Machine learning predictions based on historical earnings data and price patterns
1-Day Prediction
+2.67%
$156.05
100% positive prob.
5-Day Prediction
+6.36%
$161.66
100% positive prob.
20-Day Prediction
+8.62%
$165.09
95% positive prob.
SEC 8-K filings with transcript text
Aug 4, 2026 · 100% conf.
1D
+2.67%
$156.05
Act: +1.92%
5D
+6.36%
$161.66
Act: +1.52%
20D
+8.62%
$165.09
2 pvla-ex99_1.htm
Palvella Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
First module of the rolling NDA for QTORIN™ rapamycin for microcystic lymphatic malformations submitted to FDA, with completion of the NDA submission on track for the second half of 2026
Preparing for a planned standalone U.S. commercial launch of QTORIN™ rapamycin for microcystic lymphatic malformations in the first half of 2027, if approved
Initiation of Phase 3 trial of QTORIN™ rapamycin for the treatment of cutaneous venous malformations planned for the fourth quarter of 2026
Initiation of Phase 2 trial of QTORIN™ pitavastatin for the treatment of disseminated superficial actinic porokeratosis planned for the second half of 2026
Topline results from the Phase 2 LOTU trial of QTORIN™ rapamycin for clinically significant angiokeratomas expected in the second half of 2027
Cash, cash equivalents and short-term investments of $250.6 million as of June 30, 2026
Company to host conference call at 8:30 a.m. ET today
WAYNE, Pa., August 4, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or “the Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today reported financial results for the second quarter ending June 30, 2026 and provided a corporate update.
“We made significant progress during the second quarter, completing our pre-NDA meeting with FDA and initiating the rolling NDA submission for QTORIN™ rapamycin in microcystic lymphatic malformations,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “We are working closely with FDA under the program’s Breakthrough Therapy and Fast Track designations to expedite development and review, with the objective of potentially introducing the first approved therapy to pediatric and adult patients living with this serious, lifelong disease. Completion of the NDA submission remains on track for the second half of 2026, and we are preparing for a planned standalone commercial launch in the first half of 2027, if approved. We have recruited commercial and medical affairs leaders with deep experience in rare disease and dermatology who are now in the field executing key pre-launch activities, while we continue to advance our other rare disease programs and pursue additional opportunities across the QTORIN™ platform.”
Recent Research and Development Highlights
QTORIN™ rapamycin for microcystic lymphatic malformations (microcystic LMs)
• James Treat, M.D., of Children’s Hospital of Philadelphia presented additional Phase 3 SELVA data during a late-breaking session at the International Society for the Study of Vascular Anomalies World Congress (ISSVA), including a statistically significant improvement in the 6–11-year-old cohort and other supportive findings showing improvements in clinical signs and patient-reported outcomes with QTORIN™ rapamycin.
• Completed an in-person pre-New Drug Application (NDA) meeting with FDA which addressed nonclinical, clinical pharmacology, clinical information, and the planned evidence package for the NDA.
• Following the pre-NDA meeting, FDA granted Palvella’s request for Rolling Review of the QTORIN™ rapamycin NDA for microcystic LMs, allowing the Agency to begin reviewing completed portions of the application before submission of the full NDA.
• Submitted the first module of its rolling NDA to the FDA seeking approval of QTORIN™ rapamycin for the treatment of microcystic LMs.
• The Company remains on track to complete the NDA submission in the second half of 2026.
QTORIN™ rapamycin for cutaneous venous malformations (cutaneous VMs)
• In May 2026, at the 83rd Annual Meeting of the Society for Investigative Dermatology (“SID”), Palvella presented new data from our Phase 2 TOIVA trial of QTORIN™ rapamycin for the treatment of cutaneous VMs highlighting that 100% of patients with bleeding at baseline demonstrated improvement on the Cutaneous Venous Malformations Investigator Global Assessment Bleeding scale at Week 12.
• Dr. Treat presented additional Phase 2 TOIVA data, including 24-week results, at ISSVA demonstrating statistically significant improvements in both cVM-MCSS Height/Engorgement and cVM-MCSS Appearance at all measured time points, with increasing clinical response observed with longer duration of QTORIN™ rapamycin therapy.
• Phase 3 trial initiation remains on track for the fourth quarter of 2026 following completion of the planned End-of-Phase 2 meeting.
QTORIN™ rapamycin for clinically significant angiokeratomas
• Dosed the first patients in LOTU, a multicenter Phase 2 trial evaluating Fast Track-designated QTORIN™ rapamycin for clinically significant angiokeratomas, a rare, chronic and debilitating isolated lymphatic malfor
May 7, 2026
2 pvla-ex99_1.htm
Palvella Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
FDA Pre-New Drug Application (NDA) meeting granted for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations, with meeting expected in second quarter of 2026; NDA submission on track for second half of 2026
Accelerating U.S. launch readiness for QTORIN™ rapamycin for microcystic lymphatic malformations; BEYONDmLM.com disease awareness campaign launched to educate, engage, and empower patients, caregivers, and healthcare professionals
Initiation of Phase 3 trial of QTORIN™ rapamycin for the treatment of cutaneous venous malformations planned for second half of 2026
Initiation of Phase 2 trial of QTORIN™ pitavastatin for the treatment of disseminated superficial actinic porokeratosis planned for second half of 2026
Phase 2 LOTU trial of QTORIN™ rapamycin for clinically significant angiokeratomas initiated with topline results expected in second half of 2027
Completed upsized, oversubscribed equity financing of $230.0 million in February 2026; cash, cash equivalents and short-term investments of $261.9 million as of March 31, 2026
Company to host conference call at 8:30 a.m. ET today
WAYNE, PA., May 7, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or “the Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today reported financial results for the first quarter ending March 31, 2026 and provided a corporate update.
