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BDTX - Black Diamond Therapeutics Inc News Story

$25.5 -0.1  -0.2%

Last Trade - 07/05/21

Sector
Healthcare
Size
Mid Cap
Market Cap £660.0m
Enterprise Value £434.5m
Revenue £n/a
Position in Universe 2925th / 6858

Black Diamond Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update

Thu 25th March, 2021 11:45am
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* Patient enrollment and dosing in the Phase 1/2 clinical trial of BDTX-189
continue to track in line with projections at initiation of the study, with
dose-escalation portion on track to complete in first half of 2021; initiation
of safety expansion cohort anticipated in the second quarter of 2021 with
start of Phase 2 portion planned for second half of 2021
* BDTX-1535, a brain-penetrant MasterKey inhibitor of EGFR mutations for
glioblastoma multiforme (GBM) and solid tumors, including those that
metastasize to the brain, is on track to enter the clinic in 2022
* Pre-clinical data for MasterKey inhibitors targeting proprietary families of
BRAF and FGFR2/3 mutations supporting differentiated profiles were presented
at the European Society for Medical Oncology Targeted Anticancer Therapies
Congress (ESMO TAT); programs continue to advance with IND filings anticipated
in 2022
* Cash, cash equivalents, and investments of $315.1 million as of December 31,
2020, expected to be sufficient to fund operations into 2023
CAMBRIDGE, Mass. and NEW YORK, March 25, 2021 (GLOBE NEWSWIRE) -- Black
Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine
company pioneering the discovery and development of small molecule, MasterKey
therapies, today reported financial results for the fourth quarter and full
year ended December 31, 2020 and provided a corporate update.

“2020 was a pivotal year for Black Diamond with key progress made across our
organization,” said David M. Epstein, Ph.D., President and Chief Executive
Officer of Black Diamond Therapeutics. “We initiated and are successfully
executing Part A of our MasterKey-01 study of BDTX-189 in patients with solid
tumors harboring any MasterKey-targeted epidermal growth factor receptor
(EGFR) or human epidermal growth factor receptor 2 (HER2) genomic alterations.
We’re looking forward to sharing preliminary clinical data for this program
in the first half of this year.”

Dr. Epstein continued: “Importantly, the breadth and versatility of our drug
discovery engine leveraging the MAP platform continues to be demonstrated.
BDTX-1535, a brain-penetrant wild-type sparing EGFR inhibitor targeting a
novel family of EGFR mutations, advanced into IND-enabling studies, and we
expect to file an IND in the first half of 2022. Additionally, Black
Diamond’s early-stage programs targeting BRAF and FGFR2/3 oncogenes show
promise in their ability to address limitations of current-generation targeted
therapies. We look forward to maintaining this momentum across our pipeline
and sharing additional updates throughout 2021.”

Recent Developments

BDTX-189:
* Black Diamond continued to enroll and dose patients in the MasterKey-01
study, a Phase 1/2 clinical trial of BDTX-189. More than 50 patients have been
dosed with BDTX-189 to date. Eligibility included all solid tumors harboring
any of the more than 50 pre-defined genomic alterations in EGFR and HER2. The
Company is on track to complete the dose-escalation portion of the Phase 1
clinical trial in the first half of 2021.
* Preliminary Phase 1 clinical data will be presented at a scientific
conference in the first half of 2021.
* The Company is working toward selection of the recommended Phase 2 dose for
BDTX-189 and plans to initiate the safety expansion cohort in the second
quarter of 2021. The Phase 2 portion of the MasterKey-01 study is on track to
begin in the second half of 2021.
* In March 2021, the U.S. Food and Drug Administration (FDA) notified Black
Diamond that, because the Phase 2 portion of the MasterKey-01 study is
potentially registrational and may support a new drug application, the Company
may only enroll up to 50 patients in Phase 2 before results of routine
three-month good laboratory practice (GLP) toxicology studies have been
submitted and accepted by the FDA.
* This partial clinical hold on Phase 2 enrollment is not based on any safety
findings from the MasterKey-01 trial and has no impact on completion of our
Phase 1 study (including the planned safety expansion cohort). The Company has
initiated the three-month GLP toxicology studies and does not anticipate any
delays to its clinical trial timelines for BDTX-189.
BDTX-1535:
* In November 2020, Black Diamond announced the nomination of BDTX-1535 as the
Company’s development candidate for the treatment of GBM, as well as the
initiation of IND-enabling studies.
* Additionally, Black Diamond is exploring BDTX-1535’s potential as a
MasterKey inhibitor of a spectrum of allosteric and canonical EGFR mutations
including those solid tumors that metastasize to the brain, such as non-small
cell lung cancer.
* Black Diamond expects to file an Initial New Drug (IND) application for
BDTX-1535 in the first half of 2022.
* In November 2020, the Company presented pre-clinical data on BDTX-1535 at
the 2020 Society for Neuro-Oncology Annual Meeting: * In cell-based assays,
BDTX-1535 achieved potent inhibition of all members of the family of oncogenic
EGFR variants believed to be tumor-drivers in GBM, with selectivity versus
wild-type-EGFR.
* In mouse models, BDTX-1535 demonstrated a pharmacokinetic profile that
supports its ability to penetrate the blood-brain barrier.
* BDTX-1535 achieved complete and sustained inhibition of the phosphorylated
state of oncogenic EGFR in mouse models bearing Ba/F3 allosteric EGFR mutants,
as well as tumor growth inhibition in an intracranial PDX tumor model driven
by allosteric EGFR mutation.
Early-Stage Pipeline:
* Recently, Black Diamond presented pre-clinical data for its BRAF and
fibroblast growth factor receptor (FGFR) programs at ESMO TAT: * Black
Diamond’s BRAF program candidates have been designed for potency against a
spectrum of non-canonical Class II/III (non-V600), as well as to avoid
induction of paradoxical activation. Tumor regression in mouse models has been
observed.
* Black Diamond’s FGFR program candidates are inhibitors with broad coverage
of FGFR2 and FGFR3 oncogenes, while sparing inhibition of FGFR1 and retaining
activity against gatekeeper mutations. Tumor regression in mouse models has
been observed.
 
