Connect with us

Atai Life Sciences

Atai, Awakn make progress on treatments for alcohol use disorder

Published

on



Psychedelic drug treatment companies are racing to find a cure for alcohol use disorder or alcoholism. This week, atai Life Sciences gave investors an update on its DMT-based drug, while Awakn Life Sciences updated the market on its ketamine-based drug for the same disorder.

The World Health Organization estimates that around 400 million people suffer from AUD worldwide, with around 3 million deaths each year attributed to alcoholism. With such a large patient population, a solution would be a financial home run for these companies – not to mention the benefits to the patients.

Atai’s update

Atai Life Sciences (NASDAQ: ATAI) announced positive topline results from Beckley Psytech’s Phase 2a open-label study of BPL-003 in 12 patients with moderate to severe AUD. The company told investors that a single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence out to three months. Atai said it expects to have the Phase 2b data readout of BPL-003 midyear.

“We are encouraged by these exploratory results from Beckley Psytech, our strategic investment, which demonstrate the potential of short in-clinic psychedelic therapies to transform the treatment of substance use disorders,” said Dr. Srinivas Rao, CEO and co-founder of atai. “The high rates of sustained abstinence in this study are particularly promising given the significant challenges patients with alcohol use disorder face in achieving and maintaining abstinence. These findings add to the growing body of evidence supporting the potential of BPL-003 in treating serious mental health disorders.”

Atai’s BPL-003 is a patent-protected synthetic intranasal formulation of 5-MeO-DMT benzoate which is designed to deliver rapid and durable treatment effects from a single dose with a short in-clinic treatment time.

Awakn’s update

Awakn Life Sciences Corp. (CSE: AWKN) (OTC Pink: AWKNF) has two drugs to treat AUD, designated as AWKN-001 and AWKN-002, and both use a ketamine base. AWKN-001 is in Phase 3 in the U.K. The company told investors it is targeting a Regulation 52b hybrid application in the U.K. for AWKN-001.

“If successful, this could provide 8 years of market exclusivity, with an additional 2 years of supplementary protection, preventing competitors from marketing a similar product for the same indication,” the company said in a statement.

Concerning AWKN-002, the company said it completed a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration, which confirmed that AWKN-002 can be reviewed under the 505(b)(2) NDA pathway. The FDA also further confirmed that no additional clinical data are needed to proceed with a Phase 2b trial in patients with moderate to severe AUD.

Awakn said in a statement that it plans to submit an IND Application for AWKN-002 in the second half of 2025, followed by a Clinical Trial Application for a Phase 2b trial in the first half of 2026. If all goes well, the company will have market exclusivity for five years.

“We are excited about the progress across our key R&D programs, particularly in the areas of Alcohol Use Disorder and PTSD. With the advancements we’ve made in AWKN-001 and AWKN-002, we’re on track to deliver transformative therapies for patients in need of more effective solutions,” Anthony Tennyson, CEO of Awakn said.

Green Market Report wrote in December that Awakn would be bought by Graft Polymer (UK) PLC with Graft acquiring all of the company’s shares in a deal valued at C$8.8 million. That deal is expected to close in the summer of 2025.



Source link

mscannabiz.com
Author: mscannabiz.com

MScannaBIZ for all you Mississippi Cannabis News and Information.

Atai Life Sciences

Atai extends cash runway into 2027 despite $39M fourth-quarter loss

Published

on



Atai Life Sciences (Nasdaq: ATAI) posted a $39 million net loss for the fourth quarter of 2024 but announced Monday that it boosted its financial position with a recent equity offering that extends its operational runway into 2027.

The clinical-stage company, which mainly focuses on developing psychedelic-based treatments for mental health conditions, reported that it raised $59.2 million in net proceeds from an equity offering completed last month. Atai said the cash infusion will carry its operations beyond anticipated readouts from two key Phase 2 clinical trials, which are expected in early 2026.

“We are beginning the year in a strong financial position, thanks to the recent capital raise, which extends our runway into 2027, beyond when we expect the topline data readouts from the Phase 2 clinical trials of our two core programs, VLS-01 and EMP-01, in Q1’26,” CEO and co-founder Srinivas Rao said in a statement.

