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BDTX - Black Diamond Therapeutics Inc News Story

$24.33 0.2  0.7%

Last Trade - 20/04/21

Sector
Healthcare
Size
Mid Cap
Market Cap £624.4m
Enterprise Value £399.1m
Revenue £n/a
Position in Universe 2952nd / 6848

Black Diamond Therapeutics Reports Third Quarter 2020 Financial Results and Provides Corporate Update

Tue 10th November, 2020 12:45pm
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* Continued to enroll and dose patients in Phase 1/2 clinical trial of
BDTX-189, with Phase 1 portion on track to complete by first half of 2021
* Strengthened Board of Directors with appointment of Robert A. Ingram as
Chairman
* Bolstered executive team with appointment of Rachel Humphrey, M.D., as Chief
Medical Officer 
* Cash, cash equivalents, and investments of $333.1 million as of September
30, 2020, expected to be sufficient to fund operations into 2023
CAMBRIDGE, Mass. and NEW YORK, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Black Diamond
Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company
pioneering the discovery and development of small molecule, tumor-agnostic
therapies, today reported financial results for the third quarter ended
September 30, 2020 and provided a corporate update.

“At Black Diamond, we are leveraging our proprietary MAP platform to pioneer
a differentiated approach to drug development, in which we aggregate novel
oncogenic driver mutations into druggable families enabling the design of
potent and selective MasterKey inhibitor product candidates,” said David M.
Epstein, Ph.D., President and Chief Executive Officer of Black Diamond
Therapeutics. “This MasterKey profile extends not only to our lead product
candidate BDTX-189, which is currently progressing through Phase 1/2 clinical
development, but also throughout our early-stage pipeline. We believe the
addition of Rachel Humphrey to our executive team to shepherd these programs
through the clinic, as well as the appointment of Bob Ingram as Chairman of
our Board to lend his leadership and industry expertise, will enable us to
realize the potential of our science and to deliver precision medicines to
patients who currently lack targeted treatment options.”

Recent Developments
* Black Diamond continued to enroll and dose patients in the MasterKey-01
study, a Phase 1/2 clinical trial of BTDX-189. The Company remains on track to
complete the Phase 1 portion of the trial in the first half of 2021.
* In October 2020, Black Diamond presented pre-clinical data on BDTX-189 at
the 32nd Annual EORTC-NCI-AACR Virtual Symposium: * In cell-based assays,
BDTX-189 achieved potent inhibition of 48 ErbB mutant variants, including the
family of epidermal growth factor receptor (EGFR) and human epidermal growth
factor receptor 2 (HER2) Exon 20 insertion mutations, while maintaining
selectivity vs. wild-type EGFR (WT-EGFR).
* The potency and selectivity profile for BDTX-189 against a selection of
allosteric EGFR and HER2 mutations was compared to that of other currently
approved ErbB tyrosine kinase inhibitors (TKIs) and with ErbB TKIs currently
in clinical development. BDTX-189’s selectivity compared favorably with the
other inhibitors evaluated, which either lacked potency against the broad
panel of allosteric ErbB mutant oncogenes or did not achieve targeted
selectivity vs. WT-EGFR.
* Pre-clinical evaluation of BDTX-189’s pharmacokinetic (PK) profile
revealed that BDTX-189 achieved the desired rapid and sustained target
occupancy with rapid clearance.
* BDTX-189 demonstrated dose-dependent tumor inhibition and regression in both
engineered HER2 S310F tumor models and in EGFR Exon 20 insertion
patient-derived xenograft models.
 
