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BTAI BioXcel Therapeutics

BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel's drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BioXcel's two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.

BTAI stock data

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Calendar

10 Aug 21
26 Oct 21
31 Dec 21
Quarter (USD)
Jun 21 Mar 21 Dec 20 Sep 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 273.06M 273.06M 273.06M 273.06M 273.06M 273.06M
Cash burn (monthly) (positive/no burn) (positive/no burn) 9.2M 8.32M 7.46M 6.78M
Cash used (since last report) n/a n/a 35.71M 32.29M 28.95M 26.32M
Cash remaining n/a n/a 237.34M 240.77M 244.11M 246.74M
Runway (months of cash) n/a n/a 25.8 28.9 32.7 36.4

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
16 Aug 21 William P Kane Jr Stock Option Common Stock Grant Acquire A No No 23.84 40,000 953.6K 40,000
16 Aug 21 Javier Rodriguez Stock Option Common Stock Grant Acquire A No No 23.84 10,000 238.4K 10,000
25 Jun 21 BioXcel Common Stock Sell Dispose S Yes No 30.8283 473,250 14.59M 8,546,750
25 Jun 21 Nandabalan Krishnan Common Stock Sell Dispose S Yes No 30.8283 473,250 14.59M 8,546,750
25 Jun 21 BioXcel Common Stock Sell Dispose S No No 30.8283 473,250 14.59M 8,546,750

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

78.7% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 107 118 -9.3%
Opened positions 23 18 +27.8%
Closed positions 34 19 +78.9%
Increased positions 36 51 -29.4%
Reduced positions 33 33
13F shares
Current Prev Q Change
Total value 794.62M 1.4B -43.4%
Total shares 22.02M 20.01M +10.1%
Total puts 252K 219.5K +14.8%
Total calls 155.8K 239.1K -34.8%
Total put/call ratio 1.6 0.9 +76.2%
Largest owners
Shares Value Change
BioXcel 9.02M $416.72M 0.0%
FMR 3.11M $90.52M +39.7%
STT State Street 1.46M $42.4M +14.4%
Artemis Investment Management 1.19M $34.66M +15.6%
BLK Blackrock 1.13M $32.91M +7.4%
Alliancebernstein 943.26K $27.41M +15.6%
Vanguard 902.65K $26.23M +14.3%
Massachusetts Financial Services 287.75K $8.36M -0.3%
Geode Capital Management 276.82K $8.04M +9.6%
Altshuler Shaham 274.06K $7.96M NEW
Largest transactions
Shares Bought/sold Change
FMR 3.11M +884.97K +39.7%
Logos Global Management 0 -400K EXIT
First Light Asset Management 0 -358.44K EXIT
Altshuler Shaham 274.06K +274.06K NEW
Caas Capital Management 232.29K +232.29K NEW
Ghisallo Capital Management 225K +225K NEW
STT State Street 1.46M +183.21K +14.4%
Artemis Investment Management 1.19M +161.43K +15.6%
Luminus Management 157.1K +157.1K NEW
BX Blackstone 150K +150K NEW

