On November 12, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the third quarter ended September 30, 2025 and other recent business developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We made significant clinical and regulatory progress in the third quarter," said Brian Sullivan, CEO and co-founder of Celcuity. "At the ESMO (Free ESMO Whitepaper) Congress, we presented potentially practice-changing safety and efficacy results for the gedatolisib regimens from the PIK3CA wild-type cohort of our Phase 3 VIKTORIA-1 trial at a late breaking oral presentation. We remain on track to submit the New Drug Application for gedatolisib later this year based on data from the PIK3CA wild-type cohort. The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled with topline data expected in late Q1 2026 or during Q2 2026."

"There is an urgent need for more efficacious therapies than those currently available for patients with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor. With our strengthened balance sheet, and unprecedented efficacy results in this patient population, we are well positioned to bring gedatolisib to patients should we get FDA approval."

Third Quarter 2025 Business Highlights and Other Recent Developments

● The Company announced positive topline data for both primary endpoints of the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial that evaluated gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in patients with HR+, HER2- advanced breast cancer ("ABC") whose disease had progressed on or after prior treatment with a CDK4/6 inhibitor. Detailed safety and efficacy results were subsequently presented at a late breaking oral presentation at the 2025 ESMO (Free ESMO Whitepaper) Congress. The results demonstrate the potential for the gedatolisib regimens to be practice changing for patients with HR+, HER2- ABC.

◌ The gedatolisib-triplet (gedatolisib, fulvestrant, and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant based on a hazard ratio ("HR") of 0.24. The median progression free survival ("PFS") was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.
◌ The gedatolisib doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67% compared to fulvestrant based on a hazard ratio of 0.33. The median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.
◌ Clinical benefit of the gedatolisib regimens was consistent across patient subgroups.
◌ The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common Grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0% of patients, respectively); rash (4.6%, 5.4%, and 0% of patients, respectively); and hyperglycemia (2.3%, 2.3%, and 0% of patients, respectively).
◌ Study treatment discontinuation due to TRAEs was reported in 2.3% of patients treated with the gedatolisib triplet and 3.1% of patients with the gedatolisib doublet.
◌ The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled with topline data expected sometime in late Q1 2026 or during Q2 2026.

● Updated data from a Phase 1b study evaluating gedatolisib plus darolutamide in men with mCRPC was presented at a poster session at the 2025 ESMO (Free ESMO Whitepaper) Congress.

◌ In this Phase 1b study, 38 patients with mCRPC were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2.
◌ The six-month radiographic PFS ("rPFS") rate and median rPFS for patients from both arms combined was 67% and 9.1 months, respectively. For patients treated with 120 mg gedatolisib, the six-month rPFS rate was 74% and median rPFS was 9.5 months. For patients treated with 180 mg gedatolisib, the six-month rPFS rate was 61% and the median rPFS was 7.4 months.
◌ The combination of gedatolisib and darolutamide was generally well tolerated in the trial with mostly low-grade TRAEs. No dose limiting toxicities were observed in either arm. The only Grade 3 TRAEs for patients from both arms combined included rash (5.3%), stomatitis (2.6%), and pruritus (2.6%); no Grade 3 hyperglycemia was reported. Additionally, no Grade 4 or 5 TRAEs were observed, and no patients discontinued study treatment due to a TRAE.

● The FDA accepted the Company’s request to submit an NDA for gedatolisib under the Real-Time Oncology Review ("RTOR") program based on data from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial. The Company made its first NDA pre-submission in September 2025 and completion of the NDA submission is targeted for the fourth quarter of 2025.

● In July 2025, the first patient was dosed in VIKTORIA-2, a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for patients with HR+/HER2- ABC who are endocrine therapy resistant.

● In July 2025, the Company conducted a concurrent public offering of 2.750% convertible senior notes due 2031, common stock and pre-funded warrants. The net proceeds from the offerings were $287 million, after deducting underwriting discounts and commissions and the Company’s offering expenses.

