Last update 03 Nov 2024
Tuxobertinib
Last update 03 Nov 2024
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms BDTX 189 |
Target |
Mechanism EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists) |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Inactive Organization |
Drug Highest PhaseSuspendedPhase 2 |
First Approval Date- |
Regulation- |
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Structure
Molecular FormulaC29H29ClN6O4 |
InChIKeyHIBPKFXWOPYJPZ-UHFFFAOYSA-N |
CAS Registry2414572-47-5 |
Related
1
Clinical Trials associated with TuxobertinibMasterKey-01: A Phase 1/2, Open-label, Two-part, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics & Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB Mutations, in Patients w/ Advanced Solid Malignancies
This is a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that have select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal growth factor receptor (EGFR/ErbB1). The main goals of this study are to:
Find the recommended dose of BDTX-189 that can be given safely to participants
Learn more about the side effects of BDTX-189
Learn what the body does to BDTX-189 after it has been taken (pharmacokinetics or PK)
Determine the antitumor activity of BDTX-189 in participants with select allosteric ErbB gene mutations
Find the recommended dose of BDTX-189 that can be given safely to participants
Learn more about the side effects of BDTX-189
Learn what the body does to BDTX-189 after it has been taken (pharmacokinetics or PK)
Determine the antitumor activity of BDTX-189 in participants with select allosteric ErbB gene mutations
Start Date19 Dec 2019 |
Sponsor / Collaborator |
100 Clinical Results associated with Tuxobertinib
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100 Translational Medicine associated with Tuxobertinib
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100 Patents (Medical) associated with Tuxobertinib
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1
Literatures (Medical) associated with Tuxobertinib01 May 2024·CHEMICO-BIOLOGICAL INTERACTIONS
BDTX-189, a novel tyrosine kinase inhibitor, inhibits cell activity via ERK and AKT pathways in the EGFR C797S triple mutant cells
Article
Author: Wei, Xiangkai ; Chu, Chunhong ; Wang, Ke ; Liu, Chenxue ; Cui, Wenrui ; Wang, Rui ; Liu, Chenyang ; Zhang, Guoliang ; Xu, Huixia ; Li, Lanxin ; An, Lei ; Li, Yanming
The tertiary mutation C797S in the structural domain of the EGFR kinase is a common cause of resistance to third-generation EGFR tyrosine kinase inhibitors (TKIs). In this study, we used a potent, selective and irreversible inhibitor, BDTX-189, to target EGFR C797S triple mutant cells for cell activity. The study constructed the H1975-C797S (EGFR L858R/T790 M/C797S) cell line using the CRISPR/Cas9 method and investigated its potential as a fourth-generation tyrosine kinase inhibitor via chemosensitivity approach. The results demonstrated its ability to induce cytotoxic effects, and inhibit EGFR L858R/T790 M/C797S cell growth and proliferation in a dose-dependent manner. Meanwhile, BDTX-189 reduces the protein phosphorylation levels of EGFR, ERK, and AKT, promoting apoptosis. Furthermore, BDTX-189 not only inhibits common EGFR triple mutations but also effectively inhibits EGFR L858R mutation and EGFR L858R/T790 M mutation. These findings support the cytotoxic effect of BDTX-189 and its inhibitory effect on cell division and proliferation with the EGFR C797S triple mutation.
15
News (Medical) associated with Tuxobertinib11 Aug 2023
Announced initial clinical data from dose-escalation portion of Phase 1 clinical trial of BDTX-1535, an EGFR MasterKey inhibitor, demonstrating a favorable tolerability pro clinical proof of activity based on radiographic tumor responses and circulating tumor DNA changes in NSCLC patients harboring acquired resistance and intrinsic driver EGFR mutations
Initiated BDTX-1535 NSCLC expansion cohorts in July 2023; clinical update on BDTX-1535 Phase 1 dose escalation in GBM expected in the fourth quarter of 2023
In July 2023, Black Diamond closed an underwritten public offering of 15,000,000 shares of its common stock at a public offering price of $5.00 per share for gross proceeds of approximately $75.0 million, before deducting underwriting discounts and commissions and other offering expenses
Cash, cash equivalents, and investments of $89.5 million as of June 30, 2023; together with net proceeds from the July 2023 underwritten public offering, is expected to be sufficient to fund operations into the first half of 2025
CAMBRIDGE, Mass. and NEW YORK, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.
