On August 12, 2026 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported its financial results for the second quarter ended June 30, 2026 and provided an update on recent company developments.

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"As the FDA’s review of our BLA for INO-3107 continues to advance, we are pleased to have held the informal clinical meeting with the FDA, where we presented the totality of data supporting INO-3107’s safety and efficacy and highly differentiated approach in treating RRP, and our rationale for accelerated approval eligibility," said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. "We are confident in INO-3107’s potential to become the preferred product among patients, healthcare providers and payers, if approved, and are committed to ensuring that all patients have access to therapeutic options that work for them in reducing the need for surgery to control their disease. We look forward to the final stages of the review process and further advancing our commercial preparations."

Operational Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
The FDA’s review of the BLA for INO-3107 continues to advance under the Agency’s accelerated approval program toward a PDUFA target action date of October 30, 2026. Regulatory progress includes completion of the late-cycle review meeting and all scheduled pre-licensure inspections. An informal clinical meeting was conducted, where INOVIO presented the totality of data supporting INO-3107’s safety and efficacy and highly differentiated approach in treating RRP, along with the company’s rationale for accelerated approval eligibility. During the informal meeting, the FDA did not discuss its preliminary comment in the file acceptance letter regarding accelerated approval eligibility. In addition, the FDA stated that feedback on the confirmatory trial design would be forthcoming. INOVIO continues to believe that INO-3107 fulfills the criteria for accelerated approval by meeting an unmet clinical need and providing a meaningful therapeutic benefit over existing treatments.

In anticipation of a potential approval in 2026, INOVIO is preparing its commercial launch activities. Recently, INOVIO engaged Syneos Health to recruit and deploy Medical Science Liaisons (MSLs), and Syneos Health is also serving as the company’s contract sales organization to support commercialization in the U.S. INOVIO has also engaged or identified key commercial partners, including a third-party logistics provider, Agency of Record, specialty distributor, specialty pharmacy, and patient hub.

The FDA previously granted INO-3107 both Orphan Drug and Breakthrough Therapy designations.

VGX-3100 – Cervical Dysplasia (High-grade Squamous Intraepithelial Lesions)
In May 2026, INOVIO’s partner for VGX-3100 in Greater China, ApolloBio, announced positive topline results from its pivotal Phase 3 trial of VGX-3100 as a potential treatment for cervical dysplasia. The trial successfully met its predefined primary efficacy endpoint and demonstrated an overall favorable safety and tolerability profile. ApolloBio plans to use the results from the study to support a future filing for regulatory approval of VGX-3100 in China. VGX-3100 is INOVIO’s investigational DNA immunotherapy developed for diseases associated with high-risk human papillomavirus (HPV) types 16 and 18.

Next-Generation DNA Medicine Candidates
INOVIO presented promising data from our next-generation DNA-Encoded Monoclonal Antibody (DMAb) and DNA-Encoded Protein (DPROT) programs at the American Society of Gene and Cell Therapy Annual Meeting in May 2026 and the World Orphan Drug Congress in June 2026, highlighting positive preclinical data on Factor VIII production for Hemophilia A. INOVIO is continuing discussions with potential partners to accelerate development of this promising platform with a focus on developing additional DPROT indications in the rare disease space, including Fabry Disease and Hypophosphatasia (HPP).

General Corporate
INOVIO remains focused on financial discipline, directing resources to advance the INO-3107 program toward a potential 2026 approval and preparing for commercialization. The company strengthened its balance sheet with an underwritten public equity offering in July 2026. Net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $18.3 million.

