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IntelGenx Reports Third Quarter 2021 Financial Results

IntelGenx Reports Third Quarter 2021 Financial Results

SAINT LAURENT, Quebec, Nov. 11, 2021 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today reported financial results for the third quarter ended September 30, 2021. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

2021 Third Quarter Financial Summary:

  • Revenue was $593,000, compared to $510,000 in the 2020 third quarter.
  • Net comprehensive loss was $2.2 million, compared to $1.6 million in Q3-2020.
  • Adjusted EBITDA loss was $1.4 million, compared to $1.2 million in the 2020 third quarter.

Third Quarter and Recent Developments:

  • Resumed patient screening in the ongoing ‘BUENA’ Montelukast VersaFilm® Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”) following Health Canada’s issuance of a No Objection Letter in response to the Company’s amended Clinical Trial Application.
  • Graduated to the Toronto Stock Exchange.
  • Announced that its co-development and commercialization partner for Tadalafil oral films for the treatment of erectile dysfunction (ED) and benign prostatic hyperplasia (BPH), Aquestive Therapeutics, Inc. (NASDAQ:AQST), entered into a definitive license and supply agreement with an undisclosed leading men’s health company.
  • Announced that atai Life Sciences AG (“atai”) committed $6.0 million in future financial support to IntelGenx via amendments to the loan facility between the parties.
  • Announced that Exeltis Healthcare S.L., the Company’s commercialization partner in the European Union for RIZAPORT®, a unique treatment for acute migraines, launched the product in Spain.
  • Completed an initial shipment of CBD Filmstrips in support of Heritage Cannabis Holdings Corp.’s (CSE:CANN) Canadian market launch of its “CB4 Control” branded product.
  • Closed a $2.1 million private placement of 8% convertible notes due July 31, 2025, which the Company intends to use to finance its BUENA trial of Montelukast in AD.
  • Increased the size of the Board of Directors from six to eight with the appointments of Srinivas (Srini) G. Rao, M.D., Ph.D. and Frank Stegert.

“The past few months have been a very productive and exciting period for IntelGenx, marked by the achievement of five major milestones,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “Our graduation to the TSX, Canada’s most senior exchange, came on the heels of our successful transition from a development-stage to a commercial-stage leader in pharmaceutical films as well as our transformational partnership with atai. We were also pleased to resume patient screening in our ongoing ‘BUENA’ Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate AD. Having executed on many elements of our growth strategy this quarter, we look forward to continuing to advance our portfolio of innovative film products and product candidates.”

Financial Results:

Total revenues for the three-month period ended September 30, 2021 amounted to $593,000, an increase of $83,000, or 16%, compared to $510,000 for the three-month period ended September 30, 2020. The change is mainly attributable to increases in sales milestone revenues of $320,000, product revenues of $70,000, partially offset by a $308,000 decrease in revenues from licensing agreements.

Operating costs and expenses were $2.2 million for the third quarter of 2021, versus $1.9 million for the corresponding three-month period of 2020. The increase for the three-month period ended September 30, 2021 is mainly attributable to increases of $26,000 in R&D expense, $255,000 in manufacturing expenses, $37,000 in selling, general and administrative expenses, $17,000 in depreciation of tangible assets.

For the third quarter of 2021, the Company had an operating loss of $1.6 million, compared to an operating loss of $1.4 million for the comparable period of 2020.

Net comprehensive loss for the three-month period ended September 30, 2021 was $2.2 million, or $0.01 per basic and diluted share, compared to net comprehensive loss of $1.6 million, or $0.01 per basic and diluted share, for the comparable period of 2020.

As at September 30, 2021, the Company’s cash and short-term investments totalled $12.0 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these third quarter 2021 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (888) 506-0058 (Canada and the United States) and (973) 528-0135 (International), access code 995615. The call will also be webcast live and archived on the Company’s website at www.intelgenx.com under “Webcasts” in the Investors section.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.

Forward-Looking Information and Statements
This document may contain forward-looking information about IntelGenx’s operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’s plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com

IntelGenx Technologies Corp.

Consolidated Balance Sheet
(Expressed in Thousands of U.S. Dollars ($000’s) Except Share and Per Share Data)
(Unaudited)

September 30, 2021 December 31, 2020
Assets
Current
Cash $ 6,019 $ 1,205
Short-term investments 6,013 1,038
Accounts receivable 1,162 260
Prepaid expenses 116 162
Investment tax credits receivable 407 635
Contract asset – 354
Security deposits 204 407
Inventories 68 244
Total current assets 13,989 4,305
Leasehold improvements and equipment, net 5,348 5,851
Security deposits 252 252
Operating lease right-of-use-asset 1,050 710
Total assets $ 20,639 $ 11,118
Liabilities
Current
Accounts payable and accrued liabilities 2,304 1,989
Current portion of long-term debt – 561
Current portion of operating lease liability 248 141
Current portion of finance lease liability 35 25
Deferred revenue 192 166
Convertible notes – 1,486
Convertible debentures 5,317 –
Total current liabilities 8,096 4,368
Long-term debt 2,500 171
Convertible notes 3,965 1,505
Convertible debentures – 5,461
Operating lease liability 691 482
Finance lease liability 92 84
Deferred income tax liability 82 –
Total liabilities 15,426 12,071
Contingencies
Subsequent event
Shareholders’ equity
Capital stock, common shares, $0.00001 par value; 450,000,000 shares authorized; 150,627,761 shares issued and outstanding (2020: 111,429,532 common shares) 1 1
Additional paid-in capital 61,589 48,453
Accumulated deficit (55,005) (48,551)
Accumulated other comprehensive loss (1,372) (856)
Total shareholders’ equity (deficit) 5,213 (953)
$ 20,639 $ 11,118

