Levitee adds Noha ElSayed, an expert in compounding and pharmacy operations, to the Levitee Clinics and Levitee Pharmacies management team
ElSayed has over 20 years of experience as a pharmacist with specialization in
addiction medicine, ketamine compounding, and hepatitis C treatments
ElSayed is initially responsible for managing the oversight and optimization of five clinics and three specialized pharmacies in Alberta, with additions expected within the franchise
VANCOUVER, BC, CANADA, November 15th, 2021 /CNW/ – Levitee Labs Inc. (CSE: LVT) (OTC: LVTTF) (FSE: 7H7) (the “Company” or “Levitee”), an integrative wellness company with a diversified portfolio of healthcare and wellness assets, today announces the appointment of Noha ElSayed, B.Sc.Pharm, APA, as Executive Director, Levitee Clinics and Levitee Pharmacies, Alberta Region. Mrs. ElSayed brings a wealth of expertise gained through a variety of clinical and managerial positions held in retail pharmacies, hospitals, and primary care settings while working as a pharmacist for the last 20 years, including 11 years as a pharmacy manager.
Mrs. ElSayed earned her Bachelor of Science degree in Pharmacy and obtained her Additional Prescribing Authorities from The Alberta College of Pharmacists. She is an active member of several specialized health care networks as the International Society of Travel Medicine and The Canadian Obesity Network. Mrs. ElSayed has a passion for mental health care, addiction treatment, custom compounding, and travel health, as well as diabetes and chronic disease management education. She prides herself on staying up-to-date with the latest pharmacy practices and procedures and is an expert in custom compounding techniques and knowledge.
Mrs. ElSayed is also a specialist and expert in:
Addiction and Mental Health
Hepatitis C
Ketamine compounding
Pharmacy operations and optimization
Establishing new (greenfield) pharmacies focusing on operational excellence
Pharmacy supply chain strategies and optimization
Dermatology
“We’re thrilled to welcome Noha to the Levitee Clinics and Levitee Pharmacies team where her comprehensive pharmacy experience and business acumen will be invaluable to optimizing operations as we continue to execute on our roll-up strategy,” said Pouya Farmand, Chief Executive Officer at Levitee Labs. “She is the perfect fit for our go-forward plans, including production and distribution of pharmaceutical products and our intentions to add treatments for common medical comorbidities associated with addiction and mental health conditions, such as psychiatry, cardiology, and endocrinology.”
“I relish the opportunity to lead the Alberta Region of Levitee Clinics and Levitee Pharmacies, as our visions are aligned for a team-oriented, holistic, patient-centered approach to safely help Albertans across the disease spectrum with the latest technologies,” commented Noha ElSayed. “Levitee Labs is closing gaps in healthcare and I look forward to the future, where specialized and cutting-edge therapies are accessible for all in need.”
Mrs. ElSayed will be responsible for managing Levitee’s Alberta healthcare assets. The Company in October signed a letter of intent to acquire a controlling interest in an addiction and compounding pharmacy in Calgary and continues to explore opportunities to add to its pharmacy franchise that will be within Mrs. ElSayed’s purview.
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 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:
-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 ofPerception’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.
-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 ofPerception’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.
TORONTO, ON / November 12, 2021 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2) (“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, announced today it has leased a new clinic location in Utah (the “Wheeler Park Clinic”), and will relocate the Company’s Millcreek clinic to the Wheeler Park Clinic to better serve a growing patient base.
“Wait times to book new appointments at all Novamind clinics reflect the growing demand for our unique treatments and services,” said Pierre Bou-Mansour, Novamind’s Chief Operating Officer.
He continued, “As we scale our clinic footprint to meet that demand, we are equally committed to optimizing the patient experience and elevating the standard of care. The Wheeler Park Clinic is a great example of a space that aligns with that vision. It’s easily accessible, modern and enables the right therapeutic environment for our clients and clinicians.”
With minimal leasehold improvements, the Wheeler Park Clinic is anticipated to open in early 2022.
About Novamind
Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of Cedar Psychiatry clinics and operates Cedar Clinical Research, a contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. Both Cedar Psychiatry and Cedar Clinical Research are wholly owned subsidiaries of Novamind. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.
Contact Information
Novamind
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512
Forward-Looking Statements
This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations including the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.
Delivering psilocybin via microneedle patch unlocks potential for desired dosage forms and pharmacokinetic profiles for improved safety and effectiveness.
