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Black Diamond Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

(Positive)
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Black Diamond Therapeutics (Nasdaq: BDTX) reported Q1 2026 results and a corporate update. The company reported $118.3M in cash, cash equivalents, and investments as of March 31, 2026, and expects this to fund operations into the 2H 2028. Clinical progress includes an oral ASCO presentation of Phase 2 silevertinib data (preliminary DOR and PFS) and dosing of the first patient in a randomized Phase 2 EGFRvIII+ GBM trial.

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Positive

  • Cash position of $118.3M projected to fund operations into 2H 2028
  • First patient dosed in randomized Phase 2 trial for EGFRvIII+ GBM
  • Oral ASCO presentation of Phase 2 silevertinib data including preliminary DOR and PFS
  • Outlicensed BDTX-4933 to sharpen focus on silevertinib development

Negative

  • Net loss of $9.0M for Q1 2026 versus net income of $56.5M in Q1 2025
  • Net cash used in operations of $10.2M in Q1 2026 versus net cash provided of $53.4M in Q1 2025

News Market Reaction – BDTX

-3.55%
48 alerts
-3.55% Session close to close
+16.4% Peak Tracked
-9.7% Trough Tracked
$179.35M Market Cap
1.3x Rel. Volume

In the May 7 session, BDTX declined 3.55%, reflecting a moderate negative market reaction. Argus tracked a peak move of +16.4% during that session. Argus tracked a trough of -9.7% from its starting point during tracking. Our momentum scanner triggered 48 alerts that day, indicating elevated trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement combines Q1 2026 financials with clinical execution milestones. Black Diamond repo...
Analysis

This announcement combines Q1 2026 financials with clinical execution milestones. Black Diamond reported $118.3M in cash, cash equivalents and investments, guiding runway into 2H 2028, alongside lower R&D ($7.0M) and G&A ($4.3M) expenses. Clinically, the first patient in the randomized Phase 2 EGFRvIII+ GBM trial has been dosed and multiple ASCO presentations are planned. Investors may watch upcoming silevertinib Phase 2 DOR and PFS data, cash burn trends, and any use of the $500M shelf registration.

Key Figures

Cash & investments: $118.3M Prior cash balance: $128.7M Net cash from ops: -$10.2M +5 more
8 metrics
Cash & investments $118.3M As of March 31, 2026; expected runway into 2H 2028
Prior cash balance $128.7M Cash, equivalents and investments as of December 31, 2025
Net cash from ops -$10.2M Net cash used in operations, Q1 2026 (vs +$53.4M in Q1 2025)
R&D expenses $7.0M Q1 2026 (vs $10.5M in Q1 2025)
G&A expenses $4.3M Q1 2026 (vs $5.0M in Q1 2025)
Net loss $9.0M Q1 2026 (vs net income of $56.5M in Q1 2025)
Cash runway Into 2H 2028 Company guidance based on $118.3M cash and investments
Phase 2 GBM start First patient dosed Randomized Phase 2 silevertinib + TMZ in newly diagnosed EGFRvIII+ GBM

Previous Earnings Reports

5 past events · Latest: Mar 16 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Mar 16 Q4/FY 2025 earnings Positive +1.8% Reported FY 2025 net income with strong cash and positive Phase 2 data.
Nov 6 Q3 2025 earnings Positive +2.8% Detailed solid cash runway and upcoming silevertinib Phase 2 data readouts.
Aug 7 Q2 2025 earnings Positive -15.2% Improved cash, narrower net loss, and pipeline progress despite sharp share decline.
May 12 Q1 2025 earnings Positive +10.3% Servier deal with $70M upfront drove net income and extended cash runway.
Mar 6 Q4/FY 2024 earnings Neutral -1.1% Reported improved yet still negative full-year results with Phase 2 plans progressing.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings releases have generally been received positively, with 4 of the last 5 tagged earnings events seeing price moves aligned with broadly positive or neutral fundamentals, and only one notable divergence where positive updates coincided with a sharp decline.

Recent Company History

Over the last year, Black Diamond’s earnings updates have highlighted a strengthening cash position and a shift toward pivotal development of silevertinib. Prior quarters showed cash balances between $98.6M and $152.4M, runway generally extending into late 2027 or 2H 2028, and improving net loss metrics. The Servier deal delivered a $70M upfront payment and turned 2025 into a profitable year. Today’s Q1 2026 release continues the theme of cost discipline and runway into 2H 2028 while advancing Phase 2 programs.