“The second quarter of 2023 marked a crucial period of clinical and operational execution for Black Diamond, and I am incredibly pleased with our initial dose escalation data demonstrating a favorable tolerability pro clinical proof of activity for BDTX-1535 in NSCLC patients harboring acquired resistance and intrinsic driver EGFR mutations. With these data in hand, we believe we are well positioned for rapid advancement of this novel MasterKey inhibitor for NSCLC patients and are looking forward to meeting with FDA later this year to discuss our dose optimization strategy that may enable a potential accelerated approval pathway as well as the opportunity to study BDTX-1535 in newly diagnosed NSCLC patients with intrinsic driver mutations,” said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “Our recently completed underwritten public offering provides us with a strong cash position and extended runway to execute on the robust set of upcoming milestones for BDTX-1535 and our broader pipeline, all with the goal of bringing our MasterKey therapies to patients in need.”
Recent Developments & Upcoming Milestones:
BDTX-1535:
In June 2023, Black Diamond announced initial clinical data from the dose escalation portion of the Phase 1 clinical study of BDTX-1535, an epidermal growth factor receptor (EGFR) MasterKey inhibitor, demonstrating a favorable tolerability pro clinical proof of activity in non-small cell lung cancer (NSCLC) patients harboring both acquired resistance and intrinsic driver EGFR mutations. Key highlights from the readout include:
Confirmed radiographic partial response (PR) by RECIST 1.1 achieved across predicted therapeutic doses in 5 of 12 NSCLC patients in a subgroup, who had measurable disease at study start, and underwent post baseline tumor assessment by RECIST 1.1. One additional patient demonstrated unconfirmed PR, while the remaining six patients had stable disease.
Confirmed PRs were observed in NSCLC patients with a wide range of EGFR mutations including classical and intrinsic driver mutations and acquired C797S resistance mutation, as well as complex mutations that include a combination of classical, intrinsic, and acquired resistance mutations. Two NSCLC patients demonstrated radiographic improvement in the peripheral disease and central nervous system (CNS) metastases.
BDTX-1535 was generally well tolerated by NSCLC and glioblastoma multiforme (GBM) patients and the overall safety pro consistent with the EGFR tyrosine kinase inhibitor (TKI) class of drugs. The most common drug-related adverse events were mild to moderate rash, diarrhea, stomatitis, paronychia, nausea and fatigue. No patients experienced dose limiting toxicity at 15-200 mg once-daily (QD) doses. One of 15 patients treated at the 300 mg QD dose experienced dose limiting diarrhea and 5 of 12 patients at the 400 mg QD dose experienced dose limiting toxicity (diarrhea, 2 patients; rash, stomatitis, fatigue and decreased appetite, 1 patient each). No unexpected safety signal was identified during dose escalation.
In July 2023, Black Diamond initiated expansion cohorts to assess overall response rate (ORR) by RECIST 1.1 in NSCLC patients with EGFR acquired resistance mutations after progression on a third generation EGFR TKI and intrinsic driver mutations after progression on an EGFR TKI.
Black Diamond anticipates the following key milestones for BDTX-1535:
Presentation of the full BDTX-1535 dose escalation data in NSCLC at a medical conference in the fourth quarter of 2023.
Meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2023 to align on dosing strategy to enable a potential accelerated approval pathway in NSCLC.
Initiation of an expansion cohort in newly diagnosed NSCLC patients with intrinsic driver mutations after discussion with the FDA.
Clinical update on BDTX-1535 Phase 1 dose escalation data in recurrent GBM patients in the fourth quarter of 2023.
BDTX-4933:
BDTX-4933 is designed as a brain-penetrant, oral MasterKey inhibitor of oncogenic BRAF Class I, II and III and RAS mutations, while also avoiding paradoxical activation.
In April 2023, Black Diamond presented a poster at the 2023 American Association of Cancer Research (AACR) Annual Meeting, outlining its approach to characterizing RAF, RAS and MAPK pathways in addition to the design and preclinical development of BDTX-4933. Based on preclinical data, BDTX-4933 has a potential best-in-class pro treat cancer patients harboring oncogenic BRAF Class I, II, III and RAS mutations, with or without brain disease.
