AXSM 8-K
Axsome Therapeutics, Inc. (AXSM)
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
May 8, 2020
Date of report (Date of earliest event reported)
Axsome Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-37635 |
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45-4241907 |
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(State or other jurisdiction |
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(Commission |
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(IRS Employer |
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200 Broadway, 3rd Floor |
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10038 |
Registrant’s telephone number, including area code (212) 332-3241
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class: |
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Trading Symbol(s) |
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Name of each exchange on which registered: |
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Common Stock, Par Value $0.0001 Per Share |
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AXSM |
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The Nasdaq Global Market |
Check the appropriate box below if the Form 8-K 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))
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 May 8, 2020, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended March 31, 2020 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.
A copy of the presentation that the Company used in connection with its conference call to discuss its financial results and business update is filed as Exhibit 99.2 hereto and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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99.1 |
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99.2 |
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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.
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Axsome Therapeutics, Inc. |
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Dated: May 8, 2020 |
By: |
/s/ Herriot Tabuteau, M.D. |
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Name: |
Herriot Tabuteau, M.D. |
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Title: |
President and Chief Executive Officer |
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Exhibit 99.1
Axsome Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update
Clinical successes highlight Axsome’s accelerated evolution into a leading CNS company
Positive pivotal Phase 2/3 results for AXS-05 in Alzheimer’s disease agitation further deepen innovative pipeline
Positive efficacy results in 5 significant CNS indications with 4 candidates advance broad late-stage pipeline
Two NDA submissions, for AXS-05 in MDD and AXS-07 in migraine, on track for 4Q 2020
Pre-commercialization activities underway for potentially first-in-class or best-in-class CNS therapies
Company to host conference call today at 8:00 AM Eastern
NEW YORK, May 08, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the first quarter ended March 31, 2020.
“The recent clinical successes in our late-stage pipeline, including positive efficacy data in depression, Alzheimer’s disease agitation, migraine, narcolepsy, and fibromyalgia, highlight Axsome’s accelerated evolution into a leading, innovative CNS company,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “The ability to tackle unmet medical needs in these serious and difficult-to-treat CNS diseases, underscores the importance of our novel investigational medicines. As we move towards the submission of two NDAs in the fourth quarter, one for AXS-05 in depression and one for AXS-07 in migraine, our commercial team is focused on launch-readiness activities to ensure successful commercial execution. In parallel, we look to continue the momentum in our other late-stage development programs, including AXS-05 in Alzheimer’s disease agitation, for which we intend to meet with the FDA after the recently announced positive ADVANCE-1 pivotal trial results in this indication, and AXS-12 in narcolepsy, for which we remain on track to initiate Phase 3 trials later this year.”
CNS Pipeline Update
Axsome is developing a portfolio of differentiated, patent-protected, central nervous system (CNS) product candidates. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. The Company’s CNS pipeline includes four differentiated product candidates in active clinical development.
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AXS-05: AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is Axsome’s novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the following indications: major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimer’s disease (AD) agitation, and smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of MDD and Fast Track designations for the treatment of TRD and for the treatment of AD agitation. |
Depression: Axsome remains on track to submit a New Drug Application (NDA) for AXS-05 in MDD to the FDA in the fourth quarter of 2020. The NDA is supported by positive efficacy results from the ASCEND and GEMINI trials. A Phase 3, open-label, long-term safety extension study of AXS-05 in patients with MDD and TRD is ongoing to further support the NDA filing. To date, more than 800 patients have been dosed in this trial.
In March 2020, Axsome announced results from the Phase 3 STRIDE-1 study, a randomized, double-blind, active-controlled, multicenter, U.S. trial, in patients with confirmed TRD. In this study, AXS-05 met key secondary endpoints by rapidly and statistically significantly improving symptoms of depression as compared to the active comparator bupropion. A second Phase 3 trial of AXS-05 in TRD is planned for the third quarter of 2020.
AD Agitation: In April 2020, Axsome announced positive results from the Phase 2/3 ADVANCE-1 study, a randomized, double-blind, controlled, multicenter, U.S. trial in patients with AD agitation. In this study, AXS-05 met the primary endpoint by rapidly, substantially, and statistically significantly improving agitation in patients with AD as compared to placebo. Axsome intends to meet with the FDA to discuss these results and next steps in this development program.