Second Quarter 2026 Financial Results

Research and Development (R&D) Expenses: R&D expenses for the three months ended June 30, 2026 decreased to $10.8 million from $14.5 million for the same period in 2025. The decrease was primarily the result of lower employee and consultant compensation, including stock-based compensation, lower engineering outside services related to our device development, and lower inventory expenses, among other variances.
General and Administrative (G&A) Expenses: G&A expenses decreased to $7.8 million for the three months ended June 30, 2026 from $8.6 million for the same period in 2025.
Total Operating Expenses: Total operating expenses decreased to $18.6 million for the three months ended June 30, 2026 from $23.1 million for the same period in 2025.
Net Loss: INOVIO’s net loss for the three months ended June 30, 2026 was $6.0 million, or $0.07 per basic and diluted share, compared to a net loss of $23.5 million, or $0.61 per basic and diluted share, for the three months ended June 30, 2025. The decrease in net loss was primarily driven by a $13.9 million non-cash gain on fair value adjustment related to our warrant liabilities for the three months ended June 30, 2026. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss.
Cash, Cash Equivalents and Short-term Investments: As of June 30, 2026, cash, cash equivalents and short-term investments were $36.7 million (excluding net proceeds from the July 2026 offering of approximately $18.3 million), compared to $58.5 million as of December 31, 2025.
Cash Guidance
INOVIO estimates that current cash, cash equivalents and short-term investments balances will support operations into late first quarter 2027, through a potential launch of INO-3107, if approved. This projection includes the net proceeds of approximately $18.3 million from the public offering in July 2026, as well as an operational net cash burn estimate of approximately $18 million for the third quarter of 2026. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake.

Conference Call / Webcast Information
INOVIO’s management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

(Press release, Inovio, AUG 12, 2026, View Source [SID1234670015])

On August 12, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter ended June 30, 2026.

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"When we reset our strategy in 2024, we started with the patient and focused on where the distinct attributes of allogeneic CAR T could create a clinical advantage," said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. "ALPHA3 is the clearest expression of that strategy: identifying patients at high risk of relapse, treating before disease returns clinically, and enabling CAR T delivery where patients already receive care. We took the same patient-first approach with ALLO-329, recognizing early that chemotherapy-based lymphodepletion and treatment interruptions associated with leukapheresis in autologous therapy could create meaningful burdens for patients with autoimmune disease. Together, these programs demonstrate that the value of allogeneic CAR T extends well beyond off-the-shelf availability, offering the flexibility to address clinical and practical barriers other approaches cannot. We believe the scale of that opportunity will become increasingly apparent as our programs continue to advance."

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
Cemacabtagene ansegedleucel (cema-cel) is being evaluated in ALPHA3, the first pivotal, randomized Phase 2 trial in LBCL designed to assess whether MRD-guided treatment following first-line therapy can delay or prevent clinical relapse.

In July, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for cema-cel as 1L consolidation therapy for patients with high-risk LBCL following review of the interim futility analysis. At the protocol-defined data cutoff, triggered when the 24th patient enrolled in the ongoing study arms completed the Day 45 MRD assessment, 58.3% (7/12) of patients in the cema-cel arm achieved MRD negativity, with the majority clearing MRD by the first post-treatment assessment, compared to 16.7% (2/12) in the observation arm. This represents a 41.6% absolute difference in MRD clearance between the two arms. Published literature and cross-study benchmarks suggest that MRD clearance differences of 25-30% may lead to clinically meaningful improvement at study completion.

Cema-cel was well-tolerated as of the data cutoff with no treatment-related serious adverse events. There were no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD) or high-grade infections. No tocilizumab or steroids were administered for toxicity prophylaxis or treatment, and no patients were hospitalized for treatment-related adverse events. This profile compares favorably with the broader CAR T experience, where hospitalization for toxicity management remains common.

Most patients were treated and followed entirely in the outpatient setting. Community cancer centers accounted for approximately one-third of screening activity and cema-cel infusions, including sites with limited or no prior CAR T experience. These findings support ALPHA3’s potential to bring CAR T earlier in the course of disease and closer to where patients receive care.

