Vancouver, British Columbia–(Newsfile Corp. – June 6, 2022) – Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF) (“Lobe” or the “Company”) announces that its board of directors has authorized the implementation of a consolidation (the “Consolidation”) of the Company’s common shares (the “Shares”) on the basis of one (1) post-Consolidation Share for every six (6) pre-Consolidation Shares, which will become effective on June 9, 2022 (the “Effective Date”). Neither the Company’s name, nor its trading symbols, will change as a result of the Consolidation.
The Company currently has 229,383,983 Shares issued and outstanding. Following the Consolidation, there will be approximately 38,230,000 Shares issued and outstanding. No fractional Shares will be issued, and any fraction of a Share will be rounded up to the nearest whole number of Shares. The Shares will trade on a post-Consolidation basis under the new CUSIP #53946V206 and ISIN #CA53946V2066. The Shares are expected to begin trading on a post-Consolidation basis on the Canadian Securities Exchange when markets open on the Effective Date.
The exercise or conversion price and the number of Shares issuable under any of the Company’s outstanding convertible securities will be proportionately adjusted upon the effectiveness of the Consolidation.
Shareholders of record as of the Effective Date will receive a letter of transmittal providing instructions for the exchange of their Shares as soon as practicable following the Effective Date.
About Lobe Sciences Ltd.
Lobe Sciences is a life sciences company focused on psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.
For further information please contact:
Lobe Sciences Ltd. Philip J Young, CEO info@lobesciences.com Tel: (949) 505-5623
NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.
This does not constitute an offer to sell or a solicitation of offers to buy any securities.
Disclaimer for Forward-Looking Statements
This news release contains forward-looking statements relating to the future operations of the Company and other statements that 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 statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness, 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. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment;, that the Company’s drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company’s corporate goals and objectives; and other risk factors detailed in the Company’s continuous disclosure filings from time to time, as available under the Company’s profile at www.sedar.com. As a result, the Company cannot guarantee that any forward-looking statement will materialize and 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 only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.
Red Light Holland’s iMicrodose packs containing Psilocybe Tampanensis Truffles, produced in the Netherlands, tested at CCrest Laboratories, under a Health Canada approved Psilocybin license.
Red Light Holland and CCrest Laboratories continue to demonstrate their strong commitment to the highest standards for naturally occurring Psilocybin products.
Red Light Holland has an established alliance with CCrest Laboratories Inc. in partnership with Shaman Pharma Corp., who have been listed by Health Canada as a Psilocybin supplier to the Special Access Program.
Toronto, Ontario–(Newsfile Corp. – June 6, 2022) – Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) (“Red Light Holland” or the “Company“), an Ontario-based corporation engaged in the production, growth and sale of a premium brand of magic truffles, is pleased to announce that it has received a report from the first stability test conducted on the company’s Psilocybin Truffles sold in the Netherlands. This report was focused on optimizing shelf life and the long-term quality of the product. The report confirmed Red Light Holland’s iMicrodose packs containing tampanensis truffles have a psilocybin equivalent content to be 1.23 mg/gram one week after opening the truffles. This baseline measurement will help in future studies to research Psilocybin content over longer periods of time which will be crucial in any potential clinical use of naturally occurring Psilocybin. The report also confirmed the importance of keeping fresh truffles refrigerated after opening them, which Red Light Holland currently mentions on all iMicrodose packs sold.
The testing performed by CCrest Laboratories in Montreal, Canada demonstrates the Company’s commitment to standardization, research and development in hopes of being able to advocate to Health Canada that their farm grown truffles could be an option of naturally occurring psychedelics for those patients in need under the new Special Access Program (“SAP”). CCrest Laboratories, Red Light Holland’s partner, has been listed as a provider of Psilocybin via SAP, if and when requests are made by health practitioners and all Government approvals are met.
“Step by step we continue to move towards a standardized consistent dose of naturally occurring psilocybin truffles that can potentially benefit all legal markets,” said Todd Shapiro, CEO and Director of Red Light Holland. “As far as we know our truffles are the first to go through such rigorous testing which shows our commitment to increasing scientific knowledge of these natural products and having the best products on the market. The legal market in the Netherlands and the market opening in Oregon next year are focused on naturally occurring Psilocybin which our market research shows many people prefer over synthetics – so it’s exciting that Red Light Holland with the help of Shaman Pharma is working towards giving people what they want. We hope other governments around the world will follow to legalize the responsible use of a substance that has been used by many civilizations for thousands of years.”
“Working with natural Psilocybin is exciting and we continue to learn and progress our methods of discovery,” said Alex Grenier, CEO of Shaman Pharma and President of CCrest Laboratories.
Red Light Holland’s partner, CCrest Laboratories will continue to perform stability tests and R&D towards creating a standardized consistent dose from naturally occurring psilocybin truffles.
Red Light Holland continues to establish itself as a leader in the recreational sector and push for legal, responsible, and safe access to natural psychedelic truffles/mushrooms while Scarlette Lillie Science and Innovation pursues research and development, technology, and applied science.