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Smoking Cessation: Axsome plans to meet with the FDA in the second half of 2020 to discuss the continued clinical development of AXS-05 as an aid to smoking cessation treatment. Axsome previously announced positive results from a Phase 2 trial of AXS-05 for smoking cessation treatment conducted under a research collaboration between Axsome and Duke University.
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AXS-07: AXS-07 (MoSEIC™ meloxicam/rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine. |
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Migraine: Axsome remains on track to submit an NDA for AXS-07 in the acute treatment of migraine to the FDA in the fourth quarter of 2020. The NDA is supported by positive efficacy results from the MOMENTUM and INTERCEPT trials. A Phase 3, open-label, long-term safety extension study of AXS-07 is ongoing to further support the NDA filing. To date, more than 700 patients have been dosed in this trial. |
In April 2020, Axsome announced positive results from the Phase 3 INTERCEPT study, a randomized, double-blind, placebo-controlled, multicenter, U.S. trial, in the early treatment of migraine. In this study, AXS-07 met the two co-primary endpoints resulting in significantly greater rates of freedom from migraine pain and most bothersome migraine-associated symptoms as compared to placebo. AXS-07 also substantially and significantly prevented progression of migraine pain intensity.
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AXS-12: AXS-12 (reboxetine) is Axsome’s novel, oral, potent, and highly selective norepinephrine reuptake inhibitor for the treatment of narcolepsy. AXS-12 has been granted Orphan Drug Designation by the FDA for the treatment of narcolepsy. |
Narcolepsy: Axsome is on track to initiate Phase 3 trials of AXS-12 in the treatment of narcolepsy in the second half of 2020. Axsome previously announced positive results from the Phase 2 CONCERT study, in which AXS-12 significantly reduced the number of cataplexy attacks and excessive daytime sleepiness as compared to placebo in patients with narcolepsy.
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AXS-14: AXS-14 (esreboxetine) is Axsome’s novel, oral, potent, and highly selective norepinephrine reuptake inhibitor for the treatment of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. |
Fibromyalgia: Axsome plans to meet with the FDA in the second half of 2020 to discuss the further clinical development of AXS-14 for the treatment of fibromyalgia. AXS-14 has previously met the primary endpoints and demonstrated positive and statistically significant results in a Phase 3 and a Phase 2 trial in the treatment of fibromyalgia.
Anticipated Milestones
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NDA Filings: |
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AXS-05 in the treatment of MDD (4Q 2020) |
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AXS-07 in the acute treatment of migraine (4Q 2020) |
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FDA Meetings: |
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AXS-14 for fibromyalgia (2H 2020) |
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AXS-05 for smoking cessation (2H 2020) |
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Clinical Trial Initiations: |
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Phase 3 trial of AXS-05 in TRD (3Q 2020) |
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Phase 3 trials of AXS-12 in the treatment of narcolepsy (2H 2020) |
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Phase 3 trial of AXS-05 in Alzheimer’s disease agitation (2H 2020) |
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First Quarter 2020 Financial Results
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Research and development (R&D) expenses: R&D expenses were $27.5 million for the quarter ended March 31, 2020 and $7.6 million for the comparable period in 2019. R&D expense in the quarter included a one-time charge of $10.2 million for the Pfizer license agreement, of which $7.2 million was non-cash related. The remaining increase was due primarily to ongoing spend for our active clinical trials in the quarter which included the STRIDE-1, ADVANCE-1, and INTERCEPT trials, close-out costs for our previously completed GEMINI, MOMENTUM, and CONCERT trials, along with costs associated with the AXS-05 and AXS-07 open-label safety studies. |
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General and administrative (G&A) expenses: G&A expenses were $5.0 million for the quarter ended March 31, 2020 and $2.8 million for the comparable period in 2019. The change was primarily due to personnel costs, mainly associated with an increase in stock compensation expense, along with the build-out of the commercial function. |
