On November 6, 2025 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported a business update and announced financial results for the third quarter ended September 30, 2025.

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"Once again, the recent quarter saw the reporting of positive data from a number of clinical studies involving certepetide, including from the ASCEND, iLSTA, and CENDIFOX trials. Importantly, we also announced a strategic alliance with GATC Health to use their Multiomics Advanced Technology artificial intelligence drug discovery platform to identify product candidates for development, as well as a global license agreement in which Catalent gained access to certepetide for use across various Antibody-Drug Conjugates. Overall, it was a productive and positive quarter marked by our continued vigilance in managing expenses. As a result, we now project that our available cash will fund current operations into the first quarter of 2027," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "We anticipate a steady flow of additional data through the remainder of 2025 and into 2026."
Development Portfolio Highlights

Certepetide as a treatment for solid tumors in combination with other anti-cancer agents

Certepetide (formerly LSTA1), a proprietary, internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate the C-end rule active transport mechanism in a tumor specific manner, resulting in systemically co-administered anti-cancer agents more efficiently penetrating and accumulating in the tumor. Additionally, certepetide has been shown to modify the tumor microenvironment ("TME"), diminishing its immunosuppressive nature, enhancing cytotoxic T cell concentration in the TME and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant clinical and non-clinical data demonstrating enhanced efficacy and acceptable safety of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, RNA-based therapeutics, and Antibody-Drug Conjugates ("ADCs") in solid tumor models.

Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.). Currently, certepetide is the subject of multiple ongoing and proposed (subject to sufficient funding) global clinical studies across several solid tumor types in combination with a variety of anti-cancer regimens, including:

•ASCEND: Phase 2b double-blind, randomized (2:1 ratio), placebo-controlled trial evaluating two dosing regimens of certepetide in combination with standard-of-care ("SoC") chemotherapy (gemcitabine/nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma ("mPDAC"). The trial was conducted across 25 sites in Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group ("AGITG") and coordinated by the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney. Cohort A, with 95 patients receiving a single intravenous ("IV") dose of certepetide 3.2 mg/kg or placebo in combination with SoC, completed enrollment in the third quarter of 2023. Preliminary Cohort A data presented at the 2025 ASCO (Free ASCO Whitepaper)-GI Symposium showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo treated group. Preliminary data from Cohort B, with 63 patients receiving two IV doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with SoC, was presented at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers ("ESMO-GI") Congress on July 2, 2025. The preliminary Cohort B data demonstrate a positive signal in progression-free survival and objective response rate observed in the certepetide-treated group compared to the placebo-treated group, indicating that the addition of two doses of certepetide (Cohort B regimen) to SoC resulted in a clinically meaningful treatment effect and an attractive safety profile. Additionally, pooled data from both Cohorts A and B, which was presented at the ESMO (Free ESMO Whitepaper) Congress in October 2025, further corroborated previous findings and indicated no increase in adverse events in the certepetide-treated groups beyond those experienced in the SoC alone groups. Final data and key findings from both cohorts of the ASCEND study are anticipated for the first quarter of next year.
•BOLSTER: Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. evaluating certepetide in combination with SoC chemotherapy in first- and second-line cholangiocarcinoma ("CCA"). The Company achieved complete enrollment in first-line CCA nearly six months ahead of plan, accelerating anticipated topline data readout to fourth quarter of 2025. Based on investigator enthusiasm, a second cohort was added, evaluating certepetide in combination with SoC in subjects with second-line CCA. In September 2024, Lisata announced the first patient treated in the second-line CCA cohort and more recently, completed enrollment at approximately 20 patients to accelerate data read out and optimize capital allocation.

