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atai Life Sciences Reports Third Quarter 2021 Financial Results and Corporate Update

atai Life Sciences Reports Third Quarter 2021 Financial Results and Corporate Update

-Positive topline results from COMP360’s Phase 2b study-

-RL-007 Phase 2a topline data in cognitive impairment associated with schizophrenia expected end of Q4-

-Continued progress across 11 therapeutic programs, including initiation of Perception’s Phase 2a and DemeRx’s Phase 1/2 trials as well as interim Phase 2a RL-007 readout of first cohort-

-Launch of atai Impact, a philanthropic program to harness the power of innovative mental health approaches for social change-

-Company to host a webcast and conference call today at 08:30am EST-

BERLIN and NEW YORK, Nov. 15, 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 reported its financial results for the third quarter ended September 30, 2021, and provided its corporate update.

“Following our IPO in June, we continue to see positive momentum. We have 11 therapeutic programs underway and each clinical development milestone marks progress towards achieving our vision to heal mental health disorders so that everyone, everywhere can live a more fulfilled life,” said Florian Brand, CEO and Co-Founder.

“In response to the heterogeneity of the mental health patient population, we are developing a pharmacologically diverse array of treatments. We intend to support these treatments with innovative digital therapeutics and robust insights from our multi-modal data approach. Our ultimate goal is to tailor our treatments to individual patient needs by using a diverse set of biomarkers. We anticipate further growth of our drug development pipeline and our enabling technologies through our ‘buy and build’ approach and will remain highly active in business development.

“We recently initiated two new clinical trials: a Phase 2a trial with PCN-101 (R-ketamine) for treatment-resistant depression and a Phase 1/2 trial with DMX-1002 (ibogaine) in opioid use disorder. In terms of clinical readouts, just last week we saw positive Phase 2b data from COMPASS Pathways, the first company we funded to rigorously research the potential of psychedelics. This clinical trial demonstrated the rapid onset of effect, large effect size, and durability of COMP360 (a proprietary synthetic formulation of psilocybin) in treatment-resistant depression. We expect another important clinical readout before the end of the year for RL-007 in cognitive impairment associated with schizophrenia.

“The narrow focus on mental health treatments means that every single trial result offers important insights not only for the program in question but for all our programs, allowing us to accelerate the development of novel treatments for patients in need.”

Program Updates

COMP360 (psilocybin):
Program Details: COMP360 is a proprietary formulation of synthetic psilocybin, a 5-HT2A-R agonist being developed as an oral, potentially rapid-acting antidepressant.

Recent Advancements:

  • In November, COMPASS announced positive topline results from its Phase 2b randomized, controlled, double-blind, dose-controlled trial of COMP360 psilocybin therapy for treatment-resistant depression.
  • The 233-patient study met its primary endpoint, showing a 6.6-point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 3 weeks when comparing the 25mg dose to the 1mg dose.
  • COMP360 also showed both rapid response and durability of efficacy. Rapid onset of action with statistically significant treatment differences between the 25mg vs 1mg groups were apparent the day after COMP360 psilocybin administration. Responder rates at week 12 based upon a ≥50% decrease in MADRS total score from baseline were 32.9% and 16.4% for psilocybin doses of 25mg and 1mg respectively. Remitter rates at week 12 based upon a MADRS total score ≤10 were 26.6% and 11.4% for psilocybin doses of 25mg and 1mg respectively.
  • COMP360 was generally well tolerated.

Upcoming Milestones:

  • A pivotal Phase 3 study is anticipated to launch in 2022.

Affiliate: COMPASS Pathways

PCN-101 (R-ketamine):
Program Details: PCN-101 is a parenteral formulation of R-ketamine, a glutamatergic modulator being developed as a potentially rapid-acting antidepressant, with the potential for at-home treatment.

Recent Advancements:

  • In September 2021, Perception Neuroscience initiated the Phase 2 trial of PCN-101 (R-ketamine) for TRD. This randomized, double blind, placebo-controlled trial is designed to assess the efficacy, safety, dose response and duration of action in patients with TRD.

Upcoming Milestones: 

  • Topline data are expected at the end of 2022.

Affiliate: Perception Neuroscience

RL-007:
Program Details: RL-007, a cholinergic, glutamatergic and GABA-B receptor modulator, is an orally available compound that is being developed for the treatment of cognitive impairments associated with schizophrenia (CIAS). The currently active open-label, multi-dose, biomarker-focused Phase 2a trial of RL-007 in patients with CIAS is designed to evaluate the compound’s safety, tolerability and its impact on electroencephalogram-based biomarkers.

Recent Advancements:

  • Following the encouraging results of a recently completed interim analysis of Quantitative Electroencephalogram (qEEG) data from the eight patients in the first cohort, atai advanced a portion of a future milestone payment aiming to accelerate initiation of the subsequent trial, which, broadly, will be a double-blind, placebo controlled, proof-of-concept study focused on more traditional cognitive endpoints, including subsets of the MATRICS battery.

Upcoming Milestones: 

  • Topline data are expected by the end of 2021.

Affiliate: Recognify Life Sciences

GRX-917 (deuterated etifoxine):
Program Details: GRX-917 is an oral formulation of a deuterated version of etifoxine, a mitochondrial translocator protein agonist, designed to provide potentially rapid anxiolytic activity with improved tolerability compared to current treatments for anxiety in the United States.

Recent Advancements:

  • The Phase 1 randomized, double blind, placebo-controlled trial of GRX-917 is designed to evaluate the compound’s safety, tolerability, pharmacokinetics, as well as pharmacodynamics using qEEG. We have recently completed the single ascending dose (SAD) component of the trial, and dosing in the multiple ascending dose (MAD) component is ongoing.

Upcoming Milestones:

  • Topline data are expected in mid-2022.

Affiliate: GABA Therapeutics

DMX-1002 (ibogaine):
Program Details: DMX-1002 is an oral formulation of ibogaine, a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of opioid use disorder (OUD).

Recent Advancements:

  • In September 2021, DemeRx IB dosed the first subject in a Phase 1/2a trial of DMX-1002. This trial is designed to assess the safety, tolerability, pharmacokinetics, and efficacy of DMX-1002 and will inform future studies in patients with OUD.

Upcoming Milestones

  • Topline safety data are expected in early 2022.

Affiliate: DemeRx IB

Q3 and Recent Corporate Updates
Discovery Programs

  • Launched PsyProtix, a precision psychiatry company creating new chemical entities targeting mitochondrial dysfunction related to TRD and other mental health conditions. PsyProtix is currently engaged in discovery and preclinical development and expects to launch clinical trials in 2023.
  • Created and pharmacologically tested over 250 novel compounds at EntheogeniX based upon structures generated using computational chemistry approach. Lead candidate selection is currently ongoing.

Formulation Technologies

  • Entered into an expanded agreement with strategic partner IntelGenx, building on positive early feasibility data, to support IntelGenx’s graduation from the TSX Venture Exchange to the Toronto Stock Exchange. As part of the strategic partnership, IntelGenx has exclusively partnered with atai to develop formulations of compounds for the prevention or treatment of mental health disorders.
  • Completed a proof-of-principle study demonstrating that InnarisBio’s sol-gel based excipient technology can effectively transport compounds from the nose directly to the brain in an animal model. InnarisBio is developing its nose-to-brain excipient technology to facilitate potentially rapid, non-invasive entry into the brain for use across various drug candidates in atai’s pipeline, including Revixia, Neuronasal, and DemeRx.

Digital Therapeutics

  • Initiated a user acceptability testing of our digital therapeutics (DTx) app, one of our key enabling technologies, in patients with TRD receiving ketamine treatment.
  • In addition, we have assembled a proof-of-concept, EEG- and VR-based digital therapeutic device to support patients undergoing psychedelic therapy, and we have kicked off user feedback testing to optimize across product parameters.
  • Both technologies are expected to be implemented in Viridia and Revixia Phase 1 trials and DemeRx IB Phase 2 trial starting next year.

New Initiatives

  • Launched atai Impact, atai’s philanthropic program, established to support and collaborate with nonprofits and institutions that share atai Life Sciences’ vision, with the key pillars of: advancing education, expanding access, and supporting the wider ecosystem of mental health care. atai Impact has an initial focus on the psychedelics sector, given its emerging potential in tackling the growing mental health crisis. Its formation is underpinned by atai’s belief that harmonization across commercial and non-profit entities represents the best path forward to harness the power of innovative mental health approaches for positive social change. The atai Impact program will be initially funded by 1% of the gross proceeds from our June 2021 IPO and founders’ and shareholders’ contributions.

Third Quarter 2021 Financial Results

Cash and Cash Equivalents
Cash and cash equivalents totaled $430.3 million as of September 30, 2021, compared to $97.2 million as of December 31, 2020. The nine month increase of $333.1 million is attributed to net proceeds of $231.6 million from atai’s IPO, net proceeds of $166.4 million from Series C and Series D and common stock issuances, $20.0 million of license revenue proceeds, and $10.1 million proceeds from the sale of investments and issuance and conversion of convertible notes. Offsetting were cash payments of $32.6 million for investments in platform companies and other assets, and $62.4 million in net operating expenses and effect of foreign exchange rate changes.

Operating Costs and Expenses
Research and development (R&D) expenses were $13.4 million and $35.0 million for the three and nine months ended September 30, 2021, respectively, as compared to $3.1 million and $8.1 million for the same prior year periods. The increase of $10.3 million and $26.9 million, respectively, were attributable to personnel costs, including stock-based compensation expense, and increased contract research organization expenses related to advancements in atai’s R&D programs.

atai recorded acquisition of in-process R&D expense of $9.0 million for the nine months ended September 30, 2021, relating to its investments in Neuronasal and InnarisBio.

