01/02/2026 | Press release | Distributed by Public on 01/02/2026 06:30
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Nevada
(State or other jurisdiction of
incorporation or organization) |
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30-0784346
(I.R.S. Employer
Identification Number) |
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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Emerging growth company
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Page
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ABOUT THIS PROSPECTUS
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WHERE YOU CAN FIND MORE INFORMATION
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INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
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ABOUT PALVELLA
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RISK FACTORS
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USE OF PROCEEDS
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DESCRIPTION OF CAPITAL STOCK
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DESCRIPTION OF DEBT SECURITIES
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DESCRIPTION OF WARRANTS
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DESCRIPTION OF UNITS
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DESCRIPTION OF RIGHTS
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GLOBAL SECURITIES
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PLAN OF DISTRIBUTION
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LEGAL MATTERS
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EXPERTS
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| | | | 32 | | |
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Efficacy Endpoints at Week 12 (ITT Population)
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Mean Change
from Baseline (n=15) |
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Nominal,
Two-sided p-value |
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Dynamic Change Scales (7-point scales ranging from -3 to +3; positive values indicate improvements from baseline)
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Overall Cutaneous VM Investigator Global Assessment (Overall cVM-IGA)
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| | | | 1.5 | | | | | | <0.001 | | |
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cVM-IGA Height/Engorgement
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| | | | 1.3 | | | | | | <0.001 | | |
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cVM-IGA Appearance (visualization/color of affected veins)
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| | | | 1.5 | | | | | | <0.001 | | |
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cVM-IGA Bleeding
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| | | | 0.7 | | | | | | 0.045 | | |
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Overall Patient Global Impression of Change (PGI-C)
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| | | | 1.1 | | | | | | <0.001 | | |
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Static Severity Scales (5-point scales ranging from 1 to 5; negative values indicate improvements from baseline)
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Overall Clinician Global Impression of Severity (CGI-S)
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| | | | -1.0 | | | | | | <0.001 | | |
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cVM-MCSS (Cutaneous VM Multi-Component Static Scale) Severity of Height/Engorgement
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| | | | -1.3 | | | | | | <0.001 | | |
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cVM-MCSS Severity of Appearance (visualization/color of affected veins)
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| | | | -1.1 | | | | | | <0.001 | | |
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Overall Patient Global Impression of Severity (PGI-S)
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| | | | -0.5 | | | | | | 0.027 | | |
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SEC registration fee
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| | | $ | 41,430 | | |
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Fees and expenses of the trustee
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| | | $ | (1) | | |
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Printing expenses
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| | | $ | (1) | | |
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Legal fees and expenses
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| | | $ | (1) | | |
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Accounting fees and expenses
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| | | $ | (1) | | |
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Transfer agent fees and expenses
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| | | $ | (1) | | |
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Miscellaneous
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| | | $ | (1) | | |
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Total
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| | | $ | (1) | | |
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Exhibit
Number |
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Description of Exhibit
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| | 1.1* | | | Form of Underwriting Agreement. | |
| | 2.1 | | | Agreement and Plan of Merger, dated as of July 23, 2024, by and among Pieris Pharmaceuticals, Inc. (incorporated by reference to Exhibit 2.1 of the Company's Current Report on Form 8-K (File No. 001-37471) filed on July 24, 2024. | |
| | 3.1 | | | | |
| | 3.2 | | | Certificate of Change to Amended and Restated Articles of Incorporation (incorporated by reference to Exhibit 3.1 to the Company's Current Report on Form 8-K (File No. 001-37471) filed on April 18, 2024). | |
| | 3.3 | | | Certificate of Amendment to Articles of Incorporation (incorporated herein by reference to Exhibit 3.9 to the Company's Current Report on Form 8-K (File No. 001-37471) filed on December 16, 2024). | |
| | 3.4 | | | Certificate of Amendment to Articles of Incorporation (incorporated herein by reference to Exhibit 3.11 to the Company's Current Report on Form 8-K (File No. 001-37471) filed on December 16, 2024). | |
| | 3.5 | | | | |
| | 3.6 | | | | |
| | 4.1 | | | | |
| | 4.2 | | | | |
| | 4.3* | | | Form of Preferred Stock Certificate. | |
| | 4.4 | | |
Form of Indenture (filed herewith).
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| | 4.5* | | | Form of Note. | |
| | 4.6* | | | Form of Warrant. | |
| | 4.7* | | | Form of Warrant Agreement. | |
| | 4.8* | | | Form of Unit Agreement. | |
| | 4.9* | | | Form of Rights Agreement. | |
| | 5.1 | | |
Opinion of Brownstein Hyatt Farber Schreck, LLP (filed herewith).
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| | 5.2 | | |
Opinion of Goodwin Procter LLP (filed herewith).
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| | 23.1 | | |
Consent of Ernst & Young LLP, independent registered public accounting firm (filed herewith).
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| | 23.2 | | |
Consent of Brownstein Hyatt Farber Schreck, LLP (included in Exhibit 5.1).
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| | 23.3 | | |
Consent of Goodwin Procter LLP (included in Exhibit 5.2).
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| | 24.1 | | |
Powers of Attorney (incorporated by reference to the signature page hereto).
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| | 25.1‡ | | | Statement of Eligibility on Form T-1 under the Trust Indenture Act of 1939, as amended, of the trustee, as trustee under the indenture filed herewith. | |
| | 107 | | |
Filing Fee Table (filed herewith).
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Signature
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Title
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Date
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/s/ Wesley H. Kaupinen
Wesley H. Kaupinen
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President, Chief Executive Officer and Director
(Principal Executive Officer) |
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January 2, 2026
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/s/ Matthew E. Korenberg
Matthew E. Korenberg
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Chief Financial Officer and Treasurer
(Principal Financial Officer and Principal Accounting Officer) |
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January 2, 2026
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/s/ George M. Jenkins
George M. Jenkins
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Chairman, Board of Directors
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January 2, 2026
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/s/ Todd C. Davis
Todd C. Davis
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Director
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January 2, 2026
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/s/ Elaine J. Heron, Ph.D.
Elaine J. Heron, Ph.D.
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Director
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January 2, 2026
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/s/ Christopher Kiritsy
Christopher Kiritsy
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Director
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January 2, 2026
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/s/ Tadd S. Wessel
Tadd S. Wessel
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Director
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January 2, 2026
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