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LeonaBio, Inc.
CIK: 0001620463  ·  File(s): 333-292829  ·  Started: 2026-02-11  ·  Last active: 2026-03-31
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2026-02-11
LeonaBio, Inc.
Financial Reporting Regulatory Compliance Business Model Clarity
File Nos in letter: 333-292829
↓
CR Company responded 2026-03-31
LeonaBio, Inc.
Offering / Registration Process
File Nos in letter: 333-292829
LeonaBio, Inc.
CIK: 0001620463  ·  File(s): 333-292826  ·  Started: 2026-02-11  ·  Last active: 2026-03-31
Response Received 2 company response(s) High - file number match
UL SEC wrote to company 2026-02-11
LeonaBio, Inc.
Financial Reporting Regulatory Compliance Business Model Clarity
File Nos in letter: 333-292826
↓
CR Company responded 2026-02-20
LeonaBio, Inc.
File Nos in letter: 333-292826
References: December 18, 2025 | February 11, 2026
↓
CR Company responded 2026-03-31
LeonaBio, Inc.
Offering / Registration Process
File Nos in letter: 333-292826
LeonaBio, Inc.
CIK: 0001620463  ·  File(s): 333-282738  ·  Started: 2024-10-24  ·  Last active: 2024-10-24
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2024-10-24
LeonaBio, Inc.
Offering / Registration Process Regulatory Compliance Financial Reporting
File Nos in letter: 333-282738
↓
CR Company responded 2024-10-24
LeonaBio, Inc.
File Nos in letter: 333-282738
LeonaBio, Inc.
CIK: 0001620463  ·  File(s): 001-39503  ·  Started: 2022-04-06  ·  Last active: 2022-04-06
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2022-04-06
LeonaBio, Inc.
File Nos in letter: 001-39503
LeonaBio, Inc.
CIK: 0001620463  ·  File(s): N/A  ·  Started: 2022-03-25  ·  Last active: 2022-03-25
Orphan - no UPLOAD in window 1 company response(s) Low - unmatched response
CR Company responded 2022-03-25
LeonaBio, Inc.
Filing - Correspondence from LeonaBio, Inc.
CORRESP · 2022-03-25
Generating summary...
LeonaBio, Inc.
CIK: 0001620463  ·  File(s): 333-261073  ·  Started: 2021-11-22  ·  Last active: 2021-11-22
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2021-11-22
LeonaBio, Inc.
File Nos in letter: 333-261073
Filing - SEC Comment Letter to LeonaBio, Inc.
UPLOAD · 2021-11-22
Generating summary...
↓
CR Company responded 2021-11-22
LeonaBio, Inc.
File Nos in letter: 333-261073
Filing - Correspondence from LeonaBio, Inc.
CORRESP · 2021-11-22
Generating summary...
LeonaBio, Inc.
CIK: 0001620463  ·  File(s): N/A  ·  Started: 2021-01-06  ·  Last active: 2021-01-15
Response Received 2 company response(s) Medium - date proximity
UL SEC wrote to company 2021-01-06
LeonaBio, Inc.
Filing - SEC Comment Letter to LeonaBio, Inc.
UPLOAD · 2021-01-06
Generating summary...
↓
CR Company responded 2021-01-15
LeonaBio, Inc.
Filing - Correspondence from LeonaBio, Inc.
CORRESP · 2021-01-15
Generating summary...
↓
CR Company responded 2021-01-15
LeonaBio, Inc.
Filing - Correspondence from LeonaBio, Inc.
CORRESP · 2021-01-15
Generating summary...
LeonaBio, Inc.
CIK: 0001620463  ·  File(s): 333-248428  ·  Started: 2020-09-10  ·  Last active: 2020-09-17
Response Received 5 company response(s) High - file number match
CR Company responded 2020-09-02
LeonaBio, Inc.
File Nos in letter: 333-248428
Filing - Correspondence from LeonaBio, Inc.
CORRESP · 2020-09-02
Generating summary...
↓
UL SEC wrote to company 2020-09-10
LeonaBio, Inc.
File Nos in letter: 333-248428
Filing - SEC Comment Letter to LeonaBio, Inc.
UPLOAD · 2020-09-10
Generating summary...
↓
CR Company responded 2020-09-14
LeonaBio, Inc.
File Nos in letter: 333-248428
References: September 10, 2020
Filing - Correspondence from LeonaBio, Inc.
CORRESP · 2020-09-14
Generating summary...
↓
CR Company responded 2020-09-14
LeonaBio, Inc.
File Nos in letter: 333-248428
Filing - Correspondence from LeonaBio, Inc.
CORRESP · 2020-09-14
Generating summary...
↓
CR Company responded 2020-09-14
LeonaBio, Inc.
File Nos in letter: 333-248428
Filing - Correspondence from LeonaBio, Inc.
CORRESP · 2020-09-14
Generating summary...
↓
CR Company responded 2020-09-17
LeonaBio, Inc.
File Nos in letter: 333-248428
References: September 16, 2020
Filing - Correspondence from LeonaBio, Inc.
CORRESP · 2020-09-17
Generating summary...
LeonaBio, Inc.
CIK: 0001620463  ·  File(s): 333-248428  ·  Started: 2020-09-16  ·  Last active: 2020-09-16
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2020-09-16
LeonaBio, Inc.
File Nos in letter: 333-248428
Filing - SEC Comment Letter to LeonaBio, Inc.
UPLOAD · 2020-09-16
Generating summary...
LeonaBio, Inc.
CIK: 0001620463  ·  File(s): N/A  ·  Started: 2020-08-21  ·  Last active: 2020-08-26
Response Received 1 company response(s) Medium - date proximity
UL SEC wrote to company 2020-08-21
LeonaBio, Inc.
Filing - SEC Comment Letter to LeonaBio, Inc.
UPLOAD · 2020-08-21
Generating summary...
↓
CR Company responded 2020-08-26
LeonaBio, Inc.
References: August 20, 2020
Filing - Correspondence from LeonaBio, Inc.
CORRESP · 2020-08-26
Generating summary...
DateTypeCompanyLocationFile NoLink
2026-03-31 Company Response LeonaBio, Inc. N/A N/A
Offering / Registration Process
Read Filing View
2026-03-31 Company Response LeonaBio, Inc. N/A N/A
Offering / Registration Process
Read Filing View
2026-02-20 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2026-02-11 SEC Comment Letter LeonaBio, Inc. N/A 333-292829
Financial Reporting Regulatory Compliance Business Model Clarity
Read Filing View
2026-02-11 SEC Comment Letter LeonaBio, Inc. N/A 333-292826
Financial Reporting Regulatory Compliance Business Model Clarity
Read Filing View
2024-10-24 SEC Comment Letter LeonaBio, Inc. N/A 333-282738
Offering / Registration Process Regulatory Compliance Financial Reporting
Read Filing View
2024-10-24 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2022-04-06 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
2022-03-25 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2021-11-22 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2021-11-22 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
2021-01-15 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2021-01-15 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2021-01-06 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
2020-09-17 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-09-16 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
2020-09-14 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-09-14 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-09-14 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-09-10 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
2020-09-02 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-08-26 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-08-21 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
DateTypeCompanyLocationFile NoLink
2026-02-11 SEC Comment Letter LeonaBio, Inc. N/A 333-292829
Financial Reporting Regulatory Compliance Business Model Clarity
Read Filing View
2026-02-11 SEC Comment Letter LeonaBio, Inc. N/A 333-292826
Financial Reporting Regulatory Compliance Business Model Clarity
Read Filing View
2024-10-24 SEC Comment Letter LeonaBio, Inc. N/A 333-282738
Offering / Registration Process Regulatory Compliance Financial Reporting
Read Filing View
2022-04-06 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
2021-11-22 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
2021-01-06 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
2020-09-16 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
2020-09-10 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
2020-08-21 SEC Comment Letter LeonaBio, Inc. N/A N/A Read Filing View
DateTypeCompanyLocationFile NoLink
2026-03-31 Company Response LeonaBio, Inc. N/A N/A
Offering / Registration Process
Read Filing View
2026-03-31 Company Response LeonaBio, Inc. N/A N/A
Offering / Registration Process
Read Filing View
2026-02-20 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2024-10-24 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2022-03-25 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2021-11-22 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2021-01-15 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2021-01-15 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-09-17 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-09-14 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-09-14 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-09-14 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-09-02 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2020-08-26 Company Response LeonaBio, Inc. N/A N/A Read Filing View
2026-03-31 - CORRESP - LeonaBio, Inc.
CORRESP
 1
 filename1.htm

 CORRESP

 LEONABIO, INC. 10706 North Creek Parkway, Suite 104 Bothell, Washington 98011   March 31, 2026 VIA EDGAR U.S. Securities & Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jessica Dickerson; Joe McCann Re: LeonaBio, Inc. Registration Statement on Form S-1 Filed January 20, 2026, Amended March 31, 2026 File No. 333-292826 Acceleration Request Requested Date: April 1, 2026 Requested Time: 4:00 p.m. (Eastern time), or as soon thereafter as practicable Ladies and Gentlemen:   Pursuant to Rule 461 under the Securities Act of 1933, as amended, LeonaBio, Inc. (the “ Company ”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-292826) (the “ Registration Statement ”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, Professional Corporation, by calling Bryan King at (206) 883-2535 or, in his absence, Laura Duncan at (206) 883-2578.   Very truly yours, LeonaBio, Inc. /s/ Robert Renninger Robert Renninger Chief Financial Officer

 cc: Mark Litton, M.D., President and Chief Executive Officer, LeonaBio, Inc. Mark Worthington, General Counsel, Chief Compliance Officer and Corporate Secretary, LeonaBio, Inc. Michael Nordtvedt, Wilson Sonsini Goodrich & Rosati, Professional Corporation Bryan D. King, Wilson Sonsini Goodrich & Rosati, Professional Corporation Laura Duncan, Wilson Sonsini Goodrich & Rosati, Professional Corporation
2026-03-31 - CORRESP - LeonaBio, Inc.
CORRESP
 1
 filename1.htm