About Red Light Holland
Red Light Holland is an Ontario-based corporation engaged in the production, growth and sale (through existing Smart Shops operators and an advanced e-commerce platform) of a premium brand of magic truffles.
Shaman Pharma is a federally registered Canadian corporation with the mission to power outstanding psychedelic life science innovation. Accelerating time-to-market through its portfolio of assets, Shaman launches and consolidates revenue-driven pharma-biotech life sciences ventures focused on supplying psychedelic drugs & novel active ingredients.
Forward-Looking Statements
Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties, certain of which are beyond the control of Red Light Holland. Forward-looking statements are frequently characterized by words such as “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. Forward-looking statements include, but are not limited to: statements with respect to the Company creating a standardized consistent dose from naturally occurring psychoactive truffles; statements with respect to Health Canada’s Special Access Program, including the Company’s expectations with respect to exceeding any potential regulatory standards set by such program; statements with respect to further evaluation and testing of the Company’s naturally occurring psilocybe truffles by CCrest Laboratories for scientific and medical purposes; the potential of the Company’s products being used for scientific and medical purposes; the potential of the Company’s products being used for Health Canada’s Special Access Program; and the Company’s ability to establish itself as the leader in the recreational psychedelics sector.
Forward-looking information is based on a number of key expectations and assumptions made by Red Light Holland, including without limitation: the COVID-19 pandemic impact on the Canadian economy and Red Light Holland’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect Red Light Holland’s business; there will be a demand for Red Light Holland’s products in the future; no unanticipated expenses or costs arise; the Company will be able to continue to develop products that are allowed to be imported and sold under Health Canada’s import permit; and the partnership with Shaman Pharma Corp. will help Red Light Holland to achieve its business goals. Although the forward-looking information contained in this news release is based upon what the Company believes to be reasonable assumptions, it cannot assure investors that actual results will be consistent with such information.
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the inability of the Company to continue as a going concern; the inability of the Company to obtain all necessary governmental and/or other regulatory approvals, licenses, and permits necessary to operate and expand the Company’s facilities; the effect of regulatory and/or political change and its effect on the legislation and regulations surrounding the psychedelics industry including SAP; negative perception of the medical-use and adult-use psilocybin industry; the inability of CCrest to complete the planned testing of the Company’s products; the inability of the Company to create a standardized dose; the potential unviability of psilocybin for medical and/or scientific purposes; the inability for the company to use their psilocybin in any potential clinical use of naturally occurring Psilocybin; the inability for the Company to continue product development and research and development; the inability of the Company to continue its growth; the Company’s limited operating history; reliance on management; the Company’s requirements for additional financing; and competition for mental health and wellness investments.
Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.
Vancouver, British Columbia – TheNewswire – June 06, 2022 – Blackhawk Growth Corp. (the “Company”) (CSE:BLR) (OTC:BLRZF) (Frankfurt:0JJ) is pleased to announce the appointment of investment banker Justin Hanka as Director and Chairman of the Board of Directors to help execute corporate transactions in Blackhawk.
Mr Hanka has over 25 years of corporate transaction experience including cross border M&A, capital raising and equity capital markets in Australia and North America. Justin brings a wealth of sector expertise in insurance and financial services, ecommerce, fintech, health, pharma and medtech. Mr Hanka currently serves as Non-Executive Director of EonX, (CSE: EONX), a financial technology company and Goldcar Rental Australia & NZ, a Europcar company (PAR:EUCAR). Mr. Hanka is also the Co-founder and Executive Director of Blackhawk’s wholly-owned subsidiary, MindBio Therapeutics (“MindBio”).
Previously Mr Hanka was Chief Operating Officer of iSelect (ASX:ISU) where he was instrumental in creating the commercial relationships and operational structures to drive the company’s revenue growth from zero to $100m+ in just a few years. He previously served as Chief Executive Officer of HelpMeChoose which was acquired by ASX listed Mortgage Choice, subsequently acquired by the largest online realestate company in Australia, REA Group Limited (ASX:REA), with a market capitalization of $15B.
As Chairman and Director of Blackhawk, Mr. Hanka will drive several strategic initiatives to grow shareholder value. This includes sourcing new deal flow, executing on M&A and spin outs of Blackhawk’s existing portfolio and assisting with financing activities.
As incoming Chairman, Mr Hanka says, “As an investment issuer, Blackhawk is one of a handful of companies listed in Canada that can acquire, incubate and sell or spinout a new listing from its portfolio. The upcoming spin-out of MindBio, is a significant milestone and achievement for the Company and it demonstrates the value it can create for shareholders who receive a one for one shareholding in the newly listed entity. I look forward to working with the board to transform Blackhawk into a premium investment issuer in the capital markets”.
“Justin Hanka is a tremendous addition to the board” said Frederick Pels, CEO of Blackhawk. “His experience and commitment to Blackhawk will be relied upon as we continue to reach milestones and add shareholder value. On behalf of the board and myself, I would like to welcome Justin Hanka and we look forward to working with him.”
Scott Seguin and Dave Antony have resigned from the Board of Directors due to other business commitments. The Company wishes to thank them for their service.