Completing microneedle patch research programs with other psychedelics before year-end.
Pursuing Phase 2 clinical studies in 2022 with psilocybin and notable psychedelics.
TORONTO, November 11, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has successfully completed its first research study evaluating MicroDose-MN™, a proprietary microneedle (“MN”) patch for the intradermal delivery of psychedelics, in delivering psilocybin. These results provide support to file for an IND application with the FDA to conduct Phase 2 clinical studies in 2022 with psilocybin for various indications.
The aim of PharmaTher’s research program was to develop a suitable prototype of MicroDose-MN™ patch for transdermal (intradermal) drug delivery to confirm compatibility and suitability to deliver psilocybin. The research program scope included, full characterization of psilocybin conjugated on the microneedle patch backbone, establishment and demonstration of the loading capacity for psilocybin, and release rate evaluations for the psilocybin conjugated materials using appropriate models that will be used to support the Company’s IND application with the FDA.
The Company’s research program with psilocybin conjugated microneedles have been successfully fabricated, optimized, and characterized. Both structural aspects and ex-vivo skin insertion assessments of the psilocybin conjugated microneedles have demonstrated successful fabrication and acceptable performance. The incorporation of psilocybin per microneedle without issue and the ability to demonstrate complete ex vivo skin model release over several days demonstrates potential for larger doses and modified release profiles. With these results, the Company believes it has an acceptable prototype for completing IND-enabling studies with the aim to conduct clinical studies in 2022. Details of the research program will be published in a scientific journal.
The Company previously announced that it has entered into a collaboration agreement with Revive Therapeutics Ltd. (“Revive”) (OTCQB: RVVTF) (CSE: RVV) for the evaluation of the psilocybin MicroDose-MN™ patch and is currently in discussions with Revive in finalizing a definitive agreement to advance the clinical and commercial development. There can be no assurance that a definitive agreement will be entered into between PharmaTher and Revive.
The Company believes that its MicroDose-MN™ patch for delivering psilocybin and other psychedelics may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles. In addition, the MicroDose-MN™ patch for psychedelics aims to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office or hospital. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.
The Company is completing its evaluation of MicroDose-MN™ with 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”) and expects to provide results before the end of this year and pursue clinical studies in 2022.
The Company is actively engaged in partnering discussions for the use of its microneedle patch system to deliver psychedelics including, but not limited to, MDMA, LSD, DMT, ibogaine and mescaline. As such, PharmaTher offers potential partners a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards clinical studies in 2022.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
For more business development opportunities or information about PharmaTher, please contact:
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim”, “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
Vancouver, B.C. (November 10, 2021) – Pure Extracts Technologies Corp. (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ) (“Pure Extracts” or the “Company”), a plant-based extraction company focused on cannabis, hemp and the rapidly emerging psychedelic sector, is pleased to provide a brief summary of recent activities.
The fall season has arrived, and with it an ongoing lessening of Covid-19 health measures. This is providing a return to a degree of normalcy here in Canada. Continued optimism is driving business momentum resulting in an increase in activity throughout every aspect of our enterprise operations. Since our last update, the growing wave of nationwide optimism positions the Company to report on several positive activities we can offer our growing base of partners, stakeholders and shareholders alike.
Market Awareness and Product Distribution
Our first and strategically most important update is that Pure Extracts’ products are now listed for sale at licensed outlets throughout British Columbia (BC), Alberta (AB), Saskatchewan (SK), and Ontario (ON).
The product mix encompasses 24 SKUs currently available in each respective provincial recreational cannabis market, and further offers 9 SKUs specifically targeting the medical cannabis supply chain. To-date, Pure Extracts has manufactured approximately 50,000 vape carts and approximately 100,000 gummie packs to support retail sales.
The product lineup has been increased to include a one-gram vape cart which has met with positive consumer uptake. The THC version is in the initial launch phase in BC and AB with the CBD version in ON. Repeat orders of the one-gram product SKU had already been received at the start of the current fiscal quarter.
Pure Extracts’ CBD gummies, offered in their sector-leading unique blister packaging, continue to report uniformly growing market share across all four of the provinces. Medical sales continue to expand through the Abba Medix sales platform, notably in the CBD gummie product lineup. Leading sales figures focus clearly on our ultra-high potency CBD 50, 75 and 100 mg packs.
