Black Diamond Therapeutics, Inc.
Developing MasterKey Therapies to Defeat Cancer Resistance
November 2023
Forward-Looking Statements
This presentation contains forward-looking statements of Black Diamond Therapeutics, Inc. ("we," "us," "our") within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "potential," "continue," "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained in this presentation include, but are not limited to, statements regarding our future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters; our current and prospective product candidates, the timing and advancement of current and planned clinical trials, our ability to replicate results achieved in our preclinical studies or clinical trials; research and development costs; the competitive landscape and market for our product candidates; and the timing and success of our development and commercialization of our product candidates, including our ability to establish and maintain collaborations or strategic relationships. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward- looking statements, see the section entitled "Risk Factors" in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission (the "SEC"), as well as discussions of potential risks, uncertainties, and other important factors in our other subsequent filings with the SEC. In addition, we have not conducted any head-to-head studies comparing our product candidates to any third-party drug products or candidates, whether investigated or approved. Information regarding other drug products in this presentation is meant to provide context for illustrative purposes only. Because there are no head-to-head studies, no conclusions should be made based on cross-study comparisons. Recipients are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact.
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Cancer is a Complex and Ever-Evolving Disease
Current targeted therapies were designed against a
limited subset of oncogenic mutations
Increasing adoption of liquid biopsies reveals a broader
set of oncogenic mutations
We are Developing MasterKey Therapies to Defeat Cancer Resistance
Our oral therapies are designed so that patients
have the opportunity for a longer, healthier, active life
Black Diamond's MasterKey
approach provides one solution for many mutations and addresses larger patient populations
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Black Diamond Therapeutics At-a-Glance
Clinical-stage company | Experienced team with | Pipeline of oral, brain | ||
advancing MasterKey | deep understanding | penetrant drug | ||
therapies that expand | of cancer biology and | candidates selectively | ||
the addressable patient | oncology drug | targeting families of | ||
population | development | oncogenic mutations | ||
Lead asset BDTX-1535 | Multiple clinical | Strong balance sheet, | ||
shows durable clinical | catalysts across the | with runway into 1H25; | ||
responses in NSCLC, | pipeline in 2024 | ended Q3 2023 with | ||
with additional | $144.3M in cash | |||
opportunity in GBM | ||||
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MasterKey: One Solution for Many Mutations
Current Approach: | Black Diamond Approach: |
Targeting single mutations in individual tumor types | Targeting families of oncogenic mutations |
Limited addressable patient population | Expanded addressable patient population |
Potent against broad mutation
families (including drug resistance mutations)
Brain penetrant to treat CNS disease
Selective targeting to deliver
well-tolerated therapies
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Advancing Wholly-Owned Pipeline Across Multiple Oncology Indications
Drug | |||||||
Target | Candidate | Indication | Discovery | IND-Enabling | Phase 1 | Phase 2/3 | |
EGFR-driven | |||||||
Dose expansion cohorts enrolling with data expected 2024 | |||||||
NSCLC | |||||||
EGFR | BDTX-1535 | EGFR-driven | |||||
Dose escalation enrolled with data expected 2023; | |||||||
GBM | Window of Opportunity enrolling with data expected 2Q24 | ||||||
KRAS-driven | ||
NSCLC | ||
RAF | BDTX-4933 | Other RAS/RAF- |
driven solid | ||
tumors |
Phase 1 trial enrolling with dose escalation data expected 2024
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BDTX-1535: EGFR MasterKey Inhibitor with Clinical Proof-of-Concept
MasterKey
Spares
WT-EGFR
BDTX-1535 | Covalent |
Brain
Penetrant
Clinical
PoC
Targets EGFR classical drivers, non-classical drivers, and resistance mutations
Selective for mutations versus WT-EGFR to deliver favorable safety profile
Oral small molecule with covalent MOA for potency and durability
Designed to treat CNS tumors and brain metastases
Clinical proof-of-concept in NSCLC achieved
WT=Wild-Type; MOA=mechanism of action; CNS=Central Nervous System; NSCLC=Non-Small Cell Lung Cancer | 7 |
BDTX-1535: Phase 1 Clinical Proof-of-Concept Achieved in NSCLC
EGFR Mutant Non-Small | EGFR Altered |
Cell Lung Cancer (NSCLC) | Glioblastoma (GBM) |
Clinical proof-of-concept | Phase 1 update expected |
achieved | later in 2023 |
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BDTX-1535:
Summary of NSCLC Data
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BDTX-1535 Addresses the Most Clinically Relevant EGFR Mutations in NSCLC: Classical / Non-Classical Drivers and C797S Resistance
Evolution of the EGFR mutation landscape over the past 20 years
2005 | 2013 | 2015 | 2018 | 2023 | BDTX-1535 |
Classical drivers
L858R / Ex19del | Non-classical drivers | |||||
C797S resistance | ||||||
Mutation | Classical EGFR | |||||
landscape | mutations | |||||
described | ||||||
T790M resistance
Treatments | T790M C797S | |||
(2/3L) | (1L) | (2L) | (1L) | |
Sequencing | ||||
Mutation specific sequencing | NGS revolution | Realization of >50 non-classical driver mutations | ||
practices | ||||
BDTX-1535: opportunity to address all relevant mutations-critical for a 4th generation EFGR TKI
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Black Diamond Therapeutics Inc. published this content on 04 November 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 November 2023 13:12:06 UTC.