 CORRESP

 LEONABIO, INC. 10706 North Creek Parkway, Suite 104 Bothell, Washington 98011   March 31, 2026 VIA EDGAR U.S. Securities & Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jessica Dickerson; Joe McCann Re: LeonaBio, Inc. Registration Statement on Form S-1 Filed January 20, 2026, Amended March 31, 2026 File No. 333-292829 Acceleration Request Requested Date: April 1, 2026 Requested Time: 4:00 p.m. (Eastern time), or as soon thereafter as practicable Ladies and Gentlemen:   Pursuant to Rule 461 under the Securities Act of 1933, as amended, LeonaBio, Inc. (the “ Company ”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-292829) (the “ Registration Statement ”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, Professional Corporation, by calling Bryan King at (206) 883-2535 or, in his absence, Laura Duncan at (206) 883-2578.   Very truly yours, LeonaBio, Inc. /s/ Robert Renninger Robert Renninger Chief Financial Officer

 cc: Mark Litton, M.D., President and Chief Executive Officer, LeonaBio, Inc. Mark Worthington, General Counsel, Chief Compliance Officer and Corporate Secretary, LeonaBio, Inc. Michael Nordtvedt, Wilson Sonsini Goodrich & Rosati, Professional Corporation Bryan D. King, Wilson Sonsini Goodrich & Rosati, Professional Corporation Laura Duncan, Wilson Sonsini Goodrich & Rosati, Professional Corporation
2026-02-20 - CORRESP - LeonaBio, Inc.
Read Filing Source Filing Referenced dates: December 18, 2025, February 11, 2026
CORRESP
 1
 filename1.htm

 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
 1

 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.
 2

 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
 3

 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.
 4

 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.
 5

 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
2026-02-11 - UPLOAD - LeonaBio, Inc. File: 333-292829
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 February 11, 2026

Mark Litton
President and Chief Executive Officer
LeonaBio, Inc.
18706 North Creek Pkwy, Suite 104
Bothell, WA 98011

 Re: LeonaBio, Inc.
 Registration Statement on Form S-3
 Filed January 20, 2026
 File No. 333-292829
Dear Mark Litton:

 We have conducted a limited review of your registration statement and
have the
following comment.

 Please respond to this letter by amending your registration statement
and providing the
requested information. If you do not believe the comment applies to your facts
and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing any amendment to your registration statement and the
information you
provide in response to this letter, we may have additional comments.

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 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.
 February 11, 2026
Page 2

 We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.

 Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.

 Please contact Jessica Dickerson at 202-551-8013 or Joe McCann at
202-551-6262 with
any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Michael Nordtvedt, Esq.
</TEXT>
</DOCUMENT>
2026-02-11 - UPLOAD - LeonaBio, Inc. File: 333-292826
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 February 11, 2026

Mark Litton
President and Chief Executive Officer
LeonaBio, Inc.
18706 North Creek Pkwy, Suite 104
Bothell, WA 98011

 Re: LeonaBio, Inc.
 Registration Statement on Form S-3
 Filed January 20, 2026
 File No. 333-292826
Dear Mark Litton:

 We have conducted a limited review of your registration statement and
have the
following comment.

 Please respond to this letter by amending your registration statement
and providing the
requested information. If you do not believe the comment applies to your facts
and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing any amendment to your registration statement and the
information you
provide in response to this letter, we may have additional comments.

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 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.
 February 11, 2026
Page 2

 We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.

 Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.

 Please contact Jessica Dickerson at 202-551-8013 or Joe McCann at
202-551-6262 with
any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Michael Nordtvedt, Esq.
</TEXT>
</DOCUMENT>
2024-10-24 - UPLOAD - LeonaBio, Inc. File: 333-282738
October 24, 2024
Mark Litton
President and Chief Executive Officer
Athira Pharma, Inc.
18706 North Creek Parkway, Suite 104
Bothell, WA 98011
Re:Athira Pharma, Inc.
Registration Statement on Form S-3
Filed October 21, 2024
File No. 333-282738
Dear Mark Litton:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Bryan D. King
2024-10-24 - CORRESP - LeonaBio, Inc.
CORRESP
1
filename1.htm

  CORRESP

  October 24, 2024

  VIA EDGAR

  U.S. Securities and Exchange Commission

  Division of Corporation Finance

  Office of Life Sciences

  100 F Street, N.E.

  Washington, D.C. 20549-3720

  Attention: Alan Campbell

    Re:

    Athira Pharma, Inc.

  Registration Statement on Form S-3

  Filed October 21, 2024

  (File No. 333-282738)

  Acceleration Request

  Requested Date: October 28, 2024

  Requested Time: 4:00 P.M. Eastern Daylight Time,

  or as soon thereafter as practicable

  Ladies and Gentlemen:

  Pursuant to Rule 461 under the Securities Act of 1933, as amended, Athira Pharma, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-282738) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Michael Nordtvedt at (206) 883-2524 or Bryan King at (206) 883-2535.

  [Signature page follows]

  Securities and Exchange Commission

October 24, 2024

Page 2

    Sincerely,

    ATHIRA PHARMA, INC.

    /s/ Robert Renninger

    Robert Renninger

    Vice President of Finance

  Enclosures

  cc: Mark Litton, Athira Pharma, Inc.

  Mark Worthington, Athira Pharma, Inc.

  Michael Nordtvedt, Wilson Sonsini Goodrich & Rosati P.C.

  Bryan D. King, Wilson Sonsini Goodrich & Rosati P.C.
2022-04-06 - UPLOAD - LeonaBio, Inc.
United States securities and exchange commission logo
April 6, 2022
Jared N. Fertman, Esq.
Willkie Farr & Gallagher LLP
787 Seventh Avenue
New York, NY
10019-6099
Re:Athira Pharma, Inc.
PREC14A filed by Richard A. Kayne et al.
Filed March 30, 2022
File No. 001-39503
Dear Mr. Fertman:
            We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
            Please respond to these comments by providing the requested information or advise us as
soon as possible when you will respond.  If you do not believe our comments apply to your facts
and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Capitalized terms used herein but not defined have the meanings ascribed to them in the filing.
PREC14A filed March 30, 2022
Background of the Solicitation, page 1
1.At the top of page 2, please disclose the names of the two nominees referred to.  Please
also disclose whether the Company, in its March 1 response, commented on any nominee
other than Mr. Kayne.
2.We understand that Mr. Kayne played a role in Mr. Pickering's appointment to the Board.
Please include disclosure regarding that point, or advise us as to why such disclosure is
not material information.
Proposal No. 1 - Election of Directors, page 5
3.We note the reference on page 5 to a potential substitute nominee.  Please confirm that in
the event you select a substitute nominee prior to the Annual Meeting, you will file an

 FirstName LastNameJared N. Fertman, Esq.
 Comapany Name787 Seventh Avenue
 April 6, 2022 Page 2
 FirstName LastName
Jared N. Fertman, Esq.
787 Seventh Avenue
April 6, 2022
Page 2
amended proxy statement that (1) identifies the substitute nominee, (2) discloses whether
the nominee has consented to being named in the revised proxy statement and to serve if
elected and (3) includes disclosure required by Items 5(b) and 7 of Schedule 14A with
respect to the nominee.
General
4.Please change the references to "an Athira nominee" on page 5 from "an" Athira nominee
to "the" Athira nominee.  Similarly, throughout the proxy statement and on the proxy card,
please use the phrase "the person" instead of "one person."  Finally, on the proxy card,
ensure that the instructions correctly refer to the ability to withhold authority to vote for
the single Athira nominee for whom proxy authority is sought, rather than multiple Athira
nominees.
5.Please ensure that the disclosure required by Rule 14a-4(d)(4)(iv) is included in the proxy
statement (in addition to the proxy card).
6.The proxy statement uses an outdated Schedule 14A cover page.  Please use the correct
cover page in future filings.
7.Given the relationship between Dr. Kawas and the Participants, please add Dr. Kawas as a
Participant, or, with a view toward disclosure, advise us as to why Dr. Kawas is not in fact
a participant in the solicitation.

            We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please direct any questions to David M. Plattner, Special Counsel, at 202-551-8094.
Sincerely,
Division of Corporation Finance
Office of Mergers and Acquisitions
2022-03-25 - CORRESP - LeonaBio, Inc.
CORRESP
1
filename1.htm

atha-corresp.htm

Wilson Sonsini Goodrich & Rosati
Professional Corporation

701 Fifth Avenue
Suite 5100
Seattle, Washington 98104-7036

o: 206.883.2500
f: 206.883.2699

Michael NORDTVEDT

Internet: mnordtvedt@wsgr.com

Direct dial: (206) 883-2524

Client File No.: 57357.015

March 25, 2022

BY EDGAR

Division of Corporation Finance

Securities and Exchange Commission

100 F Street, NE

Washington, DC 20549

Re:

Preliminary Proxy Statement of Athira Pharma, Inc.

Ladies and Gentlemen:

Pursuant to Note 4 to Paragraph (a) of Rule 14a-6 promulgated under the Securities Exchange Act of 1934, as amended, the attached proxy statement of Athira Pharma, Inc. (the “Company”) is being filed in preliminary form only because the Company has commented on or referred to a potential solicitation in opposition by Richard A. Kayne.

If we can be of any assistance, or if the Staff of the Securities and Exchange Commission has any questions, please do not hesitate to contact me at the email address or telephone number above.

Very truly yours,

WILSON SONSINI GOODRICH & ROSATI

Professional Corporation

/s/ Michael Nordtvedt

Michael Nordtvedt

cc:

Athira Pharma, Inc.

