Not watering down bound capital extends cash runway until at least 2024
Facility strengthens the balance sheet expected commercial startit from Axsomes two leading CNS product candidates
NEW YORK, Sep 29, 2020 (GLOBE NEWSWIRE) – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the treatment of central nervous system (CNS) disorders, has signed up for a term loan $ 225 million secured with Hercules Capital, Inc. (NYSE: HTGC). The tied capital strengthens the company’s balance sheet through the expected commercial launches of its two leading product candidates, AXS-05 for major depressive disorder (MDD) and AXS-07 for migraine, and extends its liquidity based on the current status through at least 2024 operational plans.
“The committed, non-dilutive capital from this fixed-term credit facility increases our financial flexibility in handling the anticipated upcoming launch of our first two potentially life-changing investigational drugs for patients with depression and migraines,” said Herriot Tabuteau, MD, chief executive officer of Axsome. “At the same time, we will continue to advance the rest of our differentiated late-stage CNS pipeline, which includes two more breakthrough therapy programs, AXS-05 for Alzheimer’s disease and AXS-12 for narcolepsy, as we build a leading CNS company.”
“Hercules is proud to partner with Axsome prior to submitting its new drug submissions for AXS-05 for depression and AXS-07 for migraine and support its work to develop novel treatments for millions of patients with CNS disorders,” said Scott Bluestein , Chief Executive Officer and Chief Investment Officer of Hercules Capital. “Hercules’ significant commitment is in line with Axsome’s growth plans and is an example of the breadth of our platform and our ability to fund life science companies at all stages of development.”
Under the terms of the new $ 225 million fixed-term loan facility, it is available for $ 60 million upon completion; $ 115 million may be drawn in three separate tranches, at the option of the company, if AXS-05 is approved for MDD, if AXS-07 is approved for migraine, and if certain combined sales criteria are used for AXS-05 and AXS-07; and an additional $ 50 million is available, pending approval from Hercules Capital, to support future strategic initiatives, including further expansion or expansion of the pipeline. Of the initial $ 60 million, the company withdrew $ 50 million on completion, with the additional $ 10 million available at the company’s option. A portion of the initial drawdown was used to repay the company’s pre-existing $ 20 million principal loan with Silicon Valley Bank, along with associated final settlement fees. The new fixed-term credit facility bears a calculated variable interest rate based on the current 9.15%. It has a term until October 2025 and an initial interest payment period of 30 months, which can be extended to up to 48 months if future tranches are drawn. Axsome will issue warrants to purchase 15,541 common shares of Axsome following the initial funding of the Facility.
Additional details of the loan agreement will be filed with the Securities and Exchange Commission in a recent report on Form 8-K.
Above Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies to treat central nervous system (CNS) disorders for which treatment options are limited. For the many people facing unsatisfactory treatments for CNS disease, Axsome is accelerating the invention and adoption of life changing drugs. The core product portfolio of Axsome’s CNS product candidates includes five clinical stage candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is developed for severe depressive disorder (MDD), therapy-resistant depression (TRD), agitation of Alzheimer’s disease (AD) and for the treatment of smoking cessation. AXS-07 is being developed for the acute treatment of migraines. AXS-12 is being developed to treat narcolepsy. AXS-14 is being developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12 and AXS-14 are investigational drugs that are not approved by the FDA. For more information, please visit the company’s website at axsome.com. The Company may from time to time post material, non-public information on the Company’s website.
Above Hercules Capital, Inc.
Hercules Capital, Inc. (NYSE: HTGC) is the leading and largest specialty finance firm focused on providing senior secured venture capital loans to high growth innovative venture capital firms in a variety of technology, life sciences, and sustainable and renewable technology industries. Since its inception (December 2003), Hercules has tied up more than $ 10.5 billion in over 500 companies and is the lender of choice for entrepreneurs and venture capital firms seeking growth capital financing.
Certain matters discussed in this press release constitute “forward-looking statements”. In some cases we may use terms such as “predicted”, “believes”, “potential”, “further”, “estimates”, “expects”, “expects”, “planet”, “intends”, “may,” “could” , “Could,” “will,” “should” or other words that convey uncertainty about future events or results used to identify these forward-looking statements. In particular, the company’s statements on trends and possible future results are examples of such forward-looking statements. The forward-looking statements involve risks and uncertainties including, but not limited to, the success, timing, and cost of our ongoing clinical trials and expected clinical trials for our current product candidates, including statements about the timing of initiation, the pace of initiation and completion of the studies (including our ability to fully fund our disclosed clinical trials, which does not require material changes to our currently projected expenses), futility analysis and receipt of interim results that are not necessarily indicative of the final results of our ongoing clinical trials, and the number or The type of studies or the type of results required to support the submission of a new drug submission (“NDA”) for one of our current product candidates; our ability to fund additional clinical trials to continue developing our product candidates; the timing and our ability to obtain and maintain US Food and Drug Administration (“FDA”) or other regulatory approval or other action in relation to our product candidates (including, but not limited to, with or without special protocol assessment) ; the potential of our clinical trials to provide a basis for accelerated approval of our product candidates for the treatment of multiple indications and to accelerate their development times and commercial routes to patients (including, but not limited to, with or without breakthrough therapy mapping); the company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a price that is acceptable to the company, if at all; the successful implementation of the company’s research and development programs and collaborations; the success of the company’s licensing agreements; the market acceptance of the company’s product candidates, if approved; the Company’s anticipated capital requirements, including the Company’s expected cash runway and our ability to fund our commercial launch, which will require product approval; unforeseen circumstances or other disruptions to normal business operations resulting from or in connection with COVID-19; and other factors, including general economic conditions and regulatory developments, beyond the control of the company. The factors discussed here could mean that actual results and developments differ materially from those expressed or implied in such statements. The forward-looking statements speak only as of the date of this press release and the company assumes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
Axsome Therapeutics, Inc.
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