Black Diamond Therapeutics Reports Third Quarter 2021 Financial Results and Company Update

  • Black Diamond continues preparations for the launch of Phase 2 of the BDTX-189 MasterKey-01 study this year

  • Preclinical data from the BDTX-1535, BRAF and FGFR programs presented at the AACR-NCI-EORTC (ANE) international conference

  • Strategic partnership established with OpenEye to accelerate drug discovery efforts using cloud-based molecular dynamics technology

  • Cash, cash equivalents and investments of $ 235.0 million as at September 30, 2021, which should be sufficient to finance operations until the second half of 2023

CAMBRIDGE, Mass. And NEW YORK, Nov. 08, 2021 (GLOBE NEWSWIRE) – Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, announced today hui its financial results for the third quarter ended September 30, 2021 and provided a company update.

“Black Diamond’s approach remains deeply rooted in our proprietary Mutation-Allostery-Pharmacology (MAP) drug discovery engine, which harnesses population-level genetic sequencing that enables the identification of novel oncogenic mutations. We are well positioned to advance the differentiated MasterKey programs on a range of oncogenic targets for patient populations with unmet need, ”said David Epstein, Ph.D., President and CEO of Black Diamond Therapeutics. “We are excited about the continued progression of our pipeline of MasterKey inhibitor programs, including the BDTX-189 MasterKey-01 study, our BDTX-1535 program with an IND filing expected by the first half of 2022, and our BRAF growth factor and fibroblast receptor programs (FGFR).

Recent developments

BDTX-189:

BDTX-1535:

  • Black Diamond continues to advance BDTX-1535 through studies enabling IND and plans to file an IND application by the first half of 2022.

  • In October 2021, Black Diamond presented preclinical data for BDTX-1535 at the ANE international conference:

    • In cellular tests, BDTX-1535 obtained potent and selective inhibition of a range of EGFR mutations expressed in glioblastoma (GBM) and non-small cell lung cancer (NSCLC), including mutations canonical, non-canonical, and drug resistance, such as EGFR-C797S, which may occur following treatment with osimertinib.

    • BDTX-1535 demonstrated a favorable brain penetrating pharmacokinetic (PK) profile in mouse, rat and dog models.

    • In a range of tumor models, including intracranial GBM models and lung cancer drug resistance models expressing targeted EGFR mutations, BDTX-1535 has been shown to inhibit tumor growth dose- dependent and obtained complete regression with no noticeable impact on body weight.

Early stage pipeline:

  • Black Diamond continues to advance its early stage pipeline programs designed to target cancers caused by mutations in BRAF and FGFR. The Company expects IND deposits for both programs in 2022.

  • In October 2021, Black Diamond presented preclinical data for the BRAF and FGFR programs at the ANE international conference:

    • BRAF:

      • The presentation described preclinical data for a flagship compound in Black Diamond’s BRAF program, designed for potency and selectivity against a spectrum of non-canonical class II / III mutations, in addition to class I (V600E) mutations.

      • In cellular assays, the lead compound demonstrated potent inhibition of a spectrum of BRAF class I / II / III mutations.

      • Unlike current generation BRAF inhibitors, such as encorafenib and vemurafenib, treatment of wild-type BRAF-harboring cells (WT-BRAF) with the Black Diamond compound did not result in an increase in pERK, a signal paradoxical activation.

      • In a BRAF-KIAA1549 fusion allograft tumor model, the lead compound exhibited dose-dependent inhibition of pERK and anti-tumor efficacy.

    • FGFR:

      • The presentation illustrated the Black Diamond approach, centered on a four-pronged optimization strategy with the aim of providing an inhibitor that has broad coverage of the FGFR2 and FGFR3 oncogenes, while sparing the inhibition of FGFR1 and retaining the activity against resistance mutations.

      • In cellular assays, compounds of the FGFR program demonstrated potent and selective inhibition of a spectrum of oncogenic FGFR2 / 3 mutations, while sparing FGFR1. In addition, compounds in the FGFR program have demonstrated improved potency against resistance mutations.

      • In an in vivo study conducted in a UM-UC-14 mouse model (FGFR3-S249C), compounds of the FGFR program demonstrated anti-tumor activity. In addition, in mouse and rat models, compounds of the FGFR program did not promote hyperphosphatemia.

