On May 8, 2025 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the first quarter ended March 31, 2025 (Press release, Werewolf Therapeutics, MAY 8, 2025, View Source [SID1234652772]).

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"Werewolf continues to build on our promising data and progress across our clinical-stage programs," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "We remain on track in our Phase 1/1b clinical trial evaluating WTX-124 to share interim data and meet with the FDA to discuss potential registrational pathways in the second half of this year. Additionally, in recognition of Skin Cancer Awareness month, Werewolf is launching an educational campaign in May to highlight the differentiation of Werewolf’s conditionally activated therapeutics and patient experiences to date in the WTX-124 clinical trial. I am also pleased to report that we recently initiated a Phase 1b/2 clinical trial of WTX-330 to explore antitumor activity and optimize the exposure of our IL-12 INDUKINE molecule in the tumor microenvironment. Finally, Werewolf has been making significant progress towards nominating its first INDUCER T cell engager development candidate in the second quarter of 2025, with preclinical data demonstrating that PREDATOR masking technology successfully silenced peripheral activity and prevented cytokine release. We believe that our proprietary PREDATOR masking and targeting technology distinctly positions us to build a robust pipeline of T cell engagers with potentially best-in-class potency and safety profiles, filling a gap in the current immuno-oncology landscape."

Recent Highlights and Upcoming Milestones

WTX-124: a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule being developed as monotherapy and in combination with pembrolizumab in multiple solid tumor types.
•All expansion arms are actively enrolling patients in the ongoing Phase 1/1b clinical trial at a recommended dose of 18 mg administered intravenously every two weeks (IV Q2W).
•During the second half of 2025, Werewolf plans to present interim data from the monotherapy and combination expansion arms, including tolerability, response rate, and durability, and to engage with regulatory authorities to discuss potential registrational pathways for WTX-124, including strategies for accelerated approval.
•The data continue to demonstrate clinically meaningful anti-tumor activity with a tolerable safety profile in patients who have previously been treated with immune checkpoint inhibitors.
•Launching a skin cancer awareness campaign educating various stakeholders on WTX-124 patient outcomes to date and the innovative science underlying Werewolf’s IL-2 cytokine therapy.
WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in advanced or metastatic solid tumors.
•Initiated patient dosing in a Phase 1b/2 clinical trial (WTX-330×2102) to optimize the exposure of WTX-330 in the tumor microenvironment, following the encouraging clinical activity and tolerability seen in the WTX-330×2101 first-in-human study.

Preclinical Portfolio:
•Werewolf’s previously announced development candidates WTX-712, its Interleukin-21 (IL-21) INDUKINE molecule, and WTX-518, its binding protein resistant Interleukin-18 (IL-18) INDUKINE molecule, for the treatment of cancer, and WTX-921, a first-of-its-kind Interleukin-10 (IL-10) INDUKINE molecule for the treatment of inflammatory bowel disease (IBD) and potentially other inflammatory diseases, are available for partnering.
•Werewolf has extended its conditional activation technology to T cell engagers, utilizing a novel and highly effective anti-CD3 masking strategy for its INDUCER T cell engager molecules. Preclinical data demonstrate that the Company’s PREDATOR masking technology successfully silenced peripheral activity and prevented cytokine release in its INDUCER molecules. The Company’s first INDUCER development candidate is expected to be nominated in the second quarter of 2025.
Financial Results for the First Quarter of 2025:
•Cash position: As of March 31, 2025, cash and cash equivalents were $92.0 million, compared to $111.0 million as of December 31, 2024. Based on updated forecasting, the Company now believes its existing cash and cash equivalents as of March 31, 2025, will be sufficient to fund operational expenses and capital expenditure requirements into the fourth quarter of 2026.
•Research and development expenses: Research and development expenses were $13.1 million for the first quarter of 2025, compared to $12.9 million for the same period in 2024.
•General and administrative expenses: General and administrative expenses were $4.9 million for the first quarter of 2025, compared to $5.0 million for the same period in 2024.
•Net loss: Net loss was $18.1 million for the first quarter of 2025, compared to $16.2 million for the same period in 2024.