Spinout of MindBio Therapeutics
The Company also announces that it continues to move forward with the planned spinout of MindBio Therapeutics. To ensure sufficient time for regulatory review of the spinout, the Company has elected to move the date for the meeting of shareholders to approve the spinout until July 15, 2022. Further details regarding the spinout and the meeting will be made available in an information circular mailed to shareholders of record and posted under the profile for Blackhawk on SEDAR (www.sedar.com). Completion of the spinout remains subject to the receipt of shareholder, regulatory and court approvals.
About Blackhawk Growth
Blackhawk is an investment holding company looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes TERP Wholesale, Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, Stable Foods, MindBio Therapeutics, Digital Mind Technology, Blum Distributors Ltd. as well as an equity position in Gaia Grow Corp. (CSE:GAIA).
Please join the conversation on our Blackhawk group supporter’s telegram group at https://t.me/Blackhawkgrowthcorp and visit us online at https://www.blackhawkgrowth.com.
All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Corporation within the meaning of applicable securities laws. The Corporation provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Corporation ’s public filings under the Corporation’s SEDAR profile at www.sedar.com. Although the Corporation has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Corporation disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.
Women are nearly twice as likely to be diagnosed with depression than men, but they’re often underrepresented in clinical trials.
Additionally, individuals with chronic illnesses like HIV often suffer from depression as well, which can make them less likely to adhere to their medications.
That’s why Cannsun Medicinal Global is investigating psilocybin as a treatment for depression in women who are HIV-positive.
The phase 2 trial received approval and will begin next month in South Africa.
“It is vitally important to have a deeper understanding of how women respond to medical treatment for major depression versus men in order to develop psychedelic therapies and treatment protocols for women that have clinically significant outcomes that are safe and effective,” says Donaghue Woodman, the company’s Head of R&D and Chief Medical Information Officer.
Vancouver, British Columbia, June 3, 2022. Lexston Life Sciences Corp. (the “Company”) (CSE: LEXT) (OTCQB: LEXTF) announces that it has cancelled an aggregate of 796,000 incentive stock options (the “Cancelled Options”) previously held by certain directors, officers, employees, and consultants of the6 Company. The Cancelled Options were comprised of the following:
Number of CancelledOptions
Original Date of Grant
Expiry Date
Exercise Price
400,000
January 18, 2021
January 18, 2026
$0.50
340,000
July 5, 2021
July 5, 2026
$0.875
56,000
September 8, 2021
September 8, 2026
$0.90
On Behalf of the Board of Directors LEXSTON LIFE SCIENCES CORP. Jagdip Bal Chief Executive Officer Telephone: (604) 928-8913 The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
NEW YORK, June 3, 2022 /PRNewswire/ — AIkido Pharma, Inc. (NASDAQ:AIKI), today announced that the Company’s Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1 for 17 (the “Reverse Stock Split”). The Reverse Stock Split will become effective at 12:01 a.m. Eastern time on June 7, 2022 and the Company’s common stock will open for trading on The Nasdaq Capital Market on a post-split basis on June 7, 2022 under the Company’s existing trading symbol “AIKI”. At such time, the Company’s common stock will also commence trading under a new CUSIP number 0088753043.
We expect that the Reverse Stock Split, which was approved by stockholders at an annual stockholder meeting on May 20, 2022, will increase the market price per share of the Company’s common stock, bringing the Company into compliance with listing requirements for The Nasdaq Capital Market.
At the effective time of the Reverse Stock Split, every seventeen (17) shares of AIKI common stock issued and outstanding will be combined into one (1) share of common stock issued and outstanding, with no change to the par value of $0.0001 per share. This will reduce the Company’s outstanding common stock from approximately 89,294,446 million shares to approximately 5,252,555 million shares. Fractional shares resulting from the reverse stock split will be rounded down to the nearest whole share, and all currently issued shares of common stock held by a shareholder shall be aggregated for the purpose of determining whether the reverse stock split would result in the issuance of a fractional share. The shares and exercise prices, as applicable, underlying the Company’s outstanding equity awards and warrants will also be adjusted accordingly.
The Company’s transfer agent, Continental Stock Transfer & Trust Company (“Continental”) will provide stockholders of record holding certificates representing pre-split shares of the Company’s common stock as of the effective date, a letter of transmittal providing instructions for the exchange of shares. Registered stockholders holding pre-split shares of the Company’s common stock electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares via a broker, bank, trust or other nominee will have their positions automatically adjusted to reflect the Reverse Stock Split, subject to such broker’s particular processes, and will not be required to take any action in connection with the Reverse Stock Split.
Additional information regarding the reverse stock split can be found in the Company’s definitive proxy statement (Form DEF 14A) filed with the U.S. Securities and Exchange Commission on April 12, 2022. Continental can be reached by phone at 917-262-2378
The Company does not anticipate raising any capital in the foreseeable future.
About AIkido Pharma Inc.
AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company’s platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.
Cautionary Note on Forward-Looking Statements
This press release and any statements of stockholders, directors, employees, representatives and partners of AIkido Pharma, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the impact of the Reverse Stock Split described in this release) may differ significantly from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.