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Net loss: Net loss was $32.5 million, or $(0.88) per share for the quarter ended March 31, 2020, compared to a net loss of $10.6 million, or $(0.32) per share for the comparable period in 2019. |
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Cash: At March 31, 2020, Axsome had $197.3 million of cash compared to $220.0 million of cash at December 31, 2019. |
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Shares outstanding: At March 31, 2020, Axsome had 37,075,422 shares of common stock outstanding. |
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Financial Guidance: Axsome believes that its cash at March 31, 2020 will be sufficient to fund the company’s anticipated operations, based on its current operating plans, for at least two years. |
Conference Call Information
Axsome will host a conference call and webcast with slides today at 8:00 AM Eastern to discuss first quarter 2020 financial results as well as to provide a corporate update. To participate in the live conference call, please dial (833) 579-0911 (toll-free domestic) or (778) 560-2804 (international), and use the conference ID 4088615. The live webcast can be accessed on the "Webcasts & Presentations" page of the "Investors" section of the Company's website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. Axsome’s core CNS product candidate portfolio includes five clinical-stage candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimer’s disease (AD) agitation, and as treatment for smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of narcolepsy. AXS-14 is being developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 are investigational drug products not approved by the FDA. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We 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 success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, 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 our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority
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approval of, or other action with respect to, our product candidates (including, but not limited to, FDA’s agreement with the Company’s discontinuation of the bupropion treatment arm of the ADVANCE-1 study in accordance with the independent data monitoring committee’s recommendations); the potential for the MOMENTUM clinical trial to provide a basis for approval of AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment; the potential for the ASCEND clinical trial, combined with the GEMINI clinical trial results, to provide a basis for approval of AXS-05 for the treatment of major depressive disorder and accelerate its development timeline and commercial path to patients; 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 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 product candidates, if approved; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; 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 circumstance.
Axsome Therapeutics, Inc.
Selected Consolidated Financial Data
Statements of Operations Information:
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Three months ended |
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March 31, |
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2020 |
2019 |
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Operating expenses: |
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Research and development |
$ |
27,521,400 |
$ |
7,603,081 | |||
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General and administrative |
4,970,057 | 2,818,392 | |||||
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Total operating expenses |
32,491,457 | 10,421,473 | |||||
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Loss from operations |
(32,491,457 |
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(10,421,473 |
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Interest income (expense) |
7,311 | (218,903 |
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Net loss |
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(32,484,146 |
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(10,640,376 |
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Net loss per common share, basic and diluted |
$ |
(0.88 |
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$ |
(0.32 |
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Weighted average common shares outstanding, basic and diluted |
37,061,356 | 33,052,468 | |||||
