Financial Performance - The company reported net losses of $53.7 million and $63.0 million for the nine months ended September 30, 2024 and 2023, respectively, with an accumulated deficit of $471.1 million as of September 30, 2024[87]. - The company has incurred significant operating losses since inception in 2014, primarily funding operations through the sale of common and preferred stock[86]. - Total operating expenses for the three months ended September 30, 2024, were $18.1 million, a decrease of $5.9 million compared to $24.0 million for the same period in 2023[108]. - For the nine months ended September 30, 2024, total operating expenses were $60.5 million, a decrease of $5.1 million from $65.6 million in 2023[112]. - Cash used in operating activities for the nine months ended September 30, 2024, was $47.2 million, compared to $52.8 million in 2023, reflecting a reduction in net loss[121]. - Cash used in operating activities decreased from $52.8 million in September 2023 to $47.2 million in September 2024[126]. - Cash provided by financing activities decreased significantly from $71.98 million in September 2023 to $25.26 million in September 2024[126]. Research and Development - BDTX-1535 demonstrated a preliminary overall response rate (ORR) of 42% in a Phase 2 trial involving 19 patients with osimertinib-resistant EGFR mutations, with a duration of response (DOR) of approximately eight months or more in the first three patients achieving a partial response[83]. - BDTX-4933, the second product candidate, is currently deprioritized as the company focuses resources on advancing BDTX-1535 into pivotal development[85]. - Initial results from the first-line cohort of BDTX-1535 are anticipated in the first quarter of 2025[83]. - Research and development expenses for the three months ended September 30, 2024, were $12.9 million, down from $16.2 million in 2023, primarily due to reduced spending on early discovery projects[109]. - Research and development expenses for the nine months ended September 30, 2024, were $39.0 million, down from $44.1 million in 2023, reflecting a focus on clinical-stage assets[113]. - The company expects substantial increases in expenses related to advancing clinical trials for BDTX-1535 and operating as a public company[127]. Cash and Investments - As of September 30, 2024, the company had cash, cash equivalents, and investments of approximately $112.7 million, expected to fund operations into the second quarter of 2026[92]. - As of September 30, 2024, the company had cash, cash equivalents, and investments totaling $112.7 million[117]. - The company completed a Follow-on Offering on July 5, 2023, raising approximately $71.6 million in net proceeds[120]. - The total contractual obligations as of September 30, 2024, amounted to $27.2 million, including property leases[133]. - The company expects to require additional capital for regulatory approvals and potential acquisitions of product candidates[128]. - Future funding requirements may increase significantly due to various factors, including clinical trial costs and commercialization activities[129]. - The company may finance operations through public or private equity offerings, debt financings, and strategic partnerships[130]. Business Operations - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[93]. - The company is actively seeking partnerships for BDTX-4933 while prioritizing the development of BDTX-1535[85]. - The company is monitoring macroeconomic conditions and market volatility, which have not significantly impacted its business or financial results to date[91]. - The company has not experienced material changes in internal control over financial reporting during the reporting period[143]. - The company remains a smaller reporting company, allowing it to rely on certain exemptions from disclosure requirements[140].

Financial Performance - Black Diamond Therapeutics reported a net loss of $15.6 million for Q3 2024, compared to a net loss of $23.0 million in Q3 2023, representing a 32.6% improvement[6]. - Cash, cash equivalents, and investments totaled approximately $112.7 million as of September 30, 2024, down from $131.4 million at the end of 2023[6][10]. - Total operating expenses for Q3 2024 were $18.1 million, down from $24.0 million in Q3 2023, reflecting a 24.6% decrease[11]. Research and Development - Research and development expenses decreased to $12.9 million in Q3 2024 from $16.2 million in Q3 2023, a reduction of 20.3%[6][11]. - The overall response rate (ORR) for BDTX-1535 in patients with osimertinib-resistant EGFR mutations was reported at 42%[3]. - The duration of response (DOR) for the first three patients achieving a partial response was approximately eight months or more[3]. - 36% of newly diagnosed NSCLC patients with non-classical EGFR mutations received osimertinib or afatinib, while 60% received chemotherapy and/or immunotherapy[3]. - Black Diamond plans to provide clinical updates on BDTX-1535 in Q1 2025, including feedback on a registrational path from the FDA[2][4]. Strategic Initiatives - The company expects its cash runway to extend into Q2 2026, following a corporate restructuring plan aimed at optimizing development resources[5][7]. - Black Diamond is actively seeking partnerships for its deprioritized Phase 1 RAS/RAF inhibitor, BDTX-4933[5].

Group 1 - Black Diamond Therapeutics is preparing to report initial results from its phase 2 study of BDTX-1535 targeting first-line EGFR mutant non-small cell lung cancer (NSCLC) patients in Q1 of 2025 [1] - There may be an additional update of data related to the study [1] Group 2 - The article mentions the author is associated with Biotech Analysis Central, which includes a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [1]

Company advancing BDTX-1535 in EGFRm NSCLC towards key inflection points in Q1 2025 Will deprioritize BDTX-4933 and seek potential partners Anticipated cost savings expected to extend cash runway into Q2 2026 CAMBRIDGE, Mass., Oct. 07, 2024 (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, announced today a corporate restructuring to focus resources on adva ...

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)