Black Diamond initiated a Phase 1 clinical trial for BDTX-4933 in select indications for patients harboring all-class BRAF or RAS mutations in the second quarter of 2023.
BDTX-4876:
BDTX-4876 is a development candidate FGFR 2/3 MasterKey inhibitor, selective against FGFR 2 and 3 alterations, while sparing FGFR 1 and 4.
Black Diamond is evaluating strategic alternatives for BDTX-4876 as it deepens focus on its two clinical-stage assets.
Discovery-Stage Pipeline and MAP Drug Discovery Engine:
Black Diamond continues to leverage its Mutation-Allostery-Pharmacology (MAP) drug discovery engine to advance its discovery-stage pipeline to bring therapies to underserved patients and expects to progress another undisclosed program in solid tumors to development candidate nomination in 2023.
Corporate:
In June 2023, Black Diamond announced the promotion of Melanie Morrison to Chief Development Officer.
In July 2023, Black Diamond closed an underwritten public offering (Follow-on Offering) of 15,000,000 shares of its common stock at a public offering price of $5.00 per share for gross proceeds of approximately $75.0 million, before deducting underwriting discounts and commissions and other offering expenses.
Financial Highlights
Cash Position: Black Diamond ended the second quarter of 2023 with approximately $89.5 million in cash, cash equivalents, and investments compared to $122.8 million as of December 31, 2022. Net cash used in operations was $14.4 million for the second quarter of 2023 compared to $18.1 million for the second quarter of 2022.
Research and Development Expenses: Research and development (R&D) expenses were $13.2 million for the second quarter of 2023, compared to $16.2 million for the same period in 2022. The decrease in R&D expenses was primarily due to reduced clinical trial activities stemming from the discontinuation of the development of BDTX-189 to focus on advancement of the Company’s pipeline programs, BDTX-1535 and BDTX-4933.
General and Administrative Expenses: General and administrative (G&A) expenses were $6.9 million for the second quarter of 2023, compared to $7.0 million for the same period in 2022. The decrease in G&A expenses was primarily due to a decrease in legal and other professional fees.
Net Loss: Net loss for the second quarter of 2023 was $20.0 million, as compared to $23.2 million for the same period in 2022.
Financial Guidance
Black Diamond ended the second quarter of 2023 with approximately $89.5 million in cash, cash equivalents and investments. The Company believes that the net proceeds from the Follow-on Offering, together with its existing cash, cash equivalents and investments, will enable the Company to fund its operating expenses and capital expenditure requirements into the first half of 2025.
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage precision oncology medicine company focused on the development of MasterKey therapies that target families of oncogenic mutations in clinically validated targets. Black Diamond leverages a deep understanding of cancer genetics and onco-protein structure and function, to discover and develop innovative MasterKey therapies. The Company’s MasterKey therapies are designed to overcome resistance, minimize on-target, wild-type mediated toxicities, and be brain-penetrant to address significant unmet medical needs of patients with genetically defined cancers. The Company is advancing a robust pipeline with lead clinical-stage program BDTX-1535, targeting MasterKey mutations in both EGFR mutant-positive NSCLC and in GBM, and BDTX-4933, a program targeting RAF MasterKey mutations in solid tumors, as well as discovery-stage research programs. The Company’s proprietary MAP drug discovery engine is designed to allow Black Diamond to analyze population-level genetic sequencing tumor data and validate MasterKey mutations. For more information, please visit
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 BDTX-1535 and BDTX-4933, including the ongoing Phase 1 clinical trial and the expected timing for a potential accelerated approval pathway for BDTX-1535 in NSCLC and the upcoming clinical update on BDTX-1535 in recurrent GBM patients, exploring strategic alternatives for BDTX-4876, the continued development of the MAP drug discovery engine and the Company’s expected cash runway. Any forward-looking statements in this statement 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, 2022, 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)
June 30,
2023
December 31,
2022
(in thousands)
Cash, cash equivalents, and investments
$
89,527
$
122,807
Total assets
$
119,879
$
156,255
Accumulated deficit
$
(375,016
)
$
(334,989
)
Total stockholders’ equity (deficit)
$
82,199
$
