On May 14, 2026 Sangamo Therapeutics, Inc. (OTCQB Venture Market: SGMO), a genomic medicine company, reported recent business highlights and first quarter 2026 financial results.

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"During the first quarter, we advanced our rolling BLA submission for ST-920 and continued to progress our differentiated neurology pipeline," said Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics. "We remain focused on executing against our regulatory and clinical priorities while pursuing opportunities to secure additional funding and support the long-term potential of our pipeline."

Recent Business Highlights

Corporate Updates
•Transitioned to trading on the OTCQB Venture Market, operated by OTC Markets Group, following the receipt of a delisting determination from The Nasdaq Capital Market due to non-compliance with Nasdaq’s minimum bid requirements. Sangamo intends to appeal the delisting determination at a hearing before Nasdaq, scheduled for June 9, 2026.
•Sangamo’s common stock began trading on the OTCQB Venture Market on May 5, 2026, under the same trading symbol, SGMO.
Fabry Disease
•The rolling submission to the FDA of a BLA seeking approval of isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease under an Accelerated Approval pathway, remains in progress.
•The preclinical and clinical modules have been submitted to the FDA for review. In addition, the antibody assay companion diagnostic, which is designed to screen patients for eligibility with isaralgagene civaparvovec, has been submitted to, and accepted by, the FDA’s Center for Devices and Radiological Health (CDRH), seeking Premarket Approval (PMA).
•Isaralgagene civaparvovec has a clear pathway to accelerated approval from the FDA, using mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study. The FDA has recently affirmed to us that two-year eGFR data may serve as confirmatory evidence for traditional approval.
•In February, presented detailed data from the registrational Phase 1/2 STAAR study via four platform and poster presentations at the 22nd Annual WORLDSymposiumTM in San Diego, California.
•Sangamo is advancing the Chemistry, Manufacturing and Controls (CMC) module, ahead of completion of the rolling BLA submission for isaralgagene civaparvovec, expected as early as the summer of 2026, subject to the ability to secure adequate additional funding, while continuing business development discussions for a potential Fabry commercialization agreement.

Core Neurology Pipeline
Chronic Neuropathic Pain – ST-503
•Six sites have been activated in the Phase 1/2 STAND study evaluating ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to small fiber neuropathy (SFN), a type of chronic neuropathic pain.
•In March, a manuscript was published in Science Translational Medicine detailing the preclinical safety and pharmacology of ST-503 in human neurons, mice and nonhuman primates.
Prion Disease – ST-506
•Clinical Trial Application (CTA) enabling activities are in progress for ST-506, an investigational epigenetic regulator for the treatment of prion disease, leveraging STAC-BBB, Sangamo’s novel proprietary neurotropic adeno-associated virus (AAV) capsid.
•Held productive interaction with the MHRA, including alignment on diagnostic testing, analytical validation and nonclinical safety matters.
•The Good Laboratory Practice (GLP) toxicology study has been completed and analysis is ongoing.
29th ASGCT (Free ASGCT Whitepaper) Annual Meeting
•Participated in the 29th ASGCT (Free ASGCT Whitepaper) Annual Meeting, May 11-15, 2026, in Boston, MA, to present the progression of Sangamo’s neurology pipeline, including advances in zinc finger epigenetic regulation and developments in modular integrase technology. These presentations can be found on Sangamo’s website, in the Presentations section.
First Quarter 2026 Financial Results
Consolidated net loss for the first quarter ended March 31, 2026 was $31.0 million, or $0.08 per share, compared to a consolidated net loss of $30.6 million, or $0.14 per share, for the same period in 2025.
Revenues
Revenues for the first quarter ended March 31, 2026 were $1.4 million, compared to $6.4 million for the same period in 2025.
The decrease of $5.0 million in revenues was primarily attributable to $5.0 million in revenue relating to our collaboration agreement with Pfizer Inc. upon transfer of a specified sublicense in 2025, and a decrease of $0.8 million in revenue relating to our license agreement with Sigma-Aldrich Corporation. These decreases were partially offset by $0.5 million in revenue relating to our license agreement with Miltenyi Biotec B.V. & Co. KG.
GAAP and Non-GAAP Operating Expenses
(In millions)
Three Months Ended
March 31,
2026 2025
Research and development $ 26.6 $ 26.0
General and administrative 6.8 10.1
Total operating expenses 33.4 36.1
Depreciation and amortization (0.7) (1.0)
Stock-based compensation (1.0) (2.6)
Non-GAAP operating expenses $ 31.7 $ 32.5