Our in-house services have also experienced substantial growth in recent months. The two most active services include our white label and tolling business development for industrial-scale customers. We are extremely pleased to have signed three new white label programs for the production of vape cartridges and two of these customers are concurrently tolling their biomass through our services.
New Product Development
Pure Extracts’ development team has identified a new infused-product trend in the cannabis industry and will be executing an unveiling and product launch aimed at new product SKU’s targeting the Canadian marketplace withing the next quarter. Until then, we are keeping details to a minimum as we hope to earn marketing leverage of a very underserved product mix that we believe will position well with our brand identity and distribution ability.
Sales & Marketing
Enhanced social media & sales support strategy:
Our dedicated Pure Extracts social strategy (Pure Pulls and Pure Chews) now includes daily posting of a curated feed promoting organic engagement across Instagram, Twitter, Facebook and LinkedIn.
Creation of a dedicated Pure Mushrooms social strategy (for Maitake, Reishi, Lion’s Mane) including daily curation of information promoting organic engagement across Instagram, Twitter, Facebook and LinkedIn
Ongoing effort and close collaboration with Cannavolve, our national cannabis sales agency and their team on the ground across Canada to promote and secure additional points of purchase for Pure Pulls and Pure Chews
A full complement of sales material has been developed to support sales activities in the field.
Product knowledge training is actively underway for field sales reps and budtenders (both on-site and virtually).
Michigan Facility Update
In Michigan, the facility build-out continues to progress as the engineers finalize their renovation plans for the existing building. Pure Extracts business development and sales team has toured the Michigan market with our JV partner resulting in meetings with some of their 100+ existing dispensary clients as part of the process to develop specific products tailored to regional consumers. The operations team has identified a head extractor to manage the Michigan facility once in operation. The nominee brings deep cannabis extraction experience especially regarding live rosin and live resin production expertise.
Mushroom Sector Business Development
Our functional mushroom business continues to advance with the development of two new product SKUs including a Lion’s Mane formulation set for launch in December and a Blended product formula scheduled for launch in the first quarter of 2022. Implementation with Amazon Canada experienced some initial issues which have been overcome and we are now on-track to offer cross-border sales with the commencement of a marketing campaign focused on gaining segment visibility and sales penetration of our Pure Mushrooms brand.
Concurrently, our psilocybin enterprise continues to move forward with a joint venture (JV) between Pure Extracts and Psyence Group as Pure Psyence Corp. The JV is structured to formulate a psilocybin extract derived from Psyence Group’s high-potency psychedelic mushroom biomass for 2 clinical trials to be undertaken under the auspices of two prestigious Canadian universities.
Responses from Health Canada regarding our Dealers Licence application are pending, with a successful outcome aimed at allowing us to directly handle controlled substances at our extraction facility in British Columbia.
Near Term Summary
Our near-term goals include product launches in a soon-to-be-named Eastern Canadian province, and the listing of our products through a relationship with a national pharmacy chain. We continue to focus on distribution to medical patients through specific channel partners, with additional medical SKUs planned for 2022.
In Conclusion
As anyone following the Pure Extracts story since our inception in the Fall of 2020 can readily attest to, an incredible effort has propelled the Company forward across multiple fronts. We are very grateful to have the opportunity to work with such a dedicated and committed team who really pulled together as our entire society has had to struggle against unprecedented conditions. It’s a real joy for us all to know we have earned the trust and loyalty of so many consumers, partners and shareholders who share our vision for success. As we head towards a new year, we remain focused on growth, innovation, and value generation. We invite everyone to stay engaged with us, either through social media or by signing up on our website for regular news alerts, because we will have much more to talk about in the months ahead.
ON BEHALF OF THE BOARD
“Ben Nikolaevsky” Ben Nikolaevsky
CEO and Director
About Pure Extracts (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ)
Pure Extracts Technology Corp. features an all-new, state-of-the-art processing facility located just 20 minutes north of world-famous Whistler, British Columbia. The bespoke facility has been constructed to European Union GMP standards aiming towards export sales of products and formulations, including those currently restricted in Canada, into European jurisdictions where they are legally available. Pure Extracts was granted its Standard Processing License by Health Canada under the Cannabis Act on September 25, 2020, and its Sales Amendment on July 19, 2021. The Company’s stock began trading on the Canadian Securities Exchange (CSE) on November 5, 2020.
