TORONTO, CANADA, July 15, 2022 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD) is today providing a business and corporate update.
Awakn launches ‘Beta’ phase of its Licensing and Partnerships business in North America. Awakn has signed Memorandum of Understanding (MOU) documents with multiple well-established Clinics in North America. Once full agreements are signed, the clinics will be given access to Awakn’s proprietary ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD). Awakn’s treatment is backed by the successful Phase II b trial which resulted in 86% abstinence at 6-months post treatment. The ‘Beta’ phase will precede the full launch which is targeted for early 2023. Awakn will work with its license partners to fine tune the roll out of the treatment in advance of the full launch.
Awakn has initiated its Innovative Licensing and Access Pathway (ILAP) application for its lead program Project Kestrel. The ILAP is a UK government run initiative that supports innovative approaches to the safe, timely and efficient development of medicines. Awakn aims to accelerate the time to market for its ketamine-assisted therapy for AUD, eventually facilitating patient access to this treatment on the National Health Service (NHS).
Awakn CFO, Kate Butler is leaving the Company, effective July 31, 2022, to pursue other opportunities. Awakn has commenced the search for a permanent CFO and for the interim period Jonathan Held, Chief Business Officer, Co-founder and previous CFO has been appointed as interim CFO.
Awakn has filed a Patent Cooperation Treaty (PCT) for MDMA-assisted therapy for the treatment of AUD. This patent allows Awakn the freedom to operate and pursue its promising research and results from its Phase II a trial.
In 2021, Awakn signed a Letter of Intent (LOI) with the psychedelic company Mindcure. It was intended that Mindcure would provide their therapeutic software application (iSTRYM) as a digital system to be used in Awakn’s Licensing Partnerships. Mindcure have recently announced following a strategic review they have ceased all research projects. As a result of this development, Awakn will not be pursuing an agreement with Mindcure.
Awakn CEO, Anthony Tennyson commented “We are delighted to see our Licensing Partnerships business move into its ‘Beta’ phase as we execute on our strategy of commercializing our therapeutics. I would also like to thank Kate Butler for all her work with Awakn and wish her the very best in her next venture.”
About Awakn Life Sciences Corp.
Awakn Life Sciences Corp. is a revenue-generating biotechnology company researching, developing, and commercialising therapeutics to treat substance and behavioral addictions. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 400m people globally for which the current standard of care is inadequate. Our goal is to provide effective therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels.
Project Kestrel is the lead clinical development program of Awakn Life Sciences. Project Kestrel is supported by Awakn’s Phase II a/b ‘KARE’ clinical trial which examined ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD). The trial resulted in patients experiencing on average 86% abstinence at 6 months post treatment versus 2% before the trial which means that study participants went from being sober on average 7 days a year to being sober on average 314 days a year. Awakn is planning to initiate a Phase III trial in the UK in 2022 and plans to seek regulatory approval in the UK and the US in due course.
Notice Regarding Forward-Looking Information
This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, ”would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.
Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to:COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.
Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.
This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
Investor Enquiries: Anthony Tennyson, CEO, Awakn Life Sciences anthony.tennyson@awaknlifesciences.com
Media Enquiries: America and Canada: KCSA Strategic Communications Anne Donohoe Adonohoe@KCSA.com
Rest of World: Eat More Fruit Communications Paul Jarman / Nora Popova awakn@eatmorefruit.com
– Progress continues apace with multiple trials expected to enter clinic later this year
– First US patent granted
LONDON, July 15 2022 (GLOBE NEWSWIRE) — Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, has today published its financial results for the quarter ended May 31, 2022. A full copy of the results can be found under the Company’s profile on SEDAR at www.sedar.com. Unless otherwise indicated, all currency references are in Canadian dollars.
Financial Highlights
Cash on hand as of May 31, 2022 was $32.0 million. Cash is net of an unrealized loss of $2.3 million arising from foreign exchanges incurred due to a strengthening of the Canadian dollar against the British pound sterling (“GBP”) during the quarter; however, as most of the Company’s operating costs are incurred in GBP, the loss has little impact on the underlying cash burn of the Company.
Cash used in operating activities was $6.3 million for the three months ended May 31, 2022.
Operating expenses for the three months ended May 31, 2022 were $5.8 million.
Business Highlights (including post-period events)
Ultra Short-acting Psychedelic Program
Progress continues in the Phase I/IIa clinical trial of the Company’s lead program, SPL026 intravenous (“IV”) N,N-dimethyltryptamine (“DMT”) assisted psychotherapy for Major Depressive Disorder (“MDD”). Phase IIa patient dosing is expected to complete in the coming months. Updates on trial completion and topline data timing are anticipated throughout H2 2022.
Drug interaction Phase Ib study in MDD patients CTA submission complete; study expected to commence in H2 2022.
Assessment of safety, tolerability, pharmacokinetics and pharmacodynamics of DMT-assisted psychotherapy when administered with serotonin reuptake inhibitors (“SSRIs”), .
Preparation is ongoing for the Phase IIb international multi-site clinical trial.
Short-acting Psychedelic Programs
Phase I study evaluating SPL026 intramuscular (“IM”) is planned for H2 2022 to compare the treatment profile of IM and IV modes of administration.
Phase I study evaluating SPL028 deuterated DMT-assisted psychotherapy is planned for H2 2022.
Corporate Activity
Strong IP Portfolio with 8 granted patents and 75 patent applications pending across the Company’s psychedelic and non-psychedelic portfolio.
Two new patent grants in July 2022:
One patent received is a US patent that strengthens the company’s portfolio surrounding certain salt forms of 2R,6R-hydroxynorketamine (“6-HNK”), including SPL801B.
Second patent received is a European patent providing protection for high concentration oral dosage forms of 6-HNK salts, including SPL801B.
Continued participation in key investor events such as the PSYCH Symposium London, Jefferies Healthcare Conference and HC Wainwright Mental Health Conference.
