{"success":true,"data":{"pressRelease":{"id":"18824","rtpr_id":"nGNXBWXc3","ticker":"PVLA","exchange":"NASDAQ","all_tickers":["PVLA"],"title":"Palvella Therapeutics Announces First Patients Dosed in Phase 2 LOTU Trial of Fast Track-Designated QTORIN™ Rapamycin for Clinically Significant Angiokeratomas","author":"Globe Newswire","published_at":"2026-05-04T11:30:00.777Z","article_body":"Clinically significant angiokeratomas represent a rare, chronic and\ndebilitating lymphatic malformation with no FDA-approved therapies and an\nestimated more than 50,000 diagnosed patients in the U.S.\n\nPhase 2 single-arm, baseline-controlled trial expected to enroll up to 15\nsubjects at leading vascular anomaly centers and high-volume dermatology\ncenters in the U.S.\n\nTopline results from the Phase 2 trial are expected in the second half of 2027\n\nWAYNE, Pa., May 04, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc.\n(https://www.globenewswire.com/Tracker?data=qdIFpXkLv0xS0w-Oy4cYqH6WoZfJ56mS0Fg8BD0dCQ_MlbH1AQLfhgBVfW6-w-2wHJO22XkJoXOktXpBPtAQj7C75XHAEHNgD9CFB0S-Hqc=)\n(Palvella or “the Company”) (Nasdaq: PVLA), a clinical-stage\nbiopharmaceutical company focused on developing and commercializing novel\ntherapies to treat patients suffering from serious, rare skin diseases and\nvascular malformations for which there are no U.S. Food and Drug\nAdministration (FDA)-approved therapies, today announced that the first\npatients have been dosed in LOTU, a multicenter Phase 2 clinical trial\ndesigned to evaluate the safety and efficacy of QTORIN™ 3.9% rapamycin\nanhydrous gel (QTORIN™ rapamycin) for the treatment of clinically\nsignificant angiokeratomas.\n\n“Clinically significant angiokeratomas represent a chronic, debilitating\ncondition characterized by hyperkeratotic vascular lesions that can bleed\nwith minor trauma, are susceptible to infection, and significantly impair\npatients’ quality of life,” said Maria Buethe, MD, PhD, Division Chief of\nDermatology at Rady Children’s Hospital of Orange County and Director of\nPediatric Dermatology at the University of California, Irvine, and principal\ninvestigator of the LOTU study. “These lesions are especially burdensome\nwhen large or located in difficult to treat areas or when causing functional\nimpairments. Current management relies on invasive, often destructive\nprocedures, including laser therapy and electrocautery, which can be\nassociated with pain, scarring, recurrence, and incomplete disease control.\nAngiokeratomas do not spontaneously regress and can increase in size, number,\nand severity over time, underscoring the need for a targeted therapeutic\noption.”\n\nIn 2025, the International Society for the Study of Vascular Anomalies (ISSVA)\nclassified angiokeratomas as isolated lymphatic malformations, reflecting\nadvances in the understanding of angiokeratomas as a lymphatic disease. This\nclassification places angiokeratomas within the same ISSVA-recognized isolated\nlymphatic malformation category as microcystic lymphatic malformations, the\nlead indication for QTORIN™ rapamycin, strengthening the scientific\nrationale for extending QTORIN™ rapamycin into clinically significant\nangiokeratomas based on shared lymphatic disease biology. Emerging evidence\nimplicating dysregulated mammalian target of rapamycin (mTOR) and vascular\nendothelial growth factor (VEGF) signaling pathways in lymphatic endothelial\nproliferation and abnormal vascular morphology further supports the\nmechanistic rationale for evaluating mTOR inhibition in angiokeratomas.\nPublished case studies and real-world evidence suggest potential benefit from\noff-label mTOR inhibition; however, there are currently no FDA-approved\ntherapies for angiokeratomas.