BioXcel Therapeutics (NASDAQ:BTAI) stock is taking a beating on Friday after the commercial-stage biopharmaceutical company announced a proposed underwritten public offering for its shares.This public offering includes $60 million shares of BTAI stock. The company also intends to offer underwriters of the deal a 30-day option to acquire another $9 million of its shares. Underwriters include BofA Securities and Truist Securities.BioXcel Therapeutics says that it will use the funds from this offering for ongo ...

NEW HAVEN, Conn., Feb. 08, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the "Company") (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it has commenced an underwritten public offering of $60.0 million of shares of its common stock or, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock. In addition, t ...

Human proof of concept portion of the trial expected to begin in H1 2024; led by Georgetown Lombardi Comprehensive Cancer Center BXCL701 in combination with checkpoint inhibitor in preclinical studies demonstrated encouraging results in pancreatic cancer Initial study data expected in 2024 NEW HAVEN, Conn., Feb. 06, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-on ...

Aligns with Company's strategic focus on bringing to market BXCL501 for potential acute treatment of agitation for Alzheimer's patients  IGALMI™ market exclusivity further strengthened with receipt of issue notification for additional method of use patent (total of 8 U.S. patents, including 4 method of use patents)  NEW HAVEN, Conn., Feb. 05, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in ...

Financial Data and Key Metrics Changes - Research and development expenses decreased to $19.6 million for Q3 2023 from $22.1 million in Q3 2022, primarily due to reduced costs associated with BXCL501 SERENITY III and TRANQUILITY II clinical trials [19] - The company reported a net loss of $50.5 million for Q3 2023, compared to a net loss of $41.8 million for the same period in 2022 [20] - Selling, general and administrative expenses increased to $24.3 million for Q3 2023 from $17.1 million in Q3 2022, attributed to one-time legal fees and costs related to OnkosXcel's potential public offering [26] - Cash and cash equivalents totaled $90 million as of September 30, 2023, with an estimated runway through mid-2024 [27] Business Line Data and Key Metrics Changes - Net revenue from IGALMI was approximately $341,000 for the quarter [25] - The company is focusing on enhancing operational and financial flexibility through strategic financing agreements with Oaktree Capital and Qatar Investment Authority [15] Market Data and Key Metrics Changes - The company is positioned to address a large and underserved market for the acute treatment of agitation associated with Alzheimer's disease, with no FDA-approved drugs currently available for this indication [10] Company Strategy and Development Direction - The company is advancing its late-stage clinical programs for BXCL501, specifically the TRANQUILITY and SERENITY III programs, with a focus on at-home treatment settings [8][14] - The company aims to leverage its unique use of artificial intelligence to drive drug innovation and enhance its clinical development programs [17] - The company is prioritizing the TRANQUILITY program due to its significant market opportunity and is actively working on protocol development for the upcoming trial [75] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the alignment with the FDA regarding the development paths for TRANQUILITY and SERENITY III, which are expected to create significant value [8][9] - The management highlighted the importance of the recent positive survival data for BXCL501 in trials for metastatic castrate-resistant prostate cancer, indicating potential strategic options for OnkosXcel [23] - Management emphasized the ongoing support from strategic financial partners and the positive implications of the recent financing agreement [15][63] Other Important Information - The company is conducting a NIDA-funded trial for BXCL501 aimed at treating opioid use disorder, which is considered an emerging national threat [17] - The issuance of a J-Code by CMS is expected to streamline the reimbursement process for IGALMI, potentially increasing its market access [16][91] Q&A Session Summary Question: Can you provide more color on the TRANQUILITY development strategy? - Management confirmed alignment with the FDA to conduct a home-setting trial, emphasizing the importance of providing access to a broad patient population [30] Question: What is the ultimate path forward for BXCL501 in chronic agitation? - Management stated that while there is potential for chronic treatment, the current focus remains on acute treatment in the home setting [39] Question: Can you clarify the safety long-term requirements for submission for the TRANQUILITY program? - Management indicated that long-term safety discussions will continue with the FDA, focusing on the episodic nature of agitation [82] Question: What is the expected impact of the J-Code on sales trajectory? - Management expressed optimism that the J-Code will alleviate economic concerns for hospitals and clinics, facilitating broader use of IGALMI [91]

Table of Contents ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Delaware 82-1386754 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 555 Long Wharf Drive New Haven, CT 06511 (Address of principal executive offices) (Zip Code) (475) 238-6837 (Registrant's telephone number, including area code) N/A (Former name, former address and former fiscal year, if changed since ...

BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET Company Participants Vimal Mehta - Founder & CEO Richard Steinhart - SVP & CFO Matt Wiley - SVP & Chief Commercial Officer Robert Risinger - Chief Medical Officer, Neuroscience Frank Yocca - Chief Scientific Officer Conference Call Participants Gregory Harrison - Bank of America Colin Bristow - UBS Sumant Kulkarni - Canaccord Raghuram Selvaraju - H.C. Wainwright Yatin Suneja - Guggenheim Securities Samir Dev ...

PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=10&type=section&id=Item%201.%20Financial%20Statements) The company's June 30, 2023 financial statements show a deteriorating position with decreased cash, increased deficit, and a significant decline in equity, raising going concern doubts Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 (unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $127,545 | $193,725 | | Total assets | $140,097 | $205,853 | | **Liabilities & Equity** | | | | Total liabilities | $134,233 | $129,078 | | Accumulated deficit | $(517,856) | $(411,545) | | Total stockholders' equity | $5,864 | $76,775 | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $457 | $— | $663 | $— | | Total operating expenses | $52,871 | $36,288 | $104,274 | $67,768 | | Net loss | $(53,515) | $(37,670) | $(106,311) | $(69,142) | | Basic and diluted net loss per share | $(1.83) | $(1.35) | $(3.68) | $(2.47) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(90,559) | $(65,516) | | Net cash used in investing activities | $(20) | $(139) | | Net cash provided by financing activities | $24,399 | $66,139 | - Management has concluded there is **substantial doubt** about the company's ability to continue as a going concern due to significant losses, negative cash flows, potential debt payments, and reliance on future financing[385](index=385&type=chunk)[412](index=412&type=chunk)[277](index=277&type=chunk) [Debt and Credit Facilities](index=30&type=section&id=Note%208.%20Debt%20and%20Credit%20Facilities) The company secured $260 million in Oaktree financing, drawing $100 million by June 2023, but anticipates failing Q4 2023 revenue covenants, potentially incurring significant cure payments - The company entered into two financing agreements (OFA Facilities) with Oaktree and Qatar Investment Authority affiliates for up to **$260 million** to support IGALMI commercialization and BXCL501 clinical development[12](index=12&type=chunk) - The Credit Agreement provides for up to **$135 million** in loans, with an initial **$70 million** funded and the remaining **$65 million** available subject to milestones the company does not expect to meet[13](index=13&type=chunk)[490](index=490&type=chunk) - The RIFA provides up to **$120 million** in financing, with an initial **$30 million** funded and the remaining **$90 million** available subject to milestones the company does not expect to satisfy[17](index=17&type=chunk)[519](index=519&type=chunk)[490](index=490&type=chunk) - The Credit Agreement includes a minimum revenue covenant starting Q4 2023, which the company expects to fail, potentially requiring cure payments of up to **$7.7M**, **$10.6M**, and **$14.3M** for the testing dates ending Dec 2023, Mar 2024, and Jun 2024, respectively[515](index=515&type=chunk)[285](index=285&type=chunk)[272](index=272&type=chunk) [Stock-Based Compensation](index=39&type=section&id=Note%2011.%20Stock-Based%20Compensation) Stock-based compensation expense increased to $11.0 million in H1 2023, with 1,072 thousand options granted and 309 thousand exercised under equity plans Stock Option Activity (in thousands of shares) - Six Months Ended June 30, 2023 | Activity | Number of shares | Weighted average price per share | | :--- | :--- | :--- | | Outstanding as of January 1, 2023 | 4,882 | $17.23 | | Granted | 1,072 | $19.62 | | Forfeited | (34) | $17.13 | | Exercised | (309) | $1.65 | | **Outstanding as of June 30, 2023** | **5,604** | **$18.54** | Stock-Based Compensation Expense (in thousands) | Period | Research and development | Selling, general and administrative | Total | | :--- | :--- | :--- | :--- | | **Three Months Ended June 30, 2023** | $1,898 | $4,226 | $6,124 | | **Six Months Ended June 30, 2023** | $3,195 | $7,806 | $11,001 | [Subsequent Events (Strategic Reprioritization)](index=50&type=section&id=Note%2016.