This news release contains forward-looking statements relating to the future operations of Pure Extracts,
and the other statements are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of Pure Extracts’, are forward-looking statements and involve risks and uncertainties. A number of factors could cause actual events, performance or results to differ materially from what is projected in forward looking statements. Although we believe that the assumptions underlying these statements are reasonable, they may prove to be incorrect, and we cannot assure that actual results will be consistent with these forward-looking statements. Given these risks, uncertainties and assumptions, investors should not place undue reliance on these forward-looking statements. Whether actual results, performance or achievements will conform to the Company’s expectations and predictions is subject to a number of known and unknown risks, uncertainties, assumptions and other factors, including those listed under “Risk Factors” in the Company’s Annual Information Form. The Company does not undertake to update any forward-looking information, except as, and to the extent required by, applicable securities laws.
This news release contains information about potential sales revenue from supply agreements, which may be considered as disclosure of financial outlook under applicable securities laws. Such information is subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraph. Specifically, estimated sales revenue which may be derived from supply contracts has been calculated based on current wholesale prices and assume, among other things, that the Company will be able to find buyers for its products. The financial outlook contained in this news release was made by management as of the date of this news release and was provided for the purpose of providing readers with an understanding of the potential revenue which may be derived from any agreements recently entered into by the Company, and are not an estimate of profitability or any other measure of financial performance. Readers are cautioned that the financial outlook contained in this document should not be used for purposes other than for which it is disclosed herein.
The CSE has neither approved nor disapproved the contents of this press release.
SAFE HARBOR STATEMENT
This press release may contain forward-looking information within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Companies, its directors or its officers with respect to, among other things: (i) the Company’s financing plans; (ii) trends affecting the Companies’ financial condition or results of operations; (iii) the Companies’ growth strategy and operating strategy; and (iv) the declaration and payment of dividends. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Companies’ ability to control, and that actual results may differ materially from those projected in the forward-looking statements as a result of various factors including the risk disclosed in Grown Rogue’s Form 20-F and 6-K filings with the Securities and Exchange Commission.
STATEMENT REGARDING UNITED STATES REGULATORY FRAMEWORK FOR CANNABIS
Pursuant to Pure Extracts’ joint venture with Golden Harvests, LLC, Pure Extracts expects to derive revenues from the cannabis industry in the State of Michigan in the United States, which industry is illegal under United States federal law. The joint venture is expected to be directly or indirectly engaged in the manufacture, possession, use, sale and distribution of cannabis in the medical and/or adult-use cannabis marketplace in the State of Michigan.
The United States federal government regulates drugs through the Controlled Substances Act (21 U.S.C. § 811) (the “CSA”), which places controlled substances, including cannabis, in a schedule. Cannabis is classified as a Schedule I drug. Under United States federal law, a Schedule I drug or substance has a high potential for abuse, no accepted medical use in the United States, and a lack of accepted safety for the use of the drug under medical supervision. The United States Food and Drug Administration has not approved cannabis as a safe and effective drug for any indication.
In the United States, cannabis is largely regulated at the state level. State laws regulating cannabis are in direct conflict with the federal Controlled Substances Act, which makes cannabis use and possession federally illegal. Although certain states authorize medical and/or adult-use cannabis production and distribution by licensed or registered entities, under United States federal law, the possession, use, cultivation, and transfer of cannabis and any cannabis-related drug paraphernalia is illegal and any such acts are criminal acts under federal law. The Supremacy Clause of the United States Constitution establishes that the United States Constitution and federal laws made pursuant to it are paramount and in case of conflict between federal and state law, the federal law shall apply.
There is no guarantee that state laws legalizing and regulating the sale and use of cannabis will not be repealed or overturned, or that local governmental authorities will not limit the applicability of state laws within their respective jurisdictions. Unless and until the United States Congress amends the CSA with respect to medical and/or adult-use cannabis (and as to the timing or scope of any such potential amendments there can be no assurance), there is a risk that U.S. federal authorities may enforce current U.S. federal law. If the U.S. federal government begins to enforce U.S. federal laws relating to cannabis in states where the sale and use of cannabis is currently legal, or if existing applicable state laws are repealed or curtailed, Pure Extracts’ business, results of operations, financial condition and prospects would be materially adversely affected. For these reasons, Pure Extracts’ operations in the United States cannabis market (through the joint venture) may subject Pure Extracts to heightened scrutiny by regulators, stock exchanges, clearing agencies and other Canadian and U.S. authorities and is subject to a number of risks, including those risks that are described in the Companies’ public filings profile on SEDAR at www.sedar.com .