Peter Rands, Chief Executive Officer of Small Pharma, said:
The remainder of 2022 is expected to be a busy one for our team as we approach the latter stages of the SPL026 Phase IIa clinical trial and prepare to progress a number of new planned trials into the clinic. Although across the world, our industry is facing challenging markets right now, we believe that Small Pharma remains in a strong position with our world-class team, robust pipeline and strong cash position as we strive to change the therapeutic paradigm for these much underserved patients with the option of better mental health treatments.”
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression. Small Pharma initiated a clinical program into DMT-assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside the development of a pipeline of proprietary preclinical assets.
About DMT
DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics.
This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this news release include statements regarding the Company’s continued progression of Phase IIa clinical trials of SPL026 IV, including the expected timeline for completion of patient dosing, trial progress and the release of the Phase IIa data; the expected timeline for commencing a drug interaction patient study assessing the impact of SSRIs; the Company’s preparation for the international multi-site Phase IIb clinical trial of SPL026; the Company’s plans, expectations, timelines and possible outcomes with respect to its anticipated SPL026 study comparing IM versus IV modes of administration as well as the Company’s Phase I study of SPL028 deuterated DMT-assisted psychotherapy; the Company’s ability to pursue novel treatments to provide better mental health treatments; and the Company’s ability to develop solutions to effectively address depression through DMT-based therapies.
In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. 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 information. Such factors include but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting the Company’s business and results of operations; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.
Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The U.K. Medicines and Healthcare Products Regulatory Agency (the “MHRA”) or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next generation psychoactive compounds. The efficacy of such therapies has not been confirmed by MHRA-approved research. There is no assurance that such DMT-assisted therapies and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy and safety of potential therapies do not imply that Small Pharma verified such in clinical trials or that Small Pharma will complete such trials. If Small Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Small Pharma’s performance and operations.
The TSX Venture Exchange (“TSXV”) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.
Revenues grew 32% year-over-year to $0.74 million for the quarter
Clinic network revenues grew 59.5% from the same quarter last year and 7.5% compared to prior quarter
Achieved 24.4% gross margin and $180,845 gross profit of during Q3 2022
Ended quarter with strong cash position of $41.8 million
Completed acquisition of Novamind, positioning Numinus as a leading, integrated mental healthcare company providing psychedelic-assisted therapies
All financial results are reported in Canadian dollars unless otherwise stated.
VANCOUVER, BC, July 14, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal quarter results for the three and nine months ended May 31, 2022 (“Q3 2022”). Q3 2022 results do not reflect contributions from the acquisition of Novamind, which completed subsequent to quarter end, on June 10, 2022.
“Our fiscal third quarter was highlighted by the announcement of our acquisition of Novamind, and the activities leading up to the completion of that strategic transaction on June 10, 2022. Now, with 13 wellness clinics across North America, four clinical research sites and a dedicated psychedelics research facility, Numinus is firmly positioned as a leading mental health care company providing psychedelic-assisted therapies. We’re very pleased with how our operations are integrating and with the collaborative efforts we are already seeing across our new expanded team,” said Payton Nyquvest, Founder and CEO. “We look forward to sharing our combined performance with you when we announce our fiscal fourth quarter results – which will be the first quarter demonstrating the power of our larger, cross-border platform.”
“Today, including the contributions of Novamind, Numinus is one of the highest revenue-producing mental health care companies providing psychedelic and ketamine-assisted therapies, with more than $12 million of combined proforma annual revenues (based on trailing four quarters). We continue to be excited about the momentum building across our business and our outlook ahead. With significantly strengthened revenue streams, a growing number of client services, and positive regulatory reforms underway, our focus is squarely on reaching profitability as quickly as possible. Our strategy to accelerate Numinus’ path to profitability also includes expanding higher-margin services, increasing business development activities, and proactively managing our operating costs. Our goal is to achieve operational profitability within two years and corporate positive cashflow within three years,” concluded Mr. Nyquvest.
Third Quarter Financial Highlights
Revenues grew 31.8% year-over-year to $741,064 million in Q3 2022, due primarily to the acquisitions of Mindspace and the Neurology Centre of Toronto. Sequentially, revenues declined by 5.7% from the prior quarter, due entirely to shifting strategic priorities at Numinus Bioscience – where analytical testing services for third-party corporate clients has ceased due to changing sector dynamics. The elimination of this revenue stream was partially offset by 7.5% revenue growth achieved through Numinus’ clinic network operations.
Gross margin grew to 24.4% during Q3 2022, compared to -2.8% in Q3 2021. The improvement in gross margin is due mostly to the completion of acquisitions between periods, and the offering of higher-margin services.
Gross profit of $180,845 in Q3 2022, a significant improvement compared to the gross loss of $15,497 in Q3 2021.
Loss was $7.0 million for Q3 2022, compared to a loss of $4.8 million in Q3 2021, due in part to corporate development and legal expenses related to the acquisition of Novamind Inc.
Cash balance of $41.8 million as of May 31, 2022.
First Nine Months Financial Highlights
Revenues during the first nine months of fiscal 2022 grew 126.5% year-over-year to $2.3 million due primarily to the continued post-acquisition growth of Mindspace and the acquisition of NCT.
Gross margin during the first nine months of 2022 was 19.9%, compared to -11.1% in the same period last year.
Gross profit during the first nine months of 2022 was $460,569, a significant improvement compared to the gross loss of $113,356 in the same period of 2021.
Loss was $20.2 million for the first nine months of 2022, compared to a loss of $11.0 million in the first nine months of 2021.
Operational Highlights During and Subsequent to Q3 2022 As a reminder, operational performance for the third quarter and first nine months of fiscal 2022 does not include contributions from the acquisition of Novamind, which completed subsequent to quarter-end, on June 10, 2022.
Numinus Wellness Clinic Network
Q3 2022 revenue of $731,064, a 7.5% sequential increase from Q2 2022, and a 59.5% increase compared to $458,316 during the same period last year.
