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CORRESP
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 CORRESP

   February 20, 2026   Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549

 Attn:

 Jessica Dickerson

 Joe McCann

 Re:

 LeonaBio, Inc.

 Registration Statements on Form S-3

 Filed January 20, 2026

 File Nos. 333-292826 and 292829

 Ladies and Gentlemen: LeonaBio, Inc. (“ we ”, “ our ” or the “ Company ”) submits this letter in response to comments from the staff (the “ Staff ”) of the Securities and Exchange Commission (the “ Commission ”) received by letters dated February 11, 2026, relating to the Company’s Registration Statements on Form S-3 (File Nos. 333-292826 and 292829) each originally filed with the Commission on January 20, 2026 (the “ Forms S-3 ”). In this letter, we have recited the comment from the Staff in italicized, bold type and have followed the comment with the Company’s response. Unless otherwise indicated, defined terms used herein have the meanings set forth in the Forms S-3. Registration Statement on Form S-3 General 1. We note from your Current Report on Form 8-K filed December 18, 2025, as amended, that, in December 2025, you entered into an in-licensing agreement with Sermonix Pharmaceuticals, Inc. and that, pursuant to that agreement, you assumed the obligation for the ongoing phase 3 trial for lasofoxifene in the licensed territories; you assumed Sermonix’s agreements with third parties, including contract manufacturers that have been supplying drug substances and drug
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 products; and you are required to make payments to Sermonix’s third party service providers. Please tell us whether you will be providing the Sermonix financial statements. If you will not be providing them, please tell us why. The Company respectfully advises the Staff that the grant of exclusive licenses and rights to the Company to develop, manufacture and commercialize oral forms of the selective estrogen-receptor modulator known as lasofoxifene from Sermonix Pharmaceuticals, Inc. (“ Sermonix ”) pursuant to the Sermonix License (described below) did not constitute the acquisition of a business for purposes of Rule 8-04 of Regulation S-X (“ Rule 8-04 ”) and Item 11(b) of Form S-3. Accordingly, Sermonix financial statements are not required to be filed. Background Reference is made to the Company’s Current Report on Form 8-K, as amended, dated December 18, 2025, and the description therein of the Company’s license agreement with Sermonix, dated December 18, 2025 (the “ Effective Date ” and such agreement the “ Sermonix License ”), pursuant to which the Company received from Sermonix an exclusive, sublicensable license, under relevant patents and know-how owned or in-licensed by Sermonix, to develop, manufacture, commercialize and otherwise exploit oral forms of the estrogen-receptor modulator known as lasofoxifene (referred to generally herein as “ lasofoxifene ,” and the rights licensed by the Sermonix License, the “ Licensed Rights ”) in all countries outside of Asia and certain countries in the Middle East (the “ Licensed Territory ”). Applicable Rules Rule 8-04 of Regulation S-X and Item 11(b) of Form S-3 require audited financial statements to be filed if, during the most recent fiscal year or subsequent interim period for which a balance sheet is required, a business acquisition has occurred. In deciding whether the provisions of Rule 8-04 apply, an issuer must first determine, in accordance with guidance set forth in Article 11 of Regulation S-X, whether the acquired component constitutes the acquisition of a business rather than an acquisition of assets or other rights. Under Rule 11-01(d), a business is identified by evaluating the facts and circumstances involved and whether there is sufficient continuity of the acquired entity’s operations prior to and after the transaction so that disclosure of prior financial information is material to an understanding of future operations. There is a presumption under Rule 11-01(d) that a separate entity, subsidiary, or division is a business; however, a lesser component of an entity, such as a product line or an operating real estate property, may also be considered a business. In evaluating whether a lesser component is a business, Rule 11-01(d) requires registrants to consider (1) whether the nature of the revenue-producing activity of the component will remain generally the same as before the transaction; and (2) whether the physical facilities, employee base, market distribution system, sales force, customer base, operating rights, production techniques, or trade names remain with the component after the transaction.
