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Talphera, Inc. (Nasdaq: TLPH) is a specialty pharmaceutical company committed to the development and commercialization of innovative therapies for medically supervised settings. Talphera’s core focus includes the advancement of their flagship product candidate, Niyad™, a lyophilized formulation of nafamostat, which is currently under investigation as an anticoagulant for the extracorporeal circuit. Niyad has earned Breakthrough Device Designation from the FDA, highlighting its potential to bring significant improvements to patient care.
In addition to Niyad, Talphera is developing two pre-filled syringes in partnership with Aguettant: Fedsyra™, an ephedrine pre-filled syringe, and PFS-02, a phenylephrine pre-filled syringe. These products aim to enhance ease of administration and safety in clinical settings.
Recent milestones for the company include securing $26 million in committed capital through a combination of equity and non-dilutive financing. This funding is projected to support Talphera through a potential FDA approval of Niyad by the first half of 2025. In January 2024, Talphera announced a partial monetization of DSUVIA royalties, raising $8 million from XOMA. This strategic move allows the company to concentrate resources on advancing Niyad while still benefiting from DSUVIA's revenue streams.
Talphera's NEPHRO registration trial, evaluating Niyad, is pivotal to its success. The trial has received central Institutional Review Board (IRB) approval and is set to enroll 166 patients across multiple U.S. hospital ICUs. The primary endpoint measures mean post-filter activated clotting time over the first 24 hours, with secondary endpoints including filter lifespan and number of transfusions.
Financially, Talphera is positioned to advance its pipeline with an estimated cash balance of $9.4 million at the end of 2023. The company's cash operating expenses for 2024 are projected between $21 million and $23 million, encompassing the initiation and expected completion of the NEPHRO trial.
For more information about Talphera, Inc., its products, and ongoing trials, visit www.talphera.com.
Talphera (NASDAQ: TLPH) has announced significant developments in its NEPHRO CRRT clinical study following a meeting with the FDA. The agency has agreed to review a Prior Approval Supplement (PAS) for reducing the number of patients in the study, with the submission expected within the week. The FDA's review process will take up to 30 days.
Additionally, the FDA approved two protocol changes that will expedite enrollment: allowing the inclusion of patients on continuous renal replacement therapy (CRRT) beyond 48 hours and permitting heparin-tolerant patients at certain institutions. These changes will be implemented through a five-day protocol amendment notice, requiring no additional FDA review.
The company aims to complete the NEPHRO CRRT study by year-end, with nafamostat being developed as an alternative anticoagulant for CRRT patients under breakthrough designation status.
Talphera (TLPH) reported Q3 2024 financial results, highlighting progress in its NEPHRO CRRT study with five active sites screening patients and two additional sites expected to begin in Q4. The company ended Q3 with $11.1 million in cash and investments. Financial results showed a net loss of $3.4 million ($0.13 per share), compared to $1.4 million loss in Q3 2023. Combined R&D and SG&A expenses increased to $3.7 million from $3.4 million year-over-year, primarily due to NEPHRO study costs. The study will enroll 166 patients across up to 14 U.S. clinical sites, with the primary endpoint measured at 24 hours.
Talphera will release its third quarter 2024 financial results on November 13, 2024 after market close. The company will also host a live webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a business update. The webcast can be accessed through the Investors section of Talphera's website and will include a slide presentation. A replay will be available for 90 days post-event. Investors can join the conference call by dialing 1-800-836-8184 (North America) or 1-646-357-8785 (international) using the conference ID 89949.
Talphera (Nasdaq: TLPH), a specialty pharmaceutical company, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. The company's management will engage in a fireside chat and be available for one-on-one meetings with registered investors during the event, which is scheduled for October 15-17, 2024.
Key details of Talphera's participation include:
- Event: 2024 Maxim Healthcare Virtual Summit
- Date: October 16, 2024
- Time: 3:00 PM ET / 12:00 Noon PT
Talphera focuses on developing and commercializing innovative therapies for use in medically supervised settings. Investors and interested parties can access the fireside chat through the provided webcast link.
Talphera (Nasdaq: TLPH), a specialty pharmaceutical company, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, at the Lotte New York Palace Hotel in New York City. Talphera's management will be available for one-on-one meetings during the conference.
The company's presentation will be accessible on-demand starting September 9 at 7:00 AM ET. Interested parties can view the presentation through a provided link or by visiting the Investors section of Talphera's website at www.talphera.com. The webcast link can be found in the Investors/News & Events/Upcoming Events section.
Talphera (Nasdaq: TLPH) has announced the enrollment of the first patient in its NEPHRO CRRT registrational trial, evaluating nafamostat for anticoagulation in extracorporeal circuits. The study will involve 166 patients across 14 clinical sites in the United States. The primary endpoint is the mean post-filter activated clotting time over the first 24 hours, comparing nafamostat to placebo.
Dr. Stuart Goldstein, a renowned nephrologist, enrolled the first patient. Nafamostat has been a standard of care in Japan and South Korea for over 30 years, and Talphera aims to make it available in the U.S. market if approved. The company views this as a significant milestone in addressing the limitations of current anticoagulation options for continuous renal replacement therapy (CRRT).
Talphera (Nasdaq: TLPH) announced its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Initiation of patient screening at multiple clinical sites for the NEPHRO CRRT registrational study, which will assess nafamostat's safety and effectiveness in 166 patients across up to 14 clinical sites.
2. Cash and investments of $14.0 million as of June 30, 2024.
3. Q2 2024 financial results: Combined R&D and SG&A expenses of $4.3 million, net loss from continuing operations of $3.8 million, and net loss attributable to common shareholders of $3.8 million ($0.15 per share).
4. Appointment of Dr. Shakil Aslam as Chief Development Officer, who will succeed Dr. Palmer as Chief Medical Officer upon her retirement in October.
Talphera Inc. (Nasdaq: TLPH), a specialty pharmaceutical company, has announced it will release its second quarter 2024 financial results after market close on Wednesday, August 14, 2024. The company will host a live webcast and conference call at 4:30 p.m. Eastern Standard Time/1:30 p.m. Pacific Standard Time to discuss the results and provide a business update.
Investors can access the webcast through the company's website or join the conference call by dialing 1-800-836-8184 (North America) or 1-646-357-8785 (international) using the conference ID 28132. The webcast will include a slide presentation, and a replay will be available on Talphera's website for 90 days following the event.
Talphera, a specialty pharmaceutical company, has announced the grant of inducement awards to Dr. Shakil Aslam, the newly appointed Chief Development Officer. These awards, approved by Talphera's Board of Directors on May 20, 2024, include a non-statutory stock option for 185,000 shares and a restricted stock unit award for 32,000 shares. The stock options have an exercise price of $1.08 per share and will vest 25% on May 20, 2025, with the remaining shares vesting monthly over three years. The restricted stock units will vest in equal installments over three years, starting May 20, 2025. These awards were granted under Nasdaq Listing Rule 5635(c)(4) but are governed by Talphera's 2020 Equity Incentive Plan.
Talphera (Nasdaq: TLPH), a specialty pharmaceutical company, has announced its participation in the A.G.P. Virtual Healthcare Conference on May 21, 2024, at 10:40 a.m. ET. The management will engage in a fireside chat format to discuss the company's innovative therapies developed for medically supervised settings. This session aims to provide insights into Talphera's business strategies and future plans. Attendees can join the webcast through a provided link.
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