115,695
Black Diamond Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited)
(in thousands, except per share data)
Three Months Ended
June 30,
Six Months Ended
June 30,
2023
2022
2023
2022
Operating expenses:
Research and development
$
13,154
$
16,195
$
27,907
$
33,981
General and administrative
6,878
6,978
13,686
14,871
Total operating expenses
20,032
23,173
41,593
48,852
Loss from operations
(20,032
)
(23,173
)
(41,593
)
(48,852
)
Other income (expense):
Interest income
539
386
1,161
792
Other income (expense)
341
(143
)
405
(377
)
Total other income (expense), net
880
243
1,566
415
Net loss
$
(19,152
)
$
(22,930
)
$
(40,027
)
$
(48,437
)
Net loss per share, basic and diluted
$
(0.52
)
$
(0.63
)
$
(1.09
)
$
(1.33
)
Weighted average common shares outstanding, basic and diluted
36,516,114
36,293,856
36,500,085
36,282,636
Contact
Julie Seidel, Stern Investor Relations
(212) 362-1200
investors@bdtx.com
media@bdtx.com
Phase 1Financial StatementAACRExecutive ChangeClinical Result
09 May 2023
On track to provide clinical update from dose-escalation portion of Phase 1 clinical trial of EGFR MasterKey inhibitor BDTX-1535 in the second half of 2023; Dose Expansion cohorts expected to open in 2023
FDA clearance of IND application for BDTX-4933, RAF MasterKey inhibitor; Anticipate first patient dosing in the second quarter of 2023
Announces nomination of development candidate, BDTX-4876, for FGFR 2/3 selective inhibitor program; Company to evaluate strategic alternatives for this program
Cash, cash equivalents, and investments of $103.4 million as of March 31, 2023; Expected to be sufficient to fund operations into the third quarter of 2024
CAMBRIDGE, Mass. and NEW YORK, May 09, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, today reported financial results for the first quarter ended March 31, 2023, and provided a corporate update.
“We are incredibly pleased with the pace of execution since the start of 2023 as we continue to advance our pipeline programs, BDTX-1535 and BDTX-4933 in addition to our newest program, BDTX-4876. Having three investigational new drug (IND) acceptances in three years is exemplary of our breadth of expertise in precision oncology drug discovery and development. We are confident that our momentum will continue to bring tremendous progress across our pipeline as we head further into this transformational year for Black Diamond,” said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “2023 brings several key inflection points, including a clinical update from the dose-escalation portion of our Phase 1 trial of BDTX-1535 in patients with non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM), the initiation of a Phase 1 clinical trial for BDTX-4933, and today’s announcement of a development candidate nomination for our fibroblast growth factor receptor (FGFR) 2/3 selective program. We remain acutely focused on bringing our next-generation precision medicines to patients in need, particularly as we work to expand the addressable patient population within the broader oncogenic mutation landscape. Our sophisticated drug design and our deep-rooted commitment to effectively targeting shared, activated conformations used by oncogenic drivers for tumor growth are all enabled by our Mutation Allostery Pharmacology (MAP) drug discovery engine and ultimately realized by our MasterKey therapies.”
Recent Developments & Upcoming Milestones:
BDTX-1535:
BDTX-1535, an epidermal growth factor receptor (EGFR) MasterKey inhibitor, is being developed to treat genetically defined cancer in patients whose tumors are positive for EGFR MasterKey mutations in NSCLC, as well as in GBM. BDTX-1535 is a fourth generation EGFR inhibitor designed to be irreversible (covalent) and brain-penetrant and is unique in how it targets a family of driver and resistance mutations arising from the use of third generation EGFR inhibitors to treat EGFR-positive NSCLC.
In April 2023, Black Diamond presented two posters highlighting BDTX-1535’s preclinical development as well as the ongoing Phase 1 clinical trial at the 2023 AACR Annual Meeting. Key highlights from the preclinical poster included an outline of the unmet need for next generation EGFR inhibitors that target classical driver mutations as well as acquired and intrinsic resistance mutations expressed in the context of EGFR driver mutations in NSCLC, and EGFR alterations expressed in GBM. Black Diamond also outlined its ongoing Phase 1, open-label, multicenter clinical trial to assess the safety, tolerability, pharmacokinetics, central nervous system (CNS) penetrance and preliminary antitumor activity of BDTX-1535 in locally advanced or metastatic NSCLC with or without CNS disease or in recurrent GBM (rGBM).