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 Analysis The Company has considered the definition of a business as contemplated by Article 11 of Regulation S-X. In particular, Rule 11-01(d) states that a business should be evaluated in light of the facts and circumstances involved and whether there is sufficient continuity of the acquired entity’s operations prior to and after the transactions so that disclosure of prior financial information is material to an understanding of future operations. Rule 11-01(d)(1) Rule 11-01(d)(1) includes as a relevant factor or circumstance “whether the nature of the revenue producing activity of the component will remain generally the same as before the transaction.” Lasofoxifene is a clinical stage drug candidate and is not approved for commercial sale anywhere in the world. Even if the Company is ultimately successful in completing clinical trials and obtaining regulatory approval for the commercial sale of lasofoxifene, any revenue from sales of the approved product is years away. The absence of any revenue generated by Sermonix before the Company obtained the Licensed Rights and the substantial uncertainty of generating any potential revenue in the future supports the Company’s determination that there was no acquisition of a business within the meaning of Article 11 of Regulation S-X. Rule 11-01(d)(2) In accordance with Rule 11-01(d)(2), the Company has considered whether physical facilities, employee base, market distribution system, sales force, customer base, operating rights, production techniques, or trade names were acquired in connection with the Sermonix License. Physical Facilities The Company did not acquire any physical facilities of Sermonix in connection with the Sermonix License, supporting the Company’s determination that there was no acquisition of a business within the meaning of Article 11 of Regulation S-X. Employee Base The Sermonix License does not now, and did not at the Effective Date, require the Company to offer continuing employment to any Sermonix employees. Subsequent to entry into the Sermonix License, the Company elected to enter into separate arrangements with six employees of Sermonix to provide services to the Company relating to the development of lasofoxifene. Of these six, four were engaged as consultants to provide certain limited services and two were hired by the Company as employees. The Company’s decision to engage the six Sermonix employees as either consultants or new Company employees was made solely at the Company’s discretion to obtain limited clinical or advisory support for the global phase 3 clinical trial of oral lasofoxifene (the “ ELAINE-3 Study ”). These arrangements were not a condition to closing, nor were they negotiated, arranged, or otherwise facilitated by Sermonix. Rather, these agreements were
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 executed after the Effective Date for convenience and to support the clinical development of lasofoxifene, and these individuals are not expected to significantly contribute to future research and development activities. The Company also notes that the engagement of the six Sermonix employees was neither necessary nor sufficient for the continued development of lasofoxifene. As of the date of this letter, there are 32 people supporting the clinical development of lasofoxifene and the general operations of the Company. Of these 32 people, 20 are Company employees (excluding the two former Sermonix employees hired by the Company after the Effective Date) and six are consultants engaged by the Company (excluding the four Sermonix employees engaged as consultants by the Company after the Effective Date). Because their employment or engagement was not required by the Sermonix License, and because the Sermonix employees engaged by the Company are neither necessary nor sufficient for the continued clinical development of lasofoxifene, the Company submits to the Staff that this factor supports the Company’s determination that there was no acquisition of a business within the meaning of Article 11 of Regulation S-X. Market Distribution System Sermonix did not have a market distribution system in place for lasofoxifene as of the Effective Date. Lasofoxifene is a clinical stage drug candidate and is not approved for commercial sale anywhere in the world. Even if lasofoxifene ultimately obtains regulatory approval for commercial sale, any such approval is years away, and whether the Company will ultimately invest in building out a market distribution system is not yet known. The lack of a transfer of a market distribution system by Sermonix to the Company supports the Company’s determination that there was no acquisition of a business within the meaning of Article 11 of Regulation S-X. Sales Force Sermonix did not have a sales force in place for lasofoxifene as of the Effective Date because lasofoxifene is a clinical stage drug candidate and is not approved for commercial sale anywhere in the world. Even if lasofoxifene receives regulatory approval for commercial sale, whether the Company will ultimately invest in hiring and deploying a sales force is not yet known. The lack of a transfer of a sales force by Sermonix to the Company supports the Company’s determination that there was no acquisition of a business within the meaning of Article 11 of Regulation S-X. Customer Base Because lasofoxifene is a clinical stage drug candidate and is not approved for commercial sale anywhere in the world, there were no customers of lasofoxifene before the Effective Date and there are none as of the date hereof. The lack of a transfer of customers by Sermonix to the Company supports the Company’s determination that there was no acquisition of a business within the meaning of Article 11 of Regulation S-X.