•CENDIFOX: Investigator-initiated Phase 1b/2a open-label trial in the U.S. evaluating certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon, and appendiceal cancers. In December 2024, the Company announced enrollment completion in all three cohorts. The single-center study, conducted solely at the University of Kansas Cancer Center, was designed with a 3-cycle run-in period to ensure patients met specific criteria before receiving treatment. Of the 66 patients enrolled, 50 patients met the criteria and were treated with certepetide across three cohorts, including 24 with resectable or borderline resectable pancreatic ductal adenocarcinoma ("PDAC"), 15 with high-grade colon or appendiceal cancer and peritoneal metastasis, and 11 with oligometastatic colon cancer. The trial is expected to provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcome information. Preliminary data from the PDAC cohort, presented at the AACR (Free AACR Whitepaper) Special Conference in September 2025, showed that the combination of certepetide with FOLFIRINOX was safe and feasible. In the 10 patients who completed the therapy and underwent surgery, treatment resulted in a 50% R0 resection rate and a 70% pathologic partial response, alongside promising early survival data, including a 60% two-year overall survival rate. Importantly, the combination therapy appears to transform tumors from "immune-cold" to "immune-hot" by enhancing immune cell infiltration and increasing markers like PD-1 and PD-L1, which could significantly improve the efficacy of subsequent immunotherapies. Additional CENDIFOX data are expected in the coming months under the auspices of the investigator. The trial is funded by the University of Kansas Cancer Center and Lisata is supplying certepetide.

•Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is developing certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for first-line mPDAC. During the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase 1b/2a trial of certepetide plus gemcitabine and nab-paclitaxel conducted in Australia in patients with first-line mPDAC. Qilu has completed enrollment in its Phase 2 trial and data are expected in 2026.

•iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., a non-profit foundation, evaluating certepetide in combination with SoC chemotherapy (nab-paclitaxel and gemcitabine) plus SoC immunotherapy (durvalumab) versus SoC alone in patients with locally advanced non-resectable PDAC. Study enrollment is complete and results from an interim analysis were presented at the ESMO (Free ESMO Whitepaper)-GI Congress on July 3, 2025, showing compelling new corroborative data for certepetide. Consistent with the earlier findings presented at the 2025 ASCO (Free ASCO Whitepaper)-GI meeting, the data demonstrate certepetide’s potential to enhance immunotherapy effectiveness by provoking significant RECIST responses and improving overall response and disease control rates. Final data from this study are anticipated in the first quarter of 2026.
•GBM: A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus SOC alone in patients with newly diagnosed glioblastoma multiforme ("GBM") is being conducted across multiple sites in Estonia and Latvia and is planned to also include a site in Lithuania. The study is targeted to enroll 30 patients with a randomization of 2:1 in favor of the certepetide treatment group. Enrollment is progressing according to plan and completion is expected in 2026.
Notable business development achievements in the third quarter:
•Lisata and Catalent entered into a nonexclusive license agreement that grants Catalent global rights to evaluate certepetide and its analogs for use as SMARTag payloads across multiple ADCs designed to address difficult-to-treat diseases. As presented at the World ADC conference earlier this week, compelling positive data from Catalent’s preclinical study evaluating certepetide and its analogs as non-cytotoxic SMARTag ADC payloads showed not only improved ADC efficacy but broadened distribution of the cytotoxic payload within the tumor, supporting certepetide’s potential to enhance the targeting, penetration, and effectiveness of ADCs in advanced solid tumors.
•Lisata entered into a strategic alliance with GATC Health to exploit GATC’s AI-powered Multiomics Advanced Technology artificial intelligence drug discovery platform to optimize and accelerate drug discovery and development, including analyzing certepetide for new indications and identifying combination therapies.
Third Quarter 2025 Financial Highlights
Operating Expenses
For the three months ended September 30, 2025, operating expenses totaled $4.4 million, compared to $5.3 million for the three months ended September 30, 2024, representing a decrease of $0.9 million or 17.3%.
Research and development expenses were approximately $2.0 million for the three months ended September 30, 2025, compared to $2.5 million for the three months ended September 30, 2024, representing a decrease of $0.6 million or 22.9%. This was primarily due to lower spend on chemistry, manufacturing and controls and a reduction in Clinical department expenses partially offset by an increase in the BOLSTER trial costs.
General and administrative expenses were approximately $2.5 million for the three months ended September 30, 2025, compared to $2.8 million for the three months ended September 30, 2024, representing a decrease of $0.3 million or 12.1%. This was primarily due to lower spend on consulting and the elimination of an employee position.
Overall, net losses were $4.2 million for the three months ended September 30, 2025, compared to $4.9 million for the three months ended September 30, 2024.
Balance Sheet Highlights
As of September 30, 2025, we had cash and cash equivalents of approximately $19.0 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the first quarter of 2027.