“Following the positive Phase 3 SELVA topline results, we believe Palvella is on a clear path toward near-term NDA submission for QTORIN™ rapamycin in microcystic lymphatic malformations, with the potential for approval and U.S. commercial launch in the first half of 2027,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “Our $230.0 million financing with participation from high-quality new and existing investors meaningfully strengthens our balance sheet, which supports our plan for U.S. commercialization, and enables us to attract key talent as we prepare for a potential first-in-disease launch. At the same time, we continue to rapidly advance our pipeline beyond microcystic LMs, with the goal of expanding our QTORIN™-derived programs across six serious, rare skin diseases and vascular malformations by year-end.”
Recent Research and Development Highlights
QTORIN™ rapamycin for microcystic lymphatic malformations (microcystic LMs)
• Reported positive topline data from the Phase 3 SELVA study demonstrating statistically significant results across the primary and all pre-specified secondary endpoints.
• In collaboration with leading nonprofit and advocacy organizations, launched the “BEYOND mLM” disease awareness campaign and BEYONDmLM.com to educate and engage patients, caregivers, and healthcare professionals on microcystic lymphatic malformations.
• Announced publication in the Journal of Vascular Anomalies highlighting the distinct biology and significant unmet need in microcystic lymphatic malformations, supporting early intervention and reinforcing the scientific rationale for QTORIN™ rapamycin as a targeted therapeutic approach.
• Strengthened global intellectual property for QTORIN™ rapamycin with issuance of a European patent covering anhydrous topical compositions and methods of use, providing protection through 2038.
• Phase 3 SELVA study results to be presented at the International Society for the Study of Vascular Anomalies World Congress 2026 on May 20, 2026, marking the first presentation of these data at a major medical meeting.
• Pre-New Drug Application (NDA) meeting with the FDA granted; meeting expected in the second quarter of 2026.
• NDA submission remains on track for the second half of 2026.
QTORIN™ rapamycin for cutaneous venous malformations (cutaneous VMs)
• Phase 2 TOIVA study results to be presented at the International Society for the Study of Vascular Anomalies World Congress 2026 on May 20, 2026; additional data presentation planned at the 83rd Annual Meeting of the Society for Investigative Dermatology on May 12, 2026.
• Submitted application for FDA Breakthrough Therapy Designation in the second quarter of 2026.
• Phase 3 study initiation anticipated in the second half of 2026.
QTORIN™ rapamycin for clinically significant angiokeratomas
• Dosed first patients in the Phase 2 LOTU trial, a single-arm, baseline-controlled clinical trial of QTORIN™ rapamycin administered topically once daily for the treatment of clinically significant angiokeratomas.
• Topline results from LOTU are expected in the second half of 2027.
QTORIN™ pitavastatin for disseminated superficial actinic porokeratosis (DSAP)
• Presented q
Mar 31, 2026
2 pvla-ex99_1.htm
Palvella Therapeutics Reports Full Year 2025 Financial Results and Provides Corporate Update
New Drug Application (NDA) for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs) on track for planned submission in second half of 2026
Accelerating U.S. launch readiness for QTORIN™ rapamycin for microcystic LMs; potential to become the first FDA-approved therapy and first-line, standard-of-care treatment for serious, lifelong disease affecting an estimated more than 30,000 diagnosed patients in the U.S.
Initiation of Phase 3 trial of QTORIN™ rapamycin for the treatment of cutaneous venous malformations planned for second half of 2026
Initiation of Phase 2 trial of QTORIN™ rapamycin for the treatment of clinically significant angiokeratomas planned for second quarter of 2026
Initiation of Phase 2 trial of QTORIN™ pitavastatin for the treatment of disseminated superficial actinic porokeratosis planned for second half of 2026
Pro forma cash of approximately $274 million as of December 31, 2025 reflects net proceeds from a February 2026 equity financing; cash and cash equivalents of $58.0 million as of December 31, 2025
Company to host conference call at 8:30 a.m. ET today
WAYNE, PA., March 31, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or “the Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today reported financial results for the full year ending December 31, 2025 and provided a corporate update.
“2025 was a landmark year for Palvella, and we carried that momentum into 2026 with positive Phase 3 SELVA results in microcystic lymphatic malformations, marking a major milestone for the company and putting us on a path toward our first potential FDA approval in the first half of 2027,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “Following SELVA results, we significantly strengthened our balance sheet through an oversubscribed $230.0 million financing, enabling us to accelerate U.S. launch readiness and continue advancing novel topical product candidates from our QTORIN™ platform. Supported by Breakthrough Therapy, Fast Track, and Orphan designations, we are now focused on advancing QTORIN™ rapamycin toward an NDA submission while preparing for a planned standalone U.S. commercial launch. We believe this momentum positions us to advance our vision of building the leading rare disease biopharmaceutical company addressing serious, rare skin diseases and vascular malformations with no FDA-approved therapies.”