IntelGenx Technologies Corp.

Consolidated Statement of Comprehensive Loss
(Expressed in Thousands of U.S. Dollars ($000’s) Except Share and Per Share Data)
(Unaudited)

For the Three-Month Period
 For the Nine-Month Period
Ended September 30,
 Ended September 30,
2021 2020 2021 2020
Revenues $ 593 $ 510  $ 1,041 $ 754
Total revenues 593 510  1,041 754
Expenses
Research and development expense 874 848 1,910 2,300
Manufacturing expenses 499 244 1,598 1,042
Selling, general and administrative expense 662 625 2,419 2,167
Depreciation of tangible assets 199 182 589 536
Total expenses 2,234 1,899 6,516 6,045
Operating loss (1,641) (1,389) (5,475) (5,291)
Finance and interest income 1 3 152 405
Financing and interest expense (365) (274) (1,134) (881)
Net financing and interest income (expense) (364) (271) (982) (476)
Loss before income taxes (2,005) (1,660) (6,457) (5,767)
Deferred income tax 3 – 3 –
Net loss (2,002) (1,660) (6,454) (5,767)
Other comprehensive (loss) income
Foreign currency translation adjustment (175) 40 (518) (108)
Change in fair value 4 51 2 79
(171) 91 (516) (29)
Comprehensive loss $ (2,173) $ (1,569) $ (6,970) $ (5,796)
Basic and diluted weighted average number of shares outstanding 150,590,729 110,259,652 131,576,774 107,818,057
Basic and diluted loss per common share $ (0.01) $ (0.01) $ (0.05) $ (0.05)
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atai Life Sciences to Host Conference Call and Webcast to Discuss Third Quarter 2021 Financial Results and Provide Business Update

atai Life Sciences to Host Conference Call and Webcast to Discuss Third Quarter 2021 Financial Results and Provide Business Update

NEW YORK, Nov. 08, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it plans to host a conference call on Monday, November 15, 2021 at 8:30 a.m. ET to discuss its financial results for the quarter ended September 30, 2021 and provide a business update.

To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13724750. The live and archived webcast of this call will be available in the “Events” section of the atai Life Sciences website at ir.atai.life.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders.

atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding atai’s participation in upcoming conferences and presentations and similar statements of a future or forward-looking nature. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Contact Information

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

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atai Life Sciences to Host Conference Call and Webcast to Discuss Third Quarter 2021 Financial Results and Provide Business Update

NEW YORK, Nov. 08, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it plans to host a conference call on Monday, November 15, 2021 at 8:30 a.m. ET to discuss its financial results for the quarter ended September 30, 2021 and provide a business update.

To access the live conference call, please dial 877-407-3982 from the United States, or +1 (201) 493-6780 internationally, using the conference ID: 13724750. The live and archived webcast of this call will be available in the “Events” section of the atai Life Sciences website at ir.atai.life.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders.

atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding atai’s participation in upcoming conferences and presentations and similar statements of a future or forward-looking nature. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Contact Information

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

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atai Life Sciences to Participate in Upcoming November Investor Conferences

NEW YORK, Nov. 05, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it will participate in the following upcoming investor conferences in November:

Presentation details can be found below:

The presentations and archived webcasts will also be accessible in the Events section of atai’s website.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders.

atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. For more information, please visit www.atai.life.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

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Psychedelic music studio changes your attachment style: issue 22

Here’s what’s in store for you in today’s issue:

🍄 Psychedelic music studio receives $4.5M in funding

🍄 How your attachment style affects your trip

🍄 First-ever study with direct psilocin

🍄 A new helmet to understand the brain

🍄 And more.

Be sure to check out last week’s Daily Mushroom podcast:

The DMT Cure for Chronic Pain and PTSD

Kieran, a retired black ops vet who magically cured his neck pain with a wild DMT trip. Kieran talks about being in a constant stress state while serving and how psychedelics help him cope with ongoing PTSD.

Therapeutic banner

First-ever study with direct psilocin

When psilocybin is consumed, it’s metabolized into psilocin, which is the compound that produces most (or all) of the psychedelic effects.

Will the experience change if psilocin is administered directly?

Filament Health (FH) just received FDA-approval for a first-of-its kind study that will reveal the answer.

