Every 8-K that BioXcel Therapeutics, Inc. (BTAI) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow BTAI and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full BTAI filings page.
BioXcel Therapeutics, Inc. (BTAI) entered into a Super-Priority Senior Secured Priming Debtor-in-Possession Credit Agreement with affiliates of Oaktree Capital Management and Qatar Investment Authority providing a DIP financing facility of up to $77.25 million. This includes up to $19 million of new money term loans, drawn in two tranches of up to $9.5 million each, and up to $58.25 million of roll-up loans converting prepetition debt under the existing credit agreement on a dollar-for-dollar basis.
The loans bear interest at 13.00% per annum, with a 2.0% default premium, and require a 4.0% exit fee on any repayment or prepayment. New money interest is payable in cash, while roll-up interest is paid in kind. The facility is guaranteed by the subsidiaries and secured by first priority priming liens on substantially all assets, with superpriority administrative expense status under the Chapter 11 proceedings. Covenants include adherence to a 13‑week budget, a minimum liquidity of $250 thousand, and specified case milestones, with maturity on January 27, 2027 unless repaid earlier.
Nasdaq notified the company that its common stock will be delisted due to the Chapter 11 filing, with trading suspended at the open on September 8, 2026 and a Form 25‑NSE to remove the stock from listing and registration. The company does not intend to appeal, and the shares are expected to trade on the Pink Limited Market, which the company notes is a significantly more limited and potentially less liquid market that could further depress the trading price.
BioXcel Therapeutics, Inc. (BTAI) and two subsidiaries filed voluntary Chapter 11 petitions in Delaware on August 27, 2026 and will operate as debtors-in-possession while seeking Court approval of various first-day motions and new debtor-in-possession financing.
The proposed DIP Financing from affiliates of Oaktree Capital Management and the Qatar Investment Authority includes up to $19 million in new money term loans plus up to $58.25 million of roll-up loans converting prepetition debt. BTAI also signed a stalking horse asset purchase agreement with Teva to sell substantially all assets for $57.5 million cash, assumed liabilities, up to $67.5 million in development milestones tied to the pending IGALMI sNDA, and up to $20 million in commercial milestones, all subject to higher bids and Bankruptcy Court approval.
BioXcel Therapeutics, Inc. (BTAI) amended its existing Credit Agreement with lenders administered by Oaktree Fund Administration LLC through a Fourteenth Amendment. The lenders provided additional term loans with an aggregate principal amount of $1,250,000, for which the company paid a $250,000 upfront fee, equal to 20% of the new borrowing. These loans otherwise carry the same economic and other terms as the prior loans under the agreement.
The lenders agreed to reduce the minimum liquidity covenant from $3.0 million to $250,000. BioXcel must, on or before August 31, 2026, enter into definitive agreements for one or more lender-acceptable transactions that either repay all obligations under the Credit Agreement or constitute an alternative capital solutions transaction acceptable to the lenders. Various covenants and thresholds were also tightened, removing flexibility for certain transactions, including out-licensing of intellectual property and sales of assets.
BioXcel Therapeutics, Inc. (BTAI) reports that on August 21, 2026 it entered into a Thirteenth Amendment to its Credit Agreement and Guaranty with lenders administered by Oaktree Fund Administration LLC. The amendment extends the deadline by which BioXcel must secure a major financing or repayment transaction.
By on or prior to August 28, 2026, BioXcel must enter into definitive agreements, acceptable to the lenders, for either (A) a transaction that repays all loans and other obligations under the existing Credit Agreement, or (B) an “alternative capital solutions” transaction on terms acceptable to the lenders. The prior deadline had been August 21, 2026 under the Twelfth Amendment.
BioXcel Therapeutics, Inc. entered into a Twelfth Amendment to its Credit Agreement and Guaranty with lenders administered by Oaktree Fund Administration LLC. The amendment extends the deadline to on or prior to August 21, 2026 for BioXcel to enter definitive agreements for one or more transactions acceptable to the lenders that either repay all loans and other obligations under the Credit Agreement or constitute an alternative capital solutions transaction on terms acceptable to the lenders. The amendment also reduces the Credit Agreement’s minimum liquidity covenant, requiring minimum cash liquidity of $3.0 million instead of $6.25 million under the prior amendment.
BioXcel Therapeutics, Inc. entered into an Eleventh Amendment to its existing Credit Agreement and Guaranty with lenders administered by Oaktree Fund Administration LLC. Lenders agreed to defer to August 31, 2026 the principal and interest payment originally due June 30, 2026, now requiring a payment of $9,016,914.47 plus all accrued interest and fees through that date.