IHL-42X reduced primary endpoint apnoea hypopnea index relative to baseline at all three doses that were assessed
Low dose IHL-42X exhibited superior safety and efficacy metrics to mid and high doses
Low dose IHL-42X reduced AHI by an average of 50.7% compared to baseline with 25% of participants experiencing a reduction in the apnoea hypopnea index of greater that 80%
Oxygen desaturation index was reduced by 59.7% relative to baseline while taking low dose IHL-42X, improving sleep quality and reducing cardiovascular stress
In low dose IHL-42X samples, THC concentrations in blood were well below the limits for impaired driving the morning after dose administration
IHL-42X was well tolerated – low dose IHL-42X was observed to have a lower number of total treatment emergent adverse events than placebo
Low dose IHL-42X reduced AHI substantially more effectively than is reported for the component active pharmaceutical ingredients, dronabinol and acetazolamide, as unregistered monotherapies.
MELBOURNE, Australia, June 3, 2022 /PRNewswire/ — Incannex Healthcare Limited (NASDAQ: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has completed analysis of data from the phase 2 proof-of-concept clinical trial investigating IHL-42X for treatment of obstructive sleep apnoea (‘OSA’). IHL-42X reduced apnoea hypopnoea index (‘AHI’), improved patient reported sleep quality and was well tolerated.
The clinical trial assessed three doses of IHL-42X at reducing the AHI in patients who suffered from OSA. Data was also collected for other aspects of sleep quality, THC clearance and safety. Trial participants received each of the three doses of IHL-42X and placebo across four seven-day treatment periods, separated by one week washout periods. At the end of each treatment period, they attended the clinic for an overnight sleep study where AHI was determined, along with other measures of sleep quality, quality of life and drug safety.
The study was conducted at the University of Western Australia Centre for Sleep Science and The Alfred Hospital. A total of eleven participants were recruited to the study and ten participants completed treatment periods. The crossover design of the study permitted Incannex to generate high quality data with a reduced participant number compared to a conventional parallel arm study. Each participant serves as their own internal control and inter-participant variation is eliminated. Data analysis was completed by Novotech, the contract research organisation responsible for management of the study, as well as the Incannex scientific research team, led by Chief Scientific Officer Dr Mark Bleackley. The findings of the clinical trial are presented below.
Effect of IHL-42X on apnoea hypopnoea index (AHI)
AHI is a measure of the number of times per hour a subject’s airway is blocked (apnoea) or partially blocked (hypopnoea). It is the main criteria used to diagnose and monitor OSA. AHI data was collected during overnight polysomnography on night seven of the treatment periods.
All doses of IHL-42X reduced AHI in patients with sleep apnoea compared to baseline (Table 1). This reduction was substantially greater than observed for placebo.
At the group level the difference relative to baseline with low dose and medium dose was statistically significant (p<0.05)
When comparing directly to baseline within subjects the difference in AHI compared to baseline between all three doses and placebo was statistically significant (p<0.001) (Table 2)
Low dose IHL-42X reduced AHI by >50% relative to baseline in 62.5% of subjects and by >80% in 25% of subjects (Table 2).
Low dose IHL-42X reduced AHI to the greatest extent at both the group level and when comparing the within subject reduction relative to baseline
Low dose IHL-42X reduced AHI to a greater extent than predicted based on published data for dronabinol and acetazolamide alone (Table 3).
The reduction in AHI observed during IHL-42X treatment periods means that when treated with Incannex’s proprietary drug, subject’s breathing was interrupted less frequently during sleep. This supports Incannex’s hypothesis that IHL-42X is an effective treatment for OSA. The observation that low dose IHL-42X was the most effective at reducing AHI is encouraging for the development of IHL-42X as a pharmaceutical as a lower dose will reduce risk of side effects and the cost of goods.
Furthermore, greater reduction in AHI with low dose IHL-42X compared to dronabinol and acetazolamide at equivalent doses supports Incannex’s hypothesis that the two drugs are acting synergistically to reduce AHI and provides confidence that IHL-42X will meet the FDA’s combination rule where both APIs must contribute to the therapeutic effect of a fixed dose combination product.
Table 1. Average AHI data for baseline and each treatment period
Baseline
Placebo
Low
Medium
High
Average AHI
42.84
40.08
21.13
22.22
27.78
Standard deviation
20.33
18.16
15.92
15.52
17.61
% Reduction relative to baseline
N/A
6.44
50.69
48.13
35.16
p value compared to baseline
N/A
0.76
0.029
0.031
0.12
Table 2. Change in AHI from baseline within subject (least square mean)
Average change in AHI from baseline
p-value relative to placebo (Bonferroni adjusted)
Proportion of subjects with AHI reduction >50% relative to baseline (%)
Proportion of subjects with AHI reduction >80% relative to baseline (%)
Placebo
1.95
N/A
10
0
Low
17.51
<0.001
62.5
25
Medium
14.86
<0.001
33.3
11.1
High
16.18
<0.001
22.2
11.1
Table 3. Comparison of reduction in AHI relative to baseline with low dose IHL-42X and the predicted reduction with component drugs as monotherapies at equivalent doses based on reported data.
