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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): August 10, 2026

 

 

Axsome Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-37635

45-4241907

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

One World Trade Center, 29th Floor

 

New York, New York

 

10007

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (212) 332-3241

 

 

 

(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, Par Value $0.0001 Per Share

 

AXSM

 

Nasdaq Global 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 10, 2026, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended June 30, 2026 and provided an update on the Company’s operations. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.

In accordance with General Instruction B.2 of Form 8-K, the information included in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 hereto), shall not be deemed “filed” for the 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 filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On August 10, 2026, the Company updated its corporate presentation and posted such corporate presentation to the Company’s website. The updated corporate presentation is filed as Exhibit 99.2 hereto and incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.

Description

99.1

Press Release dated August 10, 2026.

99.2

 

Corporate Presentation.

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.

 

 

 

Axsome Therapeutics, Inc.

 

 

 

 

Date:

August 10, 2026

By:

/s/ Herriot Tabuteau, M.D.

 

 

Name:

Title:

Herriot Tabuteau, M.D.
President and Chief Executive Officer

 


EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1

img36028404_0.gif

Exhibit 99.1

 

Axsome Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update

Total 2Q 2026 net product revenue of $218.4 million, representing 46% year-over-year growth

AUVELITY® 2Q 2026 net product sales of $180.3 million, representing 51% year-over-year growth

SUNOSI® 2Q 2026 net product revenue of $35.8 million, representing 20% year-over-year growth

SYMBRAVO® 2Q 2026 net product sales of $2.3 million

AUVELITY launched for treatment of agitation associated with dementia due to Alzheimer’s disease in June 2026

NDA submission for AXS-12 for cataplexy in narcolepsy accepted by the FDA with PDUFA target action date of May 1, 2027

FOCUS-2 and FOCUS-3 Phase 3 trials of solriamfetol in children and adolescents with ADHD initiated

Company to host conference call today at 8:00 AM Eastern

NEW YORK, August 10, 2026 (Globe Newswire) – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced financial results for the second quarter of 2026 and provided a general business update.

“The second quarter was highly productive for Axsome. Our commercial business grew robustly, driven by strong underlying demand for our products, and we made important regulatory and clinical progress across our innovative neuroscience pipeline,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. “We expect our commercial momentum to build over the balance of the year, in particular with anticipated continued Auvelity growth in Alzheimer’s disease agitation and major depressive disorder. With a focus on commercial execution and advancement of our broad late-stage neuroscience pipeline targeting high unmet needs, novel indications, first-in-class mechanisms of action, and best-in-class product profiles, Axsome is well positioned to deliver substantial value to patients and shareholders.”

Second Quarter 2026 Financial Highlights

Total net product revenue was $218.4 million for the second quarter of 2026, representing 46% year-over-year growth. Total net product revenue for the comparable period in 2025 was $150.0 million.
AUVELITY net product sales were $180.3 million for the second quarter of 2026, representing 51% year-over-year growth. AUVELITY net product sales for the comparable period in 2025 were $119.6 million.
SUNOSI net product revenue was $35.8 million for the second quarter of 2026, representing 20% year-over-year growth, which consisted of $33.8 million in net product sales, $1.5 million in royalty revenue associated with SUNOSI sales in out-licensed territories, and $0.5 million in milestone revenue. SUNOSI net product revenue for the comparable period in 2025 was $30.0 million, which consisted of $28.9 million in net product sales and $1.1 million in royalty revenue.
SYMBRAVO net product sales were $2.3 million for the second quarter of 2026, representing 461% year-over-year growth. SYMBRAVO was launched in June 2025 and had net product sales of $0.4 million for the second quarter of 2025.
Total cost of revenue was $13.6 million for the second quarter of 2026. Total cost of revenue for the comparable period in 2025 was $13.4 million.

1


 

 

Research and development (R&D) expenses were $46.2 million for the second quarter of 2026, compared to $49.5 million for the comparable period in 2025. The decrease primarily reflects lower costs for AXS-05 and AXS-14.
Selling, general, and administrative (SG&A) expenses were $208.1 million for the second quarter of 2026, compared to $130.3 million for the comparable period in 2025. The increase primarily reflects commercialization activities for AUVELITY, including the sales force expansion and launch activities for the Alzheimer’s disease agitation indication, and commercialization activities for SYMBRAVO.
Net loss for the second quarter of 2026 was $51.3 million, or $(0.99) per share, compared to a net loss of $48.0 million, or $(0.97) per share, for the comparable period in 2025. The net loss in the second quarter of 2026 includes $27.1 million in stock-based compensation expense.
Cash and cash equivalents totaled $319.9 million at June 30, 2026, compared to $322.9 million at December 31, 2025.
Shares of common stock outstanding were 52,299,889 at June 30, 2026.

Financial Guidance

Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.

Commercial Highlights

AUVELITY

AUVELITY is a firstinclass oral NMDA receptor antagonist and sigma1 receptor agonist approved in the U.S. for the treatment of major depressive disorder in adults, and for the treatment of agitation associated with dementia due to Alzheimer’s disease.