%20Subsequent%20Events) A strategic reprioritization in August 2023, including a 50% workforce reduction, aims to extend cash runway into mid-2024 and reduce annual operating expenses by $80 million - On August 8, 2023, the company initiated a strategic reprioritization to extend its cash runway into mid-2024, including a **~50% workforce reduction** and a shift in focus to at-home development for BXCL501[548](index=548&type=chunk)[79](index=79&type=chunk) - The reprioritization is expected to reduce annual operating expenses by approximately **$80 million**[73](index=73&type=chunk)[79](index=79&type=chunk) - The company estimates it will incur approximately **$7-8 million** in cash costs for severance, benefits, and related expenses as a result of the restructuring[48](index=48&type=chunk)[111](index=111&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=52&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The MD&A details the company's biopharmaceutical focus, a strategic reprioritization to extend cash runway, increased spending, significant net loss, and critical liquidity concerns, including debt restructuring negotiations [Clinical Program Development](index=54&type=section&id=Clinical%20Program%20Development) Clinical development focuses on at-home BXCL501, with SERENITY III Part 1 missing its endpoint and TRANQUILITY II data integrity compromised by misconduct, while other programs are paused - The SERENITY III trial (at-home use for schizophrenia/bipolar) **did not meet its primary endpoint** in Part 1 (**p=0.077** at 2 hours), but the company sees promising signals and plans to discuss an 80 mcg dose with the FDA for Part 2[119](index=119&type=chunk)[89](index=89&type=chunk)[120](index=120&type=chunk) - The TRANQUILITY II trial (Alzheimer's agitation) **met its primary endpoint** for the 60 mcg dose; however, the trial is under investigation for **misconduct** by an investigator who enrolled approximately **40%** of the patients, raising concerns about data integrity[93](index=93&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk) - Enrollment in the TRANQUILITY III trial (moderate-to-severe dementia) was **halted** because agitation in this population appeared more chronic than episodic, requiring a different development strategy[95](index=95&type=chunk)[78](index=78&type=chunk) - As part of the reprioritization, the company has **paused development** of BXCL501 as an adjunctive treatment for Major Depressive Disorder (MDD) and has generally **suspended** its immuno-oncology programs (BXCL701)[99](index=99&type=chunk)[140](index=140&type=chunk) [Results of Operations](index=76&type=section&id=Results%20of%20Operations) Net loss increased to $106.3 million in H1 2023, driven by a 50% rise in R&D expenses to $54.8 million and a 59% increase in SG&A to $49.5 million, with minimal product revenue Research & Development Expenses (in thousands) | Period | BXCL501 | BXCL701 | Other | Total Direct | Total R&D | | :--- | :--- | :--- | :--- | :--- | :--- | | **Q2 2023** | $15,010 | $2,095 | $1,390 | $18,495 | $26,973 | | **Q2 2022** | $9,054 | $1,785 | $671 | $11,510 | $17,906 | | **H1 2023** | $31,478 | $4,763 | $2,281 | $38,522 | $54,773 | | **H1 2022** | $17,570 | $4,701 | $1,223 | $23,494 | $36,593 | - The **increase in R&D expenses** was primarily driven by higher clinical trial costs for the SERENITY III and TRANQUILITY II studies, along with increased personnel costs to support the expanded trials[222](index=222&type=chunk)[254](index=254&type=chunk)[255](index=255&type=chunk) - The **increase in SG&A expenses** was mainly due to higher personnel, marketing, and travel costs to support the U.S. commercialization of IGALMI, as well as professional fees related to the TRANQUILITY II investigation and the formation of OnkosXcel[224](index=224&type=chunk)[233](index=233&type=chunk)[259](index=259&type=chunk) [Liquidity and Capital Resources](index=86&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces critical liquidity issues and going concern doubts, with $127.5 million cash as of June 30, 2023, and is negotiating debt restructuring due to anticipated covenant breaches - Management has **substantial doubt** about the company's ability to continue as a going concern, citing significant losses, negative cash flows, and dependence on future financing[277](index=277&type=chunk)[385](index=385&type=chunk) - With **$127.5 million** in cash as of June 30, 2023, and after implementing the Reprioritization, management believes it can fund operations into **mid-2024**[239](index=239&type=chunk)[277](index=277&type=chunk) - The company is in **active negotiations** to restructure its OFA Facilities due to the expectation that it will not meet the Revenue Covenant in 2024, which could require cure payments of up to an aggregate of approximately **$34.1 million** over the next twelve months[272](index=272&type=chunk)[598](index=598&type=chunk) PART II - OTHER INFORMATION [Item 1A. Risk Factors](index=99&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial risks, including going concern doubts and debt, operational