Recent Research and Development Highlights
QTORIN™ rapamycin for microcystic LMs
• In February 2026, reported positive topline results from the Phase 3 SELVA study:
o Primary endpoint met with statistically significant improvement (mean change of +2.13; p<0.001) on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA)
o Achieved statistical significance on pre-specified key secondary endpoint (p<0.001) and all four secondary efficacy endpoints (all p<0.001)
o 95% of trial participants aged 6 years and older who completed the efficacy evaluation period improved on the mLM-IGA at Week 24
o 86% of trial participants aged 6 years and older who completed the efficacy evaluation period were rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the mLM-IGA at Week 24
o QTORIN™ rapamycin was well-tolerated, with no drug-related serious adverse events reported and systemic rapamycin levels below 2ng/mL at all timepoints for all participants
o 98% of participants who completed the efficacy evaluation period elected to continue to receive QTORIN™ rapamycin in the ongoing treatment extension period
• In Q4 2025, FDA awarded year two non-dilutive proceeds from the FDA Orphan Products Grant program to support the SELVA trial.
• In March 2026, submitted Pre-NDA meeting request to FDA, with meeting anticipated in the second quarter of 2026.
• NDA planning is underway, with submission on track for the second half of 2026.
QTORIN™ rapamycin for cutaneous venous malformations (cutaneous VMs)
• In December 2025, announced positive topline efficacy results from the Phase 2 TOIVA study, achieving statistical significance on multiple pre-specified clinician-reported and patient-reported efficacy endpoints, including dynamic change endpoints and static severity endpoints.
o 73% of trial participants (11/15 participants) improved on the Overall Cutaneous Venous Malformations Investigator Global Assessment (Overall cVM-IGA) at Week 12; 67% of trial participants (10/15 participants) rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the Overall cVM-IGA at Week 12.
• Recently completed a Preliminary Brea
Feb 24, 2026
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Washington,
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 24, 2026
(Exact name of registrant as specified in its charter)
Nevada 001-37471 30-0784346
(State or other jurisdiction of
incorporation) (Commission
File Number) (IRS Employer
Identification No.)
353 W. Lancaster Avenue, Suite 200
Wayne, Pennsylvania 19087
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (484) 253-1461
(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:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange on which
registered
Common stock, $0.001 par value per share
The Nasdaq Capital Market
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 Conditions.
On February 24, 2026, Palvella Therapeutics, Inc. (the “Company”) announced that, as of December 31, 2025, the Company had approximately $55.9 million of cash, cash equivalents and marketable securities. The Company has not yet completed its financial close procedures. As a result, this amount may differ materially from the amount that will be reflected in the Company’s consolidated financial statements for the year ended December 31, 2025. This estimate of the Company’s cash, cash equivalents and marketable securities as of December 31, 2025 is preliminary, has not been audited, does not present all information necessary for an understanding of the Company’s financial condition as of December 31, 2025 and is subject to change upon completion of the Company’s financial statement closing procedures. The preliminary financial data included in this Current Report on Form 8-K has been prepared by, and is the responsibility of, the Company’s management. In addition, Ernst & Young LLP, the Company’s independent registered public accounting firm, has not audited, reviewed, compiled, or performed any procedures with respect to this preliminary financial information and does not express an opinion or any other form of assurance with respect to this preliminary financial information. Additional information and disclosure would be required for a more complete understanding of the Company’s financial position and results of operations as of December 31, 2025.
The information furnished pursuant to this Item 2.02 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 or the Exchange Act, except as expressly set forth by specific reference in such filing.
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.
Date: February 24, 2026 By: /s/ Matthew Korenberg
Matthew Korenberg
Chief Financial Officer
Nov 10, 2025
2 pvla-ex99_1.htm
Exhibit 99.1
Palvella Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Palvella’s recently expanded rare disease pipeline now comprises QTORIN™-derived product candidates advancing in four serious, rare skin diseases that currently have no FDA-approved therapies
Top-line results for fully enrolled Phase 2 TOIVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for cutaneous venous malformations remain on track for mid-December 2025
Top-line results for fully enrolled Phase 3 SELVA trial evaluating QTORIN™ rapamycin for microcystic lymphatic malformations remain on track for the first quarter of 2026
Expanded QTORIN™ rapamycin’s development into clinically significant angiokeratomas, a rare and debilitating lymphatic disease with no FDA-approved therapies, with Phase 2 study initiation anticipated in second half of 2026
Announced new QTORIN™ product candidate, QTORIN™ pitavastatin, for the treatment of disseminated superficial actinic porokeratosis, a rare, chronic, and pre-cancerous genetic skin disease with no FDA-approved therapies, with Phase 2 study initiation anticipated in second half of 2026
Cash and cash equivalents of $63.6 million as of September 30, 2025, expected to fund operations into the second half of 2027
Company to host conference call at 8:30 a.m. ET on November 11, 2025
WAYNE, PA., November 11, 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 skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, reported financial results for the third quarter ending September 30, 2025 and provided a corporate update.
“As we enter year-end 2025, Palvella is now advancing innovative QTORIN™-derived therapies for four serious, rare skin diseases, each lacking a single FDA-approved therapy, giving us the opportunity to potentially be first for each of these deserving rare disease communities,” said Wes Kaupinen, Founder and CEO of Palvella Therapeutics. “Our lead product candidate, QTORIN™ rapamycin, continues to demonstrate its potential as a pipeline-in-a-product for mTOR-driven skin diseases, with a planned Phase 2 top-line readout in cutaneous venous malformations expected in mid-December. This will be followed by a Phase 3 topline readout in microcystic lymphatic malformations which we anticipate in the first quarter of 2026. Overall, we anticipate the next 18 months will be a catalyst-rich period highlighted by our objective to advance QTORIN™
rapamycin toward its first potential regulatory approval, with a steady flow of clinical, pre-commercialization, regulatory, and indication expansion milestones for QTORIN™ rapamycin and our additional QTORIN™ pipeline programs expected. Achievement of these milestones will advance our vision of becoming the leading biopharmaceutical company addressing serious, rare skin diseases with no FDA-approved therapies.”