Enrollment in the Phase 1 clinical trial was initiated in 2022 and dose escalation is ongoing. Dose Expansion cohorts are expected to open in 2023. Black Diamond remains on track to provide a clinical update on BDTX-1535 in the second half of 2023.
BDTX-4933:
BDTX-4933 is designed as a brain-penetrant, oral MasterKey inhibitor of oncogenic BRAF Class I, II and III and RAS mutations, while also avoiding paradoxical activation.
In the first quarter of 2023, Black Diamond received allowance of its IND application from the U.S. Food and Drug Administration (FDA).
In April 2023, Black Diamond presented a poster at the 2023 AACR Annual Meeting, outlining its approach to characterizing RAF, RAS and MAPK pathways in addition to the design and preclinical development of BDTX-4933. Based on preclinical data, BDTX-4933 has a potential best-in-class pro treat cancer patients harboring oncogenic BRAF Class I, II, III and RAS mutations, with or without brain disease.
Black Diamond expects to dose its first patient in a Phase 1 clinical trial of BDTX-4933 in patients with tumors harboring all-class BRAF or RAS mutations in the second quarter of 2023.
Discovery-Stage Pipeline and MAP Drug Discovery Engine:
Today, Black Diamond announced that it selected a development candidate, BDTX-4876, for its FGFR program. BDTX-4876 is selective against MasterKey mutations and alterations in FGFR 2 and 3, while sparing FGFR 1 and 4.
Black Diamond plans to evaluate strategic alternatives for the FGFR program as it deepens focus on its two clinical stage assets.
Black Diamond continues to leverage its MAP drug discovery engine to advance its discovery-stage pipeline to bring therapies to underserved patients.
Corporate:
In March 2023, the Company promoted Fang Ni, Pharm.D., from interim Chief Financial Officer to full-time Chief Financial Officer, in addition to his role as Chief Business Officer.
Financial Highlights
Cash Position: Black Diamond ended the first quarter of 2023 with approximately $103.4 million in cash, cash equivalents, and investments compared to $122.8 million as of December 31, 2022. Net cash used in operations was $20.0 million for the first quarter of 2023 compared to $28.6 million for the first quarter of 2022.
Research and Development Expenses: Research and development (R&D) expenses were $14.8 million for the first quarter of 2023, compared to $17.8 million for the same period in 2022. The decrease in R&D expenses was primarily due to reduced clinical trial activities stemming from the discontinuation of the development of BDTX-189 to focus on advancement of the Company’s pipeline programs, BDTX-1535 and BDTX-4933.
General and Administrative Expenses: General and administrative (G&A) expenses were $6.8 million for the first quarter of 2023, compared to $7.9 million for the same period in 2022. The decrease in G&A expenses was primarily due to a decrease in legal and other professional fees.
Net Loss: Net loss for the first quarter of 2023 was $20.9 million, as compared to $25.5 million for the same period in 2022.
Financial Guidance
Black Diamond ended the first quarter of 2023 with approximately $103.4 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 third quarter of 2024.
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage precision oncology medicine company focused on the development of MasterKey therapies that target families of oncogenic mutations in clinically validated targets. Black Diamond leverages a deep understanding of cancer genetics and onco-protein structure and function, to discover and develop innovative MasterKey therapies. The Company’s MasterKey therapies are designed to overcome resistance, minimize on-target, wild-type mediated toxicities, and be brain-penetrant to address significant unmet medical needs of patients with genetically defined cancers. The Company is advancing a robust pipeline with lead clinical-stage program BDTX-1535, targeting MasterKey mutations in both EGFR mutant-positive NSCLC and in GBM, and BDTX-4933, a program targeting RAF MasterKey mutations in solid tumors, as well as discovery-stage research programs. The Company’s proprietary MAP drug discovery engine is designed to allow Black Diamond to analyze population-level genetic sequencing tumor data and validate MasterKey mutations. For more information, please visit .