On May 8, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that the U.S. Food and Drug Administration (FDA) has approved AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy (Press release, Verastem, MAY 8, 2025, View Source [SID1234652771]). AVMAPKI FAKZYNJA CO-PACK is the first and only FDA-approved medicine for this disease. This indication is approved under accelerated approval based on the tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. AVMAPKI plus FAKZYNJA is only commercially available in the U.S. as an oral combination co-pack with the two prescription products, known as "AVMAPKI FAKZYNJA CO-PACK."

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"Today’s approval of AVMAPKI FAKZYNJA CO-PACK for patients with KRAS-mutated recurrent low-grade serous ovarian cancer represents not only the first-ever FDA-approved treatment specifically for this rare cancer but also a new day for people living with this disease who have been in desperate need of new treatment options," said Dan Paterson, president and chief executive officer of Verastem Oncology. "We are very proud to bring two innovative medicines in one combination treatment to the LGSOC community. We thank the researchers, patients, and their families participating in our clinical trials, the patient advocacy community, the FDA, and everyone at Verastem for their dedication and commitment to helping us bring AVMAPKI FAKZYNJA CO-PACK to patients in the U.S."

The accelerated approval of AVMAPKI FAKZYNJA CO-PACK is based on the Phase 2 RAMP 201 clinical trial, which evaluated the combination of AVMAPKI and FAKZYNJA in adult patients with measurable KRAS-mutated recurrent LGSOC.

"Low-grade serous ovarian cancer is a rare and highly recurrent cancer with limited effective treatment options. This first-ever FDA approval in this disease was based on the primary analysis of the Phase 2 RAMP 201 trial, in which the combination of avutometinib and defactinib resulted in a significant overall response rate for patients with a KRAS mutation while being generally well tolerated," said Rachel Grisham, M.D., Section Head, Ovarian Cancer at Memorial Sloan Kettering Cancer Center in New York, NY and Global Lead Principal Investigator of GOG-3097/ENGOT-ov81/GTG-UK/RAMP 301. "The approval of avutometinib plus defactinib brings a much-needed therapeutic option to patients and establishes this combination as the new standard of care for women with recurrent low-grade serous ovarian cancer harboring a KRAS mutation. I look forward to progressing the confirmatory Phase 3 trial, RAMP 301, where we look to continue to support the ongoing body of research of this combination in women with and without a KRAS mutation."

"To see our early research in both the FRAME and RAMP 201 trial in recurrent low-grade serous ovarian cancer advance the combination of avutometinib and defactinib to now be the first-ever FDA-approved therapy for this disease is what gives us real hope when treating patients with rare or difficult-to-treat gynecological cancers," said Professor Susana Banerjee, M.B.B.S., M.A., Ph.D., F.R.C.P, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Team Leader in Women’s Cancers at The Institute of Cancer Research, London and Global Lead Principal Investigator of ENGOTov60/GOG3052 /NCRI/RAMP201. "With this approval, we thank all of the patients and researchers who participated in this trial, and the low-grade serous ovarian cancer community for their contributions to help bring the first FDA-approved treatment for KRAS-mutated recurrent LSGOC and changing the treatment possibilities for RAS/MAPK-pathway-driven cancers. We now need to build on this milestone to bring this new treatment to patients around the world."

Prior to this approval, there were no FDA-approved treatments specifically for KRAS-mutated recurrent LGSOC, a rare and distinct ovarian cancer that differs from high-grade serous ovarian cancer in both its biology and how it responds to treatment.