Reduction in AHI compared to baseline (%)
2.5 mg dronabinol (1)
23.4
125 mg acetazolamide (2)
23.4
Low dose IHL-42X
50.7
Effect of IHL-42X on oxygen desaturation index (ODI)
Oxygen desaturation index (‘ODI’) is the number of episodes of oxygen desaturation per hour of sleep, with oxygen desaturation defined as a decrease in blood oxygen saturation (SpO2) to lower than 3% below baseline. Reduced oxygen uptake is a key component of the pathology of OSA and contributes to daytime sleepiness and the long-term health consequences associated with OSA. ODI data was collected during overnight polysomnography on night seven of the treatment periods.
All three doses of IHL-42X reduced ODI compared to baseline to a greater extent than placebo.
For low and medium dose IHL-42X the difference in reduction in ODI relative to baseline compared to placebo was statistically significant (p<0.05)
The greater reduction in ODI during IHL-42X treatment periods compared to placebo means that there is more oxygen in the subject’s blood during sleep while taking IHL-42X. This improves sleep quality and reduces risks of oxidative stress, bursts of the stress hormone cortisol, insulin resistance, altered metabolism and cardiovascular disease.
Table 4. Reduction in ODI compared to baseline during each treatment period.
Reduction in ODI relative to baseline (least squares mean)
Reduction in ODI relative to baseline (%)
p value compared to placebo (Bonferroni adjusted)
Placebo
1.8
18.3
N/A
Low
11.7
59.7
0.021
Medium
12
59.0
0.012
High
8.32
28.5
0.162
Plasma THC levels the morning after IHL-42X dosing
Countries that have set limits for THC above which driving is illegal have set those limits at 1-2 ng/mL (3-6). It is important to understand the clearance of THC after dosing with IHL-42X to determine where there will be an impact on ability to drive in countries where THC limits are in place. Plasma samples were collected 2 hours post dose 1 and the morning after dose 7 for each treatment period. Samples were analysed for concentration of THC using liquid chromatography with tandem mass spectrometry (LC-MS-MS).
The morning after dose 7, THC levels in the low dose IHL-42X samples had an average of 0.20 ng/mL and a maximum of 0.45 ng/mL. Both of which are below the thresholds for impaired driving. With medium and high dose IHL-42X the average THC concentrations the morning after dose 7 were 0.86 and 0.52 respectively.
Effect of IHL-42X on patient reported sleep quality
Each morning of the clinical trial, subjects recorded their sleep quality for the previous night as very poor, poor, fair, good, or very good. To compare patient reported sleep quality, the proportion of subjects who reported good or very good sleep each night was averaged across each treatment period. During the IHL-42X treatment periods subjects more frequently reported that their sleep quality was good or very good than placebo. The highest level of patient reported sleep quality was observed with low and high dose IHL-42X (Table 5).
Table 5. Patient reported sleep quality during each treatment period
Proportion of subjects reporting good or very good sleep quality
Placebo
26.50%
Low
49.49%
Medium
38.47%
High
50.13%
Sleep metrics captured by actigraphy
For the duration of the clinical trial, subjects wore an Actiwatch, a watch-like device that uses actigraphy to capture data on activity and sleep. IHL-42X at all doses improved sleep efficiency (what percentage of time in bed a subject is asleep), the number of awakenings per night, and the total minutes the subject was awake during the night (WASO) compared to placebo (Table 6). These improvements were greatest for low and high dose IHL-42X. This means that while taking IHL-42X subjects were asleep for a greater proportion of time they were in bed and woke up less often.
Table 6. Sleep metrics captured by actigraphy
Placebo
Low
Medium
High
Sleep efficiency
average
76.83
84.81
81.34
84.17
p value compared to placebo
N/A
0.0048
0.058
0.0078
Awakenings per night
average
49.31
35.8
41.44
37.33
p value compared to placebo
N/A
0.0053
0.055
0.012
WASO (min)
average
62.59
37.55
47.22
38.55
p value compared to placebo
NA
0.00011
0.0031
0.0010
Safety considerations
Adverse events were recorded from the time the subjects enrolled in the trial until their end of study visit. After recording of treatment emergent adverse events (TEAE) the study team, including investigators and medical monitors, reviewed the TEAEs to determine whether they were likely related to the investigational product. The TEAEs were consistent with what has been reported for dronabinol and acetazolamide alone. For each treatment period the proportion of subjects reporting one or more TEAEs (Table 7) as well as the total number of TEAEs (Table 8) were extracted from the clinical study report. Low dose IHL-42X had a similar proportion of subjects reporting TEAEs and a lower number of total TEAEs than placebo. This indicated that low dose IHL-42X is well tolerated.
Table 7. Proportion subjects of TEAEs reported for each treatment period
Placebo
Low
Medium
High
Total TEAE (%)
81.8
33.3
55.6
66.7
Related TEAE (%)
27.3
22.2
44.4
55.6
Table 8. Total number of TEAEs reported during each treatment period
Placebo
Low
Medium
High
Total TEAE
15
6
22
16
Related TEAE
7
4
16
12
References:
Carley DW, Prasad B, Reid KJ, Malkani R, Attarian H, Abbott SM, Vern B, Xie H, Yuan C, Zee PC. 2018. Pharmacotherapy of apnea by cannabimimetic enhancement, the PACE clinical trial: Effects of dronabinol in obstructive sleep apnea. Sleep 41.
