# EDGAR Filing Document

**Accession Number:** 0001454789
**File Stem:** 0001104659-25-074530
**Filing Date:** 2025-8
**Character Count:** 23269
**Document Hash:** cb0f578ed9a3f54264fc07e9e3ab8d93
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-074530.hdr.sgml**: 20250806

**ACCESSION NUMBER**: 0001104659-25-074530

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250806

**ITEM INFORMATION**: Entry into a Material Definitive Agreement

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250806

**DATE AS OF CHANGE**: 20250806

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Astria Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001454789
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37467
- **FILM NUMBER:** 251187568

**BUSINESS ADDRESS:**
- **STREET 1:** 22 BOSTON WHARF ROAD
- **STREET 2:** 10TH FLOOR
- **CITY:** BOSTON
- **STATE:** MA
- **ZIP:** 02210
- **BUSINESS PHONE:** 617-349-1971

**MAIL ADDRESS:**
- **STREET 1:** 22 BOSTON WHARF ROAD
- **STREET 2:** 10TH FLOOR
- **CITY:** BOSTON
- **STATE:** MA
- **ZIP:** 02210

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** CATABASIS PHARMACEUTICALS INC
- **DATE OF NAME CHANGE:** 20090127

?xml version='1.0' encoding='ASCII'?

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION** 

**WASHINGTON, DC 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of report (Date of earliest event reported): August 6, 2025**

**Astria Therapeutics, Inc.**

**(Exact Name of Registrant as Specified in Charter)**

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| | | |
|:---|:---|:---|
| **Delaware** | **001-37467** | **26-3687168** |
| **(State or Other Jurisdiction**<br> **of Incorporation)** | **(Commission File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

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| | |
|:---|:---|
| **22 Boston Wharf Road**<br> **10th Floor** |  |
| **Boston** **, Massachusetts** | **02210** |
| **(Address of Principal Executive Offices)** | **(Zip Code)** |

---

Registrant's telephone number, including area code: **(617) 349-1971**

**(Former Name or Former Address, if Changed Since Last Report)**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (*see* General Instruction A.2. below):

◻ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

◻ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

◻ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

◻ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| Title of each class | Trading <br> Symbol(s) | Name of each exchange on which registered |
| **Common Stock, par value $0.001 per share** | **ATXS** | **The Nasdaq Stock Market LLC** |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ◻

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

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| | |
|:---|:---|
| **Item 1.01** | **Entry into a Material Definitive Agreement.** |

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On August 6, 2025, Astria Therapeutics, Inc. (the "Company") entered into a license agreement (the "License Agreement") with Kaken Pharmaceutical, Co., Ltd. ("Kaken"), pursuant to which the Company granted an exclusive license under certain patent rights and know-how controlled by the Company for Kaken to develop, package, and commercialize navenibart, a long-acting investigational monoclonal antibody inhibitor of plasma kallikrein (the "Licensed Product"), for the prevention of hereditary angioedema ("HAE") attacks in humans (the "Field") in Japan.

Under the terms of the License Agreement, the Company will receive an upfront payment of $16.0 million, with a potential for an additional $16.0 million in total commercialization and sales milestones. In addition to these payments, on a Licensed Product-by-Licensed Product basis, the Company is eligible for tiered royalties, with the royalty rate as a percentage of net sales from the mid-teens to 30%. Kaken's royalty payment obligations commence on the first commercial sale of each Licensed Product in Japan and continue until the latest of (i) the expiration of the last to expire valid claim of specified Company patents rights covering such Licensed Product in Japan, (ii) the expiration of the last to expire regulatory exclusivity with respect to such Licensed Product in Japan, and (iii) ten (10) years following the first commercial sale of such Licensed Product in Japan (each such term with respect to a Licensed Product, the "Royalty Term"). Pursuant to the terms of the License Agreement, Kaken will also provide support for the Company's ALPHA-ORBIT Phase 3 trial in Japan, be responsible for regulatory submissions in Japan, and reimburse the Company for a portion of the costs of the navenibart Phase 3 program. Kaken is obligated to use commercially reasonable efforts to obtain regulatory approval and reimbursement approval for, and commercialize, at least one Licensed Product in the Field in Japan.

In the event the Company develops the Licensed Product for an indication outside the Field, the Company has granted Kaken a right of first negotiation with respect to commercialization rights in Japan for the Licensed Product for such indication outside the Field.

Pursuant to the License Agreement, the parties agreed to establish a joint steering committee to provide oversight of the parties' activities under the Agreement.

Unless earlier terminated, the License Agreement will expire on the expiration of the last-to-expire Royalty Term. The License Agreement may be terminated by either party for the other party's uncured material breach, insolvency or bankruptcy. Additionally, Kaken may terminate the License Agreement upon 30 days' notice for a material safety issue, or at its convenience with 90 days' notice.

The foregoing description of the terms of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement.

