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NuCana Reports First Quarter 2026 Financial Results and Provides Business Update

On May 14, 2026 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported financial results for the first quarter ended March 31, 2026 and provided an update on its clinical development program with its two lead anti-cancer medicines.

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"We are pleased to report continued progress in the first quarter of 2026 as NUC-7738 advances towards important clinical and regulatory milestones," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "During the quarter, we continued to advance enrollment for our Phase 2 NuTide:701 expansion study evaluating NUC-7738 in combination with Keytruda (pembrolizumab) in patients with PD-1 inhibitor-resistant metastatic melanoma. The clinical activity and favorable safety profile previously reported, including confirmed objective responses and prolonged disease control, continue to support the therapeutic potential of NUC-7738 in this patient population, and we look forward to reporting final data from this study, which is expected later in 2026."

"We are also delighted to announce that the U.S. Food and Drug Administration (the "FDA") cleared our Investigational New Drug application ("IND") for NUC-7738 in April 2026. This important milestone enables clinical investigation of NUC-7738 in the United States and we expect our initial focus will be in patients with melanoma. We look forward to advancing our dialogue with the FDA to determine the optimal pathway toward a potential registrational strategy for NUC-7738 in melanoma."

Mr. Griffith continued, "Beyond our near-term, anticipated milestones in melanoma, we are actively exploring opportunities to broaden the clinical utility of NUC-7738 through additional indications and combination strategies. The mechanism of action of NUC-7738, disrupting RNA polyadenylation and targeting multiple aspects of the tumor microenvironment, positions it as a potentially versatile agent across a range of tumor types, and we are encouraged by the scientific rationale supporting its evaluation in new settings. We believe these efforts have the potential to significantly expand the long-term value of NUC-7738 for patients and for NuCana."

Mr. Griffith concluded, "Our strong balance sheet, with cash resources expected to fund operations into 2029, provides us with the financial flexibility to execute on our strategic priorities and advance our pipeline. We look forward to achieving important anticipated milestones throughout the remainder of 2026."

2026 Anticipated Milestones

NUC-7738
Complete patient recruitment in the Phase 2 expansion study (NuTide:701) evaluating NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;
Announce final data from the Phase 2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;
Obtain regulatory guidance from the FDA regarding a potential registrational strategy for NUC-7738 in melanoma; and
Advance evaluation of additional indications and combination strategies.
NUC-3373
Complete evaluation of optimal combinations and indications to inform potential future clinical studies of NUC-3373.

First Quarter 2026 Financial Highlights and Cash Position

As at March 31, 2026, NuCana had cash and cash equivalents of £21.5 million compared to £24.3 million at December 31, 2025. NuCana anticipates its cash and cash equivalents at March 31, 2026 will be sufficient to fund its planned operations into 2029.

NuCana reported a net loss of £3.9 million for the quarter ended March 31, 2026, as compared to a net loss of £2.5 million for the quarter ended March 31, 2025. The net loss for the quarter ended March 31, 2026 included non-cash share-based payment expenses of £1.9 million (2025: £0.3 million).

Basic and diluted loss per ordinary share was £0.00 for the quarter ended March 31, 2026, as compared to a loss per ordinary share of £0.02 for the comparable quarter ended March 31, 2025.

(Press release, Nucana, MAY 14, 2026, View Source [SID1234665728])

Cue Biopharma Reports First Quarter 2026 Financial Results and Recent Strategic Developments

On May 14, 2026 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical stage therapeutics company focused on developing transformative therapies targeting functional cures for immunological disorders, reported first quarter 2026 financial results and highlighted recent corporate progress and upcoming milestones.

"We are excited to advance our enhanced portfolio targeting the potential for functional cures for allergic and autoimmune diseases with high unmet need. Our newly expanded pipeline reflects our strengthened strategy and position in anticipation of significant value-driving milestones in the second half of 2026," said Shao-Lee Lin, M.D., Ph.D., president and chief executive officer of Cue Biopharma. "With the recent financing, we believe our current cash runway will be sufficient to support the execution of our expected clinical milestones for CUE-221 and CUE-401. As a team, we look forward to leveraging our strength in precision immunoengineering to advance these assets and create long-term shareholder value to provide transformative therapies for patients."