Mark Worthington

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4881-4114-7160.2 - 3/25/2022 12:04:28 AM
2021-11-22 - CORRESP - LeonaBio, Inc.
CORRESP
1
filename1.htm

CORRESP

 November 22, 2021

VIA EDGAR

 U.S. Securities and Exchange Commission

 Division of Corporation Finance

 Office of Life Sciences

 100 F Street, N.E.

 Washington, D.C. 20549-3720

Attention:    Christine Westbrook

Re:
 Athira Pharma, Inc.

Registration Statement on Form S-3

Filed November 15, 2021

(File No. 333-261073)

Acceleration Request

Requested Date:    November 24, 2021

Requested Time:    4:00 P.M. Eastern Standard Time,

or as soon thereafter as practicable

Ladies and Gentlemen:

 Pursuant to Rule 461
under the Securities Act of 1933, as amended, Athira Pharma, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-261073) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its
counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our
counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Michael Nordtvedt at (206) 883-2524 or Bryan King at (206) 883-2535.

[Signature page follows]

 Securities and Exchange Commission

November 22, 2021

  Page
 2

Sincerely,

ATHIRA PHARMA, INC.

/s/ Glenna Mileson

Glenna Mileson

Chief Financial Officer

 Enclosures

cc:    Mark Litton, Athira Pharma, Inc.

Mark Worthington, Athira Pharma, Inc.

Michael Nordtvedt, Wilson Sonsini Goodrich & Rosati P.C.

Bryan D. King, Wilson Sonsini Goodrich & Rosati P.C.
2021-11-22 - UPLOAD - LeonaBio, Inc.
United States securities and exchange commission logo
November 22, 2021
Mark Litton, Ph.D.
Chief Executive Officer
Athira Pharma, Inc.
18706 North Creek Parkway
Suite 104
Bothell, WA 98011
Re:Athira Pharma, Inc.
Registration Statement on Form S-3
Filed November 15, 2021
File No. 333-261073
Dear Dr. Litton:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Bryan King, Esq.
2021-01-15 - CORRESP - LeonaBio, Inc.
CORRESP
1
filename1.htm

atha-corresp.htm

January 15, 2021

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549-3720

Attention:David Gessert

Re:

Athira Pharma, Inc.
Draft Registration Statement on Form S-1 Submitted January 6, 2021

Registration Statement on Form S-1 to be filed on January 19, 2021

(File No. 333-           )

Acceleration Request
Requested Date:Wednesday, January 20, 2021
Requested Time:4:30 P.M. Eastern Daylight Time

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, Athira Pharma, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-               ) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Michael Nordtvedt at (206) 883-2524 or Bryan King at (206) 883-2535.

[Signature page follows]

Securities and Exchange Commission

January 15, 2021

Page 2

Sincerely,

ATHIRA PHARMA, Inc.

/s/ Leen Kawas

Leen Kawas

President and Chief Executive Officer

Enclosures

cc:Glenna Mileson, Athira Pharma, Inc.

Michael Nordtvedt, Wilson Sonsini Goodrich & Rosati P.C.

Bryan D. King, Wilson Sonsini Goodrich & Rosati P.C.

Charles S. Kim, Cooley LLP

Alan D. Hambelton, Cooley LLP

Oren Lang-Furr, Ernst & Young LLP
2021-01-15 - CORRESP - LeonaBio, Inc.
CORRESP
1
filename1.htm

atha-corresp.htm

January 15, 2021

United States Securities and Exchange Commission
Division of Corporation Finance

Office of Life Sciences
100 F Street, N.E.
Washington, DC 20549

Attention:

David Gessert

Re:

Athira Pharma, Inc.
Draft Registration Statement on Form S-1 Submitted January 6, 2021

Registration Statement on Form S-1 to be filed January 19, 2021
File No. 333-

Ladies and Gentlemen:

Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Securities Act”), we wish to advise that as of the time of this filing, the underwriters have not yet made any distribution of the Preliminary Prospectus of Athira Pharma, Inc. (the “Registrant”) dated January 19, 2021. However, the underwriters are taking steps to see that all underwriters, brokers or dealers participating in the public offering of shares of the Registrant’s common stock pursuant to the above-captioned Registration Statement, as amended (the “Registration Statement”), are promptly furnished with sufficient copies of the preliminary and final prospectus to enable them to comply with the prospectus delivery requirements of Sections 5(b)(1) and (2) of the Securities Act.

We wish to advise you that the participating underwriters have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.

We hereby join in the request of the Registrant that the effectiveness of the above-captioned Registration Statement be accelerated to 4:30 p.m. Eastern Time, on Wednesday, January 20, 2021 or as soon thereafter as practicable.

[signature page follows]

Very truly yours,

GOLDMAN SACHS & CO. LLC
JEFFERIES LLC

As representatives of the Underwriters

By:

Goldman Sachs & Co. LLC

By:

/s/ Elizabeth Wood

Name:

Elizabeth Wood

Title:

Managing Director

By:

Jefferies LLC

By:

/s/ Michael Brinkman

Name:

Michael Brinkman

Title:

Managing Director

[Signature Page to Acceleration Request Letter]
2021-01-06 - UPLOAD - LeonaBio, Inc.
United States securities and exchange commission logo
January 6, 2021
Leen Kawas, Ph.D.
President and Chief Executive Officer
Athira Pharma, Inc.
18706 North Creek Parkway, Suite 104
Bothell, WA 98011
Re:Athira Pharma, Inc.
Draft Registration Statement on Form S-1
Submitted January 6, 2021
CIK No. 0001620463
Dear Mr. Kawas:
            This is to advise you that we do not intend to review your registration statement.
            We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration. We remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
            Please contact David Gessert at 202-551-2326 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-09-17 - CORRESP - LeonaBio, Inc.
Read Filing Source Filing Referenced dates: September 16, 2020
CORRESP
1
filename1.htm

atha-corresp.htm

Wilson Sonsini Goodrich & Rosati
Professional Corporation

650 Page Mill Road
Palo Alto, California 94304-1050

o: 650.493.9300
f: 650.493.6811

September 17, 2020

Via EDGAR and Courier

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549

Attention:

Michael Fay

Daniel Gordon

Deanna Virginio

Ada D. Sarmento

Re:

Athira Pharma, Inc.

Registration Statement on Form S-1

Filed August 26, 2020

Amendment No. 2 to the Registration Statement on Form S-1

Filed on September 14, 2020
File No. 333-248428

Ladies and Gentlemen:

On behalf of our client, Athira Pharma, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated September 16, 2020, relating to the above-referenced Registration Statement on Form S‑1 (the “Registration Statement”).  On behalf of the Company, we are concurrently publicly filing via EDGAR Amendment No. 3 to the Registration Statement (the “Amended Registration Statement”).

In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response.  Except for page references appearing in the headings and Staff comments below (which are references to the Registration Statement), all page references herein correspond to the pages of the Amended Registration Statement.

Amendment No. 2 to Registration Statement on Form S-1

Overview, page 1

1.

We note your revisions in response to prior comment one and reissue in part. Your statements that "ATH-1017 significantly improved P300

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san diego        san francisco        seattle        shanghai        washington, dc        wilmington, de

U.S. Securities and Exchange Commission

September 17, 2020

Page 2

latency" and "P300 latency is a functional measure that is highly correlated with cognition" appear to imply an expectation that the improvement in P300 latency will result in cognitive improvement. Please revise these statements and similar statements on pages 5, 90 and 108 to clarify that you have yet to establish a connection between the P300 latency results observed in your Phase 1 trials and improved cognition.

In response to the Staff’s comment, the Company has revised its disclosures on pages 1, 4, 89, 107, 122, and 127 of the Amended Registration Statement.

***

Please direct any questions regarding the Company’s responses or the Registration Statement to me at (206) 883 2524 or mnordtvedt@wsgr.com.

Sincerely,

WILSON SONSINI GOODRICH & ROSATI

Professional Corporation

/s/ Michael Nordtvedt

Michael Nordtvedt

cc:

Leen Kawas, Athira Pharma, Inc.

Glenna Mileson, Athira Pharma, Inc.

Bryan D. King, Wilson Sonsini Goodrich & Rosati, P.C.

Charles S. Kim, Cooley LLP

Alan D. Hambelton, Cooley LLP

Oren Lang-Furr, Ernst & Young LLP
2020-09-16 - UPLOAD - LeonaBio, Inc.
United States securities and exchange commission logo
September 16, 2020
Leen Kawas, Ph.D.
Chief Executive Officer
Athira Pharma, Inc.
4000 Mason Road, Suite 300
Seattle, WA 98195
Re:Athira Pharma, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed September 14, 2020
File No. 333-248428
Dear Dr. Kawas:
            We have reviewed your amended registration statement and have the following
comment.
            Please respond to this letter by amending your registration statement and providing the
requested information.  If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.  Unless we note
otherwise, our references to prior comments are to comments in our September 10, 2020 letter.
Amendment No. 2 to Registration Statement on Form S-1
Overview, page 1
1.We note your revisions in response to prior comment one and reissue in part. Your
statements that "ATH-1017 significantly improved P300 latency" and "P300 latency is a
functional measure that is highly correlated with cognition" appear to imply an
expectation that the improvement in P300 latency will result in cognitive improvement.
Please revise these statements and similar statements on pages 5, 90 and 108 to clarify that
you have yet to establish a connection between the P300 latency results observed in your
Phase 1 trials and improved cognition.
            You may contact Michael Fay at 202-551-3812 or Daniel Gordon at 202-551-3486 if you
have questions regarding comments on the financial statements and related matters.  Please

 FirstName LastNameLeen Kawas, Ph.D.
 Comapany NameAthira Pharma, Inc.
 September 16, 2020 Page 2
 FirstName LastName
Leen Kawas, Ph.D.
Athira Pharma, Inc.
September 16, 2020
Page 2
contact Deanna Virginio at 202-551-4530 or Ada D. Sarmento at 202-551-3798 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Michael Nordtvedt, Esq.
2020-09-14 - CORRESP - LeonaBio, Inc.
Read Filing Source Filing Referenced dates: September 10, 2020
CORRESP
1
filename1.htm

atha-corresp.htm

Wilson Sonsini Goodrich & Rosati
Professional Corporation

650 Page Mill Road
Palo Alto, California 94304-1050

o: 650.493.9300
f: 650.493.6811

September 14, 2020

Via EDGAR and Courier

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549

Attention:

Michael Fay

Daniel Gordon

Deanna Virginio

Ada D. Sarmento

Re:

Athira Pharma, Inc.

