2026.

Closed public offering in August 2025 of 24.3 million shares of Sana’s common stock, including 3.4 million shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, and pre-funded warrants to purchase 1.5 million shares of Sana’s common stock. The gross proceeds from this offering were $86.3 million before deducting underwriting discounts and commissions and offering expenses.
Raised gross proceeds of $47.4 million in 2025 from sales of common stock through Sana’s ATM.

Strengthened leadership with the appointment of new Chief Financial Officer

In the first quarter of 2026, appointed Brian Piper as Executive Vice President, Chief Financial Officer. Mr. Piper has decades of experience in financial management within the biotechnology sector – including CFO roles at Scorpion Therapeutics, Antares Therapeutics, and Prelude Therapeutics – and has successfully led financings and worked with companies to maximize their assets.

Fourth Quarter 2025 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of December 31, 2025 were $138.4 million compared to $152.5 million as of December 31, 2024. The decrease of $14.1 million was primarily driven by cash used in operations of $143.8 million, partially offset by net proceeds from equity financings of $126.4 million, proceeds from stock option exercises and Sana’s employee stock purchase plan of $2.7 million, and other cash inflows.
Research and Development Expenses: For the three and twelve months ended December 31, 2025, research and development expenses, inclusive of non-cash expenses, were $34.9 million and $132.0 million, respectively, compared to $45.1 million and $215.7 million for the same periods in 2024. The decreases of $10.2 million and $83.7 million for the three and twelve months ended December 31, 2025 compared to the same periods in 2024, respectively, were primarily due to the portfolio prioritization announced in the fourth quarter of 2024, which resulted in a reduction of the scope of research, laboratory, and clinical development activities, lower personnel-related costs, including non-cash stock-based compensation, and a decrease in facility and other allocated costs. Research and development expenses include non-cash stock-based compensation of $3.2 million and $15.2 million, respectively, for the three and twelve months ended December 31, 2025, and $3.9 million and $23.4 million for the same periods in 2024.
Research and Development Related Success Payments and Contingent Consideration: For the three and twelve months ended December 31, 2025, Sana recognized non-cash expenses of $14.1 million and $29.4 million, respectively, compared to non-cash gains of $13.4 million and $8.9 million for the same periods in 2024, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities fluctuates significantly with changes in Sana’s market capitalization and stock price.
General and Administrative Expenses: General and administrative expenses for the three and twelve months ended December 31, 2025, inclusive of non-cash expenses, were $12.2 million and $44.3 million, respectively, compared to $17.3 million and $64.0 million for the same periods in 2024. The decrease of $5.1 million for the three months ended December 31, 2025 compared to the same period in 2024 was primarily due to personnel-related costs incurred in connection with the portfolio prioritization announced in the fourth quarter of 2024. The decrease of $19.7 million for the twelve months ended December 31, 2025 compared to the same period in 2024 was primarily due to lower personnel-related costs, including non-cash stock-based compensation, due to a decrease in headcount in connection with the portfolio prioritization announced in the fourth quarter of 2024, and decreased legal and consulting fees. General and administrative expenses include non-cash stock-based compensation of $3.2 million and $10.3 million for the three and twelve months ended December 31, 2025, respectively, compared to $2.5 million and $14.3 million for the same periods in 2024.
Impairment of Long-Lived Assets: For the twelve months ended December 31, 2025, non-cash impairment of long-lived assets was $44.6 million, compared to $1.9 million for the same period in 2024. The non-cash impairment of $44.6 million recorded in the second quarter of 2025 was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington. Because of the increased availability of manufacturing capacity at third-party contract development and manufacturing organizations (CDMOs) for cell and gene therapy products as well as progress in understanding its near-term manufacturing needs, Sana expects to use CDMOs to meet its manufacturing needs at present and has suspended further build-out of internal manufacturing capabilities. Impairment of long-lived assets in 2024 consists of non-cash losses recognized for the impairment of certain laboratory equipment and leasehold improvements as a result of the portfolio prioritization in the fourth quarter of 2024.
Net Loss: Net loss for the three and twelve months ended December 31, 2025 was $58.8 million, or $0.21 per share, and $244.2 million, or $0.96 per share, respectively, compared to $49.1 million, or $0.21 per share, and $266.8 million, or $1.16 per share, for the same periods in 2024.

(Press release, Sana Biotechnology, MAR 3, 2026, View Source [SID1234663231])