Total operating expenses on a GAAP basis for the quarter ended March 31, 2026 were $33.4 million, compared to $36.1 million for the same period in 2025. Non-GAAP operating expenses, which exclude depreciation and amortization, and stock-based compensation expense, for the quarter ended March 31, 2026 were $31.7 million, compared to $32.5 million for the same period in 2025.
The decrease in total operating expenses on a GAAP basis was primarily driven by lower compensation and other personnel costs, mainly due to changes in variable compensation and lower headcount, and lower facilities and infrastructure-related expenses. These decreases were partially offset by an increase in manufacturing expenses, primarily due to BLA readiness activities for our Fabry disease program.

Cash and Cash Equivalents
As of March 31, 2026, we had cash and cash equivalents of $27.6 million, compared to cash and cash equivalents of $20.9 million as of December 31, 2025. Based on our current operating plan, including the implementation of potential additional cost reduction measures, we estimate that our cash and cash equivalents as of March 31, 2026, will be sufficient to fund our planned operations into the third quarter of 2026.
Financial Guidance for 2026
•On a GAAP basis, we expect total operating expenses in the range of approximately $110 million to $130 million in 2026, which includes estimated non-cash stock-based compensation expense, and depreciation and amortization.
•We expect non-GAAP total operating expenses, excluding estimated non-cash stock-based compensation expense of approximately $8 million, and estimated depreciation and amortization of approximately $2 million, in the range of approximately $100 million to $120 million in 2026.
•This financial guidance is subject to our ability to secure adequate additional funding for our current operating plan.
Conference Call
The Sangamo management team will hold a corporate call to further discuss program and financial updates on Thursday, May 14, at 4:30pm Eastern Time.
Participants should register for, and access, the call using this link. While not required, it is recommended you join 10 minutes prior to the event start. Once registered, participants will be given the option to either dial into the call with the number and unique passcode provided or to use the dial-out option to connect their phone instantly.
An updated corporate presentation is available in the Investors and Media section under Presentations.
The link to access the live webcast can also be found on the Sangamo website in the Investors and Media section under Events. A replay will be available following the conference call, accessible at the same link.

(Press release, Sangamo Therapeutics, MAY 14, 2026, View Source [SID1234665714])

On May 14, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported financial results for the three months ended March 31, 2026, and provided a corporate update highlighting continued execution across its SkinJect and Teverelix development programs.

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During the first quarter of 2026, Medicus continued to advance its transition into a diversified clinical-stage biotechnology company with active development programs in dermatologic oncology and urology/oncology, while replenishing its balance sheet through multiple capital market initiatives.

The Company recently reported positive, decision grade, expanded dataset findings from its Phase 2 SKNJCT-003 study evaluating SkinJect Doxorubicin Microneedle Array (D-MNA) for the treatment of nodular basal cell carcinoma (BCC), including evidence of positive dose response and registrational grade clearance rates in the 200-µg treatment cohort.

In parallel, Medicus advanced Teverelix, its next-generation long-acting GnRH antagonist acquired through the acquisition of Antev Limited, with Food and Drug Administration (FDA) clearance to initiate a Phase 2b dose optimization study in advanced prostate cancer and submission of an optimized Phase 2 protocol in acute urinary retention recurrence prevention.

Management Commentary:

"During the first quarter of 2026, Medicus continued to execute on its transformation into a diversified clinical-stage biotechnology company, highlighted by expanded positive Phase 2 SkinJect data, advancement of Teverelix into additional clinical development pathways, and continued expansion of our regulatory and strategic initiatives," stated Dr. Raza Bokhari, Medicus’ Executive Chairman & CEO. "We believe the growing strength of our clinical datasets, combined with expanded financing flexibility and continued development of AI-enabled clinical capabilities, positions the Company to pursue multiple value-driving milestones in dermatologic oncology, prostate cancer, acute urinary retention, and rare disease indications throughout 2026 and beyond."

First Quarter 2026 and Recent Corporate Highlights

SkinJect Platform (Dermatology / Oncology / Rare Disease)

SkinJect, a novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) and Gorlin Syndrome, a rare autosomal dominant disease also called nevoid BCC syndrome, collectively representing a ~$2 billion market opportunity.