* Black Diamond continued to advance its program in glioblastoma multiforme
(GBM) toward nomination of a development candidate, as well as its early-stage
pipeline programs derived from the Company’s Mutation-Allostery-Pharmacology
(MAP) platform.
* In September 2020, Black Diamond appointed biopharmaceutical veteran Robert
A. Ingram as Chairman of its Board of Directors.
* In September 2020, Black Diamond strengthened its executive team with the
appointment of Rachel Humphrey, M.D., as Chief Medical Officer.
Financial Highlights
* Black Diamond ended the third quarter of 2020 with $333.1 million in cash,
cash equivalents, and investments, compared to $78.7 million for the third
quarter of 2019. Net cash used in operations was $11.5 million for the third
quarter of 2020 compared to $5.3 million for the third quarter of 2019.
* Research and development (R&D) expenses were $12.9 million for the third
quarter of 2020 compared to $5.6 million for the third quarter of 2019. The
increase in R&D expenses was primarily related to an increase in headcount and
external fees related to the development of our MAP platform and our product
candidates, including BDTX-189.
* General and administrative (G&A) expenses were $5.6 million for the third
quarter of 2020 compared to $2.5 million for the third quarter of 2019. The
increase in G&A expenses was primarily due to increased headcount and higher
legal and other professional fees due to operating as a public company.
Upcoming Events
* The Company will present pre-clinical data on Black Diamond’s GBM program
at the Society of Neuro-Oncology 2020 Annual Meeting, taking place November
19-21, 2020: * Abstract Title: Potent, selective, and brain penetrant
inhibitors of extracellular domain EGFR oncogenic mutants expressed in GBM
demonstrate efficacy in an intracranial patient derived xenograft model
* Abstract ID: EXTH-59
* Session: Experimental and Translation Sciences Session III
 
* David M. Epstein, Ph.D., President and CEO of Black Diamond, will present at
the Jefferies Virtual London Healthcare Conference on Wednesday, November 18,
2020, at 2:40 PM GMT/9:40 AM ET.
About MasterKey-01

MasterKey-01 (NCT04209465) is a combined Phase 1/2 open-label, two-part,
multicenter study to assess the safety, tolerability, pharmacokinetics, and
anti-tumor activity of BDTX-189, in adult patients with advanced solid tumors
who have no standard therapy available or for whom standard therapy is
considered unsuitable or intolerable. Part A is a Phase 1, first-in-human,
open-label dose escalation study, comprised of initial single-patient,
accelerated titration cohorts followed by multiple-patient cohorts utilizing a
Bayesian design. Part A is designed to determine the recommended Phase 2 dose
and schedule in up to 100 patients with allosteric human epidermal growth
factor receptor 2 (HER2) or HER3 mutation; epidermal growth factor receptor
(EGFR) or HER2 exon 20 insertion mutation; HER2 amplified or overexpressing
tumor; or, EGFR exon 19 deletion or L858R mutation. Part B is a Phase 2,
open-label, multicenter basket study designed to determine antitumor activity
and safety in adult patients with solid tumors that have an allosteric HER2
mutation or EGFR or HER2 exon 20 insertion mutations using next-generation
sequencing. This part will utilize a Simon 2-stage design and enroll up to 100
patients in four cohorts: 1) non-small cell lung cancer with EGFR or HER2 exon
20 insertion mutations; 2) breast cancer with an allosteric ErbB mutation; 3)
solid tumors (except breast) with S310F/Y mutation; and, 4) other tumors
harboring allosteric ErbB mutations not included in cohorts 1-3.

About BDTX-189

BDTX-189 is an orally available, irreversible small molecule inhibitor that is
designed to block the function of family of oncogenic proteins defined by
driver mutations across a range of tumor types, and which affect both of the
epidermal growth factor receptor (EGFR) and the tyrosine-protein kinase,
ErbB-2, or human epidermal growth factor receptor 2 (HER2). BDTX-189 is
designed as a MasterKey inhibitor targeting a family of previously undrugged
and functionally similar mutations in a tumor-agnostic manner. These mutations
include extracellular domain allosteric mutations of HER2, as well as EGFR and
HER2 kinase domain Exon 20 insertions, and additional activating oncogenic
drivers of ErbB. The ErbB receptors are a group of receptor tyrosine kinases
involved in key cellular functions, including cell growth and survival.
BDTX-189 is also designed to spare normal, or wild-type, EGFR, which we
believe has the potential to improve upon the toxicity profiles of current
ErbB kinase inhibitors. Currently, there are no medicines approved by the FDA
to target all of these oncogenic mutations with a single therapy.