\n\n“We continue to see broad potential for QTORIN™ rapamycin across serious,\nrare diseases characterized by dysregulated mTOR signaling, significant\npatient burden, and no FDA-approved therapies,” said Wes Kaupinen, Founder\nand Chief Executive Officer of Palvella Therapeutics. “Clinically\nsignificant angiokeratomas represent a meaningful rare disease opportunity,\nwith an estimated more than 50,000 diagnosed patients in the U.S. and no\nFDA-approved therapies. We are advancing this program in close collaboration\nwith our scientific and medical collaborators, informed by significant unmet\nneed, recent advances in the understanding of angiokeratomas as a lymphatic\ndisease, and the central role of mTOR/VEGF signaling in lymphatic vascular\nbiology. We look forward to reporting topline results from the Phase 2 study\nin the second half of 2027.”\n\nThe Phase 2 LOTU study is a single-arm, baseline-controlled clinical trial\nevaluating QTORIN™ rapamycin administered topically once daily for the\ntreatment of clinically significant angiokeratomas. Safety and tolerability\nwill be assessed based on the incidence and severity of adverse events. This\nproof-of-concept study includes multiple measures of efficacy, including\nchange from baseline to Week 12 in clinician and patient global impression\nassessments, as well as assessments of specific clinical manifestations that\ncontribute to disease burden. The Phase 2 LOTU study is expected to enroll up\nto 15 subjects, ages six and older, at leading vascular anomaly centers and\nhigh-volume dermatology centers in the U.S.\n\nQTORIN™ rapamycin is a novel, patented 3.9% rapamycin anhydrous gel designed\nto harness the potential therapeutic benefits of rapamycin, an mTOR inhibitor,\nin affected skin, including dermal tissue where the vascular component of\nangiokeratomas resides, while minimizing systemic exposure and potential\nadverse reactions associated with systemic mTOR inhibition. QTORIN™\nrapamycin was previously granted Fast Track Designation by FDA for the\ntreatment of angiokeratomas, reflecting its potential to address an unmet\nmedical need in a serious disease with no FDA-approved therapies.\n\nAbout Palvella Therapeutics \nFounded and led by rare disease biotech veterans, Palvella Therapeutics, Inc.\n(Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on\ndeveloping and commercializing novel therapies to treat patients suffering\nfrom serious, rare skin diseases and vascular malformations for which there\nare no FDA-approved therapies. Palvella is developing a broad pipeline of\nproduct candidates based on its patented QTORIN™ platform, with an initial\nfocus on serious, rare skin diseases and vascular malformations, many of which\nare lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9%\nrapamycin anhydrous gel (QTORIN™ rapamycin), is currently being developed\nfor the treatment of microcystic lymphatic malformations, cutaneous venous\nmalformations, and clinically significant angiokeratomas. Palvella’s second\nproduct candidate, QTORIN™ pitavastatin, is currently being developed for\nthe treatment of disseminated superficial actinic porokeratosis. For more\ninformation, please visit www.palvellatx.com or follow Palvella on LinkedIn\n(https://www.globenewswire.com/Tracker?data=nb18aY9LdL63Vs861QZSUlnPjyTQ2qgNNOBth-sHYJtCKHe8f6R0F9IpCkBke9aVac2clucx_lPiJ3S9vwkFUAHiazgEUWdj9Qu2Ybjd6fbM9s9iNcsp-0DEYsEZKQClTE22rOTlkw0G2AKOU_SuR3OVtyq5Lem42m61v-ElevrjrO6CBpgcfV7LUKO5cZxnZ8ddNpgs_g-GpcGzWmhEDbum0BdefDaAGft5Ol9JX0_HfARrPcD6S3XVG4pjMMvTn2ufCBMN3a8F8uDxAO5EiqK8NEEGKAxfC4Ml0JI08-HQApuCPbF24HiQtvq1jtvk6ueMAbsEvkhG1q7i10C7uZc4pDhnELlA7nc7g5TgVwDUxiqkqQnmyAOczir7UfYjDUAfEtl7V4G7_Uj2td6PI5IUNJt8NIQ7eG20eZ-RFp2J7y1h8VV68qddlNa3Oaw8SM67zR8I2WqsGNAtFJ6w75el5tcsZs88Q-MK1DMJ00RAQFrkouK9rBuxbZsQA7g-gVefg8wCqz2EfsOfexbtaC5XJXH2AtCHXCsNBTsQqisCn2d9rN0WfAog6g7gyaMGql2SbtW56vJmblRicyHc4M6cjfVvl-lMRGA46lqg0_0XroRW1PVfJ57G95xTFxIC-2bua5-klzS2x6sGkHKpFF0GfjhEG-zG3ZrVwttWO_PiZzhWcQj7QpmYscDsBkSQR9492J7pOJbtALHelwNymYmFjCfwE67-L0Rp9_nHwxCue0Bn302J1j18075-tW2t) or