Business:

  • In September 2021, Black Diamond entered into a strategic partnership with OpenEye Scientific to incorporate OpenEye’s Orion® molecular design platform into Black Diamond’s proprietary Mutation-Allostery-Pharmacology (MAP) drug discovery engine to help to advance MasterKey inhibitor cancer therapies. OpenEye’s Orion Software-as-a-Service platform enables Black Diamond to perform rapid simulation and analysis of protein movement.

Financial Highlights

  • Black Diamond ended the third quarter of 2021 with $ 235.0 million in cash, cash equivalents and investments, compared to $ 315.1 million as at December 31, 2020. Net cash used in operations was $ 26.5 million for the third quarter of 2021, compared to $ 11.5 million in the third quarter of 2020.

  • Research and development (R&D) spending amounted to $ 27.6 million for the third quarter of 2021, compared to $ 12.9 million for the third quarter of 2020. The increase in R&D spending is mainly related an increase in staff and an increase in preclinical and clinical development expenses.

  • General and administrative (G&A) expenses were $ 7.7 million for the third quarter of 2021, compared to $ 5.6 million for the third quarter of 2020. The increase in G&A expenses is mainly due to an increase in personnel costs and other costs related to the business.

About Black Diamond Therapeutics, Inc.
Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery of MasterKey therapies. Black Diamond targets non-drug mutations in patients with genetically defined cancers. Black Diamond is built on a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company’s proprietary technology platform and drug discovery engine, the Mutation-Allostery-Pharmacology (MAP) platform, is designed to enable Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families, and develop a single small molecule therapy that targets a specific family of mutations, called MasterKey therapy. Black Diamond was founded by David M. Epstein, Ph.D., and Elizabeth Buck, Ph.D. For more information, please visit www.blackdiamondtherapeutics.com.

Forward-looking statements
Statements in this press release regarding matters which are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Since such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by these forward-looking statements. These statements include, but are not limited to, statements regarding the continued development of BDTX-189 and the launch schedule for Phase 2 of the ongoing BDTX-189 clinical trial, the continued development and advancement of BDTX. -1535 in IND- enabling studies, including expectations for filing an IND, and the development of the BRAF and FGFR programs, including the timetable for filing INDs in each program, and the expected cash flow track from the society. All forward-looking statements contained in this statement are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those stated. or implied by these forward-looking statements. . Risks that contribute to the uncertain nature of forward-looking statements include: the success, cost and timing of the Company’s product candidate development activities and planned studies and clinical trials enabling the IND, the Company’s ability to execute its strategy, regulatory developments in the United States, the Company’s ability to finance its operations and the impact that the current COVID-19 pandemic will have on the Company’s clinical trials and preclinical studies, the supply chain and the transactions, as well as the risks and uncertainties set out in its 2020 Annual Report on Form 10-K filed with the United States Securities and Exchange Commission and its other documents 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 assumes no obligation to update these statements to reflect events that occur or circumstances that exist after the date on which they were made.

Black Diamond Therapeutics, Inc.

Data from the condensed consolidated balance sheet (unaudited)

(in thousands)

September 30
2021

The 31st of December,
2020

Cash, cash equivalents and investments

$

235,008

$

315,067

Total assets

$

274,126

$

329 670

Accumulated deficit

$

(217,953

)

$

(118,224

)

Total equity for shareholders

$

218,948

$

307,758

Black Diamond Therapeutics, Inc.

Condensed Consolidated Statements of Income (unaudited)

(in thousands, excluding data per share and per share)

Three months ended
September 30

Nine months ended
September 30

2021

2020

2021

2020

Operating costs :

Research and development

$

27 626

$

12 929

$

77 165

$

30,453

general and administrative

7 738

5 551

23 627

15,934

Total operating expenses

35 364

18,480

100 792

46,387

Operating loss

(35 364

)

(18,480

)

(100,792

)

(46,387

)

Other income (expenses):

Interest charges

(1

)

Interest income

776

1,162

2 876

2,787

Other (expenses) income

(489

)

(594

)

(1,813

)

(1,027

)

Total other income (expense), net

287

568

1,063

1759

Net loss

$

(35,077

)

$

(17 912

)

$

(99,729

)

$

(44 628

)

Net loss per share, basic and diluted

$

(0.97

)

$

(0.50

)

$

(2.76

)

$

(1.42

)

Weighted average common shares outstanding, basic and diluted

36 219 137

35 927 485

36 175 249

31 860 716

Contacts:

For investors:
Nathalie Wildenradt
[email protected]

For the media:
Catherine vincent
(310) 403-8951
[email protected]

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