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Amylyx Pharmaceuticals (Nasdaq: AMLX) details Q2 loss and avexitide Phase 3 timeline

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Form Type
8-K

Rhea-AI Filing Summary

Amylyx Pharmaceuticals reported a second quarter 2026 net loss of $43.4 million, or $0.39 per share, compared with a net loss of $41.4 million, or $0.46 per share, a year earlier. Research and development expenses were $23.8 million, down from $27.2 million, while selling, general and administrative expenses rose to $21.9 million from $15.6 million, driven mainly by higher legal costs and commercial initiatives.

Cash, cash equivalents and short-term investments totaled $250.8 million as of June 30, 2026, versus $279.8 million at March 31, 2026, and the company expects its current cash runway to fund operations into 2028.

Operationally, the last participant has completed the final study visit in the pivotal Phase 3 LUCIDITY trial of avexitide for post-bariatric hypoglycemia, with topline data anticipated in late August or early September 2026 and a potential U.S. commercial launch in 2027 if approved. Amylyx also advanced an expanded access program for avexitide, continued development of AMX0114 for ALS, progressed AMX0318 toward an IND targeted for 2027, and reported longer-term data for AMX0035 in Wolfram syndrome.

Positive

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Negative

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Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Net loss Q2 2026 $43.4 million Net loss for the three months ended June 30, 2026
Net loss per share Q2 2026 $0.39 Basic and diluted net loss per share for the quarter ended June 30, 2026
R&D expenses Q2 2026 $23.8 million Research and development expenses for the three months ended June 30, 2026
SG&A expenses Q2 2026 $21.9 million Selling, general and administrative expenses for the three months ended June 30, 2026
Cash and investments $250.8 million Cash, cash equivalents and short-term investments at June 30, 2026
Total assets $264,564 Total assets at June 30, 2026, in thousands
Stockholders’ equity $239,167 Stockholders’ equity at June 30, 2026, in thousands
Weighted-average shares 111,196,883 Weighted-average shares used in computing basic and diluted net loss per share, Q2 2026
post-bariatric hypoglycemia medical
"Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia"
Post-bariatric hypoglycemia is a condition of abnormally low blood sugar that can occur after weight-loss surgery, driven by faster food passage and an exaggerated insulin response. For investors, it matters because the condition can create steady demand for diagnostics, monitoring devices, medications and specialist care, affect clinical trial design and regulatory scrutiny, and alter long-term cost and reimbursement dynamics—like a new problem that creates a market for fixes.
GLP-1 receptor antagonist medical
"avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist"
A GLP‑1 receptor antagonist is a drug that blocks the action of the GLP‑1 hormone at its cell receptor, preventing signals that normally alter blood sugar levels and appetite. Think of the receptor as a lock and the hormone as a key; the antagonist jams the lock so the key can’t turn. Investors care because these drugs can change treatment options, competitive dynamics, and regulatory or commercial value in diabetes, obesity, and related drug markets.
open-label extension medical
"Participants who complete the 16-week double-blind period are eligible to enter a 32-week open-label extension period"
An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.
antisense oligonucleotide medical
"AMX0114, an investigational antisense oligonucleotide (ASO) targeting calpain-2"
An antisense oligonucleotide is a small piece of synthetic genetic material designed to attach to specific molecules in the body’s cells, effectively blocking or modifying how genes are expressed. This technology is important because it can be used to develop targeted treatments for certain diseases, which may influence the value of biotech companies and the broader healthcare sector. Its development reflects advances in personalized medicine and gene-based therapies.
Fast Track designation regulatory
"AMX0114 is an investigational antisense oligonucleotide (ASO) with U.S. Food and Drug Administration (FDA) Fast Track designation"
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
Expanded Access Program regulatory
"initiation of a U.S. Expanded Access Program for the use of avexitide"
A program that allows patients with serious or life‑threatening conditions to receive an experimental drug or therapy before it is fully approved by regulators, when they cannot join clinical trials. Investors care because expanded access can change a treatment’s market perception, create early real‑world safety or demand signals, and affect regulatory timelines and potential revenue — like a pre‑order system that also reveals how the product performs outside controlled testing.
Net loss $43.4 million compared to $41.4 million in the same quarter of 2025
Research and development expenses $23.8 million down from $27.2 million in the second quarter of 2025
Selling, general and administrative expenses $21.9 million up from $15.6 million in the second quarter of 2025
Cash, cash equivalents and short-term investments $250.8 million down from $279.8 million at March 31, 2026
Guidance

Based on current operating plans, Amylyx expects its cash runway to fund operations into 2028.