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 Operating Rights Separate from the license of lasofoxifene, under the Sermonix License, the Company also licensed certain know-how, obtained the rights to manufacturing technology and inventory, assumed certain service provide agreements and discharged amounts owing to certain of Sermonix’s third-party service providers. As part of the consideration to be paid by the Company for the Licensed Rights, the Company agreed to discharge approximately $16.8 million owed to certain of Sermonix’s third-party service providers. The Company’s decision to discharge these payables directly was made solely for administrative convenience and does not reflect the Company’s substantive involvement in, or benefit derived from, the underlying agreements. In addition, the Company assumed various service provider agreements, including contract research organization (“ CRO ”) contracts, contract manufacturing organization (“ CMO ”) contracts, and agreements with certain other service providers that will directly conduct or support the ELAINE-3 Study. While there are numerous qualified service providers available to provide services similar to those provided by the CROs, CMOs and other service providers whose agreements were assumed by the Company, the Company notes for the Staff that switching key service providers like a CRO or CMO during the conduct of a clinical trial can introduce significant risk of delays and additional interactions with regulatory agencies. It is customary in licensing transactions in the life sciences industry for the licensee to continue working with service providers that were selected by the licensor prior to any license agreement. The Company notes to the Staff that it has full discretion to terminate any of the service provider agreements in accordance with their terms, and to seek out alternate service providers at any time and is not obligated to Sermonix to retain any particular service provider. As examples of this flexibility, the Company notes that it has entered into agreements with five service providers to provide clinical research services, assay testing services, drug substance manufacturing, drug product/packaging services, and regulatory operation services with respect to the ELAINE-3 Study following the Effective Date. Of particular note is the Company’s direct agreement with the primary CRO for the ELAINE-3 Study, which was entered into by the Company and the CRO after the Effective Date and was not an agreement to which Sermonix was previously a party. The budgeted expenses under this agreement are expected to represent the substantial majority of anticipated research and development spend for the ELAINE-3 Study. In addition, the Company expects to use certain of its existing service providers as well as new service providers to advance the ELAINE-3 Study. The Company submits to the Staff that the facts that the Company assumed certain service provider arrangements from Sermonix solely for convenience and to maintain the continuity of the ELAINE-3 Study, and that the Company is augmenting the clinical development of lasofoxifene with additional service providers, supports the Company’s determination that there was no acquisition of a business within the meaning of Article 11 of Regulation S-X.
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 Production Techniques Under the Sermonix License, while the Company licensed certain know-how, and obtained rights to manufacturing technology and inventory from Sermonix relating to lasofoxifene, neither Sermonix nor the Company themselves have any manufacturing or production capabilities. The Company intends to utilize CMOs and other service providers to manufacture lasofoxifene in quantities sufficient to advance the ELAINE-3 Study. The Company does not expect to engage CMOs to manufacture lasofoxifene for commercial sale until the Company is successful in completing clinical trials and obtaining regulatory approval. For these reasons, the Company submits to the Staff that this aspect of the Sermonix License supports the Company’s determination that there was no acquisition of a business within the meaning of Article 11 of Regulation S-X. Trade Names The Sermonix License grants the Company the right to brand lasofoxifene in the Licensed Territory using trademarks, logos and trade names that the Company determines appropriate. Given the pre-commercial nature of lasofoxifene and the significant amount of time required to advance lasofoxifene to potential regulatory approval, Sermonix and the Company have agreed to cooperate with respect to developing and implementing a global branding strategy for lasofoxifene in the future. Although Sermonix assigned to the Company certain trademarks that Sermonix had previously obtained in anticipation of commercialization of lasofoxifene in the future, these trademarks have no brand value given the pre-commercial status of lasofoxifene. In addition, the Company is not required to use such trade names and, even if the Company were to elect to use such trade names, such trade names would not be used for years, assuming the Company is able to meet or exceed its anticipated clinical development timelines and obtain regulatory approval permitting commercial sales. For the foregoing reasons, the Company submits to the Staff that this aspect of the Sermonix License supports the Company’s determination that there was no acquisition of a business for purposes Article 11 of Regulation S-X. Other Considerations Rule 11-01(d) states that the factors set forth in Rule 11-01(d)(1) and (2) are among the facts and circum