"One of the most devastating aspects of my LGSOC diagnosis was learning there are no FDA-approved treatments for this rare cancer. While there were some treatment options at the time that I could try, I made it my mission to advocate for research specific to my disease," said Nicole Andrews, chair of the STAAR Low-Grade Serous Ovarian Cancer Foundation. "Today we’re celebrating a milestone with the first-ever FDA-approved treatment option specifically for patients with recurrent LGSOC with a KRAS mutation. The low-grade serous ovarian cancer community is hopeful and excited about the potential benefits of this treatment and the progress toward improving the diagnosis, awareness, and research for LGSOC."

AVMAPKI FAKZYNJA CO-PACK is the first treatment to receive regulatory approval anywhere in the world, specifically for KRAS-mutated recurrent LGSOC. The Company believes AVMAPKI FAKZYNJA CO-PACK is also the first-ever oral, novel/novel combination therapy approved in oncology. Verastem initiated a rolling new drug application (NDA) with the FDA in May 2024 and completed its NDA submission in October 2024. The FDA granted Priority Review, and the approval was received in advance of its Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025. The FDA granted Breakthrough Therapy Designation for the treatment of patients with recurrent LGSOC after one or more prior lines of therapy, including platinum-based chemotherapy, in May 2021. Avutometinib alone or in combination with defactinib was also granted Orphan Drug Designation by the FDA for the treatment of LGSOC.

The AVMAPKI FAKZYNJA CO-PACK is expected to be available for adult patients with KRAS-mutated recurrent LGSOC in the U.S. in one week.

On May 8, 2025 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the first quarter ended March 31, 2025, and highlighted recent corporate progress (Press release, Tyra Biosciences, MAY 8, 2025, View Source [SID1234652770]).

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"In 2025, we are focused on clinical execution across our portfolio of next-generation precision therapies for oncology and skeletal dysplasia. We continued to advance TYRA-300 for ACH and intermediate risk non-muscle invasive bladder cancer and will begin dosing in BEACH301 and SURF302 in the second quarter," stated Todd Harris, CEO of TYRA. "In addition, our SURF431 study is now underway, and we dosed the first HCC patient with TYRA-430, our oral FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers."

First Quarter 2025 and Recent Corporate Highlights

TYRA-300

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Advanced Clinical Evaluation of TYRA-300 and Published Preclinical Research. TYRA continued to progress TYRA-300, an oral, investigational FGFR3-selective inhibitor, for the treatment of intermediate risk non-muscle invasive bladder cancer (IR NMIBC), pediatric achondroplasia (ACH), and metastatic urothelial cancer (mUC).
o
Advanced Phase 2 ACH Study – BEACH301 – Open for Enrollment. The study is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating TYRA-300 in children ages 3 to 10 with achondroplasia with open growth plates. The study will enroll children who are treatment-naïve (Cohort 1) and those who have received prior growth-accelerating therapy (Cohort 2) at multiple sites across the globe. Each of these cohorts is expected to enroll up to 10 participants per dose level (0.125, 0.25, 0.375, 0.50 mg/kg) for up to 12 months. The study is now enrolling a safety sentinel cohort of up to 3 treatment-naïve participants per dose level in children ages 5 to 10.
o
Advanced Phase 2 NMIBC Study Activities – SURF302. SURF302 is an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with TYRA-300 at 50 mg once-daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability.
o
Advanced Phase 1/2 mUC Study – SURF301. TYRA-300 is currently being evaluated in Part B of SURF301 (NCT05544552) at potentially therapeutic QD doses in preparation for potential future Phase 2 studies.
o
Preclinical Results with TYRA-300 Published in JCI Insight. In April 2025, preclinical results with TYRA-300 were published in JCI Insight 2025 in a manuscript titled "TYRA-300, an FGFR3 selective inhibitor, promotes bone growth in two FGFR3-driven models of chondrodysplasia." TYRA-300 was evaluated in three genetic contexts: wild-type mice, the Fgfr3Y367C/+ mouse model of ACH, and the Fgfr3N534K/+ mouse model of HCH. In each model, TYRA-300 treatment increased naso-anal length, tibia and femur length. In the two FGFR3-altered models, TYRA 300-induced growth partially restored the disproportionality of long bones. Histologic analysis of the growth plate in Fgfr3Y367C/+ mice revealed that TYRA-300 mechanistically increased both proliferation and differentiation of chondrocytes. Importantly, TYRA-300 also significantly improved the size and shape of the skull and foramen magnum in Fgfr3Y367C/+ mice. These studies demonstrate that TYRA-300 led to a significant increase in bone growth in two independent FGFR3-driven preclinical models, as well as in wild-type mice.