● In September 2025, the Company entered into an amendment to its existing senior secured term loan facility with an affiliate of Innovatus Capital Partners, LLC ("Innovatus"), and Oxford Finance LLC and certain of its affiliates (together, "Oxford"). The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders.

◌ With the release of the topline data from the PIK3CA WT cohort of the VIKTORIA-1 Phase 3 clinical trial, Celcuity achieved the Term D milestone under the term loan facility and was eligible to draw an additional $30 million. In connection with the amendment, the $30.0 million Term D loan was disbursed and the Company received net proceeds of $27.8 million.
◌ The upsized facility strengthens Celcuity’s ability to manage its capital structure efficiently while providing additional funding to support commercial launch preparations for gedatolisib and other strategic initiatives.

● In the third quarter of 2025, investors exercised warrants generating cash proceeds of $12.8 million. The warrants were issued pursuant to a private placement that closed on December 9, 2022 and had an expiration date of 75 days from the release of the topline data from the PIK3CA WT cohort of the VICTORIA-1 Phase 3 clinical trial.

Third Quarter 2025 Financial Results

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2025, compared to the third quarter ended September 30, 2024.

Total operating expenses were $42.8 million for the third quarter of 2025, compared to $30.1 million for the third quarter of 2024.

Research and development ("R&D") expenses were $34.9 million for the third quarter of 2025, compared to $27.6 million for the prior-year period. Of the approximately $7.3 million increase in R&D expenses, $5.6 million was related to increased employee and consulting expenses, $3.2 million of which related to commercial headcount additions and other launch-related activities. The remaining $1.7 million increase was primarily related to activities supporting our ongoing clinical trials.

General and administrative ("G&A") expenses were $7.9 million for the third quarter of 2025, compared to $2.5 million for the prior-year period. Of the approximately $5.4 million increase in general and administrative expenses, $4.9 million was related to increased employee and consulting expenses. Of this $4.9 million increase, $4.0 million was related to non-cash, stock-based compensation. The remaining $0.5 million of the $5.4 million increase was primarily related to professional fees, expanding infrastructure and other administrative expenses.

Net loss for the third quarter of 2025 was $43.8 million, or $0.92 loss per share, compared to a net loss of $29.8 million, or $0.70 loss per share, for the third quarter of 2024. Non-GAAP adjusted net loss for the third quarter of 2025 was $37.2 million, or $0.78 loss per share, compared to non-GAAP adjusted net loss of $27.6 million, or $0.65 loss per share, for the third quarter of 2024. 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.

Net cash used in operating activities for the third quarter of 2025 was $44.8 million, compared to $20.6 million for the third quarter of 2024.

At September 30, 2025, Celcuity reported cash, cash equivalents and short-term investments of $455.0 million. We expect cash, cash equivalents, investments and drawdowns on our debt facility to fund operations through 2027.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter 2025 financial results and provide a corporate update. 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=9d6c00e337. A replay of the webcast will be available on the Celcuity website following the live event.

(Press release, Celcuity, NOV 12, 2025, View Source [SID1234659815])

On November 12, 2025 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the third quarter 2025 and provided an overview of recent corporate highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We were thrilled to recently share positive clinical data from both our off-the-shelf CAR-T cell therapy programs, vispa-cel for second-line large B cell lymphoma and CB-011 for relapsed or refractory multiple myeloma. These results represent a defining moment for our company and the field of allogeneic CAR-T cell therapy," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "As we advance both programs, we are committed to delivering on the promise of off-the-shelf cell therapies – offering rapid treatment, scalable manufacturing, and the possibility of broad patient access."