Recent Corporate Highlights
• Appointed David W. Osborne, Ph.D., as Chief Innovation Officer to provide leadership across Palvella’s early-stage R&D pipeline, including maximizing the potential of the Company’s proprietary QTORIN™ platform. Dr. Osborne brings extensive topical product development experience and a track record of translating science into commercially available therapies, including contributing to the development of ZORYVE® (roflumilast) cream and foam while serving as Co-Founder and Chief Technical Officer of Arcutis Biotherapeutics.
• Jeffrey Martini, Ph.D., Chief Scientific Officer, presented at the Center for Dermal Research’s Innovations in Dermatological Sciences Conference at Rutgers University, showcasing the QTORIN™ platform and its lead product candidate, QTORIN™ rapamycin, in his presentation entitled “Unlocking the Potential of Topical Therapy in Rare Skin Diseases.”
Recent Research and Development Highlights
QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs)
• Following FDA’s review of an annual performance progress report submitted by Palvella, FDA awarded the year two proceeds from the FDA Orphan Products Grant program to support the ongoing SELVA trial, a single arm, baseline-controlled Phase 3 study of QTORIN™ rapamycin for microcystic lymphatic malformations.
• Top-line results from SELVA remain on track for the first quarter of 2026.
QTORIN™ rapamycin for the treatment of cutaneous venous malformations (cutaneous VMs)
• The Company completed enrollment in the Phase 2 TOIVA trial of QTORIN™ rapamycin for cutaneous VMs, meeting its recruitment target of 16 subjects enrolled at leading vascular anomaly centers.
• A peer-reviewed publication in Lymphatic Research and Biology highlighted 26 published studies evaluating the r
Aug 14, 2025
2 pvla-ex99_1.htm
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)
• Completed enrollment in the Phase 3 SELVA trial, a single-arm, baseline-controlled clinical trial of QTORIN™ rapamycin for the treatment of microcystic LMs; trial enrolled 51 subjects, exceeding its original target of 40 subjects by over 25%.
• The Company received initial proceeds from an FDA Orphan Products Grant which could total up to $2.6 million to support the Phase 3 SELVA trial. The FDA Orphan Products Grants Program provides non-dilutive funding to advance the development of promising therapies for rare diseases.
• Key presentations and posters featured at major scientific meetings included:
o Oral presentation highlighting QTORIN™ rapamycin for the treatment of microcystic LMs was presented by Amy Paller, M.S., M.D., Chair of Dermatology at Northwestern University’s Feinberg School of Medicine, at the 15th World Congress of Pediatric Dermatology; the presentation highlighted the Phase 3 SELVA trial design and reviewed Phase 2 results.
o Poster highlighting the estimated diagnosed U.S. prevalence and U.S. annual incidence of lymphatic malformations was presented at the 82nd Annual Meeting of the Society for Investigative Dermatology.
• The United States Patent and Trademark Office (USPTO) issued patent No. 12,268,673 with claims to QTORIN™ rapamycin for the treatment of microcystic LMs with anticipated patent life extending into 2038.
• Top-line results from SELVA are on track for the first quarter of 2026.
QTORIN™ rapamycin for the treatment of cutaneous venous malformations (cutaneous VMs)
• Continued execution of ongoing Phase 2 TOIVA trial, a single-arm, open-label, baseline-controlled clinical trial evaluating QTORIN™ rapamycin for the treatment of cutaneous VMs. Enrollment is ongoing, targeting approximately 15 subjects.
• The Company, in collaboration with key opinion leaders in treating venous malformations, 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.
• Top-line results from TOIVA are on track for the fourth quarter of 2025.
QTORIN™ pipeline development
• The expansion of QTORIN™ rapamycin into a third serious, rare skin disease with no FDA-approved therapies is progressing, with clinical and regulatory planning ongoing, and announcement of the program is planned for the second half of 2025.
• The second product candidate from the QTORIN™ platform for a serious, rare skin disease with no FDA-approved therapies, has achieved key pre-clinical development milestones, and announcement of the program is plan
May 15, 2025
2 pvla-ex99_1.htm
Exhibit 99.1
Palvella Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
Phase 3 SELVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) has exceeded enrollment target of 40 patients; enrollment expected to close in June 2025
Phase 3 SELVA trial top-line results anticipated in the first quarter of 2026
Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for the treatment of cutaneous venous malformations top-line results 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 LMs and cutaneous venous malformations
Cash and cash equivalents of $75.6 million as of March 31, 2025, expected to fund operations into the second half of 2027
Company to host conference call at 8:30 a.m. ET today
WAYNE, PA., May 15, 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 first quarter ending March 31, 2025 and provided a corporate update.
"We are pleased with the strong interest from clinical investigators, clinical trial sites, and study participants in our Phase 3 SELVA study which together has led to exceeding our Phase 3 enrollment target of 40 patients," said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. "Based on a recently presented epidemiology study estimating diagnosed U.S. prevalence and incidence of lymphatic malformations with cutaneous involvement, the data continue to support a large potential market opportunity for QTORIN™ rapamycin, if approved, as potentially the first targeted therapy for this serious, rare genetic disease which currently has no FDA-approved therapies."
