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Black Diamond Therapeutics (BDTX)

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, 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.

Company profile

Ticker
BDTX
Exchange
CEO
David M. Epstein
Employees
Incorporated
Location
Fiscal year end
Former names
Aset Therapeutics, Inc.
SEC CIK
Subsidiaries
Black Diamond Therapeutics (Canada) Inc. • Black Diamond Therapeutics Security Corporation ...

BDTX stock data

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

9 Aug 22
28 Sep 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 57.05M 57.05M 57.05M 57.05M 57.05M 57.05M
Cash burn (monthly) (no burn) (no burn) 7.72M 9.19M 6.02M 8.1M
Cash used (since last report) n/a n/a 22.8M 27.14M 17.78M 23.91M
Cash remaining n/a n/a 34.24M 29.91M 39.27M 33.13M
Runway (months of cash) n/a n/a 4.4 3.3 6.5 4.1

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
16 Sep 22 Robert Alexander Ingram Common Stock Grant Acquire A No No 2.62 6,584 17.25K 33,479
16 Sep 22 Velleca Mark A. Common Stock Grant Acquire A No No 2.62 4,294 11.25K 12,733
16 Sep 22 Dixon Wendy L Common Stock Grant Acquire A No No 2.62 4,103 10.75K 9,049
16 Sep 22 Behbahani Ali Common Stock Grant Acquire A No No 2.62 4,532 11.87K 20,087
29 Jun 22 Fang Ni Common Stock Buy Acquire P No No 2.4407 25,000 61.02K 69,026
93.7% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 76 88 -13.6%
Opened positions 12 11 +9.1%
Closed positions 24 20 +20.0%
Increased positions 12 22 -45.5%
Reduced positions 26 26
13F shares Current Prev Q Change
Total value 372.1M 387.69M -4.0%
Total shares 34.05M 34.68M -1.8%
Total puts 134.5K 69.6K +93.2%
Total calls 85.7K 4.5K +1804.4%
Total put/call ratio 1.6 15.5 -89.9%
Largest owners Shares Value Change
BLVGF Bellevue 4.72M $11.61M +43.2%
Versant Venture Capital VI 4.33M $145.19M 0.0%
BBBOF BB Biotech 3.99M $13.36M +15.9%
NEA Management 3.45M $8.49M 0.0%
New Enterprise Associates 16 3.45M $131.05M 0.0%
Ra Capital Management 2.59M $6.37M 0.0%
Boxer Capital 2.01M $4.96M 0.0%
Artal 1.65M $4.05M 0.0%
BLK Blackrock 1.27M $3.13M -45.4%
Flynn James E 778.79K $29.59M 0.0%
Largest transactions Shares Bought/sold Change
BLVGF Bellevue 4.72M +1.42M +43.2%
BLK Blackrock 1.27M -1.06M -45.4%
FHI Federated Hermes 159.55K -875.59K -84.6%
BBBOF BB Biotech 3.99M +548.4K +15.9%
Newtyn Management 520K +520K NEW
K2 Principal Fund 507.65K +507.65K NEW
STT State Street 76.38K -292.88K -79.3%
Healthcare Of Ontario Pension Plan Trust Fund 73.1K -284K -79.5%
JPM JPMorgan Chase & Co. 1.51K -258.96K -99.4%
Millennium Management 247.54K +247.54K NEW