The phase I trial at the University of California San Francisco will compare the effects of psilocybin and psilocin in 20 healthy patients. Psilocybin will be administered orally, whereas psilocin will be administered both orally and sublingually, meaning it will be absorbed through tissues under the tongue.

Researchers predict that direct psilocin could result in faster onset times, greater consistency and bioavailability — with fewer side effects.

A faster treatment for depressed moms

Existing treatments for post-partum depression take up to 8 weeks and often separate the mother from her baby for long periods of time, creating even more stress.

Field Trip Health (FTRP) is developing a proprietary psychedelic to change this.

The formulation, FT-104, could be administered in just one day and lasts 2-3 hours shorter than pure psilocybin. The compound leaves the mother’s system in just 24 hours, allowing her to safely breastfeed again.

FT-104 is currently in preclinical evaluation with phase I trials expected to begin in Q1 of next year.

atai accelerates schizophrenia research after promising findings

atai Life Sciences (ATAI) developed a new compound that could help treat cognitive impairment associated with schizophrenia.

The compound, RL-007, was tested on a cohort of 8 schizophrenic patients while continuing with their antipsychotic treatments. Using brain mapping and other biomarkers, researchers found that formulation improved cognition by activating receptors linked to learning and memory. 

The findings were so promising that atai decided to spend additional resources to accelerate the compound into a Phase 2a trial, which should be completed by the end of the year.

Ending the PTSD crisis

The lack of effective PTSD treatments is “a crisis,” according to the PTSD Psychopharmacology Working Group. About one in 20 people in the UK suffer from PTSD, and current treatment options are ineffective for 40% of patients.

COMPASS Pathways (CMPS) is launching a phase II trial to see if its psilocybin therapy model for treatment-resistant depression can bring relief to patients with PTSD.

The trial will assess 20 patients who experienced trauma as adults. They will be given a single dose of the psilocybin formulation followed by 12 weeks of therapy protocols.

Researchers will measure the safety of the drug as well as improvements in PTSD symptoms, functionality, and quality of life.

inspirational banner

Psychedelic music studio receives $4.5M in funding

When patients have a positive response to music during psychedelic therapy, they’re more likely to have a mystical experience which can lead to a more effective treatment.

That’s why neuroscientist Dr. Mendel Kaelen co-founded Wavepaths – a music studio that uses AI to create customized music—on the fly—in response to a patient’s emotional state!

The implications of Wavepaths go far beyond psychedelic therapy: hospitals, birth clinics, hospice centers, and schools are showing interest in the technology. It is already being used in 30+ countries and over 5,000 practitioners await its public release.

How your attachment style affects your trip

If you’ve ever struggled with attachment anxiety in your relationships, there’s promising evidence that psilocybin could be an effective treatment:

After undergoing individual therapy, group therapy, and a single psilocybin session, a group of 18 male AIDS survivors showed significantly reduced scores for attachment anxiety – an attachment style characterized by clinginess, fear of abandonment, and difficulty trusting others.

There were no significant changes in attachment avoidance, which is characterized by repressing emotions and discomfort with close relationships.

However, high attachment anxiety scores were associated with a greater chance of mystical experiences, whereas high attachment avoidance scores were linked to grief, fear, physical distress, and paranoia during the trip.

What better way to feel more secure in your relationships than through a trip? 🤩

Old Town Road to success

Lil Nas X was honoured as a visionary at the Wall Street Journal’s Innovator Awards after releasing his latest album, ‘Montero.’ Were magic mushrooms the secret behind his success?

The artist says that his first-ever mushroom trip was a pivotal moment while recording the album. The experience helped him reflect on himself and break free from feelings of self-consciousness.

“I was able to open up a lot. I was able to write actual stories about my life and put it into my music. I actually did that for the first time,” Nas explained.

business banner

A new helmet to understand the brain

The LA-based company Kernel developed a brain-imaging helmet that can track what actually happens in the brain during a psychedelic trip.

The device, Kernel Flow, was just approved by the FDA to be used in a ketamine trial sponsored by Cybin (CYBN).

Researchers will use the helmet to measure the neurological activity of 15 patients during a ketamine therapy session compared to baseline activity.

Kernel Flow is much less expensive than other brain-imaging tools and allows the patients to move freely during the session.

Trip at home with a psychedelic patch

PharmaTher (PHRM) and Revive Therapeutics (RVV) are entering into a research agreement to develop psychedelic patches that could be used at home!

The biodegradable patches will use microneedles to deliver both micro and macrodoses of psilocybin, ketamine, MDMA, LSD, DMT, ibogaine, and mescaline.

PharmaTher is currently studying the effects of the psilocybin microdose patch, with results expected by the end of this month.

The companies aim to create a delivery method that’s safe and convenient enough for patients to administer on their own, without supervision.

PharmaTher (PHRM) and Revive Therapeutics (RVV) are entering into a research agreement to develop psychedelic patches that could be used at home!

The biodegradable patches will use microneedles to deliver both micro and macrodoses of psilocybin, ketamine, MDMA, LSD, DMT, ibogaine, and mescaline.