Axsome launched AUVELITY in Alzheimer’s disease agitation in June 2026.
New-to-brand prescriptions, representing new AUVELITY patient starts, increased 126% among patients ≥65 years of age during the first eight weeks following the Alzheimer’s disease agitation launch compared to the same period in the prior quarter. New-to-brand prescriptions are considered a leading indicator of growth, reflecting expanding adoption in this patient segment. These early trends have been accompanied by positive prescriber feedback and recognition of AUVELITY’s differentiated profile in Alzheimer’s disease agitation.
Overall new-to-brand prescriptions in the second quarter of 2026 increased 26% compared to the first quarter of 2026, reflecting the early impact of the sales force expansion which was completed in the second quarter. Approximately 266,000 total prescriptions were written for AUVELITY in the second quarter of 2026, representing year-over-year and quarter-over-quarter increases of 34% and 12%, respectively.
Payer coverage for AUVELITY across all channels is currently at approximately 89% of all lives covered. The proportion of lives covered in the commercial and government (Medicare and Medicaid) channels are approximately 82% and 100%, respectively.

2


 

 

SUNOSI

SUNOSI is the first and only DNRI approved for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy.

Approximately 61,000 prescriptions were written for SUNOSI in the U.S. in the second quarter of 2026, a 14% increase compared to the same period in 2025, and an 8% increase compared to the first quarter of 2026.
Payer coverage for SUNOSI across all channels is at approximately 82% of all lives covered, including approximately 96% of commercial lives and 59% of government lives.

SYMBRAVO

SYMBRAVO is an oral, rapidly absorbed, multi-mechanistic, COX-2 preferential inhibitor and 5-HT1B/1D agonist approved in the U.S. for the acute treatment of migraine with or without aura in adults.

Approximately 23,500 prescriptions were written for SYMBRAVO in the second quarter of 2026, a 30% increase compared to the first quarter of 2026.
Payer coverage for SYMBRAVO across all channels is at approximately 57% of all lives covered, including approximately 56% of commercial lives and 57% of government lives.
The previously announced expansion of the SYMBRAVO sales force is substantially complete. Our expanded sales team of approximately 150 sales representatives will enable broader reach within the primary care market and deeper engagement with headache specialists and neurologists nationwide.

Development Pipeline

Axsome is advancing an industry-leading neuroscience pipeline of multiple, innovative, product candidates addressing a broad range of serious psychiatric and neurological conditions. Recent and anticipated progress for key pipeline programs is summarized below.

AXS-05

AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor being developed for smoking cessation.

Smoking Cessation: Axsome is on track to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in the third quarter of 2026.

Solriamfetol

Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with EDS symptoms, binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).

Attention Deficit Hyperactivity Disorder: In June and July 2026, Axsome initiated the FOCUS-3 and FOCUS-2 Phase 3, randomized, double-blind, placebo-controlled, multicenter trials evaluating the efficacy and safety of solriamfetol as a treatment for adolescents and children with ADHD, respectively. The primary endpoint in both studies is the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score.
Major Depressive Disorder: Axsome is conducting the CLARITY study, a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial evaluating the efficacy and safety of solriamfetol for the treatment of MDD with EDS symptoms.

3


 

 

Binge Eating Disorder: Axsome is conducting the ENGAGE study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in BED. The Company anticipates topline results from the ENGAGE Phase 3 trial in the fourth quarter of 2026.
Shift Work Disorder: Axsome is conducting the SUSTAIN study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in SWD in adults. The Company anticipates topline results from the SUSTAIN Phase 3 trial in 2027.

AXS-12

AXS-12 (reboxetine) is Axsome’s novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for narcolepsy.

Narcolepsy: Axsome’s NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy was accepted by the FDA and assigned a PDUFA target action date of May 1, 2027.

AXS-14

AXS-14 (esreboxetine) is Axsome’s novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine is the SS-enantiomer of reboxetine.

Fibromyalgia: Axsome is conducting the FORWARD study, a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial evaluating the efficacy and safety of AXS-14 for the management of fibromyalgia.

AXS-17

AXS-17 is Axsome’s novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator (PAM) being developed for the treatment of epilepsy.

Epilepsy: Phase 2 trial-enabling activities for AXS-17 in epilepsy are underway.

AXS-20

AXS-20 (balipodect) is Axsome’s novel oral, potent, and selective phosphodiesterase 10A (PDE10A) inhibitor being developed for the treatment of schizophrenia and Tourette syndrome.

Schizophrenia: Phase 3 trial-enabling activities for AXS-20 in schizophrenia are underway.
Tourette Syndrome: Axsome plans to evaluate AXS-20 as a potential treatment for Tourette syndrome.

4


 

 

Anticipated Milestones

Clinical Trial Initiations and Progress:
o
Phase 2/3 trial of AXS-05 in smoking cessation, initiation (3Q 2026)
Clinical Trial Topline Results:
o
Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (4Q 2026)
o
Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2027)
Regulatory and Commercial:
o
AXS-12 for narcolepsy, PDUFA target action (May 1, 2027)

Conference Call Information

Axsome will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss its second quarter 2026 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. A replay of the conference call will be available for approximately 30 days following the live event.

About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

5


 

 

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

6


 

 

Axsome Therapeutics, Inc.

Selected Consolidated Financial Data

Axsome Therapeutics, Inc.

