MindMed Announces the Start of the First-Ever Clinical Trial Combining MDMA and LSD

- MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company, announced today the start of the first ever clinical trial measuring and evaluating MDMA and LSD used in combination in the human body. The trial will be conducted at the University Hospital Basel Liechti Lab, in Basel, Switzerland .

If administered in combination with LSD, MDMA may increase positive subjective drug effects, including positive mood and empathy, and reduce the negative emotions and anxiety that are sometimes associated with LSD - producing an overall more positive experience.

MindMed is undertaking a Phase 1 clinical trial to evaluate if MDMA, when balanced and used in combination with LSD, can help offset some of the known potential unpleasant effects of LSD that occur in therapy or clinical settings. MindMed is interested in understanding how to balance both MDMA and LSD in a cohesive way to create better patient outcomes, and develop more advanced psychedelic assisted therapies, as MindMed expands both its R&D and commercial drug development pipeline. The study is anticipated to take around one year to complete.

President of MindMed, Dr. Miri Halperin Wernli added, "I believe that when LSD and MDMA are taken together they have exceptional potential to open a window into our mind which will awaken it to new levels of awareness by changing the fluidity of the ‌state‌ ‌of‌ ‌consciousness, amplifying‌ ‌changed‌ ‌perceptions,‌ ‌intensifying ‌emotions‌, ‌and‌ stimulating ‌novel‌ ‌thoughts. It is like a gateway to a multidimensional universe.‌"

The Phase 1 double-blind, placebo-controlled, 4-period crossover design study officially began this week and will assess subjective and autonomic effects aiming to determine the qualitative emotional differences between a combined MDMA and LSD experience, a pure LSD experience and a pure MDMA experience, versus a placebo.

LSD in other Phase 1 clinical trials has demonstrated an acute subjective effect on the serotonin 5-HT2A receptor stimulation, leading to ego dissolution and neuroplasticity. These properties of LSD are thought to have therapeutic effects on patients suffering from mental disorders. However, in some instances unpleasant effects can occur in therapy, causing distress to the subject through acute anxiety.

If MindMed finds the Phase 1 trial results promising, it will work with expert clinicians to undertake patient studies with treatments combining MDMA and LSD for various potential indications and mental disorders. With its recent capital raise resulting in a total of CAD $237.2m (USD $183.8m) raised to date and the essential addition of Robert Barrow as Chief Development Officer, MindMed is well positioned to capitalize on research advancements resulting from groundbreaking studies such as this.

More details on the clinical trial can be found here: https://clinicaltrials.gov/ct2/show/NCT04516902

About MindMed

MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company's groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.

MindMed trades on the Canadian exchange NEO under the symbol MMED . MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ . For more information: www.mindmed.co

MindMed Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and performance of Mind Medicine (MindMed) Inc. ("MindMed"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, MindMed's and its collaborators' ability to continue to conduct research and clinical programs, MindMed's ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, "Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Products and Product candidates and research and clinical programs now underway or planned; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Product candidates and new indications for Products; unforeseen safety issues resulting from the administration of Products and Product candidates in patients, including serious complications or side effects in connection with the use of MindMed's Products and product candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict MindMed's ability to continue to develop or commercialize Products; ongoing regulatory obligations and oversight impacting Products, research and clinical programs, and business, including those relating to patient privacy; uncertainty of market acceptance and commercial success of Products and Product candidates and the impact of studies on the commercial success of Products and Product candidates; the availability and extent of reimbursement of Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; competing drugs and product candidates that may be superior to Products and Product candidates; the extent to which the results from the research and development programs conducted by MindMed or its collaborators may be replicated in other studies and lead to therapeutic applications; the ability of MindMed to manufacture and manage supply chains for multiple products and product candidates; the ability of MindMed's collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labelling, distribution, and other steps related to MindMed's Products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of MindMed to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, other litigation and other proceedings and government investigations relating to MindMed and its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on MindMed's business, prospects, operating results, and financial condition. Any forward-looking statements are made based on management's current beliefs and judgment. MindMed does not undertake any obligation to update publicly any forward-looking statement.

Media Contact: mindmed@150bond.com

View original content to download multimedia: https://www.prnewswire.com/news-releases/mindmed-announces-the-start-of-the-first-ever-clinical-trial-combining-mdma-and-lsd-301211436.html

SOURCE Mind Medicine (MindMed) Inc.

View original content to download multimedia: https://www.newswire.ca/en/releases/archive/January2021/20/c7802.html

News Provided by Canada Newswire via QuoteMedia

Mind Medicine AQN:MMED MMEDF Psychedelics Investing

Seelos Therapeutics Announces 1-for-8 Reverse Stock Split

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its Board of Directors approved a 1-for-8 reverse stock split of its outstanding shares of common stock, to be effective as of 12:01 a.m. Eastern Time on Thursday May 16, 2024.

The Company's common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on Thursday, May 16, 2024 . Following the reverse stock split, the Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "SEEL" with the new CUSIP number, 81577F307. The reverse stock split is intended for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market.

At the effective time of the reverse split, every 8 issued and outstanding shares of the Company's common stock will be converted automatically into one share of the Company's common stock without any change in the par value per share. No fractional shares will be issued in connection with the reverse stock split, and fractional shares resulting from the reverse stock split will be rounded up to the nearest whole share. The reverse stock split will reduce the number of authorized shares of the Company's common stock from 400,000,000 shares to 50,000,000 shares and the ownership percentage of each stockholder will remain unchanged other than as a result of fractional shares. In addition, the reverse stock split will apply to the Company's common stock issuable upon the exercise of the Company's outstanding warrants and stock options, with proportionate adjustments to be made to the exercise prices thereof and under the Company's equity incentive plans, as applicable.