TYRA-200

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Advanced Phase 1 SURF201 Study. TYRA-200 is an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. SURF201 (Study in PrevioUsly Treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752) is a multi-center, open label study designed to evaluate the safety, tolerability, and pharmacokinetics of TYRA-200 and determine the optimal and maximum tolerated dose and recommended Phase 2 dose, as well as evaluate the preliminary antitumor activity of TYRA-200. The SURF201 study continues to enroll and dose adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 gene alterations.

TYRA-430

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Initiated Patient Dosing in Phase 1 Study – SURF431. TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. Patient dosing has commenced in SURF431, a Phase 1, multicenter, open-label, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations (NCT06915753). SURF431 is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TYRA-430 and determine the maximum tolerated dose and recommended Phase 2 dose, as well as evaluate the preliminary antitumor activity of TYRA-430. We believe TYRA-430 has the potential to address a significant unmet need in HCC, where there are no approved biomarker-driven, targeted therapies.

SNÅP Platform and Pipeline

•
TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions.

First Quarter 2025 Financial Results

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Cash, Cash Equivalents and Short-Term Investments. As of March 31, 2025, TYRA had cash, cash equivalents, and marketable securities of $318.9 million. The Company’s current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans through at least 2027.
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Research and Development (R&D) Expenses. R&D expenses for the three months ended March 31, 2025 were $25.0 million compared to $17.2 million for the same period in 2024. The increase was primarily driven by higher clinical costs associated with start-up activities for BEACH301, SURF302 and SURF431, as well as increased CMC and personnel-related costs, including non-cash stock-based compensation.
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General and Administrative (G&A) Expenses. G&A expenses for the three months ended March 31, 2025 were $6.9 million compared to $5.1 million for the same period in 2024. The increase was primarily driven by higher personnel-related costs, including non-cash stock-based compensation.
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Net Loss. First quarter net loss was $28.1 million compared to $18.2 million for the same period in 2024.

Upcoming Anticipated Milestones and Events

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BEACH301: dose first child with ACH with TYRA-300 – Q2 2025
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SURF302: dose first IR NMIBC patient with TYRA-300 – Q2 2025

About TYRA-300

TYRA-300 is the Company’s lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasia, including achondroplasia and hypochondroplasia. In oncology, TYRA-300 is being evaluated in mUC and IR NMIBC. In mUC, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552). The study is designed to determine the optimal and the recommended Phase 2 dose of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. In October 2024, TYRA reported interim clinical proof-of-concept data in mUC from SURF301. TYRA has received IND clearance from the US FDA to proceed with its SURF302 clinical trial in patients with IR NMIBC. In skeletal dysplasia, TYRA-300 has demonstrated positive preclinical results in achondroplasia and hypochondroplasia, and its BEACH301 clinical trial in children with achondroplasia is now enrolling.

About TYRA-200

TYRA-200 is an oral, investigational, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The Phase 1 clinical study of TYRA-200, SURF201 (NCT06160752), is a multi-center, open label study designed to evaluate the maximum tolerated dose and the recommended Phase 2 dose of TYRA-200, as well as to evaluate the preliminary antitumor activity of TYRA-200. SURF201 is currently enrolling and dosing adults with advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2.

About TYRA-430

TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The Phase 1 study (SURF431) is a multicenter, open-label, first-in-human study of TYRA-430 and is currently enrolling and dosing adults with advanced HCC and other solid tumors with activating FGF/FGFR pathway aberrations (NCT06915753).