Consolidated Balance Sheets

(In thousands, except share and per share amounts)

 

 

June 30,
2026

 

 

December 31,
2025

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

319,850

 

 

$

322,933

 

Accounts receivable, net

 

 

277,459

 

 

 

224,464

 

Inventories, net

 

 

37,883

 

 

 

27,938

 

Prepaid and other current assets

 

 

21,377

 

 

 

13,651

 

Total current assets

 

 

656,569

 

 

 

588,986

 

Equipment, net

 

 

874

 

 

 

562

 

Right-of-use asset - operating lease

 

 

19,157

 

 

 

20,858

 

Goodwill

 

 

12,042

 

 

 

12,042

 

Intangible asset, net

 

 

37,358

 

 

 

40,519

 

Non-current inventory and other assets

 

 

35,447

 

 

 

26,838

 

Total assets

 

$

761,447

 

 

$

689,805

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

78,969

 

 

$

65,537

 

Accrued expenses and other current liabilities

 

 

299,632

 

 

 

232,853

 

Operating lease liability, current portion

 

 

646

 

 

 

434

 

Contingent consideration, current

 

 

11,199

 

 

 

10,012

 

Short-term borrowings

 

 

70,000

 

 

 

70,000

 

Total current liabilities

 

 

460,446

 

 

 

378,836

 

Contingent consideration, non-current

 

 

69,135

 

 

 

77,540

 

Loan payable, long-term

 

 

117,958

 

 

 

117,746

 

Operating lease liability, long-term

 

 

21,574

 

 

 

23,182

 

Finance lease liability, long-term

 

 

9,030

 

 

 

4,206

 

Total liabilities

 

 

678,143

 

 

 

601,510

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding)

 

 

 

 

 

 

Common stock, $0.0001 par value per share (150,000,000 shares authorized, 52,299,889 and 50,882,766 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively)

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

1,505,116

 

 

 

1,394,251

 

Accumulated deficit

 

 

(1,421,817

)

 

 

(1,305,961

)

Total stockholders’ equity

 

 

83,304

 

 

 

88,295

 

Total liabilities and stockholders’ equity

 

$

761,447

 

 

$

689,805

 

 

7


 

 

Axsome Therapeutics, Inc.

Consolidated Statements of Operations (Unaudited)

(In thousands, except share and per share amounts)

 

 

Three months ended June 30,

 

 

Six months ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

216,355

 

 

$

148,959

 

 

$

405,755

 

 

$

269,317

 

Royalty revenue and milestone revenue

 

 

2,020

 

 

 

1,083

 

 

 

3,823

 

 

 

2,188

 

Total revenues

 

 

218,375

 

 

 

150,042

 

 

 

409,578

 

 

 

271,505

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue (excluding amortization and depreciation)

 

 

13,564

 

 

 

13,448

 

 

 

28,289

 

 

 

23,237

 

Research and development

 

 

46,227

 

 

 

49,541

 

 

 

98,904

 

 

 

94,326

 

Selling, general and administrative

 

 

208,137

 

 

 

130,280

 

 

 

393,133

 

 

 

251,067

 

Gain in fair value of contingent consideration

 

 

(1,496

)

 

 

(8,102

)

 

 

(906

)

 

 

(6,590

)

Intangible asset amortization

 

 

1,589

 

 

 

1,589

 

 

 

3,161

 

 

 

3,161

 

Total operating expenses

 

 

268,021

 

 

 

186,756

 

 

 

522,581

 

 

 

365,201

 

Loss from operations

 

 

(49,646

)

 

 

(36,714

)

 

 

(113,003

)

 

 

(93,696

)

Interest expense, net

 

 

(1,540

)

 

 

(1,834

)

 

 

(2,725

)

 

 

(4,265

)

Loss on debt extinguishment

 

 

 

 

 

(10,385

)

 

 

 

 

 

(10,385

)

Loss before income taxes

 

 

(51,186

)

 

 

(48,933

)

 

 

(115,728

)

 

 

(108,346

)

Income tax benefit (expense)

 

 

(128

)

 

 

960

 

 

 

(128

)

 

 

960

 

Net loss

 

$

(51,314

)

 

$

(47,973

)

 

$

(115,856

)

 

$

(107,386

)

Net loss per common share, basic and diluted

 

$

(0.99

)

 

$

(0.97

)

 

$

(2.25

)

 

$

(2.18

)

Weighted average common shares outstanding, basic and diluted

 

 

51,799,708

 

 

 

49,442,001

 

 

 

51,500,690

 

 

 

49,158,159

 

 

Investors:

Ashley Dong

Senior Director, Investor Relations

(929) 687-1614

adong@axsome.com

Media:

Darren Opland

Senior Director, Corporate Communications

(929) 837-1065

dopland@axsome.com

8


EX-99.2 3 axsm-ex99_2.htm EX-99.2

Slide 1

August 10, 2026 2Q 2026 Financial Results


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Forward looking statements & safe harbor Certain matters discussed in this presentation are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this presentation, and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. This presentation contains statements regarding the Company’s observations based upon the reported clinical data. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other data about the Company's industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Neither we nor any other person makes any representation as to the accuracy or completeness of such data or undertakes any obligation to update such data after the date of this presentation. In addition, these projections, assumptions and estimates are necessarily subject to a high degree of uncertainty and risk. Axsome, AUVELITY, SUNOSI, SYMBRAVO, and MoSEIC, are trademarks or registered trademarks of Axsome Therapeutics, Inc. or its affiliates. Except as with respect to AUVELITY and SUNOSI for their approved indications, the development products referenced herein have not been approved by the FDA. the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control.