General and administrative expenses for the three and nine months ended September 30, 2021 were $20.3 million and $66.9 million, respectively, as compared to $4.3 million and $8.7 million in the same prior year periods. The increases of $16.0 million and $58.2 million, respectively, were attributable to personnel costs, including stock-based compensation expense, professional fees, and other costs related to support of atai’s platform growth and public company requirements.

Total stock-based compensation expense for the three and nine months ended September 30, 2021 was $12.2 million and $50.0 million, respectively, as compared to $2.1 and $2.2 for the comparable prior year periods, reflecting the recognition of expense related to the achievement of IPO performance-based partial vesting conditions.

Net loss attributable to atai shareholders for the three and nine months ended September 30, 2021 was $31.2 million and $78.9 million, respectively, as compared to $83.2 million and $83.2 million for the comparable prior year periods.

Conference Call Information
atai will host a conference call and live audio webcast today at 08:30am EST to discuss its financial results and provide a corporate 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. An archived copy of the webcast will be available on the atai website for at least 30 days after the conference call.

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, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, our future operating results and financial position; 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 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 we may identify and pursue; 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. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.

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 we believe 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. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.

Contact Information

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

 

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2021 2020 2021 2020
License revenue $ 266 $ – $ 20,146 $ –
Operating expenses:
Research and development 13,363 3,058 34,974 8,056
Acquisition of in-process research and development – – 8,934 120
General and administrative 20,264 4,328 66,868 8,749
Total operating expenses 33,627 7,386 110,776 16,925
Loss from operations (33,361 ) (7,386 ) (90,630 ) (16,925 )
Other income (expense), net 6,887 (13,942 ) 2,608 6,352
Net loss before income taxes (26,474 ) (21,328 ) (88,022 ) (10,573 )
Provision for income taxes (368 ) (4 ) (432 ) (4 )
Gain on investment dilution – – 16,923 –
Losses from investments in equity method investees, net of tax (4,800 ) (61,862 ) (9,440 ) (73,693 )
Net loss (31,642 ) (83,194 ) (80,971 ) (84,270 )
Net income (loss) attributable to redeemable noncontrolling
interests and noncontrolling interests (484 ) 1 (2,040 ) (1,021 )
Net loss attributable to ATAI Life Sciences N.V. stockholders $ (31,158 ) $ (83,195 ) $ (78,931 ) $ (83,249 )
Net loss per share attributable to ATAI Life Sciences N.V. stockholders– basic and diluted $ (0.21 ) $ (0.92 ) $ (0.59 ) $ (0.92 )
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V.
stockholders — basic and diluted		 151,130,212 90,709,312 134,334,685 90,709,312

 

ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)
September 30, December 31,
2021 2020
(unaudited) (1)
Assets
Cash and cash equivalents $ 430,308 $ 97,246
Prepaid expenses and other current assets 11,551 2,076
Short term notes receivable – related party – 226
Property and equipment, net 138 71
Deferred offering costs – 1,575
Equity method investments 15,086 –
Other investments held at fair value 6,816 –
Other investments 14,256 8,044
Long term notes receivable 908 911
Long term notes receivable – related parties 3,784 1,060
Other assets 1,262 339
Total assets $ 484,109 $ 111,548
Liabilities and Stockholders’ Equity
Accounts payable $ 1,974 $ 3,083
Accrued liabilities 13,075 9,215
Current portion of contingent consideration liability – related parties 50 –
Deferred revenue 180 –
Short-term notes payable 38 –
Non-current portion of contingent consideration liability – related parties 1,947 1,705
Convertible promissory notes – related parties, net of discounts and deferred issuance costs 800 1,199
Convertible promissory notes and derivative liability – 978
Other liabilities 3,285 –
Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders 453,186 90,822
Noncontrolling interests 9,574 4,546
Total liabilities and stockholders’ equity $ 484,109 $ 111,548
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2020 are derived from the audited consolidated financial statements as of that date.
Posted on

atai Life Sciences Reports Third Quarter 2021 Financial Results and Corporate Update

-Positive topline results from COMP360’s Phase 2b study-

-RL-007 Phase 2a topline data in cognitive impairment associated with schizophrenia expected end of Q4-

-Continued progress across 11 therapeutic programs, including initiation of Perception’s Phase 2a and DemeRx’s Phase 1/2 trials as well as interim Phase 2a RL-007 readout of first cohort-

-Launch of atai Impact, a philanthropic program to harness the power of innovative mental health approaches for social change-

-Company to host a webcast and conference call today at 08:30am EST-

BERLIN and NEW YORK, Nov. 15, 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 reported its financial results for the third quarter ended September 30, 2021, and provided its corporate update.

“Following our IPO in June, we continue to see positive momentum. We have 11 therapeutic programs underway and each clinical development milestone marks progress towards achieving our vision to heal mental health disorders so that everyone, everywhere can live a more fulfilled life,” said Florian Brand, CEO and Co-Founder.

“In response to the heterogeneity of the mental health patient population, we are developing a pharmacologically diverse array of treatments. We intend to support these treatments with innovative digital therapeutics and robust insights from our multi-modal data approach. Our ultimate goal is to tailor our treatments to individual patient needs by using a diverse set of biomarkers. We anticipate further growth of our drug development pipeline and our enabling technologies through our ‘buy and build’ approach and will remain highly active in business development.

“We recently initiated two new clinical trials: a Phase 2a trial with PCN-101 (R-ketamine) for treatment-resistant depression and a Phase 1/2 trial with DMX-1002 (ibogaine) in opioid use disorder. In terms of clinical readouts, just last week we saw positive Phase 2b data from COMPASS Pathways, the first company we funded to rigorously research the potential of psychedelics. This clinical trial demonstrated the rapid onset of effect, large effect size, and durability of COMP360 (a proprietary synthetic formulation of psilocybin) in treatment-resistant depression. We expect another important clinical readout before the end of the year for RL-007 in cognitive impairment associated with schizophrenia.

“The narrow focus on mental health treatments means that every single trial result offers important insights not only for the program in question but for all our programs, allowing us to accelerate the development of novel treatments for patients in need.”

Program Updates

COMP360 (psilocybin):
Program Details: COMP360 is a proprietary formulation of synthetic psilocybin, a 5-HT2A-R agonist being developed as an oral, potentially rapid-acting antidepressant.

Recent Advancements:

  • In November, COMPASS announced positive topline results from its Phase 2b randomized, controlled, double-blind, dose-controlled trial of COMP360 psilocybin therapy for treatment-resistant depression.
  • The 233-patient study met its primary endpoint, showing a 6.6-point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 3 weeks when comparing the 25mg dose to the 1mg dose.
  • COMP360 also showed both rapid response and durability of efficacy. Rapid onset of action with statistically significant treatment differences between the 25mg vs 1mg groups were apparent the day after COMP360 psilocybin administration. Responder rates at week 12 based upon a ≥50% decrease in MADRS total score from baseline were 32.9% and 16.4% for psilocybin doses of 25mg and 1mg respectively. Remitter rates at week 12 based upon a MADRS total score ≤10 were 26.6% and 11.4% for psilocybin doses of 25mg and 1mg respectively. 
  • COMP360 was generally well tolerated.

Upcoming Milestones:

  • A pivotal Phase 3 study is anticipated to launch in 2022.

Affiliate: COMPASS Pathways

PCN-101 (R-ketamine): 
Program Details: PCN-101 is a parenteral formulation of R-ketamine, a glutamatergic modulator being developed as a potentially rapid-acting antidepressant, with the potential for at-home treatment.

Recent Advancements:

  • In September 2021, Perception Neuroscience initiated the Phase 2 trial of PCN-101 (R-ketamine) for TRD. This randomized, double blind, placebo-controlled trial is designed to assess the efficacy, safety, dose response and duration of action in patients with TRD.

Upcoming Milestones: 

  • Topline data are expected at the end of 2022.

Affiliate: Perception Neuroscience

RL-007:
Program Details: RL-007, a cholinergic, glutamatergic and GABA-B receptor modulator, is an orally available compound that is being developed for the treatment of cognitive impairments associated with schizophrenia (CIAS). The currently active open-label, multi-dose, biomarker-focused Phase 2a trial of RL-007 in patients with CIAS is designed to evaluate the compound’s safety, tolerability and its impact on electroencephalogram-based biomarkers.

Recent Advancements:

  • Following the encouraging results of a recently completed interim analysis of Quantitative Electroencephalogram (qEEG) data from the eight patients in the first cohort, atai advanced a portion of a future milestone payment aiming to accelerate initiation of the subsequent trial, which, broadly, will be a double-blind, placebo controlled, proof-of-concept study focused on more traditional cognitive endpoints, including subsets of the MATRICS battery.

Upcoming Milestones: 

  • Topline data are expected by the end of 2021.

Affiliate: Recognify Life Sciences

GRX-917 (deuterated etifoxine):
Program Details: GRX-917 is an oral formulation of a deuterated version of etifoxine, a mitochondrial translocator protein agonist, designed to provide potentially rapid anxiolytic activity with improved tolerability compared to current treatments for anxiety in the United States.