The company reported a wider net loss of $39 million for the fourth quarter that ended Dec. 31, 2024, versus to $18.3 million in the same period the previous year. For the full year 2024, Atai posted a net loss of $149.3 million, versus $40.2 million in 2023, with the difference partly attributed to non-cash decreases in fair value of assets and liabilities.

As of Dec. 31, Atai had cash, cash equivalents, restricted cash and short-term securities of $72.3 million, down from $154.2 million at the end of 2023. The company said the decrease was primarily driven by $82.4 million in cash used for operations and $15 million invested in Beckley Psytech. It was partially offset by proceeds from the partial sale of its holdings in Compass Pathways.

Despite the losses, Atai highlighted progress in its clinical pipeline, including dosing the first patient in its Phase 2 Elumina trial testing VLS-01, a buccal film formulation of DMT (dimethyltryptamine), for treatment-resistant depression. The company also initiated a Phase 2 trial of EMP-01, an oral formulation of R-MDMA, for social anxiety disorder.

Both trials are anticipated to deliver topline results in the first quarter of 2026, according to the company.

“Our team is focused on executing these trials rigorously and efficiently to drive forward our mission to transform patient outcomes in mental health,” Rao added.

The company also noted that Beckley Psytech, in which Atai has a strategic investment, recently completed enrollment in its Phase 2b study of BPL-003, an intranasal mebufotenin benzoate treatment for treatment-resistant depression, with results expected by mid-2025.

Research and development expenses for 2024 decreased to $55.5 million from $62.2 million in 2023, though the company expects these costs to rise as its programs advance into later-stage clinical trials. General and administrative expenses also decreased to $47.5 million from $63.6 million, primarily due to reductions in personnel-related expenses.



Source link

mscannabiz.com
Author: mscannabiz.com

MScannaBIZ for all you Mississippi Cannabis News and Information.

Continue Reading

Atai Life Sciences

Atai Life Sciences prices $55 million offering

Published

on



Atai Life Sciences (NASDAQ: ATAI) announced after the markets closed on Wednesday that it priced a registered underwritten offering to raise approximately $55 million. Shares rose 14% to close at $2.55 on Wednesday. In a statement, Atai said the offering consists of 26,190,477 common shares priced at $2.10 per share. 

The psychedelic drug company said it plans to use the net proceeds from this offering for general corporate purposes, including working capital, and to advance the clinical development of its product candidates and programs. 

The offering is expected to close on Feb. 14. It also granted the underwriter a 30-day option to purchase an additional 3,928,571 common shares.

Executive moves

In January, Atai announced that Co-CEO Srinivas Rao was named the sole CEO. There were additional appointments with Kevin Craig, M.D., named as chief medical officer, Glenn Short advanced to to chief scientific officer, and Gerd Kochendoerfer appointed as chief operating officer.

“We have strengthened our leadership team at a pivotal time as we advance VLS-01 and EMP-01 into Phase 2 clinical trials,” Rao said. “As we continue to focus on executing our Phase 2 clinical trials, with VLS-01 now screening patients, we look forward to the Phase 2b data readout for Beckley Psytech’s BPL-003, anticipated midyear. This is a key milestone and an important step towards the potential of commercially scalable short-duration psychedelic therapies for people with treatment-resistant depression.”

To that end, the company recently announced positive topline results from the Beckley Psytech Phase 2a open-label study of BPL-003 in 12 patients with moderate to severe alcohol use disorder.

“The results showed that a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy, induced meaningful and sustained reduction in alcohol use and heavy drinking days (HDDs) in patients with moderate to severe AUD out to 12 weeks,” the company said in a statement. “These findings add to the growing body of evidence supporting the potential of BPL-003 in treating serious mental health disorders.”

Balance sheet

Atai last reported earnings in November when Green Market Report wrote that the company reported a net loss of $26.3 million for the third quarter, down year-over-year from its net income of $43.3 million, but the clinical-stage biopharmaceutical company also noted at the time that it was well-positioned to bring multiple mental health drugs to market in the not-too-distant future.