Financial report summary

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Risks
  • We have a limited operating history and have never generated any product revenues, which may make it difficult to evaluate the success of our business to date and to assess our future viability.
  • We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.
  • We will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
  • We have limited experience in drug discovery and drug development, and we have never had a drug approved.
  • In the near term, we are dependent on the success of BXCL501 and BXCL701. If we are unable to complete the clinical development of, obtain marketing approval for or successfully commercialize BXCL501, BXCL701 and our other product candidates, either alone or with a collaborator, or if we experience significant delays in doing so, our business could be substantially harmed.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, expensive and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • Clinical trials are expensive, time-consuming and difficult to design and implement, and involve an uncertain outcome.
  • Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • BioXcel LLC’s approach to the discovery and development of product candidates based on EvolverAI is novel and unproven, and we do not know whether we will be able to develop any products of commercial value.
  • EvolverAI may fail to help us discover and develop additional potential product candidates.
  • We have obtained Fast Track Designation for BXCL501 for the treatment of acute agitation, and we may seek Fast Track designation for other indications or for our other product candidates, but we might not receive such designations, and even if we do, such designations may not actually lead to a faster development or regulatory review or approval process.
  • Even if we obtain regulatory approval for BXCL501, BXCL701 or any product candidate, we will still face extensive and ongoing regulatory requirements and obligations and any product candidates, if approved, may face future development and regulatory difficulties.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • If we are found in violation of federal or state “fraud and abuse” laws, we may be required to pay a penalty and/or be suspended from participation in federal or state health care programs, which may adversely affect our business, financial condition and results of operations.
  • We may be unable to maintain sufficient clinical trial liability insurance.
  • If our products do not gain market acceptance, our business will suffer because we might not be able to fund future operations.
  • We have been granted Orphan Drug Designation for BXCL701 for the treatment of pancreatic cancer, melanoma, acute myeloid leukemia and soft tissue sarcoma and we may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates.
  • If we are unable to develop satisfactory sales and marketing capabilities, we may not succeed in commercializing BXCL501, BXCL701 or any other product candidate.
  • We operate in a highly competitive and rapidly changing industry.
  • Even if we obtain regulatory approvals to commercialize BXCL501, BXCL701 or our other product candidates, our product candidates may not be accepted by physicians or the medical community in general.
  • Healthcare reform measures could hinder or prevent our product candidates’ commercial success.
  • BioXcel LLC has significant influence over the direction of our business, and the concentrated ownership of our common stock will prevent you and other stockholders from influencing significant decisions.
  • Approval of commercial terms between us and BioXcel LLC does not preclude the possibility of stockholder litigation, including but not limited to derivative litigation nominally against BioXcel LLC and against its directors and officers and also against us and our directors and officers.
  • We continue to depend on BioXcel LLC to provide us with certain services for our business.
  • The management of and beneficial ownership in BioXcel LLC by our executive officers and our directors may create, or may create the appearance of, conflicts of interest.
  • Any disputes that arise between us and BioXcel LLC with respect to our past and ongoing relationships could harm our business operations.
  • We are substantially dependent on third parties for the manufacture of our clinical supplies of our product candidates, and we intend to rely on third parties to produce commercial supplies of any approved product candidate. Therefore, our development of our products could be stopped or delayed, and our commercialization of any future product could be stopped or delayed or made less profitable if third party manufacturers fail to obtain approval of the FDA or comparable regulatory authorities or fail to provide us with drug product in sufficient quantities or at acceptable prices.
  • We, or third-party manufacturers on whom we rely, may be unable to successfully scale-up manufacturing of our product candidates in sufficient quality and quantity, which would delay or prevent us from developing our product candidates and commercializing approved products, if any.
  • Our failure to find third party collaborators to assist or share in the costs of product development could materially harm our business, financial condition and results of operations.
  • We rely on third parties to conduct our preclinical and clinical trials. If these third parties do not successfully perform their contractual legal and regulatory duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
  • The outbreak of the novel coronavirus disease, COVID-19, or other pandemic, epidemic or outbreak of an infectious disease may materially and adversely impact our business, including our preclinical studies and clinical trials.
  • We will need to increase the size of our organization and the scope of our outside vendor relationships, and we may experience difficulties in managing growth.
  • We depend on our senior management team, and the loss of one or more of our executive officers or key employees or an inability to attract and retain highly skilled employees could adversely affect our business.
  • Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
  • Business interruptions could adversely affect future operations, revenues, and financial conditions, and may increase our costs and expenses.
  • Our failure to successfully acquire, develop and market additional product candidates or approved drug products could impair our ability to grow.
  • It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position does not adequately protect our product candidates, others could compete against us more directly, which would harm our business, possibly materially.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If we fail to comply with our obligations in the agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose rights that are important to our business.
  • We may incur substantial costs as a result of litigation or other proceedings relating to patents and other intellectual property rights.
  • If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be significantly diminished.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets.
  • Our intellectual property may not be sufficient to protect our products from competition, which may negatively affect our business as well as limit our partnership or acquisition appeal.
  • The price of our common stock may fluctuate substantially.
  • Because certain of our stockholders control a significant number of shares of our common stock, they may have significant influence over actions requiring stockholder approval.
  • We do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.
  • We are an “emerging growth company” and “smaller reporting company” and are able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies and small reporting companies, which could make our common stock less attractive to investors.
  • We may be at risk of securities class action litigation.
  • Our certificate of incorporation and our bylaws, and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.
  • Financial reporting obligations of being a public company in the United States are expensive and time-consuming, and our management is required to devote substantial time to compliance matters.
  • If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline.
  • Future sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.
  • If we fail to comply with the rules under the Sarbanes-Oxley Act of 2002 related to accounting controls and procedures in the future, or, if we discover material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.
  • Comprehensive tax reform bills could adversely affect our business and financial condition.
Management Discussion
  • Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
  • You should read the following discussion and analysis of our financial condition and results of operations together with “Selected Financial Data” and our financial statements and the related notes appearing elsewhere in this report. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included elsewhere in this Annual Report on Form 10-K. All dollar amounts in the below Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented in U.S. dollars, and all dollar amounts are presented in thousands, unless otherwise noted or the context otherwise provides.
  • We are a clinical stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. Our drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. We believe that this differentiated approach has the potential to reduce the cost and time of drug development in diseases with a substantial unmet medical need.
Content analysis
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Legalese
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H.S. sophomore Avg
New words: algorithm, assigned, baseline, belief, Chancery, children, CJEU, complaint, constitutionality, crucial, DGCL, Feasibility, feedback, front, intermittent, letter, Liaison, lifted, MAA, multisite, parallel, paving, PDUFA, pediatric, plaintiff, PREA, refining, schizoaffective, Science, segregation, standing, supervisory, toxicology, transmit, transmitted, wear, wearable
Removed: bioavailability, bioequivalence, bridging, Cooperation, cumulative, hired, monotherapy, presidential, therefrom, title