Black Diamond Therapeutics to Participate in Upcoming Investor Conferences

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:

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!

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])

Galapagos Reports Nine Months 2025 Financial Results and Provides Business Update

On November 6, 2025 Galapagos NV (Euronext & Nasdaq: GLPG) reported its financial results for the first nine months of 2025, and provided a third quarter and recent 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!

"We successfully delivered on our commitment to define a clear path forward for Galapagos following the completion of the strategic review of our cell therapy business," said Henry Gosebruch, CEO of Galapagos. "We have built a team with world-class strategy and business development capabilities as we focus on disciplined capital stewardship and transformative business development, supporting a stronger and sustainable future for Galapagos."

Gosebruch added, "Looking ahead, we will seek to strategically deploy our capital in a disciplined manner by pursuing value-accretive transactions. Our business development team is actively evaluating a broader array of opportunities with priority given to promising small molecule and biologics programs with proof-of-concept in immunology and oncology and potential to deliver meaningful patient impact. We believe our partnership with Gilead can be a strategic advantage as we pursue these opportunities. We expect to focus on transactions that can deliver meaningful value to patients and shareholders while ensuring effective risk diversification."

"We ended the third quarter with a strong balance sheet that provides us with the flexibility to allocate capital strategically and invest in future business development opportunities," said Aaron Cox, CFO of Galapagos. "We expect to end the year with approximately €2.975 billion to €3.025 billion in cash and financial investments, excluding any business development activities and currency fluctuations. If the intention to wind down the cell therapy business is implemented and the process is completed, we would expect to be cash flow neutral to positive by the end of 2026, excluding any business development activities and currency fluctuations."

Third quarter 2025 and recent business update

Outcome of the Strategic Alternatives Process for Galapagos’ Cell Therapy Business

On October 21, 2025, Galapagos announced its intention to wind down its cell therapy business as part of the Company’s ongoing transformation. This intention is subject to the conclusion of consultations with works councils in Belgium and the Netherlands, during which Galapagos will continue to operate the business. Galapagos would consider any viable proposal to acquire all, or part of the cell therapy business, if such a proposal were to emerge during the wind down process.
If ultimately implemented, the wind down would impact approximately 365 employees across Europe, the U.S., and China, and would include the closure of sites in Leiden (the Netherlands), Basel (Switzerland), Princeton and Pittsburgh (U.S.), and Shanghai (China).
The remaining Galapagos organization is expected to be a lean organization of approximately 35-40 employees by the end of 2026, repositioned for long-term growth through transformational business development, while maintaining a dedicated presence at its headquarters in Mechelen, Belgium and its hub in Chicago, IL (U.S.).
Corporate

Senior leadership has been further strengthened with the appointment of Fred Blakeslee as Executive Vice President and General Counsel on October 16, and Sooin Kwon as Chief Business Officer and Dan Grossman as Chief Strategy Officer, effective August 4. These appointments have added strong corporate, business development and strategic assessment capabilities to the leadership team.
As part of the Company’s ongoing commitment to long-term governance and strategic continuity, several changes to the Board of Directors were announced:
Dawn Svoronos and Jane Griffiths were appointed by way of co-optation as Non-Executive Independent Directors, replacing Peter Guenter and Simon Sturge, effective July 28.
Dr. Neil Johnston has been appointed to the Board of Directors by way of co-optation as Non-Executive Independent Director, effective November 1. In addition, Devang Bhuva, current Senior Vice President of Corporate Development and Alliance Management at Gilead, has been appointed by way of co-optation as Non-Executive Non-Independent Director, effective November 1. In connection with these co-optations, Non-Executive Independent Directors Dr. Elisabeth Svanberg and Dr. Susanne Schaffert, and Non-Executive Non-Independent Director and current CFO of Gilead, Andrew Dickinson, stepped down, effective November 1. An additional Non-Executive Independent Director is expected to be appointed in the near future as part of the Board’s commitment to maintain a balanced, diversified Board composition with appropriate capabilities and profiles.
Clinical Pipeline
GLPG5101, a CD19 CAR-T candidate in Phase 1/2 across eight hematological malignancies

