Talphera, Inc. (TLPH)

In the past six months, several events have impacted Talphera, Inc.'s stock price. Talphera announced its second-quarter 2025 financial results, reporting a net loss of $3.5 million ($0.10 per share) and no revenue, aligning with analyst expectations, and provided updates on the NEPHRO clinical study, noting 15 patients enrolled and anticipating study completion by year-end 2025. Talphera announced a private placement financing of up to $29 million, with $17 million in proceeds at the first closing, with CorMedix Inc. as a lead strategic investor, alongside existing institutional investors, which was expected to provide sufficient capital through a potential Niyad PMA approval in the second half of 2026. Joe Todisco was appointed to its Board of Directors. The company reported its third-quarter 2025 financial results, with a net loss from continuing operations of $4.4 million ($0.11 per share), and cash and investments stood at $21.3 million as of September 30, 2025. Talphera announced delays in activating new clinical sites for the NEPHRO study, shifting the estimated completion timeline to the first half of 2026 from the previous expectation of year-end 2025, which also led to a reduction in the company's 2025 cash operating expense guidance. The company's share price has been volatile over the past three months compared to the US market.

There is no explicit information available regarding demand seasonality for Talphera, Inc.'s products and services. Demand is likely driven by medical need and regulatory approvals rather than traditional seasonal patterns.

Talphera, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for use in medically supervised settings, operating within the Healthcare sector and the Drug Manufacturers - Specialty & Generic industry. The company specializes in therapies for critical care environments, with its product pipeline primarily built around nafamostat, a broad-spectrum synthetic serine protease inhibitor. Its lead product candidate is Niyad, a lyophilized formulation of nafamostat, currently under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, particularly for continuous renal replacement therapy (CRRT), and has received Breakthrough Device Designation status from the FDA. Talphera is also developing LTX-608, a nafamostat formulation for direct IV infusion, being investigated for various indications including antiviral applications, ARDS, DIC, and acute pancreatitis. Additionally, the company's portfolio includes pre-filled syringe product candidates such as Fedsyra, intended for the treatment of hypotension during general anesthesia, and PFS-02, for managing hypotension and clotting disorders. The company was formerly known as AcelRx Pharmaceuticals, Inc. and rebranded to Talphera, Inc. in January 2024.

Talphera, Inc. is headquartered in San Mateo, California, United States. The company's clinical trials, such as the NEPHRO CRRT study for Niyad, are conducted at U.S. hospital intensive care units. The company's primary operational and developmental focus appears to be within the United States market, particularly concerning FDA approvals for its product candidates.

Talphera, Inc.'s brand reputation appears to be closely tied to its mission of advancing care to optimize outcomes in medically supervised settings and its progress in developing innovative therapies. The company emphasizes its focus on supporting healthcare providers by delivering advancements in patient care. Its reputation is largely shaped by its clinical development milestones and financial updates.

Talphera, Inc. has a significant institutional ownership presence, with 45 institutional owners and shareholders holding a total of 17,779,695 shares, including major institutional owners such as AIGH Capital Management LLC, Rosalind Advisors, Inc., Rock Springs Capital Management LP, Nantahala Capital Management, LLC, Bleichroeder LP, The Vanguard Group Inc, Caption Management, LLC, Geode Capital Management, Llc, Dauntless Investment Group, LLC, and Values First Advisors, Inc., and CorMedix Inc. as a top shareholder. The ownership breakdown includes 1.05% individual insiders, 19.5% public companies (with CorMedix Inc. being a significant holder), 21.2% institutions, 24.8% hedge funds, and 33.5% general public. Shareholders have experienced substantial dilution in the past year, with total shares outstanding growing by 173.7%.