Recent Research and Development Highlights
QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs)
• Announced results from the Phase 2 study of QTORIN™ rapamycin for the treatment of microcystic LMs were published in the Journal of Vascular Anomalies (JoVA).
• Expanded SELVA, the Company's Phase 3 clinical trial of QTORIN™ rapamycin for the treatment of microcystic LMs, to include patients ages 3 to 5 years old.
• The SELVA trial has exceeded its enrollment target of 40 patients ages six and older. Enrollment is expected to close in June 2025 and top-line results are anticipated in the first quarter of 2026.
• Presented a poster highlighting the estimated diagnosed U.S. prevalence and U.S. annual incidence of lymphatic malformations with cutaneous involvement at the 82nd Annual Meeting of the Society for Investigative Dermatology.
o Quantitative analysis of medical claims indicates an estimated 44,553 high probability LM patients with cutaneous involvement are projected based on the methodology developed by the authors that includes having greater than or equal to two diagnosis claims related to LM.
• Reported the United States Patent and Trademark Office granted a patent for QTORIN™ rapamycin for the treatment of microcystic LMs, the Company's fifth patent granted in the U.S. for QTORIN™ rapamycin, with anticipated patent life extending into 2038.
QTORIN™ rapamycin for the treatment of cutaneous venous malformations (cutaneous VMs)
• Announced the dosing of the first patients in TOIVA, a Phase 2 single-arm, open-label, baseline-controlled clinical trial of QTORIN™ rapamycin for the treatment of cutaneous VMs. The trial is currently enrolling patients at six sites across the U.S.
• Top-line results from TOIVA are anticipated in the fourth quarter of 2025.
First Quarter 2025 Financial Results
• Cash and cash equivalents as of March 31, 2025 were $75.6 million. Palvella expects such resources will be sufficient to fund its operations into the second half of 2027, and sufficient to accomplish its current strategic agenda.
• Research and development expenses were $4.1 million for the three months ended March 31, 2025, compared to $1.0 million for the three months ended March 31, 2024. The increase in research and development expenses was primarily due to increased spending on the clinical development of QTORIN™ rapamycin for the treatment of microcystic LMs and cutaneous venous malformations, including conducting our Phase 3 SELVA and Phase 2 TOIVA trials, which were initiated in 2024.
• General and administrative expenses were $3.8 million for the three months ended March 31, 2025, compared to $0.8 million for the three months ended March 31, 2024. The increase in general and administrative expenses was primarily driven by employee compensation expense due to he
Mar 31, 2025
2 pvla-ex99_1.htm
Exhibit 99.1
Palvella Therapeutics Reports Full Year 2024 Financial Results and Provides Corporate Update
Upon close of merger and $78.9mm concurrent private placement from a syndicate of leading healthcare-dedicated investors, completed transformation to a publicly traded rare disease biopharmaceutical company advancing a late clinical-stage pipeline and a platform for treating serious, rare genetic skin diseases
Top-line results from SELVA, a Phase 3 single-arm, baseline-controlled trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs), on track for the first quarter of 2026
Top-line results from TOIVA, a Phase 2 single-arm, baseline-controlled trial evaluating QTORIN™ rapamycin for the treatment of cutaneous venous malformations (cutaneous VMs), on track for the fourth quarter of 2025
Planned QTORIN™ pipeline expansion in second half of 2025
Cash and cash equivalents of over $83 million as of December 31, 2024 expected to fund operations into the second half of 2027
Company to host conference call at 8:30 a.m. ET today
WAYNE, PA., March 31, 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 full year ending December 31, 2024 and provided a corporate update.
"2024 was marked by significant progress towards achieving our vision of becoming the leading rare disease biopharmaceutical company focused on serious, rare genetic skin diseases," said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. "Upon the close of our merger and concurrent private placement in December 2024, we were able to rapidly advance QTORIN™ rapamycin, our lead product candidate from the QTORIN™ platform, into the Phase 3 SELVA study for the treatment of microcystic lymphatic malformations and the Phase 2 TOIVA study for the treatment of cutaneous venous malformations. Microcystic LMs and cutaneous VMs are both serious, rare, and chronically debilitating genetic diseases for which QTORIN™ rapamycin has the potential to be the first FDA-approved therapy and standard of care in the U.S.”
Mr. Kaupinen continued, “In addition to these two initial indications for QTORIN™ rapamycin, which we believe together could exceed $1 billion in U.S. peak annual sales,
we plan to broaden our pipeline in 2025 by advancing new and existing QTORIN™ programs for additional serious, rare genetic skin diseases with no FDA-approved therapies."
Recent Research and Development Highlights
QTORIN™ rapamycin for the treatment of microcystic LMs
• Microcystic LMs are a rare, chronically debilitating genetic disease caused by dysregulation of the phosphatidylinositol 3-kinase (PI3K)/mammalian target of rapamycin (mTOR) pathway. The disease is characterized by malformed lymphatic vessels that protrude through the skin and persistently leak lymph fluid (lymphorrhea) and bleed, often leading to recurrent serious infections and cellulitis that can cause hospitalization.
• There are no FDA-approved treatments for the estimated more than 30,000 individuals in the U.S. with microcystic LMs.
• In October 2024, the Company was awarded an Orphan Products Clinical Trials Program grant of up to $2.6 million from the FDA Office of Orphan Products Development to support the Phase 3 SELVA study, a 24-week, Phase 3, single-arm, baseline-controlled clinical trial of QTORIN™ rapamycin for the treatment of microcystic LMs. Out of 51 grant applications received by the FDA Orphan Products Grants Program in fiscal year 2024, Palvella’s Phase 3 clinical trial was one of seven new clinical trials that was awarded a grant.