Two abstracts have been accepted for an oral and poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held in Orlando, from December 6-9.
In August, the FDA granted RMAT designation to GLPG5101 for the treatment of relapsed/refractory mantle cell lymphoma.
GLPG3667, a small molecule TYK2 inhibitor in two Phase 3-enabling studies in systemic lupus erythematosus (SLE) and dermatomyositis (DM)

Both the SLE and DM studies have progressed well, and topline data from both studies are expected in early 2026.
On October 26, Galapagos presented in vitro pharmacology data at the American College of Rheumatology (ACR) Convergence 2025, suggesting differentiation of GLPG3667 from other TYK2 inhibitors at their clinical dose regimens.
Financial performance

Key figures for the first nine months of 2025 (consolidated)
(€ millions, except basic & diluted earnings/loss (-) per share)

September 30, 2025 September 30, 2024 % Change
Supply revenues 29.3 19.1 +53%
Collaboration revenues 182.1 181.0 +1%
Total net revenues 211.4 200.1 +6%
Cost of sales (29.3) (19.1) +53%
R&D expenses (351.9) (238.2) +48%
G&Aiand S&Miiexpenses (109.0) (93.2) +17%
Impairment of the cell therapy business (204.8) -
Other operating result 21.4 24.8 -14%
Operatingloss (462.2) (125.6) +368%
Fair value adjustments and net exchange differences (50.5) 31.8
Net other financial result 30.4 71.7
Income taxes 19.3 1.7
Net loss from continuing operations (463.0) (20.4)
Net profit from discontinued operations, net of tax 1.7 69.2
Net profit/loss (-) of the period (461.3) 48.8
Basic and diluted earnings/loss (-) per share (€) (7.0) 0.7
Financial investments, cash & cash equivalents 3,050.1 3,338.8
Details of the financial results for the first nine months of 2025
Total operating loss from continuing operations for the first nine months of 2025, amounted to €462.2 million, compared to an operating loss of €125.6 million for the first nine months of 2024. This operating loss was negatively impacted by an impairment on the cell therapy business of €204.8 million as a result of the Company’s previously announced strategic alternatives process for the cell therapy business, and the executed strategic reorganization announced in January 2025, for €135.5 million. The latter is reflected in severance costs of €47.5 million, costs for early termination of collaborations of €45.5 million, impairment on fixed assets related to small molecules activities of €9.5 million, deal costs of €21.4 million, €9.8 million accelerated non-cash cost recognition for subscription right plans related to good leavers and €1.8 million other operating expenses.

Total net revenues amounted to €211.4 million for the first nine months of 2025, compared to €200.1 million for the first nine months of 2024. The revenue recognition related to the exclusive access rights granted to Gilead for Galapagos’ drug discovery platform amounted to €172.6 million for the first nine months, for both 2025 and 2024. The deferred income balance at September 30, 2025, includes €896.4 million allocated to the Company’s drug discovery platform. Royalties on Jyseleca from Gilead amounted to €8.3 million for the first nine months of 2025 (€8.4 million for the same period last year).
Cost of sales amounted to €29.3 million for the first nine months of 2025, compared to €19.1 million for the first nine months of 2024, and related to the supply of Jyseleca to Alfasigma under the transition agreement. The related revenues are reported in total net revenues.
R&D expenses amounted to €351.9 million for the first nine months of 2025, compared to €238.2 million for the first nine months of 2024. Increased personnel expenses (mainly related to severance costs), impairment on fixed assets (related to small molecules programs) and costs for early termination of collaboration agreements lead to this increase in R&D expenses.
S&M and G&A expenses amounted to €109.0 million for the first nine months of 2025, compared to €93.2 million for the first nine months of 2024. This increase was mainly due to higher personnel costs (primarily severance costs) and higher legal and professional fees (deal costs).
Impairment of cell therapy business is a result of the Company’s previously announced strategic alternatives process for the cell therapy business whereby the Company assessed the cell therapy business associated assets’ recoverable amount in accordance with IAS 36. The recoverable amount was estimated lower than the assets’ carrying value. As a result, the Company recognized an impairment loss of €204.8 million, thereby aligning the cell therapy assets’ book value with the Company’s strategic intention to wind down the cell therapy business, which resulted in a full impairment of both the associated goodwill and intangible assets and a partial impairment of property, plant and equipment.
Other operating result amounted to €21.4 million for the first nine months of 2025, compared to €24.8 million for the first nine months of 2024, mainly driven by lower grant and R&D incentives income and no recharges to Alfasigma.
Net financial loss amounted to €20.1 million for the first nine months of 2025, compared to net financial income of €103.5 million for the first nine months of 2024.