At the end of September, Atai had $197.5 million in total assets, including $29.9 million in cash. The company noted in an investor presentation that it had enough cash to reach the milestones laid out through 2025.



Source link

mscannabiz.com
Author: mscannabiz.com

MScannaBIZ for all you Mississippi Cannabis News and Information.

Continue Reading

Atai Life Sciences

Atai posts $26M loss, but progresses on psychedelic clinical trials

Published

on


New York-based Atai Life Sciences (Nasdaq: ATAI) reported a net loss of $26.3 million for the third quarter, down year-over-year from its net income of $43.3 million, but the clinical-stage biopharmaceutical company also noted it’s well-positioned to bring multiple mental health drugs to market in the not-too-distant future.

Atai said in a release that it’s made progress toward obtaining federal approval on several psychedelic drugs, including its versions of DMT, MDMA, ibogaine and two other drugs still in development. All of the drugs are projected to hit testing milestones this year or next year, Atai forecast.

The company noted in an investor presentation that it believes it has enough cash to reach the milestones laid out through 2025.

“We continue to see progress and momentum across our pipeline,” Dr. Srinivas Rao, co-chief executive officer and co-founder of Atai, said in a release. “Our team is focused on executing these trials with the utmost scientific rigor and is driven by our goal of being the leader in developing new psychedelic treatment options to mental health patients.”

Rao said that Atai’s version of DMT, formally dubbed VLS-01 and designed to treat depression, along with its version of DMT, called EMP-01 and designed for social anxiety disorder, are both slated to begin clinical trials before the end of 2024.

This year, Atai also expects data on clinical trials for its drugs that are still in development to treat alcohol use disorder and major depressive disorder. Next year, it’s expecting even more data on other trials.

Atai also has preclinical studies planned for its version of ibogaine, with a plan in the works to submit a new drug application to the federal government and eventual clinical trials with patients.

The company is also researching possible psychedelic applications from “novel, non-hallucinogenic 5-HT2AR agonists,” which it said could be key to further antidepressant treatments, and the potential use of RL-007, an “orally bioavailable compound,” for treating schizophrenia, with ongoing clinical studies and data from those expected next year.

On Sept. 30, Atai closed on the acquisition of IntelGenX Technologies Corp., in an all-debt/equity deal that required zero cash. Atai “agreed that its senior secured debt in IntelGenx was discharged in exchange for IGX shares,” which completed the acquisition following the sign-off from a Canadian court. IntelGenX manufactures DMT and other products related to psychedelic medicines.

At the end of September, Atai had $197.5 million in total assets, including $29.9 million in cash, against $52.2 million in total liabilities.



Source link

mscannabiz.com
Author: mscannabiz.com

MScannaBIZ for all you Mississippi Cannabis News and Information.

Continue Reading
featured14 hours ago

Rhode Island Officials Pause New Hemp Retailer Licenses As They Study Sales Of THC Drinks In Liquor Stores And Bars

featured16 hours ago

Broader Launch Of Minnesota’s Marijuana Retail Market Is Almost Here, State Officials Say

featured1 day ago

Bipartisan Coalition Of 32 Attorneys General Pushes Congress To Urgently Pass Marijuana Banking Bill

featured1 day ago

Marijuana And CBD Provide ‘Significant Symptom Relief’ For Inflammatory Bowel Disease Patients, Federally Funded Study Finds

featured1 day ago

Doctor Who Allegedly Said ‘I Wonder How Much This Moron Will Pay’ Pleads Guilty

video1 day ago

Killing reported at Oklahoma marijuana grow operation

featured1 day ago

Texas Voters Want Synthetic THC Outlawed, Poll Shared By Proponents Of Reining In Hemp Industry Finds

video1 day ago

Judge rejects No Savage’s rap culture argument – NBC4 Washington

featured1 day ago

California Moves to Ban Hemp Wellness Products — And the Weed Nuns Are Fighting Back

featured1 day ago

Cannabis & Psychedelics Reported Most Effective Non-Prescription Drugs by Eating Disorder Patients

featured1 day ago

Kentucky Governor Urges Trump To Oppose Bill Blocking Marijuana Rescheduling That’s Advancing In Congress