Key Terms

egfrm, nsclc, dor, pfs, +3 more
7 terms
egfrm medical
"Phase 2 data in frontline EGFRm NSCLC patients, including preliminary DOR and PFS..."
A change in the EGFR gene (often written EGFRm) is a specific mutation that can make cells grow abnormally, commonly found in certain cancers. Think of it like a stuck accelerator in a car: it drives cell growth in a way that some drugs can specifically target. Investors watch EGFR mutations because their presence determines market size for targeted therapies, companion diagnostics and potential regulatory approvals that directly affect drug and biotech company revenue.
nsclc medical
"Phase 2 data in frontline EGFRm NSCLC patients, including preliminary DOR and PFS..."
NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.
dor medical
"frontline EGFRm NSCLC patients, including preliminary DOR and PFS data..."
DOR, short for “date of record,” is the cutoff day a company uses to decide which shareholders are eligible for a dividend, stock split, or the right to vote at a meeting. It matters to investors because ownership on that specific day—like being on a guest list when names are checked—determines whether you receive the payment or voting power, so buying or selling around the DOR affects your entitlements.
pfs medical
"frontline EGFRm NSCLC patients, including preliminary DOR and PFS data..."
Progression-free survival (PFS) is a clinical-trial measure that records how long, on average, patients live without their disease getting worse after starting a treatment. For investors, PFS acts like a stopwatch of a drug’s effectiveness: longer PFS can signal meaningful patient benefit, improve chances of regulatory approval or label strength, and raise a drug’s commercial value, while shorter or unchanged PFS can weigh on a company’s prospects.
egfrviii+ gbm medical
"Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII+ GBM..."
A tumor type defined by glioblastoma (an aggressive brain cancer) that carries the EGFRvIII mutation, a specific change in the EGFR gene that makes cells grow abnormally. Investors care because this mutation creates a distinct patient subgroup with different treatment needs and measurable diagnostic tests, making it a target for drugs and diagnostics; like finding a unique lock that only some keys (therapies) will fit, treatments aimed at EGFRvIII can drive focused clinical development and potential market value.
temozolomide medical
"silevertinib in combination with temozolomide (TMZ) in the safety lead-in portion..."
An oral chemotherapy drug that works by damaging the DNA of cancer cells so they can no longer grow and divide, most commonly used to treat certain brain tumors. For investors, temozolomide matters because clinical trial results, approvals, patent status, manufacturing supply and safety data can reshape a company’s drug revenue prospects and valuation—think of it as a key product in a biotech’s toolbox whose success or failure directly affects the business outlook.
phase 2 medical
"Oral presentation of silevertinib Phase 2 data in frontline EGFRm NSCLC patients..."
Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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  • Oral presentation of silevertinib Phase 2 data in frontline EGFRm NSCLC patients, including preliminary DOR and PFS data, to take place at the 2026 ASCO Annual Meeting
  • First patient dosed in the Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII+ GBM
  • Cash, cash equivalents, and investments of $118.3 million as of March 31, 2026, expected to be sufficient to fund operations into 2H of 2028

CAMBRIDGE, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

“We remain focused on advancing silevertinib into pivotal development and are looking forward to the 2026 ASCO Annual Meeting later this month where an oral presentation of Phase 2 data will highlight silevertinib’s potential to benefit frontline EGFRm NSCLC patients,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “Our randomized Phase 2 trial in newly diagnosed EGFRvIII+ GBM also initiated this month with the dosing of our first patient.”

Recent Developments & Upcoming Milestones:

  • In April 2026, Black Diamond announced the following presentations at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago:
    • May 30, 2026, 1:15 PM-2:45 PM CDT: Oral presentation on updated clinical data from the Phase 2 trial in patients with non-classical EGFRm NSCLC in the frontline setting, including preliminary duration of response (DOR) and progression-free survival (PFS) data (Abstract: 8519).
    • May 31, 2026, 9:00 AM-12:00 PM CDT: Poster presentation on the Phase 2 data of silevertinib in recurrent EGFRm NSCLC patients (Abstract: 8620).
    • June 1, 2026, 1:30 PM-4:30 PM CDT: Trial-in-progress poster on the randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (Abstract: TPS2098).
  • In May 2026, the first patient was dosed with silevertinib in combination with temozolomide (TMZ) in the safety lead-in portion of the randomized Phase 2 trial in patients with newly diagnosed EGFRvIII+ GBM (NCT07326566).