Business Highlights
Pipeline and Strategy

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Enhanced pipeline with CUE-221 (formerly known as Ascendant-221), a late-stage novel clinical anti-IgE asset with a dual-mechanism through an exclusive license from Ascendant Health Sciences Ltd (Ascendant Health).
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Hosted a virtual R&D Day focused on CUE-401, a potential first-in-class bifunctional cytokine designed to induce tolerance in autoimmune and inflammatory diseases.

Financial and Corporate

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Completed a private placement of pre-funded warrants and accompanying common warrants for gross proceeds of approximately $30 million, before placement agent fees and offering expenses, and aggregate net proceeds of approximately $28 million, to support the company’s clinical pipeline, including advancing CUE-221.

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Received a $7.5 million preclinical milestone payment under the Boehringer Ingelheim collaboration and license agreement for the selection and approval of Boehringer Ingelheim’s first compound for lead optimization.

Leadership

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Appointed a new President and CEO, Shao-Lee Lin, M.D., Ph.D., a biopharmaceutical executive and physician scientist with 25 years of experience in core immunology experience who has helped build multi-billion-dollar portfolios, built strong teams, and taken a company from inception to IPO. Additional executives join Cue’s legacy team in forming a growing complement of clinical and preclinical expertise across the company.

Upcoming Milestones
CUE-221:

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Cue expects to submit an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) to expand development into food allergy in the second half of 2026.

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Results from Ascendant Health’s ongoing China Phase 2 placebo-and active-controlled dose-ranging study in Chronic Spontaneous Urticaria are expected in the second half of 2026.

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Plan to initiate global, Phase 2b trial in food allergy pending Cue’s review of results from Ascendant Health’s ongoing the China Phase 2 CSU study results.

CUE-401:

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Cue expects to submit an IND to the FDA in the second half of 2026
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Phase 1 first-in-human study expected to be initiated by year-end 2026.

First Quarter 2026 Financial Results

First quarter revenue was $5.7 million compared to $0.4 million in the first quarter of 2025. The revenue earned during the three months ended March 31, 2026 was related to the Boehringer Ingelheim collaboration and license agreement. The revenue earned during the three months ended March 31, 2025 was related to the agreement with Ono Pharmaceutical, which was terminated in March 2025.

Research and development expenses were $6.9 million for the three months ended March 31, 2026 compared to $8.5 million in 2025. The decrease was primarily due to lower clinical trial costs for the company’s CUE-100 series, as well as decreases in expenditure for total employee compensation due to attrition.

General and administrative expenses were $4.2 million for both the three months ended March 31, 2026 and 2025.

Net loss for the three months ended March 31, 2026 was $5.2 million compared to $12.3 million in 2025.

As of March 31, 2026, the Company had $16.4 million in cash and cash equivalents. Subsequent to March 31, 2026, the Company has completed a $30 million private placement financing and also received a milestone payment of $7.5 million from Boehringer Ingelheim.

(Press release, Cue Biopharma, MAY 14, 2026, View Source [SID1234665727])

Cardiff Oncology Reports First Quarter 2026 Results and Provides Business Update

On May 14, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

"This quarter was marked by the positive data update from our randomized Phase 2 CRDF-004 trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer, along with key leadership additions that prepare the Company to deliver on the clinical milestones ahead," said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology.

"In April, we had a successful End‑of‑Phase 2 meeting with the FDA and aligned on the key design elements for our Phase 3 registrational trial. We plan to share additional Phase 3 details and our regulatory strategy in mid-2026. At the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting, we will present updated CRDF-004 data, which we believe will provide further insight into onvansertib’s potential in the first-line RAS-mutated metastatic colorectal cancer (mCRC) setting. In parallel, we continue to strengthen the scientific foundation of our PLK1 inhibition strategy, supported by new preclinical data evaluating combination use with an antibody-drug conjugate, as well as ongoing single-agent and combination investigator-initiated studies across multiple cancer settings. With strong clinical momentum, we remain focused on disciplined execution throughout the year."