Balance Sheet Information:
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March 31, 2020 |
December 31, 2019 |
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Cash and cash equivalents |
$ |
197,313,408 |
$ |
219,966,167 | |||
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Total assets |
197,800,871 | 220,549,760 | |||||
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Loan payable, current and long-term |
20,112,570 | 19,934,918 | |||||
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Accumulated deficit |
(208,379,639 |
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(175,895,493 |
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Stockholders’ equity |
$ |
156,156,866 |
$ |
178,722,389 | |||
Axsome Contact:
Mark Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
200 Broadway, 3rd Floor
New York, NY 10038
Tel: 212-332-3243
Email: [email protected]
www.axsome.com
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Exhibit 99.2
| NASDAQ: AXSM 1Q 2020 Financial Results and Business Update May 8, 2020 © Axsome Therapeutics, Inc. |
| Certain information contained in this presentation may include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We 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 success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials and the number or type of studies or nature of results necessary to support the filing of a new drug application for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates (including, but not limited to, FDA’s agreement with the Company’s discontinuation of the bupropion treatment arm of the ADVANCE-1 study in accordance with the independent data monitoring committee’s recommendations); the Company’s ability to obtain additional capital necessary to fund its operations; the Company’s ability to generate revenues in the future; the potential for the MOMENTUM clinical trial to provide a basis for approval of AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment; the potential for the ASCEND clinical trial, combined with the GEMINI clinical trial results, to provide a basis for approval of AXS-05 for the treatment of major depressive disorder and accelerate its development timeline and commercial path to patients; 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 successful implementation of the Company’s research and development programs and collaborations; the enforceability of the Company’s license agreements; the acceptance by the market of the Company’s product candidates, if approved; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. These factors could cause actual results and developments to be materially different from those expressed in or implied by such statements. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those projected. 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 circumstance. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other data about our 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. 2 Forward-Looking Statements & Safe Harbor © Axsome Therapeutics, Inc. FLS |
| 3 © Axsome Therapeutics, Inc. Axsome Therapeutics 1Q 2020 Financial Results and Business Update Agenda Introduction Mark Jacobson, Chief Operating Officer Business Update Herriot Tabuteau, MD, Chief Executive Officer Financial Results Nick Pizzie, Chief Financial Officer Q&A Presenters Dave Marek, Chief Commercial Officer Cedric O’Gorman, MD, Sr VP Clinical Development & Medical Affairs Concluding Remarks Herriot Tabuteau, MD, Chief Executive Officer |
| • Clinical successes highlight Axsome’s accelerated evolution into a leading CNS company • Positive efficacy results in 5 significant CNS indications with 4 differentiated product candidates advance Axsome’s broad late-stage pipeline • Positive pivotal Phase 2/3 results for AXS-05 in Alzheimer’s disease agitation further deepen Axsome’s innovative pipeline • Two NDA submissions, for AXS-05 in MDD and AXS-07 in migraine, are on track for 4Q 2020 • Pre-commercialization activities are underway for our potentially first-in-class or best-in-class CNS therapies 4 Axsome Therapeutics 1Q 2020 © Axsome Therapeutics, Inc. Corporate |
| 4M (~70% of 6M AD patients) 5 Our late-stage portfolio has generated positive data in conditions that affect >60M U.S. patients © Axsome Therapeutics, Inc. Corporate Major Depressive Disorder Treatment Resistant Depression Migraine Alzheimer’s Disease Agitation Narcolepsy Fibromyalgia NDA Submission 4Q 2020 Rapid Efficacy Demonstrated NDA Submission 4Q 2020 Positive Phase 2/3 Results Positive Phase 2 Results Positive Phase 3 Results 17M (of which 6M are TRD) 37M 5M 185K |