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 BDTX-1535, and BDTX-4933, including the ongoing Phase 1 clinical trial and the expected timing for data updates for BDTX-1535 and the timing for initiating a Phase 1 clinical trial of BDTX-4933, the continued development of the FGFR program, exploring strategic alternatives for the FGFR program, the continued development of the MAP drug discovery engine and the Company’s expected cash runway. Any forward-looking statements in this statement 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, 2022, 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,
2023
December 31,
2022
(in thousands)
Cash, cash equivalents, and investments
$
103,366
$
122,807
Total assets
$
135,582
$
156,255
Accumulated deficit
$
(355,864
)
$
(334,989
)
Total stockholders’ equity (deficit)
$
98,190
$
115,695
Black Diamond Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited)
(in thousands, except per share data)
Three Months Ended
March 31,
2023
2022
Operating expenses:
Research and development
$
14,753
$
17,786
General and administrative
6,808
7,893
Total operating expenses
21,561
25,679
Loss from operations
(21,561
)
(25,679
)
Other income (expense):
Interest income
622
406
Other income (expense)
64
(234
)
Total other income (expense), net
686
172
Net loss
$
(20,875
)
$
(25,507
)
Net loss per share, basic and diluted
$
(0.57
)
$
(0.70
)
Weighted average common shares outstanding, basic and diluted
36,483,878
36,271,291
Contact:
Julie Seidel, Stern Investor Relations
(212) 362-1200
investors@bdtx.com
media@bdtx.com
Phase 1Financial StatementINDAACRExecutive Change
09 Mar 2023
On track to provide clinical update from dose-escalation portion of Phase 1 clinical trial of EGFR MasterKey inhibitor BDTX-1535 in the second half of 2023
FDA clearance of IND application for BDTX-4933 in the first quarter of 2023, a brain-penetrant RAF MasterKey inhibitor for the treatment of all-class RAF and RAS mutant tumors; initiation of Phase 1 clinical trial expected in the first half of 2023
Presented new preclinical data demonstrating the potential of MasterKey programs BDTX-1535 and BDTX-4933 at the 34th EORTC-NCI-AACR Symposium
Cash, cash equivalents, and investments of $122.8 million as of December 31, 2022; expected to be sufficient to fund operations into the third quarter of 2024
CAMBRIDGE, Mass. and NEW YORK, March 09, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a corporate update.
“We expect 2023 to be a catalyst rich year for Black Diamond following tremendous progress for our two novel MasterKey inhibitors, with BDTX-1535 continuing to advance through our Phase 1 clinical trial and BDTX-4933 meeting critical milestones to further progress toward the clinic. The clearance of the Investigational New Drug (IND) application for BDTX-4933 by the U.S. Food and Drug Administration (FDA) earlier this year marks our third IND allowance in three years and demonstrates the strength of our MAP drug discovery engine along with the expertise of our research and clinical teams. We are driven by the clear unmet need for next-generation precision medicines to treat cancers by overcoming resistance, minimizing on-target and wild-type mediated toxicities, and addressing brain disease. We’ve designed a robust pipeline of products with brain penetration properties to address these key challenges,” said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond. “We anticipate a clinical update for BDTX-1535 in the second half of 2023. We also expect to initiate the Phase 1 clinical trial of BDTX-4933 in the first half of this year and to progress our FGFR program and another undisclosed program toward development candidate nominations in 2023. As we continue to mature our pipeline, we are acutely focused on delivering meaningful benefit to patients and we believe that our approach has the potential to strengthen the treatment landscape for genetically defined cancers.”
Recent Developments & Upcoming Milestones:
BDTX-1535:
BDTX-1535, an epidermal growth factor receptor (EGFR) MasterKey inhibitor, is being developed to treat genetically defined cancer in patients whose tumors are positive for EGFR MasterKey mutations in glioblastoma multiforme (GBM), as well as in non-small cell lung cancer (NSCLC). BDTX-1535 is fourth generation EGFR inhibitor designed to be irreversible (covalent) and brain-penetrant, and is unique in that it targets a family of driver mutations in addition to acquired resistance mutations arising from the use of third generation EGFR inhibitors to treat EGFR-positive NSCLC.
In April 2022, Black Diamond dosed the first patient in its Phase 1 global clinical trial of BDTX-1535 for the treatment of NSCLC, including in patients with brain metastases, and GBM. The dose-escalation portion of the Phase 1 clinical trial is actively recruiting and enrolling patients, and the Company remains on track to provide a clinical update on BDTX-1535 in the second half of 2023.
