BDTX-1535 dose of 200 mg daily selected for pivotal development; favorable tolerability profile and no new safety signals observed Preliminary ORR of 42% in 19 patients at 200 mg with on-target resistance EGFR mutations Encouraging durability with DOR of approximately 8 months or more for first 3 patients with a PR; 14 of 19 patients remain on treatment Regulatory feedback on registration path anticipated in Q1 2025 Initial results of BDTX-1535 in first-line NSCLC patients with non-classical EGFR mutations ...

Core Insights - Black Diamond Therapeutics is set to disclose initial phase 2 clinical trial results for BDTX1535 targeting recurrent EGFRm NSCLC on September 23, 2024 [1] - The company specializes in developing MasterKey therapies aimed at oncogenic mutations in cancer patients [3] Company Overview - Black Diamond Therapeutics is a clinical-stage oncology company focused on MasterKey therapies that target genetically defined tumors [3] - The company is advancing two clinical-stage programs: BDTX-1535, a fourth-generation EGFR MasterKey inhibitor for EGFR mutant NSCLC and GBM, and BDTX-4933, a RAF MasterKey inhibitor for KRAS, NRAS, and BRAF alterations in solid tumors [3]

Core Insights - Black Diamond Therapeutics presented real-world treatment outcomes for newly diagnosed non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations at the ESMO Congress 2024, highlighting a significant unmet need for effective therapies in this patient population [1][4] Treatment Analysis - Out of 11,434 sequenced cases of newly diagnosed and treatment-naïve EGFR mutant NSCLC, first-line treatment data was evaluated for 3,276 patients, revealing that 36% received osimertinib or afatinib, while 60% were treated with chemotherapy and/or immunotherapy [2] - Patients with non-classical EGFR mutations showed a median treatment discontinuation time of 6.0 months for osimertinib, 8.0 months for afatinib, and 4.2 months for chemotherapy, indicating limited efficacy and high toxicity associated with current treatments [3] Company Development - Black Diamond Therapeutics is advancing BDTX-1535, a fourth-generation EGFR TKI designed to target a broad spectrum of EGFR mutations, particularly non-classical mutations, and plans to disclose initial Phase 2 data in Q1 2025 [4][5] - The company aims to address the evolving landscape of EGFR mutations, which can be present in 20-30% of newly diagnosed NSCLC patients, with over 100 identified non-classical mutations [4]

Core Viewpoint - Black Diamond (BDTX) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive shift in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4]. Business Outlook - The upgrade suggests an improvement in Black Diamond's underlying business, which should encourage investors to drive the stock price higher [5][10]. - The Zacks Consensus Estimate for Black Diamond indicates expected earnings of -$1.43 per share for the fiscal year ending December 2024, representing a year-over-year change of 23.9% [8]. Zacks Rating System - The Zacks Rank system classifies stocks based on earnings estimates into five groups, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - Black Diamond's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Core Insights - Black Diamond Therapeutics is on track to announce initial Phase 2 data for BDTX-1535 in second/third-line patients with EGFR mutant non-small cell lung cancer (NSCLC) in Q3 2024 and in first-line patients in Q1 2025 [1][2] - The company has a cash position of approximately $123.0 million as of June 30, 2024, which is expected to fund operations into Q4 2025 [1][7] Upcoming Milestones - Initial Phase 2 data for BDTX-1535 in 2L/3L EGFRm NSCLC patients is expected later in Q3 2024 [3] - Initial Phase 2 data for BDTX-1535 in 1L EGFRm NSCLC patients is anticipated in Q1 2025 [3] - An abstract titled "Real World Evidence of Treatment Practices and Therapeutic Outcomes for Newly Diagnosed NSCLC Patients with Non-classical EGFR Mutations Demonstrates High Unmet Medical Need" will be presented at the 2024 ESMO Congress [3] Financial Highlights - Cash, cash equivalents, and investments decreased from $131.4 million as of December 31, 2023, to $123.0 million as of June 30, 2024 [6][11] - Research and development expenses for Q2 2024 were $12.6 million, down from $13.2 million in Q2 2023, attributed to workforce efficiencies [6][12] - General and administrative expenses increased to $9.6 million in Q2 2024 from $6.9 million in Q2 2023, primarily due to higher consulting and professional fees [6][12] Company Overview - Black Diamond Therapeutics is focused on developing MasterKey therapies targeting oncogenic mutations in cancer patients, with two main programs: BDTX-1535 for EGFR mutant NSCLC and GBM, and BDTX-4933 for KRAS, NRAS, and BRAF alterations [1][8]