Conference Call Information
Lisata will hold a live conference call today, November 6, 2025, at 4:30 p.m. Eastern Time to discuss financial results, provide a business update and answer questions. To join the conference call, please refer to the dial-in information provided below:
Dial-in information:
Participant Toll-Free dial: (800) 715-9871
Participant Toll/Int’l dial: (646) 307-1963
Conference ID: 6375221

To avoid delays, we encourage participants to dial into the conference call 10 minutes ahead of the scheduled start time.
A live webcast of the call will also be accessible under the Investors & News section of Lisata’s website and will be available for replay beginning two hours after the conclusion of the call for 12 months.

(Press release, Lisata Therapeutics, NOV 6, 2025, View Source [SID1234659557])

On November 6, 2025 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported financial results for the third quarter ended September 30, 2025, as well as business updates.

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"Recent months have been transformative for C4T, and we are in a strong position to rapidly advance cemsidomide registrational development and progress our discovery pipeline of degraders against non-oncology and oncology targets," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "We remain laser-focused on initiating cemsidomide’s next phase of development in early 2026, which includes a Phase 1b trial in combination with elranatamab as well as the Phase 2 MOMENTUM trial in combination with dexamethasone, which has potential for accelerated approval. With a successful raise of $125 million in upfront proceeds, we have extended our runway to the end of 2028, beyond important data from cemsidomide’s Phase 2 trial with dexamethasone and the Phase 1b in combination with elranatamab, strengthening our balance sheet to continue to deliver on the promise of targeted protein degradation to improve patients’ lives."

THIRD QUARTER 2025 HIGHLIGHTS AND RECENT ACHIEVEMENTS

Clinical:

Presented Phase 1 data of cemsidomide in combination with dexamethasone in multiple myeloma (MM) demonstrating a potential best-in-class profile in a heavily pre-treated patient population and supports cemsidomide’s advancement to a Phase 1b trial in combination with elranatamab and a Phase 2 MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) trial in combination with dexamethasone. C4T has completed enrollment and dose escalation for the Phase 1 trial.
In the Phase 1 trial, cemsidomide in combination with dexamethasone achieved a 40% and 53% overall response rate at the two highest dose levels, 75 µg and 100 µg, respectively. One patient at the 100 µg dose level achieved a minimal residual disease (MRD) negative complete response. Cemsidomide was well-tolerated and achieved a median duration of response of 9.3 months across all doses, supporting differentiation from other IKZF1/3 degraders.
Entered into a clinical trial collaboration and supply agreement with Pfizer for the combination of cemsidomide and elranatamab for the treatment of relapsed/refractory MM. Under the terms of the agreement, C4T will sponsor and conduct the Phase 1b trial while Pfizer will supply elranatamab (ELREXFIO), a B-cell maturation antigen CD3 targeted bispecific antibody (BCMAxCD3 bispecific), at no cost to C4T for the upcoming trial.
Continued to execute operational steps necessary for the initiation of the Phase 2 MOMENTUM trial of cemsidomide in combination with dexamethasone in the fourth line or later for the first quarter of 2026 and the Phase 1b trial of cemsidomide in combination with elranatamab in the second line or later for the second quarter of 2026.
Presented data analyzing population pharmacokinetic and exposure-response relationships for cemsidomide in MM and non-Hodgkin’s lymphoma (NHL) in a poster at the 2025 American Conference on Pharmacometrics (ACoP 2025). The analysis indicated an increased anti-myeloma effect at higher exposures and a clinically manageable exposure-safety relationship, supporting the risk-benefit analysis in heavily pre-treated MM patients.
Completed dose escalation for the Phase 1 trial of cemsidomide in NHL. Monotherapy cemsidomide demonstrated a well-tolerated profile, consistent with previous disclosures, and achieved compelling anti-lymphoma activity across all dose levels as assessed by investigators. In peripheral T-cell lymphoma (PTCL), 9 out of 22 patients achieved a partial response or better with a PET-CT-based assessment.
Partner Betta Pharmaceuticals continues to advance the CFT8919 Phase 1 dose escalation trial in Greater China.
Research and Discovery:

Highlighted leadership in designing targeted heterobivalent degraders, including CFT1946, that penetrate the blood brain barrier to achieve high central nervous system (CNS) exposures and compelling efficacy in CNS models in presentations delivered by C4T leadership at Fierce Biotech Week and the 8th Annual Targeted Protein Degradation Summit.
Earned a $2 million milestone payment from Biogen related to a patient dosing milestone for the Phase 1 trial of BIIB142, a degrader of IRAK4, which was designed by C4T.
Notified by Merck of their decision to conclude the research collaboration, which will end in late November 2025.
Financing:

Raised $125 million in gross proceeds through an underwritten offering that was led by RA Capital Management with participation from existing shareholders including OrbiMed, Soleus Capital, Lynx1 Capital Management, and Bain Capital Life Sciences. As part of the offering, there is the potential to earn up to $225 million in additional proceeds if the outstanding warrants are exercised.
KEY UPCOMING MILESTONES

Formally align with the U.S. Food & Drug Administration (FDA) on the recommended Phase 2 dose of cemsidomide for the registrational Phase 2 trial of cemsidomide in combination with dexamethasone by year-end 2025.
Initiate a Phase 2 single-arm registrational trial in the first quarter of 2026 to evaluate cemsidomide in combination with dexamethasone.
Initiate a Phase 1b trial in the second quarter of 2026 to evaluate the safety and tolerability of cemsidomide in combination with elranatamab.
UPCOMING INVESTOR EVENTS:

November 12, 2025, at 8:30 AM ET: Management will participate in a fireside chat at the Guggenheim Second Annual Healthcare Conference taking place in Boston, Massachusetts.
December 3, 2025, at 3:25 PM ET: Management will participate in a fireside chat at the 8th Evercore Healthcare Conference taking place in Coral Gables, Florida.
THIRD QUARTER 2025 FINANCIAL RESULTS

Revenue: Total revenue for the third quarter of 2025 was $11.2 million, compared to $15.4 million for the third quarter of 2024. The decrease in revenue was a result of an $8.0 million milestone from Biogen recognized in the third quarter 2024 offset by the recognition of all deferred revenue from our collaboration with Merck and the continued progress on our other collaboration programs during the third quarter of 2025.

Research and Development (R&D) Expense: R&D expense for the third quarter of 2025 was $26.0 million compared to $31.8 million for the third quarter of 2024. The decrease in R&D expense was primarily related to reduced clinical trial expense for CFT1946 as the Phase 1 trial neared completion.

General and Administrative (G&A) Expense: G&A expense for the third quarter of 2025 was $8.9 million compared to $11.8 million for the third quarter of 2024. The decrease was primarily related to lower stock-based compensation expense.

Net Loss and Net Loss per Share: Net loss for the third quarter of 2025 was $32.2 million, compared to $24.7 million for the third quarter of 2024. Net loss per share for the third quarter of 2025 was $0.44 compared to $0.35 for the third quarter of 2024.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of September 30, 2025 were $199.8 million, compared to $223.0 million as of June 30, 2025 and $267.3 million as of December 31, 2024. The decrease during the third quarter was primarily the result of cash used to fund operations and advance our programs, partially offset by $7.5 million of net proceeds from our at-the-market (ATM) equity program. Cash, cash equivalents and marketable securities as of September 30, 2025 does not include $125 million of gross proceeds raised through an equity offering in October 2025. The company expects that its current cash, cash equivalents and marketable securities will enable the company to fund its operating plan to the end of 2028.