The reverse stock split will reduce the number of issued and outstanding shares of the Company's common stock from approximately 17.4 million to approximately 2.2 million.

About Seelos Therapeutics:

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

Forward-Looking Statements:

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the reverse stock split and the timing thereof, the potential impact of the reverse split on the bid price of the Company's common stock, the potential for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market and the expected number of shares of common stock to be outstanding following the reverse stock split. These statements are based on our current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties involved include those associated with general economic and market conditions, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information

Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2 ^nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-announces-1-for-8-reverse-stock-split-302144966.html

SOURCE Seelos Therapeutics, Inc.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Compass Pathways Announces First Quarter 2024 Financial Results and Business Highlights

COMP360 phase 3 pivotal program in treatment-resistant depression (TRD) on track for top-line COMP005 trial data in fourth quarter 2024, COMP006 trial top-line data expected mid-2025
Compass announces positive phase 2 COMP360 data in post-traumatic stress disorder (PTSD)
Michael Gold to join Compass as Head of R&D
Compass enters into additional commercial collaborations, including with Reliant Medical Group, part of Optum Care
Cash position of $262.9 million at March 31, 2024
Conference call May 8 at 8:00 am ET (1:00 pm UK)

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2024 and provided an update on recent business progress.

Kabir Nath, Chief Executive Officer, said, "We were pleased to see the positive results from the phase 2 PTSD study, a condition with significant unmet need and limited therapeutic options for the people who live with it. PTSD is a logical extension for COMP360 psilocybin treatment as there is significant overlap in patients living with treatment-resistant depression and PTSD. These strong data enable us to explore the optimal path forward to advance clinical development in PTSD alongside our phase 3 pivotal program in TRD, which is on track for initial data this year. We also continue to prepare for commercialization of COMP360 in TRD if approved by the FDA and have established collaborations with important mental health providers in the US to investigate models for the delivery of COMP360 psilocybin treatment at scale in diverse care settings."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Compass Pathways announces durable improvement in symptoms through 12 weeks in open-label phase 2 study of COMP360 psilocybin in post-traumatic stress disorder

Study met primary safety endpoint; administration was well tolerated, with no serious adverse events observed
Early and clinically meaningful improvement from baseline in mean CAPS-5 total score (29.5 point reduction at week 12), with change from baseline in mean SDS total score (14.4 point reduction at week 12)
81.8% response (reduction of ≥ 15 points in CAPS-5 score), 63.6% remission (total CAPS-5 ≤ 20) rates at week 4 with 77.3% response and 54.5% remission at week 12
Measures of symptom scores relative to baseline improved following a single 25mg dose administered with psychological support (n=22)

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today announced top-line results from an open-label phase 2 study evaluating the safety and tolerability of investigational COMP360 psilocybin treatment in 22 patients with post-traumatic stress disorder (PTSD). The study met its primary safety endpoint and available secondary efficacy endpoints. Study observations included meaningful and sustained symptom improvement from baseline in mean CAPS-5 total score, a measure of disease severity, and in Sheehan Disability Scale (SDS) score, a measure of functional impairment in daily life. Administration of COMP360 was well-tolerated, with a safety profile consistent with previous studies.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

	March 31,		December 31,
	2024		2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	262,888	$	220,198
Restricted cash	389		440
Prepaid income tax	1,123		1,123
Prepaid expenses and other current assets	31,115		39,535
Total current assets	295,515		261,296
NON-CURRENT ASSETS:
Operating lease right-of-use assets	3,722		4,306
Deferred tax assets	3,659		3,336
Long-term prepaid expenses and other assets	6,097		7,049
Total assets	$	308,993	$	275,987
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable	$	9,342	$	5,892
Accrued expenses and other liabilities	7,680		11,301
Operating lease liabilities - current	2,380		2,411
Total current liabilities	19,402		19,604
NON-CURRENT LIABILITIES
Long-term debt	29,090		28,757
Operating lease liabilities - non-current	1,339		1,882
Total liabilities	49,831		50,243
SHAREHOLDERS' EQUITY:
Ordinary shares, £0.008 par value; 68,342,534 and 61,943,471 shares authorized, issued and outstanding at March 31, 2024 and December 31, 2023, respectively	699		635
Additional paid-in capital	690,222		621,645
Accumulated other comprehensive loss	(16,962)		(16,926)
Accumulated deficit	(414,797)		(379,610)
Total shareholders' equity	259,162		225,744
Total liabilities and shareholders' equity	$	308,993	$	275,987

	Three months ended March 31,
	2024		2023
OPERATING EXPENSES:
Research and development	$	24,901	$	19,035
General and administrative	13,672		12,753
Total operating expenses	38,573		31,788
Loss from operations	(38,573)		(31,788)
OTHER INCOME, NET:
Other income, net	2,388		709
Interest expense	(1,098)		—
Foreign exchange (losses) gains	(783)		2,685
Benefit from R&D tax credit	3,101		4,316
Total other income, net	3,608		7,710
Loss before income taxes	(34,965)		(24,078)
Corporate income tax expense	(222)		(130)
Net loss	$	(35,187)	$	(24,208)

Net loss per share attributable to ordinary shareholders—basic and diluted	$	(0.55)	$	(0.57)
Weighted average ordinary shares outstanding—basic and diluted	64,222,178		42,725,863

Net loss	$	(35,187)	$	(24,208)
Other comprehensive loss:
Foreign exchange translation adjustment	(36)		(578)
Comprehensive loss	$	(35,223)	$	(24,786)

MindMed Announces the Start of the First-Ever Clinical Trial Combining MDMA and LSD

Latest News

Latest Press Releases

Related News

TOP STOCKS