Bolt Biotherapeutics Reports First Quarter 2026 Financial Results and Provides Business Update

On May 12, 2026 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

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"We are encouraged by what we have seen thus far in patients treated with BDC‑4182, a next‑generation Boltbody ISAC. BDC-4182 has a unique mechanism of action , that has the potential to combine the power of ADCs with the durability of T-cell engagers and unlock a new frontier in cancer treatment," said Willie Quinn, President and Chief Executive Officer. "We continue to enroll patients with gastric and gastroesophageal cancer in our ongoing clinical trial, and we look forward to reporting initial data in the third quarter of 2026."

Recent Highlights and Anticipated Milestones


Initial clinical data from BDC-4182 Phase 1/2 study for patients with gastric and gastroesophageal cancer expected in the third quarter of 2026. BDC-4182 is a next-generation BoltbodyTM ISAC targeting claudin 18.2, a clinically validated target with expression in gastric cancer, gastroesophageal junction cancer, pancreatic cancer, and other tumor types. In preclinical models, including cancer models with low claudin 18.2 expression, BDC-4182 demonstrated significant anti-tumor activity, induced immunological memory, and outperformed cytotoxic ADCs. Bolt has implemented step-up dosing, which has been successfully used commercially for T-cell engagers, as a strategy to get to higher doses safely. The clinical trial in gastric and gastroesophageal cancers is ongoing, and the Company expects to present initial clinical data in the third quarter of 2026.

Next-generation Boltbody ISACs targeting CEA and PD-L1. Two additional ISAC programs in Bolt’s pipeline are currently on hold. Once BDC-4182 demonstrates proof-of-concept for the ISAC approach, Bolt plans to resume development of these programs. Both programs are close to clinical candidate selection.
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Bolt’s CEA-targeted ISAC comprises a novel, fully human antibody with high affinity and selectivity to CEACAM5 (CEA) conjugated to a proprietary next-generation TLR7/8 agonist via a non-cleavable linker. Bolt’s CEA ISAC induced complete and durable anti-tumor responses in preclinical models and demonstrated superior activity versus a Topo1-based ADC. The CEA ISAC was well tolerated in a non-GLP toxicology study.
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Bolt’s PD-L1 ISAC utilizes a novel human anti-PD-L1 antibody conjugated to a TLR7/8 agonist via a non-cleavable linker. This ISAC leverages a unique mechanism of action due to its ability to target both tumor and immune cells that express PD-L1. Preclinical results demonstrated that PD-L1 ISACs represent a compelling new approach to treat cancer, leveraging mechanisms that are distinct from and potentially complementary to conventional PD-1/PD-L1 blockade with the potential for enhanced immune activation and antitumor activity.


Cash, cash equivalents, and marketable securities were $23.9 million as of March 31, 2026. Cash on hand is expected to fund operations into 2027.

First Quarter 2026 Financial Results


Collaboration Revenue – Total collaboration revenue was $26,000 for the quarter ended March 31, 2026, compared to $1.2 million for the same quarter in 2025. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations.


Research and Development (R&D) Expenses – R&D expenses were $4.8 million for the quarter ended March 31, 2026, compared to $9.5 million for the same quarter in 2025. The decrease between the comparable periods was mainly due to a continued decrease in salary and related expenses primarily as a result of our restructuring, reduced clinical trial expenses and lower research and development expenses.


General and Administrative (G&A) Expenses – G&A expenses were $2.8 million for the quarter ended March 31, 2026, compared to $3.8 million for the same quarter in 2025. The decrease between the comparable periods was mainly due to a continued decrease in salary and related expenses primarily as a result of our restructuring.


Loss from Operations – Loss from operations was $7.6 million quarter ended March 31, 2026, compared to $12.1 million for the same quarter 2025.

(Press release, Bolt Biotherapeutics, MAY 12, 2026, View Source [SID1234665527])

Biomea Fusion to Participate at Upcoming Investor Conferences

On May 12, 2026 Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported that management will participate in the following investor conferences:

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H.C. Wainwright 4th Annual BioConnect Investor Conference: Biomea will participate in a fireside chat from 3:00–3:30 PM ET and in one-on-one meetings on May 19, 2026, in New York, NY.

2026 Jefferies Global Healthcare Conference: Biomea will participate in a fireside chat from 8:10–8:40 AM ET and in one-on-one meetings on June 4, 2026, in New York, NY.

An audio webcast of the fireside chats will be available here or by visiting the News & Events page under the Investors & Media section of Biomea’s website. A replay of the webcasts will be available following the live event.

