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.
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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.
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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])

On May 14, 2026 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, reported financial results for the first quarter ended March 31, 2026 and other recent business developments.

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"With positive results in both cohorts of the pivotal VIKTORIA-1 study, we believe gedatolisib regimens have the potential to advance the standard of care in the second-line setting for a significant number of patients with HR+/HER2- advanced breast cancer, regardless of PIK3CA status," said Brian Sullivan, CEO and co-founder of Celcuity. "We are on track to launch gedatolisib commercially in anticipation of its potential FDA approval in the third quarter of 2026, and we look forward to bringing this important therapy to physicians treating patients with advanced breast cancer."

Mr. Sullivan added, "Our positive Phase 3 results, combined with our promising Phase 1b clinical trial results in treatment-naive late-stage patients, provide a strong scientific rationale to evaluate gedatolisib combinations as first-line therapy. By expanding our VIKTORIA-2 study to enable evaluation of treatment-naive patients who have endocrine-sensitive breast cancer, we are positioning gedatolisib regimens to potentially be available for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status."

First Quarter 2026 Business Highlights and Other Recent Developments

● Celcuity reported positive topline results from the PIK3CA mutant-type ("MT") cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-") ("HR+/HER2-"), PIK3CA MT locally advanced or metastatic breast cancer ("ABC").

○ The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib ("gedatolisib triplet") demonstrated a statistically significant and clinically meaningful improvement in progression-free survival ("PFS") compared with alpelisib, a PI3Kα inhibitor, and fulvestrant.

○ The secondary endpoint comparing gedatolisib in combination with fulvestrant ("gedatolisib doublet") versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS.

○ Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and no new safety signals.

○ Detailed data for the gedatolisib triplet and doublet regimens will be presented in a late-breaking abstract ("LBA") oral session on June 2, 2026, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago, Illinois.

○ Celcuity intends to submit these data to the FDA in the third quarter as a supplemental New Drug Application ("sNDA") and to submit VIKTORIA-1 data to other regulatory authorities outside the U.S. following the sNDA submission.

● The Phase 3 VIKTORIA-2 clinical trial now includes two studies, Study 1 and Study 2, each with independent statistical analysis plans that include primary endpoints for their respective intent-to-treat populations. Study 1, which is ongoing, is evaluating the efficacy and safety of gedatolisib in combination with palbociclib and fulvestrant in approximately 440 patients with endocrine-resistant HR+/HER2- ABC. Study 2, which was added in conjunction with a VIKTORIA-2 protocol amendment, is evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in approximately 740 patients with treatment-naive endocrine-sensitive HR+/HER2- ABC. Eligible patients include those whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. Approximately 60,000 adults are newly diagnosed each year in the United States with endocrine-sensitive HR+/HER2- ABC.1

● To support its long-term lifecycle development plan, Celcuity submitted its first patent application to the United States Patent and Trademark Office ("USPTO") for a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib as an injection as an alternative to an infusion. Development of the subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.

● In January 2026, the FDA accepted the submission of Celcuity’s New Drug Application ("NDA") for gedatolisib in HR+/HER2- PIK3CA wild-type ("WT") ABC. The FDA granted Priority Review and assigned a Prescription Drug User Fee Act ("PDUFA") goal date of July 17, 2026.

First Quarter 2026 Financial Results

Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2026, compared to the first quarter ended March 31, 2025.

Net loss for the first quarter of 2026 was $52.8 million, or $0.97 per share, compared to a net loss of $37.0 million, or $0.86 per share, for the first quarter of 2025. Non-GAAP adjusted net loss for the first quarter of 2026 was $46.8 million, or $0.86 per share, compared to non-GAAP adjusted net loss of $34.7 million, or $0.81 per share, for the first quarter of 2025. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Total operating expenses were $50.5 million for the first quarter of 2026, compared to $36.1 million for the first quarter of 2025.

Research and development ("R&D") expenses were $33.1 million for the first quarter of 2026, compared to $29.8 million for the prior year period. The $3.3 million increase in R&D expenses was primarily due to a $3.0 million increase in employee-related and consulting expenses. The remaining increase was primarily due to a $5.4 million increase in manufacturing and other costs, partially offset by a $5.1 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial.

Selling, general and administrative ("SG&A") expenses were $17.4 million for the first quarter of 2026, compared to $6.3 million for the prior year period. The $11.1 million increase in SG&A expenses was primarily due to an $8.7 million increase in employee-related and consulting expenses, of which $6.6 million was due to commercial headcount additions and other launch-related activities, and a $2.4 million increase primarily due to software costs, professional fees and other costs.

Net cash used in operating activities for the first quarter of 2026 was $55.1 million, compared to $35.9 million for the prior year period. Cash, cash equivalents and short-term investments were $387.1 million at the end of the first quarter of 2026. We expect cash, cash equivalents, investments and drawdowns on our debt facility to finance our operations through 2027.