About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm, multicenter study to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior lines of therapy will be enrolled in the trial.

About Cemsidomide
Cemsidomide is an investigational, orally bioavailable small-molecule degrader in clinical development for the treatment of relapsed/refractory multiple myeloma. Cemsidomide is a potent and selective degrader of IKZF1/3, transcription factors that drive multiple myeloma, with unique pharmacokinetic properties. Data from the Phase 1 trial of cemsidomide in combination with dexamethasone demonstrated a differentiated safety and tolerability profile and class-leading anti-myeloma activity with durable responses. Two clinical trials are planned to further evaluate cemsidomide in relapsed/refractory multiple myeloma: the registrational Phase 2 MOMENTUM trial to evaluate cemsidomide in combination with dexamethasone expected to initiate in the first quarter of 2026 and a Phase 1b trial to evaluate cemsidomide in combination with elranatamab expected to initiate the second quarter of 2026.

About CFT8919
CFT8919 is an orally bioavailable allosteric degrader that is designed to be potent and selective against EGFR bearing an oncogenic L858R mutation. In preclinical studies, CFT8919 is active in in vitro and in vivo models of L858R driven non-small cell lung cancer. Importantly, CFT8919 retains full activity against additional EGFR mutations that confer resistance against approved EGFR inhibitors including L858R-C797S, L858R-T790M and L858R-T790M-C797S. C4T and Betta Pharmaceuticals have established a strategic partnership to develop CFT8919 in Greater China, where the Phase 1 clinical trial is underway. C4T retains development and commercialization rights for CFT8919 in the United States, European Union and rest of the world.

(Press release, C4 Therapeutics, NOV 6, 2025, View Source [SID1234659556])

On November 6, 2025 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

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"We are looking forward to sharing a clinical update later this quarter from our silevertinib Phase 2 trial in newly diagnosed patients with EGFRm NSCLC," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "The update will include ORR and preliminary duration of treatment data, while PFS data is expected in the first half of 2026."

Recent Developments & Upcoming Milestones:

Silevertinib

Later this quarter, Black Diamond plans to disclose objective response rate (ORR) and preliminary duration of treatment data from all patients (n=43) in the Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) with non-classical epidermal growth factor receptor (EGFR) mutations.
Black Diamond continues to explore partnership opportunities in NSCLC and glioblastoma (GBM) to advance silevertinib into pivotal development.
The Company intends to solicit U.S. Food and Drug Administration (FDA) feedback on a potential registrational path in frontline EGFR mutant NSCLC in the first half of 2026, when progression free survival (PFS) data from the ongoing Phase 2 trial becomes available.
Financial Highlights

Cash Position: Black Diamond ended the third quarter of 2025 with approximately $135.5 million in cash, cash equivalents, and investments compared to $98.6 million as of December 31, 2024. Net cash used in operations was $7.9 million for the third quarter of 2025 compared to net cash used in operations of $11.3 million for the third quarter of 2024.
Research and Development Expenses: Research and development (R&D) expenses were $7.4 million for the third quarter of 2025, compared to $12.9 million for the same period in 2024. The decrease in R&D expenses was primarily due to workforce efficiencies and outlicensing of BDTX-4933 to increase focus on the development of silevertinib.
General and Administrative Expenses: General and administrative (G&A) expenses were $3.5 million for the third quarter of 2025, compared to $5.2 million for the same period in 2024. The decrease in G&A expenses was primarily due to the restructuring announced in October 2024.
Net Income/Loss: Net loss for the third quarter of 2025 was $8.5 million, as compared to a net loss of $15.6 million for the same period in 2024.
Financial Guidance

Black Diamond ended the third quarter of 2025 with approximately $135.5 million in cash, cash equivalents and investments, which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the fourth quarter of 2027.