Fair value adjustments and net currency exchange results amounted to a negative amount of €50.5 million for the first nine months of 2025, compared to positive fair value adjustments and net currency exchange gains of €31.8 million for the first nine months of 2024, and were primarily attributable to €29.1 million of negative changes in fair value of financial investments, €44.0 million of unrealized currency exchange losses on our cash and cash equivalents and financial investments at amortized cost in U.S. dollars, partly offset by a positive effect of €22.7 million as consequence of the settlement of a hedging instrument.
Net other financial income amounted to €30.4 million for the first nine months of 2025, compared to net other financial income of €71.7 million for the first nine months of 2024. Interest income amounted to €31.4 million for the first nine months of 2025, compared to €70.6 million of interest income for the first nine months of 2024, due to a decrease in the interest rates and a shift from investments in term deposits generating financial income to investments in money market funds generating fair value changes. Fair value gains and interest income derived from cash, cash equivalents and financial investments excluding any currency exchange results amounted to €77.2 million for the first nine months of 2025 (compared to €108.9 million for the same period last year).
Income taxes amounted to €19.3 million for the first nine months of 2025. The increase is mainly explained by the reversal of the deferred tax liabilities linked to capitalized intangible assets related to the cell therapy business, as the Company recorded an impairment on these intangible assets.

The Company reported a net loss from continuing operations of €463.0 million for the first nine months of 2025, compared to a net loss from its continuing operations of €20.4 million for the first nine months of 2024.

Net profit from discontinued operations related to Jyseleca amounted to €1.7 million for the first nine months of 2025, compared to net profit amounting to €69.2 million for the first nine months of 2024. The net result for discontinued operations included €10.4 million of R&D expenses primarily related to the final settlement of disputed expenses with Alfasigma, and €11.4 million of other operating income related to a fair value adjustment of the contingent consideration receivable from Alfasigma as a consequence of an adjusted sales forecast. The operating profit from discontinued operations for the first nine months of 2024, was mainly related to the gain on the sale of the Jyseleca business to Alfasigma of €52.3 million.

Galapagos reported a net loss of €461.3 million for the first nine months of 2025, compared to a net profit of €48.8 million for the first nine months of 2024.

Cash position

Financial investments and cash and cash equivalents totaled €3,050.1 million on September 30, 2025, as compared to €3,317.8 million on December 31, 2024. The cash and cash equivalents and financial investments included $2,161.1 million held in U.S. dollars ($726.9 million on December 31, 2024) which could generate foreign exchange gains or losses in the financial results in accordance with the fluctuation of the EUR/U.S. dollar exchange rate as the Company’s functional currency is EUR (translated at a rate of 1.1741 €/$ at September 30, 2025).