(Press release, Biomea Fusion, MAY 12, 2026, View Source [SID1234665526])

Atara Biotherapeutics Announces First Quarter 2026 Financial Results and Operational Progress

On May 12, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the first quarter 2026 and business updates.

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Tabelecleucel (tab-cel or Ebvallo) for Post-Transplant Lymphoproliferative Disease (PTLD)

As previously communicated, Pierre Fabre Pharmaceuticals (PFP), with Atara’s support, had a productive meeting with the FDA and discussed a potential path forward to resubmitting the tab-cel Biologics License Application (BLA). The FDA agreed that a single arm study using an appropriate historical control applicable to the trial population, conducted in a pre-specified manner, could serve as an adequate and well controlled study and provide safety and efficacy data in support of a marketing application of tab-cel for the proposed indication.

PFP has indicated they intend to submit an updated dataset with additional patients and longer follow-up from the pivotal Phase 3 single arm ALLELE study as well as supportive data, as a part of the resubmission plan being defined with the FDA. Atara anticipates providing a further regulatory update in the third quarter.

First Quarter 2026 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2026 totaled $8.4 million, as compared to $8.5 million as of December 31, 2025.
Net cash used in operating activities was $3.1 million for the first quarter 2026, as compared to $28.1 million in the same period in 2025.
Total revenues were $0.5 million for the first quarter 2026, as compared to $98.1 million for the same period in 2025. The prior‑year period reflects a one‑time acceleration of revenue recognized upon the transfer of tab‑cel manufacturing responsibilities to Pierre Fabre Laboratories on March 31, 2025. In the current period, commercialization revenue relates solely to ongoing regulatory activities
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $0.8 million for the first quarter 2026, as compared to $6.0 million for the same period in 2025.
Research and development expenses were $0.2 million for the first quarter 2026, as compared to $27.4 million for the same period in 2025.
Research and development expenses also include $0.3 million of non-cash stock-based compensation expenses for the first quarter 2026, as compared to $1.6 million for the same period in 2025.
General and administrative expenses were $3.6 million for the first quarter 2026, as compared to $11.5 million for the same period in 2025.
General and administrative expenses include $0.5 million of non-cash stock-based compensation expenses for the first quarter 2026, as compared to $2.6 million for the same period in 2025.
Atara reported a net loss of $4.1 million, or ($0.29) basic and diluted loss per share, for the first quarter 2026, as compared to net income of $38.0 million, or $3.53 basic earnings per share and $3.50 diluted earnings per share, for the same period in 2025.
2026 Outlook and Cash Runway:

Operating expenses are expected to decline significantly year-over-year, reflecting the full-year benefit of cost-reduction initiatives implemented in 2025.
Atara expects its cash, cash equivalents, and short-term investments as of March 31, 2026, combined with $4.8 million of ATM proceeds after quarter end and operating efficiencies achieved in 2025, will be sufficient to fund planned operations into mid-2027.

(Press release, Atara Biotherapeutics, MAY 12, 2026, View Source [SID1234665525])

Ascentage Pharma to Participate in Three Upcoming Investor Conferences

On May 12, 2026 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) ("Ascentage Pharma" or the "Company"), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported that the Company’s management is scheduled to participate in three upcoming investor conferences.

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· B. Riley Commercial/Late-Stage Oncology Best Ideas Summit: One-on-one meetings on May 18th

· Stifel 2026 Virtual Targeted Oncology Forum: One-on-one meetings and fireside chat at 10:30 am EDT on May 19th

· Jefferies Global Healthcare Conference in New York: One-on-one meetings and presentation at 8:10 am EDT on June 3rd

The webcasts for the fireside chat and presentation can be accessed by visiting the Events page in the Investor Relations section of Ascentage Pharma’s website.

(Press release, Ascentage Pharma, MAY 12, 2026, View Source [SID1234665524])

Arvinas Reports First Quarter 2026 Financial Results and Provides Corporate Update

On May 12, 2026 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the first quarter 2026, and provided a corporate update.

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"The approval of VEPPANU is a defining achievement for Arvinas and reflects the culmination of more than a decade of focused work to translate our PROTAC science into our first approved therapy," said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. "I’m proud to lead an organization advancing an industry-leading portfolio of degraders – one that has now joined the short list of those able to bring a new therapeutic modality from discovery to approval. As we move through the remainder of the year, our focus is on delivering key data and clinical milestones that we believe will further validate our approach and clearly distinguish our programs in an increasingly competitive environment."

