UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(D)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported)
(Exact name of registrant as specified in its charter)
|
|
|
|
|
|
|
|
|
|
|
|
|
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
|
|
|
|
|
|
22 Cortlandt Street, 16th Floor |
|
|
|
|
|
(Address of principal executive offices) |
|
|
|
(Zip Code) |
|
|
|
|
|
|
Registrant’s telephone number, including area code (
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
|
|
|
|
|
|
|
Title of each class: |
|
Trading Symbol(s) |
|
Name of each exchange on which registered: |
|
|
|
|
|
|
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 8.01 Other Events.
On February 24, 2021, Axsome Therapeutics, Inc. (the “Company”), updated its corporate presentation and posted such corporate presentation to the Company’s website. The updated corporate presentation was also presented at the 10th Annual SVB Leerink Global Healthcare Conference. The updated corporate presentation is filed as Exhibit 99.1 hereto and incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
|
|
|
|
|
Exhibit No. |
|
Description |
|
|
|
|
|
99.1 |
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
1
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. |
||
|
|
|
|
|
|
|
Dated: February 24, 2021 |
|
By: |
|
/s/ Herriot Tabuteau, M.D. |
|
|
|
Name: |
|
Herriot Tabuteau, M.D. |
|
|
|
Title: |
|
President and Chief Executive Officer |
2
Corporate Presentation SVB Leerink Global Healthcare Conference February 24, 2021 © Axsome Therapeutics, Inc. Exhibit 99.1
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 For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. © Axsome Therapeutics, Inc.
Four differentiated clinical-stage CNS assets targeting significant and growing markets Patent protection to 2034-2040, worldwide rights for most product candidates Migraine Major Depressive Disorder: Breakthrough Therapy Designation Alzheimer’s Disease Agitation: Breakthrough Therapy Designation Smoking Cessation Narcolepsy: Orphan & Breakthrough Therapy Designations 4 Our CNS Candidates and Pipeline Overview © Axsome Therapeutics, Inc. Fibromyalgia
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 17M 37M 5M 185K
Novel therapy for CNS disorders: Major Depressive Disorder (MDD) Agitation in Alzheimer’s Disease (AD) Smoking Cessation 6 © Axsome Therapeutics, Inc. (dextromethorphan/bupropion) modulated delivery tablet AXS-05
7 Major Depressive Disorder: High Unmet Needs © Axsome Therapeutics, Inc. AXS-05 1) Internal primary market research; 2) Thomas, D., & Wessel, C. (2017). The State of Innovation in Highly Prevalent Chronic Diseases: Volume 1: Depression Therapies, BIO 3) Rush AJ, et al. Am J Psychiatry 2006;163:1905-1917; 4) Machado-vieira R, Salvadore G, Luckenbaugh DA, Manji HK, Zarate CA. J Clin Psychiatry. 2008;69(6):946-958. 5) Ferguson JM. Prim Care Companion J Clin Psychiatry. 2001;3(1):22-27
8 Prevalence of Depression Symptoms Before and During Pandemic © Axsome Therapeutics, Inc. AXS-05 Depression increased more than 3 fold due to pandemic and skewed toward those with more severe symptoms 1) Ettman CK, Abdalla SM, Cohen GH, Sampson L, Vivier PM, Galea S. Prevalence of Depression Symptoms in US Adults Before and During the COVID-19 Pandemic. JAMA Netw Open. 2020;3(9):e2019686. doi:10.1001/jamanetworkopen.2020.19686 22M U.S. Adults with Depression Symptoms prior to the Pandemic1 71M U.S. Adults with Depression Symptoms during the Pandemic1
9 No new oral MOA to treat MDD in over 60 years © Axsome Therapeutics, Inc. AXS-05 Source: Thomas, D., & Wessel, C. (2017). The State of Innovation in Highly Prevalent Chronic Diseases: Volume 1: Depression Therapies, BIO.