During Q3 2022, clients received a total of 5,634 appointments through Numinus clinics (including one-on-one and group therapy sessions, neurology-related appointments, paid group programs and Ketamine-assisted psychotherapy), representing a 5.9% increase in clinic appointments compared to Q2 2022.
As of May 31, 2022, Numinus had five wellness clinics and two clinical research sites. As of July 14, 2022, following the acquisition of Novamind, Numinus has 13 wellness clinics offering services to clients (one in Vancouver, one in Toronto, three in Montreal, eight in Utah and two in Arizona). In addition, the Company has four dedicated research clinics where psychedelic studies are being conducted (two in Salt Lake City, one in Vancouver and one in Montreal).
Following a review of its growth initiatives and opportunities, Numinus has decided to cancel its previously announced second wellness clinic location in Vancouver, Canada. The acquisition of Novamind has provided additional growth opportunities that the Company expects could provide higher return-on-investment.
Subsequent to the quarter, on June 23, 2022, Numinus launched a pilot mental health program for corporate clients: Corporate Ketamine-Assisted Psychotherapy (“Corporate KAP”). This Utah-based program is aimed at helping businesses improve employee mental health by offering ketamine-assisted psychotherapy as a health benefit for eligible employees.
Clinical Trials
On March 30, 2022, Numinus announced it began administering MDMA-assisted psychotherapy to clinical trial volunteers for the “multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX)” trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and organized by MAPS Public Benefit Corporation (MAPS PBC).
On May 16, 2022, Numinus announced it received Health Canada Special Access Programme (“SAP”) approval to provide psilocybin-assisted therapy to a patient with treatment-resistant depression. This was Numinus’ first psilocybin-assisted therapy treatment outside of clinical trials; amongst the first to use this regulatory mechanism through Health Canada’s SAP.
As part of the Company’s focus on accelerating its timeline to profitability, Numinus has decided to postpone its clinical trials of NBIO-01 and NBIO-03, given the high cost of clinical trials. Once the company can see a clear pathway to regulatory approvals or has achieved profitability, the clinical trials for these drug candidates will commence.
Numinus Research – Laboratory Operations
Given sector consolidation, the decreasing corporate client base for psychedelic substance analytical services and limited revenue generating opportunities, Numinus Bioscience intends to focus purely on proprietary research activities for the foreseeable future. The divisions’ analytical testing capabilities remain available for proprietary and on-request projects; however, the company has eliminated its business development activities for these services to reduce expenses in this period of sector dislocation. As this business decision was implemented partway through the quarter, Numinus Bioscience generated revenue of $10,000 during Q3 2022 and is not expected to generate any further revenue from analytical testing services until and unless sector dynamics improve to sustain those business operations.
In March 2022, Numinus Bioscience expanded its research capabilities as a result of the addition of a Public Health Agency of Canada for a Containment Level 2 (CL2) pathogens and toxins license, and the approval from Health Canada to add Ayahuasca & San Pedro to its federal license for psychedelic research.
On June 22, 2022, Numinus Bioscience filed a patent application to the World Intellectual Property Organization (WIPO), an agency of the United Nations, for a rapid production process for Psilocybe and other fungi species containing psilocybin and other compounds. A provisional patent application for the process was submitted to the United States Patent & Trademark Office (USPTO) on June 24, 2021. With this additional filing, international patent protection would extend to all WIPO member states that have signed the Patent Cooperation Treaty (PCT), including Australia, Germany, Netherlands, and the United Kingdom, where psychedelic research is currently active.
Corporate Updates
On June 27, 2022, Numinus introduced its new logo and brand identity, which will unify Numinus’ presence across North America. The rebranding activities will be accomplished in phases and completed by the end of 2022.
On April 12, 2022, Numinus announced it made an offer to acquire Novamind – positioning Numinus as a leading, integrated mental healthcare company providing psychedelic-assisted therapies. The transaction was overwhelmingly approved by Numinus and Novamind shareholders at separate shareholder meetings on June 8, 2022. On June 10, 2022, the acquisition of Novamind was completed with Novamind shareholders receiving 0.84 Numinus shares per Novamind share. As a result of the acquisition, Novamind was delisted from the CSE and OTC exchanges.
On June 10, 2022, Numinus announced several executive appointments. Michael Tan was promoted to President and Chief Operating Officer, Reid Robison was appointed Chief Clinical Officer, and Paul Thielking has been appointed Chief Science Officer.
Q3 2022 Key Performance Metrics
For the quarter ended May 31:
2022
2021
% change
Numinus Bioscience¹ revenue
10,000
103,760
-90.4 %
Numinus Clinic Network2 revenue
731,064
458,316
59.5 %
Total Revenue
$741,064
$562,076
31.8 %
Cost of revenue
(560,219)
(577,573)
-3.0 %
Gross Profit (Loss)
$180,845
$(15,497)
n.m.
Gross profit margin
24.4 %
-2.8 %
n.m.
General and administrative expenses
(5,269,941)
(2,485,805)
112.0 %
Share-based compensation
(212,321)
(610,386)
-65.2 %
Sales and marketing expenses
(441,723)
(967,670)
-54.4 %
Depreciation & Amortization
(173,219)
(76,226)
127.2 %
Research and development expenses
(506,665)
(631,124)
-19.7 %
Transaction costs
(456,747)
(8,369)
5,357.6 %
Loss before other items
$(7,008,112)
$(4,824,424)
43.5 %
Other items
(142,209)
(29,347)
384.6 %
Revaluation of contingent liability
13,868
0
100.0 %
Loss and comprehensive loss
$(7,008,112)
$(4,824,424)
45.3 %
Loss per share, basic and diluted
$(0.03)
$(0.02)
34.1 %
Average number of shares outstanding,basic and diluted
210,247,839
149,026,971
8.4 %
1 Numinus Bioscience consists of revenues generated through Numinus’ Laboratory Operations, which ceased analytical testing services to third-party corporate clients during Q3 2022.
