PVLA 8-K
Palvella Therapeutics, Inc. (PVLA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of registrant as specified in its charter)
(State or other jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of principal executive offices) |
|
(Zip Code) |
||
Registrant’s telephone number, including area code: ( |
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
|
|
The |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 14, 2025, Palvella Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2025. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information furnished pursuant to this Item 2.02, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
On August 14, 2025, the Company will hold its earnings call and use a slide presentation in conjunction with the earnings call. A copy of the presentation is furnished herewith as Exhibit 99.2, and incorporated herein by reference.
The information furnished pursuant to Item 7.01, including Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
|
Description |
99.1 |
|
Press Release of Palvella Therapeutics, Inc., dated August 14, 2025* |
99.2 |
|
Earnings Call Presentation of Palvella Therapeutics, Inc., dated August 14, 2025* |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Furnished herewith
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
Palvella Therapeutics, Inc. |
|
|
|
|
Date: |
August 14, 2025 |
By: |
/s/ Matthew Korenberg |
|
|
|
Matthew Korenberg |
|
|
|
Chief Financial Officer |
Exhibit 99.1
Palvella Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Phase 3 SELVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations completed enrollment, exceeding enrollment target by over 25%; top-line results on track for the first quarter of 2026
Top-line results for Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for cutaneous venous malformations remain on track for the fourth quarter of 2025
QTORIN™ rapamycin has the potential to be the first approved therapy and standard of care in the U.S. for microcystic lymphatic malformations and cutaneous venous malformations
Company plans to announce both a third clinical indication for QTORIN™ rapamycin and a second QTORIN™ platform candidate before year-end 2025
Cash and cash equivalents of $70.4 million as of June 30, 2025 are expected to fund operations into the second half of 2027
Company to host conference call at 8:30 a.m. ET today
WAYNE, PA., August 14, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, reported financial results for the second quarter ending June 30, 2025 and provided a corporate update.
"In the second quarter of 2025, we continued to advance Palvella’s mission of pioneering first-in-disease therapies for individuals with serious, rare genetic skin diseases," said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. "We remain on track for two near-term data readouts for QTORIN™ rapamycin, including our Phase 3 SELVA study in microcystic LMs which we believe will support a New Drug Application submission in 2026. In parallel, we are preparing to announce two new development programs in 2025, further expanding our rare disease pipeline. With strong momentum and a solid financial foundation, Palvella is well-positioned for continued growth and execution on our vision."
Recent Research and Development Highlights
QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs)
QTORIN™ rapamycin for the treatment of cutaneous venous malformations (cutaneous VMs)
QTORIN™ pipeline development
Recent Corporate Highlights
Second Quarter 2025 Financial Results
Conference Call Details
Palvella will host a conference call and live audiovisual webcast to discuss the Company's second quarter 2025 financial results and provide a corporate update at 8:30 a.m. ET today. To access the live webcast of the call with slides, please click here or visit the "Events & Presentations" section of Palvella’s website. To access the call by phone, please use this registration link, and you will be provided with dial in details. A replay of the webcast will be available approximately 2 hours after the conclusion of the call and archived for 90 days under the "Events & Presentations" section of the Company's website at www.palvellatx.com.
About Palvella Therapeutics
Founded and led by rare disease drug development veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare genetic skin diseases, many of which are lifelong in nature. 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. For more information, please visit www.palvellatx.com or follow Palvella on LinkedIn or X (formerly known as Twitter).
QTORIN™ rapamycin is for investigational use only and has not been approved or cleared by the FDA or by any other regulatory agency for any indication.
Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Palvella, as well as assumptions made by, and information currently available to, the management of Palvella. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,”
“anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the expected timing of the presentation of data from ongoing clinical trials, Palvella’s clinical development plans and related anticipated development milestones, Palvella’s cash and financial resources and expected cash runway, and the potential of, and expectations regarding, Palvella’s programs, including QTORIN™ rapamycin, and its research-stage opportunities and any additional indications or platform candidates, including its expected therapeutic potential and market opportunity. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella’s product candidates, including QTORIN™ rapamycin; the outcome of early clinical trials for Palvella’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella’s current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella to protect its intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations; and the risks and uncertainties described in the filings made by Palvella with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Palvella may face. Except as required by applicable law, 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.
