The product will fund the development of Haduvio for severe chronic pruritus in prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis
NEW HAVEN, Connecticut., September 30, 2021 / PRNewswire / – Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of an investigational Haduvio ™ therapy (nalbuphine ER) to treat serious neurological conditions, announced today hui Having has entered into a definitive agreement with a health-focused institutional investor to purchase, in a market-priced private placement under Nasdaq rules, (i) 2,373,201 common shares and the associated warrants to purchase a total of 4,746,402 common stock shares, and (ii) pre-funded warrants to purchase up to a total of 4,926,069 common shares and the associated warrants to purchase a total of 9,852,138 ordinary shares. Each common share and accompanying common share purchase warrants are sold together at a combined price of $ 1.62, and each pre-funded warrant and accompanying common share purchase warrants are sold together at a combined price of $ 1,619, for a gross product of approximately $ 11.8 million. Each pre-funded warrant will have an exercise price of $ 0.001 per share, will be exercisable immediately and may be exercised until all of the pre-funded warrants are fully exercised. Of the accompanying common stock warrants, the warrants to purchase a total of 7,299,270 shares will expire 3.5 years from the date of issue and the warrants to purchase a total of 7 299,270 shares will expire 7 years from the date of issue. The accompanying common share purchase warrants will have an exercise price of $ 1.37 per share and may be exercised immediately.
Stifel acts as the principal placement agent for the private placement. Needham acts as co-placement agent for the private placement.
The gross proceeds to the Company from the Private Placement, before deduction of the Selling Agent’s fees and other estimated offering costs payable by the Company, will be approximately $ 11.8 million. The Company intends to use the net proceeds of the private placement for the development of Haduvio as well as for working capital and other general corporate purposes. The private placement is expected to end on or around October 4, 2021, subject to the satisfaction of the usual closing conditions.
The securities for sale under the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws, and by therefore cannot be offered or sold in United States except pursuant to a current registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. The Company has agreed to file a registration statement with the SEC recording the resale of the Common Shares issued under the Private Placement and the Common Shares issuable upon exercise of the Warrants issued under the Placement. private (the “Private Placement Securities”).
This press release does not constitute an offer to sell or the solicitation of an offer to buy the Offered Securities, and there will be no sale of the Offered Securities in any State or other jurisdiction in which such an offer, solicitation or sale would be illegal prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer of Private Placement Securities under the resale registration statement will be made only by means of a prospectus.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of the experimental Haduvio therapy to treat serious neurological conditions. Trevi is leading a phase 2b/ 3 clinical trial of Haduvio for the treatment of chronic pruritus associated with lumpy prurigo (PN) and a Phase 2 trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi is also developing Haduvio for the treatment of levodopa-induced dyskinesia (DLI) in patients with Parkinson’s disease. These conditions share a common pathophysiology that is mediated by opioid receptors in the central and peripheral nervous systems.
Founded in 2011, Trevi Therapeutics is headquartered in New Haven, Connecticut.
Haduvio, an investigational therapy, is an oral sustained-release (ER) formulation of nalbuphine. Nalbuphine is a mixed opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for over 20 years in the United States and Europe. The opi- and µ-opioid receptors are known to be critical mediators of itching, coughing, and certain movement disorders. The mechanism of action of nalbuphine may also reduce the risk of abuse associated with µ-opioid agonists, as it antagonizes or blocks µ-opioid receptors. Parenteral nalbuphine is currently not classified as a controlled substance by the DEA in the United States and by regulatory authorities in most European countries. Trevi intends to offer Haduvio as the trade name for nalbuphine ER. Haduvio is an investigational therapy that has received Fast Track designation from the FDA for the proposed indication of reduction of moderate to severe pruritus in patients with prurigo nodularis. Its safety and efficacy have not been evaluated by any regulatory authority.
Statements in this press release regarding matters which are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, without limitation, statements relating to the potential sale of common goods, shares and warrants within the framework of the private placement; the intended use of the proceeds of the private placement; and other statements containing the words “believes”, “anticipates”, “plans”, “expects” and similar expressions. These statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by these forward-looking statements. Risks that contribute to the uncertain nature of forward-looking statements include: fluctuations in the price of the Trevi share; the intended use of the proceeds of the private placement; the ability of Trevi to meet customary closing conditions associated with the private placement and to complete the private placement; uncertainties regarding the success, cost and timing of Trevi’s product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi’s clinical operations and the actions taken in response to the pandemic; uncertainties regarding Trevi’s ability to execute its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory changes in the United States and in foreign countries; uncertainties regarding the expedited designation and the effect that this status may have on the regulatory review or approval process; uncertainties inherent in estimating Trevi’s cash, future expenses and other financial results, including Trevi’s ability to continue operating and its obligations under its loan facility; as well as other risks and uncertainties set out in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi assumes no obligation to update these statements to reflect events that occur or circumstances that exist after the date on which they were made.
Trevi Therapeutics, Inc.
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SOURCE Trevi Therapeutics, Inc.