X\n(https://www.globenewswire.com/Tracker?data=wE2usQnISiWxXO04b_JloVs0z36WlXgrXlER4gTlUA2pIGtPWYhfA5g3qCuKWQv_5vLx1wxtDtDXHT1JnQKzfDWkXkN2ThMKl6y8J9AKB2awex1HbsDusRDJvUy8QjRf6o1jq57NtFpFGXdY80Ee3udhwKl1Dssn4mjQouBRGijL7VgH6MmBfg3HL4ZY4FWMoYwJ2vvmFVTKzhJRx4N4j5U8bfYhRdo62yBCy82TxhsWXY-EjAacC23OZc58SgYQy1ZbJU5cT5_WxC9GuPnk5oIFc6K0Ltf19Sph-ijV44OCfeFujGGuc2frqXPGtJ2m1-9YjOfFgXG8XzyW6uJENDJsndpQm14HkE0_yEhF3mZSZZpTu4oOhIsgprrD157OCyiiZpC3k3RJ368FguqfyGHJ1W7MjJCTzem8pa8B61bYgKMOKWlXFN2PtGLRUBL3lUzkv1CwbeFvou_TP1q2Pvg08CLsX_u9nh3RA4jWkFwuHjwtOFnaUE3Kuc96d47zwOIhJqEQwxo-Am_ukufMSlN4nupUJemjw_Bs8IsirIvQp2J6JVCetLuIc4e7C1M6Oi54-GW-FmA9YxC5q7u2n-Q9rU4z5Bv_dHoBFvEcWYQ=) (formerly\nknown as Twitter).\n\nQTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use\nonly and neither has been approved by the FDA or by any other regulatory\nagency for any indication. \n\nForward-Looking Statements \nThis press release contains forward-looking statements (including within the\nmeaning of Section 21E of the Securities Exchange Act of 1934, as amended, and\nSection 27A of the Securities Act of 1933, as amended (Securities Act)). These\nstatements may discuss goals, intentions, and expectations as to future plans,\ntrends, events, results of operations or financial condition, or otherwise,\nbased on current beliefs of the management of Palvella, as well as assumptions\nmade by, and information currently available to, the management of Palvella.\nForward-looking statements generally include statements that are predictive in\nnature and depend upon or refer to future events or conditions, and include\nwords such as “may,” “will,” “should,” “would,” “expect,”\n“anticipate,” “plan,” “likely,” “believe,” “estimate,”\n“project,” “intend,” and other similar expressions or the negative or\nplural of these words, or other similar expressions that are predictions or\nindicate future events or prospects, although not all forward-looking\nstatements contain these words. Statements that are not historical facts are\nforward-looking statements. Forward-looking statements include, but are not\nlimited to, statements regarding the expected timing of the presentation of\ndata from clinical trials, Palvella’s clinical development plans and related\nanticipated development milestones, Palvella’s plans to pursue Breakthrough\nTherapy Designation, Palvella’s plans to meet with regulatory authorities,\nPalvella’s cash, financial resources and expected runway, Palvella’s\nexpectations regarding its programs, including QTORIN™ rapamycin and\nQTORIN™ pitavastatin, and its research-stage opportunities, including its\nexpected therapeutic potential and market opportunity. Forward-looking\nstatements are based on current beliefs and assumptions that are subject to\nrisks and uncertainties and are not guarantees of future performance. Actual\nresults could differ materially from those contained in any forward-looking\nstatement as a result of various factors, including, without limitation: the\nability to raise additional capital to finance operations; the ability to\nadvance product candidates through preclinical and clinical development; the\nability to obtain regulatory approval for, and ultimately commercialize,\nPalvella’s product candidates, including QTORIN™ rapamycin and QTORIN™\npitavastatin; the outcome of early clinical trials for Palvella’s product\ncandidates, including the ability of those trials to satisfy relevant\ngovernmental or regulatory requirements; the fact that data and results from\nclinical studies may not necessarily be indicative of future results;\nPalvella’s limited experience in designing clinical trials and lack of\nexperience in conducting clinical trials; Palvella’s limited experience in\ncommercial manufacturing; the ability to identify and pivot to other programs,\nproduct candidates, or indications that may be more profitable or successful\nthan Palvella’s current product candidates; the