Clinical highlights
Vispacabtagene regedleucel (vispa-cel; formerly CB-010), a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma
•On November 3, 2025, Caribou announced positive data from the ANTLER phase 1 trial demonstrating efficacy and durability on par with autologous CAR-T cell therapies in the confirmatory cohort (N=22) as well as in patients who received vispa-cel with an optimized profile (N=35). These data highlight vispa-cel’s potential as the best-in-class allogeneic CAR-T cell therapy for second-line (2L) large B cell lymphoma (LBCL).
◦As of the September 29, 2025, efficacy data cutoff date, the efficacy data for the confirmatory cohort with partial HLA matching (≥4 HLA matches; N=22) included: 82% overall response rate (ORR), 64% complete response (CR) rate, and 51% progression-free survival (PFS) at 12 months. The median follow up for the confirmatory cohort was 6.0 months.

◦The Company leveraged its large allogeneic CAR-T cell clinical data set (>140 patients dosed across multiple clinical trials) to identify key factors linked to successful patient outcomes. Two of those factors are donor age (young donors drive enhanced outcomes relative to older donors) and partial HLA matching (matching 2 or more [2+] alleles correlates with outcomes on par with autologous CAR-T cell therapies). Of the 84 patients dosed with vispa-cel, there are 35 CD19-naïve LBCL patients who received vispa-cel with an optimized profile (32 of these patients were 2L and 3 of these patients were 3L+). The optimized profile vispa-cel was manufactured from young donor-derived T cells, and the 35 patients matched a minimum of 2 HLA alleles with the T cell donor.
◦As of the September 29, 2025, efficacy data cutoff date, the efficacy data for the cohort that received vispa-cel with an optimized profile (≥2 HLA matched, young donor; N=35) included: 86% ORR, 63% CR rate, and 53% PFS at 12 months. The median follow up for the optimized profile cohort was 11.8 months, and the longest responding patient, who completed the 2-year ANTLER trial and enrolled in the long-term follow-up study, is in complete response 3 years post infusion.
◦In all patients treated in ANTLER (N=84) as of the September 2, 2025, safety data cutoff date, vispa-cel demonstrated a generally well-tolerated safety profile, which will allow for administration in the outpatient setting and at community hospitals.
•In recent interactions, the FDA has recommended the Company conduct a randomized, controlled trial in 2L LBCL CD19-naive patients who are ineligible for transplant and autologous CAR-T cell therapy. The Company intends to follow this approach with its planned pivotal phase 3 clinical trial design, which it expects to further refine through continued engagement with the FDA in the coming months.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for patients with relapsed or refractory multiple myeloma (r/r MM)
•On November 3, 2025, Caribou announced positive first clinical data from the dose escalation portion of the CaMMouflage phase 1 trial, highlighting CB-011’s potential as a best-in-class allogeneic CAR-T cell therapy for patients with r/r MM.
◦48 patients have been treated in the dose escalation portion of the CaMMouflage phase 1 trial. The Company disclosed on November 3, 2025, that the recommended dose for expansion (RDE) is a single dose of 450 million CAR-T cells following a lymphodepletion regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days.
▪In the 12-patient, BCMA-naïve cohort treated at the RDE with the selected lymphodepletion regimen, as of the September 24, 2025, data cutoff date, the efficacy data included: 92% ORR, 75% ≥CR, and 91% (10/11 evaluable patients) minimal residual disease (MRD)-negativity.
•Caribou is advancing CB-011 into dose expansion by the end of this year and expects to report dose expansion data as well as longer follow up on dose escalation data in 2026.

Upcoming events
•8th Annual Evercore Healthcare Conference, Coral Gables, FL
December 2, 2025, fireside chat at 8:45 am ET
Webcast
•Caribou to host a breakfast reception and KOL panel at the 67th ASH (Free ASH Whitepaper) Annual Meeting
December 6, 2025, 7:30 am ET
Panel of clinicians from sophisticated community hospitals and academic centers to discuss how vispa-cel could change the treatment paradigm for lymphoma by bringing CAR-T cell therapies into the community setting, closer to where patients live. Webcast details to be posted on Caribou’s Events page

Third quarter 2025 financial results
Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $2.2 million for the three months ended September 30, 2025, compared to $2.0 million for the same period in 2024.

