Definium Therapeutics, Inc 8-K, filed May 24, 2023
Definium Therapeutics, Inc. (DFTX)
About this 8-K
Definium Therapeutics, Inc filed this 8-K on May 24, 2023.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
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.) |
|
|
|
|
||
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s Telephone Number, Including Area Code: (
Not Applicable
(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 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)) |
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 7.01 |
Regulation FD Disclosure. |
On May 24, 2023, Mind Medicine (MindMed) Inc. (the “Company”) issued a press release announcing that the Company will present data on the preclinical activity of MM-402, the Company’s proprietary form of the R-enantiomer of 3,4-Methylenedioxymethamphetamine (“MDMA”), in a model for autism spectrum disorder (“ASD”), at American Society of Clinical Psychopharmacology (ASCP) 2023 Annual Meeting that is being held in Miami Beach, Florida from May 30-June 2, 2023.
In accordance with General Instruction B.2. of Form 8-K, the information in this Item 7.01 and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.
Item 8.01 |
Other Events. |
As disclosed in the Press Release, the Company will present a late-breaking poster entitled “MM-402, R(−)-3,4-Methylenedioxymethamphetamine, Demonstrates Prosocial and Therapeutic-Like Effects in Fmr1 Knockout Mice, a Preclinical Model of Autism Spectrum Disorder (due to Fragile X syndrome),” on Wednesday, May 31, 2023 at 11:15 am ET.
Item 9.01 Financial Statements and Exhibits.
Exhibit No. |
|
Description |
99.1 |
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
MIND MEDICINE (MINDMED) INC. |
|
|
|
|
|
Date: May 24, 2023 |
|
By: |
/s/ Robert Barrow |
|
|
Name: |
Robert Barrow |
|
|
Title: |
Chief Executive Officer |
Exhibit 99.1
MindMed to Present Data on the Preclinical Activity of MM-402 at the American Society of Clinical Psychopharmacology (ASCP) 2023 Annual Meeting
– Preclinical data in ASD model demonstrate prosocial effects of MM-402 –
NEW YORK, May 24, 2023 — Mind Medicine (MindMed) Inc (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today the upcoming presentation of preclinical data of MM-402, the Company’s proprietary form of the R-enantiomer of 3,4-Methylenedioxymethamphetamine (“MDMA”), in a model for autism spectrum disorder (“ASD”) at the ASCP 2023 Annual Meeting that is being held in Miami Beach, FL from May 30-June 2, 2023. The Company plans to initiate its first clinical trial of MM-402 in 2023.
The late-breaking poster entitled “MM-402, R(−)-3,4-Methylenedioxymethamphetamine, Demonstrates Prosocial and Therapeutic-Like Effects in Fmr1 Knockout Mice, a Preclinical Model of Autism Spectrum Disorder (due to Fragile X syndrome),” will be presented on Wednesday, May 31, 2023 at 11:15 am ET. This study demonstrated that administration of MM-402 increased social interaction in a characterized preclinical model of ASD. MM-402 exhibited a robust effect on social interaction and was more potent than racemic MDMA with reduced hyperactivity effects.
“We are very pleased with these promising preclinical data, which provide the first evidence of prosocial activity of MM-402 in an ASD model and support the potential applications to enhancing social functioning in individuals with ASD,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “Importantly, MM-402 was able to achieve increased social interaction without the level of hyperactivity seen with racemic MDMA. With even further preclinical evidence to support our approach, we are extremely excited to initiate our Phase 1 clinical trial of MM-402 later this year.”
In addition to MindMed’s preclinical research program for MM-402, MindMed’s collaborators at University Hospital Basel (“UHB”) in Switzerland are currently enrolling participants in a Phase 1 investigator-initiated trial of R-MDMA, S-MDMA and R/S-MDMA in healthy volunteers. The Phase 1 trial is a randomized, placebo-controlled, double-blind, 5-period crossover study. The trial plans to enroll 24 healthy subjects, who will each receive doses of R-MDMA (125 and 250 mg), S-MDMA (125 mg), MDMA (125 mg), and placebo. Acute subjective effects in this study are being assessed using the Visual Analog Scales (“VAS”) and the 5 Dimensions of Altered States of Consciousness (“5D-ASC”) along with measurement of autonomic, endocrine and mood effects, among others. Additional information about this trial is available on our website (mindmed.co) and on clinicaltrials.gov (identifier: NCT05277636).
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.
Forward-Looking Statements
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding anticipated results and timing of clinical trials and the potential benefits of the Company’s product candidates. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023 under headings such as “Special Note Regarding Forward-Looking Statements,” and “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.
For Media & Investor Inquiries, please contact:
Maxim Jacobs, CFA
Vice President, Investor Relations and Corporate Communications
Mind Medicine (MindMed) Inc.
ir@mindmed.co
media@mindmed.co