[PART I - FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) Unaudited financial statements for Q2 and H1 2024 report net losses of $19.9 million and $38.1 million, with $123.0 million in cash and investments as of June 30, 2024 Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $32,811 | $56,221 | | Investments | $90,160 | $75,179 | | Total current assets | $126,754 | $134,034 | | Total assets | $149,986 | $158,567 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $18,439 | $19,646 | | Total liabilities | $38,965 | $41,831 | | Total stockholders' equity | $111,021 | $116,736 | | Total liabilities and stockholders' equity | $149,986 | $158,567 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30 | Six Months Ended June 30 | | :--- | :--- | :--- | :--- | :--- | | | **2024** | **2023** | **2024** | **2023** | | Research and development | $12,556 | $13,154 | $26,101 | $27,907 | | General and administrative | $9,574 | $6,878 | $16,275 | $13,686 | | Loss from operations | $(22,130) | $(20,032) | $(42,376) | $(41,593) | | Net loss | $(19,909) | $(19,152) | $(38,134) | $(40,027) | | Net loss per share, basic and diluted | $(0.36) | $(0.52) | $(0.71) | $(1.09) | Condensed Consolidated Statements of Cash Flows (in thousands) | Six Months Ended June 30, | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(35,925) | $(34,399) | | Net cash (used in) provided by investing activities | $(12,994) | $41,981 | | Net cash provided by financing activities | $25,508 | $51 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's clinical-stage oncology focus, recent capital raises, sufficient cash runway for 12 months, and stock-based compensation and lease obligations - The company is a clinical-stage oncology company developing MasterKey therapies using its Mutation-Allostery-Pharmacology (MAP) drug discovery engine[21](index=21&type=chunk) - As of June 30, 2024, the company had sold 4,490,853 shares through its ATM Program, raising gross proceeds of approximately **$25.0 million**. In July 2023, a Follow-on Offering raised net proceeds of about **$71.9 million**[23](index=23&type=chunk) - Management expects that its cash, cash equivalents, and investments will be sufficient to fund planned operations for at least the next 12 months from the financial statement issuance date[24](index=24&type=chunk) - As of June 30, 2024, total unrecognized compensation cost related to unvested stock-options was **$17.3 million**, expected to be recognized over a weighted average period of 2.9 years[54](index=54&type=chunk) - The company has entered into sublease agreements for its office space in Cambridge, MA (terminating Aug 2028) and its office/lab space in New York, NY (terminating June 2026)[62](index=62&type=chunk)[63](index=63&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operational progress, highlighting clinical program advancements, reduced net loss, and a $123.0 million cash position funding operations into Q4 2025 [Overview](index=25&type=section&id=Overview) Black Diamond, a clinical-stage oncology company, advances BDTX-1535 and BDTX-4933 programs with upcoming data readouts and a cash runway into Q4 2025 - The company is advancing two primary clinical-stage programs: BDTX-1535 (EGFR inhibitor) and BDTX-4933 (RAF inhibitor)[74](index=74&type=chunk) - Key upcoming milestones include BDTX-1535 Phase 2 results in Q3 2024 and Q1 2025, and a BDTX-4933 Phase 1 update in Q4 2024[77](index=77&type=chunk)[80](index=80&type=chunk) - As of June 30, 2024, the company had cash, cash equivalents, and investments of approximately **$123.0 million**, which is expected to fund operations into the fourth quarter of 2025[87](index=87&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Operating results for H1 2024 show decreased R&D expenses to $26.1 million, increased G&A to $16.3 million, and an improved net loss of $38.1 million Comparison of Results of Operations (in thousands) | Six Months Ended June 30, | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development | $26,101 | $27,907 | $(1,806) | | General and administrative | $16,275 | $13,686 | $2,589 | | Total operating expenses | $42,376 | $41,593 | $783 | | Net loss | $(38,134) | $(40,027) | $1,893 | Research & Development Expense Breakdown (in thousands) | Six Months Ended June 30, | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | BDTX-1535 expenses | $10,977 | $7,161 | $3,816 | | BDTX-4933 expenses | $3,071 | $3,397 | $(326) | | Other research programs | $1,157 | $4,893 | $(3,736) | | Personnel expenses | $8,674 | $9,779 | $(1,105) | | Total R&D | $26,101 | $27,907 | $(1,806) | [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is driven by equity financings, with $123.0 million in cash and investments as of June 30, 2024, projected to fund operations into Q4 2025 - The company has funded operations through its IPO, a 2023 Follow-on Offering, and an ATM Program, which has generated gross proceeds of approximately **$25.0 million** as of June 30, 2024[107](index=107&type=chunk)[109](index=109&type=chunk)[111](index=111&type=chunk) Summary of Cash Flows (in thousands) | Six Months Ended June 30, | 2024 | 2023 | | :--- | :--- | :--- | | Cash used in operating activities | $(35,925) | $(34,399) | | Cash (used in) provided by investing activities | $(12,994) | $41,981 | | Cash provided by financing activities | $25,508 | $51 | - Existing cash, cash equivalents, and investments of **$123.0 million** are expected to fund operating expenses and capital expenditure requirements into the fourth quarter of 2025[117](index=117&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Black Diamond Therapeutics is not required to provide the information for this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this item[129](index=129&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2024, with no material changes to internal controls during the quarter - Based on an evaluation as of the end of the reporting period, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[130](index=130&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[131](index=131&type=chunk) [PART II - OTHER INFORMATION](index=39&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently party to and is not aware of any material legal proceedings[70](index=70&type=chunk)[133](index=133&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the detailed discussion of risk factors in the company's Annual Report on Form 10-K for the year ended December 31, 2023 - For a discussion of risk factors, readers are encouraged to carefully consider the information in Part I, "Item 1A. Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2023[134](index=134&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales occurred this quarter, and there is no material change in the planned use of IPO proceeds - There were no recent sales of unregistered equity securities[134](index=134&type=chunk) - There has been no material change in the company's planned use of the net proceeds from its IPO as described in the final prospectus[136](index=136&type=chunk) [Item 3. Defaults Upon Senior Securities](index=39&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[136](index=136&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[137](index=137&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) The Chief Scientific Officer entered a Rule 10b5-1 trading plan on May 30, 2024, for up to 160,000 shares, commencing August 29, 2024 - On May 30, 2024, Elizabeth Buck, the Chief Scientific Officer, entered into a Rule 10b5-1 trading plan scheduled to commence on August 29, 2024. The plan allows for the sale of up to **160,000 shares** of common stock[137](index=137&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, which include certifications by the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act, and Inline XBRL documents - The report includes standard exhibits such as CEO/CFO certifications (pursuant to Rules 13a-14(a) and 15d-14(a), and Section 906 of Sarbanes-Oxley) and XBRL data files[141](index=141&type=chunk)