Registration Statement on Form S-1

Filed August 26, 2020

Amendment No. 1 to the Registration Statement on Form S-1

Filed on September 9, 2020
File No. 333-248428

Ladies and Gentlemen:

On behalf of our client, Athira Pharma, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated September 10, 2020, relating to the above-referenced Registration Statement on Form S‑1 (the “Registration Statement”).  On behalf of the Company, we are concurrently publicly filing via EDGAR Amendment No. 2 to the Registration Statement (the “Amended Registration Statement”).

In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response.  Except for page references appearing in the headings and Staff comments below (which are references to the Registration Statement), all page references herein correspond to the pages of the Amended Registration Statement.

Registration Statement on Form S-1
Overview, page 1

1.

We note your response to prior comment 1. Your statement that "ATH-1017 significantly improved brain activity as measured by P300 latency, a

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U.S. Securities and Exchange Commission

September 14, 2020

Page 2

functional measure that highly correlates with cognition" appears to imply an expectation that the improvement in P300 latency will result in cognitive improvement as you state on page 8. Please revise this and any similar statements to clarify that you have yet to establish a connection between the P300 latency results observed in your Phase 1 trials and improved cognition. Please further revise your disclosure to provide appropriate context for various conclusions and predictions as to the performance of your product candidates and revise and/or remove any statements that imply efficacy. For example, please revise your statement on page 2 that appears to conclude that your ATH platform has the ability to “enhance the body’s repair mechanism of HGF/MET” and the last sentence under "Differentiated Approach" on page 7 that appears to conclude that treatment with ATH-1017 will produce certain beneficial effects. Please remove the row related to ATH-1017 from the chart on page 8 as the disclosure makes a prediction regarding the efficacy of the treatment as noted above. We note your disclosure on page 4 that "average latency across the AD treatment group had returned to levels close to those observed in healthy elderly subjects by the end of an 8-day treatment cycle" and a similar statement on page 135 that ATH-1017 “normalized” the P300 latency of AD subjects in a Phase 1b clinical trial within 8 days of treatment. Please remove any reference to normalization as it implies efficacy and instead present the data that you used to draw the conclusion. Please also disclose how you selected the healthy young and healthy elderly volunteers in your Phase 1 clinical trials and how you determined that they were healthy.

In response to the Staff’s comment, the Company has revised its disclosures throughout the Amended Registration Statement.

Our Pipeline and ATH Platform, page 2

2.

We note your disclosure that you may cross-reference the already active IND for ATH-1017 for the treatment of AD in the second IND for ATH-1017 for the treatment of PDD. Please revise your disclosure to clarify whether the second IND for PDD has been submitted to the FDA. If not yet submitted, please move the line for PDD to reflect its current status in pre-clinical development. We note your response to prior comment 3 that the company intends to initiate the Phase 2/3 LIFT-AD clinical trial in early September yet your disclosure in the prospectus indicates that the company intends to initiate the trial by the end of 2020. Until you initiate the trial, please remove any references to the company being in the "late" clinical-stage.

U.S. Securities and Exchange Commission

September 14, 2020

Page 3

In response to the Staff’s comment, the Company has revised its pipeline chart. The Company respectfully advises the Staff that the Company has initiated the Phase 2/3 LIFT-AD clinical trial.

Risks Associated with Our Business, page 9

3.

We note your response and revisions to prior comment 7. Please revise this section to highlight the risks associated with using EEG methods and the risks associated with having limited data from only 11 AD subjects from your Phase 1 trials.

In response to the Staff’s comment, the Company has revised its disclosures on pages 10 and 23 of the Amended Registration Statement.

Insights from Approved Therapies, page 120

4.

We note your revised disclosure in response to prior comment 10. Please revise to make the disclosure added to the Source note below Figure 12 part of the lead-in paragraph to Figure 12. Please also revise your disclosure to clarify whether the similarities disclosed between the studies of donepezil and rivastigmine are also the same for the ATH-1017 Phase 1 clinical trial. We note, for example, that there is no trend line for a placebo control in the ATH-1017 graph and that the subjects included both healthy and AD patients. If not similar to the studies of donepezil and rivastigmine, please revise to disclose why such comparisons are appropriate or remove the comparisons.

In response to the Staff’s comment, the Company has revised its disclosures to remove Figure 12 and related disclosures from the Amended Registration Statement.

Event-Related Potential, page 128

5.

We note your response to prior comment 11. Please revise your disclosure to include a discussion of the objective data observed to support your statement that "the sustained effects on P300 latency observed in the pre-dose recordings on subsequent testing days...most likely reflect the long-term regeneration of neuronal connections and the improvement in brain function." Alternatively, please remove the statement.

In response to the Staff’s comment, the Company has revised its disclosures on page 128 of the Amended Registration Statement.

U.S. Securities and Exchange Commission

September 14, 2020

Page 4

Our Neuropsychiatric Program (ATH-1019), page 134

6.

We note your response to prior comment 12. Please revise your disclosure to include a discussion of the objective data observed to support your statement that ATH-1019 "has been shown to activate the HGF/MET system, and distribute to the CNS, and is neuroactive in animal models." Alternatively, you may describe what you have designed ATH-1019 to do and remove the statement.

In response to the Staff’s comment, the Company has revised its disclosures on page 134 of the Amended Registration Statement.

Our Collaboration and Grant Agreements

Washington State University Research Foundation License Agreement and Amended and Restated Washington State University License Agreement, page 140

7.

We note your response to prior comment 13. Please note that we consider the royalty term to be a material term of a license agreement that should be disclosed in the registration statement. Please disclose when the royalty term is currently expected to expire. We note your disclosure that the term of the agreement will continue until the earlier of the date that no valid claim in a licensed patent remains enforceable or payment of earned royalties, once such payments begin, ceases for more than four consecutive calendar quarters. Please revise to disclose when the licensed patents are currently expected to expire. Please also revise your disclosure in this section to include the information from your response regarding whether you expect the joint ownership of the patent with Pacific Northwest Biotechnology, Inc. to have any effect on your license of the patent or your development of the product candidates to which the patent relates.

In response to the Staff’s comment, the Company has revised its disclosures on page 141 of the Amended Registration Statement.

***

Please direct any questions regarding the Company’s responses or the Registration Statement to me at (206) 883 2524 or mnordtvedt@wsgr.com.

Sincerely,

WILSON SONSINI GOODRICH & ROSATI

Professional Corporation

U.S. Securities and Exchange Commission

September 14, 2020

Page 5

/s/ Michael Nordtvedt

Michael Nordtvedt

cc:

Leen Kawas, Athira Pharma, Inc.

Glenna Mileson, Athira Pharma, Inc.

Bryan D. King, Wilson Sonsini Goodrich & Rosati, P.C.

Charles S. Kim, Cooley LLP

Alan D. Hambelton, Cooley LLP

Oren Lang-Furr, Ernst & Young LLP
2020-09-14 - CORRESP - LeonaBio, Inc.
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September 14, 2020

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

Attention:

Michael Fay

Daniel Gordon

Deanna Virginio

Ada D. Sarmento

Re:

Athira Pharma, Inc.

Registration Statement on Form S-1

File No. 333-248428

Acceleration Request

Requested Date:  Thursday, September 17, 2020

Requested Time:  4 P.M. Eastern Time

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, Athira Pharma, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-248428) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Michael Nordtvedt at (206) 883-2524 or Bryan King at (206) 883-2535.

[Signature page follows]

Securities and Exchange Commission

September 14, 2020

Page 2

Sincerely,

ATHIRA PHARMA, Inc.

/s/ Leen Kawas

Leen Kawas

President and Chief Executive Officer

cc:

Glenna Mileson, Athira Pharma, Inc.

Michael Nordtvedt, Wilson Sonsini Goodrich & Rosati P.C.

Bryan D. King, Wilson Sonsini Goodrich & Rosati P.C.

Charles S. Kim, Cooley LLP

Alan D. Hambelton, Cooley LLP

Oren Lang-Furr, Ernst & Young LLP
2020-09-14 - CORRESP - LeonaBio, Inc.
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September 14, 2020

United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549

Attention:

Deanna Virginio

Ada D. Sarmento

Michael Fay

Daniel Gordon

Re:Athira Pharma, Inc.

Registration Statement on Form S-1 (File No. 333-248428)

Ladies and Gentlemen:

Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended, we wish to advise that between September 14, 2020 and the date hereof, approximately 4,550 copies of the Preliminary Prospectus dated September 14, 2020 were distributed to prospective underwriters, institutional investors and prospective dealers in connection with the above-captioned Registration Statement.

We wish to advise you that the participating underwriters have informed us that they have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.

We hereby join in the request of the registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time, on Thursday, September 17, 2020 or as soon thereafter as practicable.

