On March 5, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported fourth quarter and full year 2025 financial results and provided a corporate update.

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!

"We are encouraged by the early launch trajectory of KOMZIFTI and the positive feedback from physicians, pharmacists and payers on its differentiated clinical profile," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "With a compelling combination of efficacy, safety, compatibility, and simplicity, we believe KOMZIFTI is well positioned to lead in R/R NPM1-mutated AML. In 2026, we expect multiple clinical milestones in the combination and frontline settings that could significantly broaden the opportunity for ziftomenib across the AML treatment continuum. In addition, our solid tumor programs, including ziftomenib in gastrointestinal tumors and darlifarnib in both renal cell carcinoma and KRASG12C-mutated solid tumors, continue to advance, representing a potential addressable population of more than 200,000 patients. Importantly, our strong balance sheet, bolstered by anticipated collaboration milestones, provides the capital required to reach key value-inflecting frontline Phase 3 data and advance our next wave of novel therapies."

2025 Highlights and Recent Developments

KOMZIFTI Commercial Launch

Granted full approval by the U.S Food and Drug Administration (FDA) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. KOMZIFTI is the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutant (NPM1-m) AML.
Generated $2.1 million in net product revenue in the fourth quarter of 2025, based on approximately five weeks of commercial sales following November 13 approval.
Added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 2A recommended treatment option for adults with R/R NPM1-m AML.
Delivered product in channel within five business days of FDA approval, triggering a $135 million milestone payment from Kyowa Kirin.
Received rapid payer coverage within the first 90 days – approximately 80% of private payers had established published coverage policies, all aligned with the label with no additional restrictions.
Added to the FDA Orange Book, with listed patents extending up to July 2044, which support long-term market exclusivity in the United States.
Advancing Ziftomenib Across the AML Treatment Continuum

Initiated pivotal KOMET-017 Phase 3 frontline trials evaluating ziftomenib in combination with intensive and non-intensive chemotherapy in patients with NPM1-m or KMT2A-rearranged (KMT2A-r) AML in the frontline setting. Received two $30 million milestone payments from Kyowa Kirin in connection with first patient dosing in each of the two Phase 3 trials.
Presented positive Phase 1a/1b KOMET-007 (NCT05735184) data at ASH (Free ASH Whitepaper) 2025 demonstrating a favorable safety profile and encouraging antileukemic activity for ziftomenib in combination with venetoclax and azacitidine (ven/aza) in newly diagnosed NPM1-m AML as well as patients with R/R NPM1-m or KMT2A-r AML.
Dosed the first patient in the FLT3 inhibitor cohort of KOMET-007 trial evaluating ziftomenib combined with quizartinib plus cytarabine and daunorubicin (7+3) induction chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD/NPM1 co-mutations.
Solid Tumor Pipeline Progress

Initiated Phase 1b dose expansion in the FIT-001 trial evaluating darlifarnib plus cabozantinib in advanced renal cell carcinoma (RCC).
Presented preclinical and preliminary clinical data at ESMO (Free ESMO Whitepaper) 2025 highlighting the potential of darlifarnib to enhance the anti-tumor activity of PI3Kα inhibitors, KRAS inhibitors, and antiangiogenic tyrosine kinase inhibitors across multiple solid tumor indications.
2026 Strategic Priorities and Anticipated Milestones

Kura expects 2026 to be a data-rich year with multiple potential value inflection points:

KOMZIFTI Commercial Execution

Establish clear differentiation in the menin inhibitor class
Deliver strong quarter-over-quarter growth in revenue and adoption
Achieve leading class share in R/R NPM1-m AML setting
Ziftomenib – Development in Frontline AML

Continue enrollment in the pivotal KOMET-017 Phase 3 trials
Present updated KOMET-007 data for ziftomenib plus 7+3 in frontline NPM1-m/KMT2A-r AML (1H 2026)
Advance enrollment of KOMET-007 cohort for ziftomenib, quizartinib, and 7+3 quadruplet combination in frontline NPM1-m/FLT3-ITD AML
Ziftomenib – Development in R/R AML

Publish data for ziftomenib plus ven/aza in R/R NPM1-m AML (1H 2026)
Present preliminary KOMET-008 data for ziftomenib and gilteritinib combination in R/R NPM1-m/FLT3-m AML (2H 2026)
Ziftomenib and Menin Inhibition – Expansion into Solid Tumors

Advance enrollment of KOMET-015 for ziftomenib and imatinib combination in gastrointestinal stromal tumors (GIST)
Progress preclinical development of a next-generation menin inhibitor for use in combination therapy for solid tumors
Darlifarnib

Present preliminary clinical data for darlifarnib plus adagrasib in KRASG12C-mutated solid tumors (1H 2026)
Present updated Phase 1a data with ~ 1 year of additional follow-up for darlifarnib plus cabozantinib in advanced RCC (2H 2026)
KO-7246 (Next-Generation Menin Inhibitor)

Advance KO-7246 into IND-enabling studies for diabetes and cardiometabolic disease
Present additional preclinical data for menin inhibitors in Type 1 and Type 2 diabetes
Fourth Quarter 2025 Financial Results

Net product revenue: $2.1 million (first five weeks of commercial sales following November 13 approval of KOMZIFTI).
Collaboration revenue: $15.2 million, compared to $53.9 million for Q4 2024, reflecting non-cash revenue recognition under the collaboration agreement with Kyowa Kirin.
R&D expenses: $64.4 million, compared to $52.3 million for Q4 2024, primarily driven by advancement of ziftomenib combination trials, including KOMET-017.
SG&A expenses: $39.1 million, compared to $24.1 million for Q4 2024, reflecting commercialization-related investments.
Net loss: $81.0 million, compared to $19.2 million for Q4 2024. Net loss includes $11.3 million in non-cash, share-based compensation expense, compared to $8.6 million for the same period in 2024.
As of December 31, 2025, Kura had $667.2 million in cash, cash equivalents and short-term investments, compared to $727.4 million as of December 31, 2024.