PharmaTher is currently studying the effects of the psilocybin microdose patch, with results expected by the end of this month.

The companies aim to create a delivery method that’s safe and convenient enough for patients to administer on their own, without supervision.

Creating a myriad of drugs with AI

Using an AI drug discovery program, Mydecine (MYCO) successfully added a novel psilocin analogue with improved delivery and stability to its pipeline.

The AI technology synthesizes billions of drug candidates and filters them based on psychedelic-related targets such as how they bind to receptors.

Mydecine also filed a patent for nanoemulsion technology. Nanoemulsion can:

  • help the company develop compounds inspired by traditional plant medicines such as reishi and cordyceps mushrooms
  • improve control in delivery, which is critical in microdosing and customizing dosages
  • advance development of over-the-counter consumer products
legal banner

Detroit decriminalizes psychedelics!

With a 61% to 39% win, Detroit became the fourth city in Michigan to widely decriminalize possession and therapeutic use of psychedelics.

Over 80% voted to establish a reparations committee that will address historical discrimination against Black communities through housing and economic development programs.

Industry Quick Hits

Oct 29 – Oppenheimer initiates COMPASS Pathways (CMPS) with a buy rating and $50 price target Read more…

Oct 29 – Braxia Scientific (BRAX) Announces Voting Results from the Annual General Meeting of Shareholders Read more…

Nov 1 – Blackhawk Growth’s (BLR) MindBio Therapeutics Looks to Expand Microdosing Clinical Trials Read more…

Nov 1 – Algernon Pharmaceuticals (AGN) reports positive pre-clinical data on DMT candidate to treat stroke Read more…

Nov 1 – Small Pharma (DMT) reports second quarter highlights Read more…

Nov 2 – Braxia Scientific (BRAX) Graduates First Cohort of Medical Professionals From Psilocybin-Assisted Therapy Training Program Read more… 

Nov 2 – U.S. FDA Approves Nova Mentis (NOVA) Orphan Drug Application Read more…

Nov 2 – Tryp Therapeutics (TRYP) Submits IND Application for Phase 2a Clinical Trial in Fibromyalgia Read more…

Nov 3 – Amanita Muscaria Mushroom Successfully Added to the Natural Health Products Ingredients Database (NHPID) of Canada Read more…

Nov 4 – Awakn Life Sciences (AWKN) Announces The Findings From Phase II A/B Study Are To Be Published In American Journal Of Psychiatry Read more…

Nov 5 – Novamind (NM) Reports FY2021 Financial Results and Operating Highlights Read more…

Nov 5 – NeonMind (NEON) Biosciences Named As A Top Industry Innovator In Inaugural Issue Of Psychedelia Magazine Read more…

Video of the Week

Trippy Mushroom-Themed Resort

Playlist of the Week

60s - 70s stoner rock
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atai Life Sciences Announces Supportive Interim Data from First 8-Patient Cohort of Phase 2a Trial for Novel Treatment of Cognitive Impairment Associated with Schizophrenia

atai Life Sciences Announces Supportive Interim Data from First 8-Patient Cohort of Phase 2a Trial for Novel Treatment of Cognitive Impairment Associated with Schizophrenia

These data have given atai confidence to support an accelerated clinical development timeline

NEW YORK, Nov. 01, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”) today announced that it has observed encouraging interim data from the first 8-patient cohort of its Phase 2a trial, demonstrating potential pro-cognitive effects of its compound RL-007, a cholinergic, glutamatergic, and GABA type B receptor modulator, for Cognitive Impairment Associated with Schizophrenia (CIAS).

These early data have led atai to commit additional financial resources, enabling an accelerated clinical development timeline for RL-007, even ahead of completion of the ongoing Phase 2a trial.

The interim Phase 2a readout reported promising assessments for the 8-patient cohort from two quantitative biomarkers, qEEG (quantitative electroencephalogram) and ERP (evoked-response potential) and indicated changes that are consistent with improved cognition. CIAS is a major unmet need for those living with schizophrenia, with no effective treatments currently available.1 Full results of the current Phase 2a trial are expected by the end of 2021.

The financial boost by atai will enable immediate initiation of planning stages for the next clinical trial, ahead of schedule and prior to the Phase 2a’s conclusion. The atai RL-007 trials are being conducted by Recognify Life Sciences, an atai Life Sciences platform company.

“With these data, from the interim analysis of the ongoing Phase 2a trial, we are encouraged to accelerate the overall development of RL-007 for CIAS,” said Matthew Pando, PhD, CEO and Co-Founder of Recognify Life Science. “I would like to express my deepest gratitude to the patient volunteers who have supported our clinical trial thus far. I believe that, with continued support, we have the potential to bring benefit to patients living with schizophrenia and its often very challenging cognitive impacts.”

“We believe that, although preliminary, these promising data give us confidence to further support and expedite the clinical trajectory for RL-007 and we look forward to the full data set,” said Florian Brand, CEO and Co-Founder of atai Life Sciences. “With its unique mechanism of action, we think that RL-007 has potential to address a major unmet need in terms of addressing the cognitive deficits that can be so debilitating for people with schizophrenia.”