10 GEMINI Study of AXS-05 in MDD: MADRS Change and Remission © Axsome Therapeutics, Inc. AXS-05 Change in MADRS Total Score Achievement of Remission Abbreviations: DM = Dextromethorphan; BUP = Bupropion. Major Depressive Disorder: Breakthrough Therapy Designation
11 Alzheimer’s Disease Agitation: High Unmet Medical Need © Axsome Therapeutics, Inc. AXS-05 1Alzheimer’s Association. Alzheimers Dement. 2020;16(3):391+. 2Tractenberg R, et al. J Neuropsychiatry Clin Neurosci. 2002;14:11-18. 3Porsteinsson AP, et al. Expert Opin Pharmacother. 2017; 18:6, 611-620. 4Rabins PV et al. Alzheimers Dement. 2013; 9:204-207. Agitation is seen in up to 70% of Alzheimer’s Disease (AD) patients2: Emotional distress, aggressive behaviors, disruptive irritability, and disinhibition Managing agitation is a major priority in AD3,4: Associated with accelerated cognitive decline, earlier nursing home placement, and increased mortality risk No approved medication = high unmet medical need: U.S. Patients Current and Projected1,2
12 AXS-05: Alzheimer’s Disease Agitation © Axsome Therapeutics, Inc. AXS-05 Primary endpoint met in ADVANCE-1 pivotal Phase 2/3 trial Second pivotal trial initiated – ACCORD Phase 3, placebo-controlled, randomized withdrawal trial FDA Breakthrough Therapy Designation received Abbreviations: DM = Dextromethorphan; BUP = Bupropion. 1Alzheimer’s Association. Alzheimers Dement. 2020;16(3):391+. 2Tractenberg R, et al. J Neuropsychiatry Clin Neurosci. 2002;14:11-18. 3Porsteinsson AP, et al. Expert Opin Pharmacother. 2017; 18:6, 611-620. 4Rabins PV et al. Alzheimers Dement. 2013; 9:204-207. ADVANCE-1 Study: Change in CMAI Total Score
Novel therapy for: Migraine 13 (MoSEIC™ meloxicam/rizatriptan) AXS-07 © Axsome Therapeutics, Inc.
14 AXS-07: MoSEIC™ Meloxicam + Rizatriptan for Migraine © Axsome Therapeutics, Inc. AXS-07 Unmet need for improved efficacy in migraine: disability on par with dementia, quadriplegia, active psychosis1,2 AXS-07: novel, oral, rapidly absorbed, multi-mechanistic Rapid and sustained efficacy as compared to placebo and active comparator rizatriptan, in three positive Phase 3 trials: MOMENTUM, in patients with history of inadequate response, vs. placebo and rizatriptan INTERCEPT, in early treatment, vs. placebo MOVEMENT, long-term open-label treatment, up to 12 months NDA submission planned early 2Q 2021 1Menken et al. Arch Neurol. 2000;57:418-420. 2Shapiro and Goadsby. Cephalalgia. 2007;27:991-4. Migraine NDA Submission Planned INTERCEPT Study: Migraine Pain Freedom
Novel therapy for: Narcolepsy 15 (reboxetine) AXS-12 © Axsome Therapeutics, Inc.
Debilitating sleep disorder characterized by excessive daytime sleepiness and cataplexy Limited treatment options Positive Phase 2 results with AXS-12 Significant reduction in cataplexy attacks and EDS Significant improvement in cognitive function Phase 3 trial initiation anticipated in 2Q 2021 16 AXS-12 (reboxetine): Narcolepsy AXS-12 © Axsome Therapeutics, Inc. Phase 3 Planned CONCERT Study: Change in Weekly Cataplexy Attacks
Novel therapy for: Fibromyalgia 17 esreboxetine AXS-14 © Axsome Therapeutics, Inc.
18 AXS-14 (esreboxetine): Fibromyalgia Overview © Axsome Therapeutics, Inc. AXS-14 Debilitating, chronic, CNS disorder characterized by widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment; ~90% affected are women Limited treatment options—only 3 approved agents: Current treatments has variable efficacy and do not address all symptoms AXS-14 (esreboxetine) is the SS-enantiomer of racemic reboxetine Positive Phase 3 and Phase 2 efficacy results with AXS-14 in fibromyalgia FDA meeting anticipated 2Q 2021 Decision Resources Group 2019
19 Barriers to Entry © Axsome Therapeutics, Inc. Corporate >50 Issued U.S. Patents >40 Issued O-U.S. Patents Claims extending to 2034-40 >40 pending Proprietary Manufacturing Drug Product Formulation >40 issued U.S. Patents >40 issued O-U.S. Patent Claims extending to 2036 >40 pending Proprietary Manufacturing Drug Product Formulation AXS-14 AXS-12 Pending U.S. Patents Pending U.S. Patents Orphan Drug Designation
20 Our Team © Axsome Therapeutics, Inc. Corporate Management Herriot Tabuteau, MD Founder & CEO Nick Pizzie, CPA, MBA Chief Financial Officer Mark Jacobson, MA Chief Operating Officer Kevin Laliberte, PharmD EVP, Product Strategy Lori Englebert SVP, Commercial & Business Dev. Amanda Jones, PharmD SVP, Clinical Development Cedric O’Gorman, MD, MBA SVP, Medical Affairs Board of Directors Roger Jeffs, PhD Former President, Co-CEO, Director United Therapeutics Corp. Prior positions at Amgen and Burroughs Wellcome Mark Saad Former CFO Bird Rock Bio, Inc. Former COO of the Global Healthcare Group at UBS Mark Coleman, MD President National Spine and Pain Centers Diplomat of the American Board of Anesthesiology Herriot Tabuteau, MD Chairman
21 Our Clinical and Regulatory Milestones Corporate © Axsome Therapeutics, Inc.
For more information, please contact Mark Jacobson Chief Operating Officer 212-332-3243 mjacobson@Axsome.com axsome.com