Recent Advancements:

  • The Phase 1 randomized, double blind, placebo-controlled trial of GRX-917 is designed to evaluate the compound’s safety, tolerability, pharmacokinetics, as well as pharmacodynamics using qEEG. We have recently completed the single ascending dose (SAD) component of the trial, and dosing in the multiple ascending dose (MAD) component is ongoing.

Upcoming Milestones:

  • Topline data are expected in mid-2022.

Affiliate: GABA Therapeutics

DMX-1002 (ibogaine):
Program Details: DMX-1002 is an oral formulation of ibogaine, a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of opioid use disorder (OUD).

Recent Advancements:

  • In September 2021, DemeRx IB dosed the first subject in a Phase 1/2a trial of DMX-1002. This trial is designed to assess the safety, tolerability, pharmacokinetics, and efficacy of DMX-1002 and will inform future studies in patients with OUD.

Upcoming Milestones

  • Topline safety data are expected in early 2022.

Affiliate: DemeRx IB

Q3 and Recent Corporate Updates
Discovery Programs

  • Launched PsyProtix, a precision psychiatry company creating new chemical entities targeting mitochondrial dysfunction related to TRD and other mental health conditions. PsyProtix is currently engaged in discovery and preclinical development and expects to launch clinical trials in 2023.
  • Created and pharmacologically tested over 250 novel compounds at EntheogeniX based upon structures generated using computational chemistry approach. Lead candidate selection is currently ongoing.

Formulation Technologies

  • Entered into an expanded agreement with strategic partner IntelGenx, building on positive early feasibility data, to support IntelGenx’s graduation from the TSX Venture Exchange to the Toronto Stock Exchange. As part of the strategic partnership, IntelGenx has exclusively partnered with atai to develop formulations of compounds for the prevention or treatment of mental health disorders.
  • Completed a proof-of-principle study demonstrating that InnarisBio’s sol-gel based excipient technology can effectively transport compounds from the nose directly to the brain in an animal model. InnarisBio is developing its nose-to-brain excipient technology to facilitate potentially rapid, non-invasive entry into the brain for use across various drug candidates in atai’s pipeline, including Revixia, Neuronasal, and DemeRx.

Digital Therapeutics

  • Initiated a user acceptability testing of our digital therapeutics (DTx) app, one of our key enabling technologies, in patients with TRD receiving ketamine treatment.
  • In addition, we have assembled a proof-of-concept, EEG- and VR-based digital therapeutic device to support patients undergoing psychedelic therapy, and we have kicked off user feedback testing to optimize across product parameters.
  • Both technologies are expected to be implemented in Viridia and Revixia Phase 1 trials and DemeRx IB Phase 2 trial starting next year.

New Initiatives

  • Launched atai Impact, atai’s philanthropic program, established to support and collaborate with nonprofits and institutions that share atai Life Sciences’ vision, with the key pillars of: advancing education, expanding access, and supporting the wider ecosystem of mental health care. atai Impact has an initial focus on the psychedelics sector, given its emerging potential in tackling the growing mental health crisis. Its formation is underpinned by atai’s belief that harmonization across commercial and non-profit entities represents the best path forward to harness the power of innovative mental health approaches for positive social change. The atai Impact program will be initially funded by 1% of the gross proceeds from our June 2021 IPO and founders’ and shareholders’ contributions.

Third Quarter 2021 Financial Results

Cash and Cash Equivalents
Cash and cash equivalents totaled $430.3 million as of September 30, 2021, compared to $97.2 million as of December 31, 2020. The nine month increase of $333.1 million is attributed to net proceeds of $231.6 million from atai’s IPO, net proceeds of $166.4 million from Series C and Series D and common stock issuances, $20.0 million of license revenue proceeds, and $10.1 million proceeds from the sale of investments and issuance and conversion of convertible notes. Offsetting were cash payments of $32.6 million for investments in platform companies and other assets, and $62.4 million in net operating expenses and effect of foreign exchange rate changes.

Operating Costs and Expenses
Research and development (R&D) expenses were $13.4 million and $35.0 million for the three and nine months ended September 30, 2021, respectively, as compared to $3.1 million and $8.1 million for the same prior year periods. The increase of $10.3 million and $26.9 million, respectively, were attributable to personnel costs, including stock-based compensation expense, and increased contract research organization expenses related to advancements in atai’s R&D programs.

atai recorded acquisition of in-process R&D expense of $9.0 million for the nine months ended September 30, 2021, relating to its investments in Neuronasal and InnarisBio.

General and administrative expenses for the three and nine months ended September 30, 2021 were $20.3 million and $66.9 million, respectively, as compared to $4.3 million and $8.7 million in the same prior year periods. The increases of $16.0 million and $58.2 million, respectively, were attributable to personnel costs, including stock-based compensation expense, professional fees, and other costs related to support of atai’s platform growth and public company requirements.

Total stock-based compensation expense for the three and nine months ended September 30, 2021 was $12.2 million and $50.0 million, respectively, as compared to $2.1 and $2.2 for the comparable prior year periods, reflecting the recognition of expense related to the achievement of IPO performance-based partial vesting conditions.

Net loss attributable to atai shareholders for the three and nine months ended September 30, 2021 was $31.2 million and $78.9 million, respectively, as compared to $83.2 million and $83.2 million for the comparable prior year periods.

Conference Call Information
atai will host a conference call and live audio webcast today at 08:30am EST to discuss its financial results and provide a corporate 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. An archived copy of the webcast will be available on the atai website for at least 30 days after the conference call.

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, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, our future operating results and financial position; 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 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 we may identify and pursue; 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. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.

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 we believe 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. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.

Contact Information

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

ATAI LIFE SCIENCES N.V. 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 
(Amounts in thousands, except share and per share amounts) 
(unaudited) 
          
  Three Months Ended Nine Months Ended 
  September 30, September 30, 
   2021   2020   2021   2020  
License revenue $266  $–  $20,146  $–  
Operating expenses:         
Research and development  13,363   3,058   34,974   8,056  
Acquisition of in-process research and development  –   –   8,934   120  
General and administrative  20,264   4,328   66,868   8,749  
Total operating expenses  33,627   7,386   110,776   16,925  
Loss from operations  (33,361)  (7,386)  (90,630)  (16,925) 
Other income (expense), net  6,887   (13,942)  2,608   6,352  
Net loss before income taxes  (26,474)  (21,328)  (88,022)  (10,573) 
Provision for income taxes  (368)  (4)  (432)  (4) 
Gain on investment dilution  –   –   16,923   –  
Losses from investments in equity method investees, net of tax  (4,800)  (61,862)  (9,440)  (73,693) 
Net loss  (31,642)  (83,194)  (80,971)  (84,270) 
Net income (loss) attributable to redeemable noncontrolling         
interests and noncontrolling interests  (484)  1   (2,040)  (1,021) 
Net loss attributable to ATAI Life Sciences N.V. stockholders $(31,158) $(83,195) $(78,931) $(83,249) 
Net loss per share attributable to ATAI Life Sciences N.V. stockholders– basic and diluted $(0.21) $(0.92) $(0.59) $(0.92) 
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V.
   stockholders — basic and diluted		  151,130,212   90,709,312   134,334,685   90,709,312  
          
ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEET
(Amounts in thousands)
    
 September 30,December 31,
  2021  2020 
 (unaudited)  (1) 
Assets   
Cash and cash equivalents$430,308 $97,246 
Prepaid expenses and other current assets 11,551  2,076 
Short term notes receivable – related party –  226 
Property and equipment, net 138  71 
Deferred offering costs –  1,575 
Equity method investments 15,086  – 
Other investments held at fair value 6,816  – 
Other investments 14,256  8,044 
Long term notes receivable 908  911 
Long term notes receivable – related parties 3,784  1,060 
Other assets 1,262  339 
Total assets$484,109 $111,548 
Liabilities and Stockholders’ Equity   
Accounts payable$1,974 $3,083 
Accrued liabilities 13,075  9,215 
Current portion of contingent consideration liability – related parties 50  – 
Deferred revenue 180  – 
Short-term notes payable 38  – 
Non-current portion of contingent consideration liability – related parties 1,947  1,705 
Convertible promissory notes – related parties, net of discounts and deferred issuance costs 800  1,199 
Convertible promissory notes and derivative liability –  978 
Other liabilities 3,285  – 
Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders 453,186  90,822 
Noncontrolling interests 9,574  4,546 
Total liabilities and stockholders’ equity$484,109 $111,548 
    
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2020 are derived from the audited consolidated financial statements as of that date.
Posted on

Smoke weed with a veteran on DMT: issue 23

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

🍄 How weed influences your trip

🍄 Healing veterans with DMT

🍄 The results from the biggest psilocybin study ever!

🍄 At-home ketamine therapy

🍄 And more.

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

Functional Mushrooms for Health & Nutrition with FreshCap CEO Tony Shields

In the episode of the Daily Mushroom Podcast, we have Tony Shields, CEO of FreshCap. Tony’s knowledge on mushrooms is deep and expansive and stems from a childhood fascination with these magnificent fungi. If you want to learn more about the benefits of functional mushrooms, this podcast is for you.

Therapeutic banner

The results from the world’s biggest psilocybin trial are in!

COMPASS Pathways’ (CMPS) stock dropped nearly 30% after announcing mixed study findings and Q3 financial results on Monday.

The company conducted a trial on 233 patients to determine the best psilocybin dose for treatment-resistant depression (TRD).

All three groups showed improvements the day after receiving the dose. The group with the largest dose had the best results, with 36.7% of patients showing at least a 50% decrease in depression scores and 29.1% in remission at week 3. A quarter of the patients showed sustained improvements until week 12.