Schizophrenia is a mental health disorder primarily characterized by hallucinations, delusions, and disordered thinking. This condition effects over 21 million people globally and approximately 3.5 million people in the United States.2,3

CIAS is a major unmet need for those living with schizophrenia. Cognitive deficits are frequently present in patients diagnosed with schizophrenia, and such deficits contribute to the marked disability associated with this condition, impacting the ability of patients to carry out some basic living tasks, like pursuing education and holding down a job.4

About the RL-007 Phase 2a trial
The ongoing Phase 2a trial is a single-arm, single blind, multiple dose study of oral RL-007 administered to subjects with schizophrenia who are currently stable on a protocol-allowed antipsychotic regimen. Subjects continue their antipsychotic treatment without change throughout the course of this study. All subjects receive four doses of placebo followed by six doses of RL-007, although subjects are blinded to the dose strength or sequence of active and placebo capsules.

About RL-007

RL-007 has a unique mechanism of action, impacting both cholinergic and gamma-aminobutyric acid type B (GABA type B) receptor systems, which are both are central to learning and memory functions. With its unique mechanism of action, we believe RL-007 may enhance pro-cognitive functioning, such as neuronal signaling, learning, and memory.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders.

atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

References:
1. Hsu WY, Lane HY, Lin CH. Medications Used for Cognitive Enhancement in Patients With Schizophrenia, Bipolar Disorder, Alzheimer’s Disease, and Parkinson’s Disease. Front Psychiatry. 2018;9:91.
2. Charlson FJ, Ferrari AJ, Santomauro DF, et al. Global Epidemiology and Burden of Schizophrenia: Findings From the Global Burden of Disease Study 2016. Schizophr Bull. 2018;44(6):1195-1203.
3. Wander C. Schizophrenia: opportunities to improve outcomes and reduce economic burden through managed care. Am J Manag Care. 2020;26(3 Suppl):S62-S68.
4. Bowie CR, Harvey PD. Cognitive deficits and functional outcome in schizophrenia. Neuropsychiatr Dis Treat. 2006;2(4):531-536.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include express or implied statements relating to, among other things, statements regarding the potential outcome of Recognify’s ongoing Phase 2a trial for its lead compound, RL-007; the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; the commercialization of our current product candidates and any other product candidates that we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates that we may identify and purse; the timing of, and our ability to obtain and maintain, regulatory approvals; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, and in atai’s other filings with the SEC. Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although atai believes that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release (or to conform these statements to actual results or revised expectations), other than to the extent required by applicable law.

Contact Information

For atai:

Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

 

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atai accelerates schizophrenia research after promising findings

atai Life Sciences Announces Supportive Interim Data from First 8-Patient Cohort of Phase 2a Trial for Novel Treatment of Cognitive Impairment Associated with Schizophrenia

atai Life Sciences (ATAI) developed a new compound that could help treat cognitive impairment associated with schizophrenia (CIAS) such as attention deficits and issues with memory and executive function.

atai Life Sciences (ATAI) developed a new compound that could help treat cognitive impairment associated with schizophrenia.

The compound, RL-007, was tested on a cohort of 8 schizophrenic patients while continuing with their antipsychotic treatments. Using brain mapping and other biomarkers, researchers found that formulation improved cognition by activating receptors linked to learning and memory. 

The findings were so promising that atai decided to spend additional resources to accelerate the compound into a Phase 2a trial, which should be completed by the end of the year.

PDF of article

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atai Life Sciences Announces Supportive Interim Data from First 8-Patient Cohort of Phase 2a Trial for Novel Treatment of Cognitive Impairment Associated with Schizophrenia

These data have given atai confidence to support an accelerated clinical development timeline

NEW YORK, Nov. 01, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”) today announced that it has observed encouraging interim data from the first 8-patient cohort of its Phase 2a trial, demonstrating potential pro-cognitive effects of its compound RL-007, a cholinergic, glutamatergic, and GABA type B receptor modulator, for Cognitive Impairment Associated with Schizophrenia (CIAS). 

These early data have led atai to commit additional financial resources, enabling an accelerated clinical development timeline for RL-007, even ahead of completion of the ongoing Phase 2a trial.

The interim Phase 2a readout reported promising assessments for the 8-patient cohort from two quantitative biomarkers, qEEG (quantitative electroencephalogram) and ERP (evoked-response potential) and indicated changes that are consistent with improved cognition. CIAS is a major unmet need for those living with schizophrenia, with no effective treatments currently available.1 Full results of the current Phase 2a trial are expected by the end of 2021.

The financial boost by atai will enable immediate initiation of planning stages for the next clinical trial, ahead of schedule and prior to the Phase 2a’s conclusion. The atai RL-007 trials are being conducted by Recognify Life Sciences, an atai Life Sciences platform company. 