• Two posters, including data supporting QTORIN™ rapamycin as a potential targeted therapy for the treatment of microcystic LMs and a review of the Phase 3 SELVA study, were presented at the 12th Pediatric Dermatology Research Alliance (PeDRA) Annual Conference in October 2024.
• In November 2024, Palvella dosed the first patient in the Phase 3 SELVA study.
• Breakthrough Therapy Designation, Orphan Drug Designation, and Fast Track Designation from the U.S. FDA have been granted to QTORIN™ rapamycin for the treatment of microcystic LMs. Orphan Drug Designation has also been granted by the European Medicines Agency.
• Top-line results from SELVA are anticipated in the first quarter of 2026.
QTORIN™ rapamycin for the treatment of cutaneous VMs
• Cutaneous VMs are a rare genetic disease caused by mutations in genes that cause overactivation of the PI3K/mTOR signaling pathway, leading to dysfunctional veins within the skin. These malformations can cause substantial morbidity and f
Mar 27, 2024
pirs20240323_8k.htm
false 0001583648
0001583648
2024-03-27 2024-03-27
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 27, 2024
(Exact name of registrant as specified in its charter)
Nevada
001-37471
30-0784346
(State or other jurisdiction of
Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
225 Franklin Street, 26th Floor
02110
Boston, MA
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
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☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value per share
The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 March 27, 2024, Pieris Pharmaceuticals, Inc. (the “Company”) issued a press release in which it announced a strategy for the Company to maximize its ability to capture the potential milestones from certain existing licensing and collaboration agreements, while maintaining the capability to consider other strategic opportunities that it believes may increase stockholder value. In the press release, the Company announced that as of December 31, 2023, the Company had $26.4 million in cash and investments. The Company remains committed to obtaining value for its products in prior development, including cinrebafusp alfa, as well as its proprietary platform capabilities through, for example, out-licensing or sale.
The cash and investments information above is based on preliminary, unaudited information and management estimates for the year ended December 31, 2023, is not a comprehensive statement of the Company’s financial results as of and for the year ended December 31, 2023 and is subject to completion of the Company’s financial closing procedures and may change. The Company’s independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, this preliminary estimate.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” including the estimate of the Company’s cash and investments as of December 31, 2023 set forth in the press release in Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
The information in the press release attached as Exhibit 99.1 to this report, except for the estimate of the Company’s cash and investments as of December 31, 2023 as set forth in the press release, is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1
Press Release, dated March 27, 2024.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
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.
Dated: March 27, 2024
/s/ Tom Bures
Tom Bures
Chief Financial Officer
Jul 18, 2023
pirs20230705_8k.htm
false 0001583648
0001583648
2023-07-17 2023-07-17
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 18, 2023 (July 17, 2023)
(Exact name of registrant as specified in its charter)
Nevada
001-37471
30-0784346
(State or other jurisdiction of
Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
225 Franklin Street, 26th Floor
02110
Boston, MA
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
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☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value per share
The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 1.02 Termination of a Material Definitive Agreement
On July 17, 2023, AstraZeneca AB (“AstraZeneca”) provided Pieris Pharmaceuticals, Inc. (the “Company”) with a written notice of termination of the License and Collaboration Agreement, dated as of May 2, 2017, and subsequently amended, by and among AstraZeneca, the Company, Pieris Pharmaceuticals GmbH and Pieris Australia Pty Limited, and the Non-Exclusive Anticalin Platform Technology License Agreement, dated as of May 2, 2017, and subsequently amended, by and among AstraZeneca, the Company, and Pieris Pharmaceuticals GmbH (collectively, the “Agreements”). The termination will be effective October 15, 2023 (the “Termination Date”), or 90 days from the date on which AstraZeneca notified the Company of its intent to terminate the Agreements.
Pursuant to the Agreements, AstraZeneca and the Company agreed to collaborate on the research, development and commercialization of Anticalin-based therapeutics as part of the Company’s respiratory franchise, including the phase 2a study of elarekibep. The termination will include both elarekibep and the remaining active discovery stage program. AstraZeneca’s decision to terminate the Agreements was based on non-clinical safety findings in a 13-week toxicology study of elarekibep in non-human primates previously disclosed by the Company. Following the Termination Date, the Company will be free to choose to further develop its assets that were the subject of the Agreements; the Company will evaluate the programs and its rights under the Agreements and determine its strategic options after its review.
The foregoing is only a summary of the material terms of the Agreements, does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreements, which were filed as Exhibits 10.1 and 10.2 to the Company’s Quarterly Report on Form 10-Q (File No. 001-37471) with the Securities and Exchange Commission (the “SEC”) on April 26, 2018; Amendment No. 2, dated as of March 29, 2021, to the License and Collaboration Agreement, which was filed as Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q with the SEC on May 17, 2021; Amendments No. 3 and 4, dated as of June 9, 2022 and June 30, 2022, respectively, to the License and Collaboration Agreement, which were, Exhibit 10.2 and 10.3 to the Company’s Quarterly Report on Form 10-Q with the SEC on August 4, 2022; Amendment No. 5, dated as of August 1, 2022, to the License and Collaboration Agreement, which was filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q with the SEC on November 4, 2022; and Amendment No. 1, dated as of March 29, 2021, to the Non-Exclusive Anticalin Platform Technology License Agreement, which was filed as Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q with the SEC on May 17, 2021.