[Signature page follows]

Very truly yours,

GOLDMAN SACHS & CO. LLC

JEFFERIES LLC

As representatives of the Underwriters

By:

Goldman Sachs & Co. LLC

By:

/s/ Elizabeth Wood

Name:

Elizabeth Wood

Title:

Managing Director

By:

Jefferies LLC

By:

/s/ Michael Brinkman

Name:

Michael Brinkman

Title:

Managing Director
2020-09-10 - UPLOAD - LeonaBio, Inc.
United States securities and exchange commission logo
September 10, 2020
Leen Kawas, Ph.D.
Chief Executive Officer
Athira Pharma, Inc.
4000 Mason Road, Suite 300
Seattle, WA 98195
Re:Athira Pharma, Inc.
Registration Statement on Form S-1
Filed August 26, 2020
Amendment No. 1 to Registration Statement on Form S-1
Filed September 9, 2020
File No. 333-248428
Dear Dr. Kawas:
            We have reviewed your registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            Please respond to this letter by amending your registration statement and providing the
requested information.  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1
Overview, page 1
1.We note your response to prior comment 1.  Your statement that "ATH-1017 significantly
improved brain activity as measured by P300 latency, a functional measure that highly
correlates with cognition" appears to imply an expectation that the improvement in P300
latency will result in cognitive improvement as you state on page 8.  Please revise this and
any similar statements to clarify that you have yet to establish a connection between the
P300 latency results observed in your Phase 1 trials and improved cognition.  Please
further revise your disclosure to provide appropriate context for various conclusions and
predictions as to the performance of your product candidates and revise and/or remove

 FirstName LastNameLeen Kawas, Ph.D.
 Comapany NameAthira Pharma, Inc.
 September 10, 2020 Page 2
 FirstName LastNameLeen Kawas, Ph.D.
Athira Pharma, Inc.
September 10, 2020
Page 2
any statements that imply efficacy. For example, please revise your statement on page 2
that appears to conclude that your ATH platform has the ability to “enhance the body’s
repair mechanism of HGF/MET” and the last sentence under "Differentiated Approach"
on page 7 that appears to conclude that treatment with ATH-1017 will produce certain
beneficial effects. Please remove the row related to ATH-1017 from the chart on page 8 as
the disclosure makes a prediction regarding the efficacy of the treatment as noted above.
We note your disclosure on page 4 that "average latency across the AD treatment group
had returned to levels close to those observed in healthy elderly subjects by the end of an
8-day treatment cycle" and a similar statement on page 135 that ATH-1017 “normalized”
the P300 latency of AD subjects in a Phase 1b clinical trial within 8 days of treatment.
Please remove any reference to normalization as it implies efficacy and instead present
the data that you used to draw the conclusion. Please also disclose how you selected the
healthy young and healthy elderly volunteers in your Phase 1 clinical trials and how you
determined that they were healthy.
Our Pipeline and ATH Platform, page 2
2.We note your disclosure that you may cross-reference the already active IND for ATH-
1017 for the treatment of AD in the second IND for ATH-1017 for the treatment of PDD.
Please revise your disclosure to clarify whether the second IND for PDD has been
submitted to the FDA. If not yet submitted, please move the line for PDD to reflect its
current status in pre-clinical development. We note your response to prior comment 3 that
the company intends to initiate the Phase 2/3 LIFT-AD clinical trial in early September
yet your disclosure in the prospectus indicates that the company intends to initiate the trial
by the end of 2020. Until you initiate the trial, please remove any references to the
company being in the "late" clinical-stage.
Risks Associated with Our Business, page 9
3.We note your response and revisions to prior comment 7.  Please revise this section to
highlight the risks associated with using EEG methods and the risks associated with
having limited data from only 11 AD subjects from your Phase 1 trials.
Insights from Approved Therapies, page 120
4.We note your revised disclosure in response to prior comment 10. Please revise to make
the disclosure added to the Source note below Figure 12 part of the lead-in paragraph to
Figure 12. Please also revise your disclosure to clarify whether the similarities disclosed
between the studies of donepezil and rivastigmine are also the same for the ATH-1017
Phase 1 clinical trial. We note, for example, that there is no trend line for a placebo
control in the ATH-1017 graph and that the subjects included both healthy and AD
patients. If not similar to the studies of donepezil and rivastigmine, please revise to
disclose why such comparisons are appropriate or remove the comparisons.

 FirstName LastNameLeen Kawas, Ph.D.
 Comapany NameAthira Pharma, Inc.
 September 10, 2020 Page 3
 FirstName LastNameLeen Kawas, Ph.D.
Athira Pharma, Inc.
September 10, 2020
Page 3
Event-Related Potential, page 128
5.We note your response to prior comment 11. Please revise your disclosure to include a
discussion of the objective data observed to support your statement that "the sustained
effects on P300 latency observed in the pre-dose recordings on subsequent testing
days...most likely reflect the long-term regeneration of neuronal connections and the
improvement in brain function." Alternatively, please remove the statement.
Our Neuropsychiatric Program (ATH-1019), page 134
6.We note your response to prior comment 12. Please revise your disclosure to include a
discussion of the objective data observed to support your statement that ATH-1019 "has
been shown to activate the HGF/MET system, and distribute to the CNS, and is
neuroactive in animal models." Alternatively, you may describe what you have designed
ATH-1019 to do and remove the statement.
Our Collaboration and Grant Agreements
Washington State University Research Foundation License Agreement and Amended and
Restated Washington State University License Agreement , page 140
7.We note your response to prior comment 13. Please note that we consider the royalty term
to be a material term of a license agreement that should be disclosed in the registration
statement. Please disclose when the royalty term is currently expected to expire. We note
your disclosure that the term of the agreement will continue until the earlier of the date
that no valid claim in a licensed patent remains enforceable or payment of earned
royalties, once such payments begin, ceases for more than four consecutive calendar
quarters. Please revise to disclose when the licensed patents are currently expected to
expire. Please also revise your disclosure in this section to include the information from
your response regarding whether you expect the joint ownership of the patent with Pacific
Northwest Biotechnology, Inc. to have any effect on your license of the patent or your
development of the product candidates to which the patent relates.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            Refer to Rules 460 and 461 regarding requests for acceleration.  Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
            You may contact Michael Fay at 202-551-3812 or Daniel Gordon at 202-551-3486 if you
have questions regarding comments on the financial statements and related matters.  Please
contact Deanna Virginio at 202-551-4530 or Ada D. Sarmento at 202-551-3798 with any other
questions.

 FirstName LastNameLeen Kawas, Ph.D.
 Comapany NameAthira Pharma, Inc.
 September 10, 2020 Page 4
 FirstName LastName
Leen Kawas, Ph.D.
Athira Pharma, Inc.
September 10, 2020
Page 4
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Michael Nordtvedt, Esq.
2020-09-02 - CORRESP - LeonaBio, Inc.
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Wilson Sonsini Goodrich & Rosati

Professional Corporation

701 Fifth Avenue

Suite 5100

Seattle, Washington 98104-7036

o: 206.883.2500

f: 206.883.2699

CONFIDENTIAL TREATMENT REQUESTED

BY ATHIRA PHARMA, INC.: ATHA-0002

September 2, 2020

CERTAIN PORTIONS OF THIS LETTER HAVE BEEN OMITTED FROM THE VERSION SUBMITTED VIA EDGAR.  CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.  INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS LETTER WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.  THE OMITTED PORTIONS ARE BRACKETED IN THIS PAPER LETTER FOR EASE OF IDENTIFICATION.

Via EDGAR and Email

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549

Attention:

Michael Fay

Daniel Gordon

Deanna Virginio

Ada D. Sarmento

Re:

Athira Pharma, Inc.

Registration Statement on Form S-1

Filed August 26, 2020

File No. 333-248428

Option Pricing Review

Ladies and Gentlemen:

We are submitting this letter on behalf of Athira Pharma, Inc. (the “Company”) in connection with the review by the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) of the Company’s Registration Statement on Form S-1 filed on August 26, 2020 (the “Registration Statement”).  Because of the commercially sensitive nature of certain information contained herein, this submission is accompanied by a request for confidential treatment for selected portions of this letter.  The Company has filed a separate letter with the Office of Freedom of Information and Privacy Act Operations in connection with the confidential treatment request, pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83.  For the Staff’s reference, we have enclosed a copy of the Company’s letter to the Office of Freedom of Information and Privacy Act Operations, as well as a copy of this correspondence, marked to show the portions redacted from the version submitted via EDGAR and for which the Company is requesting confidential treatment.  For the convenience of the Staff, we are providing to the Staff by email copies of this letter.  Acronyms used but not defined herein shall have the meanings set forth in the Registration Statement.

austin        beijing        boston        brussels        hong kong        london        los angeles        new york        palo alto
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Securities and Exchange Commission

CONFIDENTIAL TREATMENT REQUESTED

September 2, 2020

BY ATHIRA PHARMA, INC.: ATHA-0002

Page 2

The purpose of this letter is to notify the Staff that the price range to be included on the cover of the Company’s preliminary prospectus is expected to be within a range of $[***] and $[***] per share of common stock, which after giving effect to the expected one-to-[***] reverse split ratio, correlates to a range of $[***] and $[***] per share, in order to enable the Staff to complete its review of the Company’s option pricing and fair value determinations and to provide an update regarding offering timing considerations.  This preliminary price range was determined, in large part, on various discussions that took place between August 26, 2020 and the date hereof among the Company and representatives of Goldman Sachs & Co. LLC, Jefferies LLC and Stifel, Nicolaus & Company, Incorporated, the lead underwriters for the offering. Prior to printing preliminary prospectuses and commencing the roadshow, the Company and its underwriters will further refine and narrow this price range, so the breadth of the price range is consistent with SEC guidance.  To facilitate the Staff’s analysis, all of the prices in this letter are stated on a pre-reverse split basis.

The Company supplementally advises the Staff that the price range noted above is subject to further revision based on market conditions, business developments and other factors.