On May 8, 2025 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, reported financial results for the first quarter ended March 31, 2025, and provided corporate updates (Press release, Terns Pharmaceuticals, MAY 8, 2025, View Source [SID1234652769]).

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"Terns had a strong start to 2025, marked by continued excellent execution on our two lead clinical programs. The dose escalation portion of the TERN-701 Phase 1 study for CML was completed in less than a year, and we are thrilled to report that we have initiated enrollment in the dose expansion portion of the study," stated Amy Burroughs, chief executive officer of Terns. "The rapid enrollment in our Phase 2 FALCON trial of TERN-601 in obesity highlights strong interest from patients and clinical investigators in the differentiated profile of this oral small molecule GLP1-RA. We remain on track to deliver meaningful data from both these studies in the second half of this year and have a cash runway that extends into 2028."

"TERN-701 showed highly encouraging safety with no dose limiting toxicities in dose escalation up to the maximum dose of 500 mg, linear pharmacokinetics with once daily dosing, and compelling molecular responses in patients with high CML disease burden who had responded poorly to multiple prior therapies including asciminib," said Emil Kuriakose MD, chief medical officer of Terns. "The favorable safety profile and dose-related increase in molecular responses with TERN-701 allowed us to select doses at the top end of the dose range to take forward to dose expansion."

Recent Clinical Pipeline Developments and Anticipated Milestones

TERN-701: Oral, small-molecule next-generation allosteric BCR-ABL inhibitor for chronic myeloid leukemia (CML)

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In April 2025, Terns enrolled the first patient in the dose expansion portion of the Phase 1 CARDINAL study of TERN-701 for CML. Patients will be randomized to one of two dose cohorts (320 mg or 500 mg QD) with up to 40 patients per arm. Doses were selected based on the totality of safety, efficacy, and PK/PD data from dose escalation
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Terns plans to report additional safety and efficacy data from the dose escalation and expansion portions of the study in 4Q 2025, when the study has sufficient patient enrollment and duration of follow-up to meaningfully assess 6-month major molecular response rates (regulatory approval endpoint) and inform the path to a pivotal trial
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In December 2024, Terns announced interim data from the TERN-701 dose escalation portion of the study, showing:
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Starting at the lowest dose, compelling molecular responses in heavily pre-treated CML patients with high baseline BCR-ABL transcript levels
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Encouraging safety profile with no dose limiting toxicities, adverse event-related treatment discontinuations or dose reductions at any dose

TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity

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Key objectives of the FALCON Phase 2 trial are to demonstrate competitive weight loss at 12-weeks, a class-leading safety/tolerability profile, and the simplest dose titration amongst GLP1-RA therapies
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The FALCON Phase 2 trial is ongoing with top-line 12-week data expected in 4Q 2025
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U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601
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Once-daily dosing with or without food in adults with obesity or who are overweight, without diabetes (BMI ranges from ≥30 to <50 kg/m2 or ≥27 to <30 kg/m2 with at least one weight-related comorbidity)
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Patients randomized to one of four active cohorts (n=30 per cohort): 250 mg, 500 mg, 500 mg slow titration, 750 mg or placebo
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Primary endpoint is percent change from baseline in body weight compared to placebo over 12 weeks
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Secondary endpoints include safety, tolerability and proportion of patients achieving 5% weight loss or greater
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Doses and titration schema for the Phase 2 were selected based on positive results from the Phase 1 study, announced in September 2024, which demonstrated weight loss over 28-days up to 5.5% and favorable safety and tolerability despite rapid dose titration every three days

Pipeline and Partnering Programs

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TERN-800 Series: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist
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Terns is prioritizing its discovery efforts on nominating a GIPR antagonist development candidate based on in-house discoveries and growing scientific rationale supporting the potential of GLP-1 agonist/GIPR antagonist combinations for obesity