In October 2022, Black Diamond presented two posters at the 34th European Organisation for Research and Treatment of Cancer—National Cancer Institute—American Association for Cancer Research (EORTC-NCI-AACR) Symposium in Barcelona, Spain, with new preclinical data. The Company detailed anti-tumor activity of BDTX-1535 in preclinical models and highlighted that BDTX-1535 is designed using Black Diamond’s proprietary MAP drug discovery engine to target EGFR mutations of both NSCLC and GBM. Black Diamond also showcased BDTX-1535’s ability to achieve potent anti-tumor activity against EGFR alterations and amplification across preclinical models of NSCLC classical driver, intrinsic resistance and acquired resistance EGFR mutations and GBM, including intercranial patient derived xenograft models.
BDTX-4933:
BDTX-4933 is designed as a brain-penetrant, small molecule MasterKey reversible oral inhibitor of oncogenic BRAF Class I, II and III active RAF dimers promoted by upstream oncogenic alterations expressed by human cancers, while also avoiding paradoxical activation.
In the first quarter of 2023, Black Diamond received allowance of its IND application from the FDA. The Company expects to initiate a Phase 1 clinical trial of BDTX-4933 in patients with tumors harboring all-class BRAF or RAS mutations in the first half of 2023.
In October 2022, Black Diamond presented a poster at the 34th EORTC-NCI-AACR Symposium highlighting preclinical data showing BDTX-4933 to be a brain-penetrant RAF MasterKey inhibitor active against tumors that are driven by a Class I, II, or III BRAF mutation, as well as by other oncogenic RAS pathway alterations that promote constitutive RAF dimer activation. BDTX-4933 demonstrated potent, on-target inhibition of the RAF-MEK-ERK signaling pathway and anti-tumor activity in multiple preclinical models, including intracranial tumor models.
Discovery-Stage Pipeline and MAP Drug Discovery Engine:
Black Diamond continues to leverage its MAP drug discovery engine to advance its discovery-stage pipeline to bring therapies to underserved patients. Black Diamond anticipates progressing its fibroblast growth factor receptor (FGFR) program towards development candidate nomination and nomination of a development candidate against an undisclosed target in 2023.
Corporate:
In June 2022, Black Diamond appointed Sergey Yurasov, M.D., Ph.D., as its Chief Medical Officer, bringing over 25 years of oncology drug development experience and regulatory expertise.
In December 2022, Black Diamond announced that existing board member, Mark Velleca, M.D., Ph.D., was appointed to succeed Robert (Bob) A. Ingram as the Chairman of the Board of Directors.
In December 2022, Black Diamond announced the spinout of Launchpad Therapeutics, Inc. (Launchpad), an antibody-focused precision oncology company incorporating Black Diamond’s undisclosed early discovery stage antibody programs enabled by the MAP drug discovery engine. In conjunction with the transaction, a $30 million Series A financing was co-led by Versant Ventures and New Enterprise Associates (NEA) to fund discovery and development activities of the new company. Black Diamond retains a minority equity interest in Launchpad to enable further value creation.
Financial Highlights
Cash Position: Black Diamond ended 2022 with approximately $122.8 million in cash, cash equivalents, and investments compared to $209.8 million as of December 31, 2021. Net cash used in operations was $85.1 million for the year ended December 31, 2022 compared to $100.1 million for the year ended December 31, 2021.
Research and Development Expenses: Research and development (R&D) expenses were $14.6 million for the fourth quarter of 2022, compared to $19.7 million for the same period in 2021. Research and development expenses were $64.4 million for the year ended December 31, 2022, compared to $96.8 million for the year ended December 31, 2021. The decrease in R&D expenses was primarily due to reduced clinical trial activities stemming from the discontinuation of the development of BDTX-189 to focus on upcoming milestones for our pipeline programs, BDTX-1535 and BDTX-4933.
General and Administrative Expenses: General and administrative (G&A) expenses were $7.2 million for the fourth quarter of 2022, compared to $6.4 million for the same period in 2021, and $28.4 million for the year ended December 31, 2022, compared to $30.0 million for the year ended December 31, 2021. The decrease in G&A expenses was primarily due to a decrease in legal and other professional fees.