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Our Mission Develop and deliver transformative medicines to improve the brain health of millions of individuals


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Positioned for significant and durable growth 3 marketed products MDD Migraine AD agitation EDS in OSA or narcolepsy 6 novel product candidates Singular CNS portfolio Psychiatry + Neurology 10 pipeline indications COMMERCIAL Portfolio BROAD PIPELINE Expanding franchise Continued growth Launch phase Psychiatry Neurology Smoking cessation ADHD Binge eating disorder MDD with EDS symptoms Schizophrenia Narcolepsy Fibromyalgia Shift work disorder Epilepsy Tourette syndrome


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2Q 2026 performance COMMERCIAL GROWTH PIPELINE PROGRESS UPCOMING MILESTONES NDA submission for AXS-12 for cataplexy in narcolepsy accepted by the FDA Initiated FOCUS-2 and FOCUS-3 Phase 3 trials of solriamfetol in children and adolescent with ADHD Clinical trials ongoing in five indications of high unmet need Phase 2 trial-enabling activities for AXS-17 in epilepsy underway Phase 3 trial-enabling activities for AXS-20 in schizophrenia underway AXS-12 PDUFA target action (May 1, 2027) Initiation of pivotal Phase 2/3 trial of AXS-05 in smoking cessation (3Q 2026) Topline results of the ENGAGE Phase 3 trial of solriamfetol in binge eating disorder (4Q 2026) Topline results of the SUSTAIN Phase 3 trial of solriamfetol in shift work disorder (2027) Total product revenue Completed AUVELITY sales force expansion to ~630 representatives Launched AUVELITY in Alzheimer’s disease agitation in June $218.4M (+46% YoY)


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Leading neuroscience pipeline with deep stratification Phase 1 Phase 2 Phase 3 NDA AXS-05 (dextromethorphan-bupropion) AXS-12 (reboxetine) AXS-17 NMDA antagonist and sigma-1 agonist Highly selective NRI and dopamine modulator GABAA α2,3 subtype-selective PAM Smoking Cessation Tourette Syndrome Psychiatry Neurology ADHD Binge Eating Disorder MDD with EDS Shift Work Disorder Narcolepsy Fibromyalgia Schizophrenia Epilepsy DNRI and TAAR1 agonist Solriamfetol Highly selective NRI and dopamine modulator AXS-14 (esreboxetine) Selective PDE10A inhibitor AXS-20 (balipodect) NMDA = N-methyl-D-aspartate; CYP2D6 = Cytochrome P450 Family 2 Subfamily D Member 6; DNRI = Dopamine-norepinephrine reuptake inhibitor; TAAR1 = Trace amine-associated receptor 1; 5-HT = 5-Hydroxytryptamine; NRI = Norepinephrine reuptake inhibitor; GABA = gamma-aminobutyric acid Please see full Prescribing Information for AUVELITY, SUNOSI, and SYMBRAVO at www.AUVELITY.com, www.SUNOSI.com, and www.SYMBRAVO.com, respectively.


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Advancing new frontiers across 10 serious CNS conditions 1. U.S. Department of Health and Human Services 2020; 2. Hughes JR, et al. 2004; 3. Facts About ADHD in Adults. CDC 2024; 4. Sibley MH, et al. 2022; 5. Hudson JI, et al. 2007; 6. Hein M, et al. 2019; 7. Ringeisen H, et al. 2023; 8. Narcolepsy Network 2024; 9. Swick TJ. 2015; 10. Vincent, et al. 2013; 11. Liu Y, et al. 2016; 12. Sateia MJ. 2014; 13. Alterman T, et al. 2013; 14. Wickwire EM. 2017; 15. Epilepsy CDC 2025; 16. Chen Z, et al. 2018; 17. Tourette Syndrome. CDC 2025 PSYCHIATRY Shift work disorder 15M+ 0 working Americans may be impacted12-14 new medications approved since 2007 Smoking cessation 34M+ ~70% adults in the U.S. smoke cigarettes1 of smokers say they want to quit2 MDD with EDS symptoms ~50% 0 of MDD patients have concomitant EDS6 FDA-approved treatments ADHD 22M+ >90% people in the U.S. live with ADHD3 of pediatric ADHD persist into adulthood4 7M+ people impacted in the U.S.5 Binge eating disorder FDA-approved treatment 1 Epilepsy ~3.4M >1/3 people in the U.S. live with epilepsy15 of patients don’t respond to treatment16 Narcolepsy 185K ~70% people in the U.S. are affected by narcolepsy8 of patients suffer from cataplexy9 >50% people in the U.S. have fibromyalgia10 17M+ Fibromyalgia of patients discontinue treatment in the first year11 NEUROLOGY Schizophrenia ~3.7M people in the U.S. have schizophrenia and related psychotic disorders7 Tourette syndrome ~0.6% of children in the U.S. may suffer from Tourette syndrome17


