Amylyx (NASDAQ: AMLX) advances AMX0318 for rare hypoglycemia treatment

Rhea-AI Filing Summary

Amylyx Pharmaceuticals reported that it has selected AMX0318, a long-acting GLP-1 receptor antagonist, as a new development candidate for treating post-bariatric hypoglycemia and other rare diseases. AMX0318 was discovered through a research collaboration with Gubra A/S, which specializes in peptide-based drug discovery and preclinical research.

Under this collaboration, Gubra is eligible to receive more than $50 million in success-based development and commercialization milestone payments, plus mid-single digit royalties on worldwide net sales if AMX0318 progresses successfully. The selection and handover of the development candidate immediately triggers $4 million in milestone payments to Gubra.

Amylyx also updated its corporate presentation for use with investors and analysts, furnishing the new presentation as Exhibit 99.1.

Insights

Biotech pipeline and partnerships analyst

Amylyx adds AMX0318 to its pipeline under a milestone- and royalty-based deal with Gubra.

The update shows Amylyx advancing AMX0318, a long-acting GLP-1 receptor antagonist, into formal development for post-bariatric hypoglycemia and other rare diseases. This expands the company’s pipeline beyond its existing programs and targets a specialized metabolic complication after bariatric surgery, which may have limited but focused patient populations.

Financially, the economics are heavily milestone-based. Gubra can receive more than $50 million in development and commercialization milestones, along with mid-single digit royalties on worldwide net sales. The development candidate selection and handover trigger an immediate $4 million payment to Gubra, indicating near-term cash outflow but aligning most costs with future progress.

The collaboration structure places execution risk primarily on whether AMX0318 can successfully clear IND-enabling work, obtain regulatory clearance, and generate meaningful clinical data. The furnished corporate presentation (Exhibit 99.1) is intended to provide additional context on the program and broader strategy, while forward-looking statements language highlights typical biotech uncertainties around timelines, funding needs, and the possibility that early-stage results may differ from later-stage outcomes.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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): January 8, 2026

AMYLYX PHARMACEUTICALS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-41199		46-4600503
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

55 Cambridge Parkway, Suite 6W,
Cambridge, MA		02142
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 682-0917

43 Thorndike St.,

Cambridge, MA 02141

(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:

☐ 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:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		AMLX		Nasdaq Global Select Market

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. ☐

Item 8.01 Other Events

On January 8, 2026, Amylyx Pharmaceuticals, Inc. (the “Company”) announced the selection of AMX0318, a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, as a development candidate for post-bariatric hypoglycemia and other rare diseases. AMX0318 was identified through a research collaboration with Gubra A/S (“Gubra”), a company specializing in peptide-based drug discovery and preclinical contract research services.

Under the terms of the research collaboration, Gubra is eligible to receive more than $50 million in success-based development and commercialization milestones plus mid-single digit royalties on worldwide net sales. The selection and handover of the development candidate will provide milestone payments of $4 million to Gubra.

Item 7.01 Regulation FD Disclosure

On January 8, 2026, the Company updated its corporate presentation for use in meetings with investors, analysts and others from time to time. A copy of the presentation is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 7.01. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.

The information in Item 7.01 of this Current Report on Form 8-K and in Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any filing by the Company, under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Forward-Looking Statements

Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Amylyx’ expectations regarding: the therapeutic potential for AMX0318, the expected timeline for the IND-enabling studies and IND submission for AMX0318, the payments and royalties to be received by Gubra, and the expected timeline for certain development, regulatory, and commercial milestones. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx’ program development activities; Amylyx’ ability to execute on its regulatory development plans and expectations regarding the timing of results from its planned data announcements and initiation of clinical studies; the risk that early-stage results may not reflect later-stage results; Amylyx’ ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx’ operations, as well as the risks and uncertainties set forth in Amylyx’ United States Securities and Exchange Commission (SEC) filings, including Amylyx’ Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

Exhibit Number		Description
99.1		Corporate Presentation, furnished herewith.
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.

				AMYLYX PHARMACEUTICALS, INC.
Date: January 8, 2026				By:		/s/ James M. Frates
						James M. Frates
						Chief Financial Officer

FAQ

What did Amylyx Pharmaceuticals (AMLX) announce about AMX0318?

Amylyx announced it has selected AMX0318, a long-acting GLP-1 receptor antagonist, as a development candidate for treating post-bariatric hypoglycemia and other rare diseases.

What is AMX0318 and what condition is Amylyx targeting?

AMX0318 is described as a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist. Amylyx plans to develop it for post-bariatric hypoglycemia and other rare diseases.

What are the financial terms between Amylyx and Gubra for AMX0318?

Under the research collaboration, Gubra is eligible to receive more than $50 million in success-based development and commercialization milestones, plus mid-single digit royalties on worldwide net sales of AMX0318.

How much will Gubra receive immediately from Amylyx for AMX0318?

The selection and handover of AMX0318 as a development candidate will provide $4 million in milestone payments to Gubra.

What did Amylyx disclose about its updated corporate presentation?

Amylyx stated that it updated its corporate presentation for meetings with investors, analysts and others. The presentation is furnished as Exhibit 99.1 and is treated as furnished, not filed, under securities laws.

How does the Amylyx–Gubra collaboration structure potential future royalties?

If AMX0318 is successfully developed and commercialized, Gubra is entitled to mid-single digit royalties on worldwide net sales, in addition to success-based milestone payments.

What risks and uncertainties did Amylyx highlight around AMX0318?

Amylyx noted that statements about AMX0318’s therapeutic potential, the timing of IND-enabling studies and IND submission, payments and royalties to Gubra, and development, regulatory, and commercial milestones are forward-looking and subject to risks, including development success, regulatory progress, funding, and broader macroeconomic and public health factors.