BioXcel Therapeutics Files 2023 Annual Report on Form 10-K

Ticker: BTAI · Form: 10-K · Filed: Mar 22, 2024 · CIK: 1720893

Sentiment: neutral

Topics: 10-K, BioXcel Therapeutics, Annual Report, Pharmaceuticals, SEC Filing

TL;DR

<b>BioXcel Therapeutics filed its 2023 10-K, detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

BioXcel Therapeutics, Inc. (BTAI) filed a Annual Report (10-K) with the SEC on March 22, 2024. BioXcel Therapeutics, Inc. filed its 2023 Form 10-K on March 22, 2024. The company's fiscal year ends on December 31st. The filing covers the fiscal year ended December 31, 2023. The company's principal executive offices are located at 555 Long Wharf Drive, New Haven, CT 06511. The SIC code for BioXcel Therapeutics, Inc. is 2834 (Pharmaceutical Preparations).

Why It Matters

For investors and stakeholders tracking BioXcel Therapeutics, Inc., this filing contains several important signals. This filing provides a comprehensive overview of BioXcel Therapeutics' financial health, operational activities, and strategic direction for the past fiscal year, crucial for investors and stakeholders to assess the company's performance and future prospects. As a 10-K filing, it contains audited financial statements and detailed disclosures on risks, management's discussion, and other material information required by the SEC, offering a complete picture of the company's status.

Risk Assessment

Risk Level: medium — BioXcel Therapeutics, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical industry, which is subject to significant regulatory oversight, clinical trial risks, and intense competition, as detailed in the filing's risk factors section.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to understand BioXcel Therapeutics' current financial position and potential challenges.

Financial Highlights

revenue
29930000
revenue Growth
7.3%

Key Numbers

Key Players & Entities

FAQ

When did BioXcel Therapeutics, Inc. file this 10-K?

BioXcel Therapeutics, Inc. filed this Annual Report (10-K) with the SEC on March 22, 2024.

What is a 10-K filing?

A 10-K is a comprehensive annual financial report required by the SEC, covering audited financials, business operations, risk factors, and management discussion. This particular 10-K was filed by BioXcel Therapeutics, Inc. (BTAI).

Where can I read the original 10-K filing from BioXcel Therapeutics, Inc.?

You can access the original filing directly on the SEC's EDGAR system. The filing is publicly available and includes all exhibits and attachments submitted by BioXcel Therapeutics, Inc..

What are the key takeaways from BioXcel Therapeutics, Inc.'s 10-K?

BioXcel Therapeutics, Inc. filed this 10-K on March 22, 2024. Key takeaways: BioXcel Therapeutics, Inc. filed its 2023 Form 10-K on March 22, 2024.. The company's fiscal year ends on December 31st.. The filing covers the fiscal year ended December 31, 2023..

Is BioXcel Therapeutics, Inc. a risky investment based on this filing?

Based on this 10-K, BioXcel Therapeutics, Inc. presents a moderate-risk profile. The company operates in the pharmaceutical industry, which is subject to significant regulatory oversight, clinical trial risks, and intense competition, as detailed in the filing's risk factors section.

What should investors do after reading BioXcel Therapeutics, Inc.'s 10-K?

Review the detailed financial statements and risk factors in the 10-K to understand BioXcel Therapeutics' current financial position and potential challenges. The overall sentiment from this filing is neutral.

Risk Factors

Key Dates

Filing Stats: 4,383 words · 18 min read · ~15 pages · Grade level 16.2 · Accepted 2024-03-22 16:40:50

Key Financial Figures

Filing Documents

Forward Looking Statements

Forward Looking Statements 3 Summary Risk Factors 5 Part I. Item 1.

Business

Business 8 Item 1A.

Risk Factors

Risk Factors 55 Item 1B. Unresolved Staff Comments 117 Item 1C . Cybersecurity 117 Item 2.

Properties

Properties 119 Item 3.

Legal Proceedings

Legal Proceedings 119 Item 4. Mine Safety Disclosures 119 Part II. Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 119 Item 6. Reserved 120 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 121 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 136 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 136 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 137 Item 9A.

Controls and Procedures

Controls and Procedures 137 Item 9B . Other Information 137 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 139 Part III. Item 10. Directors, Executive Officers and Corporate Governance 140 Item 11.

Executive Compensation

Executive Compensation 140 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 141 Item 13. Certain Relationships and Related Transactions, and Director Independence 141 Item 14. Principal Accounting Fees and Services 141 Part IV. Item 15. Exhibits and Financial Statement Schedules 141 Item 16. Form 10-K Summary 146

Signatures

Signatures 147 Table of Contents

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). The words "anticipate," "believe," "can," "continue," "could," "designed," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All statements contained in this Annual Report on Form 10-K, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding: our sales strategy for IGALMI TM ; strategy relating to, anticipated benefits from, and cost savings from our Reprioritization (as defined herein); our ability to raise additional capital and continue as a going concern; developments relating to our TRANQUILITY program; the size of our total addressable markets and related underlying estimates; our plans relating to clinical trials and marketing applications for our product candidates; our plans to research, develop and commercialize our current and future product candidates; our plans to seek to enter into collaborations for the development and commercialization of certain product candidates; the potential benefits of any future collaboration; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; the timing of and results of discussions we have with regulators; the rate and degree of market acceptance, clinical utility, number of presc

Business

Item 1. Business Overview BioXcel Therapeutics, Inc. ("BTI," the "Company," "we," "us" or "our") is a biopharmaceutical company utilizing artificial intelligence ("AI") to develop transformative medicines in neuroscience and, through the Company's wholly owned subsidiary, OnkosXcel Therapeutics LLC ("OnkosXcel"), immuno-oncology. We are focused on utilizing cutting-edge technology and innovative research to develop high-value therapeutics aimed at transforming patients' lives. We employ various AI platforms to reduce therapeutic development costs and potentially accelerate development timelines. Our approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. We believe this differentiated approach has the potential to reduce the expense and time associated with drug development in diseases with substantial unmet medical needs. On April 6, 2022, we announced that the United States ("U.S.") Food and Drug Administration ("FDA") approved IGALMI TM (dexmedetomidine (or "Dex")) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. IGALMI TM is approved to be self-administrated by patients under the supervision of a health care provider. On July 6, 2022, we announced that IGALMI TM was commercially available in doses of 120 and 180 microgram ("mcg"). Our most advanced neuroscience candidate is BXCL501. In indications other than those approved by the FDA as IGALMI TM , BXCL501 is an investigational, proprietary, orally dissolving film formulation of Dex in development for the treatment of agitation associated with psychiatric and neurological disorders. We are continuing to develop BXCL501 for the potential acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting and for the potential acute treatment of agitation (non-d

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