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| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.** |

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On August 6, 2025, the Company issued a press release (the "Press Release") announcing, among other things, the entry into the License Agreement and the license of commercialization rights for navenibart in Japan to Kaken. The Press Release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.

The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

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| | |
|:---|:---|
| **Item 8.01.** | **Other Events.** |

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The Company expects that its cash, cash equivalents and short-term investments as of June 30, 2025, together with the Kaken upfront payment and expected reimbursement of a portion of the Company's Phase 3 program costs, will be sufficient to fund its current operating plan into 2028. The Company's current operating plan includes (i) for navenibart, support for all program activities through completion of our ALPHA-ORBIT Phase 3 trial, including activities related to the planned ORBIT-EXPANSE long-term trial and Phase 3 development and testing of drug device combinations, and (ii) for STAR-0310, the completion of the ongoing Phase 1a clinical trial of healthy subjects. Advancing the development of navenibart, any drug device combination for navenibart, STAR-0310 or any future product candidates will require a significant amount of capital, and the Company's existing cash, cash equivalents and short-term investments, together with the Kaken upfront and expected cost reimbursements from Kaken, will not be sufficient to enable the Company to fund the completion of development of any of its product candidates, including navenibart, any drug device combination for navenibart, STAR-0310 or any future product candidate. The Company will need to obtain substantial additional funding to complete the development and commercialization of navenibart, any drug device combination for navenibart, STAR-0310 or any future product candidates and support its continuing operations, future clinical trials and expansion of its pipeline.

*Cautionary Note Regarding Forward Looking Statements*

 

Any statements in this Current Report on Form 8-K about future expectations, plans and prospects for the Company, including statements about the Company's current operating plan and the Company's anticipated cash runway, among other things, statements containing the words "believes," "anticipates," "plans," "expects," "may" and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation and completion of clinical trials and clinical development of the Company's product candidates, including navenibart and STAR-0310; expectations for regulatory approvals to conduct trials or to market products; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements, including commercialization of navenibart if regulatory approval is obtained; other matters that could affect the availability or commercial potential of the Company's product candidates; and general economic and market conditions and other factors discussed in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, each as filed with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. In addition, the forward-looking statements included in this Current Report on Form 8-K represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

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(d) Exhibits

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| | |
|:---|:---|
| **Exhibit Number** | **Description of Exhibit** |
| [99.1](tm2522358d1_ex99-1.htm) | [Press Release, dated August 6, 2025](tm2522358d1_ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **ASTRIA THERAPEUTICS, INC.** | **ASTRIA THERAPEUTICS, INC.** |
| Date: August 6, 2025 | By: | /s/ Ben Harshbarger |
|  |  | Ben Harshbarger |
|  |  | Chief Legal Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](tm2522358d1_ex99-1img001.jpg)

**Astria Therapeutics Enters into Licensing Agreement with Kaken Pharmaceutical to Develop and Commercialize Navenibart for HAE in Japan**

*-- Up to $32 Million in Upfront and Milestone Payments, Plus Royalties --*

*-- Kaken Expertise in Commercializing Innovative Therapies Supports Navenibart's Potential to be First-Choice HAE Treatment in Japan --*

*-- Updated Cash Runway Supports the Company's Operating Plan Into 2028 --*

**BOSTON, Mass., August 6, 2025 –** <u>Astria Therapeutics, Inc.</u> (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that it has exclusively licensed development and commercialization rights in Japan to Kaken Pharmaceutical, Co., Ltd., a Japanese specialty pharmaceutical company, for navenibart, a long-acting investigational monoclonal antibody inhibitor of plasma kallikrein, in Phase 3 development for the preventative treatment of hereditary angioedema (HAE). Under the agreement, Astria will receive an upfront payment of $16 million, with the potential for an additional $16 million in total commercialization and sales milestones. In addition to these payments, Astria is also eligible for tiered royalties with the royalty rate as a percentage of net sales up to 30%, and partial Phase 3 cost reimbursement.

"We are thrilled to partner with Kaken for the development and commercialization of navenibart in Japan, which advances our strategy to enable broad access to navenibart globally," said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. "In addition to our shared values that put patients first, Kaken brings strong relationships with the Japanese medical community that we believe will support both our Phase 3 ALPHA-ORBIT trial as well as the potential commercialization of navenibart in the future."

"Our partnership with Astria for the development and commercialization of navenibart supports our strategy of providing therapies that address unmet medical needs in the Japanese community," said Hiroyuki Horiuchi, President and Representative Director of Kaken. "We believe that navenibart is a complementary fit with our HAE portfolio, providing patients in Japan with the potential for low-burden treatments to better manage their disease."

"As a physician that treats people with HAE, I am incredibly excited about the potential of a preventative therapy with navenibart's profile," said Dr. Michihiro Hide, President, Hiroshima City Hospital Organization. "I believe that navenibart could have a significant impact on the lives of HAE patients in Japan where people living with HAE are seeking options that allow them to be protected from their HAE attacks with very low treatment burden."