The amendment also changes covenant terms by lowering the agreement’s minimum liquidity requirement, so BioXcel must maintain minimum cash liquidity of $6.25 million instead of $7.5 million. Certain subsidiaries continue as guarantors under the amended credit facility.
BioXcel Therapeutics has amended its loan agreement with Oaktree to gain near-term flexibility on debt payments and liquidity covenants. Under the Tenth Amendment, accrued and unpaid interest through June 30, 2026 will be paid in kind and added to the loan principal. Principal that was due June 30, 2026 is deferred to July 31, 2026, when the company must pay $9,016,914.47 plus additional accrued interest and fees. The amendment also lowers the minimum liquidity covenant from $12.5 million to $7.5 million, and BioXcel agreed to a 1.00% fee on outstanding principal, also paid in kind and added to the loan balance.
BioXcel Therapeutics reported first quarter 2026 results and a key regulatory milestone. The FDA accepted a supplemental New Drug Application for IGALMI for at-home use in agitation tied to bipolar disorders or schizophrenia and set a November 14, 2026 PDUFA action date. The company is also advancing BXCL501 in late-stage trials for agitation in Alzheimer’s dementia and is evaluating strategic options with an advisor for the IGALMI franchise.
Net revenue from IGALMI was $206 (thousands) versus $168 (thousands) a year earlier. Operating expenses were $10,429 (thousands), driven mainly by $7,191 (thousands) in SG&A and $2,955 (thousands) in R&D, leading to a net loss of $12,691 (thousands), compared with $7,254 (thousands) in 2025. Cash, cash equivalents and restricted cash were $17,180 (thousands) as of March 31, 2026, and total stockholders’ equity was a deficit of $105,543 (thousands). The company notes conditions and events that raise substantial doubt about its ability to continue as a going concern.
BioXcel Therapeutics, Inc. entered into a Ninth Amendment to its Credit Agreement and Guaranty and, on April 15, 2026, granted the lenders warrants to purchase up to 1,353,729 shares of common stock at an exercise price of $0.01 per share. These Amendment Warrants expire on the seventh anniversary of issuance.
On April 15, 2026, BioXcel also signed a Fourth Amended and Restated Registration Rights Agreement with the lenders, under which it agreed to register the common shares issuable upon exercise of the Amendment Warrants. The securities were issued in a private transaction relying on Section 4(a)(2) of the Securities Act.
BioXcel Therapeutics, Inc. reported that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application for IGALMI. The filing covers use for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home, outpatient setting.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026, which is when the agency is scheduled to complete its review of this application.
BioXcel Therapeutics, Inc. reported fourth quarter and full-year 2025 results while advancing plans to expand IGALMI into at-home use. Net revenue from IGALMI was $256,000 in the fourth quarter and $642,000 for 2025, down from $366,000 and $2.3 million in 2024 as the company shifted to minimal commercial effort ahead of a potential relaunch in the outpatient setting.
R&D expenses were $6.7 million in the fourth quarter and $30.3 million for 2025, roughly flat year over year, as spending supported the SERENITY At-Home Phase 3 safety trial and other late-stage work. SG&A expenses fell to $3.8 million in the quarter and $20.5 million for the year, down sharply from $4.1 million and $34.5 million in 2024, reflecting lower personnel, legal and commercial costs following a clinical reprioritization.
The company reported an operating loss of $10.3 million and net loss of $12.5 million for the fourth quarter of 2025, and an operating loss of $50.5 million with a net loss of $69.9 million for the full year. Cash used in operating activities improved to approximately $57.6 million in 2025 from $72.0 million in 2024, and cash, cash equivalents and restricted cash totaled $28.8 million as of December 31, 2025. BioXcel has submitted a supplemental New Drug Application seeking to expand IGALMI’s label to at-home treatment of agitation in bipolar disorders and schizophrenia, and also highlights that conditions and events raise substantial doubt about its ability to continue as a going concern.
BioXcel Therapeutics, Inc. entered into a securities purchase agreement for a registered direct offering of common stock, pre-funded warrants, and accompanying common stock warrants. The company agreed to sell 2,480,294 shares of common stock with accompanying warrants and pre-funded warrants exercisable for up to 2,020,491 shares with accompanying warrants, at combined offering prices of $1.739 and $1.738, respectively.