R&D expenses: Research and development expenses were $22.4 million for the three months ended September 30, 2025, compared to $30.4 million for the same period in 2024. The decrease was primarily related to decreases in clinical trial-related activities, including manufacturing for the Company’s clinical CAR-T cell therapy product candidates, personnel-related expenses related to its reduction in workforce and strategic pipeline prioritization, and other facilities and allocated expenses.

G&A expenses: General and administrative expenses were $9.2 million for the three months ended September 30, 2025, compared to $9.8 million for the same period in 2024. This decrease was primarily related to a decrease in personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization and was partially offset by an increase in legal and other service-related expenses.

Cash, cash equivalents, and marketable securities: Caribou had $159.2 million in cash, cash equivalents, and marketable securities as of September 30, 2025, compared to $249.4 million as of December 31, 2024. Caribou expects its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan, including dose expansion for CB-011 and certain start-up activities for its planned vispa-cel pivotal trial, into 2H 2027. The Company is exploring multiple options to fully fund its planned vispa-cel pivotal trial.

About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations for B-NHL.

About the ANTLER phase 1 clinical trial
The ANTLER clinical trial is a multicenter, open-label phase 1 trial evaluating vispa-cel in adult patients with r/r B-NHL. Eighty-four patients have been treated in the ANTLER clinical trial as of September 2, 2025. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation evaluating 40×106, 80×106, and 120×106 CAR-T cell dose levels with a lymphodepletion (LD) regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Forty-one second-line large B cell lymphoma (2L LBCL) patients were enrolled in the dose expansion portion, and 80×106 CAR-T cells was selected as the recommended phase 2 dose (RP2D). An additional 22 2L LBCL patients were enrolled in the confirmatory cohort, which prospectively evaluated the Company’s partial HLA matching strategy. Five patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the CaMMouflage phase 1 clinical trial. To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. CB-011 has been granted Fast Track and Orphan Drug designations by the FDA.

About the CaMMouflage phase 1 clinical trial
The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirteen patients were treated with a single dose of CB-011 (50×106 [N=3], 150×106 [N=7], and 450×106 [N=3] CAR-T cells) with an LD regimen of 300 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days, and 35 patients were treated with a single dose of CB-011 (150×106 [N=6], 300×106 [N=13], 450×106 [N=13], and 800×106 [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days. The dose expansion portion of the trial will evaluate safety and efficacy of CB-011 at 450×106 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at clinicaltrials.gov.

(Press release, Caribou Biosciences, NOV 12, 2025, View Source [SID1234659814])

On November 12, 2025 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence ("AI") and machine learning to enable the successful development of pharmaceuticals and biologics, reported that it will present a technical talk at the upcoming AI Drug Discovery & Development Summit 2025, taking place November 18–20, 2025, in Boston, Massachusetts.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BullFrog AI’s presentation, titled "Human-in-the-Loop Agent Workflows with bfPREP," will be delivered as part of Technical Insights Session 1 on Wednesday, November 19, 2025. The session will provide an inside look at how BullFrog AI operationalizes AI agents for real-world analytics within its bfPREP data preparation solution, transforming the "magic" of demos into dependable, reproducible workflows for life sciences organizations.

"AI agents can be powerful tools, but reliability in production depends on disciplined engineering and quality control," said Vin Singh, CEO of BullFrog AI. "At this session, we’ll share how bfPREP makes human-in-the-loop AI practical for pharmaceutical data operations, enabling structured outputs, stable schemas, and consistent performance across large, complex datasets. Our technology is not just theoretical; it’s being deployed in real-world drug development environments in order to help clients accelerate analytics and make better decisions faster. As we continue to expand the BullFrog Data Networks platform, we believe bfPREP could play a defining role in scaling AI adoption across the biopharma industry."

bfPREP is BullFrog AI’s dedicated data cleansing and preparation module within its BullFrog Data Networks Solutions Library. Purpose-built for the life sciences industry, bfPREP automates the detection, correction, and standardization of clinical, omics, and real-world data, converting fragmented information into analysis-ready datasets. The platform’s biomedical-first intelligence and human-in-the-loop validation ensure data integrity and reproducibility, making it a foundational component of BullFrog AI’s mission to improve drug development efficiency.