Clinical Highlights

Upcoming Event: Reporting Updated Onvansertib Data in Rapid Oral Presentation at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2026

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The Company will report detailed updated data from its randomized Phase 2 CRDF-004 trial evaluating onvansertib in combination with FOLFIRI/bev or FOLFOX/bev in patients with first-line RAS-mutated mCRC in a rapid oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, taking place May 29–June 2 in Chicago. More information about the presentation is available here.

Completed End-of-Phase 2 Meeting with the FDA and Aligned on the Design of the Phase 3 Registrational Trial in Patients with First-line RAS-mutated mCRC

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In consultation with the U.S. Food and Drug Administration (FDA), Cardiff selected the 30 mg dose of onvansertib for evaluation with FOLFIRI/bev chemotherapy regimen for the Phase 3 trial in patients with first-line RAS-mutated mCRC. Additional details of the clinical trial will be shared by mid-2026.

Key Opinion Leader Engagements Highlight Onvansertib Clinical Data and Opportunity in mCRC

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In March, Cardiff hosted a KOL webinar featuring internationally recognized leaders in colorectal cancer research, Drs. Scott Kopetz and Heinz-Josef Lenz. The webinar focused on the evolving treatment landscape in first-line RAS-mutated mCRC and onvansertib’s potential as a novel therapeutic approach in the management of RAS-mutated mCRC. A replay of the webcast is available in the Events section of the Company’s website.

Announced Positive Update from our Randomized Phase 2 Trial of Onvansertib in First-line RAS-mutated mCRC

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In January, Cardiff provided topline data from its ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC. The 30 mg onvansertib + FOLFIRI/bevacizumab (bev) arm achieved a confirmed objective response rate (ORR) of 72.2% compared to 43.2% across the combined standard-of-care (SoC) arms. The 30 mg onvansertib dose in combination with FOLFIRI/bev also demonstrated marked improvement in progression-free survival (PFS) versus FOLFIRI/bev (HR: 0.38) and combined SoC of FOLFOX/bev and FOLFIRI/bev (HR: 0.37, p<0.05), with no significant added toxicity observed. More details available here.

Preclinical Highlights

Company Presented New Preclinical Data at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting Supporting Rationale for Onvansertib in Combination with Antibody Drug Conjugates

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Cardiff presented new preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting in April demonstrating that onvansertib enhanced the activity of the HER2-targeted antibody-drug conjugate trastuzumab deruxtecan (T-DXd), driving tumor regression and overcoming resistance in HER2-low breast cancer models. More details are available here.

Corporate Update

Key Leadership Appointments Strengthen Executive Team to Support Company’s Next Phase of Growth

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In April, the Company announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO. She will continue as a member of the Board of Directors. The Company also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff’s commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.

First Quarter 2026 Financial Results

Liquidity, cash burn, and cash runway

As of March 31, 2026, Cardiff Oncology had approximately $46.1 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the first quarter of 2026 was approximately $12.3 million, a decrease of approximately $0.5 million from $12.8 million for the same period in 2025.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into the first quarter of 2027.

Operating results

Total operating expenses were approximately $12.9 million for the three months ended March 31, 2026, a decrease of $1.6 million from $14.5 million for the same period in 2025. The decrease in operating expenses was primarily due to a decrease of $3.7 million in R&D expenses, mainly clinical trial expenses and preclinical activities, partially offset by an increase of $2.1 million in SG&A expenses, primarily for employee severance agreements and corresponding modifications of stock options.

(Press release, Cardiff Oncology, MAY 14, 2026, View Source [SID1234665726])

Tempest Reports First Quarter 2026 Financial Results and Provides Business Update

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.

"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])

Sutro Biopharma Reports First Quarter 2026 Financial Results and Business Highlights

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.

"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])