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Solriamfetol ADHD Singular CNS portfolio with >$18B in annual peak sales potential $0.5-$1B AXS-14 Fibromyalgia AXS-12 Narcolepsy $0.5-$1B Solriamfetol MDD with EDS $0.5-$1B AXS-05 Smoking Cessation $1-$1.5B $0.3-$0.5B $8B+ $0.5-$1B AXS-17 Epilepsy AXS-20 Schizophrenia AXS-20 Tourette syndrome Psychiatry Neurology $1-$3B Solriamfetol Binge eating disorder $0.5-$1B Solriamfetol Shift work disorder $0.3-$0.5B


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Financial Highlights


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2Q 2026 financial summary 2Q = three months ended June 30; *Includes royalty revenue associated with sales in out-licensed territories and milestone revenue Net Product Revenue $218.4 $150.0 46% AUVELITY $180.3 $119.6 51% SUNOSI* $35.8 $30.0 20% SYMBRAVO $2.3 $0.4 461% R&D Expense $46.2 $49.5 -7% SG&A Expense $208.1 $130.3 60% 2Q 2026 2Q 2025 % Change $ millions


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AUVELITY® quarterly net revenue performance AUVELITY 2Q 2026 net produce revenue of $180.3M (51% YoY growth) +51%


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SUNOSI 2Q 2026 net produce revenue of $35.8M (20% YoY growth) SUNOSI® quarterly net revenue performance +20%


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Cash Balance: (as of June 30, 2026) $319.9M Debt (Face Value): (as of June 30, 2026) $190M Market Cap: (as of August 7, 2026) $11.0B Shares Outstanding: (as of June 30, 2026) 52.3M Options, RSUs, and Others Outstanding*: 8.1M Runway to reach cash flow positivity, based on the current operating plan Financial snapshot *Includes 5.9M options, 2.0M RSUs, and 0.2M others as of June 30, 2026


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Commercial Update


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Well-positioned for accelerating commercial growth PEAK SALES POTENTIAL Launched AUVELITY in Alzheimer’s disease agitation in June Expanded sales force of ~630 representatives Acceleration in new patient starts and new prescriber activation Strong early NBRx growth trend among 65+ patients just weeks into launch Consistent growth driven by durable demand Strong underlying demand growth Improvements in market access $8B+ $0.3B-$0.5B $0.5B-$1B HIGHLIGHTS / GROWTH DRIVERS ~$9.5B total commercial opportunity across marketed products


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First and only oral NMDA antagonist and sigma-1 agonist for MDD and Alzheimer’s disease agitation1,2 NMDA = N-methyl-D-aspartate; MDD = Major depressive disorder 1. AUVELITY [Prescribing Information]. Axsome Therapeutics, Inc., New York, NY; 2. Thomas D, Wessel C. BIO 2017; 3. Iosifescu DV, et al. 2022 16 MAJOR DEPRESSIVE DISORDER Only oral antidepressant with rapid-acting efficacy reflected in FDA label1 Rapid symptom improvement starting at week 1 and remission as early as week 2, sustained at week 61,3 Only approved treatment demonstrating substantial symptom improvement and statistically significantly longer time to relapse1 Distinct safety/tolerability profile with no new boxed warning; most common adverse reactions were dizziness and dyspepsia1 Alzheimer’s disease agitation


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Continued momentum reflects underlying MDD growth and early impact from the sales force expansion TRx = Total prescriptions ACCELERATING PRESCRIBER GROWTH +26% QoQ NBRx growth ~69,000 Unique writers since launch ~89% Total covered lives ~82% Commercial covered lives ~100% Medicare and Medicaid covered lives GROWING PATIENT ADOPTION STRONG MARKET ACCESS Source: Symphony METYS Quarterly TRx Launch to Date +21% QoQ growth in activated new writers >350,000 Patients treated since launch ~266,000 TRx in 2Q 2026


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First and only dopamine and norepinephrine reuptake inhibitor for EDS associated with narcolepsy or OSA1 EDS = Excessive daytime sleepiness; OSA = Obstructive sleep apnea; DNRI = Dopamine-norepinephrine reuptake inhibitor 1. SUNOSI [Prescribing Information]. Axsome Therapeutics, Inc., New York, NY; 2. Schweitzer PK, et al. 2019 First and only wakefulness promoting agent proven to improve wakefulness through 9 hours1 Improvements in cognitive functioning vs. placebo demonstrated in clinical trials 90% of patients reported feeling better with SUNOSI 150 mg2


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Durable demand continues to drive growth nTRx = Normalized total prescriptions Source: Symphony METYS. nTRx normalizes number of pills in each TRx for 30-day period. Quarterly nTRx Launch to Date EXPANDING PRESCRIBER reach ~61,000 TRx in 2Q 2026 ~109,000 Patients treated since launch >17,000 Unique writers since launch ~82% Total covered lives ~96% Commercial covered lives ~59% Medicare and Medicaid covered lives STEADY PATIENT GROWTH Broad payer COVERAGE


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Novel, oral, rapidly-absorbed, multi-mechanistic approach for the acute treatment of migraine1 1. SYMBRAVO [Prescribing Information]. Axsome Therapeutics, Inc., New York, NY Single, oral dose provided rapid migraine pain freedom and return to normal functioning within 2 hours1 Harnesses Axsome’s MoSEIC™ rapid absorption technology to target multiple pathways underlying a migraine attack Superior efficacy demonstrated across a broad range of migraine severity (mild, moderate, severe)1