In the first quarter 2026, the Company made the following noteworthy advances in the SkinJect program:

Reported positive topline and expanded dataset findings from the Phase 2 SKNJCT-003 clinical study evaluating D-MNA for nodular basal cell carcinoma.
Expanded analysis demonstrated positive dose-response trends and clinically meaningful clearance activity in the 200-µg treatment cohort.
Company believes the dataset supports continued FDA engagement regarding potential registrational development pathways.
Completed enrollment of 90 patients in the U.S.-based Phase 2 SKNJCT-003 study.
Continued expansion activities for the SKNJCT-004 UAE-based clinical study evaluating SkinJect in additional geographic markets.
Submitted an Orphan Drug Designation application to the FDA for SkinJect in Gorlin Syndrome patients.
Continued collaboration with the Gorlin Syndrome Alliance to support compassionate access and expanded access development initiatives.
Teverelix Platform (Prostate + Women’s Health)

Teverelix, a next generation GnRH antagonist, is a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate, collectively representing an ~$6 billion market opportunity.

In the first quarter 2026, the Company made the following noteworthy advances in the Teverelix program:

FDA provided "study may proceed" clearance for the Company’s Phase 2b dose optimization study evaluating Teverelix in advanced prostate cancer.
Submitted optimized Phase 2 protocol to the FDA for prevention of recurrent acute urinary retention in men with benign prostatic hyperplasia.
Presented additional clinical data relating to Teverelix at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026.
Successfully amended the LifeArc licensing agreement, reducing the royalty rate payable on worldwide net sales from approximately 4% to 2%.
Other Strategic and Corporate Initiatives:

In the first quarter 2026, the Company continued to make progress in other relevant strategic and corporate initiatives, some of which are highlighted below:

Continued development of the Company’s AI-enabled clinical development collaboration with Reliant AI.
Expanded ATM financing capacity from up to approximately $15.3 million to up to $50 million subsequent to quarter end.
Continued evaluation of additional strategic acquisition and partnering opportunities aligned with the Company’s multi-strategy development platform.
Financial Highlights (Q1 2026):

During the first quarter of 2026, the Company continued to replenish its capital position through utilization of its at-the-market ("ATM") facility and Standby Equity Purchase Agreement ("SEPA"), securing approximately $10 million in aggregate gross financing proceeds during the quarter. Subsequent to quarter end, the Company also expanded its ATM facility from up to approximately $15.3 million to up to $50 million.

The Company operates as a clinical-stage enterprise and expects to incur operating losses for the foreseeable future. As disclosed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, substantial doubt exists regarding the Company’s ability to continue as a going concern without additional financing. However, management believes the Company continues to have access to additional capital resources through public and private equity offerings, debt financings, strategic collaborations, licensing arrangements, and other financing initiatives. Financial results of the Company for the quarter ended March 31, 2026, include:

Cash and cash equivalents: $6.4 million as of March 31, 2026 (vs. $4.0 million as of March 31, 2025)
Operating expenses: $8.6 million (vs. $5.1 million in Q1 2025)
General & administrative: $5.9 million (vs. $3.1 million in Q1 2025)
Research & development: $2.7 million (vs. $2.0 million in Q1 2025)
Net loss: $9.0 million (vs. $5.1 million in Q1 2025)
Loss from operations: $8.6 million (vs. $5.1 million in Q1 2025)
Net loss per share: $0.31 (vs. $0.42 in Q1 2025)
The Company’s complete unaudited financial statements and results of operations for the quarter ended March 31, 2026 are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 14, 2026.

Expected Upcoming Catalysts in 2026

The Company expects 2026 to remain a catalyst-rich year with multiple anticipated milestones, including:

End-of-Phase 2 FDA meeting (SkinJect) to define registrational pathway
Potential registrational trial design alignment under 505(b)(2) framework
Advancement of Gorlin Syndrome Orphan Drug designation, Registrational grade IND and Pediatrics Rare Disease Voucher Program
Continued evaluation of HelixNano-enabled platform expansion opportunities
Expansion of Teverelix into women’s health (endometriosis) using genomics-enabled clinical strategy
Progression of agentic AI-driven clinical development platform with Reliant AI
Ongoing strategic partnering discussions across both core programs, Skinject and Teverelix
Potential expansion of strategic collaborations and licensing discussions
The Company believes its current financing infrastructure, including the expanded ATM facility and existing capital market access, provides flexibility to support ongoing operations and advancement of its clinical development programs.