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TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist
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Based on non-clinical studies, THR-β is a complementary mechanism to GLP-1, potentially providing broader metabolic and liver benefits in addition to increased weight loss

Corporate Updates

Members of Terns’ senior leadership team will participate in the following upcoming investor conferences:

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Jefferies Global Healthcare Conference in New York City, New York being held June 3rd – June 5th, 2025
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Goldman Sachs 46th Annual Global Healthcare Conference in Miami, Florida being held June 9th – June 11th, 2025

Webcasts of these events can be accessed at the Terns website under the "Events & Presentations" tab on the "Investors" section of the Company’s website on the day of the event: View Source

First Quarter 2025 Financial Results

Cash Position: As of March 31, 2025, cash, cash equivalents and marketable securities were $334.3 million, as compared with $358.2 million as of December 31, 2024. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2028.

Research and Development (R&D) Expenses: R&D expenses were $18.7 million for the quarter ended March 31, 2025, as compared with $18.6 million for the quarter ended March 31, 2024.

General and Administrative (G&A) Expenses: G&A expenses were $8.7 million for the quarter ended March 31, 2025, as compared with $6.9 million for the quarter ended March 31, 2024.

Net Loss: Net loss was $23.9 million for the quarter ended March 31, 2025, as compared with $22.4 million for the quarter ended March 31, 2024.

On May 8, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the first quarter of 2025 and recent business highlights (Press release, Sutro Biopharma, MAY 8, 2025, View Source [SID1234652763]).

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"In the first quarter, we announced a strategic decision to shift Sutro’s product candidate focus from luvelta to our pipeline of wholly-owned novel exatecan and dual-payload ADCs. As part of this review, we selected STRO-004—a next-generation Tissue Factor-targeting exatecan/Topo 1 ADC—as our lead clinical candidate, supported by strong preclinical data that point to its best-in-class potential," said Jane Chung, Sutro’s Chief Executive Officer. "At AACR (Free AACR Whitepaper), we presented on STRO-004’s potent, dose-dependent anti-tumor activity and favorable safety profile across multiple dose levels and highlighted the unique capabilities of our XpressCF+ cell-free platform to develop novel dual-payload ADCs—an approach that holds significant promise for some of the most difficult-to-treat cancers. Additionally, next week, we have the opportunity to present preclinical data on STRO-006 for the first time, demonstrating encouraging pharmacokinetics (PK) and anti-tumor activity."

Ms. Chung continued: "We currently are on track to deliver three new INDs over the next three years, starting with STRO-004, which is expected to enter clinical studies in the second half of this year. Our rich pipeline, made possible by our optimized cell-free platform, is designed to engage complex, hard-to-drug targets with next-generation single- and dual-payloads. We are also already seeing the extraordinary capabilities of our platform yield important advances in our collaboration with Astellas, with the recent initiation of an IND-enabling toxicology study for the first dual-payload immunostimulatory ADC program under our collaboration, triggering a milestone payment to Sutro. Our team remains inspired by the immense potential of our platform and pipeline, and the substantial benefit it can bring to patients and to our partners."

Corporate and Program Updates

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In March, Sutro announced completion of a strategic portfolio review resulting in the prioritization of its wholly-owned next-generation ADC programs. While Sutro will not continue the development of luveltamab tazevibulin (luvelta) on its own, it remains open to partnership opportunities.

Wholly-Owned Pipeline

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STRO-004: Sutro’s novel exatecan Tissue Factor ADC has been prioritized as the Company’s lead program, with an initial focus on solid tumors. The Company is preparing to submit an IND and initiate a first-in-human study in the second half of 2025.
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STRO-006: Sutro’s differentiated integrin beta-6 (ITGB6) ADC is expected to enter clinical development in 2026, aimed at multiple solid tumors.
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Dual-Payload Program: An IND for Sutro’s first wholly-owned dual-payload ADC is anticipated to be filed in 2027.