2 Numinus Clinic Network revenues generated through NCT, Mindspace and Numinus Health.
Numinus’ condensed consolidated financial statements for the three and nine months ended May 31, 2022 and related management’s discussion and analysis are available on Numinus’ Investor Relations website at www.investors.numinus.com and under the Company’s profile on SEDAR at www.sedar.com. These documents were prepared in accordance with IFRS.
Conference Call and Webcast Details
Interested parties are invited to participate in the Company’s Q3 2022 results conference call and webcast. On the call Numinus executives will review the Company’s performance and recent initiatives, and answer questions from analysts.
Date:
Thursday, July 14, 2022
Time:
5:30 p.m. (EST)
Dial-In:
1 (888) 330-3632 (Toll-free North America), 1 (646) 960-0837 (International)
Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Neither Numinus Wellness Inc., nor any of its subsidiaries is a professional corporation licensed to practice health services. In jurisdictions where health services may only be provided by a corporation if that corporation holds a valid permit to do so, Numinus and its subsidiaries operate in a management services function to affiliated professional corporations, who provide health services to patients. Numinus and its subsidiaries do provide health services directly to patients in those jurisdictions where authorized to do so.
Forward-looking statements
This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, “believes”, “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the impact of the Russia-Ukraine conflict on the global economy; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.
SOURCE Numinus Wellness Inc.
For further information: Investor Contact: Jamie Kokoska, Vice President, Investor Relations & Communications, jamie.kokoska@numinus.com, +1 833-686-4687; Media Contact, Hilary Strath, Director, Communications, hilary.strath@numinus.com
Completed strategic review and announced intention to separate the Field Trip Discovery and Field Trip Health divisions into two independent public companies.
Earned patient services revenues of $1.7 million in fiscal fourth quarter, an increase of 26.7% over the prior quarter and 228% year over year. Full year patient services revenue was $4.9 million, up from $0.96 million in the same period of the prior year.
At March 31, 2022, Field Trip had approximately $63.7 million in unrestricted cash and cash equivalents.
On April 5, 2022, granted U.S Patent for the first novel psychedelic molecule in development, molecule FT-104, for exclusive rights for the composition of matter, use and manufacturing of a family of hemi-ester compounds of hydroxytryptamines, including FT-104 until 2040.
In May, 2022, launched Field Trip at Home Powered by Nue Life, an advanced wellness platform for personalized, at-home psychedelic care. The program’s ketamine treatments, interactive companion app, and virtual aftercare programs, provides an alternative to in-clinic care for those seeking treatment, but who are unable to travel to one of Field Trip’s existing locations.
TORONTO, June 29, 2022 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (TSX: FTRP; FTRP.WT; NASDAQ: FTRP) (“FieldTrip“), a leader in the development and delivery of psychedelic therapies, reported fiscal fourth quarter and full year 2022 results for the period ended March 31, 2022 and provided a business update. All results are reported under International Financial Reporting Standards (“IFRS“) and in Canadian dollars, unless otherwise specified.
Corporate Reorganization
Post quarter end, Field Trip announced the completion of its previously announced strategic review and the intention to complete a reorganization that will separate the Field Trip Discovery and Field Trip Health Divisions into two independent public companies (the Spinout Transaction). The reorganization will be completed by way of a Plan of Arrangement (the Arrangement). Field Trip Discovery will be renamed Reunion Neuroscience Inc. (Reunion) and continue to focus on the research and development of novel psychedelic molecules such as FT-104. Field Trip Health will be renamed Field Trip Health & Wellness Ltd. (Field Trip H&W) and will continue its focus on developing proprietary, competitive and differentiated psychedelic-assisted therapies (PAT) through innovation in therapeutic protocols, with a view of achieving the best patient outcomes in the treatment of mental health and mood disorders.
Pursuant to the terms of the Arrangement, each share of the Company will be exchanged for one common share of Reunion and approximately 0.86 common shares of Field Trip H&W. Following the completion of the Arrangement, Reunion will remain listed on the NASDAQ Stock Market and Toronto Stock Exchange, and Field Trip H&W, subject to exchange approval, will list on the TSX Venture Exchange.
Concurrent with closing of the Arrangement, Field Trip H&W is expected to complete a series of private placement financings (the Concurrent Financing) for gross proceeds of $20.0 million, led by Oasis Management Company and Field Trip. Following board approval on June 14, 2022, Field Trip announced that it will increase its initial investment from $5.0 million to $9.8 million for a 21.79% equity interest in Field Trip H&W.
On June 27, 2022, the Company announced its shareholders had approved the Arrangement and Concurrent Financing (thereby approving the Spinout Transaction), at a special meeting of shareholders. In addition, subject to completion of the Arrangement, shareholders approved the Field Trip H&W equity incentive plan and authorized Field Trip H&W to reserve and allot for issuance, and issue, upon the exercise of options, up to 10% of the number of common shares in Field Trip H&W issued and outstanding from time to time, on a non-diluted basis.
On June 29, 2022, the Company received final court approval for the Spinout Transaction by way of the Arrangement. The closing of the Arrangement remains subject to regulatory approvals, including conditional listing approval by the TSX Venture Exchange. It is expected that the closing of the arrangement will occur on or around August 2022.
The Company’s management team and the Board believe that the separation of the two business divisions will establish two independent, leading businesses in their respective areas in the psychedelics sector and ultimately result in maximized long-term value for the Company’s shareholders.
Joseph del Moral, Field Trip’s Co-founder and CEO, said, “Now that the strategic review has concluded, we are focused on the future for the separate drug development and clinics businesses and allowing them to execute on their respective strategic priorities. We are pleased that we were able to secure the financing to execute on our plan in the current challenging market environment, and we are confident that we are setting the companies up for long-term success and increased shareholder value.”