Unfortunately, 12 patients experienced serious adverse events such as suicidal ideation or self harm, but these behaviours are common in patients with TRD.

The company is preparing for a larger trial beginning next year.

COMPASS also announced that it lost $15.8 million or $0.38 per share in Q3, an improvement compared to its $1.30 loss per share in Q3 of last year.

Here’s a graph that shows the impact on levels of depression reported by trial patients: 👇🏽

Why ketamine is so effective at preventing suicide

Researchers have known for years that ketamine can reduce depression symptoms and suicidal ideation in as little as 24 hours, but a recent study helps us understand why it’s so beneficial.

The study showed that a single dose of ketamine rapidly improved cognitive function, problem-solving abilities, and distorted thinking in suicidal patients.

“Being able to think more clearly can make someone feel less suicidal,” explains Ravi. N. Shah, MD, one of the researchers.

Ketamine was more effective than Midazolam, a benzodiazepine used as a sedative for surgeries. After the dose, suicidal ideation was diminished for up to 6 weeks.

Treating alcoholism and depression with half the dose

Cybin (CYBN) announced that its psilocybin formulation for depression and alcoholism, CYB003, could be more effective than oral psilocybin.

The company conducted preclinical testing on multiple species of animals. Researchers found that CYB003 has nearly double the brain penetration compared to oral psilocybin, resulting in a 50% reduction in dosage, variability, and onset time.

A smaller dosage has potential to reduce negative side effects such as nausea. The formulation could lead to shorter sessions which would make treatment more affordable!

inspirational banner

Can weed make your trip better?

A bit of weed could make your trip more spiritual and less scary.

A survey of 321 people suggests that using cannabis while on psychedelics increases the odds of mystical experiences, ego deaths, and intense visuals. 

The data also showed that low doses of cannabis reduced the chances of bad trip, whereas high doses increased feelings of fear and insanity.

Healing veterans with DMT

In honour of Veteran’s Day, we’re sharing how a Special Ops veteran cured his chronic pain and PTSD with DMT.

Asher Gibson was diagnosed with PTSD and traumatic brain injury after countless combats across the world. Prescription medications began to dominate his life, so he turned to psychedelic healing.

After smoking DMT, the powerful compound found in ayahuasca, Asher was blasted out of his body and traveled through different dimensions to the beginning of time.

“I remember my whole head being ecstatic and numb, like the most wonderful electrical massage on my brain. The feeling moved down my neck and shoulders and eventually filled my entire body.”

After the trip, Asher’s debilitating neck and shoulder pain was almost non-existent and his mental state subsided to manageable levels. He is no longer dependent on prescription drugs.

“While DMT isn’t the magic button that fixes everything, I believe it’s a powerful guide to help you do the work yourself,” he explains.

To bring this kind of relief to other veterans, consider supporting the Heroic Hearts Project – a non-profit organization that provides ayahuasca retreats for veterans with combat experience or military sexual trauma.

Insurance coverage for ketamine therapy

A major hurdle of making psychedelic therapy accessible to all will be getting the treatment covered by insurance.

That’s why we’re excited to share that Novamind (NM) has secured coverage for ketamine treatments from four major health insurance providers: Blue Cross Blue Shield, the University of Utah, PEHP Health & Benefits and MBA Benefit Administrators!

The company’s Chief Medical Officer says that this a promising signal that insurance providers are interested in more effective mental health treatments as research emerges.

Novamind has also opened a call center dedicated to insurance verification to ensure that patients are approved and reimbursed as quickly as possible.

business banner

Congrats to the top psychedelic companies of 2021!

These leading psychedelic companies were recognized for their accomplishments at Microdose Psychedelic Insights’ Wonderland: Miami – the world’s largest psychedelic business event, ever.

Company of the Year: Cybin Inc. (CYBN)

Psilocybin Company of the Year: MycroDose Therapeutics (private)

Ketamine Company of the Year: Field Trip Health (FTRP)

Ibogaine Company of the Year: MindMed (MNMD)

DMT Company of the Year: Psilera Bioscience (private)

LSD Company of the Year: MindMed (MNMD)

MDMA Company of the Year: MAPS (non-profit)

Platform Company of the Year: MindMed (MNMD)

Drug Development Company of the Year: Awakn Life Sciences (AWKN)

Retreat of the Year: Synthesis

Clinic of the Year: Awakn Life Sciences (AWKN)

B2C Tech Company of the Year: Fireside Project (non-profit)

B2B Tech Company of the Year: MycroDose Therapeutics (private)

Try psychedelic therapy at home in these states

TripSitter Clinic Corp. now offers at-home ketamine therapy in 10 states! 

The company, which is part of Origin Therapeutics’ portfolio, expanded its services to eight new states: Arizona, Colorado, Michigan, Washington, Florida, New York, Ohio, and Virginia, in addition to California and Illinois.

Patients can receive a prescription for oral ketamine after a virtual consultation with a physician. They then take the medication at home with virtual guidance, followed by therapy sessions.

This is a promising step toward greater ketamine accessibility. 💪🏼

legal banner

Psilocybin production increases 11,900% in 2021

To keep up with the growing demand for psychedelic research, the DEA is yet again increasing the legal production quotas for certain Schedule I substances.

The original proposal for psilocybin was just 50 grams, which increased to 1,500 grams in September. The final quota is now 6,000 grams – a total increase of 11,900%!

Production of both MDMA and DMT increased 6,300% from 50 grams to 3,200 grams.

Industry Quick Hits

Nov 5 – Fluence Raises $1.6M for Psychedelic Therapy Training Read more…

Nov 5 – MAPS and Momentum Events Announce Collaboration on Psychedelic Science 2023 Read more…

Nov 8 – Blackhawk Growth’s (BLR) MindBio Therapeutics Completes Safety Milestone in its Phase 1 Clinical Trials Read more…

Nov 8 – Delic Corp (DELC) Acquisition Of Ketamine Wellness Centers Is Complete Read more…

Nov 8 – NeonMind (NEON) And SRx Health Solutions Announce Strategic Alliance To Establish Specialty Mental Health Clinics For Interventional Psychiatry Treatments Read more…

Nov 9 – MYND Life Sciences (MYND) Executes LOI to Enter into a Clinical Research Collaboration with Revitalist Read more…

Nov 9 – Nova Mentis (NOVA) Files Genetic Neuroinflammatory Disease Patent Read more…

Nov 9 – Herbal Supplement Giant, Irwin Naturals (IWINF), To Enter THC & Psychedelics Industries Read more…

Nov 11 – PharmaTher (PHRM) Announces Positive Research Results for Psilocybin Microneedle Patch Read more…

Video of the Week

DMT Quest Documentary

Playlist of the Week

60s - 70s stoner rock
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Goodness Growth Holdings Announces Third Quarter 2021 Financial Results

Goodness Growth Holdings Announces Third Quarter 2021 Financial Results

VIEW ALL NEWS

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COMPASS Pathways announces positive topline results from groundbreaking phase IIb trial of investigational COMP360 psilocybin therapy for treatment-resistant depression

COMPASS Pathways announces positive topline results from groundbreaking phase IIb trial of investigational COMP360 psilocybin therapy for treatment-resistant depression

Largest randomised, controlled, double-blind psilocybin therapy study ever completed shows rapid and sustained response for patients receiving a single dose of COMP360 psilocybin with psychological support

COMPASS management team to host an investor conference call today at 1.00pm UK (8.00am ET)

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced that its groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression has achieved its primary endpoint for the highest dose, with a 25mg dose of COMP360 demonstrating a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with a rapid and durable treatment response*.

In the randomised, controlled, double-blind trial, a single dose of investigational COMP360 psilocybin was given to 233 patients in conjunction with psychological support from specially trained therapists. All patients discontinued antidepressants prior to participation. The trial was powered to compare two active doses of COMP360, 25mg and 10mg, against a comparator 1mg dose. The 25mg group vs the 1mg group showed a -6.6 difference on the MADRS* depression scale at week 3 (p<0.001). The 25mg group demonstrated statistical significance on the MADRS efficacy endpoint on the day after the COMP360 psilocybin administration (p=0.002). The 10mg vs 1mg dose did not show a statistically significant difference at week 3. The MADRS was assessed by independent raters who were remote from the trial site, and blind to intervention and study design, effectively creating a triple blind. At least twice the number of patients in the 25mg group showed response and remission* at week 3 and week 12, compared with the 1mg group. The protocol-defined sustained response* up to week 12 was double, with 20.3% of patients in the 25mg group vs 10.1% in the 1mg group. Using a definition of sustained response* that is consistent with other TRD studies, the difference was more than double, with 24.1% of patients in the 25mg group vs 10.1% in the 1mg group. COMP360 was generally well tolerated, with more than 90% of treatment-emergent adverse events (TEAEs) being mild or moderate in severity. 179 patients reported at least one TEAE; the most common TEAEs across treatment groups (>10% overall incidence) were headache, nausea, fatigue and insomnia. There were 12 patients who reported treatment-emergent serious adverse events (TESAEs). These TESAEs included suicidal behaviour, intentional self-injury, and suicidal ideation, which are regularly observed in a treatment-resistant depression patient population, and which occurred more frequently in the 25mg group than in the 10mg or 1 mg groups. Overall, 209 patients completed the study; there were five withdrawals from the 25mg group, nine from the 10mg, and 10 from the 1mg.