Financial Highlights

  • Cash Position: Black Diamond ended the first quarter of 2026 with approximately $118.3 million in cash, cash equivalents, and investments compared to $128.7 million as of December 31, 2025. Net cash used in operations was $10.2 million for the first quarter of 2026 compared to net cash provided by operations of $53.4 million for the first quarter of 2025.
  • Research and Development Expenses: Research and development (R&D) expenses were $7.0 million for the first quarter of 2026, compared to $10.5 million for the same period in 2025. The decrease in R&D expenses was primarily due to the progression of our Phase 2 clinical trial for silevertinib in NSCLC and outlicensing of BDTX-4933 to increase focus on the development of silevertinib.
  • General and Administrative Expenses: General and administrative (G&A) expenses were $4.3 million for the first quarter of 2026, compared to $5.0 million for the same period in 2025. The decrease in G&A expenses was primarily due to the realization of continued operational efficiencies.
  • Net Loss: Net loss for the first quarter of 2026 was $9.0 million, as compared to net income of $56.5 million for the same period in 2025.

Financial Guidance

  • Black Diamond ended the first quarter of 2026 with approximately $118.3 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 second half of 2028.

About Black Diamond Therapeutics

Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company’s MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain penetrant to treat central nervous system disease. The Company is advancing silevertinib, a brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR-mutant NSCLC and GBM. For more information, please visit www.blackdiamondtherapeutics.com.

From time to time, we may use our website or our LinkedIn profile at www.linkedin.com/company/black-diamond-therapeutics to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.blackdiamondtherapeutics.com. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our LinkedIn page is not incorporated into, and does not form a part of, this press release.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the continued development and advancement of silevertinib, including the ongoing Phase 2 clinical trials and the timing of clinical updates for silevertinib in patients with EGFRm NSCLC and in patients with newly diagnosed EGFRvIII+ GBM, the potential of silevertinib to address the unmet medical need for newly diagnosed GBM patients and for newly diagnosed NSCLC patients with non-classical EGFR mutations and benefit patients with NSCLC across multiple lines of therapy, the potential future development plans for silevertinib in NSCLC and GBM, and the Company’s expected cash runway. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the United States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Black Diamond Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data (Unaudited)
(in thousands)

 March 31,
2026
 December 31,
2025
 (in thousands)
Cash, cash equivalents, and investments$118,258  $128,652 
Total assets$132,922  $143,010 
Accumulated deficit$(473,776) $(464,740)
Total stockholders’ equity$104,300  $112,211 


Black Diamond Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited)
(in thousands, except per share data)

 Three Months Ended
March 31,
  2026   2025
License revenue$  $70,000
Operating expenses:   
Research and development$7,003  $10,506
General and administrative 4,256   4,964
Total operating expenses 11,259   15,470
Income (loss) from operations (11,259)  54,530
Other income (expense):   
Interest income 1,023   595
Other income (expense) 1,200   1,417
Total other income (expense), net 2,223   2,012
Net income (loss)$(9,036) $56,542
    
Net income (loss) per share - basic$(0.16) $1.00
Net income (loss) per share - diluted$(0.16) $0.98
    
Weighted average common shares outstanding - basic 57,233,413   56,663,798
Weighted average common shares outstanding - diluted 57,233,413   57,673,099


Contact

For Investors:
investors@bdtx.com

For Media:
media@bdtx.com


FAQ

What did Black Diamond Therapeutics (BDTX) report for cash on March 31, 2026?

The company reported $118.3 million in cash, cash equivalents, and investments. According to the company, this balance is expected to fund anticipated operating expenses and capital requirements into the second half of 2028.

When will BDTX present silevertinib Phase 2 data at ASCO 2026 and what will be shown?

An oral presentation is scheduled for May 30, 2026 and will include preliminary DOR and PFS data. According to the company, the session covers updated frontline non-classical EGFRm NSCLC Phase 2 results.

Has Black Diamond dosed patients in its EGFRvIII+ GBM trial (BDTX) and what was the first step?

Yes, the first patient was dosed in the safety lead-in of the randomized Phase 2 EGFRvIII+ GBM trial. According to the company, dosing combined silevertinib with temozolomide under NCT07326566.

What were Black Diamond's R&D and G&A expenses for Q1 2026 (BDTX)?

R&D expenses were $7.0M and G&A expenses were $4.3M for Q1 2026. According to the company, decreases reflect Phase 2 progression and operational efficiencies compared with Q1 2025.

How did Black Diamond's cash flow from operations change in Q1 2026 for BDTX?

Net cash used in operations was $10.2M in Q1 2026 versus net cash provided of $53.4M in Q1 2025. According to the company, the shift reflects changes in operating activities year over year.