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SAN MATEO, Calif. - Talphera, Inc. (NASDAQ:TLPH), a specialty pharmaceutical company whose stock has declined over 43% in the past year, has received approval from the U.S. Food and Drug Administration (FDA) to reduce the number of patients in its NEPHRO CRRT study. According to InvestingPro data, the company maintains a relatively strong financial position with a current ratio of 4.42, indicating sufficient liquid assets to meet short-term obligations. The study, initially set to include 166 patients, will now enroll 70, with six patients already participating. This reduction aims to maintain the study’s primary endpoint with a 90% power level, according to Talphera CEO Vince Angotti.
The NEPHRO CRRT study, which is central to the development of Talphera’s anticoagulant product candidate Niyad™, is expected to be completed by the end of 2025. Niyad™ has received Breakthrough Device Designation from the FDA and is being evaluated for use in the extracorporeal circuit during renal replacement therapy.
In conjunction with the study’s downsizing, Talphera announced a private placement financing led by existing investors Nantahala Capital and Rosalind Advisors, potentially raising up to $14.8 million. The first closing, scheduled for April 2, 2025, is expected to generate $4.925 million in gross proceeds. The financing is structured in three tranches, with the second and third tranches contingent upon reaching specific patient enrollment milestones in the NEPHRO CRRT study.
The company’s cash and investments totaled $8.9 million as of December 31, 2024. The expected proceeds from the financing, up to $14.8 million, should provide the necessary capital to support the completion of the NEPHRO CRRT study. InvestingPro analysis indicates the company is rapidly burning through cash, though it maintains more cash than debt on its balance sheet. Based on InvestingPro’s Fair Value analysis, the stock appears to be trading below its intrinsic value. Discover more insights and 12 additional ProTips for Talphera on InvestingPro.
Talphera will issue common stock shares and pre-funded warrants in the private placement, which is being conducted under Section 4(a)(2) of the Securities Act of 1933 and Regulation D. The securities have not been registered under the Act or state securities laws, and thus cannot be offered or sold in the U.S. without registration or an exemption. Talphera has agreed to file a registration statement with the SEC for the resale of the common stock and shares underlying the pre-funded warrants.
This update is based on a press release statement and does not constitute an offer to sell or a solicitation of an offer to buy any securities. Talphera’s forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. The company’s overall financial health score stands at 1.92, rated as "FAIR" by InvestingPro, with analysts setting price targets ranging from $3 to $6 per share.
In other recent news, Talphera has been in the spotlight with several key developments. The company is conducting a single registrational study on its lead product, Niyad, which has received Breakthrough Therapy designation. Talphera has submitted a Prior Approval Supplement (PAS) to the FDA aimed at reducing the number of patients required for its NEPHRO CRRT study, a move intended to expedite patient enrollment. The FDA has agreed to review this request, and the review is expected to be completed within 30 days of submission.
Rodman & Renshaw initiated coverage on Talphera with a Buy rating and a price target of $4.00, highlighting the company’s focus on the acute care sector. Analysts from the firm expressed confidence in the potential success of the ongoing study, citing substantial historical evidence of nafamostat’s use in Japan and South Korea. Talphera anticipates that the protocol modifications will support the completion of the trial by the end of the year. Updates on the study’s enrollment and data readouts are expected to influence Talphera’s stock performance throughout 2025.
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