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TALPHERA (TLPH)

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Earnings summaries and quarterly performance for TALPHERA.

Recent press releases and 8-K filings for TLPH.

Talphera Reports Q3 2025 Results, Updates Financing, and Revises Nephrostudy Timeline
TLPH
Earnings
Guidance Update
New Projects/Investments
  • Talphera reported a cash balance of $21.3 million as of September 30, 2025, and Q3 2025 cash operating expenses of $3.4 million.
  • The company completed a $17 million first tranche financing in September, which included a $5 million strategic minority investment from CorMedix. An additional $12 million second tranche is committed upon achieving the nephrostudy primary endpoint and a stock price trading above $0.69 for five consecutive days post-announcement. This financing, combined with existing cash, is expected to provide sufficient capital through at least an anticipated PMA approval in late 2026.
  • The estimated completion of the nephrostudy enrollment has been revised to the first half of 2026, a delay from the previous guidance of end of 2025, due to slower-than-anticipated activation of new clinical sites.
  • Talphera has reduced its 2025 cash operating expense guidance to $14-$15 million from $16-$17 million, with the difference expected to be realized in the first half of 2026.
Nov 12, 2025, 9:30 PM
Talphera Announces Third Quarter 2025 Financial Results and Corporate Update
TLPH
Earnings
Guidance Update
Board Change
  • Talphera reported a net loss of $4.4 million, or $0.11 per basic and diluted share, for the third quarter of 2025. The company's cash and investments balance was $21.3 million as of September 30, 2025.
  • The company closed a $17 million first tranche private placement financing in September 2025, led by CorMedix, Inc., and anticipates that this, along with conditional future tranches, will provide sufficient capital through a potential Niyad PMA approval in late 2026. Additionally, in October 2025, Talphera received approximately $1.6 million from waived conditions of a private placement.
  • For the NEPHRO study, 5 of the 9 target profile clinical sites are now activated, with the study's completion anticipated in H1 2026.
  • Joseph Todisco, CEO of CorMedix, was appointed to Talphera's board of directors in October 2025, following CorMedix's strategic investment. Cash operating expenses for 2025 are now expected to be in the range of $14 million to $15 million, a reduction from the previously provided range.
Nov 12, 2025, 9:12 PM
Talphera Announces Third Quarter 2025 Financial Results and Corporate Update
TLPH
Earnings
Guidance Update
New Projects/Investments
  • Talphera reported a net loss of $4.4 million, or $0.11 per basic and diluted share, for the third quarter of 2025.
  • As of September 30, 2025, the company's cash and investments balance was $21.3 million, with management anticipating sufficient cash through a potential PMA approval of Niyad in late 2026, when combined with conditional future tranches of previous financings.
  • In September 2025, Talphera closed a $17 million first tranche financing led by CorMedix, and subsequently received an additional $1.6 million in October 2025 from certain purchasers who waived conditions for further private placement closings.
  • The NEPHRO clinical study has 5 of 9 target profile clinical sites activated, and completion of the study is expected in H1 2026.
  • Talphera updated its 2025 cash operating expenses guidance (excluding stock-based compensation) to a reduced range of $14 million to $15 million.
Nov 12, 2025, 9:05 PM
Talphera Appoints Joe Todisco to Board of Directors
TLPH
Board Change
New Projects/Investments
M&A
  • Talphera, Inc. announced the appointment of Joe Todisco, CEO of CorMedix Inc., to its Board of Directors.
  • This appointment stems from CorMedix's strategic investment in Talphera in September 2025, which granted CorMedix the right to nominate a board representative.
  • CorMedix also received a 60-day exclusive negotiation period to potentially acquire Talphera, contingent on the announcement of NEPHRO CRRT clinical study results.
  • Mr. Todisco anticipates Talphera's lead product candidate, Niyad™, could achieve potential approval in 2026 and become a new standard of care for anticoagulation in CRRT.
Oct 21, 2025, 12:30 PM
Talphera Announces NEPHRO CRRT Trial Enrollment Milestone
TLPH
New Projects/Investments
Guidance Update
  • Talphera, Inc. announced the enrollment of 17 patients in its 70-patient pivotal NEPHRO CRRT clinical trial, representing approximately 25% enrollment.
  • This 17-patient enrollment milestone was a required condition to close the second tranche of a three-tranche financing that was announced in March 2025.
  • The company remains on track for planned study completion by the end of 2025, with an accelerated recruitment rate where over 90% of enrolled patients are now from new target profile sites.
Aug 25, 2025, 12:30 PM