Key Highlights and Recent Developments
During the fiscal fourth quarter, Field Trip continued to advance its drug discovery work which is focused on the research and development of its novel molecule, FT-104, as well as other molecules under development, specifically the FT-200 series. The Field Trip Health clinics business achieved operational efficiencies and increased customer reach as well as announcing innovative strategic partnerships to offer new psychedelic-assisted treatment options.
Field Trip Discovery
FT-104
Field Trip Discovery is leading the development of the next generation of custom synthetic molecules targeting serotonin 5HT2A receptors. FT-104 is the first drug candidate in development by the Company. FT-104, given the name “Isoprocin Gutarate”, is anticipated to produce a psychedelic trip of about 2-3 hours. The structure of FT-104 is based on classical serotonin 2A psychedelics, like psilocybin, which have been reported to be useful in treating a variety of mood disorders, including depression, anxiety and substance abuse.
FT-104 completed Phase 1 enabling studies in early 2022 and is now entering the clinical stage of development in 2022. In late 2021, FT Discovery entered an agreement with an Australian Clinical Research Organization (CRO) to perform a Phase 1 trial with the objective to study the safety, tolerability and pharmacokinetics of single, escalating doses of FT-104 in healthy human volunteer participants. Exploratory objectives include characterization of the intensity, duration and subjective feeling of the psychoactive experience produced by the study drug. The Phase 1 protocol was developed in collaboration with our CRO and our clinical advisory team, was approved by the Human Research Ethics Committee and is being implemented at the clinical trial site where screening and recruitment have begun. Dosing of participants in the study is expected to begin shortly.
On April 5, 2022, the Company was granted a patent for claims related to FT-104. The patent application entitled, “Tryptamine Prodrugs,” grants exclusive rights to Field Trip for the composition of matter, formulations, methods of use and methods of manufacture for a family of hemi-ester compounds of hydroxytryptamines, including Isoprocin. Patent protection will extend to at least mid-2040.
FT-200 Group
During the quarter, Field Trip continued to progress research and development of its FT-200 molecule group. Research so far is showing that candidates in the FT-200 Group are demonstrating interesting pharmacological differences with classical psychedelics that might make them safer serotonin 2A (5HT-2A or “2A”) agonists with a broader use potential in mental healthcare. The aim of the work is to reduce or eliminate the potential for cardiovascular related harm by decreasing the relative activity at the serotonin 2B (5HT-2B or “2B”) receptor. Early stage candidates are under continued investigations.
Dr. Nathan Bryson, Field Trip’s Chief Scientific Officer, said, “Field Trip Discovery has benefited greatly from our association with the clinics division over the past 2 years to better understand the responsible use and enormous potential of psychedelic drug-assisted psychotherapy to produce durable relief for patients. As Reunion Neuroscience, we feel we bring a unique perspective to the development of the next generation, regulated psychedelic medicines, such as FT-104, a proprietary clinical-stage prodrug designed to produce a short duration experience, and FT-200, a family of molecules with potentially reduced cardiovascular risk profiles.”
Field Trip Health Centers
Throughout the fiscal fourth quarter, the Company continued to implement operational improvements to reduce costs and increase throughput at its Field Trip Health Centers. In addition, the clinics saw an improvement in marketing efficiency and revenue growth as a result of improved marketing and digital client acquisition strategies that have increased conversion of new clients to the clinics. Consequently, Field Trip Health Centers achieved fiscal fourth quarter revenue of $1.72 million, representing an increase of 26.7% over the prior quarter and more than three times higher than the same period of the prior year.
During the quarter, the Company announced the opening of its Vancouver, BC and Washington, DC locations. Coming out of the strategic review, and with the increased emphasis on client acquisition through its digital platforms, Trip and Field Trip at Home™, as well as ongoing efficiency improvements of its in-center offerings, Field Trip has deferred the opening of additional new clinics.
Subsequent to quarter end, Field Trip launched its Field Trip at Home™ Powered by Nue Life platform, which provides ketamine treatments from the comfort of a person’s home, providing an alternative to in-clinic care. Through this arrangement, Field Trip offers increased accessibility and convenience for those interested in pursuing the powerful treatment outcomes of ketamine therapy outside of a clinic setting through Nue Life’s at-home and telehealth offerings.
Ronan Levy, Field Trip’s Co-founder and Executive Chairman, commented, “Our Field Trip Health centers have played an important role in enabling access to ketamine and psilocybin assisted treatments that have helped change the lives of those living with depression, anxiety and other mental health conditions. With the future separation of the clinics business, we will be uniquely focused to build upon this strong foundation and direct our efforts into growth in client numbers, while also implementing operational improvements to scale efficiently, continuing the momentum of revenue growth we achieved during the fourth quarter. Furthermore, we will increase our focus on using digital platforms, such as Trip and Field Trip at Home™, to increase our reach. We will work to leverage our existing Field Trip Health Centers to maximize their impact while reducing capital requirements going forward.”
Financial Highlights
For the fiscal fourth quarter ended March 31, 2022, the Company earned patient services revenues of $1,724,102 from its twelve clinics in operation, an increase of $1,197,667 or 228%, over the fourth quarter ended March 31, 2021. The District of Columbia clinic began generating revenues in March 2022. On a year over year comparative basis, revenue of $526,435 in Q4 2021 was generated from the Toronto, New York, Santa Monica, Chicago and Atlanta clinics. The quarter over quarter revenue increase was in part due to the one additional clinic as compared to the prior quarter. Revenue for the fiscal year ended March 31, 2022 was $4,860,129, an increase of $3,899,234 or 406% over the prior fiscal year primarily due to twelve operating clinics compared to five in the prior fiscal year.
Net loss for the fiscal fourth quarter of $14,170,285 was primarily due to total operating costs of $14,323,644 as further detailed below. This compares with a net loss of $7,950,590 in the fiscal fourth quarter of 2021. The increase from the prior year primarily reflects the Company’s focus on growing the clinics business and continued investment in its drug development pipeline. Net loss for fiscal year ended March 31, 2022 of $54,691,130 was primarily due to total operating costs of $57,902,159 and $2,075,004 in interest expense and foreign exchange losses. Net loss for the comparative prior fiscal year was $23,117,607.