| 6 Late-Stage Indications with Potential Total U.S. Peak Sales of Up to $9B Corporate Program/ MOA Indication Launch Year Est. Est. Peak U.S. Sales Key Highlights AXS-05 NMDA receptor antagonist with multimodal activity MDD 2021 $1B - $2B • Novel, oral, NMDA receptor antagonist • Rapid and substantial effect, as early as week 1 • Breakthrough Therapy Designation TRD 2023 $0.5B - $1B • Symptom improvement in resistant population • Rapid and substantial effect, as early as week 1 • Improvement in cognitive function observed Alzheimer’s Disease Agitation 2023 $1.5B - $3B • Rapid and substantial effect, as early as week 2 • Not associated with cognitive impairment or sedation • Currently no approved products for AD agitation AXS-07 MoSEIC™ COX-2 pref. inhibitor + 5-HT1B/1D agonist Migraine 2021 $0.5B - $1B • Superior efficacy vs. gold standard in patients with history of inadequate response • Prevention of pain progression with early treatment; rapid relief AXS-12 Highly selective NE reuptake inhibitor Narcolepsy 2023 $0.5B - $1B • Improved cataplexy, EDS, cognitive function • Daytime dosing; well tolerated • Not expected to be scheduled AXS-14 Highly selective NE reuptake inhibitor Fibromyalgia 2023 $0.5B - $1B • Reduced pain and improved function • Effect on fatigue, a difficult-to-treat symptom • Only 3 approved treatments © Axsome Therapeutics, Inc. |
| 7 AXS-05 Depression Franchise © Axsome Therapeutics, Inc. Depression MDD NDA-Enabling Efficacy Studies: 1:1 Status: 1:1 inadequate responders Bupropion Open Label Safety Study: AXS-05 Positive results Bupropion AXS-05 Met key secondary endpoints • Completion expected 3Q 2020 TRD Efficacy Study: Placebo AXS-05 Bupropion AXS-05 Positive results 6 months, N=300 1 year, N = 100 1:1 1 1 ASCEND (N=80) GEMINI (N=327) STRIDE-1 (N=799) |
| 1:1 8 AXS-07 Migraine Program © Axsome Therapeutics, Inc. Migraine NDA-Enabling Efficacy Studies: Status: Placebo AXS-07 Rizatriptan AXS-07 2:2:2:1 Placebo MoSEIC™ Meloxicam Positive results Positive results Open Label Safety Study: AXS-07 • Completion expected 3Q 2020 6 months, N=300 1 year, N = 100 1 INTERCEPT (N=302) MOMENTUM (N=1594) |
| 9 AXS-05 Alzheimer’s Disease Agitation © Axsome Therapeutics, Inc. AD Agitation Status: ADVANCE-2 (N=TBD) NDA-Enabling Efficacy Studies: ADVANCE-1 (N=366) Randomization Bupropion AXS-05 Placebo Positive results • Initiation 2H 2020 Placebo AXS-05 1:1 |
| Financial Update 10 © Axsome Therapeutics, Inc. Nick Pizzie CHIEF FINANCIAL OFFICER AXSOME THERAPEUTICS, INC. |
| 11 Key Financial Information © Axsome Therapeutics, Inc. Financial • Financial guidance: Cash anticipated to fund operating requirements for at least two years. (in millions) 1Q '20 4Q '19 Cash and Cash Equivalents $ 197.3 $ 220.0 1Q '20 1Q '19 Research & Development $ 27.5 $ 7.6 General & Administrative $ 5.0 $ 2.8 Interest Expense $ - $ 0.2 Net Loss $ 32.5 $ 10.6 One-time Expense - Pfizer License Agreement $ 10.2 $ - Pro-forma Net Loss $ 22.3 $ 10.6 |
| 12 Q&A © Axsome Therapeutics, Inc. |
| Concluding Remarks 13 © Axsome Therapeutics, Inc. Herriot Tabuteau, MD CHIEF EXECUTIVE OFFICER AXSOME THERAPEUTICS, INC. |
| • Four differentiated clinical-stage CNS assets targeting significant and growing markets • Patent protection to 2034-2036, worldwide rights for most product candidates Product Candidate Phase 1 Phase 2 Phase 3 NDA AXS-05 (DM + BUP) AXS-07 (MoSEIC™ Mx + Riz) AXS-12 (Reboxetine) AXS-14 (Esreboxetine) Abbreviations: BUP = Bupropion; CNS = Central Nervous System; DM = Dextromethorphan; Mx = Meloxicam; Riz = Rizatriptan; Migraine Major Depressive Disorder: Breakthrough Therapy Designation Treatment Resistant Depression: Fast Track Designation Alzheimer’s Disease Agitation: Fast Track Designation Smoking Cessation Narcolepsy: U.S. Orphan Designation 14 Our CNS Candidates and Pipeline Overview © Axsome Therapeutics, Inc. Fibromyalgia |
| 15 Our Clinical and Regulatory Milestones Corporate Product Candidate Indication 2020 AXS-05 (DM + BUP) MDD ● NDA submission (4Q) TRD ✓ STRIDE-1 Phase 3 topline results ● Phase 3 trial start (3Q) AD Agitation ✓ ADVANCE-1 Phase 3 topline results ● ADVANCE-2 trial start (2H) Smoking Cessation ● FDA meeting (2H) AXS-07 (MoSEIC™ Mx + Riz) Migraine ✓ INTERCEPT Phase 3 topline results ● NDA submission (4Q) AXS-12 (Reboxetine) Narcolepsy ● Phase 3 trial start (2H) AXS-14 (Esreboxetine) Fibromyalgia ● FDA meeting (2H) Abbreviations: AD = Alzheimer’s Disease; BUP = Bupropion; DM = Dextromethorphan; MDD = Major Depressive Disorder; Mx = Meloxicam; Riz = Rizatriptan; TRD = Treatment Resistant Depression ✓ Accomplished milestone ● Upcoming milestone © Axsome Therapeutics, Inc. |
| For more information, please contact Mark Jacobson Chief Operating Officer 212-332-3243 [email protected] axsome.com |