(Press release, Skinject, MAY 14, 2026, View Source [SID1234665740])

On May 14, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for patients with cancer, reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

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"The quarter was marked by strong execution across our lead clinical programs, commercial readiness efforts, and further strengthening of our balance sheet," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. "Our primary focus remains on preparing for our planned BLA submission in Q4 2026 for aglatimagene in localized, intermediate- to high-risk prostate cancer. In parallel, we continue to follow patients from our phase 3 localized prostate cancer trial, with extended follow up data to be presented in a plenary oral presentation in May 2026 at AUA and additional biomarker data to be announced in Q3 2026. We are also encouraged by the persistent survival tail observed after extended follow-up from our phase 2a NSCLC trial and look forward to the planned initiation of a pivotal NSCLC phase 3 trial in June 2026."

Dr. Tak continued, "On the commercial readiness front, we are encouraged by our progress in building a differentiated, partnership-driven model that leverages the expertise of world-class organizations EVERSANA and IDEA Pharma. We believe this approach can enhance speed, flexibility, and scalability, positioning Candel for a successful and timely commercial launch of aglatimagene, if approved, for patients with localized prostate cancer."

First Quarter 2026 & Recent Highlights

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Aglatimagene besadenovec (CAN-2409) – Prostate Cancer
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The Company continues to advance its pre-BLA readiness initiative, including its Chemistry, Manufacturing, and Controls (CMC) activities, and preparation of clinical study reports and BLA modules.
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The Company will report follow-up clinical data from its phase 3 trial of aglatimagene in prostate cancer in an oral presentation at the American Urological Association (AUA) 2026 Annual Meeting Plenary Program being held in Washington D.C. from May 15-18, 2026. In Q3 2026, the Company expects to present additional biomarker data.
•
The Company plans to conduct process validation with its Contract Development and Manufacturing Organization in Q2 2026 to enable its anticipated submission of a BLA in Q4 2026. Clinical material from the new process has been manufactured and filled into vials. Candel intends to use this material in the pivotal phase 3 clinical trial in NSCLC.
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The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of localized prostate cancer. The phase 3 clinical trial of aglatimagene in localized prostate cancer was conducted under a Special Protocol Assessment with respect to certain aspects of the study design, agreed with the FDA.
•
Aglatimagene besadenovec (CAN-2409) – Non-Small Cell Lung Cancer (NSCLC)
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The Company reported an additional 12 months of extended follow-up from its clinical trial of aglatimagene plus valacyclovir in combination with continued ICI therapy in patients with advanced NSCLC, who had an inadequate response to prior ICI treatment. The reported data included:
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Extended long-term survival observed after an additional year of follow-up in an ongoing phase 2a clinical trial, with 50% of the 46 patients with advanced NSCLC treated per-protocol with aglatimagene surviving beyond 24 months, despite prior inadequate response to ICI and multiple adverse baseline prognostic factors.
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Among the patients surviving beyond 24 months and with PD-L1 status available, 85% (17/20) had baseline PD-L1 tumor proportion scores (TPS) below 50% (a population typically less responsive to ICI), supporting the potential of aglatimagene to upregulate PD-L1 in the tumor microenvironment and convert non-responders to ICI into responders.
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Median overall survival (mOS) was 25.4 months in the evaluable patients with inadequate response to ICI in cohorts 1 and 2 (per-protocol population), 21.5 months among evaluable patients exhibiting progressive disease at baseline despite prior ICI therapy (cohort 2), and 25.4 months in the subgroup of patients with non-squamous histology within cohort 2, supporting the rationale for a precision medicine-based design for the phase 3 pivotal trial planned for initiation in June 2026.
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Post-treatment tumor biopsies demonstrated an increase in pro-inflammatory gene expression, which was significantly associated with long-term survival, supporting activation of inflammatory pathways within the tumor microenvironment following aglatimagene treatment.
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Expansion of T-cell receptor (TCR) repertoire diversity was observed after treatment both within the tumor and in peripheral blood, consistent with broad activation of anti-tumor immunity through enhanced exposure of tumor antigens following aglatimagene therapy.
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Following a positive end-of-phase 2 meeting with the FDA in July 2025, the Company is preparing to initiate a pivotal phase 3 clinical trial of aglatimagene in NSCLC in June 2026.
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The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC.
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Linoserpaturev (CAN-3110) – Recurrent High-Grade Glioma (rHGG)
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In February 2026, at the 7th Annual Glioblastoma Drug Development Summit, the Company shared insights from its herpes simplex virus (HSV)-based platform and its linoserpaturev program through workshop presentations and panel discussions focused on advancing biomarker-driven clinical development in glioblastoma.
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The Company submitted an IND for linoserpaturev to advance the ongoing development of this asset in rHGG in Q4 2025 and received clearance to proceed from the FDA in Q1 2026.
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The FDA previously granted Fast Track Designation and Orphan Drug Designation to linoserpaturev in rHGG.•
Recent Corporate Events
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In April 2026, the Company announced a commercialization agreement with EVERSANA to support the potential U.S. launch of aglatimagene in localized prostate cancer. EVERSANA joins IDEA Pharma, a division of SAI MedPartners, who has been providing path-to-market strategies and strategic positioning for aglatimagene. This operating model gives Candel immediate access to leading commercial capabilities, while maintaining financial flexibility, capital efficiency, and scientific focus that has driven the Company’s progress to date.
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On February 23, 2026, Candel issued and sold 18,348,624 shares of common stock at a price to the public of $5.45 per share for aggregate gross proceeds of approximately $100 million, which will be used to complete critical launch readiness, medical affairs, pre-commercialization, and commercial activities for aglatimagene in early, localized prostate cancer, ongoing development costs related to the phase 3 trial of aglatimagene in NSCLC, and for general corporate purposes.
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On February 19, 2026, Candel announced a $100 million royalty funding agreement with funds managed by RTW Investments, LP (RTW), subject to FDA approval of aglatimagene in localized, intermediate- to high-risk, prostate cancer. Under the terms of the agreement, RTW will receive a tiered single digit percentage of annual net sales of aglatimagene in the U.S., subject to a cap. Funds will strengthen the Company’s balance sheet for potential U.S. commercial launch of aglatimagene in intermediate- to high-risk localized prostate cancer.
Anticipated Milestones