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FAQ

What were Amylyx Pharmaceuticals (AMLX) key financial results for Q2 2026?
Amylyx reported a net loss of $43.4 million, or $0.39 per share, for the quarter ended June 30, 2026, versus a $41.4 million loss, or $0.46 per share, in 2025. Operating expenses totaled $45.7 million.

How much cash does Amylyx Pharmaceuticals (AMLX) have and what is the runway?
Amylyx had $250.8 million in cash, cash equivalents and short-term investments at June 30, 2026, down from $279.8 million at March 31, 2026. Based on current operating plans, the company expects a cash runway into 2028.

What is the status of Amylyx Pharmaceuticals (AMLX) Phase 3 LUCIDITY trial?
The last participant has completed the final visit in the 16-week double-blind period of the pivotal Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia. Topline data are expected in late August or early September 2026.

Which pipeline programs did Amylyx Pharmaceuticals (AMLX) highlight in this update?
Amylyx highlighted avexitide for post-bariatric hypoglycemia, AMX0114 for ALS, AMX0035 for Wolfram syndrome, and AMX0318, a novel GLP-1 receptor antagonist with IND-enabling studies underway and an IND filing targeted for 2027.

How did Amylyx Pharmaceuticals (AMLX) operating expenses change year over year in Q2 2026?
In Q2 2026, R&D expenses fell to $23.8 million from $27.2 million, mainly from lower AMX0035 spending, while SG&A expenses rose to $21.9 million from $15.6 million due to higher legal costs and commercial strategic investments.

What nonclinical or access initiatives did Amylyx Pharmaceuticals (AMLX) report?
Amylyx started a U.S. Expanded Access Program for avexitide in adults with post-bariatric hypoglycemia, entered a second research collaboration with Gubra A/S, and continued working with the FDA on a planned Phase 3 trial in Wolfram syndrome.
0001658551false00016585512026-08-062026-08-06

 

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): August 6, 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 2.02 Results of Operations and Financial Condition.

 

On August 6, 2026, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Form 8-K”).

The information provided in this Form 8-K, including Exhibit 99.1 hereto, 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 it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

 

Exhibit

Number

Description

 

 

 99.1

Press Release of the Company, dated August 6, 2026

  104

 Cover Page Interactive Data File (embedded with 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: August 6, 2026

By:

/s/ James M. Frates

James M. Frates

Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

Amylyx Pharmaceuticals Reports Second Quarter 2026 Financial Results

 

•
Last participant completed final study visit in the 16-week double-blind period of the pivotal Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia; topline data on track and anticipated in late August or early September 2026
•
Cash runway expected to fund operations into 2028
•
Management to host conference call and webcast today at 8:00 a.m. Eastern Time

CAMBRIDGE, Mass., August 6, 2026 – Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial and business results for the second quarter ended June 30, 2026.

 

“With the last participant’s final study visit recently completed, we are eagerly anticipating the expected topline data readout of the pivotal Phase 3 LUCIDITY trial in post-bariatric hypoglycemia in late August or early September,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. “In parallel, we are continuing to advance our NDA readiness and our pre-commercial work to support a potential submission and commercial launch of avexitide in 2027, if approved. At ENDO in June 2026, we activated our disease state education campaign, ‘Uncover the Mystery of Post-Bariatric Hypoglycemia,’ designed to increase awareness and understanding action around PBH. We look forward to sharing updates as we work toward potentially delivering the first FDA-approved therapy for the PBH community.”