This randomised, controlled, multicentre, double-blind phase IIb trial is the largest psilocybin therapy clinical trial ever conducted, with 233 patients from 10 countries in North America and Europe. 94% of the patients had no prior experience with psilocybin. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III programme, which COMPASS expects to begin in 2022.

Depression that isn’t helped after two or more adequate antidepressive treatments is referred to as treatment-resistant depression (TRD)1,2. More than 100 million people worldwide are affected by TRD1,2, and as many as 30% of these attempt suicide at least once during their lifetime3,4. The TRD population is by definition more difficult to treat and more likely to relapse than patients with major depressive disorder. In 2018, COMPASS received FDA Breakthrough Therapy designation for its COMP360 psilocybin therapy for TRD.

George Goldsmith, CEO and Co-founder, COMPASS Pathways, said: “No one is untouched by the mental health crisis – everyone has a story. We urgently need options for people who are not helped by existing therapies. We set out to explore the safety and efficacy of COMP360 psilocybin therapy in treatment-resistant depression, through a rigorous and large-scale trial, and to find an appropriate dose to take to the next stage. I am delighted that we have succeeded in doing this. We have demonstrated our ability to execute an innovative, multicentre, multinational clinical trial programme – and in the midst of a global pandemic. Our work follows the efforts and achievements of so many researchers before us, and we are grateful to all of them and for the opportunity to work with the mental health care community to transform patient experience and patient outcomes. With our world-leading psychedelic research over the last few years, we have now created a unique and extensive data lake; this provides an unprecedented opportunity to further evaluate and optimise psilocybin therapy for patients suffering with serious mental health illness. With these compelling data, we will urgently progress our clinical development programme and move closer to making this therapy accessible to patients in need, if approved.”

Key findings:

  • COMP360 25mg vs 1mg: a difference of -6.6 points in change from baseline in MADRS total scores at week 3 (p<0.001), with a statistically significant difference seen from day 2 up to week 6
  • COMP360 10mg vs 1mg: a non-statistically significant numerical treatment difference of -2.5 points at week 3 (p=0.184)
  • At least double the number of MADRS responders, remitters, and sustained responders with 25mg vs 1mg; rapid response and remission from day 2 to week 3
    • 36.7% (29 patients) in 25mg group showed response at week 3, compared with 17.7% (14 patients) in 1mg group
    • 29.1% (23 patients) in 25mg group were in remission at week 3, compared with 7.6% (6 patients) in 1mg group
    • 24.1% (19 patients) in 25mg group were sustained responders at week 12, compared with 10.1% (8 patients) in 1mg group
  • COMP360 was generally well tolerated, with more than 90% of treatment-emergent adverse events (TEAEs) mild or moderate in severity
  • Treatment-emergent adverse event (TEAE) incidence
    • 5% (66 patients) in 25mg group
    • 7% (56 patients) in 10 mg group
    • 2% (57 patients) in 1 mg group
  • Treatment-emergency serious adverse event (TESAE) incidence
    • 3% (5 patients) in 25mg group
    • 0% (6 patients) in 10 mg group
    • 3% (1 patient) in 1mg group

David J Hellerstein MD, a Principal Investigator on the trial and Professor of Clinical Psychiatry at the Columbia University Irving Medical Center, said: “Treatment-resistant depression is a common and devastating condition, affecting tens of millions of people, with few effective treatments. This is the largest modern study of a psychedelic drug, combined with psychological support, enrolling over 200 people with TRD. In this groundbreaking study, a single dose of psilocybin, given in conjunction with psychological support, generated a rapid response that lasted up to 12 weeks. Remission rates appear to be higher than seen in traditional medication studies. We now have evidence from a large well-designed trial that psilocybin may be effective for people with treatment-resistant major depressive disorder. These findings suggest that COMP360 psilocybin therapy could play a major role in psychiatric care, if approved.”

Michael Pollock, CEO at the Depression and Bipolar Support Alliance (DBSA), said: “Many people suffering with severe forms of depression find that existing treatments don’t work for them. We support any attempt to investigate alternative therapies. The approach of cycling through drugs that aren’t working is inadequate for anyone who is living with a mental health condition and disheartening for the family members and healthcare professionals who care for them. The results seen from this study are an early indicator of hope for those who are desperately in need of help.”

Robin Carhart-Harris PhD, Director of the Psychedelics Division at the Weill Institute for Neurosciences at the University of California San Francisco, and Ralph Metzner Distinguished Professor of Neurology, Psychiatry and Behavioral Sciences, said: “This is an important and exciting moment for the mental health care community. It builds upon more than two decades of research into the viability of psychedelic compounds to treat mental health conditions and demonstrates the potential it has in helping people living with treatment-resistant depression. It’s encouraging to see how far this field has progressed in the last 20 years and I look forward to further research.”

In addition to this topline data, COMPASS is conducting comprehensive secondary analyses which are expected to further inform the clinical development programme for COMP360 psilocybin therapy. In the meantime, this promising topline data will be shared in an expeditious manner with regulators as part of an ongoing dialogue.

Conference call

The COMPASS management team will host a conference call at 1:00pm UK (8.00am ET) on 9 November. The call can be accessed by dialing (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 34908054.

The call will also be webcast on the Investors section of the COMPASS Pathways website. The webcast will be archived for 30 days.

About treatment-resistant depression (TRD)

More than 320 million people globally suffer with major depressive disorder (MDD)5, the leading cause of disability worldwide and one of the fastest growing mental health illnesses6. About a third of these patients – 100 million people – aren’t helped by existing therapies and suffer with treatment-resistant depression (TRD)7. TRD carries two to three times the medical costs of a non-TRD MDD patient, and patients with TRD have a higher all-cause mortality compared with non-TRD MDD patients8.

About the COMP360 psilocybin therapy phase IIb study

The phase IIb study was a dose-finding study, assessing the safety and efficacy of COMP360 psilocybin therapy at three doses: 1mg, 10mg, 25mg. A total of 233 patients enrolled in the study and were randomised and blinded into three arms comprising 79 patients for each of the 25mg and 1mg doses, and 75 patients for the 10mg dose. Patients were followed up for 12 weeks. The trial used the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression; assessments were made by an independent, blinded rater. The primary endpoint is the change in the MADRS total score from baseline to week 3.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. We are headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS’s business strategy and goals, the future accessibility of COMP360 psilocybin therapy, COMPASS’s ability to continue to advance its research, including COMP360, COMPASS’s expectations regarding the benefits of its psilocybin therapy, including COMP360 and COMPASS’s ability to advance new psychedelic compounds in other areas of unmet mental health need. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

Enquiries

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

 

 

 

*Notes: MADRS = Montgomery-Åsberg Depression Rating Scale; response = ≥50% decrease in MADRS total score from baseline; remission = MADRS total score ≤10; protocol-defined sustained response = patients meeting the MADRS response criteria from week 3 until week 12; sustained response = patients meeting the MADRS response criteria at week 3 and at week 12, and at least at one visit out of week 6 and week 9

  1. WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf
  2. Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388
  3. Bergfeld IO, Mantione M, Figee M, Schuurman PR, Lok A, Denys D. Treatment-resistant depression and suicidality. Journal of Affective Disorders. 2018;235:362-367
  4. Dong M, Lu L, Zhang L, et al. Prevalence of suicide attempts in bipolar disorder: a systematic review and meta-analysis of observational studies. Epidemiology and Psychiatric Sciences. 2020;29:e63
  5. WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf [Accessed 21 October 2021]
  6. WHO (2012). Depression: A Global Crisis [Online]. Available at: https://www.who.int/mental_health/management/depression/wfmh_paper_depression_wmhd_2012.pdf [Accessed 21 October 2021]
  7. Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388.
  8. Gang L, Fife D, Wong G, Sheehan JJ, et al. All-cause mortality in patients with treatment-resistant depression: a cohort study in the US population. Annuals of General Psychiatry. 2019; 18:23
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Levitee Labs Publishes First Combined Revenue Figures for September 2021 and October 2021

Levitee Labs Publishes First Combined Revenue Figures for September 2021 and October 2021

  • Levitee Labs achieves combined September 2021 and October 2021 revenues of $1,553,728
  • Consistent revenue growth and acquisitions across core divisions of the company, including Levitee Clinics, Levitee Pharmacies, and Earth Circle Organics

VANCOUVER, BC, CANADA, November 8th, 2021 /CNW/ – Levitee Labs Inc. (CSE: LVT) (OTC: LVTTF) (FSE: 7H7) (the “Company” or “Levitee Labs”), an integrative wellness company with a diversified portfolio of healthcare and wellness assets, is pleased to publish revenue figures for the month of September 2021 and October 2021. On a consolidated basis, the Company has recorded (unaudited) revenue of $1,553,728 combined for both months.

Levitee Labs has seen consistent growth across all its divisions, with accumulated revenue from September to October broken down into the following subdivisions: 28.1% for Levitee Clinics, 40.7% for Levitee Pharmacies, and 31.1% for Earth Circle Organics and other wellness products. Earth Circle Organics, Levitee’s direct-to-consumer and wholesaler of supplements and superfoods products increased sales 7.7% from September to October. This has been primarily achieved through further scaling the direct-to-consumer business and further optimization of the multidisciplinary aspects of Levitee Labs’ healthcare assets, incorporating novel mental health and treatment modalities.

Founder and CEO Pouya Farmand stated, “Creating a meaningful impact on our communities and building shareholder value are not mutually exclusive. We are proud that Levitee Labs is now the largest non-governmental provider of addiction care in the Province of Alberta, servicing over 35,000 patients annually while building shareholder value for our investors through centralizing accretive acquisitions, technologically enhancing our portfolio of assets, and integrating new treatment modalities for our patients.”