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Updated extended follow-up data from the positive phase 3 clinical trial of aglatimagene in patients with localized, intermediate- to high-risk localized prostate cancer, will be reported in an oral presentation at the AUA 2026 Annual Meeting Plenary Program being held in Washington D.C. from May 15-18, 2026.
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The Company plans to initiate a pivotal phase 3 clinical trial of aglatimagene in patients with metastatic, non-squamous, NSCLC, and progressive disease despite ICI treatment in June 2026.
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Biomarker data related to the effects of aglatimagene in patients with localized prostate cancer is expected in Q3 2026.
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The Company expects to present mature mOS data and an update on long-term survivors from arm C of its phase 1b clinical trial of linoserpaturev in patients with rHGG in Q4 2026.
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Submission of BLA for aglatimagene in prostate cancer is planned for Q4 2026.

Financial Results for the First Quarter Ended March 31, 2026

Research and Development Expenses: Research and development expenses were $9.8 million for the first quarter of 2026 compared to $4.0 million for the first quarter of 2025. The increase was primarily due to higher clinical trial and manufacturing costs, in support of the Company’s aglatimagene programs, and an increase in employee-related expenses. Research and development expenses included a non-cash stock compensation expense of $0.6 million for the first quarter of 2026, as compared to a non-cash stock compensation expense of ($0.1) million for the first quarter of 2025.

General and Administrative Expenses: General and administrative expenses were $6.4 million for the first quarter of 2026, compared to $4.1 million for the first quarter of 2025. The increase was primarily due to higher commercial readiness costs and an increase in employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $0.8 million for the first quarter of 2026, as compared to a non-cash stock compensation expense of $0.4 million for the first quarter of 2025.

Net Income/Loss: Net loss for the first quarter of 2026 was $8.9 million compared to net income of $7.4 million for the first quarter of 2025 and included net other income of $7.4 million and $15.5 million, respectively. The decrease in net other income was primarily related to the change in the fair value of the Company’s warrant liabilities.