Existing Collaborations for Next-Generation ADCs

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Ipsen: A drug development program is ongoing with Ipsen for STRO-003, a ROR1 ADC.
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Astellas: Two research and development programs are ongoing with Astellas for dual-payload immunostimulatory ADCs (iADCs), one of which has initiated an IND-enabling toxicology study triggering a milestone payment to Sutro.

These collaborations remain a strategic priority given their long-term value creation potential and the increasing relevance of specialized ADCs in the treatment of cancer.

Medical Conferences

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21st Annual PEGS Boston: The Essential Proteins Engineering & Cell Therapy Summit: In May, Sutro will present promising preclinical data with STRO-006, highlighting its superior anti-tumor activity compared to first generation ITGB6 ADCs at clinically relevant dose levels, as well as its favorable PK and tolerability profile.
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2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting: In April, Sutro presented encouraging preclinical results with STRO-004 and its dual-payload ADC programs. Among the highlights, a single dose of STRO-004 led to promising overall response and disease control rates in Tissue Factor-positive patient-derived xenograft models spanning multiple cancer types. Additionally, STRO-004 has a favorable safety profile in cynomolgus monkeys up to 50 mg/kg, the highest dose tested.
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Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer: In March, expanded data were presented in a late-breaking oral presentation from the dose-optimization portion of the REFRαME-O1 trial with luvelta in patients with platinum resistant ovarian cancer. In the study, luvelta demonstrated encouraging antitumor activity in patients with late-stage ovarian cancer across all levels of Folate Receptor-α expression of 25% or greater, including an improved overall response rate, a low discontinuation rate, and a consistent safety profile across dose levels.

Upcoming Investor Conferences

Management will participate in the following upcoming healthcare investor conferences. Webcasts of the presentations will be accessible through the News & Events page of the Investor Relations section of the Company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the event.

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TD Cowen’s 6th Annual Oncology Innovation Summit, May 27-28, 2025, Virtual
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Jefferies 2025 Global Healthcare Conference, June 3-5, 2025, in New York

Organization

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As part of the restructuring, Jane Chung, President and Chief Operating Officer, assumed the responsibilities as Chief Executive Officer and was appointed as a member of the Sutro Board. The Company is also reducing its organizational headcount by nearly 50 percent and decommissioning its manufacturing facility by year-end 2025. Manufacturing capabilities to support the next-generation ADC pipeline have been fully established and scaled up externally.

First Quarter 2025 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of March 31, 2025, Sutro had cash, cash equivalents and marketable securities of $249.0 million, as compared to $316.9 million as of December 31, 2024. Cost reductions subsequently realized from the restructuring, combined with refocused clinical development priorities give the Company an expected cash runway into early 2027, excluding additional anticipated milestones from existing collaborations.

Revenue

Revenue was $17.4 million for the quarter ended March 31, 2025, as compared to $13.0 million for the quarter ended March 31, 2024, with the 2025 amount related principally to the Astellas collaboration. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Research & Development (R&D) and General & Administrative (G&A) Expenses

Total R&D and G&A expenses for the quarter ended March 31, 2025 were $64.9 million, as compared to $69.6 million for the quarter ended March 31, 2024. The 2025 period includes non-cash expenses for stock-based compensation of $5.5 million and depreciation and amortization of $1.9 million, as compared to $6.1 million and $1.8 million, respectively, in the 2024 period. For the quarter ended March 31, 2025, R&D expenses were $51.6 million and G&A expenses were $13.3 million.

Restructuring and Related Costs

Restructuring and related costs for the quarter ended March 31, 2025 were $21.0 million. Sutro will continue to recognize restructuring and related costs in future periods for the deprioritization of the luvelta program, of which it expects to recognize a significant portion in 2025. The ultimate amount of expense will be affected by the timing to complete Sutro’s cost commitments to its third-party CROs and CMOs and the full wind-down of the clinical trials. Sutro will revise its estimates of the costs to deprioritize these studies for the luvelta program and the amount of severance and benefits paid to employees as new information becomes available to the Company in future periods.