The Company achieved its 2026 goal of activating more than 80 sites approximately six months ahead of schedule, driven by strong execution and increased investigator interest following the interim futility analysis. The Company now expects approximately 100 sites to be active by year-end, with the significant majority in the United States and additional sites in Canada, Australia and South Korea. This expansion is expected to support enrollment momentum, broaden access to the trial, and provide more sites with hands-on experience administering cema-cel ahead of a potential commercial launch.

ALPHA3 is expected to randomize approximately 220 MRD+ patients to either cema-cel consolidation or close observation, with enrollment anticipated to be completed by year-end 2027. The next program update tied to the interim event-free survival (EFS) analysis is expected in mid-2027.

ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease
ALLO-329 is a next-generation, dual-targeting anti-CD19/CD70 AlloCAR T product incorporating the Company’s proprietary Dagger technology. The product was designed to address allogeneic rejection by targeting activated CD70-positive host T cells, with the goal of supporting CAR T-cell expansion while reducing or eliminating the need for conventional chemotherapy-based lymphodepletion.

The ongoing Phase 1 RESOLUTION trial is a dose-escalation study evaluating cell dose of ALLO-329 and the role played by Dagger with and without lymphodepletion across multiple autoimmune indications, including systemic lupus erythematosus, scleroderma, and inflammatory myositis.

Enrollment continues at a brisk pace across cohorts, dose levels and lymphodepletion strategies. The Company remains on track to provide a clinical and translational update in the fourth quarter of 2026.

2026 Second Quarter Financial Results
•Research and development expenses were $30.7 million for the second quarter of 2026, which includes $2.1 million of non-cash stock-based compensation expense.
•General and administrative expenses were $20.8 million for the second quarter of 2026, which includes $10.3 million of non-cash stock-based compensation expense.
•Net loss for the second quarter of 2026 was $42.7 million, or $0.13 per share, including non-cash stock-based compensation expense of $12.4 million.
•The Company had $423.6 million in cash, cash equivalents, and investments as of June 30, 2026.

Based on its cash, cash equivalents, and investments as of June 30, 2026, the Company currently projects its cash runway into 2029. Guidance for operating expense in 2026 is expected to be approximately $165 million. GAAP Operating Expenses are expected to be approximately $225 million, including estimated non-cash stock-based compensation expense of approximately $35 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT/5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, AUG 12, 2026, View Source [SID1234670014])

On August 12, 2026 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and reported financial results for the second quarter ended June 30, 2026.

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"In the second quarter, we remained focused on disciplined execution across our pipeline as we continued to advance our next generation of masked immuno-oncology therapies toward the clinic. Today, we are excited to announce FDA clearance of our IND for XTX501, a bispecific PD-1 / masked IL-2 that we believe has the potential to become a foundational backbone therapy for solid tumors," said René Russo, Pharm.D., president and chief executive officer of Xilio. "At the same time, we are advancing IND-enabling studies for our multi-specific, masked T cell engagers targeting CLDN18.2 and PSMA+STEAP1. Together, these programs highlight the potential to leverage our masking technology to unlock the next generation of sophisticated, multi-specific I-O therapies for people living with cancer."

Pipeline Progress and Business Updates

XTX501: bispecific PD-1 / masked IL-2

XTX501 is a novel bispecific PD-1 / masked IL-2 that has the potential to be a foundational backbone therapy for solid tumors, including in combination with other agents. XTX501 is designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function while overcoming IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents.

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Xilio received clearance from the U.S. Food and Drug Administration (FDA) for the company’s investigational new drug application (IND) to proceed to a Phase 1/2 clinical trial for XTX501.
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Xilio expects to initiate dosing in the Phase 1 portion of the trial in patients with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors in the second half of 2026. Xilio plans to report initial Phase 1 data in patients with metastatic NSCLC in the second half of 2027.

Masked T Cell Engager Programs

Xilio is leveraging its proprietary, clinically-validated masking technology and modular T cell engager (TCE) architectures to advance two wholly-owned masked TCE programs, as well as an additional masked TCE program in collaboration with AbbVie Group Holdings Limited (AbbVie).