Timing Considerations

The Company supplementally advises the Staff that it anticipates printing its preliminary prospectus on or about September 9, 2020 and commencing its road show as early as September 10, 2020, with a target pricing date as early as September 15, 2020.

Historical Fair Value Determinations

To facilitate the Staff’s review, the table below contains a complete list of all options granted during the period from July 1, 2019 through the date of this letter (the “Review Period”). The Company has not made any other equity incentive grants during the Review Period.

Grant Date

Shares

Underlying

Options

Granted

Fair Value

Per  Share

August 15, 2019

1,850,000

$

0.17

October 18, 2019

130,000

0.17

January 29, 2020

305,000

0.17

February 26, 2020

50,000

0.17

Moreover, the Company expects that its board of directors (the “Board”) will act to make additional equity awards during the week of August 31, 2020, which grants would become effective on the date the Registration Statement becomes effective. The exercise price of any options so granted would be equal to the initial public offering price in the Company’s initial public offering. The Company advises the Staff that such awards will be disclosed in the Company’s preliminary prospectus.

Overview of Option Pricing and Fair Value Determinations

Each time the Board has granted options, it has granted those options with an exercise price intended to be equal to the fair value of the underlying shares on the date of the grant.  Given the absence of an active trading market for the Company’s equity, determining the fair value of the Company’s common stock has required the Board to make complex and subjective judgments.  In doing so, the Board considered a combination of valuation methodologies.

Securities and Exchange Commission

CONFIDENTIAL TREATMENT REQUESTED

September 2, 2020

BY ATHIRA PHARMA, INC.: ATHA-0002

Page 3

The Company and its Board have consistently sought to comply with the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “AICPA Practice Aid”).  The Company obtained independent valuations from nationally recognized independent valuation firms, to assist the Board in making its determination of fair value and to ensure that all relevant business developments were considered in making valuation determinations.

Throughout the Review Period, the Board consisted of individuals with significant experience in business, finance, and investing in and valuing companies, including determining the fair value of the common stock of such companies.  In each instance, the Board reached its determination of the estimated fair value of the Company’s common stock after discussion and made its determination in good faith, based on the information available on the date of grant, including the methodology and key assumptions in the third-party valuations described in additional detail below.

Each fair value estimate was based on a variety of factors, which included the following:

•

the Company’s results of operations and financial position, including its levels of available capital resources;

•

the Company’s stage of development and material risks related to its business;

•

progress of the Company’s research and development activities;

•

the Company’s business conditions and projections;

•

the valuation of publicly traded companies in the life sciences and biotechnology sectors, as well as recently completed mergers and acquisitions of peer companies;

•

the lack of marketability of the Company’s common stock as a private company;

•

the prices at which the Company sold shares of its convertible preferred stock to outside investors in arms-length transactions;

•

the rights, preferences, and privileges of the Company’s convertible preferred stock relative to those of its common stock;

•

the likelihood of achieving a liquidity event for the Company’s securityholders, such as an initial public offering or a sale of the Company, given prevailing market conditions;

•

the hiring of key personnel and the experience of management;

•

trends and developments in the Company’s industry; and

•

external market conditions affecting the life sciences and biotechnology industry sectors.

In valuing the Company’s shares, the Board determined the equity value of the Company’s business generally using various valuation methods, including combinations of methods, as deemed appropriate under the circumstances applicable at the valuation date and was supported by independent third-party valuations as of March 31, 2019 and June 30, 2020.

March 31, 2019 Valuation

In connection with the March 31, 2019 valuation, the third-party valuation firm used a market approach. This approach measured the value of an asset or business through an analysis of recent sales or offerings of comparable investments or assets. When applied to the valuation of equity interests, consideration was given to the financial condition and operating performance of the entity being appraised relative to those of publicly traded entities operating in the same or similar lines of business, potentially subject to corresponding economic, environmental, and political factors and considered to be reasonable investment alternatives. The prior sales of company stock methodology (or backsolve method of the option pricing method (“the “OPM”)) of the market approach derived the implied equity value for a company from a recent transaction involving the company’s own securities. The basis for application of this method was transactions in equity securities of the enterprise with unrelated investors or among unrelated investors themselves.

Securities and Exchange Commission

CONFIDENTIAL TREATMENT REQUESTED

September 2, 2020

BY ATHIRA PHARMA, INC.: ATHA-0002

Page 4

The third-party valuation firm relied on the backsolve method for the March 31, 2019 valuation using the Company’s Series A convertible preferred stock financing. While the Series A round was originally priced in October 2015, the Company believed the transaction remained an appropriate indication of value at the time of the valuation as negotiations with the applicable outside institutional investors in arms-length transactions around this priced round occurred as late as October 24, 2017 and the Company received a follow-on investment at this same price per share in March 2018. Also, the Company used an equity adjustment in conjunction with the backsolve method to account for changes at the Company, in its industry, and in the economy as a whole since the price negotiations took place in October 2017 along with the additional capital which came in March 2018.

The equity values derived from the backsolve method were allocated to each of the Company’s classes of stock using the OPM. The OPM uses the preferred stockholders’ liquidation preferences, participation rights, dividend policy, and conversion rights to determine how proceeds from a liquidity event shall be distributed among the various ownership classes at a future date. The OPM uses the Black-Scholes option-pricing model to price the call options.  The OPM is appropriate to use when the range of possible outcomes is so difficult to predict that forecasts would be highly speculative, as was the case when the Company utilized this methodology.

The valuation was prepared on a minority, non-marketable interest basis using the equity value derived from an OPM backsolve method performed on the Company’s Series A convertible preferred stock issuance based on negotiations with the applicable outside institutional investors in arms-length transactions. The OPM backsolve method indicated an equity value of $29.1 million based on the offering price of $1.25 per share of Series A convertible preferred stock. This total equity value was subsequently adjusted to capture the value raised in additional Series A extensions following October 2017 and to reflect changes in the Company and industry between October 2017 and March 2019. Following the equity adjustment, the concluded equity value indication was $30.7 million. After the aggregate equity value was determined and allocated to the various classes of the Company’s capital stock, a discount for lack of marketability (“DLOM”) was applied to the estimated fair value of the Company’s common stock. A DLOM is applied based on the premise that a private company valuation analysis relies on data from publicly traded companies, which are marketable, and the common stock of a private company is not. In determining a DLOM, consideration was given to the financial performance and nature of the Company and its early-stage nature, sale/transfer restrictions associated with the Company’s common stock, the relative lack of voting power associated with the common stock in comparison to the preferred stock, and the inability to influence decisions regarding the Company, the Company’s dividend policy, and the significant holding period associated with the common stock, among other factors. The Company applied a DLOM of 45.0% and the fair value of the common stock was determined to be $0.17 per share as of March 31, 2019.

In early February 2020, the Company received an initial term sheet in connection with its anticipated Series B convertible preferred stock financing which suggested a pre-money valuation of $1.28 per share, only a $0.03 increase over the Series A convertible preferred stock price. With this arms-length third party valuation, the Company concluded there was not a material change in the valuation of its common stock as of the date of the receipt of such term sheet. Additionally, subsequent to receipt of the February 2020 term sheet and in response to market uncertainties related to the COVID-19 pandemic and declines in market prices of biotechnology stocks generally, the final terms of the financing were amended to provide for a per share Series B preferred stock price of $1.15 and 25% warrant coverage with respect to the Series B convertible preferred stock sold in the financing, with the per share exercise price equal to $0.01 per share.  Accordingly, the Company believes that no event occurred between the March 31, 2019 valuation and the first quarter 2020 option grants that resulted in an increase in value.

June 30, 2020 Valuation

In anticipation of making equity awards following the closing of the Series B financing, a third-party valuation analysis was conducted as of June 30, 2020 (with the valuation report issued on July 16, 2020);  however, no awards were made or will be made using this valuation. In connection with this June 30, 2020 valuation, the third-party valuation firm used both the backsolve method, which was used for a “stay private” scenario in the probability weighted expected return method (“PWERM”) using the Company’s Series B convertible preferred stock financing that was led by outside institutional investors in arms-length transactions and which occurred in May and June 2020, and a scenario-based method, which was used for the initial public offering scenario in the PWERM. The expected timing of the initial public offering and scenario weightings were based on management estimates.

Securities and Exchange Commission

CONFIDENTIAL TREATMENT REQUESTED

September 2, 2020

BY ATHIRA PHARMA, INC.: ATHA-0002

Page 5

The PWERM involved the estimation of future potential outcomes for a company, as well as values and probabilities associated with each respective potential outcome. This method is particularly useful when discrete future outcomes can be predicted at a high confidence level with a probability distribution. The common stock per share value determined using this approach is ultimately based upon probability-weighted per share values resulting from the various future s
2020-08-26 - CORRESP - LeonaBio, Inc.
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Wilson Sonsini Goodrich & Rosati

Professional Corporation

701 Fifth Avenue

Suite 5100

Seattle, Washington 98104-7036

o: 206.883.2500

f: 206.883.2699

August 26, 2020

Via EDGAR and Courier

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549

Attention:

Michael Fay

Daniel Gordon

Deanna Virginio

Ada D. Sarmento

Re:

Athira Pharma, Inc.

Draft Registration Statement on Form S-1

Submitted July 24, 2020

CIK No. 0001620463

Ladies and Gentlemen:

On behalf of our client, Athira Pharma, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated August 20, 2020, relating to the above-referenced Draft Registration Statement on Form S‑1 (the “Draft Registration Statement”).  On behalf of the Company, we are concurrently publicly filing via EDGAR a revised draft of the Registration Statement (the “Registration Statement”).

In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response.  Except for page references appearing in the headings and Staff comments below (which are references to the Draft Registration Statement), all page references herein correspond to the pages of the Registration Statement.