Webcast and Conference Call Information

To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865.

A live webcast presentation can also be accessed using this weblink: View Source;tp_key=2f73ec65ba. A replay of the webcast will be available on the Celcuity website following the live event.

(Press release, Celcuity, MAY 14, 2026, View Source [SID1234665699])

On May 14, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported financial results for the quarter ended March 31, 2026, and provided a corporate update.

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"We made strong progress in the first quarter as we continued to execute across our lead program TPST-2003," said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. "We advanced key activities supporting the planned initiation of our U.S. registrational study of TPST-2003 in patients with rrMM, including announcing our lead manufacturing partner AGCTC and taking delivery of the TPST-2003 lentiviral vector, a critical component in the manufacturing of TPST-2003. At the same time, we strengthened our ability to unlock value across our remaining portfolio with the appointment of Andrew Fang, Ph.D., as our Head of Business Development, whose focus on strategic partnerships, licensing and corporate transactions will help position us for long-term growth. We believe these milestones further reinforce our momentum and our path toward delivering meaningful impact for patients and shareholders alike."

Recent Highlights

TPST-2003
Positive interim results across two ongoing clinical trials (REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with rrMM, and POEMS-1 Phase 1 trial evaluating TPST-2003 in the rare disease, POEMS syndrome), both of which are being sponsored and conducted by Tempest’s partner, Novatim Immune Therapeutics:
100% complete response (CR) rate among all 15 CAR-T-naïve efficacy evaluable patients treated with TPST-2003 across REDEEM-1 and POEMS-1 trials.
Favorable safety profile with no Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) in REDEEM-1 trial appears to be emerging as a potentially differentiating attribute in its class.
Prior investigator-initiated trial (IIT) reached median progression free survival (PFS) of 23.1 months, including in patients with extramedullary disease.
44 patients with rrMM treated to date across three studies.
The selection of Cincinnati Children’s AGCTC as the lead contract development and manufacturing partner to conduct the formal technology transfer of TPST-2003, Tempest’s dual-targeting CD19/BCMA CAR-T therapy under development for the treatment of relapsed/refractory multiple myeloma (rrMM). Further to the selection of AGCTC as lead partner, AGCTC took delivery of the TPST-2003 lentiviral vector, a critical component used in the manufacturing of TPST-2003, supporting plans to initiate the first potentially registrational study to evaluate a dual-targeting CAR-T therapy in patients with rrMM, including patients who are experiencing extramedullary disease (EMD), later this year.
Corporate:
Announced the appointment of Andrew Fang, Ph.D., as Head of Business Development. In his role, Dr. Fang will lead Tempest’s global business development efforts, including strategic partnerships, cross-border licensing and corporate transactions, with a particular focus on expanding Tempest’s outreach and partnering efforts in China.
Announced closing of strategic asset acquisition of new dual-targeting CAR-T assets from Factor Bioscience Inc. and Erigen LLC ("Asset Acquisition").
The transaction brought Tempest a portfolio of next-generation CAR-T assets, including TPST-2003, a clinical-stage dual-targeting CD-19/BCMA CAR-T with strategic partner-funded biologics license application ("BLA") filing in China planned for 2027.
In March 2026, Tempest announced up to $6 million private placement (the "2026 Offering") of common stock and warrants, with $2 million upfront and up to $4 million of potential aggregate gross proceeds upon the exercise in full of warrants, subject to shareholder approval.
Financial Results

First Quarter 2026

Tempest ended the quarter with $1.8 million in cash and cash equivalents, compared to $7.7 million on December 31, 2025. The decrease was primarily due to one-time transaction-associated costs incurred prior to or upon closing the Asset Acquisition, offset by net proceeds from the 2026 Offering of $1.7 million.
Net loss and net loss per share for the quarter were $27.7 million and $2.53, respectively, compared to $10.9 million and $3.16, respectively, for the three months ended March 31, 2025.
Research and development expenses for the quarter were $0.1 million compared to $7.6 million for the three months ended March 31, 2025. The $7.5 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives initiated in April 2025 and resulting in the Asset Acquisition completed in February 2026.
General and administrative expenses for the quarter were $5.4 million compared to $3.3 million for the same period in 2025. The $2.1 million increase was primarily due to one-time costs resulting from the Asset Acquisition completed in February 2026.
Acquired in-process research and development expenses for the quarter were $22.1 million compared to nil for the three months ended March 31, 2025. Costs incurred prior to or upon closing the Asset Acquisition in the three months ended March 31, 2026 were expensed as acquired in-process research and development.

(Press release, Tempest Therapeutics, MAY 14, 2026, View Source [SID1234665716])