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Prescription growth driven by increasing demand TRx = Total prescriptions PRESCRIBER GROWTH ~23,500 TRx in 2Q 2026 ~19,500 Patients treated since launch ~4,700 Unique writers since launch ~57% Total covered lives ~56% Commercial covered lives ~57% Medicare and Medicaid covered lives PATIENT GROWTH Established market access Source: Symphony METYS Weekly TRx Launch to Date


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Development Pipeline


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70% of smokers want to quit2 Only 3-5% who attempt to quit without assistance are successful for 6-12 months2 AXS-05 for smoking cessation 1. U.S. Department of Health and Human Services 2020; 2. Hughes JR, et al. 2004 Single largest cause of preventable disease and death in the U.S., accounting for nearly 1 in 5 deaths1 Associated with over $300 billion in annual costs in the U.S.1 ~34M adults in the U.S. smoke cigarettes, ~50% of whom live with a smoking-related disease1


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1. Raony I, et al. 2022; 2. Halff EF, et al. 2023 Solriamfetol was initially developed as a dopamine and norepinephrine reuptake inhibitor (DNRI) with wake-promoting effects Preclinical and clinical evidence1,2 suggest TAAR1 plays a role in neuropsychiatric conditions related to the dysregulation of monoaminergic transmission Multimodal activity of solriamfetol selectively inhibits the reuptake of dopamine and norepinephrine and exhibits agonist activity at TAAR1 receptors in the brain Unique pharmacology supports potential utility in a broad range of CNS conditions Solriamfetol


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Solriamfetol Phase 3 development programs ADHD = Attention deficit hyperactivity disorder; MDD = Major depressive disorder; BED = Binge eating disorder; SWD = Shift work disorder ADHD Positive FOCUS Phase 3 trial in adults with ADHD (N=516) Initiated FOCUS-2 and FOCUS-3 Phase 3 trials in children and adolescents with ADHD Approved in EDS associated with OSA and narcolepsy MDD with EDS BED SWD Ongoing CLARITY Phase 3 trial in MDD with EDS symptoms Ongoing ENGAGE Phase 3 trial in adults with binge eating disorder (N=450) Topline data anticipated in 4Q 2026 Ongoing SUSTAIN Phase 3 trial in adults with shift work disorder (N=450) Topline data anticipated in 2027 Solriamfetol


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Attention deficit hyperactivity disorder (ADHD) 1. Facts About ADHD in Adults. CDC 2024; 2. Data and Statistics on ADHD. CDC 2024; 3. Attention-Deficit/Hyperactivity Disorder. NIMH 2024 Chronic neurobiological and developmental disorder affecting an estimated ~22M people in the U.S.1, including ~7M children aged 3-17 years old2 Associated with significant impairment in social, academic, and occupational functioning and development3 Characterized by a persistent pattern of inattention and/or hyperactive-impulsive behaviors3


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Significant improvements in overall ADHD severity vs. placebo (CGI-S, p=0.017)c AISRS Total Score LSM Change (±SE) FOCUS Phase 3 Triala CMAI = Cohen-Mansfield Agitation Inventory; LSM = least-squares mean; SE = standard error; SR = sustained release a. p-values shown for solriamfetol 150 mg p-values are nominal; b. Clinical response defined as ≥30% reduction in AISRS; c. solriamfetol 150 mg Axsome Therapeutics, Inc. Data on file. 17.7-point reduction in the AISRS total score at Week 6 with solriamfetol vs. 14.3-point reduction with placebo (p=0.039)b Significantly greater percentage of patients receiving solriamfetol achieved a clinical responseb vs. placebo (p=0.024)c Well tolerated with a side effect profile consistent with the established safety profile of solriamfetol Statistically significant improvements in ADHD symptoms with solriamfetol treatment Primary endpoint: Change from baseline in AISRS total score at Week 6 Solriamfetol 300 mg Solriamfetol 150 mg Placebo p=0.036 p=0.041 p=0.039


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Solriamfetol in ADHD pediatric Phase 3 trial designs ADHD-RS-5 = ADHD Rating Scale Solriamfetol (dose 1) Solriamfetol (dose 2) Placebo 1:1:1 R Screening (5 weeks) Double-blind Phase (6 weeks) Follow-up (1 week) Baseline FOCUS-3 Phase 3 Trial N=468 Key eligibility criteria 12 to <18 years of age with diagnosis of ADHD (DSM-5) Primary endpoint Change from baseline in ADHD-RS-5 total score Solriamfetol (dose 1) Solriamfetol (dose 2) Placebo 1:1:1 R Screening (5 weeks) Double-blind Phase (6 weeks) Follow-up (1 week) Baseline FOCUS-2 Phase 3 Trial N=468 Key eligibility criteria 6 to <12 years of age with diagnosis of ADHD (DSM-5) Primary endpoint Change from baseline in ADHD-RS-5 total score


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MDD with excessive daytime sleepiness symptoms 1. Rush AJ, et al. 2006; 2. Major Depression. NIMH 2023; 3. Hasin DS, et al. 2018; 4. Hein M, et al. 2019 Major depressive disorder (MDD) is one of the most common mental disorders in the U.S., impacting ~21M adults each year2,3 Approximately 50% of patients with MDD also experience excessive daytime sleepiness (EDS)4, for which there are no approved treatments MDD patients with EDS have difficulty maintaining wakefulness, resulting in impaired daily functioning and increased safety risks