Net Loss: Net loss for the fourth quarter of 2022 was $21.1 million, as compared to $25.9 million for the same period in 2021. Net loss for the year ended December 31, 2022 was $91.2 million compared to $125.6 million for the year ended December 31, 2021.
Financial Guidance
Black Diamond ended 2022 with approximately $122.8 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 third quarter of 2024.
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage precision oncology medicine company focused on the development of MasterKey therapies that target families of oncogenic mutations in clinically validated targets. Black Diamond leverages a deep understanding of cancer genetics and onco-protein structure and function, to discover and develop innovative MasterKey therapies. The Company’s MasterKey therapies are designed to overcome resistance, minimize on-target, wild-type mediated toxicities, and be brain-penetrant to address significant unmet medical needs of patients with genetically defined cancers. The Company is advancing a robust pipeline with lead clinical-stage program BDTX-1535, targeting MasterKey mutations in both EGFR mutant-positive non-small cell lung cancer (NSCLC) and in glioblastoma multiforme (GBM), and BDTX-4933, a program targeting RAF MasterKey mutations in solid tumors, as well as discovery-stage research programs. The Company’s proprietary Mutation-Allostery-Pharmacology, or MAP drug discovery engine, is designed to allow Black Diamond to analyze population-level genetic sequencing tumor data and validate MasterKey mutations. For more information, please visit
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 BDTX-1535 and BDTX-4933, including the ongoing Phase 1 clinical trial and the expected timing for data updates for BDTX-1535 and the timing for initiating a Phase I clinical trial of BDTX-4933, the continued development of the FGFR program, including plans for nominating a development candidate, in addition to plans to disclose an additional development candidate against a new target, the continued development of the MAP drug discovery engine and the Company’s expected cash runway. Any forward-looking statements in this statement 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, 2022, 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)
December 31,
2022
2021
(in thousands)
Cash, cash equivalents, and investments
$
122,807
$
209,786
Total assets
$
156,255
$
247,682
Accumulated deficit
$
(334,989
)
$
(243,820
)
Total stockholders’ equity (deficit)
$
115,695
$
195,900
Black Diamond Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited)
(in thousands, except per share data)
Three Months Ended
December 31,
Year Ended
December 31,
2022
2021
2022
2021
Operating expenses:
Research and development
$
14,609
$
19,664
$
64,437
$
96,829
General and administrative
7,243
6,416
28,391
30,043
Total operating expenses
21,852
26,080
92,828
126,872
Loss from operations
(21,852
)
(26,080
)
(92,828
)
(126,872
)
Other income (expense):
Interest income
677
588
2,031
3,464
Other income (expense)
115
(375
)
(354
)
(2,188
)
Gain on sale of IP
2,232
—
2,232
—
Total other income (expense), net
3,024
213
3,909
1,276
Equity in (losses) of unconsolidated entity
(2,250
)
—
(2,250
)
—
Net loss
$
(21,078
)
$
(25,867
)
$
(91,169
)
$
(125,596
)
Net loss per share, basic and diluted
$
(0.59
)
$
(0.71
)
$
(2.52
)
$
(3.47
)
Weighted average common shares outstanding, basic and diluted
36,389,492
36,229,809
36,325,586
36,189,002
Contact:
Julie Seidel, Stern Investor Relations
(212) 362-1200
investors@bdtx.com
media@bdtx.com
Phase 1Executive ChangeFinancial StatementINDAACR
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Mediastinal Cancer | Phase 2 | NL | 01 Jun 2021 | |
| Advanced Malignant Solid Neoplasm | Phase 2 | US | 19 Dec 2019 | |
| Advanced Malignant Solid Neoplasm | Phase 2 | DK | 19 Dec 2019 | |
| Advanced Malignant Solid Neoplasm | Phase 2 | FR | 19 Dec 2019 | |
| Advanced Malignant Solid Neoplasm | Phase 2 | ES | 19 Dec 2019 |
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 1 | 46 | ctcwgrheay(wyjpzfmrdi) = gtxhxpikyp jehyyetiir (fixdzjodxf ) View more | Positive | 20 May 2021 |
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