Total operating expenses in the fiscal fourth quarter were $14,323,644 and were comprised of the following: general and administration expenses of $7,432,602, patient services expenses of $2,691,335, research and development (R&D) expenses of $2,333,724, depreciation and amortization of $1,124,854, sales and marketing expenses of $434,781 and occupancy costs of $306,798. This compares with total operating costs of $7,752,620 in the fiscal fourth quarter of 2021. The year over year increase in total operating expenses is primarily due to increased general and administrative costs associated with being a public company, higher patient services expense due to larger number of clinics opened as well as higher R&D expenses as the Company progresses on its drug development programs, partially offset by lower sales and marketing and occupancy expenses. Total operating costs for fiscal year 2022 were $57,902,159 compared with $20,055,929 in fiscal year 2021.
Balance Sheet
As of March 31, 2022 Field Trip had unrestricted cash and cash equivalents and restricted cash of $64,496,653.
Selected Consolidated Financial Information
The following table sets forth selected financial information derived from the Company’s unaudited condensed interim financial statements for the fiscal fourth quarter and audited full year 2022 ended March 31, 2022 prepared in accordance with IAS 34 in a manner consistent with the Company’s annual audited financial statements. The following information should be read in conjunction with the financial statements and management’s discussion and analysis, which are available on the Company’s website at www.fieldtriphealth.com and under the Company’s SEDAR profile at www.sedar.com.
FIELD TRIP HEALTH LTD
STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
3 months ended
3 months ended
Fiscal Year Ended
Fiscal Year Ended
March 31, 2022
March 31, 2021
March 31, 2022
March 31, 2021
$
$
$
$
Revenue
Patient services
1,724,102
526,435
4,860,129
960,895
1,724,102
526,435
4,860,129
960,895
Operating Expenses
General and administration
7,432,602
4,130,894
32,276,757
10,514,029
Occupancy costs
306,798
433,279
1,667,985
897,391
Sales and marketing
434,781
714,223
3,893,426
1,686,941
Research and development
2,333,274
922,894
7,310,688
3,514,258
Depreciation and amortization
1,124,854
539,321
3,603,067
1,394,404
Patient services
2,691,335
1,012,009
9,150,236
2,048,906
14,323,644
7,752,620
57,902,159
20,055,929
Other Income (Expenses)
Interest income
84,349
38,714
425,904
51,037
Interest expense
(372,290
)
(112,928
)
(1,096,343
)
(303,296
)
Other income (expense)
(1,282,802
)
(611,158
)
(978,661
)
(1,600,172
)
Reverse takeover listing expense
–
(39,033
)
–
(2,170,142
)
Net Loss
(14,170,285
)
(7,950,590
)
(54,691,130
)
(23,117,607
)
Net Loss per Share – Basic and Diluted
(0.25
)
(0.18
)
(0.95
)
(0.70
)
Conference Call
The Company will conduct a conference call and webcast to discuss these results on Thursday, June 30, 2022 at 8:30 a.m. ET. To access the call, please dial 1-877-407-9716 (within the U.S.) or 1-201-493-6779 (outside the U.S.) and provide conference ID 13730739. A live webcast of the conference call can be accessed via the Events and Presentations section of the Field Trip Health Investor Relations website here.
For those unable to attend the live call, a telephonic replay will be available until 11:59 p.m. ET on Thursday, July 7, 2022. To access the replay dial 1-844-512-2921 (within the U.S.) or 1-412-317-6671 (outside the U.S.) and provide conference ID 13730739. The webcast will be archived and available in the Events and Presentations section of the Field Trip Health Investor Relations website approximately one hour after the conclusion of the live call.
About Field Trip Health Ltd.
Field Trip is a global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics and our Field Trip Health division building centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we seek to help people in need with a simple, evidence-based way to heal and heighten engagement with the world.
Follow us on Twitter and Instagram: @fieldtriphealth.
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Cautionary Note Regarding Forward-Looking Information
This release includes forward-looking information (within the meaning of Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995) regarding Field Trip and its business. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including the timing, completion and potential outcomes of the Spinout Transaction, the funds available to Field Trip and the use of such funds, the ability of Field Trip to operate its clinics, the construction and commencement of construction of additional clinics, the development, patentability and viability of FT-104 and the FT-200 Group, the ability of Field Trip to complete an investigational new drug application and obtain regulatory approvals, as required, prior to initiating clinical trials for FT-104 and molecules within the FT-200 Group, the ability of Field Trip to meet eligibility requirements for clinical testing and through to more complex clinical trials, the ability of Field Trip to obtain regulatory approvals prior to each clinical trial and the ability of Field Trip to generate patient member growth, interest in the training program, interest in the various treatment programs by therapists and patients, the ability of management to sustain and continue optimization of its clinical operations, the timing and results of its research and development programs, approval of phase 1 human trials, if any, the risk that future clinical studies may not proceed as expected or may produce unfavorable results, the opening of additional clinics, the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Additional information relating to Field Trip, including its Annual Information Form, can be located on the SEDAR website at www.sedar.com and on the EDGAR section of the SEC’s website at www.sec.gov.
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.
Neither the Toronto Stock Exchange, nor its Regulation Services Provider, have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.
– Company reiterates key pipeline and strategic milestones for 2022 –
TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today reported audited financial results for its fiscal year ended March 31, 2022 and recent business highlights. The Company also reiterated its anticipated pipeline and strategic milestones for the remainder of 2022.
“Cybin made important progress across the board in recent months, accelerating both our pipeline of proprietary investigational psychedelic-based treatments and strategic partnership programs. Our successful preclinical work has set the foundation for a seamless transition to in-human trials,” said Doug Drysdale, Chief Executive Officer of Cybin. “Over a very short time horizon, we have evolved into a multi-program clinical-stage company, which marks the dedication of the Cybin team to developing improved treatment options for mental health conditions.”