“With these data, from the interim analysis of the ongoing Phase 2a trial, we are encouraged to accelerate the overall development of RL-007 for CIAS,” said Matthew Pando, PhD, CEO and Co-Founder of Recognify Life Science. “I would like to express my deepest gratitude to the patient volunteers who have supported our clinical trial thus far. I believe that, with continued support, we have the potential to bring benefit to patients living with schizophrenia and its often very challenging cognitive impacts.” 

“We believe that, although preliminary, these promising data give us confidence to further support and expedite the clinical trajectory for RL-007 and we look forward to the full data set,” said Florian Brand, CEO and Co-Founder of atai Life Sciences. “With its unique mechanism of action, we think that RL-007 has potential to address a major unmet need in terms of addressing the cognitive deficits that can be so debilitating for people with schizophrenia.” 

Schizophrenia is a mental health disorder primarily characterized by hallucinations, delusions, and disordered thinking. This condition effects over 21 million people globally and approximately 3.5 million people in the United States.2,3

CIAS is a major unmet need for those living with schizophrenia. Cognitive deficits are frequently present in patients diagnosed with schizophrenia, and such deficits contribute to the marked disability associated with this condition, impacting the ability of patients to carry out some basic living tasks, like pursuing education and holding down a job.4 

About the RL-007 Phase 2a trial
The ongoing Phase 2a trial is a single-arm, single blind, multiple dose study of oral RL-007 administered to subjects with schizophrenia who are currently stable on a protocol-allowed antipsychotic regimen. Subjects continue their antipsychotic treatment without change throughout the course of this study. All subjects receive four doses of placebo followed by six doses of RL-007, although subjects are blinded to the dose strength or sequence of active and placebo capsules.

About RL-007

RL-007 has a unique mechanism of action, impacting both cholinergic and gamma-aminobutyric acid type B (GABA type B) receptor systems, which are both are central to learning and memory functions. With its unique mechanism of action, we believe RL-007 may enhance pro-cognitive functioning, such as neuronal signaling, learning, and memory. 

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders.

atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

References:
1. Hsu WY, Lane HY, Lin CH. Medications Used for Cognitive Enhancement in Patients With Schizophrenia, Bipolar Disorder, Alzheimer’s Disease, and Parkinson’s Disease. Front Psychiatry. 2018;9:91.
2. Charlson FJ, Ferrari AJ, Santomauro DF, et al. Global Epidemiology and Burden of Schizophrenia: Findings From the Global Burden of Disease Study 2016. Schizophr Bull. 2018;44(6):1195-1203.
3. Wander C. Schizophrenia: opportunities to improve outcomes and reduce economic burden through managed care. Am J Manag Care. 2020;26(3 Suppl):S62-S68.
4. Bowie CR, Harvey PD. Cognitive deficits and functional outcome in schizophrenia. Neuropsychiatr Dis Treat. 2006;2(4):531-536.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include express or implied statements relating to, among other things, statements regarding the potential outcome of Recognify’s ongoing Phase 2a trial for its lead compound, RL-007; the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; the commercialization of our current product candidates and any other product candidates that we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates that we may identify and purse; the timing of, and our ability to obtain and maintain, regulatory approvals; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, and in atai’s other filings with the SEC. Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although atai believes that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release (or to conform these statements to actual results or revised expectations), other than to the extent required by applicable law.

Contact Information

For atai:

Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

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Autistic children try microdosing at a psychedelic farmer’s market: issue 20

Here’s what’s in store for you in today’s issue:

🍄Autistic children try microdosing

🍄 Group psychedelic therapy cures depression

🍄 Psychedelic farmer’s markets?

🍄 DMT granted innovative medicine designation

🍄 And more.

You’ll want to stay till the end to learn how someone found enlightenment on a trippy hike.

(Did a good friend forward this to you? If so be sure to subscribe here)

Be sure to check out this week’s Daily Mushroom podcast:
The Truth About Psilocybin and the Brain

Julia Joyes is a neuroscientist and research director at TheraPsil, a leading non profit organization making a difference to mental health in Canada. In this episode, we take a closer look at psilocybin’s impact on the brain. 

Therapeutic banner

The first study investigating psilocybin’s impact on children

According to preclinical research conducted by Nova Mentis (NOVA), psilocybin has potential to reduce anxiety in autistic patients and could improve cognitive function in patients with fragile x syndrome (FXS), a genetic condition that causes learning impairments.

Now, the company is forming a joint venture with Mycrodose Therapeutics to accelerate R&D into the treatment. The partnership will use Mycrodose Therapeutics’ patented systems to deliver a self-administered and non-invasive microdose.

The joint venture plans to conduct human clinical trials on a broad range of patients with FXS and autism, including pediatric patients. This will be the first study investigating psilocybin’s impact on children.

Group psychedelic therapy cures depression!

On Tuesday, Compass Pathways (CMPS) received a US patent for COMP360, its proprietary formulation of crystalline psilocybin. On Wednesday, the company announced positive findings from an open-label study using the formulation to treat depression in cancer patients.