The company’s masked TCEs are designed with a masked CD3 targeting domain and one or more tumor-associated antigen (TAA) binding domains as part of the core molecule design. In addition, the company’s modular architecture enables the incorporation of a co-stimulatory domain designed to further enhance potency and durability of T cell response, as well as the potential to mask the TAA binding domain(s) and/or mask the co-stimulatory signaling domain. Upon tumor-selective activation, Xilio’s TCE molecules are designed to release a potent, short half-life TCE in the tumor microenvironment.

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Xilio is advancing IND-enabling studies for a potential first-in-class masked TCE program targeting CLDN18.2 and a potential first-in-class multi-specific, masked TCE program targeting PSMA and STEAP1 with built-in co-stimulatory signaling. CLDN18.2 is a TAA expressed in gastrointestinal cancers (gastric, pancreatic and esophageal), and PSMA and STEAP1 are TAAs expressed in prostate cancer.
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Xilio plans to submit INDs for its CLDN18.2 and PSMA+STEAP1 programs in the second half of 2027.

Efarindodekin alfa: masked IL-12

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Xilio is evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 2 clinical trial in patients with advanced solid tumors and expects to deliver an option data package to Gilead Sciences, Inc. (Gilead) in the first half of 2027.

Recent Corporate Updates

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Xilio appointed Ben Harshbarger as its chief legal officer in June 2026. Ben has over 20 years of executive leadership and legal expertise within the biopharmaceutical industry. Read more here.

Second Quarter 2026 Financial Results

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Cash Position: Cash and cash equivalents were $136.0 million as of June 30, 2026, compared to $137.5 million as of December 31, 2025.
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Collaboration and License Revenue: Collaboration and license revenue was $18.7 million for the quarter ended June 30, 2026, compared to $8.1 million for the quarter ended June 30, 2025. The increase was driven by an increase in collaboration and license revenue recognized under the collaboration and license agreements with AbbVie and Gilead.
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Research & Development (R&D) Expenses: R&D expenses were $14.6 million for the quarter ended June 30, 2026, compared to $15.3 million for the quarter ended June 30, 2025. The decrease was primarily driven by decreased clinical development activities related to vilastobart and decreased manufacturing activities for XTX501, partially offset by increased costs related to masked TCE programs and indirect research and development and increased personnel-related costs.
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General & Administrative (G&A) Expenses: G&A expenses were $7.6 million for the quarter ended June 30, 2026, compared to $7.1 million for the quarter ended June 30, 2025. The increase was primarily driven by an increase in personnel-related costs.
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Net Loss: Net loss was $6.4 million for the quarter ended June 30, 2026, compared to a net loss of $15.8 million for the quarter ended June 30, 2025.

Cash Runway

Based on its current operating plans, Xilio anticipates that its existing cash and cash equivalents will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2028.

This estimate excludes up to $36.2 million in additional gross proceeds in the second half of 2026 if all outstanding Series C warrants are exercised at their current exercise price and any potential additional milestone payments, option-related fees or other contingent payments under Xilio’s collaboration and license agreements with AbbVie and Gilead, including up to $31.0 million in near-term milestones and option extension fees that could be achieved under the AbbVie collaboration through the first half of 2027.

About XTX501 and the Phase 1/2 Clinical Trial

XTX501 is an investigational bispecific PD-1 / masked IL-2 designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function while overcoming IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents. Xilio is evaluating the safety and tolerability of XTX501 as a monotherapy in patients with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors in the Phase 1 portion of a first-in-human, multi-center, open-label Phase 1/2 clinical trial at multiple sites in the United States. Please refer to NCT07688577 on www.clinicaltrials.gov for additional details.

(Press release, Xilio Therapeutics, AUG 12, 2026, View Source [SID1234670010])

On August 12, 2026 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported financial results for the three months ended June 30, 2026, and provided a corporate update.