Recent Business and Pipeline Highlights:
Announced U.S. Institutional Review Board (“IRB”) approval for its first-in-human Phase 1/2a trial of CYB003 in major depressive disorder (“MDD”). The Company received IRB approval less than two weeks after submitting an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration. The Company expects to initiate the Phase 1/2a study in mid-2022 pending IND approval with a potential interim data readout expected at the end of 2022.
Accelerated clinical development of CYB004 for the potential treatment of anxiety disorders through the planned acquisition of a Phase 1 study from Entheon Biomedical Corp. (“Entheon”).The CYB004-E Phase 1 study is currently underway at the Centre for Human Drug Research in the Netherlands. The study is evaluating the pharmacokinetics (“PK”) and pharmacodynamics of intravenous N,N-dimethyltryptamine (“DMT”) in 50 healthy volunteers who smoke tobacco. This is the largest Phase 1 DMT clinical study conducted to date. The study is expected to provide dose optimization and safety data to guide the clinical path forward for CYB004, the Company’s deuterated DMT molecule, and will replace the previously planned CYB004 pilot study. Preclinical data for CYB004 announced in April 2022 showed significant advantages over inhaled and intravenous DMT, including improved bioavailability, longer duration of effect, and rapid onset of effect and low variability.
Strengthened the Company’s IP portfolio with an international patent application for CYB004. In February 2022, Cybin was granted a patent by the U.S. Patent and Trademark Office covering new chemical entity claims for CYB004 and various deuterated forms of DMT and 5-MeO-DMT until 2041. Cybin also announced the publication of an international patent application by the World Intellectual Property Organization covering inhalation delivery methods for multiple psychedelic molecules, including CYB004.
Reported positive preliminary data from a pilot study of Kernel Flow®, confirming Flow’s ability to successfully measure psychedelic effects on the brain. Flow is a wearable neuroimaging technology device that can quantify brain activity in real time during a psychedelic experience with the potential to support data-driven, personalized psychedelic treatments. These pilot data from an ongoing feasibility study suggested that Flow measurements confirmed changes in functional connectivity after ketamine dosing, which persisted for several days after administration. The pilot data also validated the design of the ongoing Phase 1 Flow feasibility study.
Publication of peer-reviewed journal article in Frontiers in Psychology introducing EMBARK, Cybin’s model of psychedelic-assisted psychotherapy. The EMBARK psychotherapy model will be used to support patients in upcoming clinical trials assessing CYB003 and CYB004 in MDD, alcohol use disorder (“AUD”) and anxiety disorders. The Company has compiled a team of 28 expert faculty and advisors from leading universities and psychedelic research and training organizations for the EMBARK program.
Upcoming Pipeline and Strategic Milestones:
The Company expects to achieve the following milestones across its pipeline and partnership programs:
CYB003: Deuterated psilocybin analog for the potential treatment of MDD and AUD
The Company expects to initiate its Phase 1/2a placebo-controlled clinical trial of CYB003 in up to 32 MDD patients in the coming weeks.
The Company plans to report initial safety and PK data from the Phase 1/2a study in Q4 CY2022.
CYB004: Deuterated DMT for the potential treatment of anxiety disorders
The previously announced planned acquisition of a Phase 1 DMT study from Entheon is expected to close in the coming weeks subject to the completion of certain closing conditions and obtaining all necessary approvals.
CYB005: Phenethylamine derivative for the potential treatment of neuroinflammation
Cybin plans to report preclinical data for CYB005 in Q3 CY2022 at which time the Company expects to nominate a candidate and complete its assessment of the potential path forward for this candidate, including whether it be internally or by way of potential third party partners.
Kernel Flow®
The Phase 1 Flow feasibility study is underway. This is a four-week study assessing the participant’s experience wearing Flow, as well as brain activity, following the administration of ketamine.
“We gain confidence every day in our ability to create a true paradigm shift in the way mental health conditions are understood and treated. By working to develop treatment options that can potentially offer improved efficacy, greater remission rates, and longer duration of effects, we have the potential to provide patients and providers with a new standard of care. We look forward to continued momentum and sharing meaningful data readouts later this year,” Drysdale continued.
Fiscal Year 2022 Financial Highlights:
Cash and cash equivalents totaled to C$53.6 million as of March 31, 2022.
Cash-based operating expenses totaled C$13.0 million for the quarter ended March 31, 2022, of which C$3.8 million were one-time, non-recurring costs. Non-cash expenses totaled C$5.1 million for a net loss of C$18.1 million.
Cash-based operating expenses totaled C$45.8 million for the year ended March 31, 2022, of which C$11.6 were one-time, non-recurring costs. Non-cash expenses totaled C$21.8 million for a net loss of C$67.6 million.
Cash flows used in operating activities were C$9.7 million for the quarter ended March 31, 2022 of which C$1.4 million were one-time, non-recurring costs.
Cash flows used in operating activities were C$45.2 million for the year ended March 31, 2022 of which C$10.7 million were one-time, non-recurring costs.
“Our financial position remains strong. Despite the overall softness in the markets, we are pleased with our industry leadership position and remain confident that we are on the right path forward to progress psychedelics into therapeutics,” concluded Drysdale.
Additional non-cash consideration in the amount of C$4,655.29 is being issued to the previous shareholders of Adelia Therapeutics Inc. in respect of the achievement of a previously announced milestone on April 1, 2022.
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 news release related to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding sharing additional data later this year, the Company’s CYB003 Phase 1/2a trial in mid-2022 and anticipated results, the potential closing of the Entheon acquisition, statements regarding the Company’s Phase 1 DMT clinical study for CYB004 and anticipated results, the Company’s plan to report interim safety and PK data from the Phase 1/2a study in Q4 CY2022, the Company’s statements regarding its preclinical data for CYB005 and partnering opportunities, statements regarding the Phase 1 Flow feasibility study and expected results, statements regarding the EMBARK psychotherapy model and anticipated results and the Company’s plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.