The accompanying warrants carry a $1.614 exercise price per share, are immediately exercisable, and expire five years after issuance. The offering, conducted under an effective Form S-3 shelf registration, closed with aggregate gross proceeds of approximately $7.8 million. Rodman & Renshaw LLC acted as exclusive placement agent, earning a 6.0% cash fee on gross proceeds, warrants equal to 4.0% of shares placed (180,031 shares) at a $2.0175 exercise price, and specified expense reimbursements.
Separately, under a warrant amendment agreement, the exercise price of certain outstanding warrants to purchase up to 1,385,083 shares held by the purchaser was reduced to $1.614 per share and their term extended to five years following closing, in exchange for approximately $173,135 and a 6.0% cash fee to the placement agent on that amount.
BioXcel Therapeutics filed an update on its market assessment for IGALMI, its treatment for acute agitation in bipolar disorder and schizophrenia, focused on potential at-home (outpatient) use. This work is tied to a recently submitted supplemental New Drug Application seeking U.S. approval for at-home administration.
The updated opportunity analysis used results from the SERENITY At-Home clinical study, interviews with 15 prescribers and 5 payer leaders, and survey responses from 180 experienced prescribers, plus patient-level claims data to estimate how many diagnosed and treated patients might be candidates for IGALMI. The filing also highlights extensive forward-looking risks, including funding needs, substantial doubt about the company’s ability to continue as a going concern, regulatory and commercialization uncertainties, and the possibility that agitation episode volume and the total addressable market for IGALMI could be overestimated.
BioXcel Therapeutics, Inc. entered into milestone and retention bonus agreements with certain key employees, including senior management, following its submission of a supplemental New Drug Application to the FDA for at-home treatment of agitation in bipolar disorder or schizophrenia with IGALMI®.
Each agreement provides an aggregate cash bonus of $225,000 per employee and $650,000 for the Chief Executive Officer, split between an initial lump-sum payment at signing and a final payment on April 15, 2026. The final payment depends on continued employment and the absence of a Default or Event of Default under the company’s Credit Agreement with Oaktree. The final bonus can be accelerated if the company raises at least $25 million in capital or completes a Change of Control or other material transaction before April 15, 2026, and is subject to forfeiture and repayment if the employee is terminated for Cause or resigns without Good Reason before specified 2026 dates.
BioXcel Therapeutics, Inc. filed a current report describing a key regulatory milestone for its drug IGALMI®. The company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking to expand IGALMI’s use to an at-home setting for the acute treatment of agitation associated with bipolar disorders or schizophrenia. IGALMI was previously approved in April 2022 as the first and only orally dissolving sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults under the supervision of a healthcare provider. The new sNDA aims to broaden IGALMI’s label to cover at-home use for a wider patient population, an area where the company notes there are currently no FDA-approved treatment options.
BioXcel Therapeutics, Inc. reported that Mark Pavao is joining the company as Interim Chief Commercial Officer, effective around January 12, 2026. His role is to support the potential launch of IGALMI in the at-home setting.
The company plans to submit a supplemental New Drug Application (sNDA) this month seeking FDA approval for IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. The filing also reiterates that these plans are forward-looking and subject to various risks and uncertainties.
BioXcel Therapeutics, Inc. reported results of its annual stockholder meeting. A total of 9,726,849 shares of common stock were represented, about 44.68% of shares outstanding as of October 31, 2025.
Stockholders elected three Class I directors, June Bray, Sandeep Laumas, M.D., and David Mack, and ratified Ernst & Young LLP as independent auditor for 2025. They also approved, on an advisory basis, the compensation of the company’s named executive officers.
Stockholders approved an amendment to the certificate of incorporation authorizing the board, within 12 months and if deemed necessary to regain compliance with Nasdaq Capital Market minimum bid price requirements, to implement a reverse stock split at a ratio between 1-for-2 and 1-for-20. An adjournment proposal related to this amendment was approved but ultimately not used.
BioXcel Therapeutics, Inc. filed a Form 8-K stating that it issued a press release with its financial results for the three months ended September 30, 2025 and a business update. The press release is attached as Exhibit 99.1 and is incorporated by reference for those details.
The company notes that the information in this Form 8-K under Item 2.02, including Exhibit 99.1, is being furnished rather than filed under securities laws, which affects how it is treated for certain legal purposes.