video1 day ago

New York cannabis board approves 52 new licenses, pushes total to 1,851

featured1 day ago

South Park Loves Marijuana – The Fresh Toast

featured1 day ago

Lo Más Reciente de High Times en Español

featured1 day ago

DEA Judge Overseeing Cannabis Rescheduling Process Retires

featured1 day ago

GOP Senator Threatens To Block Spending Bill If Hemp THC Product Ban Stays In, Sources Say

featured2 days ago

The Best Delicious Summer Cocktails

featured2 days ago

The Race to Nowhere: How Chasing Potency Undermines Cannabis Quality (Opinion)

featured2 days ago

Weed & Psychedelics Are Doing for Eating Disorders What Big Pharma Couldn’t, Survey Says

featured2 days ago

Congressional Committee Pushes To ‘Eliminate’ Illegal Marijuana Grows And Tackle Money Laundering By Chinese-Linked Cannabis Operations

featured2 days ago

Supreme Court Will Discuss Ban On Marijuana Users’ Gun Ownership In September

video2 days ago

Watch: £1m cannabis factory found in town’s old Woolworths store | News

featured2 days ago

Texas cannabis legalization bill filed in hemp-focused special session (Newsletter: July 25, 2025)

Mississippi Cannabis News2 days ago

Mississippi AG takes aim at hemp products, including Delta THC | State

California Cannabis Updates1 year ago

Alert: Department of Cannabis Control updates data dashboards with full data for 2023 

Breaking News1 year ago

Connecticut Appoints The US’s First Cannabis Ombudsperson – Yes there is a pun in there and I’m Sure Erin Kirk Is Going To Hear It More Than Once!

best list12 months ago

5 best CBD creams of 2024 by Leafly

Business10 months ago

EU initiative begins bid to open access to psychedelic therapies

Bay Smokes1 year ago

Free delta-9 gummies from Bay Smokes

cbd1 year ago

New Study Analyzes the Effects of THCV, CBD on Weight Loss

autoflower seeds10 months ago

5 best autoflower seed banks of 2024 by Leafly

California1 year ago

May 2024 Leafly HighLight: Pink Runtz strain

Breaking News1 year ago

Curaleaf Start Process Of Getting Their Claws Into The UK’s National Health System – With Former MP (Resigned Today 30/5/24) As The Front Man

Mississippi Cannabis News1 year ago

Mississippi city official pleads guilty to selling fake CBD products

cannabis brands10 months ago

Discover New York’s dankest cannabis brands [September 2024]

Mississippi Cannabis News1 year ago

Horn Lake denies cannabis dispensary request to allow sale of drug paraphernalia and Sunday sales | News

Mississippi Cannabis News1 year ago

Local medical cannabis dispensary reacts to MSDH pulling Rapid Analytics License – WLBT

Hemp1 year ago

Press Release: CANNRA Calls for Farm Bill to Clarify Existing State Authority to Regulate Hemp Products

Breaking News1 year ago

Nevada CCB to Accept Applications for Cannabis Establishments in White Pine County – “Only one cultivation and one production license will be awarded in White Pine County”

best list1 year ago

5 best THC drinks of 2024 by Leafly

Arkansas10 months ago

The Daily Hit: October 2, 2024

best list1 year ago

6 best CBD gummies of 2024 by Leafly

best list1 year ago

5 best delta-9 THC gummies of 2024 by Leafly

Breaking News1 year ago

Weekly Update: Monday, May 13, 2024 including, New Guide for Renewals & May Board meeting application deadline

Mississippi Cannabis News1 year ago

People In This State Googled ‘Medical Marijuana’ The Most, Study Shows

Breaking News1 year ago

PRESS RELEASE : Justice Department Submits Proposed Regulation to Reschedule Marijuana

Asia Pacific & Australia1 year ago

Thailand: Pro-cannabis advocates rally ahead of the government’s plan to recriminalize the plant

California Cannabis Updates1 year ago

Press Release: May 9, STIIIZY and Healing Urban Barrios hosted an Expungement Clinic & Second Chance Resource Fair

Trending