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"This is a transformative time for TScan with our first pivotal study now enrolling at major transplant centers across the U.S.," said Gavin MacBeath, Ph.D., Chief Executive Officer. "A key priority during the first half of this year was demonstrating the performance of our improved commercial-ready manufacturing process. Data from Cohort C of the ALLOHA trial, generated using this process, reinforces our confidence in both our manufacturing and the clinical potential of TSC-101 as we enter our Phase 3 study. Building on the encouraging efficacy we have observed with TSC-101, we are also expanding our heme program to address additional HLA types, with Phase 1 trials of TSC-102-A01 and TSC-102-A03 expected to begin in the fourth quarter of this year."

Recent Corporate Highlights

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In July, the Company announced that it has dosed the first patient in the ongoing Phase 3 ALLOHA-2 clinical trial evaluating TSC-101 for the treatment of patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (allo-HCT). The Company anticipates completion of enrollment and reporting of topline data from this pivotal study mid-2028.

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In June, the Company reported positive initial data from Cohort C of the Phase 1 ALLOHA study (NCT05473910) and additional patient characteristics are described below.
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~90% first-pass manufacturing success rate (17/19) with commercial-ready process.
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Most patients enrolled in Cohort C had poor prognostic features, with 86% of patients (12/14) being minimal residual disease (MRD)-positive prior to transplant and 86% (12/14) having mixed donor chimerism at their first assessment post-transplant.
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Despite having aggressive disease with a high risk of relapse, patients infused with TSC-101 have demonstrated meaningful clinical benefit from the product candidate. 79% of patients (11/14) achieved complete donor chimerism within ~three weeks of receiving their first infusion of TSC-101; an additional two had improving chimerism following TSC-101, which is consistent with eliminating residual cancer cells and correlates with preventing post-transplant relapse.
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TSC-101 continued to be well-tolerated, with observed safety consistent with post-HCT adverse events.

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In June, the Company announced that it has entered into an agreement with Cellares, the first integrated development and manufacturing organization (IDMO), to assess Cellares’ fully automated Cell Shuttle and Cell Q platforms as a potentially scalable and cost-efficient path to commercial manufacturing.

Pipeline Progress and Upcoming Anticipated Milestones

Heme Malignancies Program: TScan’s lead TCR-T therapy candidate, TSC-101, is designed to treat residual disease and prevent relapse in patients with heme malignancies undergoing allogeneic HCT (ALLOHA-2 trial, NCT07702578).

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Share updated data on patients treated in Cohort C of the Phase 1 ALLOHA study in the fourth quarter of 2026.
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Initiate Phase 1 study of TSC-102-A01 and TSC-102-A03 in the fourth quarter of 2026 with initial data in 2027.
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Share updated data, inclusive of over 1-year of follow-up time, on Cohort C patients of the ALLOHA study in the first half of 2027.

Solid Tumor Program: The Company’s strategy is to treat patients with multiple TCR-T therapy candidates to overcome tumor heterogeneity.

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Currently developing methods to engineer TCR-Ts in vivo to treat solid tumors, with initial candidates in preclinical development.
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Established a roadmap for filing an investigational new drug (IND) application by H2 2027 after recent INTERACT engagement with the U.S. Food and Drug Administration (FDA).

Autoimmunity Program: The Company has discovered novel targets for ankylosing spondylitis and other HLA-B*27-associated autoimmune disorders and is currently developing potential treatment options.

Second Quarter 2026 Financial Results

Revenue: Revenue for the second quarter of 2026 was $1.1 million, compared to $3.1 million for the second quarter of 2025. The decrease was primarily due to timing of research activities pursuant to the Company’s collaboration agreement with Amgen.

