Pieris Pharmaceuticals(PIRS) - 2025 Q2 - Quarterly Results

Palvella Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update Palvella Therapeutics reports Q2 2025 financial results and corporate updates, highlighting pipeline progress and strong financial position Key Highlights Overview of Q2 2025 achievements and milestones, including clinical trial progress, pipeline expansion, and financial runway - Phase 3 SELVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel for microcystic lymphatic malformations completed enrollment, exceeding the target by over 25%[1] - Top-line results for the Phase 3 SELVA trial are on track for the first quarter of 2026[1] - Top-line results for the Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for cutaneous venous malformations remain on track for the fourth quarter of 2025[1] - The company plans to announce both a third clinical indication for QTORIN™ rapamycin and a second QTORIN™ platform candidate before year-end 2025[1] Cash and Cash Equivalents | As of | Amount (million USD) | | :--- | :--- | | June 30, 2025 | $70.4 | - Cash and cash equivalents are expected to fund operations into the second half of 2027[1] - Palvella is well-positioned for continued growth and execution on its vision, with strong momentum and a solid financial foundation[3] Recent Research and Development Highlights Details the advancement of QTORIN™ rapamycin in clinical trials for microcystic LMs and cutaneous VMs, and broader pipeline development QTORIN™ Rapamycin for Microcystic Lymphatic Malformations (microcystic LMs) - Completed enrollment in the Phase 3 SELVA trial with 51 subjects, exceeding the original target of 40 subjects by over 25%[6] - Received initial proceeds from an FDA Orphan Products Grant, which could total up to $2.6 million, to support the Phase 3 SELVA trial[6] - The USPTO issued patent No. 12,268,673 for QTORIN™ rapamycin for the treatment of microcystic LMs, with anticipated patent life extending into 2038[6] - Top-line results from the SELVA trial are on track for the first quarter of 2026[6] QTORIN™ Rapamycin for Cutaneous Venous Malformations (cutaneous VMs) - Continued execution of the ongoing Phase 2 TOIVA trial, a single-arm, open-label, baseline-controlled clinical trial evaluating QTORIN™ rapamycin for cutaneous VMs, with enrollment ongoing and targeting approximately 15 subjects[6] - Completed a nationally representative, blinded, real-world observational study estimating the U.S. annual prevalence of cutaneous VMs, with findings submitted to a peer-reviewed journal[6] - Top-line results from the TOIVA trial are on track for the fourth quarter of 2025[6] QTORIN™ Pipeline Development - The expansion of QTORIN™ rapamycin into a third serious, rare skin disease with no FDA-approved therapies is progressing, with an announcement planned for the second half of 2025[10] - A second product candidate from the QTORIN™ platform for a serious, rare skin disease has achieved key pre-clinical development milestones, with an announcement planned for the second half of 2025[10] Recent Corporate Highlights Covers key corporate achievements, including executive appointments, intellectual property advancements, and market index inclusions - Wes Kaupinen, Palvella's Founder and CEO, participated in the FDA's CEO Forum with Commissioner Marty A. Makary, M.D., M.P.H, and other senior FDA officials on June 5th[10] - Strengthened executive leadership team with the appointment of Ashley Kline, a rare disease commercial veteran, as Chief Commercial Officer[10] - The USPTO issued patent No. 12,329,748 encompassing a wide range of composition and method-of-use claims for QTORIN™ rapamycin and other mTOR inhibitors, with patent term expected through at least 2038[10] - The Company was added to the Russell 3000® and Russell 2000® indexes on June 27, 2025[10] Second Quarter 2025 Financial Results Comprehensive review of Palvella's financial performance for Q2 and six months ended June 30, 2025, including cash, expenses, and net loss Financial Overview Cash and Cash Equivalents | As of | Amount (million USD) | | :--- | :--- | | June 30, 2025 | $70.4 | - Palvella expects its cash resources to be sufficient to fund operations into the second half of 2027[10] Research and Development Expenses (Three Months Ended June 30) | Period | Amount (million USD) | | :--- | :--- | | 2025 | $5.1 | | 2024 | $1.4 | - The increase in R&D expenses was primarily due to increased spending on the clinical development of QTORIN™ rapamycin for microcystic LMs and cutaneous VMs, including the Phase 3 SELVA and Phase 2 TOIVA trials initiated in 2H 2024[10] General and Administrative Expenses (Three