Schmickl CN, Landry SA, Orr JE, Chin K, Murase K, Verbraecken J, Javaheri S, Edwards BA, Owens RL, Malhotra A. 2020. Acetazolamide for OSA and central sleep apnea: a comprehensive systematic review and meta-analysis. Chest 158:2632–2645.
Vindenes, V., et al., (2012) Impairment based legislative limits for driving under the influence of non-alcohol drugs in Norway, Forensic Science International 219(1-3,)1-11
Wolff, K, et al., Driving Under the Influence of Drugs: Report from the Expert Panel on Drug Driving, Department of Transport, London, 2013.
This announcement has been approved for release to ASX by the Incannex board of directors.
About Incannex Healthcare Limited
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public.
Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. Incannex is listed on the Australian Stock Exchange (ASX) with stock code “IHL” and also has American Depository Shares listed on NASDAQ under code “IXHL”.
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex’s views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex’s views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited Mr Joel Latham Managing Director and Chief Executive Officer +61 409 840 786 joel@incannex.com.au
US IR Contact Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com
TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE AMERICAN:CYBN) (“Cybin” or the “Company”), a biotechnology company focused on progressing Psychedelics to Therapeutics™, is pleased to announce that Adelia Therapeutics Inc. (“Adelia”), a wholly-controlled subsidiary of Cybin, has achieved the milestones identified as Y2, Q2 (i), (vi), Y2, Q3 (ii), Year 2 Q4 (i) and Year 3 Q1 (i), (ii), (iii) as contemplated by the terms of a contribution agreement dated December 4, 2020 (the “Transaction Agreement”) among Cybin, Cybin Corp., Cybin US Holdings Inc. (the “Acquiror”), a wholly-controlled subsidiary of Cybin, and all of the previous shareholders of Adelia (the “Adelia Shareholders”).
Pursuant to the terms of the Transaction Agreement, Class B common shares in the capital of the Acquiror (the “Class B Shares”) shall be issued to the Adelia Shareholders, in satisfaction of the $2,033,309.79 (approximately US$1,616,431.98) due to them on meeting a portion of the relevant milestones, at an effective issue price determined in accordance with the Transaction Agreement and applicable securities law. The Class B Shares issued by the Acquiror to the Adelia Shareholders are exchangeable for common shares in the capital of Cybin (the “Cybin Shares”) on a 10 Cybin Shares for 1 Class B Share basis, at the option of the holder thereof, subject to customary adjustments. No Class B Shares were exchangeable prior to December 14, 2021, and not more than: (i) 33 1/3% of the Class B Shares will be exchangeable prior to December 14, 2022; (ii) 66 2/3% of the Class B Shares will be exchangeable prior to December 14, 2023; and (iii) thereafter, 100% of the Class B Shares will be exchangeable.
Additional information related to the transaction is available in the Transaction Agreement, which is filed under Cybin’s profile on SEDAR (www.sedar.com) and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov.
About Cybin
Cybin is a leading ethical biotechnology company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics™ by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
About Adelia
Adelia is a wholly-controlled subsidiary of the Company, that aims to develop medicinal psychedelics with improved dosing efficacy and therapeutic indices to address unmet medical needs. Adelia’s primary focus is on the development of treatment regimens consisting of proprietary psychedelic molecules and related clinical protocols. This proprietary development strategy is based on chemical modifications to the known and well understood tryptamine derivatives that significantly modify their pharmacokinetic properties without changing their therapeutic potential. These proprietary approaches seek to minimize inter-patient variability by better controlling drug metabolism without loss of efficacy that together have been shown to produce more predictable and favorable patient outcomes.
Cautionary Notes and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward looking statements in this news release include statements regarding the Company’s development of innovative drug delivery systems, novel formulation approaches and potential treatment regimens for psychiatric disorders and Adelia’s proprietary development strategy and development of medicinal psychedelics with improved dosing efficacy and therapeutic indices to address unmet medical needs.
These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the three and six months ended December 31, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.
Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved nor disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.
Unless otherwise indicated, all dollar amounts in this news release are expressed in Canadian dollars.
Investor & Media: Leah Gibson Vice President, Investor Relations & Strategic Communications Cybin Inc. irteam@cybin.com – or – media@cybin.com
TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, today announced the team of 28 esteemed faculty and advisors who will lead the Company’s EMBARK Psychedelic Facilitator Training Program. Recognizing the crucial importance of supporting psychedelic study facilitators with quality training, Cybin has brought together recognized leaders and senior psychedelic-assisted psychotherapy trainers from leading universities and psychedelic research and training organizations.
“For EMBARK, we have set out to build an extraordinary training program in psychedelic-assisted psychotherapy. We don’t think a single person holds all the answers. Instead, we have gathered together the wisdom of 28 of the world’s leading experts in psychedelic practice as teachers, supervisors, and advisors for our program. They are the recognized leaders in their fields, and I’m deeply grateful for their skill, integrity, and heartfelt teachings,” said Dr. Alex Belser, Chief Clinical Officer at Cybin.
