Investment will support upcoming IGALMI™ commercial activity in the U.S. and further clinical pipeline development
NEW HAVEN, Conn., April 19, 2022 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (NASDAQ: BTAI) (the “Company” or “BioXcel Therapeutics”), a company that uses artificial intelligence methods to develop Commercial-stage biopharmaceutical company transforming medicines in neuroscience and immuno-oncology, today announced a strategic financing agreement with Oaktree Capital Management, LP (“Oaktree”) and funds managed by the Qatar Investment Authority (“QIA”).Under the agreement, Oaktree and QIA will provide up to $260 million in total funding to support the commercial activities of the company’s IGALMI™ (dexmedetomidine) sublingual membrane.In addition, the financing is intended to support the expansion of BXCL501 clinical development efforts, including a pivotal Phase 3 program for the acute treatment of agitation in Alzheimer’s disease (AD) patients, as well as the company’s additional neuroscience and immuno-oncology clinical project.
The long-term strategic financing process is led by Oaktree and includes the following components:
Under the agreement, BioXcel Therapeutics will receive approval from the U.S. Food and Drug Administration (FDA) for the use of the company’s BXCL501 product for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.This condition was met on April 5, 2022, following FDA approval of IGALMI.
Key features of the financing include an interest-only term line of credit with a five-year term and FDA approval of BXCL501 for the acute treatment of agitation associated with Alzheimer’s disease.The line of credit includes great flexibility for future business development and monetization events, including BXCL701, the company’s investigational oral innate immune activator.Under the terms of the Income Interest Financing Agreement, Oaktree and QIA will receive tiered Income Interest Financing payments, subject to a maximum return cap, on net sales of IGALMI and any other future BXCL501 products in the United States.Income interest financing rates range from 0.375% to 7.750% of annual net sales of IGALMI and any other future BXCL501 products in the U.S. Redemption of income interest financing agreements at lower multiples within the first three years.The strategic financing also includes a potential equity investment of up to $5 million in the company’s common stock, at the option of Oaktree and QIA, subject to a credit agreement at a price per share equivalent to a 10% premium over the 30% premium that would cause Oaktree and/or QIA to exercise the option The daily volume-weighted average price.
Following the closing of this transaction, along with the company’s cash balance and expected business plan, BioXcel Therapeutics expects to have substantial multi-year working capital.The full execution of this financing will give the company a cash runway into 2025.
“Following our recent approval of IGALMI and today’s financing announcement, we have never been better positioned to realize our vision of being the leading artificial intelligence neuroscience company,” said Dr. Vimal Mehta, CEO of BioXcel Therapeutics. “We are delighted Strengthening our cash position primarily with non-dilutive capital as we prepare to launch IGALMI and advance our three-pillar portfolio growth strategy for this franchise, which includes pursuing additional indications, expanding our geographic reach and expanding medical IGALMI’s setting is available. In the meantime, we remain committed to advancing our additional neuroscience and immuno-oncology portfolio, including BXCL502 and BXCL701.”
“We are delighted to partner with BioXcel Therapeutics during this upcoming period of expected growth, particularly the recent approval and anticipated commercial launch of IGALMI as an acute treatment for agitation associated with adult schizophrenia or bipolar I or II disorder,” said Aman Kumar, Co-Portfolio Manager of Oaktree Life Sciences Lending.”The company has an exciting, AI-driven approach to drug discovery and development, and we look forward to funding the expansion of these efforts and assisting the company in bringing new and innovative treatments to patients around the world.”
Additional information regarding the strategic financing is set out in BioXcel Therapeutics’ Form 8-K filing with the U.S. Securities and Exchange Commission (SEC).
IGALMI (dexmedetomidine) sublingual film, formerly known as BXCL501, is a proprietary oral dissolving film formulation of dexmedetomidine indicated for the acute treatment of patients with schizophrenia or bipolar disorder under the supervision of a healthcare provider Adult agitation associated with Type I or II disorder.The safety and efficacy of IGALMI have not been established beyond 24 hours after the first dose.On April 5, 2022, the U.S. Food and Drug Administration (FDA) approved IGALMI based on data from two pivotal randomized, double-blind, placebo-controlled, parallel-group Phase 3 trials evaluating IGALMI for acute treatment Agitation associated with schizophrenia.SERENITY I) or bipolar I or II disorder (SERENITY II).