BioXcel Therapeutics announced a scientific poster presentation on BXCL501, a sublingual dexmedetomidine film for treating agitation associated with bipolar disorder or schizophrenia in the home setting. The Phase 3 study poster was presented at the Neuroscience Education Institute Conference on November 7, 2025 by Dr. Leslie Citrome.
The poster is furnished as Exhibit 99.1 and incorporated by reference. This 8-K provides visibility into the ongoing clinical program but does not detail trial results or financial terms.
BioXcel Therapeutics (BTAI) updated its regulatory timeline, stating it now expects to complete submission of a supplemental New Drug Application (sNDA) for an IGALMI® label expansion early in the first quarter of 2026.
The filing highlights two recently completed studies that will anchor the sNDA package: the SERENITY At-Home pivotal Phase 3 safety trial for agitation associated with bipolar disorders or schizophrenia, which delivered positive topline safety and exploratory efficacy data in August 2025, and an October 2025 correlation study that also reported positive results. IGALMI® is currently FDA‑approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings, and the planned sNDA seeks to expand use to at‑home settings.
BioXcel Therapeutics (BTAI) announced positive correlation results linking the patient/caregiver-rated mCGI-S scale with the clinician-rated PEC from the SERENITY At Home program, supporting its planned supplemental NDA in the first quarter of 2026.
The prospective, open-label, in-clinic study in 33 patients showed strong, statistically significant correlations between PEC and mCGI-S (ρ=0.89; p<0.0001 for patients and ρ=0.88; p<0.0001 for informants). No serious adverse events were reported, and the safety profile remains consistent with the IGALMI® label.
BioXcel Therapeutics, Inc. reported that it has completed enrollment, on September 13, 2025, in an open-label clinical study of approximately 30 patients evaluating the correlation between the mCGI-S measurement and the PEC scale in agitation. The company expects to release results in the fourth quarter of 2025, and to include these data, together with SERENITY At-Home Phase 3 safety results, in a supplemental new drug application planned for the first quarter of 2026.
Between July 1, 2025 and September 15, 2025, BioXcel raised an aggregate of $37.3 million, including approximately $27.6 million from selling 9,312,892 shares under its at-the-market equity program and approximately $9.7 million from the exercise of warrants for 2,300,000 shares. As of September 12, 2025, the company had 19,646,801 shares outstanding and believes its cash and cash equivalents will fund operating and capital needs into the first quarter of 2026, subject to various assumptions and risk factors.
BioXcel Therapeutics reported results from the SERENITY At-Home Phase 3 trial showing 246 patients randomized and data collected on 2,628 agitation episodes over 12 weeks in 215 patients. Of those, 2,437 episodes were treated in 208 patients and 168 patients (81%) completed the full 12-week trial. Treated patients averaged 11.7 agitation episodes each; episodes were classified as mild (664), moderate (1,369) or severe (395). All patients successfully self-administered the film. Enrolled patients were 45% bipolar and 55% schizophrenia. The company now estimates a total addressable market of 57–77 million annual agitation episodes versus a prior estimate of 23 million, citing higher episode frequency supported by trial and survey data. Patient and physician feedback indicated a significant unmet need for an effective fast-acting at-home treatment; patients said they would take BXCL501 for 80% of episodes and 90% would take it at onset.
BioXcel Therapeutics reported topline operational and safety observations from its SERENITY At-Home Pivotal Phase 3 trial of BXCL501 for agitation. The company randomized 246 patients and collected data on 2,628 agitation episodes, treating 2,437 episodes in 208 patients; 168 patients (81%) completed the 12-week trial and treated patients averaged 11.7 episodes each. All patients could self-administer the film and there were no drug-related serious adverse events, syncopes, falls, or severe treatment-emergent adverse events reported. Based on episode frequency seen in the trial and external surveys, the company estimates 57 million to 77 million annual agitation episodes in U.S. at-home settings and cites strong patient interest in using BXCL501.
BioXcel Therapeutics, Inc. filed a prospectus supplement for the offer and sale of up to $80,000,000 shares of common stock under its at-the-market program with Canaccord Genuity LLC. This program allows the company to sell common stock from time to time through Canaccord Genuity acting as sales agent. The filing also notes that Honigman LLP issued a legal opinion on the validity of the shares issuable under the Equity Distribution Agreement and the prospectus supplement, and this opinion is included as an exhibit to the report.
BioXcel Therapeutics reported that it received positive pre-sNDA meeting comments from the U.S. FDA for its planned supplemental new drug application (sNDA) for BXCL501 to treat agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting. Based on this written feedback, the company believes its planned regulatory package will be sufficient to support the sNDA submission, which remains on track for the first quarter of 2026.