Thirty patients were administered COMP360 in group therapy sessions of two to four people. Twenty-four people experienced at least a 50% reduction in depression symptoms within three weeks of treatment, which was sustained at week eight, and fifteen people were in total remission from depression.

The average depression score dropped from 25.9 to just 6.8!

The company notes that the study was not blinded or placebo-controlled, so the findings are subject to expectancy bias, but the results show promise that both COMP360 and group therapy models are effective.

Trip your way to a healthier lifestyle

Psychedelics improve mental health, but can that translate into better physical health too?

A recent study found that people who have tried psychedelics at least once in their life had a 23% lower chance of heart disease and a 12% lower chance of diabetes in the past year.

Other research indicates that psychedelic use is tied to healthier lifestyle choices such as increased exercise, reduced smoking and alcohol consumption, and a balanced diet.

Researchers also theorize that psychedelics could stimulate brain receptors that are linked to both mental and cardiometabolic health.

inspirational banner

DMT receives innovative medicine designation

DMT-assisted therapy could be approved in the UK sooner than expected!

Yesterday, Small Pharma (DMT) received an Innovation Passport Designation for its DMT-assisted therapy program for depression – a status given to promising medicines to expedite development. The passport gives the company access to the Innovative Licensing and Access Pathway (ILAP) to reduce time to market and facilitate patient access to the treatment.

The designation is essentially the UK’s version of a Breakthrough Therapy Designation, which the FDA granted to Compass Pathways (CMPS) and Usona Institute in 2018 and 2019, respectively, for their psilocybin-assisted therapy programs.

Small Pharma also launched a Phase 2a clinical trial for DMT-assisted therapy on Tuesday and began trading on the OTCQB market on Wednesday under the symbol “DMTTF”.

The largest psychedelic event in history

Curious about the latest advancements in psychedelic medicine, psychedelic retreats, microdosing, or the role of technology in the psychedelics sector? Then you won’t want to miss Microdose HQ’s Wonderland: Miami – the largest psychedelic medicine business event to date!

The two-day event on Nov. 8-9 will have keynote presentations from some of the biggest names in the psychedelic sector including including Robin Carhart-Harris, Matthew W. Johnson, Rick Doblin, and David Nutt.

(Mike Tyson and Lamar Odon will also share their experiences with psychedelic healing!)

The speakers will cover a vast range of unique topics: 

  • Shamanic protocols for making investment decisions…
  • Psychedelics and sports…
  • The threat of corporate domination in the industry…
  • And more.

Get your your ticket or virtual access pass here!

business banner

Be an early investor 🤑

Want to be an early investor in a psychedelics company? Now’s your chance!

Ei.Ventures is currently looking to raise $50M through a Regulation A+ Framework – a type of offering that allows the general public, not just institutional or accredited investors, to buy shares in a company before it goes public.

“I’m really passionate about democratizing investment opportunities so any investor can reap the rewards, and take all of the risks of early investment in game-changing companies,” said David Nikzad, the company’s founder, who was an early investor in Airbnb , Betterment, and Vidyard.

Ei.Ventures is developing a transdermal psilocybin patch and is preparing to launch a functional mushroom line early next year. Shares are selling for $4.94 each with a minimum purchase of 101 shares, and the company has already raised $20M. Take advantage of the offer here.

The world’s biggest psychedelic therapy provider

Field Trip Health (FTRP) just got one step closer to reaching its goal of running 75 psychedelic therapy clinics by 2024.

The company opened three new treatment centers in Seattle, Vancouver and Fredericton. It now administers ketamine-assisted therapy at eight clinics across North America and one in Amsterdam.

The treatment is proving to be effective with clients’ depression scores dropping from an average of 17 (severe) to 6 (mild) and benefits lasting at least 120 days.

74 studies on 50 compounds 🤯

This week, Cybin Inc. (CYBN) completed its 74th preclinical study to advance its proprietary molecules, CYB003 and CYB004, toward clinical research.

The company has evaluated 50 novel compounds in its preclinical research, narrowing it down to four lead candidates. including CYB003 for alcohol use disorder and CYB004 for anxiety disorders.

Compared to classic psychedelics, the formulations are showing:

  • Faster onset times
  • Shorter durations
  • High oral bioavailability
  • Significant brain penetration, and
  • Less variability between subjects

Human clinical trials are expected to begin early next year to work toward an Investigational New Drug (IND) status.

legal banner

Psychedelic farmer’s markets coming to Cali!

Oakland could legalize the sale of psychedelics as early as next year!

The city decriminalized the use and cultivation of many psychedelics back in 2019, and now, activists are building on their progress with a “Go Local” Legislative Initiative. The initiative would create a community-based model to allow people to legally purchase natural psychedelics like psilocybin and ayahuasca from local producers.

The initiative will gather research on how best to implement the model over the next year and will introduce a legislation in the summer of 2022.

Some possible reforms being considered include allowing commercial agriculture in residential zones, creating “sacred plant adult farmer’s market permits,” and allowing cannabis dispensaries with 100% local ownership to sell entheogens, among many others.