1Q 2026 Business Highlights and Recent Developments

Approved Product
VEPPANU (vepdegestrant): Oral PROTAC ER degrader
As part of Arvinas global collaboration with Pfizer, the companies:

Announced the approval of VEPPANU for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
This approval marks the first time the U.S. Food and Drug Administration (FDA) has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy.
Entered into a license agreement with Rigel Pharmaceuticals, Inc. for the for the exclusive global development, manufacturing, and commercialization rights for VEPPANU.
On May 8, 2026, the National Comprehensive Cancer Network (NCCN) added vepdegestrant (VEPPANU) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer. Vepdegestrant (VEPPANU) was added as a Category 2A treatment option for patients with hormone receptor (HR)-positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitor.*
Pipeline
ARV-102: Oral PROTAC LRRK2 degrader

Presented Phase 1 data for ARV-102 at the 2026 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD 2026) showing greater than 50% LRRK2 degradation in cerebrospinal fluid (CSF) of patients with Parkinson’s disease treated for 28 days. Additional key findings from the trial showed:
Reduction of key endolysosomal and neuroinflammatory biomarkers (e.g., CD68, GPNMB) previously shown to be elevated in neurodegenerative diseases like Parkinson’s disease and progressive supranuclear palsy (PSP).
This level of biomarker modulation has not previously been demonstrated by LRRK2 inhibitors.
Dose-dependent exposure increases in CSF after multiple doses, indicating brain penetration.
Approximately 50% or greater LRRK2 reduction in CSF at all doses by day 14 and maintained through day 28, indicating substantial central LRRK2 protein degradation.
ARV-102 was generally safe and well tolerated with no serious adverse events reported after multiple doses.
ARV-806: Novel PROTAC KRAS G12D degrader

Completed dose escalation enrollment in the Phase 1 clinical trial evaluating ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).
ARV-393: Oral PROTAC BCL6 degrader

Initiated a Phase 1 combination trial with glofitamab in patients with diffuse large B-cell lymphoma (DLBCL).
Continued dose escalation in the Phase 1 trial in patients with non-Hodgkin’s lymphoma (NHL).
Multiple responses observed in early cohorts at doses below the predicted effective exposure level in patients with both B- and T-cell lymphomas.
ARV-027: Oral PROTAC polyQ-AR degrader

Initiated a first-in-human Phase 1 clinical trial in healthy volunteers.
Presented preclinical data at the 2026 Kennedy’s Disease Association Conference.
In an aggressive spinal bulbar muscular atrophy mouse model, ARV-027 degraded polyQ-AR in muscle, which led to meaningful functional improvements and extended survival.
ARV-6723: Oral PROTAC HPK1 degrader

Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Immuno-Oncology Conference that we believe support clinical investigation of ARV-6723 in patients with solid tumors harboring high- or low-immunogenic tumor microenvironments (TME), including immune checkpoint inhibitor (ICI)-resistant tumor settings.
Robust single-agent antitumor and proinflammatory activity observed in multiple syngeneic tumor models, including those with immunosuppressive TMEs, and showed greater preclinical activity than an investigational HPK1 inhibitor or an anti-PD-1 antibody.
Presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating greater antitumor activity than standard-of-care ICIs or an investigational HPK1 inhibitor.
Unlike an inhibitor and ICIs, ARV-6723 reversed T-cell exhaustion, reversed the immunosuppressive TME, and boosted innate cell immunity in ICI-(aPD1 and aCTLA4) resistant models.
Novel pan-KRAS degrader:

Presented preclinical data at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics.
Robust efficacy observed in CDX models of pancreatic, colorectal, and lung cancer.
Greater tumor growth inhibition than a pan-RAS (ON) inhibitor demonstrated in a KRAS G13D model.
Enhanced combination efficacy with immune checkpoint blockade compared with a pan-RAS (ON) inhibitor observed in a KRAS G12D syngeneic model.
Corporate

Announced the appointment of Randy Teel, Ph.D., as President, Chief Executive, and Director.
Dr. Teel succeeds John Houston, Ph.D., who retired from his role as President, Chief Executive Officer, and Chair of Arvinas’ Board of Directors. Dr. Houston will continue to serve as a member of the Board and has entered into a consulting agreement with Arvinas to provide consulting and advisory services to the Company.
Briggs Morrison, M.D., was elected by the Board to serve as Chair of the Arvinas Board of Directors.
Anticipated Upcoming Milestones and Expectations