R&D Expenses: Research and development (R&D) expenses for the second quarter of 2026 were $23.4 million, compared to $32.6 million for the second quarter of 2025. The decrease of $9.2 million was primarily driven by a decrease in laboratory supplies, research materials, and studies due to the timing in the purchase of supplies and consumables, and decrease spend on contracted services, as well as savings in connection with the Company’s previously announced strategy to prioritize the clinical development of its heme program. R&D expenses included non-cash stock compensation expense of $1.2 million and $1.7 million for the second quarter of 2026 and 2025, respectively.

G&A Expenses: General and administrative (G&A) expenses for the second quarter of 2026 were $8.1 million, compared to $9.1 million for the second quarter of 2025. The decrease of $1.0 million was primarily due to a decrease in personnel costs. G&A expenses included non-cash stock compensation expense of $1.2 million and $1.6 million for the second quarter of 2026 and 2025, respectively.

Net Loss: Net loss was $30.4 million for the second quarter of 2026, compared to $37.0 million for the second quarter of 2025, and included net interest income of $0.8 million and $2.4 million, respectively.

Cash Position: Cash and cash equivalents as of June 30, 2026, were $100.2 million, excluding $5.0 million of restricted cash. The Company believes that its existing cash resources will be sufficient to fund its current operating plan into the second quarter of 2027. The Company did not achieve certain non-covenant related milestones by June 30, 2026 as provided under its existing debt agreement, therefore the updated cash runway reflects commencement of the two-year term loan amortization beginning in the fourth quarter of 2026.

Share Count: As of June 30, 2026, the Company had 67,779,255 issued and outstanding shares of common stock, consisting of 63,502,667 shares of voting common stock and 4,276,588 shares of non-voting common stock, as well as 62,246,707 outstanding pre-funded warrants to purchase shares of voting common stock at an exercise price of $0.0001 per share. Pro forma outstanding shares, inclusive of both common stock and pre-funded warrants, were 130,025,962 as of June 30, 2026.

(Press release, TScan Therapeutics, AUG 12, 2026, View Source [SID1234670009])

On August 12, 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 second quarter ended June 30, 2026 and recent business highlights. Sutro also provided data showing a favorable tolerability profile and early signals of clinical activity from its ongoing Phase 1 study of STRO-004, the Company’s potential best-in-class Tissue Factor (TF)-targeting DAR8 exatecan ADC, in heavily pretreated patients with advanced solid tumors.

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"During the second quarter, we continued to execute swiftly across our next-generation ADC portfolio, highlighted by encouraging early clinical data from our ongoing Phase 1 study of STRO-004, having rapidly enrolled our initial dose escalation cohorts in just seven months and now optimizing our go-forward dose," said Jane Chung, Sutro’s Chief Executive Officer. "We have observed early clinical responses alongside favorable safety, tolerability, and a differentiated pharmacokinetic (PK) profile in patients with few remaining treatment options. The favorable tolerability profile and wider therapeutic index of our DAR8 exatecan ADC allows us to dose higher than other TF-targeting ADCs. These findings strengthen our confidence in STRO-004’s potential to deliver meaningful clinical benefit and provide the opportunity to safely combine with other therapies, while further validating our proprietary ADC platform."

"Additionally, we are excited to enter the clinic with STRO-006 in the near future, our second clinical program in less than a year, reflecting the continued acceleration of our pipeline strategy. We also look forward to advancing STRO-227, our first wholly-owned dual-payload ADC, toward IND submission later this year, joining our partner Astellas’ dual-payload iADC programs in the clinic. Our progress this quarter underscores the continued advancement of our portfolio and our commitment to delivering differentiated therapies for patients while creating long-term value for shareholders."