(Press release, Black Diamond Therapeutics, NOV 6, 2025, View Source [SID1234659555])

On November 6, 2025 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported its participation in upcoming investor conferences. Presentation details with President and Chief Executive Officer, Mark Velleca, M.D., Ph.D., are as follows:

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Stifel Healthcare Conference fireside chat at 9:20am ET on Tuesday, November 11, 2025
Guggenheim 2nd Annual Healthcare Innovation Conference fireside chat at 9:00am ET on Wednesday, November 12, 2025
Piper Sandler 37th Annual Healthcare Conference fireside chat at 1:00pm ET on Thursday, December 4, 2025
Raymond James CEO Strategy Series at 10:00am ET on Friday, December 5, 2025. Investors who are interested in attending should reach out to their Raymond James representative
Webcasts will be available at the start of the presentations on the investor relations section of the Company’s website, www.blackdiamondtherapeutics.com. Replays of the presentations will also be available and archived on the site for 90 days.

(Press release, Black Diamond Therapeutics, NOV 6, 2025, View Source [SID1234659554])

On November 6, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the third quarter of 2025.

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"These strong financial results reinforce our position as a global oncology leader with exceptional topline growth and a strong balance sheet," said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. "BRUKINSA is now the global revenue leader in the BTKi class, supported by long-term efficacy and safety data and a growing body of evidence reinforcing its scientific hypothesis of sustained BTK inhibition. Our late-stage hematology portfolio continues to advance with sonrotoclax, a potentially best-in-class BCL2 inhibitor that has demonstrated impressive clinical results, and our BTK CDAC BGB-16673, further strengthening our leadership in B cell malignancies, including CLL. With one of the most promising oncology pipelines in the industry, we are poised to deliver multiple data and regulatory milestones that will drive long-term value."

(Amounts in thousands of U.S. dollars and unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 % Change 2025 2024 % Change
Net product revenues $ 1,395,013 $ 993,447 40 % $ 3,805,619 $ 2,661,511 43 %
Other revenue $ 17,271 $ 8,152 112 % $ 39,244 $ 20,906 88 %
Total revenue $ 1,412,284 $ 1,001,599 41 % $ 3,844,863 $ 2,682,417 43 %
GAAP income (loss) from operations $ 163,114 $ (120,265) 236 % $ 262,101 $ (488,774) 154 %
Adjusted income (loss) from operations* $ 341,184 $ 65,630 420 % $ 755,486 $ (33,247) 2372 %

GAAP net income (loss) $ 124,841 $ (121,350) 203 % $ 220,431 $ (492,905) 145 %
Adjusted net income (loss)* $ 303,663 $ 51,582 489 % $ 692,622 $ (71,020) 1075 %
GAAP basic EPS per ADS $ 1.13 $ (1.15) 198 % $ 2.03 $ (4.71) 143 %
Adjusted basic EPS per ADS* $ 2.76 $ 0.49 463 % $ 6.38 $ (0.68) 1038 %
GAAP diluted EPS per ADS $ 1.09 $ (1.15) 195 % $ 1.96 $ (4.71) 142 %
Adjusted diluted EPS per ADS* $ 2.65 $ 0.48 452 % $ 6.14 $ (0.68) 1003 %
Free Cash Flow* $ 354,469 $ 54,714 548 % $ 561,916 $ (615,974) 191 %

Third Quarter 2025 Financial Results
Revenue for the third quarter of 2025 was $1.4 billion, compared to $1.0 billion in the prior-year period driven primarily by growth in BRUKINSA product sales in the U.S. and Europe.
Product Revenue totaled $1.4 billion for the third quarter of 2025 compared to $993 million in the prior-year period. The increase in product revenue was primarily attributable to increased sales of BRUKINSA. The U.S. continued to be the Company’s largest market, with product revenue of $743 million compared to $504 million in the prior-year period. In-licensed products from Amgen and TEVIMBRA (tislelizumab) also contributed to product revenue growth.
•U.S. sales of BRUKINSA totaled $739 million in the third quarter of 2025, representing growth of 47% over the prior-year period driven primarily by robust demand growth across all indications and modest benefit due to net pricing. BRUKINSA continues to maintain its leading new patient share across the BTKi class due to its differentiated, best-in-class clinical profile. BRUKINSA sales in Europe totaled $163 million in the third quarter of 2025, representing growth of 68% compared to the prior-year period, driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.
•Sales of TEVIMBRA totaled $191 million in the third quarter of 2025, representing growth of 17% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the third quarter of 2025 was 85.9% compared to 82.8% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in our portfolio. Gross margin also benefited from production productivity improvements for both BRUKINSA and TEVIMBRA. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 86.3% for the third quarter of 2025, compared to 84.9% in the prior-year period.
Operating Expenses
The following table summarizes operating expenses for the third quarter of 2025:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q3 2025 Q3 2024 % Change Q3 2025 Q3 2024 % Change
Research and development $ 523,662 $ 496,179 6 % $ 445,904 $ 405,545 10 %
Selling, general and administrative $ 528,998 $ 455,223 16 % $ 434,484 $ 380,737 14 %
Total operating expenses $ 1,052,660 $ 951,402 11 % $ 880,388 $ 786,282 12 %