To Pure Extracts’ knowledge, no statement has been made by federal authorities or prosecutors regarding the risk of enforcement action with respect to state-sanctioned marijuana activities in the state of Michigan.
No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.
Focused on generating data through proprietary biomarkers and diagnostic testing of inflammation
VANCOUVER, BC, Nov. 9, 2021 /CNW/ – MYND LIFE SCIENCES INC. (“MYND” or the “Company”) (CSE: MYND) (OTC: MYNDF) is pleased to announce its wholly-owned subsidiary MYND DIAGNOSTICS INC. (“MYND Diagnostics“) has executed a binding letter of intent (“LOI“) with REVITALIST LIFESTYLE AND WELLNESS LTD. (“Revitalist“) (CSE:CALM) (OTC:RVLWF) (FSE: 4DO) to enter into a clinical research collaboration studying a link between diagnostic results and improved patient outcomes using MYND Diagnostics’ proprietary anti-inflammatory peptide (“MAP“) biomarker. The MAP diagnostic is intended to give health care providers an objective monitoring tool to detect and diagnose mental illness more accurately than the current diagnostic methodology, which can be very subjective. If successful, this biomarker test has the potential to lead to earlier diagnosis of mental illness and ongoing treatment decisions with the goal of improving patient outcomes by providing more tailored and efficacious treatments.
The goal of the collaboration with Revitalist is to utilize their broad network of clinics with patients suffering from mental illness to commence clinical trials to demonstrate MAP’s ability to diagnose and monitor mental health in order to gain approval by the U.S. Food and Drug Administration (“FDA“). The parties anticipate that initial clinical trial will be focused on patients with mental health issues who had previously been infected with COVID-19 and are seeking medical help for post COVID-19 mental health symptoms (“Brain Fog“). The World Health Organization reports that COVID-19 has affected more than 249 million individuals1. Research indicates that approximately 50% on average of those with COVID-19 have reported having lasting effects2. Revitalist has a network of over 2,300 patients through its multiple clinics in the United States, with many of those patients having been previously infected with COVID-19 and seeking specialized treatments to deal with Brain Fog and other lasting effects.
Dr. Lyle Oberg, MD, CEO of MYND stated “A critical step in diagnostics development is demonstrating that an investigational tool produces consistent results. With the new collaboration we intend to design next phase clinical validation studies and take blood samples from existing patients at Revitalist with an expectation that we will submit the MYND biomarker (MAP) data to the FDA for approval in Q2 of 2022. The Company anticipates generating near-term revenue through research and development projects related to MAP. Ultimately, MYND intends to work with physicians to adopt MAP in their practices and provide access to patients and insurance providers for reimbursement when utilizing our proprietary diagnostic. We anticipate that working with Revitalist will be our first of many mental health studies. Their comprehensive network of patients and expert providers will provide the MYND Diagnostics team with optimal research conditions to study MAP in patients so dearly needing better diagnostic and treatment options.”
Kathryn Walker, CEO of Revitalist stated “We are excited to be working with MYND Diagnostics to potentially diagnose and monitor mental health using MAP. Prior to MAP the only diagnostic for mental health was an interview with the patient regarding their history of symptoms, which of course can be very subjective. A diagnostic tool such as MAP would allow for a more objective diagnosis and monitoring, hopefully resulting in a higher level of care and treatments for our patients. One size doesn’t fit all with mental health and treatments that work for some may not work for others. Utilizing MAP would allow us to quickly adjust treatments to better address patient specific mental health issues.”
ABOUT MYND LIFE SCIENCES INC.
MYND Life Sciences Inc., the parent company of MYND Diagnostics Inc., is a medical biotech drug research and development company focused on neuro-pharmaceutical and novel psilocybin drug development, diagnostics and vaccines. The Company is advancing pharmaceuticals through rigorous science and clinical trials, while diligently patenting and safeguarding its intellectual property. For more information and to subscribe to the Company’s mailing list, please visit https://myndsciences.com/contact/
ABOUT REVITALIST LIFESTYLE AND WELLNESS
Revitalist Lifestyle and Wellness Ltd. is a publicly traded company, headquartered in Knoxville, Tennessee, with five clinics operating across the United States and expanding. Revitalist is dedicated to empowering individuals toward an improved quality of well-being through a combination of comprehensive care and future-centric treatments provided by medical professionals, mental health experts, and chronic pain specialists. Since opening their first clinic in 2018, Revitalist has provided thousands of infusions for patients suffering from treatment-resistant conditions. Additionally, Revitalist offers a number of lifestyle optimization services and vitamin infusions that can bring anyone closer to total wellness.