Wholly-Owned Pipeline

STRO-004 Early Safety and Signals of Clinical Activity Highlights:

Dose escalation continues with strong execution, with dose levels 1–5 mg/kg (n=49) enrolled faster than expected. The study, called STRIVE-01, is currently optimizing between doses of 4 and 5 mg/kg, and the maximum tolerated dose has not yet been defined. This US-only based trial, which began in November 2025, includes heavily pretreated patients (median of 3 prior lines of therapy [range 1–7]) across eight tumor types unselected for TF expression. In pancreatic and colorectal cancer patients, 100% of patients received one or more prior irinotecan-containing regimens, which has been associated with reduced activity of topoisomerase 1 inhibitor payloads. Key observations as of the data cutoff date of July 24, 2026 include:

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Multiple responses, including confirmed and ongoing unconfirmed partial responses, across three tumor types in RECIST-evaluable patients to date; including pancreatic cancer, head and neck cancer, and non-small cell lung cancer at dose levels 3-4 mg/kg
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Favorable tolerability profile, with mostly low-grade adverse events (AEs) observed. Overall discontinuation rate due to AEs was low at 6%.
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All-grade treatment related adverse events (TRAEs) >15% were nausea (33%), fatigue (29%), and anemia (18%)
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Other TRAEs of note that occurred in >5% of patients included:
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Hematologic events: Neutrophil count decreased (6%), platelet count decreased (6%)
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On-target TF-related events: Epistaxis (12%), stomatitis (10%), mucosal inflammation (8%), conjunctivitis (8%), dry eye (7%); these events were predominantly grade 1-2
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Grade 3+ events: Anemia (14%); all grade 3
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DLTs occurred only at the highest dose level tested (5 mg/kg), and appeared to be largely driven by target-related toxicity, resulting in dose reduction but no study drug discontinuations
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Predictable PK in patients, consistent with preclinical data, demonstrating dose-proportional ADC exposures at all doses, with no evidence of Target Mediated Drug Disposition
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STRO-004 has a half-life of nearly seven days, preserving 98% DAR8 configuration, while free exatecan concentration remains low, delayed, and formation-limited
"We are encouraged by the emerging STRO-004 clinical PK profile, which demonstrate the stability of our ADC construct and validate the design principles of our platform," said Hans-Peter Gerber, Ph.D., Sutro’s Chief Scientific Officer. "Compared with conventional DAR8 exatecan ADCs, STRO-004 delivered 25-50% more ADC exposure with at least 50% less circulating payload concentration, allowing us to dose at the highest end of the dosing range for the class. We observed comparable PK with STRO-006 (Topo1i) and our dual payload ADC STRO-227 (Topo1i x MMAE) in preclinical experiments, which gives us confidence in the potential of our advanced design capabilities to widen the therapeutic index across our ADC pipeline."

The next STRIVE-01 study update is targeted for the first half of 2027. Initiation of expansion cohorts is planned for the first half of 2027.

STRO-006: Sutro’s next-generation, highly selective integrin β6 (ITGB6)-targeting ADC with a DAR8 exatecan payload, is designed for the treatment of multiple solid tumors. The Company expects to initiate a Phase 1 clinical trial in the third quarter of 2026.

STRO-227: Sutro’s wholly-owned DAR10 dual-payload ADC targeting PTK7, consisting of MMAE (DAR2) and exatecan (DAR8) payloads 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).

The first program, which targets TROP2, continues to actively dose patients, resulting in a $10 million milestone payment received by Sutro in April 2026.

The second program continues to progress under the collaboration, and based on current development timelines, Sutro expects Astellas to enter the clinic by the end of 2026.

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.

Wells Fargo 21st Annual Healthcare Conference (Boston, MA • September 8-10)

Cantor Global Healthcare Conference (New York, NY • September 9-11)

H.C. Wainwright 28th Annual Global Investment Conference (New York, NY • September 14-16)

Second Quarter 2026 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of June 30, 2026, Sutro had cash, cash equivalents and marketable securities of $164.3 million, as compared to $202.6 million as of March 31, 2026.

Revenue

Revenue was $9.8 million for the quarter ended June 30, 2026, as compared to $63.7 million for the quarter ended June 30, 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 June 30, 2026 were $39.5 million, as compared to $48.7 million for the quarter ended June 30, 2025.

(Press release, Sutro Biopharma, AUG 12, 2026, View Source [SID1234670008])