substantial competition\nPalvella faces in discovering, developing, or commercializing products; the\nnegative impacts of global events on operations, including ongoing and planned\nclinical trials and ongoing and planned preclinical studies; the ability to\nattract, hire, and retain skilled executive officers and employees; the\nability of Palvella to protect its intellectual property and proprietary\ntechnologies; reliance on third parties, contract manufacturers, and contract\nresearch organizations; and the risks and uncertainties described in the\nfilings made by Palvella with the Securities and Exchange Commission (SEC),\nincluding the annual report on Form 10-K, quarterly reports on Form 10-Q and\ncurrent reports on Form 8-K, filed with or furnished to the SEC and available\nat www.sec.gov. The events and circumstances reflected in our forward-looking\nstatements may not be achieved or occur, and actual results could differ\nmaterially from those projected in the forward-looking statements. New risk\nfactors and uncertainties may emerge from time to time, and it is not possible\nfor management to predict all risk factors and uncertainties that Palvella may\nface. Except as required by applicable law, Palvella does not plan to publicly\nupdate or revise any forward-looking statements contained herein, whether as a\nresult of any new information, future events, changed circumstances or\notherwise. This press release contains hyperlinks to information that is not\ndeemed to be incorporated by reference into this press release.\n\nContact Information \n\nInvestors \nWesley H. Kaupinen \nFounder and CEO, Palvella Therapeutics \nwes.kaupinen@palvellatx.com \n\nMedia \nMarcy Nanus \nManaging Partner, Trilon Advisors LLC \nmnanus@trilonadvisors.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/83fd569b-5e6c-46ad-882a-6430f8ab755a)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXBWXc3","title":"Palvella Therapeutics Announces First Patients Dosed in Phase 2 LOTU Trial of Fast Track-Designated QTORIN™ Rapamycin for Clinically Significant Angiokeratomas","author":"Globe Newswire","ticker":"PVLA","created":"2026-05-04T11:30:00.777Z","tickers":["PVLA"],"exchange":"NASDAQ","article_body":"Clinically significant angiokeratomas represent a rare, chronic and\ndebilitating lymphatic malformation with no FDA-approved therapies and an\nestimated more than 50,000 diagnosed patients in the U.S.\n\nPhase 2 single-arm, baseline-controlled trial expected to enroll up to 15\nsubjects at leading vascular anomaly centers and high-volume dermatology\ncenters in the U.S.\n\nTopline results from the Phase 2 trial are expected in the second half of 2027\n\nWAYNE, Pa., May 04, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc.\n(https://www.globenewswire.com/Tracker?data=qdIFpXkLv0xS0w-Oy4cYqH6WoZfJ56mS0Fg8BD0dCQ_MlbH1AQLfhgBVfW6-w-2wHJO22XkJoXOktXpBPtAQj7C75XHAEHNgD9CFB0S-Hqc=)\n(Palvella or “the Company”) (Nasdaq: PVLA), a clinical-stage\nbiopharmaceutical company focused on developing and commercializing novel\ntherapies to treat patients suffering from serious, rare skin diseases and\nvascular malformations for which there are no U.S. Food and Drug\nAdministration (FDA)-approved therapies, today announced that the first\npatients have been dosed in LOTU, a multicenter Phase 2 clinical trial\ndesigned to evaluate the safety and efficacy of QTORIN™ 3.9% rapamycin\nanhydrous gel (QTORIN™ rapamycin) for the treatment of clinically\nsignificant angiokeratomas.