Pipeline
ARV-102: Oral PROTAC LRRK2 degrader

Initiate Phase 1b clinical trial in patients with PSP upon receipt of FDA clearance to proceed (2H 2026, pending regulatory feedback).
Potential to initiate a registrational trial in PSP in late 2026, pending regulatory feedback.
Share additional biomarker data from Phase 1 trial in patients with Parkinson’s disease (2H 2026).
ARV-806: Novel PROTAC KRAS G12D degrader

Initiate enrollment in the dose expansion cohort of the Phase 1 trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).
Share initial clinical data in patients with solid tumors harboring KRAS G12D mutations (2026).
ARV-393: Oral PROTAC BCL6 degrader

Share updated clinical data from the ongoing Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin’s lymphoma (ClinicalTrials.gov Identifier: NCT06393738) at a medical congress (2H 2026).
Continue enrollment of a combination cohort with glofitamab in patients with DLBCL in the ongoing Phase 1 clinical trial.
ARV-027: Oral PROTAC polyQ-AR degrader

Continue enrollment in the Phase 1 clinical trial in healthy volunteers.
ARV-6723: Oral PROTAC HPK1 degrader

Initiate Phase 1 clinical trial in patients with advanced solid tumors (mid-2026).
ARV-6723 is Arvinas’ first immuno-oncology clinical candidate.
Approved Product
VEPPANU (vepdegestrant): Oral PROTAC ER degrader
As part of Arvinas’ global collaboration with Pfizer, the companies plan to:

Complete closing of the licensing transaction of VEPPANU to Rigel, which is subject to the parties’ receipt of any necessary consents or approvals, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of March 31, 2026, is sufficient to fund planned operating expenses and capital expenditure requirements into the second half of 2028.

First Quarter Financial Results
Cash, Cash Equivalents, and Marketable Securities Position: As of March 31, 2026, cash, cash equivalents, and marketable securities were $614.9 million as compared with $685.4 million as of December 31, 2025. The decrease in cash, cash equivalents, and marketable securities of $70.5 million for the three months ended March 31, 2026, was primarily related to cash used in operations of $67.5 million, unrealized losses on marketable securities of $1.6 million, and the purchase of lab equipment and leasehold improvements of $1.3 million.

Research and Development Expenses: Generally Accepted Accounting Principles (GAAP) research and development (R&D) expenses were $60.3 million for the quarter ended March 31, 2026, as compared with $90.8 million for the quarter ended March 31, 2025. The decrease in R&D expenses of $30.5 million for the quarter was primarily due to a decrease in compensation and related personnel expenses of $15.6 million, which are not allocated by program, and a decrease in external expenses of $14.2 million. External expenses include program-specific expenses, which decreased by $9.5 million, primarily driven by a decrease in our vepdegestrant (ARV-471) program of $15.2 million, partially offset by an increase in our ARV-806 program of $5.6 million, and non-program specific expenses, which decreased by $4.7 million.

Non-GAAP R&D expenses were $54.3 million for the quarter ended March 31, 2026, as compared with $79.3 million for the quarter ended March 31, 2025, excluding $0.3 million of restructuring expense for the quarter ended March 31, 2026, and $5.7 million and $11.5 million of non-cash stock-based compensation expense for the quarters ended March 31, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

General and Administrative Expenses: GAAP General and administrative (G&A) expenses were $19.1 million for the quarter ended March 31, 2026, as compared with $26.6 million for the quarter ended March 31, 2025. The decrease in G&A expenses of $7.5 million for the quarter was primarily due to a decrease in professional fees of $5.3 million.

Non-GAAP G&A expenses were $13.0 million for the quarter ended March 31, 2026, as compared with $23.1 million for the quarter ended March 31, 2025, excluding $0.8 million of restructuring expenses for the quarter ended March 31, 2026, and $5.3 million and $3.5 million of non-cash stock-based compensation expense for the quarter ended March 31, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

Revenue: Revenue was $15.6 million for the quarter ended March 31, 2026, as compared with $188.8 million for the quarter ended March 31, 2025. Revenue for the quarter is related to the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer and the collaboration and license agreement with Pfizer. The decrease of $173.2 million was primarily due to a decrease in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer driven by changes in total program cost estimates recognized in 2025 resulting from the removal of two Phase 3 trials from the development plan.

Investor Call & Webcast Details
Arvinas will host a conference call and webcast today, May 12, 2026, at 8:00 a.m. ET to review its first quarter 2026 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days.

(Press release, Arvinas, MAY 12, 2026, View Source [SID1234665523])