BDTX-189 is currently being evaluated in a Phase 1/2 clinical trial
(MasterKey-01) in adult patients with advanced solid tumors with at least one
MasterKey mutation who have no standard therapy available or for whom standard
therapy is considered unsuitable or intolerable. In July 2020, the U.S. Food
and Drug Administration (FDA) granted Fast Track designation to BDTX-189 for
the treatment of adult patients with solid tumors harboring an allosteric HER2
mutation or an EGFR or HER2 Exon 20 insertion mutation who have progressed
following prior treatment and who have no satisfactory treatment options.

About Black Diamond

Black Diamond Therapeutics is a precision oncology medicine company pioneering
the discovery of small molecule, tumor-agnostic therapies. Black Diamond
targets undrugged mutations in patients with genetically defined cancers.
Black Diamond is built upon a deep understanding of cancer genetics, protein
structure and function, and medicinal chemistry. The Company’s proprietary
technology platform, Mutation-Allostery-Pharmacology (MAP) platform, is
designed to allow 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 in a tumor-agnostic manner that targets a specific family of
mutations. Black Diamond was founded by David M. Epstein, Ph.D. and Elizabeth
Buck, Ph.D., and, beginning in 2017, together with Versant Ventures, began
building the MAP platform and chemistry discovery engine. For more
information, please visit www.blackdiamondtherapeutics.com.

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 future plans
or expectations for the Mutation-Allostery-Pharmacology platform, including
the potential of the Company’s strategy and product candidates, and the
continued development and advancement of the Company’s pipeline, including
BDTX-189, the GBM program and other early-stage pipeline programs. 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: the success, cost, and timing of the
Company’s product candidate development activities and planned clinical
trials, the Company’s ability to execute on its strategy, regulatory
developments in the United States, the Company’s ability to fund operations,
and the impact that the current COVID-19 pandemic will have on the Company’s
clinical trials, supply chain, and operations, as well as those risks and
uncertainties set forth in its 2019 annual report on Form 10-K filed with the
United States Securities and Exchange Commission and its other 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)

                                          September 30, 2020           December 31, 2019        
 Cash, cash equivalents, and investments  $        333,072             $       154,666          
 Total assets                             $        346,435             $       158,295          
 Derivative liabilities                   $        —                   $       16               
 Convertible preferred stock              $        —                   $       200,573          
 Accumulated deficit                      $        (95,598  )          $       (50,970  )       
 Total stockholders’ equity (deficit)     $        327,345             $       (47,157  )       



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

                                                                                                             Three Months Ended September 30,                       Nine Months Ended September 30,                       
                                                                                                             2020                           2019                    2020                           2019                   
 Operating expenses:                                                                                                                                                                                                      
 Research and development (inclusive of $190, $3,480, $2,293 and $8,497 respectively, with a related party)  $       12,929                 $      5,634            $       30,453                 $      14,293          
 General and administrative (inclusive of $0, $176, $0 and $357 respectively, with a related party)          5,551                          2,514                   15,934                         4,695                  
 Total operating expenses                                                                                    18,480                         8,148                   46,387                         18,988                 
 Loss from operations                                                                                        (18,480          )             (8,148         )        (46,387          )             (18,988         )      
 Other income (expense):                                                                                                                                                                                                  
 Interest expense                                                                                            —                              —                       (1               )             —                      
 Interest income                                                                                             1,162                          1                       2,787                          21                     
 Change in fair value of derivative liabilities                                                              —                              (1,116         )        —                              (6,416          )      
 Other (expense) income                                                                                      (594             )             (5             )        (1,027           )             —                      
 Total other income (expense), net                                                                           568                            (1,120         )        1,759                          (6,395          )      
 Net loss                                                                                                    $       (17,912  )             $      (9,268  )        $       (44,628  )             $      (25,383  )      
 Net loss per share, basic and diluted                                                                       $       (0.50    )             $      (4.50   )        $       (1.42    )             $      (12.36   )      
 Weighted average common shares outstanding, basic and diluted                                               35,927,485                     2,065,676               31,860,716                     2,054,115              
                                                                                                                                                                                                                          

Contacts:

For Investors:
Natalie Wildenradt
investors@bdtherapeutics.com

For Media:
Kathy Vincent
(310) 403-8951
media@bdtherapeutics.com

(https://www.globenewswire.com/NewsRoom/AttachmentNg/b8da4d92-789b-4f0a-a1e2-2739af370155)



GlobeNewswire, Inc. 2020
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