Amylyx signs avexitide supply deals, $30M fee

Amylyx Pharmaceuticals, Inc. (AMLX) announced long-term manufacturing arrangements for its avexitide drug substance, contingent on regulatory approval.

Rhea-AI Filing Summary

Amylyx Pharmaceuticals, Inc. (AMLX) announced long-term manufacturing arrangements for its avexitide drug substance, contingent on regulatory approval. On September 8, 2026, the company entered into a Manufacturing and Supply Agreement with Bachem Americas, Inc., and on September 1, 2026, it signed a term sheet with Polypeptide Group AG for similar supply.

Beginning in 2028, Amylyx has agreed, under both arrangements, to purchase a minimum annual quantity of avexitide at agreed supply prices, with periodic forecasts of demand that are partially binding. The Bachem agreement includes annual price adjustments effective each January 1 and requires Amylyx to pay certain maintenance fees and expenses. It has a five-year initial term and automatically renews for successive three-year periods unless terminated for reasons such as material breach, bankruptcy, insolvency, or certain regulatory actions.

Under the Polypeptide term sheet, Amylyx will pay a $30 million upfront fee for capacity reservation and related commitments and plans to finalize a definitive Polypeptide Manufacturing Agreement with fixed volume-based pricing, subject to annual adjustment. Both Bachem and Polypeptide will act as non-exclusive suppliers, and Amylyx may use additional manufacturers.

Positive

• Amylyx established two non-exclusive long-term suppliers for commercial avexitide, which supports future large-scale manufacturing capability if the drug is approved.
• The Bachem agreement and planned Polypeptide Manufacturing Agreement include multi‑year minimum supply commitments starting in 2028, providing clearer visibility into future production capacity for avexitide.

Negative

• Amylyx will pay Polypeptide a $30 million upfront fee for capacity reservation, representing a significant near‑term cash outflow tied to a product that still depends on regulatory approval.
• Minimum annual purchase obligations and annual price adjustments under both manufacturing arrangements may create fixed cost commitments and potential exposure to rising production costs over time.

Filing Explained

The filing says the full Bachem manufacturing agreement and Polypeptide term sheet will be filed as exhibits to Amylyx’s Form 10-Q for the quarter ending September 30, 2026; Polypeptide’s commitments remain subject to a definitive agreement.

8-K Event Classification

Item 1.01 — Entry into a Material Definitive Agreement

1 item

Item 1.01 Entry into a Material Definitive Agreement Business

The company signed a significant contract such as a merger agreement, credit facility, or major partnership.

Key Figures

Upfront fee to Polypeptide: $30 million Minimum purchase commencement: 2028 Initial term of Bachem agreement: 5 years +2 more

5 metrics

Upfront fee to Polypeptide $30 million Capacity reservation payment under the Polypeptide Term Sheet

Minimum purchase commencement 2028 Start year for minimum annual avexitide purchases from Bachem and Polypeptide

Initial term of Bachem agreement 5 years Duration of the initial Bachem Manufacturing Agreement before renewals

Bachem renewal period 3 years Automatic renewal length for successive Bachem terms

Price adjustment frequency Annual Supply price adjusted each January 1 based on costs such as labor and utilities

Key Terms

Manufacturing and Supply Agreement, term sheet, capacity reservation, volume-based pricing, +1 more

5 terms

Manufacturing and Supply Agreement financial

"entered into a Manufacturing and Supply Agreement (the “Bachem Manufacturing Agreement”)"

term sheet financial

"the Company entered into a term sheet (the “Polypeptide Term Sheet”)"

A term sheet is a short, non-binding summary of the main points agreed between parties before a formal investment, loan, or acquisition is completed. Think of it as a blueprint that lists price, ownership split, key rights and conditions, and timelines so everyone knows the deal’s structure before lawyers draft final contracts. Investors care because it signals the likely economic terms, risks, and protections they will get and can make or break whether a transaction proceeds.

capacity reservation financial

"the Company will pay a $30 million upfront fee to Polypeptide for capacity reservation"

A capacity reservation is a contractual agreement where a buyer or customer pays to hold a specific amount of production, storage, service, or infrastructure capacity so it will be available when needed. Think of it like booking and paying for a parking spot or airline seat in advance: it guarantees availability and often involves fixed fees or minimum commitments. For investors, these agreements affect a company’s revenue predictability, cash flow timing, cost structure, and ability to meet demand or scale operations.

volume-based pricing financial

"to fixed volume-based pricing, as may be adjusted on an annual basis"

forward-looking statements regulatory

"Statements contained in this on Form 8-K regarding matters that are not historical facts are “forward-looking statements”"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

FAQ

What agreements did Amylyx Pharmaceuticals (AMLX) announce regarding avexitide manufacturing?

Amylyx entered a Manufacturing and Supply Agreement with Bachem Americas on September 8, 2026, and a term sheet with Polypeptide Group on September 1, 2026, to manufacture and supply avexitide drug substance for long‑term commercial needs, if the drug is approved.

How much will Amylyx (AMLX) pay Polypeptide under the new avexitide term sheet?

Amylyx will pay Polypeptide a $30 million upfront fee under the Polypeptide Term Sheet. The payment is for capacity reservation and in consideration of Polypeptide’s commitments that will be detailed in a future definitive Polypeptide Manufacturing Agreement.

When do the minimum purchase commitments for avexitide begin under Amylyx’s new agreements?