BioXcel Therapeutics, Inc. is a biopharmaceutical company using artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology.The company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates as well as big data and proprietary machine learning algorithms to identify new therapeutic indicators.The company’s commercial product IGALMI (developed as BXCL501) is a proprietary dexmedetomidine sublingual film formulation approved by the FDA for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults .BXCL501 is also being evaluated for the acute treatment of Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder.The company is also developing BXCL502, a potential treatment for chronic anxiety in dementia, and BXCL701, an investigational, orally administered systemic innate immune activator, for the treatment of aggressive prostate cancer and advanced solid tumors, which are are refractory or untreated checkpoint inhibitors.For more information, visit www.bioxceltherapeutics.com.
BofA Securities acted as sole structural advisor to BioXcel Therapeutics and Cooley LLP acted as legal advisor to BioXcel Therapeutics.Sullivan & Cromwell LLP is serving as legal counsel to Oaktree and Shearman & Sterling LLP is serving as legal counsel to QIA.
Oaktree is a leading global investment management firm specializing in alternative investments, with $166 billion in assets under management as of December 31, 2021.The firm emphasizes an opportunistic, value-oriented and risk-controlled approach to credit, private equity, and real estate investing.assets and listed stocks.The company has more than 1,000 employees and offices in 20 cities around the world.For more information, visit Oaktree’s website at http://www.oaktreecapital.com/.
The Qatar Investment Authority (“QIA”) is the sovereign wealth fund of the State of Qatar.QIA was established in 2005 to invest and manage the National Reserve Fund.QIA is one of the largest and most active sovereign wealth funds in the world.QIA invests in a wide range of asset classes and geographies and works with leading institutions around the world to build a globally diversified portfolio with a long-term vision to deliver sustainable returns and contribute to the prosperity of Qatar.For more information about QIA, please visit its website www.qia.qa.
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.Forward-looking statements in this press release include, but are not limited to: commercial launch of IGALMI in the U.S. to treat agitation in patients with schizophrenia and bipolar disorder; clinical development plans, including the company’s ongoing development of BXCL501, for the treatment of patients with dementia Agitation and as an adjunctive treatment for major depressive disorder; the company’s future growth plans; anticipated financing pursuant to agreements with Oaktree and QIA and the company’s estimated cash runway and expected adequacy of the company’s capital resources.When used herein, words including “anticipate,” “will,” “plan,” “potential,” “may,” “continue,” “intend,” “design,” “target,” and similar expressions mean In identifying forward-looking-looking statements.In addition, any statements or information, including any underlying assumptions, regarding expectations, beliefs, plans, forecasts, objectives, performance or other characteristics of future events or circumstances, are forward-looking.All forward-looking statements are based on the company’s current expectations and various assumptions.The company believes that its expectations and beliefs have a reasonable basis, but they are inherently uncertain.The company may not live up to its expectations, and its beliefs may not prove to be correct.Actual results may differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, but not limited to: the Company’s need for substantial additional capital and its ability to raise capital if required; the FDA and similar foreign authorities The regulatory approval process is lengthy, time-consuming, expensive and inherently unpredictable; the company has limited experience in drug discovery and drug development; regulators may not accept or agree with the company’s assumptions, estimates, calculations, conclusions or analyses, or may The importance of interpreting or weighing the data in different ways, which may affect the value of a particular program, the approval or commercialization of a particular product candidate or the product and the company in general; the company has no experience in marketing and selling pharmaceuticals and has no experience with IGALMI or BXCL501 sales and marketing arrangements; IGALMI or the Company’s other product candidates may not be acceptable to physicians or the general medical community; the Company may not be able to obtain marketing approval for BXCL501 in Europe or other jurisdictions; the Company may require substantial additional capital to develop and conduct Clinical trials associated with its product candidates and supporting their operations; companies must comply with a wide range of applicable regulations; healthcare reforms may adversely affect future commercial success.These and other important factors are discussed under the heading “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2021, as these factors may appear from time to time in its other filings with the SEC Updates, available on the SEC’s website at www.sec.gov.These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements in this press release.Any such forward-looking statements represent management’s estimates as of the date of this press release.Although the company may choose to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change.These forward-looking statements should not be construed as representing the company’s views on any date after the date of this press release.
1 The financing also includes warrants to purchase shares of the company’s common stock and warrants to purchase units of the company’s subsidiary LLC, as described more fully in the current report on Form 8-K to be filed on April 19, 2022.
Post time: May-07-2022