EMBARK is a leading-edge model of psychedelic-assisted psychotherapy co-developed by Alex Belser, PhD, and Bill Brennan, PhD. EMBARK provides six clinical domains (Existential-Spiritual, Mindfulness, Body Aware, Affective-Cognitive, Relational, and Keeping Momentum). Additionally, EMBARK is built upon four care cornerstones: trauma-informed care, culturally-informed care, ethically rigorous care, and collective care.
“Because of the multi-dimensional, profound content of psychedelic-assisted psychotherapy sessions, a training to prepare therapists to do this work requires more ethical education than what is offered by the traditional, stand-alone ethics lecture. Cybin’s EMBARK accepted that challenge and created a program in which ethical inquiry undergirds all of its programming,” said Kylea Taylor, LMFT, author of The Ethics of Caring and creator of InnerEthics®.
EMBARK faculty membersinclude:
Anthony Back, MD, Professor of Medicine at the University of Washington in Seattle, and the Fred Hutchinson Cancer Research Center. He is the Principal Investigator for a Phase 2 clinical trial to treat frontline clinicians experiencing COVID-related burnout and distress.
Alex Belser, PhD, co-creator of EMBARK, Chief Clinical Officer at Cybin, Chair of Cybin’s Clinical Advisory Board, and Co-Investigator on a psilocybin clinical trial at Yale University.
Bill Brennan, PhD, co-creator of EMBARK and author researching best practices for psychedelic psychotherapy.
NiCole T. Buchanan, PhD, Clinical-Community Psychologist, Professor, and Justice, Equity, Diversity, and Inclusion (JEDI) consultant.
Stacia Butterfield, certified Holotropic Breathwork practitioner and a teacher with Grof Transpersonal Training.
Jeffrey Guss, MD, psychiatrist, psychoanalyst, researcher and teacher specializing in psychoanalytic therapy and psychedelic therapy. He is a Lead Trainer at Fluence and Clinical Assistant Professor of Psychiatry at the NYU School of Medicine.
Amir Inamdar, MBBS, DNB (Psych), MFPM, psychiatrist, pharmaceutical physician, drug developer and Cybin’s Chief Medical Officer.
Alex Kelman, PhD, Senior Director for the EMBARK Training Program and Attending Psychologist and Assistant Clinical Professor at the University of California, Los Angeles.
Adele Lafrance, PhD, developer of emotion-focused treatment modalities, and Strategic Lead and Clinical Investigator for MDMA-Assisted Therapy Research
Manuela Mischke-Reeds, MA, MFT, somatic psychotherapist and teacher, co-director of the Hakomi Institute of California, Chief Mental Health Officer at Abroad.
Marcela Ot’alora, G, MA, LPC, trainer, researcher and advocate for the safe and ethical use of psychedelic therapy. She is a lead trainer for the MAPS MDMA Therapy Training Program.
Florie St. Aime, LCSW, invites others into liberation practices through social justice organizing, group facilitation, individual psychotherapy, supervision and holding sacred space.
Kylea Taylor, MFT, created and teaches InnerEthics®, a self-reflective approach to ethics education that she first described in her book The Ethics of Caring.
Advisors, Clinical Supervisors, and Subject Matter Expertsinclude:
Melissa Field, Senior Manager of Clinical Process and Training at Cybin.
Ingmar Gorman, PhD, CEO and Co-Founder of Fluence, a clinical psychologist, and former site Co-Principal Investigator and therapist for MAPS MDMA-assisted psychotherapy trials.
Charlotte Harrison, clinical trial consultant collaborating with the Cybin team on protocol and training development. She has worked in clinical research for over a decade, including overseeing MAPS’ MDMA-assisted psychotherapy program.
Diane Hollman, Senior Director of Clinical Alliances at Cybin.
Franklin King, MD, Instructor at Harvard Medical School and psychiatrist at Massachusetts General Hospital where he serves as the Director of Training and Education at the Center for Neuroscience of Psychedelics.
Robert Krause, DNP APRN-BC, Co-director of Centered PLLC, researcher, therapist, and educator. He has lectured at Yale University and is visiting faculty in the Consciousness Studies Department at the Graduate Institute. A graduate of CIIS’s founding cohort in Psychedelic Assisted Therapy, he is also a MAPS therapist in an expanded access protocol.
John Krystal, MD, Chair at Yale University’s Department of Psychiatry and Co-Director of Yale’s Center for Clinical Investigation.
Dennis McKenna, PhD, author or co-author of three books and over 50 peer-reviewed papers on the chemistry, ethnopharmacology, and neuroscience of psychedelics, as well as other botanical medicines. He is a founding board member of Heffter Research Institute, and the founder and President of the McKenna Academy of Natural Philosophy, which is focused on psychedelic education and the preservation of traditional knowledge, facilitating its integration with scientific knowledge.
Elizabeth Nielson, PhD, CVO and Co-Founder of Fluence, a site Co-Principal Investigator and therapist for MAPS MDMA-assisted psychotherapy trials, and an investigator in NYU’s study of psilocybin-assisted psychotherapy for Alcohol Use Disorder.