All products would have to be grown, produced, and tested locally.

Another unanimous win 🎉

After yet another unanimous vote, Easthampton became the fourth city in Massachusetts to decriminalize possession and cultivation of psychedelics!

Will this European island legalize shrooms?

Malta may legalize cannabis, but residents don’t want the reforms to stop there.

In a recent survey, 447 people in Malta were asked if they think the country should legalize any other substances beyond cannabis. Magic mushrooms was the most popular response with 45% in favour of its legalization.

LSD was the next most common response at 27%, but 56% did not see a need for any other drugs to be legalized.

Industry Quick Hits

Oct 18 – Johns Hopkins Receives $4M from the NIH – The First Federal Grant for Psychedelic Research in 50 years Read more…

Oct 19 – FSD Pharma (HUGE) Signs Agreement With Covar Pharmaceuticals To Support The Development Of Lucid-Psych Read more…

Oct 19 – Psyched Wellness (PSYC) says preliminary data reveals potential new functional property of Amanita mushroom for treating skin conditions Read more…

Oct 19 – Bank Of America Shuts Down Account Of Cannabis & Psychedelics Research Institute Registered With DEA Read more…

Oct 19 – atai Life Sciences (ATAI) Launches atai Impact, a Philanthropic Program to Harness the Power of Innovative Mental Health Approaches for Positive Social Change Read more…

Oct 20 – Tryp Therapeutics (TRYP) Reports Clinical Hold on Proposed Phase 2a Study in Eating Disorders Read more… 

Oct 20 – LOVE Pharma (LUV) Announces Development of Muco-Adhesive Sublingual Psilocybin Strip Read more…

Oct 21 – Journal of the Royal Society of Medicine Publishes New COVID-19 Suicide Research Led by Braxia Scientific (BRAX) CEO Dr. Roger McIntyre Read more…

Oct 22 – Novamind (NM) Unveils Stealth Mode Investment in Alto Neuroscience Read more…

Video of the Week

Dr. Bronner’s Support for Psychedelic-Assisted Therapy and Plant Medicines

Playlist of the Week

Lo-Fi | psychedleia
mushrooms on scale
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atai Life Sciences Launches atai Impact, a Philanthropic Program to Harness the Power of Innovative Mental Health Approaches for Positive Social Change

atai Life Sciences Launches atai Impact, a Philanthropic Program to Harness the Power of Innovative Mental Health Approaches for Positive Social Change

atai Impact is committed to advancing education, expanding access and supporting the wider ecosystem of mental health care

NEW YORK and BERLIN, Oct. 19, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company, today announced the launch of its new philanthropic program, atai Impact, in line with atai Life Sciences’ vision, to heal mental health disorders so that everyone, everywhere can live a more fulfilled life.

atai Impact has been developed to harness the power of innovative mental health approaches for positive social change, committed to advancing education, expanding access and supporting the wider ecosystem.

Its establishment is based on atai Life Sciences’ position that, while a for-profit model is the swiftest and most robust means of unlocking new modalities for patients in need, this model alone cannot address all aspects of the escalating global mental crisis.

Therefore, atai Life Sciences believes having harmonization among commercial and non-profit entities is the ideal way forward. The initial focus of atai Impact will be on the psychedelic sector, given its emerging potential in tackling the growing mental health crisis.

Supporting and collaborating with nonprofits and institutions that share its vision of healing mental health disorders, atai Impact will operate across three central pillars:

  1. Education: to help destigmatize mental health, promote better understanding of the potential of psychedelics in mental health care, and foster the next generation of neuro-innovators.
  2. Access: to support equal access to innovative and effective mental health support, for everyone, everywhere, regardless of geography or demographics.
  3. Ecosystem: to contribute to the sustainability of diverse stakeholder communities and environments, including indigenous resources.

“The launch of atai Impact is a very proud moment for everyone at atai Life Sciences and for me, personally. While we believe a for-profit model is the best way to get new treatments to patients in need, not all aspects of the global mental health crisis can be effectively addressed by this model alone,” said Florian Brand, Chief Executive Officer and Co-founder of atai Life Sciences.

“I’ve been moved by the huge volume of support, internally and externally, that we have had in bringing atai Impact to life and by the commitment of so many of our staff, founders and investors who’ve already joined me in contributing a portion of their own company equity to this important program. We are in active discussions with multiple stakeholders towards meaningful initiatives that we believe can help make a real difference to the future of psychedelic medicine and mental health care worldwide.”

The atai Impact program will be initially funded by 1% of the gross proceeds from atai Life Sciences’ June 2021 Initial Public Offering (NASDAQ) and founders’ contributions. In addition, atai Life Sciences has created a Volunteer Paid Time Off Policy, equal to 1% of employees’ time, and is working with the Equity for Impact initiative to encourage employees and investors to donate a portion of their equity to charitable endeavors.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release (including without limitation, the atai Impact program and any other future philanthropic endeavors by atai) that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information

For atai:

Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life