\n\n“Clinically significant angiokeratomas represent a chronic, debilitating\ncondition characterized by hyperkeratotic vascular lesions that can bleed\nwith minor trauma, are susceptible to infection, and significantly impair\npatients’ quality of life,” said Maria Buethe, MD, PhD, Division Chief of\nDermatology at Rady Children’s Hospital of Orange County and Director of\nPediatric Dermatology at the University of California, Irvine, and principal\ninvestigator of the LOTU study. “These lesions are especially burdensome\nwhen large or located in difficult to treat areas or when causing functional\nimpairments. Current management relies on invasive, often destructive\nprocedures, including laser therapy and electrocautery, which can be\nassociated with pain, scarring, recurrence, and incomplete disease control.\nAngiokeratomas do not spontaneously regress and can increase in size, number,\nand severity over time, underscoring the need for a targeted therapeutic\noption.”\n\nIn 2025, the International Society for the Study of Vascular Anomalies (ISSVA)\nclassified angiokeratomas as isolated lymphatic malformations, reflecting\nadvances in the understanding of angiokeratomas as a lymphatic disease. This\nclassification places angiokeratomas within the same ISSVA-recognized isolated\nlymphatic malformation category as microcystic lymphatic malformations, the\nlead indication for QTORIN™ rapamycin, strengthening the scientific\nrationale for extending QTORIN™ rapamycin into clinically significant\nangiokeratomas based on shared lymphatic disease biology. Emerging evidence\nimplicating dysregulated mammalian target of rapamycin (mTOR) and vascular\nendothelial growth factor (VEGF) signaling pathways in lymphatic endothelial\nproliferation and abnormal vascular morphology further supports the\nmechanistic rationale for evaluating mTOR inhibition in angiokeratomas.\nPublished case studies and real-world evidence suggest potential benefit from\noff-label mTOR inhibition; however, there are currently no FDA-approved\ntherapies for angiokeratomas.\n\n“We continue to see broad potential for QTORIN™ rapamycin across serious,\nrare diseases characterized by dysregulated mTOR signaling, significant\npatient burden, and no FDA-approved therapies,” said Wes Kaupinen, Founder\nand Chief Executive Officer of Palvella Therapeutics. “Clinically\nsignificant angiokeratomas represent a meaningful rare disease opportunity,\nwith an estimated more than 50,000 diagnosed patients in the U.S. and no\nFDA-approved therapies. We are advancing this program in close collaboration\nwith our scientific and medical collaborators, informed by significant unmet\nneed, recent advances in the understanding of angiokeratomas as a lymphatic\ndisease, and the central role of mTOR/VEGF signaling in lymphatic vascular\nbiology. We look forward to reporting topline results from the Phase 2 study\nin the second half of 2027.”\n\nThe Phase 2 LOTU study is a single-arm, baseline-controlled clinical trial\nevaluating QTORIN™ rapamycin administered topically once daily for the\ntreatment of clinically significant angiokeratomas. Safety and tolerability\nwill be assessed based on the incidence and severity of adverse events. This\nproof-of-concept study includes multiple measures of efficacy, including\nchange from baseline to Week 12 in clinician and patient global impression\nassessments, as well as assessments of specific clinical manifestations that\ncontribute to disease burden. The Phase 2 LOTU study is expected to enroll up\nto 15 subjects, ages six and older, at leading vascular anomaly centers and\nhigh-volume dermatology centers in the U.S.\n\nQTORIN™ rapamycin is a novel, patented 3.9% rapamycin anhydrous gel designed\nto harness the potential therapeutic benefits of rapamycin, an mTOR inhibitor,\nin affected skin, including dermal tissue where the vascular component of\nangiokeratomas resides, while minimizing systemic exposure and potential\nadverse reactions associated with systemic mTOR inhibition. QTORIN™\nrapamycin was previously granted Fast Track Designation by FDA for the\ntreatment of angiokeratomas, reflecting its potential to address an unmet\nmedical need in a serious disease with no FDA-approved therapies.\n\nAbout Palvella Therapeutics \nFounded and led by rare disease biotech veterans, Palvella Therapeutics, Inc.