Item 2.02 Results of Operations and Financial Con
Jun 21, 2023
pirs20230618_8k.htm
false 0001583648
0001583648
2023-06-21 2023-06-21
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 21, 2023
(Exact name of registrant as specified in its charter)
Nevada
001-37471
30-0784346
(State or other jurisdiction of
Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
225 Franklin Street, 26th Floor
02110
Boston, MA
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
☐
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☐
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☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value per share
The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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.
As of May 31, 2023, Pieris Pharmaceuticals, Inc.'s (the “Company”) certain unaudited financial results included a cash balance of $53.2 million.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” furnished hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On June 21, 2023, the Company issued a press release announcing that partner AstraZeneca yesterday communicated to the Company its decision to discontinue and cease dosing in the ongoing clinical studies of elarekibep, an inhaled IL-4 receptor alpha inhibitor under development for the treatment of asthma. This decision was based on lung findings from a non-clinical 13-week GLP toxicology study with dry powder inhaler-formulated elarekibep, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development. AstraZeneca’s decision was made independent of any data from the Phase 2a study. The Company will expedite a review of the implications of the data and AstraZeneca’s decision on the program and will review its overall corporate priorities prior to sharing a further update.
A copy of the press release issued by the Company is attached as Exhibit 99.1 to this report and is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1
Press Release, dated June 21, 2023.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
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.
Dated: June 21, 2023
/s/ Tom Bures
Tom Bures
Chief Financial Officer
May 10, 2023
pirs20230126b_8k.htm
false 0001583648
0001583648
2023-05-10 2023-05-10
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 10, 2023
(Exact name of registrant as specified in its charter)
Nevada
001-37471
30-0784346
(State or other jurisdiction of
Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
225 Franklin Street, 26th Floor
02110
Boston, MA
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value per share
The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 May 10, 2023, Pieris Pharmaceuticals, Inc. (the “Company”) issued a press release announcing certain financial results for the quarter ended March 31, 2023. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” including Exhibit 99.1 furnished hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
Furnished hereto as Exhibit 99.2 is the May 2023 Investor Presentation of the Company.
The information set forth under this “Item 7.01. Regulation FD Disclosure,” including Exhibit 99.2 furnished hereto, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1
Press Release, dated May 10, 2023.
99.2
Investor Presentation, dated May 2023.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
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.
Dated: May 10, 2023
/s/ Tom Bures
Tom Bures
Chief Financial Officer
Mar 29, 2023
pirs20221130_8k.htm
false 0001583648
0001583648
2023-03-29 2023-03-29
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 29, 2023
(Exact name of registrant as specified in its charter)
Nevada
001-37471
30-0784346
(State or other jurisdiction of
Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
225 Franklin Street, 26th Floor
02110
Boston, MA
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value per share
The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 March 29, 2023, Pieris Pharmaceuticals, Inc. (the “Company”) issued a press release announcing certain financial results for the quarter ended December 31, 2022. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” including Exhibit 99.1 furnished hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
Furnished hereto as Exhibit 99.2 is the March 2023 Investor Presentation of the Company.
The information set forth under this “Item 7.01. Regulation FD Disclosure,” including Exhibit 99.2 furnished hereto, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1
Press Release, dated March 29, 2023.
99.2
Investor Presentation, dated March 2023.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
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.
Dated: March 29, 2023
/s/ Tom Bures
Tom Bures
Chief Financial Officer
Nov 2, 2022
pirs20220831_8k.htm
false 0001583648
0001583648
2022-11-02 2022-11-02
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 2, 2022
(Exact name of registrant as specified in its charter)
Nevada
001-37471
30-0784346
(State or other jurisdiction of
Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
255 State Street, 9th Floor
02109
Boston, MA
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value per share
The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 November 2, 2022, Pieris Pharmaceuticals, Inc. (the “Company”) issued a press release announcing certain financial results for the quarter ended September 30, 2022. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” including Exhibit 99.1 furnished hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
Furnished hereto as Exhibit 99.2 is the November 2022 Investor Presentation of the Company.
The information set forth under this “Item 7.01. Regulation FD Disclosure,” including Exhibit 99.2 furnished hereto, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1
Press Release, dated November 2, 2022.
99.2
Investor Presentation, dated November 2022.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
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.
Dated: November 2, 2022
/s/ Tom Bures
Tom Bures
Chief Financial Officer
Aug 4, 2022
pirs-20220804
0001583648False00015836482022-08-042022-08-04
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 4, 2022
(Exact name of registrant as specified in its charter)
Nevada001-3747130-0784346
(State or other jurisdiction of Incorporation)(Commission File Number)(IRS Employer Identification No.)
255 State Street, 9th Floor 02109
Boston,
MA
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par value per sharePIRS The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 4, 2022, Pieris Pharmaceuticals, Inc. (the “Company”) issued a press release announcing certain financial results for the quarter ended June 30, 2022. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” including Exhibit 99.1 furnished hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
Furnished hereto as Exhibit 99.2 is the August 2022 Investor Presentation of the Company.
The information set forth under this “Item 7.01. Regulation FD Disclosure,” including Exhibit 99.2 furnished hereto, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press Release, dated August 4, 2022.
99.2 Investor Presentation, dated August 2022.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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.