Now in its fourth year, the AI Drug Discovery & Development Summit has become a premier global event for innovators applying AI across the pharmaceutical value chain, from early discovery through clinical trials. The 2025 summit will convene 500+ attendees and 100+ expert speakers over three days of technical sessions, keynotes, and networking designed to push the boundaries of AI-driven innovation in drug discovery and development.

(Press release, Bullfrog AI, NOV 12, 2025, View Source [SID1234659813])

On November 12, 2025 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, and Bristol Myers Squibb (NYSE: BMY), a leading biopharmaceutical company, reported an expanded strategic collaboration aimed at accelerating the development of innovative cancer therapies and increasing access to clinical trials for patients across the U.S.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Central to the collaboration is SCRI’s Accelero, a next-generation clinical trial delivery model that streamlines operations and accelerates trial execution across SCRI’s expansive network of more than 200 locations. By aligning Bristol Myers Squibb’s pioneering oncology pipeline with SCRI’s research infrastructure and expertise, the collaboration is designed to bring cutting-edge research directly to patients—where they live and receive care.

"At Bristol Myers Squibb, we recognize that accelerating clinical trial enrollment requires not only scientific innovation but also operational innovation. This includes a deep commitment to equity and inclusion, while we look to accelerate overall patient enrollment," said Mokash Sharma, Senior Vice President, Global Development Operations, Bristol Myers Squibb. "Improving access to clinical research isn’t just about science—it’s about trust, and meeting people where they are. By leveraging data-driven strategies through our collaboration with Sarah Cannon Research Institute, we’re working to ensure that more patients—especially those from medically underserved populations—have access to vital cancer research advances in their communities. This partnership reflects our shared vision to transform clinical trial delivery and advance health equity across the oncology landscape."

Through this collaboration, SCRI and Bristol Myers Squibb are expanding access to Bristol Myers Squibb’s innovative therapies by embedding clinical trials in community settings. With more than 1,300 physicians engaged in research across over 20 states, SCRI’s network enables broader participation in clinical trials.

"Together, SCRI and Bristol Myers Squibb are translating innovative science into clinical trials and accelerating patient enrollment through SCRI’s Accelero model that prioritizes speed, quality, and access, and ultimately brings promising therapies to patients faster and closer to home," said Dee Anna Smith, Chief Executive Officer, SCRI. "We look forward to the impact we will have together as we reach more patients and continue to redefine how clinical trials are delivered across the country."

In the early phase of the collaboration, SCRI achieved a 45% reduction in study startup timelines across eight Bristol Myers Squibb clinical trials—significantly outperforming timelines observed at non-SCRI sites. By scaling these capabilities across SCRI’s research network, the collaboration reinforces a shared commitment to transforming clinical trial delivery and ensuring that more people can access the latest cancer treatments and innovations.

(Press release, Bristol-Myers Squibb, NOV 12, 2025, View Source [SID1234659812])

On November 12, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the third quarter ended September 30, 2025, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the third quarter, we focused on developing BDC-4182, the first next-generation Boltbody ISAC in our pipeline. We are actively enrolling patients with gastric and gastroesophageal cancer in the Phase 1 dose-escalation study. We now look forward to presenting initial data in the third quarter of 2026," said Willie Quinn, President and Chief Executive Officer. "With our cash runway now expected to extend into 2027, we are in a financial position to create long-term value for our shareholders and fulfill our mission of bringing new treatment options to patients with cancer."

