Second year proceeds granted following FDA review of annual performance progress report on Phase 3 SELVA single-arm, baseline-controlled trial; up to $2.6 million in non-dilutive funding anticipated over the grant period Top-line data from SELVA expected in the first quarter of 2026; New Drug Application (NDA) submission planned for second half of 2026 WAYNE, Pa., Oct. 13, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on de ...

Second year proceeds granted following FDA review of annual performance progress report on Phase 3 SELVA single-arm, baseline-controlled trial; up to $2.6 million in non-dilutive funding anticipated over the grant period Top-line data from SELVA expected in the first quarter of 2026; New Drug Application (NDA) submission planned for second half of 2026 WAYNE, Pa., Oct. 13, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on de ...

Core Viewpoint - Palvella Therapeutics is expanding its QTORIN™ rapamycin development program to include clinically significant angiokeratomas, a rare skin disease with no FDA-approved therapies available for over 50,000 diagnosed patients in the U.S. [1][2] Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for serious, rare skin diseases without FDA-approved treatments [5] - The company is led by veterans in rare disease drug development and is developing a pipeline based on its patented QTORIN™ platform [5] Product Development - The company plans to initiate a Phase 2 trial for QTORIN™ rapamycin targeting clinically significant angiokeratomas in the second half of 2026, following a meeting with the FDA in the first half of 2026 [3] - QTORIN™ rapamycin is also being evaluated in ongoing clinical trials for microcystic lymphatic malformations (Phase 3 SELVA study) and cutaneous venous malformations (Phase 2 TOIVA study) [3] Disease Context - Clinically significant angiokeratomas are characterized by lymphatic-derived skin lesions that can cause bleeding, pain, and functional impairment, with no tendency for spontaneous regression [2] - Current treatment options are limited and involve potentially destructive procedures that carry significant risks [2]

Clinically significant angiokeratomas are characterized by lymphatic-derived skin lesions that can persistently bleed and significantly impact quality-of-life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients Company plans to initiate a Phase 2 trial evaluating QTORIN™ rapamycin for clinically significant angiokeratomas in the second half of 2026 Company to host webcast conference call today, September 24, 2025 at 8:30am ET WAYNE, Pa., Sept. 24, 2025 (GLOBE NEWSWIR ...

Phase 2 TOIVA trial successfully met recruitment target, enrolling 16 subjects at leading vascular anomaly centers; top-line data expected in mid-December 2025 Venous malformations are the most common type of vascular malformation, with skin involvement impacting an estimated approximately 50-80% of patients, which can result in bleeding, thrombosis, ulceration, disfigurement, and proliferation QTORIN™ rapamycin has the potential to be the first approved therapy in the U.S. for more than an estimated 75,000 ...

Palvella Therapeutics (PVLA) 2025 Conference September 04, 2025 02:45 PM ET Speaker0All right, good afternoon, everybody. My name is Alexa. I'm from the Kanter Biotech Equity Research Team, and we're honored to have Wes here today from Palvella Therapeutics. He will be presenting a slide deck. I wanted to just say thank you to Wes and the Palvella team for joining us at our Kanter Healthcare Conference. I'm excited for everybody to learn more about the Palvella story.Speaker1Great, good afternoon, everyone. ...

Co-Founder and former Chief Technical Officer of Arcutis Biotherapeutics brings extensive topical product development experience, including track record of translating science into commercially available therapies Dr. Osborne to guide expansion of QTORIN™ platform, including second QTORIN™ product candidate on track to be announced by year-end 2025 WAYNE, Pa., Sept. 03, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company ...

Co-Founder and former Chief Technical Officer of Arcutis Biotherapeutics brings extensive topical product development experience, including track record of translating science into commercially available therapies Dr. Osborne to guide expansion of QTORIN™ platform, including second QTORIN™ product candidate on track to be announced by year-end 2025 WAYNE, Pa., Sept. 03, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company ...

Core Insights - The Phase 3 SELVA trial for QTORIN™ rapamycin has completed enrollment, exceeding its target by over 25%, with top-line results expected in Q1 2026 [1][5] - The Phase 2 TOIVA trial for QTORIN™ rapamycin is on track for results in Q4 2025 [1][9] - QTORIN™ rapamycin aims to be the first approved therapy for microcystic lymphatic malformations and cutaneous venous malformations in the U.S. [1][3] - The company plans to announce a third clinical indication for QTORIN™ rapamycin and a second candidate from the QTORIN™ platform by the end of 2025 [1][9] Research and Development Highlights - Enrollment in the Phase 3 SELVA trial included 51 subjects, surpassing the original target of 40 [5] - The company received initial proceeds from an FDA Orphan Products Grant, potentially totaling $2.6 million, to support the SELVA trial [5] - Key presentations at scientific meetings included an oral presentation on the SELVA trial design and Phase 2 results [5] - The USPTO issued patent No. 12,268,673 for QTORIN™ rapamycin, with a patent life extending into 2038 [5] Financial Overview - As of June 30, 2025, the company reported cash and cash equivalents of $70.4 million, expected to fund operations into the second half of 2027 [1][9] - Research and development expenses for Q2 2025 were $5.1 million, up from $1.4 million in Q2 2024, primarily due to increased clinical development spending [9][17] - General and administrative expenses rose to $4.1 million in Q2 2025 from $1.5 million in Q2 2024, driven by increased employee compensation and public company operating costs [9][17] - The net loss attributable to common stockholders for Q2 2025 was $9.5 million, or $0.86 per share, compared to a net loss of $4.4 million, or $2.47 per share, in Q2 2024 [9][17] Corporate Developments - The company is expanding its rare disease pipeline with plans for two new development programs in 2025 [3][9] - The appointment of Ashley Kline as Chief Commercial Officer strengthens the executive leadership team [9] - The company was added to the Russell 3000® and Russell 2000® indexes on June 27, 2025 [9]

Core Viewpoint - Palvella Therapeutics, Inc. is set to report its second quarter 2025 financial results on August 14, 2025, and will host a conference call for investors to discuss these results and provide a corporate update [1][2]. Company Overview - Palvella Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare genetic skin diseases that lack FDA-approved treatments [4]. - The company is developing a pipeline of product candidates utilizing its patented QTORIN™ platform, with a primary focus on lifelong rare genetic skin diseases [4]. - Palvella's lead product candidate, QTORIN 3.9% rapamycin anhydrous gel, is currently undergoing evaluation in the Phase 3 SELVA clinical trial for microcystic lymphatic malformations and the Phase 2 TOIVA clinical trial for cutaneous venous malformations [4]. Financial Communication - A conference call for investors will take place at 8:30 a.m. ET on August 14, 2025, to discuss the financial results and provide updates on the company [2]. - The call will be accessible via a live webcast and by phone, with a replay available approximately two hours after the call [3].