risks from clinical trial misconduct, and high dependency on BXCL501 and third-party services [Financial and Operational Risks](index=99&type=section&id=Financial%20and%20Operational%20Risks) The company faces high financial risk, including going concern doubts, significant debt with potential $34.1 million cure payments, and risks from its strategic reprioritization and workforce reduction - The company has identified conditions that raise **substantial doubt** about its ability to continue as a going concern and will need to raise **substantial additional funding** to continue operations[579](index=579&type=chunk)[572](index=572&type=chunk)[326](index=326&type=chunk) - The company has significant indebtedness (**$101.6M** principal as of June 30, 2023) and expects to be required to make cure payments for failing to meet its Revenue Covenant in 2024, which could total approximately **$34.1 million** over the next 12 months[597](index=597&type=chunk)[598](index=598&type=chunk)[306](index=306&type=chunk) - The strategic reprioritization and workforce reduction may result in **unintended consequences**, such as loss of institutional knowledge, and may **not achieve the anticipated benefits or cost savings**[984](index=984&type=chunk)[570](index=570&type=chunk)[325](index=325&type=chunk) [Clinical Development and Regulatory Risks](index=109&type=section&id=Clinical%20Development%20and%20Regulatory%20Risks) Critical risks include investigator misconduct in TRANQUILITY II, potentially invalidating data, and the risky strategic focus on at-home BXCL501 due to limited data and SERENITY III's missed endpoint - A principal investigator in the TRANQUILITY II trial, who enrolled **~40%** of patients, engaged in **misconduct**, including fabricating email correspondence regarding an SAE, creating a risk that the **FDA will not accept the data** to support a marketing application[601](index=601&type=chunk)[603](index=603&type=chunk)[604](index=604&type=chunk) - The company has **limited clinical data** supporting the safety and efficacy of BXCL501 for at-home use, which is now a strategic priority, and the SERENITY III Part 1 trial for this setting **did not meet its primary efficacy endpoint**[607](index=607&type=chunk)[587](index=587&type=chunk) - The company faces the risk that the **FDA may not approve** its product candidates, may disagree with clinical trial design, or that trial results may **not meet the required level of statistical significance**[613](index=613&type=chunk)[616](index=616&type=chunk)[595](index=595&type=chunk) [Reliance on Third Parties and Related Parties](index=161&type=section&id=Reliance%20on%20Third%20Parties%20and%20Related%20Parties) The company is highly dependent on third-party manufacturers for supply and BioXcel LLC for R&D services, with the expiration of exclusivity creating competitive risks - The company is **substantially dependent on third-party manufacturers** like ARx for clinical and commercial supplies of its products and must adhere to cGMP standards[837](index=837&type=chunk)[838](index=838&type=chunk)[334](index=334&type=chunk) - The company continues to **depend on BioXcel LLC** for services, including access to its EvolverAI platform, to identify and develop product candidates, and the **exclusivity agreement expired** in March 2023[817](index=817&type=chunk)[818](index=818&type=chunk)[333](index=333&type=chunk) - BioXcel LLC's **significant ownership (~29%)** and the roles of affiliated individuals on the Board create **potential conflicts of interest** that could influence business decisions[811](index=811&type=chunk)[819](index=819&type=chunk)[364](index=364&type=chunk)

BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q1 2023 Earnings Conference Call May 8, 2023 8:00 AM ET Company Participants Vimal Mehta - Chief Executive Officer & Founder Rob Risinger - Chief Medical Officer, Neuroscience Matt Wiley - Chief Commercial Officer Richard Steinhart - Chief Financial Officer Conference Call Participants Robyn Karnauskas - Truist Securities Mary Kate - Bank of America Colin Bristow - UBS Yatin Suneja - Guggenheim Partners Sumant Kulkarni - Canaccord Genuity Ram Selvaraju - H.C. Wainwri ...

Contractual Obligations and Commitments In April 2022, the Company signed a commercial supply agreement that requires minimum annual payments for the first three years of the agreement that in aggregate total $10,000 for the three-year period and the minimum commitment for 2023 is $3,000. In February 2022, we signed a distribution agreement with a third-party to distribute product related to BXCL501 in the U.S. The distributor will be paid defined fees for its services under the agreement, which can be term ...