* The Company anticipates IND filings for both programs in 2022.
Corporate:
* Black Diamond recently appointed oncology clinical development veteran Kapil
Dhingra, M.D., to its Board of Directors.
* In September 2020, Black Diamond appointed biopharmaceutical veteran Robert
A. Ingram as Chairman of its Board of Directors.
* In the second half of 2020, Black Diamond strengthened its executive team
with the appointment of Rachel Humphrey, M.D., as Chief Medical Officer and
Fang Ni, Pharm.D., as Chief Business Officer.
Financial Highlights
* Black Diamond ended 2020 with $315.1 million in cash, cash equivalents, and
investments compared to $154.7 million as of December 31, 2019. Net cash from
financing activities for the year ended December 31, 2020 was $214.9 million
compared to $127.8 million for the year ended December 31, 2019. Net cash used
in operations was $52.1 million for the year ended December 31, 2020 compared
to $24.7 million for the year ended December 31, 2019.
* Net loss for the year ended December 31, 2020 was $67.3 million compared to
$35.3 million for the year ended December 31, 2019.
* Research and development (R&D) expenses were $48.2 million for the year
ended December 31, 2020 compared to $21.8 million for the year ended December
31, 2019. The increase in R&D expenses was primarily related to increase in
headcount, pre-clinical development, and IND filing of BDTX-189.
* General and administrative (G&A) expenses were $21.4 million for the year
ended December 31, 2020, compared to $7.6 million for the year ended December
31, 2019. The increase in G&A expenses was primarily due to an increase in
personnel and other corporate-related costs.
Upcoming Events
* Pre-clinical data on BDTX-189 and BDTX-1535 will be presented as
late-breaking poster presentations at the American Association for Cancer
Research Virtual Annual Meeting, taking place April 10-15, 2021. Presentation
details are as follows: * Prospective pre-clinical modeling to estimate
clinical pharmacokinetics and doses of BDTX-189, an inhibitor of allosteric
ErbB mutations in advanced solid malignancies * Date and Time: Saturday, April
10, 8:30 AM ET
* Abstract Number: LB127
 
* CNS penetrant, irreversible inhibitors potently inhibit the family of
allosteric oncogenic EGFR mutants expressed in GBM and demonstrate efficacy in
patient-derived xenograft models * Date and Time: Saturday, April 10, 8:30 AM
ET
* Abstract Number: LB140
 
 
* David M. Epstein, Ph.D., President and CEO of Black Diamond, is scheduled to
present at the 10(th) Annual J.P. Morgan Napa Valley Forum on Wednesday, March
31, 2021 at 3:00 PM 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 U.S.
Food and Drug Administration (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 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 Therapeutics
Black Diamond Therapeutics is a precision oncology medicine company pioneering
the discovery of small molecule, MasterKey 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 and drug discovery engine,
Mutation-Allostery-Pharmacology, or 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 the continued
development of BDTX-189 and the timing for completing the dose escalation
portion, initiating the safety expansion cohort, or starting the Phase 2
portion of the ongoing clinical trial of BDTX-189, 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 timing for nominating development candidates in each program. 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 IND-enabling
and 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 and pre-clinical studies, 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)

                                          December 31,                               
                                          2020                  2019                 
                                          (in thousands)                             
 Cash, cash equivalents, and investments  $   315,067           $   154,666          
 Total assets                             $   329,670           $   158,295          
 Derivative liabilities                   $   —                 $   16               
 Convertible preferred stock              $   —                 $   200,573          
 Accumulated deficit                      $   (118,224  )       $   (50,970  )       
 Total stockholders’ equity (deficit)     $   307,758           $   (47,157  )       
                                                                                     

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

                                                                                                            Three Months Ended December 31,                              Year Ended December 31,                                
                                                                                                            2020                             2019                        2020                          2019                     
 Operating expenses:                                                                                                                                                                                                            
 Research and development (inclusive of $71, $1,469, $2,364 and $9,966 respectively, with a related party)  $     17,756                     $     7,460                 $     48,209                  $     21,753             
 General and administrative (inclusive of $0, $88, $0 and $445, respectively, with a related party)         5,427                            2,884                       21,361                        7,579                    
 Total operating expenses                                                                                   23,183                           10,344                      69,570                        29,332                   
 Loss from operations                                                                                       (23,183        )                 (10,344       )             (69,570        )              (29,332        )         
 Other income (expense):                                                                                                                                                                                                        
 Interest expense                                                                                           —                                —                           (1             )              —                        
 Interest income                                                                                            1,254                            440                         4,041                         461                      
 Change in fair value of derivative liabilities                                                             —                                23                          —                             (6,393         )         
 Other income (expense)                                                                                     (697           )                 6                           (1,724         )              6                        
 Total other income (expense), net                                                                          557                              469                         2,316                         (5,926         )         
 Net loss                                                                                                   $     (22,626  )                 $     (9,875  )             $     (67,254  )              $     (35,258  )         
 Net loss per share, basic and diluted                                                                      $     (0.63    )                 $     (4.63   )             $     (2.05    )              $     (16.99   )         
 Weighted average common shares outstanding, basic and diluted                                              36,023,503                       2,139,961                   32,907,100                    2,075,753                

Contacts:
For Investors:
Natalie Wildenradt
investors@bdtx.com

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

 

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GlobeNewswire, Inc. 2021
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