Sarah Scheld, MA, EMBARK Training Program Consultant.
Jordan Sloshower, MD, MSc, psychiatrist and researcher at Yale University where he serves as an investigator and therapist in several clinical trials of psilocybin-assisted therapy. Jordan is also a clinical investigator in MAPS’ Expanded Access Program for MDMA-assisted therapy of PTSD and serves as a lead trainer with Usona Institute’s psilocybin facilitator training program.
Andrew Solomon, PhD, professor of clinical psychology at Columbia and a lecturer in psychiatry at Yale, is the National Book Award-winning author of The Noonday Demon and Far from the Tree, a writer for The New Yorker, and a writer and speaker on politics, psychology, and the arts.
Cybin’s Clinical Advisory Boardincludes:
Anthony Back, MD, Professor of Medicine at the University of Washington School of Medicine in Seattle and the Fred Hutchinson Cancer Research Center. He is the Principal Investigator for a Phase 2 clinical trial to treat frontline clinicians experiencing COVID-related burnout and distress.
Alex Belser, PhD, Chief Clinical Officer at Cybin and Chair of Cybin’s Clinical Advisory Board.
Maurizio Fava, MD, Psychiatrist-in-Chief in the Department of Psychiatry at Massachusetts General Hospital, and an Associate Dean for Clinical and Translational Research at Harvard Medical School.
Tom Laughren, MD, Director at Laughren Psychopharm Consulting, LLC, and the Former Director of FDA’s Division of Psychiatry Products.
Lynn Marie Morski, MD, JD, President of the Psychedelic Medicine Association.
Cybin launched the EMBARK Psychedelic Facilitator Training Program for study facilitators in October 2021. The program offers psychedelic clinical trial facilitators the foundational training needed to provide skillful and ethical care to treat participants receiving psychedelic-assisted therapy. The curriculum prepares facilitators to work with a range of experiences that may arise for participants in each domain, and to ground their work in each care cornerstone.
For more information on the EMBARK program, please click here.
About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics™ by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
Cautionary Notes and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.
These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended December 31, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.
Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.
Investors & Media: Leah Gibson Vice President, Investor Relations & Strategic Communications Cybin Inc. irteam@cybin.com – or – media@cybin.comSource: Cybin Inc.
MIAMI, June 03, 2022 (GLOBE NEWSWIRE) — Ehave, Inc. (OTC Pink: EHVVF) (the “Company”), a leading healthcare services and technology company, announced today its KetaDASH subsidiary will accept delivery of its KetaDASH Mobile Unit in Miami Beach Florida on June 10, 2022. The KetaDASH Mobile Unit is a custom high-end medical van utilizing KetaDASH’s software platform. By bringing exclusive Ketamine IV treatments directly to the patient, KetaDASH will empower doctors and patients with real-time health data for better clinical decisions and health outcomes.
Ehave’s KetaDASH subsidiary began operations in the Sacramento and San Francisco area earlier this year. KetaDASH is a managed service organization focused on the psychedelic sector with the mission of helping physicians streamline their practice operations, create new revenue opportunities, and achieve better patient outcomes. KetaDASH treatments are conducted by a team of experienced physicians, therapists and nurses who will come to your home, office, or mobile location and provide a complete ketamine treatment experience, after an initial telemedicine visit. The KetaDASH Mobile Unit is specifically designed to focus on safety, setting, comfort and efficacy of treatments. This innovative service departs from in-clinic intravenous, treatment or unsupervised telehealth models to an at-home ketamine administration with telehealth and in-person medical supervision. A typical KetaDASH experience incorporates a prescribing doctor, a nurse for administration and monitoring, and psychotherapists for integration, all from the comfort of the patient’s home. Follow KetaDASH on Instagram at www.instagram.com/ketadash.usa.
Ben Kaplan, CEO of Ehave, said, “Ketamine is an FDA approved drug that has been used for over 50 years as a safe dissociative anesthetic that is now being studied as a treatment for major depression. In certain psychiatric conditions, such as treatment-resistant depression, anxiety, post-traumatic stress disorder and alcohol abuse, ketamine has shown very encouraging results.”
Mr. Kaplan continued, “I am honored to include pictures of our KetaDASH Mobile Unit, which we created together. As we make plans to go live this summer in Miami Beach, one very important message is that I would like to say ‘Thank You’ to all of the team members and license partners. Most importantly, I would like to say ‘Thank you’ to our shareholders, who have helped us make all of this happen.”
About Ehave, Inc.
Ehave is a leading healthcare services and technology company, focused on progressing psychedelics-to-Therapeutics by engineering novel compounds and new treatment protocols for treating brain health. Together with our network of scientists and mental health professionals, we are on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues, leveraging clinical data to help us achieve optimal patient outcomes. Ehave’s operations span across the entire USA, Canada, Jamaica, and Australia. Additional information on Ehave can be found on the Company’s website at: www.ehave.com.
Forward-Looking Statement Disclaimer
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading “Risk Factors” in Ehave, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC’s website, http://www.sec.gov.
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