This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of MYND to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this release.
Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
None of the securities issued in connection with the Offering will be registered under the United States Securities Act of 1933, as amended (the “1933 Act”), and none of them may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the 1933 Act. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities in any state where such offer, solicitation, or sale would be unlawful.
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
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.
*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
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
Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388
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
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
Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388.
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
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.
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World’s first systematic, pharmacokinetic/pharmacodynamic study of non-psychedelic doses of psilocybin
TORONTO, Nov. 8, 2021 /PRNewswire/ – Diamond Therapeutics Inc. (“Diamond”), a drug development company focused on non-hallucinogenic, psychedelic-based therapies for use in the treatment of mental health, today announced the dosing of the first cohort of its Phase 1 clinical trial. The trial is evaluating the safety and tolerability of low dose, non-hallucinogenic psilocybin in healthy volunteers.
“This trial will allow us to identify a safe and non-hallucinogenic dose of psilocybin. The results will help inform future clinical trials to evaluate psilocybin’s potential for treating mental health disorders,” says Dr. Edward Sellers, Professor Emeritus, Pharmacology and Toxicology, Medicine and Psychiatry at the University of Toronto and Chair of the Scientific Advisory Board for Diamond Therapeutics. “We plan to thoroughly evaluate the potential of low-dose psilocybin through a rigorous clinical trial program and believe that this is just the beginning,” adds Dr. Sellers.
The randomized, double-blind Phase 1 trial is the first systematic, placebo-controlled, single ascending dose pharmacokinetic/pharmacodynamic study of very low doses of psilocybin in humans. It is designed to assess safety and tolerability. The trial is being conducted in Toronto under the supervision of principal investigator Dr. Isabella Szeto of BioPharma Services Inc., the contract research organization working with Diamond. It will assess up to 80 subjects with escalating doses of psilocybin.
Diamond Therapeutics’ non-human research study published in the journal Frontiers in Pharmacology earlier this year demonstrated that very low, non-hallucinogenic doses and concentrations of psilocybin and its metabolite psilocin can enhance motivation and attention. Diamond believes this indicates a potential for therapeutic use in treating psychiatric disorders, including anxiety and depression. The study was the first to rigorously evaluate low doses of psilocybin and show that hallucinogenic effects are not needed for potential therapeutic benefits.
In the U.S., one in five adults experiences mental illness each year. The economic cost is also high, approximately $225 billion in 2019. Novel therapeutic options are needed to help alleviate these burdens and address unmet needs in the treatment of mental health disorders.
“We are pleased to have begun assessments of low doses of psilocybin in human trials and are optimistic the results from this study will provide the data necessary to advance rapidly to later-stage studies,” says Dr. Michael McDonnell, Chief Medical Officer of Diamond.
“This is a significant milestone for Diamond and, potentially, for the future of mental health treatment,” adds Judy Blumstock, CEO of Diamond. “We have a strong clinical research team who are focused on unlocking the full potential of low dose psilocybin in treating psychiatric disorders, and in a way that is affordable and accessible to patients.”
About Diamond Therapeutics Diamond Therapeutics is a drug development company based in Toronto, Ontario. Our mission is to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a broad patient cohort —maximizing the positive impact better drugs can have on global mental health. To learn more about Diamond, visit www.diamondthera.com.
Cautionary Statements Regarding Forward-Looking Information This news release includes certain “forward-looking information” under applicable Canadian securities legislation. Forward-looking information includes statements other than statements of historical fact that can be identified by phrases such as “expects”, “anticipates”, “intends”, “aims”, “plans” and “believes”, and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements in this news release include, but are not limited to, the potential effects of low dose psilocybin and other psychedelic treatments, the potential use in treating mental health conditions and the timing and completion of Diamond’s clinical programs and trials. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; that factors may occur which impede Diamond’s future business plans; the results of continued development, marketing and sales; and other factors beyond the control of Diamond. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. Diamond disclaims any intention or obligation to update or revise any forward-looking information in this news release, whether as a result of new information, future events or otherwise, except as required by law.
SOURCE Diamond Therapeutics Inc.
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