Cash Position: Cash and cash equivalents, as of March 31, 2026, were $194.8 million compared to $119.7 million as of December 31, 2025. Based on current operating plans, the Company expects that its existing cash and cash equivalents, as of March 31, 2026, will be sufficient to fund operations into Q1 2028.

About aglatimagene besadenovec (CAN-2409)

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the FDA or any other regulatory authority for any use.

About linoserpaturev (CAN-3110)

Linoserpaturev is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where linoserpaturev was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, Science Translational Medicine presented findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of rHGG from the U.S. Food and Drug Administration (FDA).

(Press release, Candel Therapeutics, MAY 14, 2026, View Source [SID1234665698])

On May 14, 2026 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the first quarter of 2026 and recent business highlights.

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"During the first quarter, we continued to execute across our clinical and preclinical portfolio, positioning Sutro for key data readouts later this year," said Jane Chung, Sutro’s Chief Executive Officer. "Dose escalation is rapidly progressing in our Phase 1 trial of STRO-004, and we remain on track to report initial safety, pharmacokinetic and early activity data in mid-2026, which we believe will provide important insights into its clinical profile and our platform as a whole. This clinical momentum is reinforced by preclinical data we presented at the recent AACR (Free AACR Whitepaper) Annual Meeting, which highlighted the robust and consistent antitumor activity of STRO-004, as well as continued progress across our broader ADC pipeline."

"In parallel, we are advancing our next-generation ADC candidates, STRO-006, targeting ITGB6, and STRO-227, our first wholly-owned dual-payload ADC targeting PTK7, as we work toward IND submissions this year. We are also pleased to see our first partnered dual-payload iADC with Astellas entering the clinic, marking an important validation of our platform’s ability to generate differentiated multi-payload ADCs. With a strengthened balance sheet and continued disciplined execution, we believe we are well positioned to deliver meaningful progress across our programs in 2026."

Wholly-Owned Pipeline

STRO-004: Sutro continues to advance its ongoing first-in-human Phase 1 dose-escalation trial of STRO-004, a Tissue Factor (TF)-targeting ADC with a DAR8 Topo1 payload, in patients with advanced solid tumors. The Company expects to report initial clinical data in mid-2026, including safety and tolerability, pharmacokinetic exposure, and early activity data. In preclinical studies, STRO-004 demonstrated a favorable safety profile, including a highest non-severely toxic dose (HNSTD) of 50 mg/kg in non-human primates, supporting the clinical starting dose of 1 mg/kg.

STRO-006: Sutro’s next-generation, highly selective integrin β6 (ITGB6)-targeting ADC with a DAR8 Topo1 payload, designed for the treatment of multiple solid tumors. The program continues to advance toward clinical development, with an IND submission anticipated in 2026.

STRO-227: Sutro’s wholly-owned DAR10 dual-payload ADC targeting PTK7, combining MMAE (DAR2) and a Topo1 payload (DAR8) to enable complementary mechanisms of action within a single molecule. The program remains on track for IND submission in 2026 and represents a key component of Sutro’s strategy to expand its pipeline of novel-format dual-payload ADCs.

Next-Generation ADC Collaborations

Astellas: Two research and development programs are progressing under Sutro’s collaboration with Astellas focused on dual-payload immunostimulatory ADCs (iADCs).

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The first program, targeting TROP2, has entered the clinic and is actively dosing patients, resulting in a $10 million milestone payment received by Sutro in April 2026.
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The second program continues to progress in an IND-enabling toxicology study.

Medical Conferences

American Association for Cancer Research (AACR) (Free AACR Whitepaper), April 17-22, 2026, San Diego, California

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Sutro presented new preclinical data at AACR (Free AACR Whitepaper) from across its pipeline of ADC discovery programs, including an oral presentation on STRO-004. Among the highlights, STRO-004 demonstrated robust and consistent antitumor activity across multiple TF-expressing solid tumor PDX models, with improved anti-tumor activity versus benchmark ADCs. Additionally, STRO-006 and STRO-227 showed meaningful, dose-dependent antitumor activity across solid tumor models. More details can be found in the press release here.
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In addition to these presentations, Sutro’s strategic partner, Astellas Pharma, also reviewed preclinical results from its TROP2-targeted iADC program, ASP2998, at AACR (Free AACR Whitepaper). The oral presentation, titled "ASP2998, a TROP2-targeted immunostimulatory antibody-drug conjugate (iADC) with dual payloads, demonstrates potent efficacy and a favorable safety profile in nonclinical models," highlighted the progress in development of next-generation iADCs leveraging Sutro’s cell-free protein synthesis platform. ASP2998 is a first-in-class iADC that combines cytotoxic and immune-stimulatory mechanisms to enhance antitumor efficacy. Inclusion of a STING agonist augments the antitumor efficacy, immune activation and durable tumor immunity of ASP2998, supporting its superior activity over toxin-only anti-TROP2 ADCs. Preclinically, ASP2998 demonstrated a favorable safety profile, supporting a promising therapeutic index.
STRO-006 and STRO-227 show meaningful, dose-dependent antitumor activity across solid tumor models