Mr. Farmand continued by saying, “As we march forward with the overall advancement of the Levitee Labs portfolio of wellness assets, we are proud to be generating substantive and consistent recurring revenue and we look to aggressively expand on this positive momentum in the ensuing months.”

The Company will look to maintain its consistent growth trajectory and execute on its aggressive expansion plans for the upcoming twelve months. The goal of the Company remains to generate revenue through strategic M&A, increasing margins, and further developing its portfolio of assets through organic growth pathways. 

 

About Levitee Labs Inc.

Levitee is establishing itself as a leader in the integrative wellness space. Through leveraging an M&A regimen that focuses on the centralization of complementary integrative wellness assets, Levitee aims to transform mental health and addiction treatments through the integration of psychedelic medicines and therapies. The Company’s current portfolio of assets includes: Levitee Clinics™, a group of five operating addiction and pain treatment clinics in Alberta; Levitee Pharmacies™, three pharmacies operating in Alberta specialized in filling prescriptions for patients with substance use disorders, mental health conditions, and chronic pain; BlockMD, the first technology company in Alberta to receive provincial approval for electronic-prescriptions in the addiction treatment space; and Earth Circle Organics, a direct-to-consumer and wholesaler of supplements and superfood products with 180+ SKUs in its product lineup across three brands. Further information about Levitee is available on its website at www.leviteelabs.com.

 

Forward-Looking Statements

This news release contains certain statements that may constitute forward-looking information under applicable securities laws. All statements, other than those of historical fact, which address activities, events, outcomes, results, developments, performance, or achievements that Levitee anticipates or expects may or will occur in the future (in whole or in part) should be considered forward-looking information. Such information may involve, but is not limited to, statements respecting Levitee’s business plans and proposed products, and the benefits derived from mushroom-infused products; the expected use of proceeds from the Loan; the acquisitive growth potential of Levitee once acquisitions are completed; the expectation that Levitee will continue to execute its accretive acquisition program, and the contribution of such program to Levitee’s future growth potential; the closing of Tranche 1, including the Levitee’s ability to satisfy the Tranche 1 closing conditions; the closing of any future tranches under the Loan, including Levitee’s ability to satisfy the closing conditions for future tranches of the Loan; and Levitee’s objective to transform mental health and addiction treatments through the integration of psychedelic medicines and therapies. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or statements formed in the future tense or indicating that certain actions, events or results “may”, “could”, “would”, “might” or “will” (or other variations of the forgoing) be taken, occur, be achieved, or come to pass. These statements and other forward-looking information are based on assumptions made by Levitee based on currently available competitive, financial and economic data and operating plans, strategies or beliefs as of the date of this news release as well as management’s current expectations or beliefs regarding future growth, results of operations, future capital (including the amount, nature and sources of funding thereof) and expenditures. These assumptions may also be based on information obtained from third-party industry analysts and other third-party sources. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Levitee as of the date such statements are made, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to risks associated with the following: Levitee’s limited history of operations; ability to secure additional financing; negative cash flow from operating activities since inception; regulatory requirements; changes in consumer preferences; supply of raw materials; reliance on a limited number of products; brand awareness; the ability to develop, market and produce new products; dependence on certain key senior managers; reliance on third parties for manufacturing and packaging; potential product liability claims and product recalls; and significant competition. For additional information regarding these risks, please see the risk factors identified and reported in Levitee’s public filings under its SEDAR profile at www.sedar.com. Any and all forward-looking information contained in this press release is expressly qualified by this cautionary statement. Readers are cautioned not to place undue reliance on forward-looking statements or information. The forward-looking information is made as of the date of this news release, and Levitee assumes no obligation to publicly update or revise such forward-looking information, except as required by applicable securities laws. The CSE (operated by CNSX Markets Inc.) has neither approved nor disapproved of the contents of this press release and accepts no responsibility for the adequacy or accuracy hereof.

For further information about Levitee Labs Inc., please contact:

Media Contact:

media@leviteelabs.com

Investor and Corporate Communications:

ir@leviteelabs.com

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Delic Corp Acquisition Of Ketamine Wellness Centers Is Complete

Delic Corp Acquisition Of Ketamine Wellness Centers Is Complete

Delic Completes Acquisition of Ketamine Wellness Centers (KWC), Becomes Largest Psychedelic Wellness Chain in United States

National Presence Across 10 States Provides Millions with Access to New Medicines and Treatments for a Variety of Health Conditions Twelve Operational Today, 15 Additional Clinics to Open within 18 Months. Kevin Nicholson, CEO of KWC, Promoted to Chief Operating Officer for Delic Corp

VANCOUVER, BRITISH COLUMBIA – November 9, 2021 – Delic Holdings Corp. (“Delic” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0) (Original Source), a leader in new medicines and treatments for a modern world, today announced the official, completed acquisition of Ketamine Wellness Centers Arizona LLC (“KWC”), becoming the largest chain of wellness centers providing ketamine treatments in the U.S. KWC is a limited liability corporation formed under the laws of Arizona, which operates 10 ketamine infusion treatment clinics, across Arizona, Colorado, Florida, Illinois, Minnesota, Nevada, Texas, Utah, and Washington. Delic paid USD$3,293,933 and issued 241,258.50 multiple voting shares. With the close of this transaction, Delic’s consolidated revenue run rate is $11MM.

Transaction Highlights:

  • This acquisition establishes Delic as the largest ecosystem of mental health clinics in the United States.
  • KWC has been operating profitably and expanding significantly with 2020 revenues in excess of USD$3.5MM, on track for USD$4.5MM in 2021. This brings Delic’s pro forma annualized revenue to in excess of USD$8 million.
  • Delic has been focused on opening locations in secondary cities with considerable demand, in an effort to provide access to the most patients.
  • Delic expects to drive considerable patients to KWC through its media platform and build on the existing national leadership position already in place.
  • Established history of providing FDA-approved ketamine infusion services: The management team at KWC has been in business for 6 years expanding services throughout the United States.
  • Management expertise: The acquisition of KWC will add a team of 60+ medical professionals and ‎employees bringing a wealth of industry ‎experience and knowledge to Delic.

Over the last six years, the team at KWC has expanded across the country, from Arizona to Florida, while overseeing 60,000 treatments delivered to date and generating 2020 revenue of USD$3.5MM, trending toward USD$4.5MM in 2021. Prior to this Transaction, KWC has grown without taking outside capital. KWC will operate under the Delic umbrella, under the direction and guidance of Kevin Nicholson, CEO of KWC and the new Chief Operating Officer for Delic Corp. In this new role, Nicholson will focus on the growth and expansion of the psychedelic wellness clinics for the company.

KWC adds to Delic’s existing portfolio of two clinics operated by Ketamine Infusion Centers LLC (“KIC”) in California and Arizona, cementing its position as the leading and largest wellness provider in the country. Delic expects to open 15 additional clinics across the country over the coming 18 months, further expanding access to millions who can benefit from new medicines and treatments for a variety of mental health conditions and adds to their position as a central hub of education, media, and cultural conversations around these new medicines and treatments. With a recent successful private placement of $7MM, Delic is actively scouting new locations in cities with a growing patient base.

Matt Stang, co-founder and CEO of Delic commented, “We are thrilled to officially welcome the KWC team to the Delic family and cement our place as the largest network of treatment clinics in the U.S. With the addition of KWC, we can now reach millions of people suffering from various mental health conditions who have lost hope of finding effective, affordable treatments. As more treatments, such as MDMA and psilocybin, become FDA-authorized for medical use, we have the potential to help millions more people through the clinics.”

“On behalf of the entire KWC team, we are very excited about officially becoming a part of the Delic family,” said Nicholson. “They are an industry leader and uphold the highest standards in developing new, science-backed medicines and treatments and making them more accessible to a wider group of people. With the full support of Delic behind us, KWC will be on an accelerated path to growing our network of clinics throughout the U.S. and bringing more effective, affordable treatments to communities. They will also help us increase awareness of the clinics significantly and drive up patient counts.”

Delic is committed to addressing the mental health crisis by increasing access to science-backed benefits for all and reframing the psychedelic conversation. The company does this through an umbrella of related owned and operated businesses to support scaling the impact and reach of treatment, including 1) the largest and most accessible network of physical clinics to administer effective treatments, 2) a licensed lab to develop IP, R&D and innovative high quality and safe product lines, and 3) trusted media and e-commerce platforms and in-person events to market the services directly to patients and consumers and gain data.

Transaction Summary

Under the terms of the Merger Agreement, Delic acquired all of the membership interests of KWC through a reverse triangular merger between KWC and a wholly-owned subsidiary of Delic. (the “Transaction“) for an aggregate purchase price of USD$10,000,000. Delic issued multiple voting shares in the capital of Delic (“Consideration Shares“) to the members of KWC (the “Members“), having an aggregate value of USD$5,000,000, less a holdback equal to USD$1,000,000, at a price per Consideration Share of US $0.1658 (being the ten trading day volume weighed average trading price (“VWAP“) of the Consideration Shares on the Canadian Securities Exchange (the “Exchange“) as of November 3, 2021). Delic further satisfied the purchase price by paying to the Members, an amount equal to USD$5,000,000 in cash consideration with approximately US$3,293,933 paid on the closing date, US$296,541 to be paid on forgiveness of a loan to KWC from The Health Resources and Services Administration,   USD$750,000 to be paid on the date that is 12 months following the closing date, and the final USD$750,000 to be paid on the date that is 24 months following the closing date.