Total net decrease in cash and cash equivalents and financial investments amounted to €267.7 million during the first nine months of 2025, compared to a net decrease of €345.7 million during the first nine months of 2024. This net decrease was composed of (i) €145.1 million of operational cash burn, which includes cash in of €77.7 million related to the return on financial investments) (ii) €118.6 million of negative exchange rate differences, positive changes in fair value of current financial investments, variation in accrued interest income, (iii) €20.0 million convertible loan issued to a third party, and (iv) €16.0 million of net cash is related to the sale of subsidiaries.

Financial guidance

Galapagos anticipates ending 2025 with approximately €2.975 billion to €3.025 billion in cash, cash equivalents and financial investments, excluding any business development activities and currency fluctuations. In the event that the Board would effectively proceed with a full wind down decision of the cell therapy business (i.e., if the intention is confirmed after works council processes), the Company would expect to incur the following spend related to the cell therapy business: €100 million to €125 million of operating cash impact from Q4 2025 through 2026 and €150 million to €200 million of one-time restructuring cash impact in 2026. If the intention to wind down is implemented and the process is completed, the Company would expect to be cash flow neutral to positive by the end of 2026, excluding any business development activities and currency fluctuations.

Conference call for investors and analysts

Galapagos will host a conference call on November 6, 2025, at 14:00 CET / 08:00 AM ET, during which the company will also share further details on its business development strategy. To participate, please register using this link. Dial-in details will be provided upon registration. Participants can join the call 10 minutes before the start time using the access information received by email or via the "call me" feature. The live call and presentation will be available on glpg.com or via the following link. A replay and related materials will be available shortly after the call in the investors section of the website.

(Press release, Galapagos, NOV 6, 2025, View Source [SID1234659570])

Puma Biotechnology Reports Third Quarter 2025 Financial Results

On November 6, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the third quarter ended September 30, 2025. Unless otherwise stated, all comparisons are for the third quarter of 2025 compared to the third quarter of 2024.

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!

Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Product revenue, net in the third quarter of 2025 was $51.9 million, compared to $56.1 million in the third quarter of 2024. Product revenue, net in the first nine months of 2025 was $144.2 million, compared to $140.8 million in the first nine months of 2024.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $8.8 million, or $0.18 per basic share and $0.17 per diluted share, for the third quarter of 2025, compared to net income of $20.3 million, or $0.41 per basic and diluted share, for the third quarter of 2024. Net income for the first nine months of 2025 was $17.7 million, or $0.35 per basic and diluted share, compared to net income of $11.0 million, or $0.23 per basic share and $0.22 per diluted share, for the first nine months of 2024.

Non-GAAP adjusted net income was $10.5 million, or $0.21 per basic and diluted share, for the third quarter of 2025, compared to non-GAAP adjusted net income of $22.4 million, or $0.46 per basic share and $0.45 per diluted share, for the third quarter of 2024. Non-GAAP adjusted net income for the first nine months of 2025 was $23.0 million, or $0.46 per basic and diluted share, compared to non-GAAP adjusted net income of $17.5 million, or $0.36 per basic and diluted share, for the first nine months of 2024. Non-GAAP adjusted net income excludes stock-based compensation expenses. For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the third quarter of 2025 was $9.7 million, compared to $11.0 million in the third quarter of 2024. Net cash provided by operating activities for the first nine months of 2025 was $27.4 million, compared to net cash provided by operating activities of $23.3 million in the first nine months of 2024. At September 30, 2025, Puma had cash, cash equivalents and marketable securities of $94.4 million, compared to cash, cash equivalents and marketable securities of $101.0 million at December 31, 2024.