Financial report summary

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Risks
  • Risks related to the development of our product candidates
  • We are very early in our development efforts and are substantially dependent on our clinical-stage product candidates, BDTX-1535 and BDTX-189. If we are unable to advance BDTX-1535, BDTX-189 or any of our other product candidates through clinical development, obtain regulatory approval and ultimately commercialize BDTX-1535 or BDTX-189 or any of our other product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates. We may find it difficult to enroll patients in our Phase 1 clinical trial for BDTX-1535 or our open-label Phase 1/2 clinical trial for BDTX-189 with the genetic mutations these product candidates are designed to target.
  • We have limited experience as a company in conducting clinical trials.
  • Our preclinical studies and clinical trials may fail to demonstrate adequately the safety, potency, purity and efficacy of any of our product candidates, which would prevent or delay development, regulatory approval and commercialization.
  • We may not be able to file INDs or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
  • Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics for our product candidates could harm our drug development strategy and operational results.
  • Since the number of patients that we plan to dose in our Phase 1 clinical trial of BDTX-1535 and our Phase 1/2 clinical trial of BDTX-189 is small, the results from such clinical trials, once completed, may be less reliable than results achieved in larger clinical trials, which may hinder our efforts to obtain regulatory approval for our product candidates.
  • Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future clinical trial results. We may encounter substantial delays in clinical trials, or may not be able to conduct or complete clinical trials on the expected timelines, if at all. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.
  • We may conduct clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • Our discovery and preclinical development is focused on the development of precision medicines for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs is novel and may never lead to marketable products.
  • Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to use and expand our MAP drug discovery engine to build a pipeline of product candidates with commercial value.
  • The market opportunities for our product candidates may be relatively small as it will be limited to those patients who are ineligible for or have failed prior treatments and our estimates of the prevalence of our target patient populations may be inaccurate.
  • Business or economic disruptions or global health concerns could seriously harm our development efforts and increase our costs and expenses.
  • We or third parties upon whom we depend may be adversely affected by natural disasters and/or global health pandemics, and our business, financial condition and results of operations could be adversely affected.
  • Manufacturing our product candidates is complex and we may encounter difficulties in production. We will rely on third parties to manufacture our preclinical and clinical product supplies, and we may rely on third parties to produce and process our product candidates, if approved. If we encounter such difficulties, our ability to provide supply of our product candidates for preclinical studies and clinical trials or for commercial purposes could be delayed or stopped.
  • We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue.
  • A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • Risks related to our financial position and capital requirements
  • Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • We have incurred significant losses since inception, and we expect to incur losses over the next several years and may not be able to achieve or sustain revenues or profitability in the future.
  • We have not generated any revenue from our product candidates and may never be profitable.
  • We will need substantial additional funding. If we are unable to raise capital when needed, we would be compelled to delay, reduce or eliminate our product development programs or commercialization efforts.
  • Risks related to government regulation
  • We are very early in our development efforts. Most of our product candidates are still in early clinical or preclinical development. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
  • Our clinical trials may fail to demonstrate adequately the safety and efficacy of any of our product candidates, which would prevent or delay regulatory approval and commercialization.
  • We may in the future seek orphan drug status for BDTX-1535, BDTX-189 and some of our other future product candidates, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug status, including market exclusivity, which may cause our revenue, if any, to be reduced.
  • A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • A Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval.
  • Accelerated approval by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • If we are unable to successfully validate, develop and obtain regulatory approval for companion diagnostic tests for our drug candidates that are required or experience significant delays in doing so, we may not realize the full commercial potential of these drug candidates.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • The insurance coverage and reimbursement status of newly-approved products is uncertain. Our product candidates may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
  • Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
  • Inadequate funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • If we are unable to obtain and maintain patent and other intellectual property protection for BDTX-1535, BDTX-189, our MAP drug discovery engine and our other product candidates and technology, or any other product candidates or technology we may develop, or if the scope of intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to commercialize BDTX-1535, BDTX-189, or any other product candidates or technology may be adversely affected.
  • If we fail to comply with our obligations in any future agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our future licensors, we could lose license rights that are important to our business.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • Any issued patents we may own or in-license in the future covering our product candidates could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, including the USPTO.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
  • If we do not obtain patent term extension and data exclusivity for any of our current or future product candidates we may develop, our business may be materially harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected.
  • Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
  • Third-party claims of intellectual property infringement, misappropriation or other violations may be costly and time consuming and may prevent or delay our product discovery and development efforts.
  • We may be involved in lawsuits to protect or enforce our intellectual property rights, including any patents we may own or in-license in the future, which could be expensive, time-consuming and unsuccessful.
  • We may be subject to claims challenging the inventorship or ownership of any intellectual property, including any patents we may own or in-license in the future.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information or alleged trade secrets of third parties or competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
  • Risks related to our reliance on third parties
  • We rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
  • We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.
  • We currently rely and expect to rely in the future on the use of manufacturing suites in third-party facilities or third parties to manufacture our product candidates. Our business could be harmed if we are unable to use third-party manufacturing suites or if the third party manufacturers fail to provide us with sufficient quantities of our product candidates or fail to do so at acceptable quality levels or prices.
  • Our manufacturing process needs to comply with FDA regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in or termination of our clinical programs and suspension or withdrawal of any regulatory approvals.
  • If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • Risks related to managing growth and employee matters
  • We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Our internal computer systems, or those used by our third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of the development programs of our product candidates.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • Risks related to ownership of our common stock
  • The price of our stock is volatile, and you could lose all or part of your investment.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • We do not intend to pay dividends on our common stock, so any returns will be limited to the value of our stock.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence over matters subject to stockholder approval.
  • We are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.
  • We are incurring, and will continue to incur, significant increased expenses and administrative burdens as a public company, which could have an adverse effect on our business, financial condition and results of operations.
  • Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
  • If securities or industry analysts publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control, which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • Our bylaws designate a certain court as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
  • If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.
  • Changes to patent law in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Changes in tax law could adversely affect our business and financial condition.
  • We may be unable to adequately protect our information systems from cyberattacks, which could result in the disclosure of confidential or proprietary information, including personal data, damage our reputation, and subject us to significant financial and legal exposure.
Management Discussion
  • The decrease of $10.5 million for the three months ended June 30, 2022 was primarily due to a decrease of $4.8 million in spend relating to BDTX-189 associated with reduced 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. In addition, we decreased spend relating to other research programs and platform development by $4.1 million for the three months ended June 30, 2022 due to reduced spending on early discovery projects, compared to the three months ended June 30, 2021.
  • General and administrative expenses were $7.0 million for the three months ended June 30, 2022 compared to $8.0 million for the three months ended June 30, 2021. This was primarily a result of flat personnel-related costs and a decrease in legal and other professional fees.
  • Other income was $0.2 million for the three months ended June 30, 2022, compared to $0.4 million for the three months ended June 30, 2021. The decrease was primarily attributable to amortization of premium on investments decreasing at a higher rate in 2022 compared to 2021 and interest income decreasing due to market conditions.

Content analysis

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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. junior Avg
New words: attract, cell, competing, dose, escalation, Food, glioblastoma, instability, key, lung, political, retain
Removed: active, bind, director, improve, operational, targeted, toxicity