In addition, the Members are eligible to receive additional Consideration Shares upon each new clinic opened by KWC that posts three consecutive months of profitability and minimum revenue of USD$135,000, during those three months, such additional Consideration Shares to have an aggregate value of USD$100,000 per clinic opening, based on a price per share equal to the 10 trading day VWAP of the Consideration Shares on the Exchange immediately prior to the date such milestone is achieved. The milestones are subject to an aggregate cap of 30 new clinic milestones or USD$3,000,000 in additional Consideration Shares.

The Members have agreed that any Consideration Shares issued will be ‎subject to a contractual hold ‎‎period, with 10% of the share consideration to be released on the date that is six months and one day following closing, ‎and 15% ‎released every six months thereafter over a period ‎of 36 months. In addition, Members have agreed to enter into voting support agreements with Delic having a term of two years, pursuant to which the Members will ‎vote as directed by the board of directors of ‎Delic, subject to customary carve-outs.

About Ketamine Wellness Centers

Ketamine Wellness Centers (KWC) is the largest ketamine therapy provider in the United States with 10 clinic locations serving communities across eight states. Since 2011 KWC has been a trusted leader in bringing IV ketamine therapy into mainstream health care. KWC has provided over 60,000 treatments to clinically eligible patients, from young adults to seniors, in addition to developing specialized programs for veterans and first responders. The KWC team, including a core group of physicians, psychologists, clinicians, and executives, is dedicated to providing value-based, personalized, clinically controlled ketamine infusion care for people suffering from treatment-resistant depression, anxiety, PTSD, OCD and chronic pain. KWC’s scalable business and treatment model is designed for further rapid expansion along with breakthrough innovations in effective therapies and services.

About Delic Corp, Inc.

Delic is a leader in new medicines and treatments for a modern world, improving access to health benefits across the country and reframing the conversation on psychedelics. The company owns and operates an umbrella of related businesses, including the largest chain of psychedelic wellness clinics in the country, including Ketamine Infusion Centers and Ketamine Wellness Centers; the only licensed entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology, Delic Labs; the premier psychedelic wellness event, Meet Delic; and trusted media and e-commerce platforms Reality Sandwich and Delic Radio. Delic is backed by a team of industry and cannabis veterans and a diverse network, whose mission is to provide education, research, high-quality products, and effective treatment options to the masses. 

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and does not accept responsibility for the adequacy or accuracy of this release.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities ‎in the United States. The securities have not been and will not be registered ‎under the United States ‎Securities Act of 1933, as amended (the “U.S. Securities Act“), or any state ‎securities laws and may not be offered or ‎sold within the United States unless registered under the U.S. ‎Securities Act and applicable state securities laws or an ‎exemption from such registration is available.‎

Forward-Looking Information and Statements

This press release contains certain “forward-looking information” within the meaning of applicable ‎Canadian securities ‎legislation and may also contain statements that may constitute “forward-looking ‎statements” within the meaning of ‎the safe harbor provisions of the United States Private Securities ‎Litigation Reform Act of 1995. Such forward-looking ‎information and forward-looking statements are not ‎representative of historical facts or information or current ‎condition, but instead represent only the ‎Company’s beliefs regarding future events, plans or objectives, many of ‎which, by their nature, are ‎inherently uncertain and outside of Delic’s control. Generally, such forward-looking ‎information or ‎forward-looking statements can be identified by the use of forward-looking terminology such as ‎‎”plans”, ‎‎”expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, ‎‎‎”anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may ‎contain ‎statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be ‎taken”, “will continue”, ‎‎”will occur” or “will be achieved”. The forward-looking information and forward-‎looking statements contained herein ‎may include, but are not limited to: potential benefits of the Transaction; anticipated continued growth in the health and wellness sector (and, in particular, related to psychedelics); the ability of Delic to successfully achieve business ‎objectives, including opening 15 additional clinics over 18 months, ‎and expectations ‎for other economic, ‎business, and/or competitive factors.‎

By identifying such information and statements in this manner, Delic is alerting the reader that ‎such ‎information and statements are subject to known and unknown risks, uncertainties and other factors ‎that may cause ‎the actual results, level of activity, performance or achievements of Delic to be ‎materially different from those ‎expressed or implied by such information and statements. Such risks and other factors may include, but are not limited to:  incorrect assessment of the value and potential benefits of the Transaction; direct and indirect material adverse effects from the COVID-19 pandemic; inability to obtain future financing on suitable terms; failure to obtain required regulatory and other approvals; risks inherent in the psychedelic treatment sector; changes in applicable laws and regulations; and failure to comply with applicable laws and regulations.

In addition, in connection with the forward-looking ‎information and forward-looking statements contained in this press ‎release, Delic has made certain ‎assumptions. These assumptions include, but are not limited to: the potential impact of the announcement or consummation of milestone payments on ‎relationships, ‎including with regulatory bodies, employees, suppliers, customers and competitors; ‎changes in general economic, ‎business and political conditions, including changes in the financial ‎markets; changes in applicable laws; compliance ‎with extensive government regulation; and the diversion ‎of management time on the Transaction.‎

Should one or more of these risks, uncertainties or other factors materialize, or should assumptions ‎underlying the ‎forward-looking information or statements prove incorrect, actual results may vary ‎materially from those described ‎herein as intended, planned, anticipated, believed, estimated or ‎expected.‎

Although Delic believes that the assumptions and factors used in preparing, and the expectations ‎contained ‎in, the forward-looking information and statements are reasonable, undue reliance should not ‎be placed on such ‎information and statements, and no assurance or guarantee can be given that such ‎forward-looking information and ‎statements will prove to be accurate, as actual results and future events ‎could differ materially from those anticipated ‎in such information and statements. The forward-looking ‎information and forward-looking statements contained in this ‎press release are made as of the date of ‎this press release, and Delic does not undertake to update any ‎forward-looking information ‎and/or forward-looking statements that are contained or referenced herein, except in ‎accordance with ‎applicable securities laws. All subsequent written and oral forward- looking information and ‎statements ‎attributable to Delic or persons acting on its behalf is expressly qualified in its entirety by this ‎‎notice.‎

Media & Investor Relations Contact

Rich Rodriguez

rich@deliccorp.com 

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Seelos Therapeutics Announces FDA Acceptance of Investigational New Drug Application and Grant of Fast Track Designation for SLS-005 (IV Trehalose) for the Treatment of Spinocerebellar Ataxia

Seelos Therapeutics Announces FDA Acceptance of Investigational New Drug Application and Grant of Fast Track Designation for SLS-005 (IV Trehalose) for the Treatment of Spinocerebellar Ataxia

NEW YORK, Nov. 8, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted Seelos’ Investigation New Drug (IND) application to study SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of spinocerebellar ataxia (SCA). The FDA has also granted the program Fast Track designation in the U.S. for SCA, and SLS-005 has previously received Orphan Drug designation for spinocerebellar ataxia type 3 (SCA3) from the FDA and from the European Medicines Agency in the EU. 

“SCA is a highly debilitating neurodegenerative disease that currently lacks a cure or an approved therapeutic and as such, patients manage symptoms through physical therapy and other symptomatic treatments,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “SLS-005 has already displayed encouraging open label human data in SCA3, the most common type of SCA, and our team has taken that experience and knowledge into the design and plans for our global Phase IIb/III placebo-controlled study. We look forward to initiating this study in early 2022 and our recent capital raises have accounted for the expected development costs for initiating this study.”

Prior to Seelos acquiring the program, SLS-005 had already been studied in a six-month open label Phase IIa study that also included an additional six-month follow up in patients with SCA3, also known as Machado-Joseph Disease (Zaltzman 2020). The open label study evaluated 14 patients with SCA3 over a six-month period and found the average score on the Scale for Assessment and Rating of Ataxia (SARA), a well-recognized clinical tool for measuring functional impairment associated with the disease, remained stable. Six patients received treatment for as long as 12 months and continued to maintain stable SARA scores. In comparison, natural history data suggests that individuals with SCA3 would be expected to show a measurable increase on SARA within a 12-month period, which is indicative of disease progression and worsening of symptoms.  

Additionally, Seelos was named as one of the initial members of the National Ataxia Foundation (NAF) Drug Development Collaborative, an industry consortium that has the principal goal of accelerating the development of treatments for Ataxia.

“On behalf of the National Ataxia Foundation and the ataxia community we represent, we’re thrilled that Seelos Therapeutics has received both IND acceptance and Fast Track designation from the FDA,” said Andrew Rosen, NAF Executive Director.  “Seelos is a founding member of the NAF Drug Development Collaborative and NAF looks forward to working closely with Seelos to support the company as its program progresses.”

About Spinocerebellar Ataxia

Spinocerebellar Ataxia is a serious disease caused by degeneration of the cerebellum with an onset usually in adult life. Clinically, it is characterized by progressive unsteadiness of gait and stance, impaired coordination of limb movements, slurred speech, and abnormal eye movements. Spinocerebellar ataxia type 3, also known as Machado-Joseph disease (MJD), is characterized by progressive cerebellar ataxia and is known to cause progressively severe disability and often premature death approximately 10-20 years from onset of symptoms.