The following table summarizes operating expenses for the year-to-date period ended September 30, 2025 and 2024:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q3 YTD 2025 Q3 YTD 2024 % Change Q3 YTD 2025 Q3 YTD 2024 % Change
Research and development $ 1,530,445 $ 1,411,283 8 % $ 1,311,156 $ 1,193,494 10 %
Selling, general and administrative $ 1,526,199 $ 1,326,379 15 % $ 1,271,650 $ 1,116,805 14 %
Total operating expenses $ 3,056,644 $ 2,737,662 12 % $ 2,582,806 $ 2,310,299 12 %

Research and Development (R&D) Expenses increased for the third quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage, and offset by lower development upfront and milestone fees. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $0.2 million and $5 million in the third quarter of 2025 and 2024, respectively.
Selling, General and Administrative (SG&A) Expenses increased for the third quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment in global commercial expansion, primarily in the U.S. and Europe. SG&A expenses as a percentage of product sales were 38% for the third quarter of 2025, compared to 46% in the prior-year period.
Net Income/(Loss) and GAAP/Non-GAAP Earnings Per Share
GAAP net income for the third quarter of 2025 was $125 million, an increase of $246 million over the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.

For the third quarter of 2025, basic and diluted earnings per share was $0.09 and $0.08 per share and $1.13 and $1.09 per American Depositary Share (ADS), respectively, compared to basic loss of $0.09 per share and $1.15 per ADS in the prior-year period.
Free Cash Flow for the third quarter of 2025 was $354 million, an increase of $300 million over the prior-year period.
For further details on BeOne’s Third Quarter 2025 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the third quarter of 2025 filed with the U.S. Securities and Exchange Commission.
Full Year 2025 Guidance
BeOne has updated its full year 2025 revenue and expense guidance. Guidance is summarized below:
Prior FY 2025 Guidance1
Current FY 2025 Guidance1
Total Revenue $5.0 – $5.3B $5.1 – $5.3B
GAAP Operating Expenses
(R&D and SG&A) $4.1 – $4.4B $4.1 – $4.3B
GAAP Gross Margin % Mid to high -80% range Unchanged
GAAP Operating Income Positive FY 2025 Unchanged
Cash Flow Positive FY 2025 free
cash flow Unchanged

1 Does not assume any potential new, material business development activity or unusual/non-recurring items. Assumes September 30, 2025, foreign exchange rates.
BeOne’s total revenue guidance for full year 2025 of $5.1 billion to $5.3 billion includes expectations for strong revenue growth driven by BRUKINSA’s U.S. leadership position and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the mid- to high-80% range due to mix and production efficiencies as compared to 2024. BeOne’s guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage. Non-GAAP operating expenses, which exclude costs related to share-based compensation, depreciation and amortization expense, are expected to track with GAAP operating expenses, with reconciling items unchanged from existing practice. Operating expense guidance does not assume any potential new, material business development activity or unusual/non-recurring items.
Third Quarter Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•Approved in 75 markets globally with reimbursement in 57 markets.
•Received European Commission (EC) approval of a film-coated tablet formulation of for all approved indications; launched tablet formulation in the U.S.
TEVIMBRA (tislelizumab)
•Approved in 47 markets globally with reimbursement in 16 markets.
•Received EC approval in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by TEVIMBRA monotherapy as adjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
•Achieved first subject enrolled in Phase 3 trial for subcutaneous formulation for the treatment of first-line gastric cancer (GC).
•Achieved submission in Japan for the treatment of first-line GC.