 

Second Quarter and Recent Updates:

•
The last participant has recently completed the final study visit in the 16-week double-blind period of the pivotal Phase 3 LUCIDITY clinical trial of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation in post-bariatric hypoglycemia (PBH). LUCIDITY enrolled 78 participants and is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of avexitide in adults with PBH following Roux-en-Y gastric bypass (RYGB) surgery. Participants who complete the 16-week double-blind period are eligible to enter a 32-week open-label extension period.
•
Amylyx presented two posters at the Endocrine Society’s Annual Meeting (ENDO 2026) in June 2026. The first poster characterized the clinical, economic, and humanistic burden of PBH in the U.S. on both a patient and systemic level, evaluating how Level 2 and 3 hypoglycemic events in PBH impact healthcare utilization, productivity, and overall cost. The second poster described participant-centric trial design considerations for the LUCIDITY trial of avexitide in PBH.
•
Amylyx announced the initiation of a U.S. Expanded Access Program for the use of avexitide to treat adults with PBH following RYGB surgery in May 2026. Initial eligible patients include individuals who have completed the LUCIDITY trial or participated in a prior trial of avexitide in PBH following RYGB surgery.
•
Amylyx entered into a second research collaboration with Gubra A/S in July 2026 to identify potential development candidates for a rare endocrine disease of high unmet need.
•
Amylyx presented data from its first-in-human, dose-ranging Phase 1 LUMINA clinical trial of AMX0114, an investigational antisense oligonucleotide (ASO) targeting calpain-2 for the potential treatment of amyotrophic lateral sclerosis (ALS), at the 2026 European Network to Cure ALS (ENCALS) Annual Meeting in June 2026. AMX0114 showed no drug-related serious adverse events (AEs) and no serious neurological AEs in Cohort 1, supporting continued evaluation at higher dose levels. Cohort 1 evaluated the lowest of four planned dose levels. Cohorts 1 (12.5 mg) and 2 (25 mg) are fully enrolled, and Cohort 3 (50 mg) is currently enrolling.

1

 

 

•
Amylyx announced the peer-reviewed publication of Week 24 and Week 48 results from the Phase 2 open-label HELIOS clinical trial of AMX0035 in adults living with Wolfram syndrome in The Journal of Clinical Investigation in May 2026. The results reinforced consistency of observed stabilization or improvement across multiple outcomes related to disease progression, including pancreatic beta cell function, glycemic control, vision, and overall symptom burden. AMX0035 was generally well-tolerated, consistent with previously presented safety data.
•
Amylyx also presented longer-term Week 96 data from HELIOS in June 2026. At Week 96, measures of pancreatic function and other measures of glycemic control were stable or improved relative to baseline in most participants. Visual acuity and patient- and clinician-reported outcomes showed patterns consistent with disease stabilization with interpretation limited by the open-label, single-arm design and small sample size (n=9 participants with data at Week 96). The safety profile of AMX0035 in HELIOS at Week 96, Week 48, and Week 24 were generally consistent with prior safety data from the studies of AMX0035. Nearly all AEs were mild or moderate, and there were no serious AEs related to AMX0035 treatment. The Company continues to work with the FDA on a Phase 3 trial in Wolfram syndrome.

 

Upcoming Expected Milestones:

•
Topline data readout for the Phase 3 LUCIDITY clinical trial of avexitide in PBH is on track and anticipated in late August or early September 2026. LUCIDITY is evaluating the FDA-agreed-upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. The design of the LUCIDITY trial was informed by data from five prior clinical trials of avexitide in PBH, which showed consistent effects, most notably statistically significant reductions in Level 2 and Level 3 hypoglycemic events. Across previous clinical trials, avexitide was generally well-tolerated with a favorable safety profile. If approved, commercial launch of avexitide is anticipated in 2027.
•
Investigational New Drug (IND)-enabling studies for AMX0318, a novel GLP-1 receptor antagonist for long-acting administration to treat PBH and other rare diseases, are underway with an IND filing targeted for 2027. AMX0318 was selected as a development candidate after demonstrating robust preclinical and chemical properties, including a favorable pharmacokinetic profile that may support long-acting administration, a robust chemical stability profile, strong in vitro potency, evidence of in vivo activity and tolerability, and high solubility. AMX0318 was identified through a research collaboration with Gubra A/S, a company specializing in peptide-based drug discovery and preclinical contract research services.

 

Financial Results for the Second Quarter Ended June 30, 2026

 

R&D Expenses: Research and development expenses for the second quarter of 2026 were $23.8 million, compared to $27.2 million for the same period in 2025. The decrease was primarily due to a decrease in spending related to AMX0035 for the treatment of progressive supranuclear palsy. The decrease was offset primarily by an increase in spending related to the clinical development of avexitide in PBH and other costs related to avexitide. Research and development expenses include $2.5 million of stock-based compensation expense for the quarter ended June 30, 2026, compared to $2.0 million of stock-based compensation expense for the quarter ended June 30, 2025.