\n(Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on\ndeveloping and commercializing novel therapies to treat patients suffering\nfrom serious, rare skin diseases and vascular malformations for which there\nare no FDA-approved therapies. Palvella is developing a broad pipeline of\nproduct candidates based on its patented QTORIN™ platform, with an initial\nfocus on serious, rare skin diseases and vascular malformations, many of which\nare lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9%\nrapamycin anhydrous gel (QTORIN™ rapamycin), is currently being developed\nfor the treatment of microcystic lymphatic malformations, cutaneous venous\nmalformations, and clinically significant angiokeratomas. Palvella’s second\nproduct candidate, QTORIN™ pitavastatin, is currently being developed for\nthe treatment of disseminated superficial actinic porokeratosis. For more\ninformation, please visit www.palvellatx.com or follow Palvella on LinkedIn\n(https://www.globenewswire.com/Tracker?data=nb18aY9LdL63Vs861QZSUlnPjyTQ2qgNNOBth-sHYJtCKHe8f6R0F9IpCkBke9aVac2clucx_lPiJ3S9vwkFUAHiazgEUWdj9Qu2Ybjd6fbM9s9iNcsp-0DEYsEZKQClTE22rOTlkw0G2AKOU_SuR3OVtyq5Lem42m61v-ElevrjrO6CBpgcfV7LUKO5cZxnZ8ddNpgs_g-GpcGzWmhEDbum0BdefDaAGft5Ol9JX0_HfARrPcD6S3XVG4pjMMvTn2ufCBMN3a8F8uDxAO5EiqK8NEEGKAxfC4Ml0JI08-HQApuCPbF24HiQtvq1jtvk6ueMAbsEvkhG1q7i10C7uZc4pDhnELlA7nc7g5TgVwDUxiqkqQnmyAOczir7UfYjDUAfEtl7V4G7_Uj2td6PI5IUNJt8NIQ7eG20eZ-RFp2J7y1h8VV68qddlNa3Oaw8SM67zR8I2WqsGNAtFJ6w75el5tcsZs88Q-MK1DMJ00RAQFrkouK9rBuxbZsQA7g-gVefg8wCqz2EfsOfexbtaC5XJXH2AtCHXCsNBTsQqisCn2d9rN0WfAog6g7gyaMGql2SbtW56vJmblRicyHc4M6cjfVvl-lMRGA46lqg0_0XroRW1PVfJ57G95xTFxIC-2bua5-klzS2x6sGkHKpFF0GfjhEG-zG3ZrVwttWO_PiZzhWcQj7QpmYscDsBkSQR9492J7pOJbtALHelwNymYmFjCfwE67-L0Rp9_nHwxCue0Bn302J1j18075-tW2t) or X\n(https://www.globenewswire.com/Tracker?data=wE2usQnISiWxXO04b_JloVs0z36WlXgrXlER4gTlUA2pIGtPWYhfA5g3qCuKWQv_5vLx1wxtDtDXHT1JnQKzfDWkXkN2ThMKl6y8J9AKB2awex1HbsDusRDJvUy8QjRf6o1jq57NtFpFGXdY80Ee3udhwKl1Dssn4mjQouBRGijL7VgH6MmBfg3HL4ZY4FWMoYwJ2vvmFVTKzhJRx4N4j5U8bfYhRdo62yBCy82TxhsWXY-EjAacC23OZc58SgYQy1ZbJU5cT5_WxC9GuPnk5oIFc6K0Ltf19Sph-ijV44OCfeFujGGuc2frqXPGtJ2m1-9YjOfFgXG8XzyW6uJENDJsndpQm14HkE0_yEhF3mZSZZpTu4oOhIsgprrD157OCyiiZpC3k3RJ368FguqfyGHJ1W7MjJCTzem8pa8B61bYgKMOKWlXFN2PtGLRUBL3lUzkv1CwbeFvou_TP1q2Pvg08CLsX_u9nh3RA4jWkFwuHjwtOFnaUE3Kuc96d47zwOIhJqEQwxo-Am_ukufMSlN4nupUJemjw_Bs8IsirIvQp2J6JVCetLuIc4e7C1M6Oi54-GW-FmA9YxC5q7u2n-Q9rU4z5Bv_dHoBFvEcWYQ=) (formerly\nknown as Twitter).\n\nQTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use\nonly and neither has been approved by the FDA or by any other regulatory\nagency for any indication. \n\nForward-Looking Statements \nThis press release contains forward-looking statements (including within the\nmeaning of Section 21E of the Securities Exchange Act of 1934, as amended, and\nSection 27A of the Securities Act of 1933, as amended (Securities Act)). These\nstatements may discuss goals, intentions, and expectations as to future plans,\ntrends, events, results of operations or financial condition, or otherwise,\nbased on current beliefs of the management of Palvella, as well as assumptions\nmade by, and information currently available to, the management of Palvella.\nForward-looking statements generally include statements that are predictive in\nnature and depend upon or refer to future events or conditions, and include\nwords such as “may,” “will,” “should,” “would,” “expect,”\n“anticipate,” “plan,” “likely,” “believe,” “estimate,”\n“project,” “intend,” and other similar expressions or the negative or\nplural of these words, or other similar expressions that are predictions or\nindicate future events or prospects, although not all forward-looking\nstatements contain these words. Statements that are not historical facts are\nforward-looking statements. Forward-looking statements include, but are not\nlimited