Prospectus Summary
Overview, page 1

1.

We note statements throughout the prospectus that imply efficacy, such as "[n]onclinical studies and Phase 1 clinical trials with ATH-1017 demonstrated improvements in brain network activity indicating positive effects on brain function," "multiple dosing of ATH-1017 significantly improved brain activity" in AD subjects, ATH-1017 "normalized the P300 latency of AD subjects in a Phase lb clinical trial," "data indicate ATH-1017 treatment has recovered disruptions to brain function and network connectivity, likely through several components of the mechanism, including NMDA receptor modulation, increased connectivity through recovery of synaptic density, and overall improvement in neuronal health and function," and a large magnitude improvement in P300 latency that was observed for ATH-1017 is "expected to produce a correlated cognitive improvement." These are just examples. Please revise your disclosure throughout your prospectus to revise these and similar statements to eliminate conclusions or predictions that your product candidates are or will be effective as determinations of efficacy are solely within the authority of the FDA. You may provide a summary of the

austin        beijing        boston        brussels        hong kong        london        los angeles        new york        palo alto
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Securities and Exchange Commission

August 26, 2020

Page 2

objective data from your trials in the Business section where full and proper context can be provided without including conclusions related to efficacy.

In response to the Staff’s comment, the Company has revised its disclosures on pages 1, 4, 88 and 128 of the Registration Statement. With respect to the other above referenced statements, the Company respectfully submits that they are not statements that imply efficacy, but are rather factual descriptions of qEEG and P300 latency results from the Phase 1 trial. For example, on page 1 of the Registration Statement, the Company states “Nonclinical studies and Phase 1 clinical trials with ATH-1017 demonstrated improvements in brain network activity indicating potentially positive effects on brain function. In the AD subjects, multiple dosing of ATH-1017 significantly improved brain activity as measured by P300 latency, a functional measure that is highly correlated with cognition.” We respectfully submit that the second sentence of this disclosure, as revised, adequately clarifies that the improvements in brain network activity are based on the measurements of P300 latency, and not a conclusion as to the efficacy of ATH-1017.

P300 latency is a well-established objective measure that reflects the cognitive state, and is prolonged in patients with cognitive impairment such as AD. The P300 signal is generated by a neuronal network across several brain regions as cognitive processing occurs. Disruptions to neuronal health and synaptic function lead to disruptions in the network and result in prolonged (or worsening) P300 latencies and reduced cognitive processing in AD and other dementing conditions. Our data demonstrate an improvement in the prolonged P300 latencies in AD patients upon ATH-1017 treatment, suggesting that treatment improved brain function (cognitive processing) because the direction of change was towards historically established P300 latency values for healthy individuals. Similar to P300 latency, qEEG measures, which are generated by synchronous neuronal activity across networks, are also disrupted in AD patients due to impaired brain function and AD patients display reduced gamma power. Our data demonstrate an increase in gamma power, suggesting an improvement in the ability of the neuronal networks to generate gamma waves in patients with reduced gamma activity.

2.

We note your disclosure in this section and in the Business section that you plan to initiate a "pivotal" Phase 2/3 clinical trial for ATH-1017, LIFT-AD. We also note your statement on page 129 that LIFT-AD will need to achieve a statistically significant improvement separately on both the ADAS-Cog-11 and ADCS-CGIC in order to be considered a pivotal trial supportive of FDA approval for mild to moderate AD. Please revise the disclosure in these sections to make it clear that even if you receive positive data from LIFT-AD, you cannot be certain that the FDA or other regulators will find such data sufficient for approval of ATH-1017 or will not require you to conduct additional trials. Please also expand your disclosure to briefly explain what ADAS-cog, ADAS-cog-11 and ADCS-CGIC stand for the first time that each term is used in the prospectus.

In response to the Staff’s comment, the Company has revised its disclosures on pages 5 and 131 of the Registration Statement, as well as on pages 8, 120, 131 and elsewhere.

Our Pipeline and ATH Platform, page 3

3.

We note that you have included in your pipeline table ATH-1019, ATH-1018 and ATH-Discovery, all of which are in the discovery phase. Given the early-stage development of these programs, please explain why each program is sufficiently material to your business to warrant inclusion in your pipeline table. Please also remove the shaded portions of the lines in your pipeline table so that your pipeline table accurately reflects the current stage of development for each indication for ATH-1017 and remove the second line for the AD indication. Please clarify in footnote 3 whether you have already filed an IND for ATH-1017 for the treatment of PDD. Given that you have not yet initiated Phase 3 clinical trials for any of your product candidates, please also revise your statement that you are a "late" clinical-stage biopharmaceutical company throughout the prospectus.

Securities and Exchange Commission

August 26, 2020

Page 3

In response to the Staff’s comment, the Company has revised its pipeline table and related disclosures on pages 3, 89, and 108 of the Registration Statement to remove the reference to ATH-Discovery, the shaded portions of the lines in the table, and the second line for the AD indication and to add clarifying disclosure regarding ATH-1017 for the treatment of PDD. We respectfully advise the Staff that ATH-1018 and ATH-1019 have progressed beyond discovery phase. ATH-1018 and ATH-1019 are lead compounds that have been identified through rigorous screening efforts in which they have demonstrated the ability to significantly activate the target HGF/MET system, and have displayed desired drug-like characteristics including oral bioavailability, stability, and optimized pharmacokinetics. They have shown positive effects in relevant preclinical models, indicating in vivo activity. ATH-1018 and ATH-1019 are advancing to additional in vivo testing towards INDs. In addition, we would draw the Staff’s attention to page 78 of the Registration Statement where the Company intends to disclose that a significant portion of the use of proceeds from the offering contemplated by the Registration Statement will be dedicated to development activities related to ATH-1018 and ATH-1019. We respectfully submit that each program is material to the Company’s business and an investor’s understanding of the Company’s prospects and therefore warrants inclusion in the pipeline table. In addition, we respectfully submit that the description of the Company as a “late” clinical stage biopharmaceutical company is appropriate. It is common practice for a biopharmaceutical company that has initiated a clinical trial that may be sufficient to support approval to be referred to as “late” clinical stage. Based on its discussions with the U.S. Food and Drug Administration, the results of the LIFT-AD trial could potentially support the approval of ATH-1017, if the trial results provide evidence that ATH-1017 is both effective and safe for the proposed indication. The Company expects to initiate the Phase 2/3 LIFT-AD clinical trial in early September and anticipates including disclosure to that effect in a future amendment to the Registration Statement.

Our Strategy, page 5

4.

We note your disclosure here and in the Business section that your strategy is to "rapidly advance" ATH-1017 through clinical development for AD and to initiate two clinical trials for AD by the end of 2020 in order to "accelerate [y]our development timelines." Please revise this disclosure to remove any implication that you will be successful in commercializing your product candidates in a rapid or accelerated manner as such statements are speculative. In this regard, we note your disclosure that your product candidates are based on new approaches and novel technology, which makes it difficult to predict the time and cost of product candidate development and the regulatory approval process.

In response to the Staff’s comment, the Company has revised its disclosures on pages 5 and 108 of the Registration Statement.

Implications of being an emerging growth company, page 10

5.

Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications.

In response to the Staff’s comment, we have provided the Staff with all written communications presented to potential investors in reliance on Section 5(d) of the Securities Act on a supplemental basis by letter of even date herewith. These materials are only being made available for viewing by potential investors during the Company’s presentations, and no copies are being retained by any potential investor.

To the extent the Company conducts additional meetings, it expects to use the same or similar materials, and the Company undertakes to provide the Staff with copies of any additional written communications that are presented to potential investors in the future by it or anyone authorized to do so on its behalf in reliance on Section 5(d) of the Securities Act of 1933, as amended, whether or not such potential investors retain copies of such communications.

Securities and Exchange Commission

August 26, 2020

Page 4

Risk Factors
Our development of ATH-1017 may never lead to a marketable product, page 21

6.

We note your disclosure that you are developing ATH-1017 as a "first-in-class" small molecule aimed at restoring neuronal health. This term suggests that the product candidate is effective and likely to be approved. Accordingly, please delete this reference.

In response to the Staff’s comment, the Company has revised its disclosure on page 20 of the Registration Statement.

Our approach to targeting brain growth factors through the use of small molecules is based on a novel therapeutic approach, page 22

7.

We note your disclosure here that data from certain subjects in your Phase la and lb clinical trials were not obtained due to problems encountered with the placement of the EEG electrodes. Please revise your discussion of these trials throughout the prospectus to disclose this and to state, if true, that your trial descriptions are not representative of all trial participants. Please also disclose how many subjects were impacted and in which patient populations.

In response to the Staff’s comment, the Company has revised its disclosures on pages 21 and 126 of the Registration Statement.

Market, Industry and Other Data, page 77

8.

Your statements cautioning investors not to give "undue weight" to estimates, projections and other information concerning market, industry and other data as well as your statements that such information is "inherently imprecise" implies a disclaimer of responsibility with respect to the third party information. Please revise these statements to eliminate any implication that investors are not entitled to rely on the information included in your registration statement.

In response to the Staff’s comment, the Company has revised its disclosure on page 77 of the Registration Statement.

Our Differentiated Approach, page 114

9.

Please revise to provide legible graphics on page 114. We note that the text accompanying the pictures is illegible.

In response to the Staff’s comment, the Company has revised its graphics on pages 115 and 116 of the Registration Statement.

Figure 12. ATH-1017 Had a Large and Rapid Effect on P300 Latency in AD Subjects, page 120

10.

We refer to your graphics comparing your P300 latency results to results observed after treatment with approved therapies Donepezil and Rivastigmine. Since you have not conducted head to head trials, please revise your disclosure to clearly state this fact and disclose why you believe this comparison is appropriate. If you provide disclosure regarding results from other trials, expand your disclosure to provide the other information regarding these trials that would help an investor make a meaningful comparison (e.g., number of patients, dosage, how the baseline was measured in each study, etc.).

