PALVELLA THERAPEUTICS INC

As filed with the Securities and Exchange Commission on December 30, 2024

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORMS-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

(Exact name of registrant as specified in its charter)

125 Strafford Ave

Suite 360

Wayne, Pennsylvania 19087

(484)253-1461

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Wesley H. Kaupinen

President and Chief Executive Officer

125 Strafford Ave

Suite 360

Wayne, Pennsylvania 19087

(484) 253-1461

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Christopher D. Miller

Joseph Walsh

Troutman Pepper Hamilton Sanders LLP

400 Berwyn Park

899 Cassatt Road

Berwyn, Pennsylvania 19312

(610) 640-7800

**Approximate Date of Commencement of Proposed Sale to the Public:**From time to time after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

EXPLANATORY NOTE

On December 13, 2024 (the “Closing Date”), Palvella Therapeutics, Inc., a Nevada corporation (the “Company” or “Palvella”) (previously named Pieris Pharmaceuticals, Inc. and our predecessor company (“Pieris”)), consummated the previously announced merger pursuant to the terms of that certain Agreement and Plan of Merger, dated as of July 23, 2024 (the “Merger Agreement”), by and among the Company, Polo Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Pieris (the “Merger Sub”), and Palvella Therapeutics, Inc., a Delaware corporation (“Legacy Palvella”).

Pursuant to the Merger Agreement, on the Closing Date, (i) Merger Sub merged with and into Legacy Palvella, with Legacy Palvella as the surviving company in the merger and, after giving effect to such merger, continuing as a wholly owned subsidiary of the Company (the “Merger”) and (ii) the Company’s name was changed from Pieris Pharmaceuticals, Inc. to Palvella Therapeutics, Inc.

In accordance with the terms and subject to the conditions of the Merger Agreement, (i) immediately prior to the effective time of the Merger, each outstanding share of Legacy Palvella capital stock (including shares of Legacy Palvella common stock and Legacy Palvella preferred stock) (excluding dissenting shares) was converted into the right to receive a number of shares of Palvella common stock, and (ii) at the effective time of the Merger, the Company issued an aggregate of approximately 6,787,415 shares of its common stock to Legacy Palvella stockholders, based on an exchange ratio of 0.309469242 shares of the Company’s common stock for each share of Legacy Palvella capital stock outstanding immediately prior to the Merger, but excluding shares to be canceled pursuant to the Merger Agreement, resulting in approximately 8,316,929 shares of the Company’s common stock being issued and outstanding immediately following the effective time of the Merger.

Concurrently with the execution of the Merger Agreement on July 23, 2024, Pieris entered into a securities purchase agreement (the “Purchase Agreement”) with the selling stockholders identified in this prospectus, pursuant to which, among other things, on the Closing Date and immediately following the consummation of the Merger, the selling stockholders purchased (either for cash or in exchange for the termination and cancellation of outstanding convertible promissory notes issued by Legacy Palvella), and the Company issued and sold to the selling stockholders, an aggregate of 3,168,048 shares of the Company’s common stock at a price per share equal to $13.9965 (the “Purchase Price”), and/or in lieu of the Company’s common stock to certain purchasers who so choose due to beneficial ownership concerns, pre-funded warrants (the “Pre-Funded Warrants”) to purchase 2,466,456 shares of the Company’s common stock at a purchase price per Pre-Funded Warrant equal to the Purchase Price minus $0.001 (the “PIPE Financing”). The gross proceeds from the PIPE Financing were approximately $78.9 million, consisting of approximately $60.0 million in cash and the conversion of approximately $18.9 million of principal and interest payable under the outstanding convertible notes issued by Legacy Palvella, before paying estimated expenses. The closing of the PIPE Financing occurred on December 13, 2024, immediately following the consummation of the Merger.

On December 13, 2024, the Company and the selling stockholders identified in this prospectus entered into a registration rights agreement (the “Registration Rights Agreement”) pursuant to which the such selling stockholders are entitled to certain resale registration rights with respect to shares of the Company’s common stock issued to the selling stockholders and any shares of the Company’s common stock issuable upon exercise of the Pre-Funded Warrants. Pursuant to the Registration Rights Agreement, the Company is required to prepare and file a resale registration statement with the Securities and Exchange Commission (“SEC”) within 30 days following the closing of the PIPE Financing. The Company is obligated to use commercially reasonable efforts to cause this registration statement to be declared effective by the SEC within 90 days following the closing of the PIPE Financing (or within 120 days following the closing of the PIPE Financing if the SEC reviews the registration statement). The registration statement of which this prospectus is a part relates to the resale of the shares of common stock issued in the PIPE Financing and the shares of common stock issuable upon exercise of the Pre-Funded Warrants issued in the PIPE Financing.

As of the open of trading on December 16, 2024, the common stock of the Company began trading on the Nasdaq Capital Market under the symbol “PVLA.”

The information in this preliminary prospectus is not complete and may be changed. Neither we nor the selling stockholders may sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED DECEMBER 30, 2024

PRELIMINARY PROSPECTUS

Up to 5,634,504 Shares of Common Stock

This prospectus relates to the proposed offer and resale or other disposition from time to time by the selling stockholders identified in this prospectus of up to (i) 3,168,048 shares of our common stock, par value $0.001 per share, and (ii) 2,466,456 shares of our common stock underlying pre-funded warrants (the “Pre-Funded Warrants”) held by certain of the selling stockholders. The shares of common stock registered by this prospectus are collectively referred to herein as the “Resale Shares.”

We are registering the resale of the Resale Shares pursuant to a registration rights agreement (the “Registration Rights Agreement”) between us and the selling stockholders. Our registration of the resale of the Resale Shares does not mean that the selling stockholders will offer or sell all or any of the Resale Shares. The selling stockholders may offer, sell or distribute all or a portion of their Resale Shares from time to time directly or indirectly through one or more underwriters, broker-dealers or agents, and in one or more public or private transactions, which may involve crosses or block transactions. The Resale Shares may be sold in one or more transactions at fixed prices, at prevailing market prices at the time of the sale or at negotiated prices. See the section entitled “Plan of Distribution” for more information.

We will not receive any proceeds from any sale of the Resale Shares by the selling stockholders pursuant to this prospectus. Upon any exercise of the Pre-Funded Warrants by payment of cash, however, we will receive the nominal cash exercise price paid by the holders of the Pre-Funded Warrants. We have agreed to bear the expenses in connection with the registration of the resale of the Resale Shares to be offered by this prospectus by the selling stockholders except for any underwriting discounts and commissions or transfer taxes relating to the sale of the Resale Shares, which will be borne by the selling stockholders.

Our common stock is listed on the Nasdaq Capital Market under the symbol “PVLA.” On December 27, 2024, the closing price for our common stock, was $12.00 per share.

See the section entitled“Risk Factors”** beginning on page 9 of this prospectus to read about factors you should consider before buying our securities.**

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus is , 2024.