Months Ended June 30) | Period | Amount (million USD) | | :--- | :--- | | 2025 | $4.1 | | 2024 | $1.5 | - The increase in G&A expenses was primarily driven by increased employee compensation due to headcount additions, as well as increases in expenses related to operating as a publicly-traded company[10] Net Loss Attributable to Common Stockholders (Three Months Ended June 30) | Period | Net Loss (million USD) | EPS (USD) | | :--- | :--- | :--- | | 2025 | $9.5 | $0.86 | | 2024 | $4.4 | $2.47 | Shares Outstanding | As of | Shares | | :--- | :--- | | August 8, 2025 | 13,735,390 | Condensed Consolidated Statements of Operations Condensed Consolidated Statements of Operations (in thousands USD) | Operating Expenses (3 Months Ended June 30) | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $5,118 | $1,442 | | General and administrative | $4,132 | $1,466 | | Total operating expenses | $9,250 | $2,908 | | Loss from operations | $(9,250) | $(2,908) | | Total other income (expense), net | $(221) | $(1,264) | | Net loss | $(9,471) | $(4,172) | | Less: Cumulative Series D preferred dividends | — | $(194) | | Net loss attributable to common stockholders | $(9,471) | $(4,366) | | Net loss per share — basic and diluted | $(0.86) | $(2.47) | | Weighted-average number of common shares used in computing net loss per share — basic and diluted | 11,052,741 | 1,770,167 | | Operating Expenses (6 Months Ended June 30) | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $9,192 | $2,426 | | General and administrative | $7,929 | $2,241 | | Total operating expenses | $17,121 | $4,667 | | Loss from operations | $(17,121) | $(4,667) | | Total other income (expense), net | $(535) | $(2,041) | | Net loss | $(17,656) | $(6,708) | | Less: Cumulative Series D preferred dividends | — | $(388) | | Net loss attributable to common stockholders | $(17,656) | $(7,096) | | Net loss per share — basic and diluted | $(1.60) | $(4.01) | | Weighted-average number of common shares used in computing net loss per share — basic and diluted | 11,033,327 | 1,770,167 | Condensed Consolidated Balance Sheet Information Condensed Consolidated Balance Sheet Information (in thousands USD) | As of | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $70,433 | $83,602 | | Other current assets | $3,314 | $4,632 | | Total current assets | $73,747 | $88,234 | | Total assets | $73,747 | $88,234 | | Liabilities and Stockholders' Equity | | | | Current liabilities | $9,616 | $12,038 | | Non-current liabilities | $16,351 | $13,589 | | Total liabilities | $25,967 | $25,627 | | Total stockholders' equity | $47,780 | $62,607 | | Total liabilities and stockholders' equity | $73,747 | $88,234 | Conference Call Details Provides information regarding the company's Q2 2025 earnings conference call and webcast - Palvella hosted a conference call and live audiovisual webcast to discuss Q2 2025 financial results and provide a corporate update at 8:30 a.m. ET on August 14, 2025[11] - A replay of the webcast will be available approximately 2 hours after the conclusion of the call and archived for 90 days on the company's website[11] About Palvella Therapeutics Provides an overview of Palvella Therapeutics' mission, focus, and lead product candidates - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies[12] - The company is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare genetic skin diseases[12] - Palvella's lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being evaluated in the Phase 3 SELVA clinical trial in microcystic lymphatic malformations and the Phase 2 TOIVA clinical trial in cutaneous venous malformations[12] Forward-Looking Statements Standard legal disclosure concerning the nature and risks associated with forward-looking statements made in the press release - This press release contains forward-looking statements discussing goals, intentions, and expectations as to future plans, trends, events, results of operations, or financial condition[14] - Forward-looking statements are based on current beliefs and assumptions subject to risks and uncertainties, and actual results could differ materially due to various factors, including the ability to raise additional capital, advance product candidates, obtain regulatory approval, and protect intellectual property[16] - Palvella does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as required by applicable law[16] Contact Information Provides contact details for investor and media inquiries - Investor contact: Wesley H. Kaupinen, Founder and CEO, Palvella Therapeutics, wes.kaupinen@palvellatx.com[18] - Media contact: Marcy Nanus, Managing Partner, Trilon Advisors LLC, mnanus@trilonadvisors.com[18]