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Placebo Solriamfetol (150 mg) CLARITY Phase 3 trial design Key eligibility criteria 18-65 years of age with diagnosis of MDD (DSM-5 criteria) Excessive daytime sleepiness symptoms Open-label Period Double-blind Phase Baseline CLARITY Phase 3 Trial 1:1 R Primary endpoint Time from randomization to relapse of depressive symptoms Solriamfetol (150 mg) 1:1 Randomization (Patients achieving treatment response)


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Binge eating disorder 1. Hudson JI, et al. 2007; 2. Swanson SA, et al. 2011; 3. Kessler RM, et al. 2016; 4. McElroy SL, et al. 2020 BED is thought to involve issues with food reward processing, impulse control, cognitive control, and appetite regulation1,3 Unmet medical need associated with a 2- to 3-fold increased risk of psychiatric and medical comorbidities4 >7 million people in the U.S. have BED1 Binge eating disorder (BED) is the most common eating disorder, affecting 2.8% of adults and 1.6% of adolescents in the US1,2 BED is 1.75x more common in women than in men1


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Solriamfetol inhibits the reuptake of dopamine and norepinephrine, neurotransmitters implicated in the pathophysiology of binge eating disorder1-3 Pre-clinical and clinical data support potential effects of solriamfetol on appetite, food consumption, and weight4,5 Evaluating solriamfetol as a potential treatment for binge eating disorder TAAR1 = Trace amine-associated receptor 1 1. Giel KE, et al. 2022; 2. Bello NT, Hajnal A. 2010; 3. Pruccoli J, et al. 2021; 4. Malhotra A, et al. 2022; 5. SUNOSI [Prescribing Information]. Axsome Therapeutics, Inc. New York, NY. Solriamfetol (150 mg) Solriamfetol (300 mg) Placebo 1:1:1 R Screening (4 weeks) Double-blind Phase (12 weeks) Follow-up (1 week) Baseline ENGAGE Phase 3 Trial N=450 Key eligibility criteria 18-55 years of age with diagnosis of BED (DSM-5) Primary endpoint Change from baseline in days with binge eating episodes


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Shift work has long been associated with multiple serious health complaints and a 23% greater risk of sustaining a work-related injury4-5 Shift work disorder 1. Sateia MJ. 2014; 2. Alterman T, et al. 2013; 3. Wickwire EM. 2017; 4. Smith L, et al. 1994; 5. Akerstedt T, Wright KP. 2009; 6. Czeisler CA, et al. 2005 No new medications approved since 2007 and considerable residual sleepiness reported when medication is used6 ~15 million U.S. workers may suffer from SWD Approximately 1 in 3 people working in the U.S. work an alternate shift2 10-43% have SWD1,3 Shift work disorder (SWD) is a combination of excessive sleepiness during wakefulness and persistent insomnia during daytime sleep when working outside a 7 a.m. to 6 p.m. workday1


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Placebo Solriamfetol (150 mg) Evaluating solriamfetol as a potential treatment for shift work disorder MWT = Maintenance of Wakefulness Test Key eligibility criteria 18-65 years of age with diagnosis of SWD (ICSD-2 or ICSD-3) Screening (1-4 weeks) Double-blind Phase (up to 12 weeks) Baseline SUSTAIN Phase 3 Trial 1:1 R Primary endpoint Change from baseline in MWT N=450 Follow-up (1 week)


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1. Szabo ST, et al. 2019; 2. Krahn LE, Zee PC, Thorpy MJ. 2022; 3. Scammell TE. 2015; 4. Stahl SM, Grady MM. 2003; 5. Burgess CR, Peever JH. 2013; 6. Wu MF, et al. 1999; 7. Bruinstroop E, et al. 2012 Norepinephrine and dopamine play important roles in sleep-wake regulation (both) and in maintaining muscle tone during wakefulness (norepinephrine)1-3 AXS-12 inhibits the reuptake of both neurotransmitters, improving both norepinephrine and cortical dopamine signaling in the brain The loss of orexin input inhibits the production of these neurotransmitters1,2 Decreased norepinephrine signaling is thought to contribute to cataplexy, EDS, and cognitive impairment1,4-7 Decreased dopamine signaling is thought to contribute to EDS and cognitive impairment1,4 Novel pharmacological approach for the treatment of narcolepsy AXS-12 (reboxetine)


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Narcolepsy 1. Narcolepsy Network 2024; 2. Sateia MJ. 2014; 3. Narcolepsy. NINDS 2024; 4. España RA, Scammell TE. 2011; 5. Swick TJ. 2015 Rare and debilitating neurological condition that affects approximately 185,000 people in the U.S.1 Characterized by cataplexy, excessive daytime sleepiness (EDS), hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep2-4 Up to 70% of patients suffer from cataplexy, or the sudden reduction or loss of muscle tone while awake5


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Rate ratio* p=0.007 p=0.006 p=0.031 p=0.031 p=0.018 p<0.001 p=0.002 *Ratio of change in the AXS-12 group divided by the ratio of change in the placebo group (rate ratio of 1 = no difference) CONCERT SYMPHONY Rapid and robust reductions in cataplexy with AXS-12 treatment NDA for AXS-12 for cataplexy in narcolepsy accepted by the FDA with PDUFA target action date of May 1, 2027