Dated: August 4, 2022 /s/ Tom Bures
Tom Bures
Chief Financial Officer
May 11, 2022
pirs-20220511
00015836482022Q1False00015836482022-05-112022-05-11
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 11, 2022
(Exact name of registrant as specified in its charter)
Nevada001-3747130-0784346
(State or other jurisdiction of Incorporation)(Commission File Number)(IRS Employer Identification No.)
255 State Street, 9th Floor 02109
Boston,
MA
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par value per sharePIRS The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 May 11, 2022, Pieris Pharmaceuticals, Inc. (the “Company”) issued a press release announcing certain financial results for the quarter ended March 31, 2022. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” including Exhibit 99.1 furnished hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
Furnished hereto as Exhibit 99.2 is the May 2022 Investor Presentation of the Company.
The information set forth under this “Item 7.01. Regulation FD Disclosure,” including Exhibit 99.2 furnished hereto, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press Release, dated May 11, 2022.
99.2 Investor Presentation, dated May 2022.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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.
Dated: May 11, 2022 /s/ Tom Bures
Tom Bures
Chief Financial Officer
Mar 1, 2022
pirs-20220301
00015836482022Q1False00015836482022-03-012022-03-01
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 1, 2022
(Exact name of registrant as specified in its charter)
Nevada001-3747130-0784346
(State or other jurisdiction of Incorporation)(Commission File Number)(IRS Employer Identification No.)
255 State Street, 9th Floor 02109
Boston,
MA
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par value per sharePIRS The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 March 1, 2022, Pieris Pharmaceuticals, Inc. (the “Company”) issued a press release announcing certain financial results for the fiscal year ended December 31, 2021. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” including Exhibit 99.1 furnished hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
Furnished hereto as Exhibit 99.2 is the March 2022 Investor Presentation of the Company.
The information set forth under this “Item 7.01. Regulation FD Disclosure,” including Exhibit 99.2 furnished hereto, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press Release, dated March 1, 2022.
99.2 Investor Presentation, dated March 2022.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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.
Dated: March 1, 2022 /s/ Tom Bures
Tom Bures
Chief Financial Officer
Jan 24, 2022
pirs-20220124
00015836482022Q1FalseNASDAQ00015836482022-01-242022-01-24
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 24, 2022
(Exact name of registrant as specified in its charter)
Nevada001-3747130-0784346
(State or other jurisdiction of Incorporation)(Commission File Number)(IRS Employer Identification No.)
255 State Street, 9th Floor 02109
Boston,
MA
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par value per sharePIRSThe Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 January 24, 2022, Pieris Pharmaceuticals, Inc. (the “Company”) presented the January 2022 Investor Presentation announcing certain unaudited financial results for the fiscal year ended December 31, 2021. A copy of the presentation is furnished as Exhibit 99.1 to this report.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” including Exhibit 99.1 furnished hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
Furnished hereto as Exhibit 99.1 is the January 2022 Investor Presentation of the Company.
The information set forth under this “Item 7.01. Regulation FD Disclosure,” including Exhibit 99.1 furnished hereto, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Investor Presentation, dated January 2022.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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.
Dated: January 24, 2022 /s/ Tom Bures
Tom Bures
Chief Financial Officer
Nov 2, 2021
pirs-20211102
00015836482021Q3FalseNASDAQ00015836482021-11-022021-11-02
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 2, 2021
(Exact name of registrant as specified in its charter)
Nevada001-3747130-0784346
(State or other jurisdiction of Incorporation)(Commission File Number)(IRS Employer Identification No.)
225 State Street, 9th Floor 02109
Boston,
MA
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par value per sharePIRSThe Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 November 2, 2021, Pieris Pharmaceuticals, Inc. (the “Company”) issued a press release announcing certain financial results for the quarter ended September 30, 2021. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
99.1 Press Release Dated November 2, 2021.
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.
Dated: November 2, 2021 /s/ Tom Bures
Tom Bures
Chief Financial Officer
Aug 4, 2021
pirs-20210804
00015836482021Q2FalseNASDAQ00015836482021-03-302021-03-30
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 4, 2021
(Exact name of registrant as specified in its charter)
Nevada001-3747130-0784346
(State or other jurisdiction of Incorporation)(Commission File Number)(IRS Employer Identification No.)
225 State Street, 9th Floor 02109
Boston,
MA
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: 857-246-8998
N/A
(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:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par value per sharePIRSThe Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 4, 2021, Pieris Pharmaceuticals, Inc. (the “Company”) issued a press release announcing certain financial results for the quarter ended June 30, 2021. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
Attached hereto as Exhibit 99.2 and incorporated by reference herein is the August 2021 Investor Presentation of Pieris Pharmaceuticals, Inc.
The information set forth under this “Item 7.01. Regulation FD Disclosure,” including Exhibit 99.2 attached hereto, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
99.1 Press Release Dated August 4, 2021.
99.2 Investor Presentation, Dated August 2021.
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.
Dated: August 4, 2021 /s/ Tom Bures
Tom Bures
Vice President, Finance
This page provides Palvella Therapeutics Inc. (PVLA) earnings call transcripts from SEC 8-K filings along with AI-powered predictions for post-earnings price movements. Our machine learning models analyze historical earnings data, pre-earnings price patterns, volume changes, and volatility to predict 1-day, 5-day, and 20-day returns after each earnings release.
Earnings transcripts are sourced directly from SEC EDGAR filings. Predictions are generated using gradient boosting models trained on PVLA's historical earnings reactions. All predicted returns are shown as percentages, and predicted prices are calculated from the closing price at the time of prediction. Past performance does not guarantee future results.