This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.
Contact Information
Investors
Wesley H. Kaupinen
Founder and CEO, Palvella Therapeutics
[email protected]
Media
Marcy Nanus
Managing Partner, Trilon Advisors LLC
PALVELLA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
5,118 |
|
|
$ |
1,442 |
|
|
$ |
9,192 |
|
|
$ |
2,426 |
|
General and administrative |
|
|
4,132 |
|
|
|
1,466 |
|
|
|
7,929 |
|
|
|
2,241 |
|
Total operating expenses |
|
|
9,250 |
|
|
|
2,908 |
|
|
|
17,121 |
|
|
|
4,667 |
|
Loss from operations |
|
|
(9,250 |
) |
|
|
(2,908 |
) |
|
|
(17,121 |
) |
|
|
(4,667 |
) |
Total other income (expense), net |
|
|
(221 |
) |
|
|
(1,264 |
) |
|
|
(535 |
) |
|
|
(2,041 |
) |
Net loss |
|
$ |
(9,471 |
) |
|
$ |
(4,172 |
) |
|
$ |
(17,656 |
) |
|
$ |
(6,708 |
) |
Less: Cumulative Series D preferred dividends |
|
|
— |
|
|
|
(194 |
) |
|
|
— |
|
|
|
(388 |
) |
Net loss attributable to common stockholders |
|
$ |
(9,471 |
) |
|
$ |
(4,366 |
) |
|
$ |
(17,656 |
) |
|
$ |
(7,096 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share — basic and diluted |
|
$ |
(0.86 |
) |
|
$ |
(2.47 |
) |
|
$ |
(1.60 |
) |
|
$ |
(4.01 |
) |
Weighted-average number of common shares used in computing net loss per share — basic and diluted |
|
|
11,052,741 |
|
|
|
1,770,167 |
|
|
|
11,033,327 |
|
|
|
1,770,167 |
|
PALVELLA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
(in thousands)
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
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 |
|
First-in-disease therapies for patients with rare genetic skin diseases Q2 2025 Financial Results & Corporate Update August 14, 2025
Forward Looking Statements This presentation contains forward-looking statements of Palvella Therapeutics, Inc. (the Company”) within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained in this presentation include, but are not limited to, statements regarding the Company’s future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters, the Company’s current and prospective product candidates and any additional indications or platform candidates, the Company's planned research and development activities, the Company's planned clinical trials, including timing of receipt of data from the same, the planned regulatory framework for the Company's product candidates, the strength of the Company's intellectual property portfolio, and projections of the Company’s future financial results and other metrics. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon current estimates and assumptions of the Company and its management and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this presentation. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition, the ability of the company to grow and manage growth, maintain relationships with suppliers and retain its management and key employees; the success, cost and timing of the Company’s product development activities, studies and clinical trials; changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business or competitive factors; the Company’s estimates of expenses and profitability; the evolution of the markets in which the Company competes; the ability of the Company to implement its strategic initiatives and continue to innovate its existing products; and the ability of the Company to defend its intellectual property. Nothing in this Presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. Industry and Market Data The Company may from time to time provide estimates, projections and other information concerning its industry, the general business environment, and the markets for certain conditions, including estimates regarding the potential size of those markets and the estimated incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events, circumstances or numbers, including actual disease prevalence rates and market size, may differ materially from the information reflected in this presentation. Unless otherwise expressly stated, we obtained this industry, business information, market data, prevalence information and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources, in some cases applying our own assumptions and analysis that may, in the future, prove not to have been accurate. Trademarks This Presentation may contain trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners. Solely for convenience, some of the trademarks, service marks, trade names and copyrights referred to in this Presentation may be listed without the TM, SM © or ® symbols, but the Company will assert, to the fullest extent under applicable law, the rights of the applicable owners, if any, to these trademarks, service marks, trade names and copyrights.