 

SG&A Expenses: Selling, general, and administrative expenses for the second quarter of 2026 were $21.9 million, compared to $15.6 million for the same period in 2025. This increase was primarily due to higher legal expenses and increased investment in commercial strategic initiatives. Selling, general, and administrative expenses include $5.8 million of stock-based compensation expense for the quarter ended June 30, 2026, compared to $5.4 million of stock-based compensation expense for the quarter ended June 30, 2025.

 

Net Loss: Net loss for the three months ended June 30, 2026 was $43.4 million, or $0.39 per share, compared to net loss of $41.4 million, or $0.46 per share, for the same period in 2025.

 

Cash Position: Cash, cash equivalents, and short-term investments were $250.8 million at June 30, 2026, compared to $279.8 million at March 31, 2026. Based on its current operating plans, Amylyx expects a cash runway into 2028.

2

 

 

 

Investor Conference Call Information

Amylyx’s management team will host a conference call today, August 6, 2026, at 8:00 a.m. ET. To access the conference call, please dial +1 (888) 880-3330 (U.S. & Canada) or +1 (646) 357-8766 (international) at least 10 minutes prior to the start time and ask to be joined into the Amylyx Pharmaceuticals call. A live audio webcast of the call will be available under “Events and Presentations” in the Investor section of the Company’s website, https://investors.amylyx.com/events-presentations. The webcast will be archived and available for replay for 90 days following the event.

 

Available Information

Amylyx periodically provides other information for investors on the Company’s corporate website, https://amylyx.com, and the Company’s investor relations website, https://investors.amylyx.com. This includes press releases and other information about financial performance, information on corporate governance, and details related to our annual meeting of stockholders. Amylyx intends to use its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Amylyx’s website, in addition to following the Company’s press releases, SEC filings, and public conference calls and webcasts.

 

About Avexitide

Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in five Phase 1 and Phase 2 clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI). The U.S. Food and Drug Administration (FDA) has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for the treatment of hyperinsulinemic hypoglycemia (which includes PBH and congenital HI). In PBH, an exaggerated GLP-1 response leads to excessive insulin secretion, resulting in recurrent hypoglycemic events. Avexitide is a GLP-1 receptor antagonist designed to competitively bind to the GLP-1 receptor on pancreatic islet beta cells and inhibit the exaggerated GLP-1-driven insulin response characteristic of PBH, reducing inappropriate insulin secretion and stabilizing blood glucose levels. In two Phase 2 PBH clinical trials, avexitide demonstrated highly statistically significant reductions in hypoglycemic events.

 

About Post-Bariatric Hypoglycemia (PBH)

PBH is a chronic metabolic condition that is estimated to affect approximately 8% of people in the U.S. who have undergone the two most common types of bariatric surgery, sleeve gastrectomy and Roux-en-Y gastric bypass (approximately 160,000 people in the U.S.). PBH is thought to be driven by an exaggerated glucagon-like peptide-1 (GLP-1) response, primarily in response to food intake, leading to persistent, recurrent, and often debilitating rapid drops in blood glucose, known as hypoglycemia. The American Diabetes Association (ADA) recognizes hypoglycemia as a potential medical emergency because low blood glucose levels can compromise the body’s ability to maintain essential physiologic processes. In addition, hypoglycemia in the context of PBH may manifest as neuroglycopenia – an inadequate supply of glucose to the brain – which can cause confusion, cognitive dysfunction, loss of consciousness, and seizures. PBH can be associated with substantial disability, compromising safety, disrupting independent living, and affecting nutritional status and overall quality of life. Despite the substantial burden, there are currently no FDA-approved therapies for PBH.

 

About the LUCIDITY Trial

LUCIDITY (NCT06747468) is a 78-participant, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in participants with PBH following RYGB surgery. The Phase 3 trial is being conducted at 21 sites in the U.S. Participants were randomized 3:2 to receive either 90 mg of avexitide subcutaneously once daily or placebo. The trial includes an up to six-week screening period, including a three-week run-in period, a 16-week double-blind treatment period, and an open-label extension (OLE) period with a duration of 32 weeks. The primary efficacy objective of LUCIDITY is to evaluate the FDA-agreed-upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Safety and tolerability will also be evaluated.