Recent Highlights and Anticipated Milestones

•
Initial clinical data for BDC-4182 Phase 1 study for patients with gastric and gastroesophageal cancer expected in the third quarter of 2026. BDC-4182 is a next-generation Boltbody ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. Following a strong immune response that was observed at the initial dose levels, Bolt modified the clinical trial protocol to allow for step-up dosing, which has been successfully used commercially for T-cell engagers. The clinical trial is ongoing and the Company expects to present initial clinical data in the third quarter of 2026.
o
In November at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), Bolt presented preclinical data supporting the clinical development of BDC-4182. The data indicate that the claudin 18.2 ISAC stimulates a powerful, tumor-dependent immune response that culminates in complete tumor regression and the establishment of immunological memory. The ensuing T cell-dependent immunity was robust enough to prevent the growth of tumors lacking claudin 18.2 expression during rechallenge experiments. Furthermore, the ISAC demonstrated superior anti-tumor activity compared to both Topo1- and MMAE-based ADCs, particularly in a low-antigen model of claudin 18.2-expressing cancer. Taken together, these findings provide a strong rationale for the ongoing clinical development of BDC-4182.
•
Presented updated preclinical results for next-generation Boltbody ISACs targeting CEA and PD-L1 at SITC (Free SITC Whitepaper).
o
Bolt’s CEACAM5 (CEA) ISAC features a novel, fully human antibody with high affinity and selectivity for membrane-bound CEA while minimizing binding to other CEACAMs and soluble

CEA. Our CEA ISAC is conjugated to a proprietary TLR7/8 agonist via a non-cleavable linker and drives enhanced phagocytosis of CEA-positive tumor cells and immune activation relative to an ISAC created with an alternative CEA antibody, tusamitamab. Bolt’s CEA ISAC induced complete and durable anti-tumor responses in preclinical models and was more effective than a Topo1-based ADC at lower doses and in a lower antigen density tumor model. Bolt’s CEA ISAC was well tolerated in a non-GLP toxicology study and is available for partnering.
o
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. The poster also highlights the potential advantage of using an active Fc and a dual TLR7 and TLR8 agonist, design choices that may confer a competitive advantage versus other PD-L1 ISACs in development.
•
Collaborations with Genmab and Toray ongoing. Genmab and Bolt’s collaboration continues to explore research and development of additional next-generation ISAC programs for the treatment of cancer. The Toray collaboration combines the Company’s immunostimulatory linker-payloads with Toray antibodies targeting Caprin-1, a tumor-specific antigen that is strongly expressed on the cell membrane in multiple solid tumor types.
•
Seeking a partner for further BDC-3042 development. BDC-3042 is a proprietary agonist antibody that targets dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). Bolt completed the Phase 1 dose escalation study and presented the clinical results at the American Associates for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting that took place in April 2025. BDC-3042 is available for partnering.
•
Cash, cash equivalents, and marketable securities were $38.8 million as of September 30, 2025. Cash position is expected to fund multiple milestones and operations into 2027.

Third Quarter 2025 Financial Results

• Collaboration Revenue – Total collaboration revenue was $2.2 million for the quarter ended September 30, 2025, compared to $1.1 million for the same quarter in 2024. 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 $6.5 million for the quarter ended September 30, 2025, compared to $13.8 million for the same quarter in 2024. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses, a decrease in clinical expenses primarily related to the discontinued development of trastuzumab imbotolimod, formerly known as BDC-1001 in May 2024.

• General and Administrative (G&A) Expenses – G&A expenses were $3.3 million for the quarter ended September 30, 2025, compared to $3.8 million for the same quarter in 2024. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring.

• Loss from Operations – Loss from operations was $7.7 million for the quarter ended September 30, 2025, compared to $16.4 million for the same quarter in 2024.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

(Press release, Bolt Biotherapeutics, NOV 12, 2025, View Source [SID1234659811])