Investor Conferences

Management will participate in the following upcoming healthcare investor conferences. When available, the 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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Jefferies Global Healthcare Conference (New York, NY • June 2-4)

Corporate Updates

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Sutro strengthened its cash position with an underwritten offering of 7,868,383 shares of its common stock at a price of $13.98 per share, resulting in gross proceeds of $110.0 million, before deducting underwriting discounts and commissions and other offering expenses. The Company’s cash runway is now expected into at least the second quarter of 2028, excluding additional anticipated milestones from our existing collaborations.
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The luvelta program has been closed and there will be no additional investment in the program. Sutro is not currently pursuing further business development opportunities for the program.

First Quarter 2026 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of March 31, 2026, Sutro had cash, cash equivalents and marketable securities of $202.6 million, as compared to $141.4 million as of December 31, 2025.

Revenue

Revenue was $14.5 million for the quarter ended March 31, 2026, as compared to $17.4 million for the quarter ended March 31, 2025, with the 2026 amount related principally to the Astellas collaboration.

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

Total R&D and G&A expenses for the quarter ended March 31, 2026 were $44.1 million, as compared to $64.9 million for the quarter ended March 31, 2025.

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H.C. Wainwright 4th Annual BioConnect Investor Conference (New York, NY • May 19)
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TD Cowen 7th Annual Oncology Innovation Summit (Virtual • May 26 – 27)

(Press release, Sutro Biopharma, MAY 14, 2026, View Source [SID1234665715])

On May 14, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported positive preclinical findings from an ongoing translational immuno-oncology study evaluating its lead candidate, SIL204, in human KRAS-mutated pancreatic cancer cells. The study demonstrated a statistically significant increase in surface expression of major histocompatibility complex class I (MHC-I), also known as HLA-ABC, following treatment with SIL204 in human pancreatic cancer cells harboring the KRAS G12R mutation, as measured by flow cytometry.

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"These findings are particularly encouraging because they suggest SIL204 may influence biological pathways involved in the tumors evading the immune cells which are supposed to protect against the tumors, in addition to its previously demonstrated direct anti-tumor activity," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Checkpoint inhibitors have historically shown limited efficacy in pancreatic cancer in part because T cells often fail to adequately recognize these tumors. We believe the observed increase in MHC-I expression further supports an additional positive role of SIL204 in the area of immunotherapy which could facilitate positive outcomes in the treatment of pancreatic cancer."

MHC-I is essential for enabling cytotoxic T cells to recognize and attack tumor cells. Loss or suppression of MHC-I expression is widely recognized as a key mechanism by which tumors evade immune detection and resist immune-mediated destruction. Research has shown that oncogenic KRAS signaling contributes to immune evasion through suppression of antigen presentation and impairment of T-cell recognition pathways in pancreatic cancer and other KRAS-driven tumors.

Pancreatic cancer remains among the most immunologically resistant solid tumors and has historically demonstrated limited responsiveness to immune checkpoint inhibitor therapies such as anti-PD-1 agents, including pembrolizumab (Keytruda), outside of select biomarker-defined patient populations. By increasing MHC-I expression, SIL204 may help restore immune visibility of KRAS-mutated tumor cells, potentially supporting future therapeutic strategies designed to enhance responsiveness to PD-1/PD-L1 blockade.

Published research has increasingly highlighted the relationship between KRAS signaling, antigen presentation, and immune checkpoint resistance, with multiple recent studies suggesting that reversing KRAS-associated immune suppression may improve immune-mediated anti-tumor activity.

(Press release, Silexion Therapeutics, MAY 14, 2026, View Source [SID1234665741])