The Company believes that its cash, cash equivalents and short-term investments as of December 31, 2025, will be sufficient to fund its current operating plan into the fourth quarter of 2027. When combined with the anticipated $180 million in payments under the collaboration agreement with Kyowa Kirin, these resources are expected to fund the ziftomenib AML program through the topline results from the first pivotal Phase 3 KOMET-017 frontline trial, anticipated in 2028.

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 8:00 a.m. ET / 5:00 a.m. PT today, March 5, 2026, to discuss financial results and to provide a corporate update. A live webcast and archived replay of the event will be available here or online from the Investors section of the Company’s website at www.kuraoncology.com.

(Press release, Kura Oncology, MAR 5, 2026, View Source [SID1234663300])

On March 5, 2026 Hopewell Therapeutics, Inc., a Boston-based next-generation lipid nanoparticle (LNP) company ("Hopewell"), reported that it entered into a sublicense agreement with Foxcroft Therapeutics, Inc., the developer of novel cancer vaccines ("Foxcroft"), granting Foxcroft a global sublicense to certain of its tissue-targeting LNPs (ttLNPs). Hopewell and Foxcroft will collaborate on their evaluation of Hopewell’s ttLNPs as potential delivery vehicles for Foxcroft’s cancer vaccines.

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!

Hopewell is currently developing ttLNPs as a delivery vehicle for a broad range of clinical and therapeutic applications, including vaccines, gene therapies, immune-oncology, and pulmonary therapies, targeting tissues in the lung, brain, bone marrow, ovaries, spleen, lymph nodes, kidneys, liver, and other vital organs. Pre-clinical testing has demonstrated Hopewell ttLNPs to perform more effectively than other LNPs available in the market.

In February 2025, Dr. Qiaobing Xu, Founder and President of Hopewell, authored a paper entitled "Antitumour vaccination via the targeted proteolysis of antigens isolated from tumour lysates," which described a novel tumor lysate-based cancer vaccine, delivered through LNPs that target the lymph nodes.1

In September 2025, Foxcroft obtained from Tufts University the exclusive global license to this cancer vaccine technology. The present Hopewell sublicense gives Foxcroft access to multiple ttLNPs as candidate delivery vehicles for its vaccine. Foxcroft plans to conduct confirmatory testing of vaccine formulations in large mammal trials, starting with a canine clinical trial expected to commence later this year.

The Hopewell sublicense includes a significant, non-refundable, up-front license fee to Hopewell, royalties on net sales, regulatory milestone payments, and up to $100 million of sales-based milestone payments.

"Hopewell is thrilled to announce the first sublicense of its ttLNP technology in the exciting field of cancer vaccines," commented Dr. Xu. "We look forward to supporting Foxcroft to bring this important anti-cancer therapy to human testing as quickly as possible."

Foxcroft’s management stated, "We recognize that Hopewell’s LNP library provides superior targeted delivery solutions for a number of clinical and therapeutic applications, including our vaccine. Over the months ahead, we are excited to work further with the Hopewell team to further evaluate the sublicensed LNPs."

(Press release, Hopewell Therapeutics, MAR 5, 2026, View Source [SID1234663318])

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.

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 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.

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!

"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 4, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) ("Can-Fite" or the "Company"), a biotechnology company advancing a pipeline of proprietary small-molecule drugs targeting oncological and inflammatory diseases, reported the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 795,869 American Depositary Shares (ADSs), having an exercise price of $9.34 per ADS, issued by Can-Fite in July 2025, at a reduced exercise price of $5.00 per ADS. The ADSs representing ordinary shares issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form F-1 (File No. 333-288890). The closing of the offering is expected to occur on or about March 5, 2026, subject to satisfaction of customary closing conditions.

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!

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, Can-Fite will issue new unregistered warrants to purchase up to 1,591,738 ADSs. The new warrants will have an exercise price of $5.00 per ADS, will be immediately exercisable until the twenty-four month anniversary of the effective date of the Resale Registration Statement.

The gross proceeds to Can-Fite from the exercise of the warrants are expected to be approximately $4.0 million, prior to deducting placement agent fees and offering expenses. The Company intends to use the net proceeds for funding research and development and clinical trials and for other working capital and general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act"), and, along with the ADSs issuable upon exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. Can-Fite has agreed to file a registration statement with the SEC covering the resale of the shares of ADSs issuable upon exercise of the new warrants (the "Resale Registration Statement").

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

(Press release, Can-Fite BioPharma, MAR 4, 2026, View Source [SID1234663255])