The pre-sNDA interaction focused on aligning with the FDA on the content and format of the submission, including clinical, nonclinical, and chemistry, manufacturing and controls requirements. BioXcel considers the meeting objectives achieved through the FDA’s written responses and cancelled the previously scheduled in-person meeting, with the preliminary written comments now serving as the official record. Acceptance of the sNDA will still depend on the FDA’s review of the complete filing.
BioXcel Therapeutics, Inc. reported receiving positive preliminary meeting comments from the U.S. Food and Drug Administration (FDA) ahead of a planned pre-supplemental New Drug Application (pre-sNDA) meeting scheduled for August 20, 2025. The company is reviewing this feedback and plans to provide an update next week. The upcoming pre-sNDA meeting is intended to align with the FDA on the proposed format and content of BioXcel’s planned sNDA submission, covering clinical, nonclinical, and chemistry, manufacturing and controls (CMC) requirements.
BioXcel Therapeutics furnished a press release announcing financial results for the three months ended June 30, 2025 and provided a business update; that press release is included as Exhibit 99.1 to this Form 8-K. The company expressly states the information is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act, and therefore is not incorporated by reference into registration statements except as expressly noted.
The report also identifies Exhibit 104 (cover page interactive XBRL tags). The Form itself does not contain the financial line items or tables; readers must consult Exhibit 99.1 for the detailed results and the business commentary.
BioXcel Therapeutics, Inc. disclosed participation by its CEO in a Canaccord fireside chat and detailed compliance with an Oaktree financing covenant tied to a Fifth Amendment to its credit agreement. The covenant required staged capital raises: $7.0M (Raise 1), $18.0M cumulative by March 15, 2025 (Raise 2), and $29.0M cumulative by mid-August 2025 or 30 days after a clinical readout.
The company completed a November 2024 public offering (net ≈ $6.2M), a March 2025 registered direct (net ≈ $13.0M), and an ATM program that sold 5,774,018 shares for net proceeds of ≈ $11.2M. As of August 8, 2025 the company reported ≈ $30.4M in aggregate net proceeds and 13,709,124 shares outstanding, satisfying the Oaktree Financing Covenant. The filing attaches the press release and Inline XBRL cover page as exhibits.
BioXcel Therapeutics disclosed a corporate presentation on its website describing the commercial opportunity for BXCL501 in connection with upcoming SERENITY At-Home Phase 3 study results. The filing states the presentation is attached as Exhibit 99.1 and that the exhibit contains forward-looking statements, which are based on current expectations and subject to limitations disclosed in the exhibit and the company’s other SEC filings.
The report does not present clinical data, financial results, or material transactions; it serves to communicate the company’s commercial case for BXCL501 and to make related forward-looking commentary available to investors.
BioXcel Therapeutics (BTAI) filed an 8-K to disclose completion of the “last-patient-last-visit” milestone in its SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 120 mcg for the acute treatment of agitation in bipolar disorder and schizophrenia.
- Randomized, double-blind, placebo-controlled design; >200 patients treated across 22 U.S. sites, with no site >11 % of enrollment.
- Patient mix was balanced between the two indications and the “vast majority” completed the 12-week study.
- >2,200 agitation episodes were captured, providing a sizable safety data set.
- Top-line results are expected later this month; management reiterates plans for a subsequent sNDA submission.
No financial metrics were provided. The filing consists mainly of forward-looking statements outlining regulatory intentions and associated risks.
BioXcel Therapeutics (BTAI) filed an 8-K announcing it has submitted a pre-supplemental NDA (pre-sNDA) package to the FDA seeking to expand IGALMI’s label to cover at-home treatment of acute agitation in schizophrenia or bipolar disorders. The FDA has scheduled the pre-sNDA meeting for 20 Aug 2025; BioXcel aims to confirm alignment on data requirements and formatting before filing the full sNDA. Management also intends to reconfirm guidance from a 6 Mar 2024 Type C meeting, in which the FDA deemed the company’s development plan a reasonable path to support the proposed 120 mcg BXCL501 outpatient indication.
No financial metrics were disclosed. The filing consists primarily of regulatory updates and forward-looking statements reminding investors of associated risks. Successful FDA agreement could open a materially larger market by allowing IGALMI to be self-administered outside clinical settings, but approval is still contingent on future FDA review.