Multiple High-Impact Near-Term Milestones by Q1 2026 Phase 3 data in microcystic LMs (Q1:26) – exceeded enrollment target Phase 2 data in cutaneous VMs (Q4:25) Additional mTOR-driven indication for QTORINTM Rapamycin (2H:25) New QTORINTM Program (2H:25) QTORINTM QTORINTM PLATFORM QTORINTM 3.9% rapamycin anhydrous gel is for investigational use only and has not been approved or cleared by the FDA or by any other regulatory agency. The safety or efficacy has not been established for any use. QTORINTM 3.9% rapamycin anhydrous gel 1 2 3 4
QTORINTM Rapamycin: Potential To Be First FDA-Approved Therapy for Serious, Rare, Lifelong Disease Phase 3 data in microcystic LMs (Q1:26) – exceeded enrollment target Key presentations and posters at major scientific meetings SID poster supports > 30,000 estimated diagnosed prevalence and > 1,500 annual incidence of microcystic lymphatic malformations in the U.S. NDA planning accelerating Chief Commercial Officer hired; U.S. launch planning underway Phase 3 SELVA trial over-enrolled and on track for Q1 2026 readout 1 Ashley Kline Chief Commercial Officer Amy Paller, MD
Phase 2 data in cutaneous VMs (Q4:25) Large growing base of real-world evidence supporting off-label systemic rapamycin as targeted therapy for internal venous malformations QTORINTM Rapamycin: Potential To Be First FDA-Approved Therapy for Serious, Rare, Chronically Debilitating Disease Phase 2 TOIVA trial on track for Q4 2025 readout 2 Megha Tollefson, MD Principal Investigator Phase 2 TOIVA trial enrollment ongoing PoC study to enroll ~15 patients No statistical hierarchy of endpoints Estimated U.S. diagnosed prevalence: > 75,000 Epi study completed to determine cutaneous-only and mixed population FDA Fast Track Designation granted (2024) Significant unmet need for targeted, localized therapy for cutaneous venous malformations
Epidermis Dermis Subcutaneous / Internal VM Cutaneous VM Bleeding, thrombosis, ulceration, disfigurement, and proliferation can significantly impact patient QoL QTORINTM Rapamycin Targets Cutaneous Venous Malformations: On Target, In Tissue
QTORINTM Pipeline Development
QTORINTM Rapamycin: “Pipeline-in-a-Product” to Address Broad Range of mTOR-Driven Skin Diseases Larger, controlled studies are needed to define optimal concentrations, formulations, and dosing schedules. “ “ >25 mTOR-driven skin diseases Vascular anomalies, genodermatoses, non-vascular neoplasms, and others Need for safe and effective FDA-approved therapy for these indications 2015 2021 2025
Key Value Drivers from Pipeline Programs in Second Half of 2025 Additional mTOR-driven indication for QTORINTM Rapamycin (2H:25) New QTORINTM Program (2H:25) QTORINTM QTORINTM PLATFORM QTORINTM 3.9% rapamycin anhydrous gel QTORINTM 3.9% rapamycin anhydrous gel is for investigational use only and has not been approved or cleared by the FDA or by any other regulatory agency. The safety or efficacy has not been established for any use. QTORINTM rapamycin next indication Serious, rare, no FDA-approved therapies mTOR drives disease pathology Commercially attractive New QTORINTM program Serious, rare, no FDA-approved therapies Well-defined genetics Clear biology Commercially attractive Targeting <$10mm and <2.5 years to Phase 2 POC data Measured Dose Pump 3 4
Financial Update
Q2 2025 Financial Highlights and 2025 Outlook ~2 years Runway into 2H 2027 $70.4 million Cash at 6/30/2025 $9.3 million R&D + G&A expenses in Q2 2025 ~$55 million Projected cash at year end June 2025 Update Strong Cash Position Palvella added to Russell 2000® & Russell 3000®
Q&A Striving to be first for rare disease patients