Under both the Bachem Manufacturing Agreement and the Polypeptide Term Sheet, Amylyx agreed that beginning in 2028 it will purchase a minimum quantity of avexitide drug substance per calendar year for the term of each agreement.

What are the key terms of the Bachem Manufacturing Agreement for Amylyx (AMLX)?

The Bachem Manufacturing Agreement has a five‑year initial term with automatic three‑year renewals. Amylyx must buy a minimum annual quantity from 2028, provide partially binding forecasts, pay certain maintenance fees, and accept annual price adjustments effective each January 1.

Are Bachem and Polypeptide exclusive suppliers to Amylyx for avexitide?

No. Both Bachem and Polypeptide will be non‑exclusive suppliers of avexitide drug substance. Amylyx retains the ability to procure supplies from one or more alternate manufacturers in addition to these two companies.

Is avexitide already approved for commercial use by Amylyx (AMLX)?

No. The agreements state that Bachem and Polypeptide will supply avexitide drug substance for commercial use, if approved, indicating that commercialization still depends on obtaining and maintaining necessary regulatory approvals.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 09/08/2026 - 04:54 PM Accepted by SEC EDGAR 09/08/2026 - 04:54 PM Learn about SEC filing dates

false 0001658551 0001658551 2026-09-01 2026-09-01

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): September 1, 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, Massachusetts		02142
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (617) 682-0917

Not Applicable

(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 1.01. Entry into a Material Definitive Agreement.

On September 8, 2026, Amylyx Pharmaceuticals, Inc. (the “Company”) entered into a Manufacturing and Supply Agreement (the “Bachem Manufacturing Agreement”) with Bachem Americas, Inc. (“Bachem”) and on September 1, 2026, the Company entered into a term sheet (the “Polypeptide Term Sheet”) with Polypeptide Group AG (“Polypeptide”), pursuant to which Bachem and Polypeptide, respectively, will manufacture and supply the Company’s long-term supply requirements of avexitide drug substance for commercial use, if approved. Bachem and Polypeptide will be non-exclusive suppliers and the Company may procure supplies from one or more alternate manufacturers.

Bachem Manufacturing Agreement

Pursuant to the Bachem Manufacturing Agreement, beginning in 2028, the Company has agreed to purchase a minimum quantity of avexitide drug substance per calendar year during the term of the Bachem Manufacturing Agreement at the applicable supply price. Under the Bachem Manufacturing Agreement, the Company will provide periodic estimates of its supply needs to Bachem, a portion of which will be binding upon both parties. The supply price will be adjusted on an annual basis, effective on January 1 of each year, to reflect increases in, among other things, labor, utilities and overhead. The Company will also pay certain other maintenance fees and expenses as contemplated by the Supply Agreement.

The Bachem Manufacturing Agreement has an initial term of five years and will automatically renew for successive three-year periods, unless earlier terminated in accordance with its terms. Either party may terminate the Bachem Manufacturing Agreement upon prior written notice under certain circumstances, including for material breach (subject to specified cure periods) or bankruptcy or insolvency. The Company may also terminate the Bachem Manufacturing Agreement upon certain regulatory actions or objections.

The Bachem Manufacturing Agreement contains customary representations, warranties and covenants, including with respect to the ownership of any intellectual property created pursuant to the Bachem Manufacturing Agreement, as well as provisions relating to acceptance, warranty, quality, testing and inspection, audit, access to information, indemnification, confidentiality and other matters.

Polypeptide Term Sheet

Pursuant to the Polypeptide Term Sheet, the Company and Polypeptide shall negotiate in good faith and promptly enter into a definitive written agreement consistent with the terms set forth in the Polypeptide Term Sheet and other mutually agreeable terms and conditions (the “Polypeptide Manufacturing Agreement”). Under the Term Sheet, the Company will pay a $30 million upfront fee to Polypeptide for capacity reservation and in consideration of the commitments described therein.

Pursuant to the Polypeptide Term Sheet, and subject to the execution of the Polypeptide Manufacturing Agreement, the Company and Polypeptide have agreed, among other things: (i) that beginning in 2028, the Company will purchase a minimum quantity of avexitide drug substance per calendar year during the term of the Polypeptide Manufacturing Agreement at the applicable supply price; (ii) that the Company will provide periodic estimates of its supply needs to Polypeptide, a portion of which will be binding upon both parties, and (iii) to fixed volume-based pricing, as may be adjusted on an annual basis.

The foregoing descriptions of the Bachem Manufacturing Agreement and Polypeptide Term Sheet are qualified in their entirety by reference to the full text of the Bachem Manufacturing Agreement and Polypeptide Term Sheet, respectively, copies of which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ending September 30, 2026.

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, the Company’s ability to successfully complete the development and commercialization of avexitide, including its ability to obtain and maintain regulatory approvals for avexitide and scale its third-party manufacturing capabilities; the Company’s plans regarding, and its ability to maintain, obtain, and negotiate favorable terms of, any manufacturing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize avexitide, including with respect to the Bachem Manufacturing Agreement and the Polypeptide Manufacturing Agreement (together, the “Manufacturing Agreements”); and the expected benefits of the Manufacturing Agreements. Any forward-looking statements in this Current Report 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’s program development activities; Amylyx’s 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’s ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx’s operations, as well as the risks and uncertainties set forth in Amylyx’s United States Securities and Exchange Commission (“SEC”) filings, including Amylyx’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent filings with the SEC. All forward-looking statements contained in this Current Report 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.

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: September 8, 2026				By:		/s/ James M. Frates
						James M. Frates
						Chief Financial Officer

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