Kaken will also provide support for the ALPHA-ORBIT Phase 3 trial in Japan, be responsible for regulatory submissions in Japan, and will reimburse Astria for a portion of the costs of the navenibart Phase 3 program.

Including the upfront payment from Kaken and the expected reimbursement by Kaken of a portion of the Company's Phase 3 program costs, the Company expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2028.

**About Navenibart:**

Navenibart is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Our goal with navenibart is to provide rapid and sustained HAE attack prevention with a validated mechanism and trusted modality administered subcutaneously every 3 and 6 months. We aim to empower people living with HAE to live life without limitations from their disease.

**About Astria Therapeutics**:

Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by allergic and immunologic diseases. Our lead program, navenibart (STAR-0215), is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Our second program, STAR-0310, is a monoclonal antibody OX40 antagonist in clinical development for the treatment of atopic dermatitis. Learn more about our company on our website, <u>www.astriatx.com</u>, or follow us on Instagram @AstriaTx and on Facebook and LinkedIn.

**About Kaken Pharmaceutical, Co., Ltd.**:

Kaken Pharmaceutical is a specialty pharmaceutical company in Japan with strong experience in developing and commercializing novel pharmaceuticals in the fields of orthopedics and dermatology. Kaken concentrates its R&D resources in areas such as immune system, nervous system, infectious diseases, and rare diseases with unmet medical needs. Kaken, in its philosophy, strives to improve the quality of life of patients through the development and distribution of superior pharmaceuticals. For further information, visit <u>www.kaken.co.jp/english</u>.

**Forward Looking Statements:**

This press release contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: the goals and objectives of the ALPHA-ORBIT trial; the potential therapeutic benefits of navenibart as a treatment for HAE; the potential attributes and profile of navenibart as a treatment for HAE, including its potential to be a life-changing, market leading preventative treatment for HAE, and our overall vision and goals for the navenibart program; our corporate strategy and vision, including our mission is to bring life-changing therapies to patients and families affected by allergic and immunologic diseases; and statements about the Company's current operating plan and cash runway. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "goals," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," "would," or "vision," and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Astria's current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, future financial performance, results of pre-clinical and clinical results of the Astria's product candidates and other future conditions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties related to: changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business, and/or competitive factors; risks inherent in pharmaceutical research and development, such as: adverse results in our drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies may not be replicated in clinical trials, that the preliminary, initial or interim results from clinical trials may not be indicative of the final results, that the results of early stage clinical trials, such as the results from the ALPHA-STAR Phase 1b/2 clinical trial, may not be replicated in later stage clinical trials, such as the planned Phase 3 development program, the risk that we may not be able to enroll sufficient patients in our clinical trials on a timely basis, and the risk that any of our clinical trials may not commence, continue or be completed on time, or at all; decisions made by, and feedback received from, the U.S. Food and Drug Administration and other regulatory authorities on our regulatory and clinical trial submissions and other feedback from potential clinical trial sites, including investigational review boards at such sites, and other review bodies with respect to navenibart, STAR-0310, and any other future development candidates; our ability to manufacture sufficient quantities of drug substance and drug product for navenibart, STAR-0310, and any other future product candidates on a cost-effective and timely basis, and to develop dosages and formulations for navenibart, STAR-0310, and any other future product candidates that are patient-friendly and competitive; our ability to develop biomarker and other assays, along with the testing protocols therefor; our ability to obtain, maintain and enforce intellectual property rights for navenibart, STAR-0310 and any other future product candidates; our potential dependence on collaboration partners; competition with respect to navenibart, STAR-0310, or any of our other future product candidates; the risk that survey results, modeling data and market research may not be accurate predictors of the commercial landscape for HAE, the ability of navenibart to compete in HAE and the anticipated position and attributes of navenibart in HAE based on clinical data to date, its preclinical profile, pharmacokinetic modeling, market research and other data; risks that any of our clinical trials of STAR-0310 may not commence, continue or be completed on time, or at all; risks that results of preclinical studies of STAR-0310 will not be replicated in clinical trials; our ability to manage our cash usage and the possibility of unexpected cash expenditures; our ability to obtain necessary financing to conduct our planned activities, including the costs associated with commercializing navenibart if regulatory approval is obtained, and to manage unplanned cash requirements; the risks and uncertainties related to our ability to recognize the benefits of any additional acquisitions, licenses or similar transactions; and general economic and market conditions; as well as the risks and uncertainties discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the period ended December 31, 2024 and in other filings that we may make with the Securities and Exchange Commission. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Astria may not actually achieve the forecasts or expectations disclosed in our forward-looking statements, and investors and potential investors should not place undue reliance on Astria's forward-looking statements.

Neither Astria, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Astria's views as of any date subsequent to the date hereof.

###

<u>Astria Contact:</u> 

**Investor Relations and Media:**

Elizabeth Higgins

<u>investors@astriatx.com</u>