Securities and Exchange Commission

August 26, 2020

Page 5

In response to the Staff’s comment, the Company has revised its disclosure on pages 122 and 123 of the Registration Statement.

Event-related Potential, page 125

11.

Please provide support for your statement that "the sustained effects on P300 latency observed in the pre-dose recordings on subsequent testing days . . . most likely reflect the long-term regeneration of neuronal connections and the improvement in brain function."

In response to the Staff’s comment, we are providing the requested support on a supplemental basis by letter of even date herewith.

Our Neuropsychiatric Program (ATH-1019), page 131

12.

We note your statement that ATH-1019 "has been shown to activate the HGF/MET system, and distribute to the CNS, and is neuroactive in animal models." Please provide the data that you used to make this conclusion.

In response to the Staff’s comment, we are providing the requested support on a supplemental basis by letter of even date herewith.

Our Collaboration and Grant Agreements
Washington State University Research Foundation License Agreement and Amended and Restated Washington State University License Agreement, page 137

13.

Please disclose the royalty term and termination provisions for the amended and restated license agreement and file the agreement as an exhib
2020-08-21 - UPLOAD - LeonaBio, Inc.
United States securities and exchange commission logo
August 20, 2020
Leen Kawas, Ph.D.
Chief Executive Officer
Athira Pharma, Inc.
4000 Mason Road, Suite 300
Seattle, WA 98195
Re:Athira Pharma, Inc.
Draft Registration Statement on Form S-1
Submitted July 24, 2020
CIK No. 0001620463
Dear Dr. Kawas:
            We have reviewed your draft registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.We note statements throughout the prospectus that imply efficacy, such as "[n]onclinical
studies and Phase 1 clinical trials with ATH-1017 demonstrated improvements in brain
network activity indicating positive effects on brain function," "multiple dosing of ATH-
1017 significantly improved brain activity" in AD subjects, ATH-1017 "normalized the
P300 latency of AD subjects in a Phase 1b clinical trial," "data indicate ATH-1017
treatment has recovered disruptions to brain function and network connectivity, likely
through several components of the mechanism, including NMDA receptor modulation,
increased connectivity through recovery of synaptic density, and overall improvement in

 FirstName LastNameLeen Kawas, Ph.D.
 Comapany NameAthira Pharma, Inc.
 August 20, 2020 Page 2
 FirstName LastNameLeen Kawas, Ph.D.
Athira Pharma, Inc.
August 20, 2020
Page 2
neuronal health and function," and a large magnitude improvement in P300 latency that
was observed for ATH-1017 is "expected to produce a correlated cognitive
improvement." These are just examples. Please revise your disclosure throughout your
prospectus to revise these and similar statements to eliminate conclusions or predictions
that your product candidates are or will be effective as determinations of efficacy are
solely within the authority of the FDA. You may provide a summary of the objective data
from your trials in the Business section where full and proper context can be provided
without including conclusions related to efficacy.
2.We note your disclosure in this section and in the Business section that you plan to initiate
a "pivotal" Phase 2/3 clinical trial for ATH-1017, LIFT-AD. We also note your statement
on page 129 that LIFT-AD will need to achieve a statistically significant improvement
separately on both the ADAS-Cog-11 and ADCS-CGIC in order to be considered a
pivotal trial supportive of FDA approval for mild to moderate AD. Please revise the
disclosure in these sections to make it clear that even if you receive positive data from
LIFT-AD, you cannot be certain that the FDA or other regulators will find such data
sufficient for approval of ATH-1017 or will not require you to conduct additional trials.
Please also expand your disclosure to briefly explain what ADAS-cog, ADAS-cog-11 and
ADCS-CGIC stand for the first time that each term is used in the prospectus.
Our Pipeline and ATH Platform, page 3
3.We note that you have included in your pipeline table ATH-1019, ATH-1018 and ATH-
Discovery, all of which are in the discovery phase. Given the early-stage development of
these programs, please explain why each program is sufficiently material to your business
to warrant inclusion in your pipeline table. Please also remove the shaded portions of the
lines in your pipeline table so that your pipeline table accurately reflects the current stage
of development for each indication for ATH-1017 and remove the second line for the AD
indication. Please clarify in footnote 3 whether you have already filed an IND for ATH-
1017 for the treatment of PDD. Given that you have not yet initiated Phase 3 clinical trials
for any of your product candidates, please also revise your statement that you are a "late"
clinical-stage biopharmaceutical company throughout the prospectus.
Our Strategy, page 5
4.We note your disclosure here and in the Business section that your strategy is to "rapidly
advance" ATH-1017 through clinical development for AD and to initiate two clinical
trials for AD by the end of 2020 in order to "accelerate [y]our development timelines."
Please revise this disclosure to remove any implication that you will be successful in
commercializing your product candidates in a rapid or accelerated manner as such
statements are speculative. In this regard, we note your disclosure that your product
candidates are based on new approaches and novel technology, which makes it difficult to
predict the time and cost of product candidate development and the regulatory approval
process.

 FirstName LastNameLeen Kawas, Ph.D.
 Comapany NameAthira Pharma, Inc.
 August 20, 2020 Page 3
 FirstName LastNameLeen Kawas, Ph.D.
Athira Pharma, Inc.
August 20, 2020
Page 3
Implications of being an emerging growth company, page 10
5.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Risk Factors
Our development of ATH-1017 may never lead to a marketable product, page 21
6.We note your disclosure that you are developing ATH-1017 as a "first-in-class" small
molecule aimed at restoring neuronal health. This term suggests that the product candidate
is effective and likely to be approved. Accordingly, please delete this reference.
Our approach to targeting brain growth factors through the use of small molecules is based on a
novel therapeutic approach, page 22
7.We note your disclosure here that data from certain subjects in your Phase 1a and 1b
clinical trials were not obtained due to problems encountered with the placement of the
EEG electrodes.  Please revise your discussion of these trials throughout the prospectus to
disclose this and to state, if true, that your trial descriptions are not representative of all
trial participants.  Please also disclose how many subjects were impacted and in which
patient populations.
Market, Industry and Other Data, page 77
8.Your statements cautioning investors not to give "undue weight" to estimates, projections
and other information concerning market, industry and other data as well as your
statements that such information is "inherently imprecise" implies a disclaimer of
responsibility with respect to the third party information.  Please revise these statements to
eliminate any implication that investors are not entitled to rely on the information included
in your registration statement.
Our Differentiated Approach, page 114
9.Please revise to provide legible graphics on page 114. We note that the text accompanying
the pictures is illegible.
Figure 12. ATH-1017 Had a Large and Rapid Effect on P300 Latency in AD Subjects, page 120
10.We refer to your graphics comparing your P300 latency results to results observed after
treatment with approved therapies Donepezil and Rivastigmine. Since you have not
conducted head to head trials, please revise your disclosure to clearly state this fact and
disclose why you believe this comparison is appropriate. If you provide disclosure
regarding results from other trials, expand your disclosure to provide the other information
regarding these trials that would help an investor make a meaningful comparison (e.g,

 FirstName LastNameLeen Kawas, Ph.D.
 Comapany NameAthira Pharma, Inc.
 August 20, 2020 Page 4
 FirstName LastNameLeen Kawas, Ph.D.
Athira Pharma, Inc.
August 20, 2020
Page 4
number of patients, dosage, how the baseline was measured in each study, etc.).
Event-related Potential, page 125
11.Please provide support for your statement that "the sustained effects on P300 latency
observed in the pre-dose recordings on subsequent testing days . . . most likely reflect the
long-term regeneration of neuronal connections and the improvement in brain function."
Our Neuropsychiatric Program (ATH-1019), page 131
12.We note your statement that ATH-1019 "has been shown to activate the HGF/MET
system, and distribute to the CNS, and is neuroactive in animal models." Please provide
the data that you used to make this conclusion.
Our Collaboration and Grant Agreements
Washington State University Research Foundation License Agreement and Amended and
Restated Washington State University License Agreement, page 137
13.Please disclose the royalty term and termination provisions for the amended and restated
license agreement and file the agreement as an exhibit or explain the basis for your
determination that it is not required to be filed. We also note that your licensed patents
under this agreement include WSU’s rights to a patent jointly owned with Pacific
Northwest Biotechnology, Inc. Please discuss whether you expect this joint ownership to
have any effect on your license of the patent or your development of the product candidate
to which the patent relates.
Principal Stockholders, page 174
14.Please revise your disclosure to identify the natural person or persons who have voting
and investment control of the shares held by the entities affiliated with RTW Master Fund,
Ltd., Viking Global Opportunities Illiquidity Investments Sub-Master LP and the entities
affiliated with Franklin Templeton Investments. Please also revise your disclosure to
identify the natural person or persons who share, along with Mr. Edelman, voting and
dispositive power over the shares held by Perceptive Life Sciences Master Fund Ltd.
Financial Statements
Notes to Financial Statements
7. Significant Agreements, page F-15
15.Please clarify how you determined that the grant liability is an eligible item under ASC
825-10-15-4.  If applicable, describe how the grant liability meets the definition of a
financial liability.
            You may contact Michael Fay at 202-551-3812 or Daniel Gordon at 202-551-3486 if you
have questions regarding comments on the financial statements and related matters.  Please
contact Deanna Virginio at 202-551-4530 or Ada D. Sarmento at 202-551-3798 with any other

 FirstName LastNameLeen Kawas, Ph.D.
 Comapany NameAthira Pharma, Inc.
 August 20, 2020 Page 5
 FirstName LastName
Leen Kawas, Ph.D.
Athira Pharma, Inc.
August 20, 2020
Page 5
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Michael Nordtvedt, Esq.

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