Black Diamond Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update • Initial Phase 2 data of BDTX-1535 in 2L/3L patients with EGFRm NSCLC on track for later in Q3 2024 • On track to announce initial Phase 2 data of BDTX-1535 in 1L patients with non-classical EGFRm NSCLC in Q1 2025, and initial Phase 1 data of BDTX-4933 in KRASm NSCLC in Q4 2024 • Upcoming poster presentation at 2024 ESMO Congress in September, titled "Real World Evidence of Treatment Practices and Therape ...

Results from Phase 1 dose escalation trial of BDTX-1535 in GBM patients demonstrated a favorable safety and tolerability profile, and encouraging anti-tumor activity and duration of treatment Initial data from Phase 0/1 "trigger" ("window of opportunity") investigator-sponsored trial demonstrated BDTX-1535 achieved clinically meaningful drug levels in brain tumor tissue CAMBRIDGE, Mass., June 01, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (NASDAQ:BDTX), a clinical-stage oncology company devel ...

Investors are always looking for stocks that are poised to beat at earnings season and Black Diamond Therapeutics, Inc. (BDTX) may be one such company. The firm has earnings coming up pretty soon, and events are shaping up quite nicely for their report.That is because Black Diamond Therapeutics is seeing favorable earnings estimate revision activity as of late, which is generally a precursor to an earnings beat. After all, analysts raising estimates right before earnings — with the most up-to-date informati ...

• the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval; • the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining, expanding and enforcing our intellectual property rights and defending intellectual property-related claims; Table of Contents If we raise additional funds through collaborations, strategic partnerships and alliances or mark ...