About the National Ataxia Foundation (NAF) and the NAF Drug Development Collaborative

NAF is a nonprofit organization established in 1957 to help persons with ataxia and their families. The Foundation’s mission is to accelerate the development of treatments and a cure while working to improve the lives of those affected by ataxia. NAF is the only organization in the United States dedicated to the disease that serves all types of ataxias. NAF works closely with the world’s leading ataxia researchers, promoting exchanges of ideas and innovation in ataxia discovery. 

The NAF Drug Development Collaborative provides a centralized source for access to resources needed to support research and development of ataxia therapies. Members will benefit from the integration of the patient experience with sound ataxia scientific and clinical expertise. NAF brings more than 60 years of experience in supporting patients and caregivers and connecting them with research and clinical trial opportunities. NAF has also funded a network of ataxia clinicians at sites around the US that will be a critical component of the Collaborative’s work. Specific objectives of the Collaborative include natural history and biosample data collection, development of biomarkers, validation of rating scales, clinical trial design, patient-reported outcomes, and other data necessary for the development and approval of safe and effective therapies.

For more information on NAF: https://www.ataxia.org/

About Trehalose

Trehalose is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier, stabilizes proteins, and importantly activates autophagy, which is the process that clears material from cells. In several animal models of diseases, associated with abnormal cellular protein aggregation or storage of pathologic material, it has been shown to reduce aggregation of misfolded proteins and reduce accumulation of pathologic material. Trehalose activates autophagy through the activation of Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression. Activation of TFEB is an emerging therapeutic target for a number of diseases with pathologic accumulation of storage material.

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) or Post-Traumatic Stress Disorder (PTSD), Amyotrophic lateral sclerosis (ALS), Spinocerebellar ataxia (SCA), Sanfilippo syndrome, Parkinson’s disease, other psychiatric and movement disorders plus orphan diseases.

For more information, please visit our website: http://seelostherapeutics.com, the content of which is not incorporated herein by reference.

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 design and plans for the global Phase IIB/III placebo-controlled study of SLS-005 in SCA (the “Study”), the expected timeline for commencing the Study and Seelos’ available capital and expected development costs to initiate the Study. These statements are based on Seelos’ current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, or initiating the Study, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the results from the prior studies of SLS-005 may not be replicated or may be materially different from the results of the Study or other future trials and studies of SLS-005), the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and 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.

_____________________

Zaltzman R, Elyoseph Z, Lev N, Gordon CR. Trehalose in Machado-Joseph Disease: Safety, Tolerability, and Efficacy. Cerebellum. 2020 Oct; 19(5):672-679. doi: 10.1007/s12311-020-01150-6. PMID: 32514820.

Contact Information
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com 
www.seelostherapeutics.com
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

SOURCE Seelos Therapeutics, Inc.

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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.

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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.

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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.

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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
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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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MINDCURE Provides Update on Studies and Clinical Trials

MINDCURE Provides Update on Studies and Clinical Trials

VANCOUVER, BC, Nov. 4, 2021 /CNW/ – Mind Cure Health Inc. (CSE: MCUR) (OTCQX: MCURF) (FRA: 6MH) (“MINDCURE” or the “Company”), a leader in advanced proprietary technology and research for psychedelics, is pleased to provide an operational progress update on the strategic initiatives of its operating segments – MINDCURE Research and MINDCURE Technology.

MINDCURE Research:

Synthetic Ibogaine Production Update
In March 2021, MINDCURE announced the initiation of chemical synthesis routes for the production of fully synthetic ibogaine. In July 2021, the Company applied for patents on two routes to full chemical synthesis and initiated the production of Good Laboratory Practice (“GLP”) ibogaine leading to the production of Good Manufacturing Practice (“GMP”) ibogaine in order to scale and manufacture a global supply of fully synthetic ibogaine. MINDCURE is currently on schedule and expects to have GLP supply available for research partners beginning in Q2 of 2022.

Pre-Clinical Update
MINDCURE confirms that it is preparing to ship ibogaine drug material to its pre-clinical research partner. The material will initially be used for broad cardiac and neurologic screens, with the potential to conduct in-depth behavioral studies. This program has been identified as MSYNTH-001, and the Company expects results from the first studies during the first quarter of 2022.

In addition to advancing the scale of its synthetic ibogaine program, MINDCURE continues to explore options for drug pipeline expansion. Two candidate selection programs are currently underway, known internally as MC-106 and MC-808. The Company will provide further information on these programs in the second quarter of 2022.

Clinical Trial Update
MINDCURE has completed its draft research protocol for the use of MDMA and psychotherapy to treat female sexual hypoactive desire disorder, known as The Desire Project. The Company expects a pre-IND meeting with the FDA to be scheduled in the first quarter of 2022 and for its Phase 2 trial to begin by the third quarter of 2022. Further, site initiation and initial screening are planned for March 2022, with recruitment and enrollment to follow.

“We are proud to report that MINDCURE’s core research programs are progressing rapidly, showcasing our disciplined commitment to advancing MINDCURE’s drug research and commercial production programs. Concurrently, we maintain a focus on identifying opportunities to expand our drug development pipeline,” said Kelsey Ramsden, President & Chief Executive Officer of MINDCURE.

MINDCURE Technology:

Digital Platform iSTRYM Update
The Company released the minimum viable product (“MVP”) of its digital therapeutics (DTx) technology, iSTRYM, into partner clinics across North America in August. MINDCURE is pleased to announce that it has exceeded its previously announced target and timeline of 10 clinics by the end of 2021. The Company has already partnered with 20 ketamine clinics in nine states in the US and three provinces in Canada and plans to expand to the broader mental health market in 2022.

In addition, MINDCURE will begin full commercial deployment to all partner clinics in early 2022, with expansion plans to the UK and Europe by the fourth quarter of 2022.

In addition to its recently announced letter of intent with Awakn Life Sciences Corp. to distribute their Ketamine for Alcohol Use Disorder (“AUD”) protocol in North America via iSTRYM, MINDCURE will expand its selection of existing ketamine protocols with an additional MINDCURE developed protocol in the first quarter of 2022. The Company is continuing on its path toward becoming a leader in the distribution of best-in-class therapy protocols for both partners and providers.

Observational Study Update
MINDCURE is pleased to announce that its Integration Protocol Research Study is complete. As previously announced in March 2021, unconditional ethics approval from Veritas IRB was received for the study. The data has been amassed and findings incorporated into the MVP of iSTRYM. As a next step, the Company’s research partners will submit findings for publication. Understanding integration protocols and practices is an important part of providing best-in-class care specific to psychedelic medicines in practice.

Corporate Update

MINDCURE has further engaged Sandstone Media LLC (“Sandstone”) to provide a broad range of product and brand awareness, marketing and media services, including message development, content creation, social media, advertising, marketing and retargeting, which may include related investor relations services. Sandstone will be paid up to USD$375,000 for the execution and management of the campaign.

Lastly, the Company has granted a total of 30,000 stock options to certain employees pursuant to the terms of the Company’s long term incentive plan (“Plan”). The stock options are exercisable at a price of $0.33 per share and subject to the terms of the Plan.

About MINDCURE
Mind Cure Health (“MINDCURE”) is a life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health. The company is developing digital therapeutics technology and researching psychedelic compounds to support access to safe, evidence-based psychedelic-assisted therapies globally.  Learn more at mindcure.com, and follow us on LinkedIn, Facebook, Twitter, and Instagram.

On Behalf of the Board of Directors
Kelsey Ramsden, President & CEO
Phone: 1-888-593-8995

Forward-Looking Information
Certain information presented in this news release may constitute “forward-looking information” within the meaning of applicable securities laws regarding MINDCURE and its business. Forward-looking information generally can be identified by the use of terms and phrases such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “feel”, “intend”, “may”, “plan”, “predict”, “project”, “subject to”, “will”, “would”, and similar terms and phrases.

Forward-looking information is based on a number of key expectations and assumptions made by management of MINDCURE, including, without limitation: the COVID-19 pandemic impact on the Canadian economy and MINDCURE’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect MINDCURE’s business; the Company will develop its products as expected and that they will attain the outcomes anticipated; there will be a demand for MINDCURE’s products in the future; no unanticipated expenses or costs arise; MINDCURE will be able to continue to identify products that make them ideal candidates for providing solutions for treating mental health; that strategic partnerships entered by the Company will create the opportunities and outcomes anticipated; that MINDCURE will advance wellness worldwide; that trading on the OTCQX will attract additional investment and provide additional liquidity for shareholders.

Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. Forward-looking information inherently entails known and unknown risks and uncertainties about the future and actual results and involves significant risks and uncertainties and should not be read as a guarantee of future performance or results as actual results may differ materially from those expressed or implied in such forward-looking information. Those risks and uncertainties include, among other things, risks related to: successful clinical studies relating to ibogaine and the Desire Project, successfully synthesizing and manufacturing of ibogaine, the successful development, integration and deployment of iSTRYM, the successful development of appropriate Ketamine protocols, and acquiring adequate protection of any IP developed. Although MINDCURE has attempted to identify important factors that could cause actual results, performance or achievements to differ materially from those described in forward-looking information presented, there may be other factors that cause results, performance or achievements to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements as no forward-looking information can be guaranteed.

Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and MINDCURE does not undertake any obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.

The CSE has neither approved nor disapproved the contents of this press release and the CSE does not accept responsibility for the adequacy or accuracy of this release.

For further information

MINDCURE Investor Relations

investors@mindcure.com

1-888-593-8995

Media Inquiries

Annie Graf / Kristin Cwalinski

KCSA Strategic Communications

mindcure@kcsa.com