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Adapted from Siracusa, R. et al. 2021 Fibromyalgia pain is thought to be partially caused by dysregulated signaling in the descending analgesic system Norepinephrine, one of the key neurotransmitters in this pathway, has predominantly pain-inhibitory effects AXS-14 is a potent and selective enantiomer of racemic reboxetine that inhibits the reuptake of norepinephrine, resulting in increased norepinephrine activity and decreased pain signaling AXS-14 (esreboxetine) Novel pharmacological approach for the management of fibromyalgia (FM)


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Fibromyalgia 1. Vincent, et al. 2013; 3. Choy E, et al. 2010; 3. Arnold LM, et al. 2008; 4. Bair MJ, Krebs EE. 2020; 5. Clauw DJ. 2024 Chronic and debilitating neurological pain syndrome resulting from a dysfunction in central pain processing2,3 Characterized by widespread musculoskeletal pain, fatigue, disturbed sleep, mood disturbances, cognitive impairment, and hypersensitivity to sensory sitmuli4,5 Associated with substantial physical disability and reduced emotional and social wellbeing, financial burden, and reduced quality of life2,3 An estimated ~17 million people in the U.S. are impacted by fibromyalgia1


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Rapid and robust improvements in fibromyalgia symptoms with AXS-14 treatment Baseline * * *** * ** *** *** ** *** *** **** **** **** *** *** **** Baseline * ** *** *** *** ** *** *** ** **** Baseline * * Pain reductiona Phase 3 efficacy results (N=1,122) Efficacy and safety of AXS-14 compared to placebo evaluated in >1,000 individuals with fibromyalgia across Phase 2 and Phase 3 clinical trials for up to 14 weeks Rapid and significant reductions in pain scores, improvements in patient-reported global functioning, fatigue, and overall symptom severity FORWARD Phase 3 trial ongoing a. p-values are defined as: *p<0.05, **p<0.01, ***<0.001, ****p<0.0001


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Placebo AXS-14 (8 mg) FORWARD Phase 3 trial design Key eligibility criteria ≥18 years of age with diagnosis of fibromyalgia Open-label Period (12 weeks) Double-blind Phase (up to 12 weeks) Baseline FORWARD Phase 3 Trial 1:1 R Primary endpoint Time from randomization to loss of therapeutic response AXS-14 (8 mg) 1:1 Randomization (Patients achieving treatment response)


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1. Epilepsy. CDC 2025; 2. Chen Z, et al. 2018 Despite currently available treatment options, <1/3 of patients do not response to treatment2 AXS-17 was safe and well tolerated in clinical studies in >700 patients to date and demonstrated compelling anti-convulsant activity in preclinical seizure models Phase 2 trial-enabling activities underway Epilepsy is a chronic and debilitating neurological disorder affecting ~3.4M people in the U.S.1 Novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator (PAM) for epilepsy AXS-17


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1. Ringeisen H, et al. 2023; 2. Tourette Syndrome. CDC 2025 Potential first-in-class selective PDE10A inhibitor for neuropsychiatric conditions AXS-20 Schizophrenia Demonstrated a favorable safety and tolerability profile in clinical studies in >360 individuals to date Completed a proof-of-concept Phase 2 trial in patients with schizophrenia Phase 3 trial-enabling activities for AXS-20 in schizophrenia underway Tourette syndrome Evaluating AXS-20 as a potential treatment for Tourette syndrome ~3.7M people in the U.S. have schizophrenia and related psychotic disorders1 1 out of every 162 children in the U.S. may suffer from Tourette syndrome2


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Strong intellectual property portfolio AUVELITY AXS-12 SUNOSI AXS-14 SYMBRAVO Product Highlights Protected by a robust patent estate extending to at least 2043, multiple pending Proprietary drug product formulation and methods of treatment Protected by a robust patent estate extending to at least 2042, multiple pending Proprietary drug substance, drug product formulation, and methods of treatment Protected by a robust patent estate extending to at least 2045, multiple pending Proprietary MoSEICTM formulation, drug product formulation, and methods of treatment Orphan Drug Designation Claims extending to at least 2039; 10 issued U.S. patents and 6 issued O.U.S. patents, multiple pending Proprietary drug substance, drug product formulation, and methods of treatment Claims extending to at least 2045; 1 issued U.S. patent, multiple pending Proprietary drug substance, drug product formulation, and methods of treatment


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Leadership team Roger Jeffs, PhDCEO, Liquidia CorporationFormer President, Co-CEO, Director United Therapeutics Corp. Prior positions at Amgen and Burroughs Wellcome Herriot Tabuteau, MDFounder & CEO Management Board of Directors Nick Pizzie, CPA, MBAChief Financial Officer Mark Jacobson, MAChief Operating Officer Hunter Murdock, JDGeneral Counsel Ari MaizelChief Commercial Officer Mark Saad CEO, NuLids, LLCFormer COO of the Global Healthcare Group at UBS Mark Coleman, MDMedical Director, National Spine and Pain CentersDiplomat of the American Board of Anesthesiology Susan Mahony, PhD Former SVP of Eli Lilly and President Lilly Oncology Prior positions at BMS, Amgen and Schering-Plough Herriot Tabuteau, MD Chairman


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Thank you