 

About AMX0114

AMX0114 is an investigational antisense oligonucleotide (ASO) with U.S. Food and Drug Administration (FDA) Fast Track designation for the potential treatment of ALS. AMX0114 targets calpain-2 (CAPN2), a

3

 

 

calcium-activated protease that is one of the fundamental drivers of axonal degeneration and consequent disease progression in ALS. In preclinical studies, treatment with AMX0114 resulted in potent, dose-dependent, and durable reduction in CAPN2 mRNA and calpain-2 protein levels in disease-relevant cell models of axonal degeneration. This translated to improved neuronal survival, including in a model of TDP-43 ALS, and reductions in extracellular neurofilament light (NfL) levels across multiple disease models and paradigms of neuronal injury. AMX0114 was generally well-tolerated in LUMINA trial participants enrolled in Cohort 1 (n=12), with no treatment-related serious adverse events (SAEs).

 

About Amylyx Pharmaceuticals

At Amylyx, our mission is to usher in a new era of treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are currently focused on four investigational therapies across several endocrine conditions and neurodegenerative diseases in which we believe can make the greatest impact. For more information, visit amylyx.com and follow us on LinkedIn and X. For investors, please visit investors.amylyx.com.

 

Forward-Looking Statements

Statements contained in this press release 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’s expectations regarding: the therapeutic potential of avexitide as a treatment for PBH; the timing for the topline data readout and completion of the Phase 3 LUCIDITY clinical trial of avexitide; the timing for potential commercialization of avexitide, if approved; the expected enrollment and progress of the Expanded Access Program for avexitide; the therapeutic potential for AMX0114 as a treatment for ALS; the expected enrollment and progress of the LUMINA trial; the therapeutic potential of AMX0318 and the expected timeline for a potential IND submission; the therapeutic potential of AMX0035 as a treatment for Wolfram syndrome and plans for a Phase 3 trial; the potential benefits of expedited program and orphan designations held by Amylyx; the potential benefits of the research collaborations with Gubra A/S; and financial performance, cash runway and longer-term strategy. Any forward-looking statements in this press release and related comments in the Company’s earnings conference call 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; 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 press release and related comments in our earnings conference call 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.

4

 

 

AMYLYX PHARMACEUTICALS, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

UNAUDITED

 

(in thousands)

 

 

 

 

June 30, 2026

 

 

December 31, 2025

 

Assets

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

250,760

 

 

$

316,979

 

Prepaid expenses and other current assets

 

 

5,578

 

 

 

6,692

 

Other assets

 

 

8,226

 

 

 

8,974

 

Total assets

 

$

264,564

 

 

$

332,645

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

20,142

 

 

$

21,429

 

Other liabilities

 

 

5,255

 

 

 

5,957

 

Total liabilities

 

 

25,397

 

 

 

27,386

 

Stockholders’ equity

 

 

239,167

 

 

 

305,259

 

Total liabilities and stockholders' equity

 

$

264,564

 

 

$

332,645

 

 

AMYLYX PHARMACEUTICALS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

UNAUDITED

 

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

23,768

 

 

$

27,217

 

 

$

51,379

 

 

$

49,336

 

Selling, general and administrative

 

 

21,925

 

 

 

15,640

 

 

 

38,093

 

 

 

31,324

 

Total operating expenses

 

 

45,693

 

 

 

42,857

 

 

 

89,472

 

 

 

80,660

 

Loss from operations

 

 

(45,693

)

 

 

(42,857

)

 

 

(89,472

)

 

 

(80,660

)

Other income, net

 

 

2,270

 

 

 

1,414

 

 

 

4,765

 

 

 

3,310

 

Net loss

 

$

(43,423

)

 

$

(41,443

)

 

$

(84,707

)

 

$

(77,350

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share — basic and diluted

 

$

(0.39

)

 

$

(0.46

)

 

$

(0.76

)

 

$

(0.88

)

Weighted-average shares used in computing net loss per share — basic and diluted

 

 

111,196,883

 

 

 

89,138,568

 

 

 

110,881,872

 

 

 

87,427,345

 

 

 

Media

Amylyx Media Team

+1 (857) 320-6191

amylyxmediateam@amylyx.com

 

Investors
Lindsey Allen
Amylyx Pharmaceuticals, Inc.
+1 (857) 320-6244
Investors@amylyx.com

5

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