to, statements regarding the expected timing of the presentation of\ndata from clinical trials, Palvella’s clinical development plans and related\nanticipated development milestones, Palvella’s plans to pursue Breakthrough\nTherapy Designation, Palvella’s plans to meet with regulatory authorities,\nPalvella’s cash, financial resources and expected runway, Palvella’s\nexpectations regarding its programs, including QTORIN™ rapamycin and\nQTORIN™ pitavastatin, and its research-stage opportunities, including its\nexpected therapeutic potential and market opportunity. Forward-looking\nstatements are based on current beliefs and assumptions that are subject to\nrisks and uncertainties and are not guarantees of future performance. Actual\nresults could differ materially from those contained in any forward-looking\nstatement as a result of various factors, including, without limitation: the\nability to raise additional capital to finance operations; the ability to\nadvance product candidates through preclinical and clinical development; the\nability to obtain regulatory approval for, and ultimately commercialize,\nPalvella’s product candidates, including QTORIN™ rapamycin and QTORIN™\npitavastatin; the outcome of early clinical trials for Palvella’s product\ncandidates, including the ability of those trials to satisfy relevant\ngovernmental or regulatory requirements; the fact that data and results from\nclinical studies may not necessarily be indicative of future results;\nPalvella’s limited experience in designing clinical trials and lack of\nexperience in conducting clinical trials; Palvella’s limited experience in\ncommercial manufacturing; the ability to identify and pivot to other programs,\nproduct candidates, or indications that may be more profitable or successful\nthan Palvella’s current product candidates; the substantial competition\nPalvella faces in discovering, developing, or commercializing products; the\nnegative impacts of global events on operations, including ongoing and planned\nclinical trials and ongoing and planned preclinical studies; the ability to\nattract, hire, and retain skilled executive officers and employees; the\nability of Palvella to protect its intellectual property and proprietary\ntechnologies; reliance on third parties, contract manufacturers, and contract\nresearch organizations; and the risks and uncertainties described in the\nfilings made by Palvella with the Securities and Exchange Commission (SEC),\nincluding the annual report on Form 10-K, quarterly reports on Form 10-Q and\ncurrent reports on Form 8-K, filed with or furnished to the SEC and available\nat www.sec.gov. The events and circumstances reflected in our forward-looking\nstatements may not be achieved or occur, and actual results could differ\nmaterially from those projected in the forward-looking statements. New risk\nfactors and uncertainties may emerge from time to time, and it is not possible\nfor management to predict all risk factors and uncertainties that Palvella may\nface. Except as required by applicable law, Palvella does not plan to publicly\nupdate or revise any forward-looking statements contained herein, whether as a\nresult of any new information, future events, changed circumstances or\notherwise. This press release contains hyperlinks to information that is not\ndeemed to be incorporated by reference into this press release.\n\nContact Information \n\nInvestors \nWesley H. Kaupinen \nFounder and CEO, Palvella Therapeutics \nwes.kaupinen@palvellatx.com \n\nMedia \nMarcy Nanus \nManaging Partner, Trilon Advisors LLC \nmnanus@trilonadvisors.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/83fd569b-5e6c-46ad-882a-6430f8ab755a)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-05-04T11:30:00.812245544Z","server_sent_at_ms":1777894200812},"received_at":"2026-05-04T11:30:00.865Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}