Full Press Release Details
CorMedix is making a strategic investment in Talphera as the lead investor, supported by existing stockholders Nantahala, Rosalind and Rock Springs with several new institutional investors
$17 millionin proceeds at first closing with the potential to receive an additional$12 millionacross one additional tranche upon the achievement of the primary endpoint in the NEPHRO clinical study
The completion of this financing is expected to provide the company with sufficient capital through the planned approval of a Niyad PMA in the second half of 2026
SAN MATEO, Calif.,Sept. 8, 2025/PRNewswire/ -- Talphera, Inc. (Nasdaq:TLPH), (Talphera), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced it has entered into securities purchase agreements with CorMedix Inc. and certain institutional investors for the sale and issuance of shares of common stock and pre-funded warrants in lieu of shares to purchase common stock in a private placement for total potential proceeds of up to$29 million. CorMedix is making a strategic investment in Talphera common stock priced at the market, while the institutional investors will purchase common stock and pre-funded warrants in lieu thereof, priced at the market, in an initial closing and with an additional tranche of$12 millionupon achievement of the primary endpoint in the NEPHRO CRRT study, and the company's stock trading at a minimum agreed price.
"We are pleased we have secured funding that provides us with the opportunity to be fully funded through a potential approval of the Niyad PMA, which is anticipated in the second-half of next year," statedVince Angotti, Talphera CEO. "The strong interest in this financing, particularly from CorMedix, who recognizes the potential value of Niyad in the acute care market, as well as our existing and new institutional investors, further enforces our strong belief that nafamostat is a valuable product for physicians as they currently have no ideal options for anticoagulation for CRRT. If approved, Niyad would become the first available FDA-approved regional anticoagulant for CRRT. Furthermore, the accelerated momentum in enrollment in our NEPHRO CRRT clinical study provides continued confidence in our goal to complete the study by the end of the year," continued Angotti.
The Private Placement
The private placement is led by CorMedix Inc (Nasdaq:CRMD), a commercial stage pharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, and includes institutional investors Nantahala Capital, Rosalind Advisors, and Rock Springs Capital, and has the potential to raise gross proceeds of up to$29 million, which amount includes (i)$17 millionin the first closing (which is expected to occur onSeptember 10, 2025), (ii)$12 millionin a second closing with such institutional investors upon the achievement of the primary endpoint in the Company's NEPHRO CCRT study (the "Milestone Event"), and a minimum stock price of at least$0.6875per share for five consecutive days following a public announcement of the achievement of the Milestone Event.
In the first closing, Talphera will issue 25,036,363 shares of common stock and 5,845,455 pre-funded warrants, at a price of$0.55per share and$0.549per pre-funded warrant, respectively. The pre-funded warrants will have an exercise price of$0.001per share. In the second closing, upon achievement of theMilestone Eventand if closing conditions are met, Talphera expects to issue additional shares of common stock and pre-funded warrants in the amount of$12 million, at a price of$0.55per share and$0.549per pre-funded warrant, respectively, with the allocation between common stock and prefunded warrants to be determined at that time.
In connection with the closing of this transaction, the Company has provided CorMedix with a 60-day period of exclusivityfollowingthe announcement of theachievement of the primary endpoint and topline clinical study results from theNEPHRO CRRT clinical study to negotiate a definitive agreement to acquire Talphera. CorMedix also has the right to nominate a representative to the Talphera Board of Directors.
The offer and sale of the securities described above are being offered and sold in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder, and have not been registered under the Act, or applicable state securities laws. Accordingly, such securities may not be offered or sold inthe United Statesexcept pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
The Company has agreed to file a registration statement under the Act with the Securities and Exchange Commission (the "SEC"), covering the resale of the shares of common stock to be issued in the private placement and the shares of common stock underlying the pre-funded warrants no later than 15 days following the closing date, and to use reasonable best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days following the closing date in the event of a "full review" by the SEC.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
About Talphera, Inc.Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA).
This release is intended for investors only. For additional information about Talphera, please visitwww.talphera.com.