"We are very happy to report the continuation of our positive earnings trend, which is driven by increased demand for NERLYNX," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "According to our current projections, 2025 will mark the first year-over-year demand increase for NERLYNX in the United States since 2018 and we are very pleased with our commercial execution, which contributed to this. We are also pleased with our continued clinical progress in the advancement of alisertib for patients facing chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer in ALISCATM-Breast1 and for patients with extensive-stage small cell lung cancer in ALISCATM-Lung1, where there continues to be a need for new treatment."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (H1 2026) and (ii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H1 2026)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the third quarter of 2025, total revenue was $54.5 million, of which $51.9 million was product revenue, net and $2.6 million was royalty revenue. This compares to total revenue of $80.5 million for the third quarter of 2024, of which $56.1 million was product revenue, net and $24.4 million was royalty revenue. This decrease in product revenue, net, compared to the three months ended September 30, 2024, was attributable to a decrease in product supply revenue to our international licensees (reduction in China sales), and higher Gross to Net reduction, partially offset by an increase in U.S. sales resulting from an 8% increase in bottles of NERLYNX sold in the U.S. market and an increase in net selling price. For the first nine months of 2025, total revenue was $152.9 million, of which $144.2 million was product revenue, net and $8.7 million was royalty revenue. This compares to total revenue of $171.4 million for the first nine months of 2024, of which $140.8 million was product revenue, net and $30.6 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $44.9 million for the third quarter of 2025, compared to $58.4 million for the third quarter of 2024. Operating costs and expenses in the first nine months of 2025 were $132.7 million, compared to $153.8 million in the first nine months of 2024.

Cost of Sales

Cost of sales was $12.2 million for the third quarter of 2025, compared to $29.1 million for the third quarter of 2024. Cost of sales was $35.0 million for the first nine months of 2025, compared to $50.5 million for the first nine months of 2024. The year-to-date decrease was primarily due to timing of sales made into China by our sub-licensee and the related cost of products shipped and royalty expense.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $16.8 million for the third quarter of 2025, unchanged from the third quarter of 2024. SG&A expenses for the first nine months of 2025 were $52.5 million, compared to $63.5 million for the first nine months of 2024. The $11.0 million year-over-year decrease in SG&A expenses resulted primarily from legal fees associated with the AstraZeneca litigation in 2024.

Research and Development Expenses

Research and development (R&D) expenses were $15.9 million for the third quarter of 2025, compared to $12.5 million for the third quarter of 2024. R&D expenses for the first nine months of 2025 were $45.2 million, compared to $39.8 million for the first nine months of 2024. The $5.4 million year-over-year increase in R&D expenses resulted primarily from increased alisertib study activity.

(Press release, Puma Biotechnology, NOV 6, 2025, View Source [SID1234659586])

Servier’s New and Updated Data at 2025 ASH Annual Meeting Highlight Commitment to Hematology Research

On November 6, 2025 Servier reported that it will present new and updated data at the 67th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), December 6-9, 2025, in Orlando, Florida. Presentations will highlight clinical and real-world data from Servier’s hematology portfolio and underscore Servier’s leadership in isocitrate dehydrogenase (IDH) mutant acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

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!

Notably, Servier will present an updated response and safety analysis from a Phase 1 study of TIBSOVO (ivosidenib) combined with intensive chemotherapy in newly diagnosed IDH1-mutated AML in an oral presentation on Monday, December 8 at 4:45 p.m. The data demonstrate the addition of TIBSOVO to intensive induction and consolidation chemotherapy followed by single-agent TIBSOVO maintenance produces long-term responses with an acceptable safety profile. The benefit of this frontline regimen is being assessed in a Phase 3 randomized, blinded trial.

"Servier’s presentations at this year’s ASH (Free ASH Whitepaper) Annual Meeting reflect our ongoing commitment to maximizing the potential of the medicines in our portfolio, leaving no stone unturned as we endeavor to deliver innovative treatment options to as many eligible patients as possible, said Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. "We’re expanding our existing understanding of the clinical benefits of TIBSOVO to uncover its full potential in AML and MDS, while simultaneously advancing the research and development of investigational treatment options in our growing hematology pipeline."

(Press release, Servier, NOV 6, 2025, https://www.prnewswire.com/news-releases/serviers-new-and-updated-data-at-2025-ash-annual-meeting-highlight-commitment-to-hematology-research-302606336.html [SID1234659614])

Black Diamond Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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.

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 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])