Select Clinical-Stage Programs
Hematology
•Sonrotoclax (BCL2 inhibitor):
◦Received FDA Breakthrough Therapy Designation as a treatment for adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
◦Completed enrollment of Phase 2 trial for the treatment of adult patients with R/R Waldenstrom’s macroglobulinemia (WM), which is potentially registration enabling.
•BGB-16673 (BTK CDAC):
◦Achieved first subject enrolled in global Phase 3 head-to-head study versus noncovalent BTK inhibitor pirtobrutinib for the treatment of adult patients with R/R CLL.

Breast/Gynecologic Cancers
•BC-C9074 (B7-H4 ADC): Achieved proof-of-concept.
Lung Cancer
•BG-58067 (MTA-cooperative PRMT5 inhibitor): Achieved proof-of-concept.
•Tarlatamab (AMG 757): Achieved first subject enrolled in global Phase 3 trial for the treatment of first-line extensive-stage small cell lung cancer.
GI Cancers
•BGB-B2033 (GPC3x41BB bispecific antibody): Achieved proof-of-concept.

Inflammation & Immunology
•BGB-45035 (IRAK4 CDAC):
◦Achieved proof-of-concept for target tissue degradation in healthy volunteers.

◦Achieved first subject enrolled in Phase 2 trial for the treatment of moderate to severe rheumatoid arthritis.

•BGB-16673:Achieved first subject enrolled in Phase 1b trial for the treatment of chronic spontaneous urticaria.

Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•Orphan Drug Designation and regulatory submission in Japan for the treatment of marginal zone lymphoma.
1H 2026
TEVIMBRA
•Anticipate Japan approval for the treatment of first-line gastric cancer.
2H 2026
Hematology
•Sonrotoclax (BCL2 inhibitor):
◦Initiate enrollment of Phase 3 trial in combination with BRUKINSA versus acalabrutinib+venetoclax (AV).
1H 2026
◦Initiate enrollment in Phase 3 trial for the treatment of multiple myeloma.
2H 2026
•BGB-16673 (BTK CDAC):
◦Data readout for potential accelerated approval submission for the treatment of R/R CLL.
1H 2026
Breast/Gynecologic Cancers
•BGB-43395 (CDK4 inhibitor):
◦Initiate Phase 3 trial for the treatment of first-line HR-positive, HER2-negative metastatic breast cancer.
1H 2026
GI Cancers
•Zanidatamab (HER2-targeting bispecific antibody) for the treatment of first-line HER2-positive gastroesophageal adenocarcinoma:
◦Readout of primary progression-free survival data from Phase 3 trial (Herizon GEA-301) in collaboration with Zymeworks/Jazz.
2H 2025
Inflammation and Immunology
•BGB-45035 (IRAK4 CDAC):
◦Initiate Phase 2 trial for the treatment of atopic dermatitis.
1H 2026

Other Highlights
•Entered into an agreement with Royalty Pharma to sell royalty rights on the worldwide sales, excluding China, of Amgen’s IMDELLTRA (tarlatamab-dlle) for up to $950 million.
•Announced Pharmacyclics’ decision not to appeal a U.S. Patent and Trademark Office Final Written Decision invalidating all claims of Pharmacyclics’ U.S. Patent No. 11,672,803 related to BRUKINSA, which fully resolved the patent infringement lawsuit brought by Pharmacyclics.
Conference Call and Webcast
The Company’s earnings conference call for the third quarter 2025 will be broadcast via webcast at 8:00 a.m. ET on Thursday, November 6, 2025, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation and a replay of the webcast will also be available.

(Press release, BeOne Medicines, NOV 6, 2025, View Source [SID1234659553])