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 year ended March 31, 2022, and the Company’s annual information form for the year ended March 31, 2022, 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.
Investor & Media Contact:
Leah Gibson Vice President, Investor Relations & Strategic Communications Cybin Inc. irteam@cybin.com – or – media@cybin.comSource: Cybin Inc.
Awakn delivered revenue growth of 24% in the quarter
TORONTO, CANADA, June 14, 2022 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (‘Awakn’), a biotechnology company, researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announced today its financial results and business highlights for the three months ended April 30, 2022. All results are reported under International Financial Reporting Standards (“IFRS”) and in Canadian dollars (“CAD”), unless otherwise specified.
Anthony Tennyson, Chief Executive Officer of Awakn Life Sciences, stated, “Today’s results demonstrate the significant momentum building in our business across both our research and development pipeline and in our therapeutics commercialization business. The addiction treatment market opportunity is, unfortunately, large and growing, and Awakn is uniquely positioned to offer proven therapeutics supported by data to sufferers for whom the current standard of care is inadequate and relapse rates are unacceptably high.
During the quarter we achieved a number of significant milestones, including the completion of the world’s first Ketamine study for a range of behavioural addictions including Gambling Disorder, Internet Gaming Disorder, Binge Eating Disorder and Compulsive Sexual Behavior Disorder. We also received regulatory approval for our flagship London clinic. Q1 was another period in which we made significant progress towards our goal of bringing effective therapeutics to addiction sufferers in desperate need.”
Filed patents for a new class of entactogen-like molecules, which are a class of psychoactive substances that produce distinctive emotional and social effects that Awakn believes has great potential to treat both substance and behavioral addictions
Appointed Kevin Lorenz as U.S. Head of Commercial Development. Mr. Lorenz will lead Awakn’s therapeutics commercialization activities in the U.S., starting with the launch of its Licensing Partnership business which is scheduled and expected to generate revenue in the second half of 2022.
1Q22 Financial Highlights:
Delivered revenue of $253,154 via Awakn’s clinics for the three months ended April 30, 2022, compared to $Nil in the prior year. This represents a 23.9% or $48,834 versus the three months ended January 31, 2022.
Revenue during the three-month period was primarily driven by the provision of ketamine-assisted therapies at the Oslo clinic in Norway and the Bristol clinic in the UK as the flagship London clinic in the UK only commenced delivering treatments in April 2022
As of April 30, 2022, the Company had $2,818,998 million in cash
Milestones Anticipated in H2 2022
Receive regulatory and ethics approval for Phase III clinical trial for Ketamine-Assisted Therapy for the treatment of Alcohol Use Disorder
Completion of the behavioral study of Ketamine in Gambling addiction
Therapeutics Commercialization through launching licensing partnerships utilizing the company’s intellectual property (IP) Ketamine-Assisted Therapy for Treatment of Alcohol Use Disorder (“KARE”) in the US and Canada
New Chemical Entity drug development: Initiate lead optimization program
Open additional Awakn Psychedelic-Assisted Psychotherapy Clinic
Awakn has applied for several grants, one of which the company expects to receive a response on by end of Q2, and if successful, would cover a substantial amount of the cost of Phase III clinical trial
About Awakn Life Sciences Corp.
Awakn Life Sciences is a biotechnology company, researching, developing, and commercializing combined therapeutics to treat addiction, with a focus on Alcohol Use Disorder. Awakn’s team consists of renowned research experts, world leading chemists, scientists, psychiatrists, and psychologists. Addiction is one of the biggest unmet medical needs of our time, affecting over 20% of the global population and is an industry valued at over $100bn per annum. Awakn is working to disrupt this underperforming industry by advancing the next generation of drugs and therapies to be used in combination, through preclinical research and clinical stage trials.
This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, ”would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.
Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to:COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.
Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.
This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
Investor Enquiries: Anthony Tennyson, CEO, Awakn Life Sciences anthony.tennyson@awaknlifesciences.com
Media Enquiries: America and Canada: KCSA Strategic Communications Anne Donohoe Adonohoe@KCSA.com
Rest of World: ROAD Communications Paul Jarman / Nora Popova Awakn@roadcommunications.co.uk
– Reporting its financial results and continued progress across short-acting psychedelics portfolio – Executive team and IP position strengthened LONDON, June 09, 2022 (GLOBE NEWSWIRE) — Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, has today published its financial results for the fiscal year ended February 28, 2022. A complete copy of the audited consolidated financial statements prepared in accordance with International Financial Reporting Standards and the corresponding management’s discussion and analysis can be found under the Company’s profile on SEDAR at www.sedar.com. Unless otherwise indicated, all currency references are in Canadian dollars.
Financial Highlights
Cash on hand as of February 28, 2022 of $40.7 million Cash used in operating activities of $16.2 million for the 12 months ended February 28, 2022. Operating expenses for the 12 months ended February 28, 2022 were $18.1 million. Business Highlights (including post-period events)
Ultra Short-acting Psychedelic Program: SPL026
The Company’s lead program, SPL026 intravenous (“IV”) N,N-dimethyltryptamine (“DMT”) assisted psychotherapy in major depressive disorder (“MDD”), is in the Phase IIa part of the Phase I/IIa clinical trial, with completion of patient dosing expected in coming months. Drug interaction patient study expected to commence in H2 2022, assessing the impact of selective serotonin reuptake inhibitors (“SSRIs”) on the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with psychotherapy. Preparation is continuing for the international multi-site Phase IIb clinical trial, with further scientific advice requested from the United States Food and Drug Administration (the “FDA”), the UK Medicines and Healthcare products Regulatory Agency (the “MHRA”) and the European Medicines Agency (the “EMA”). A centralized Contract Research Organization to support the execution of the study has been selected. Short-acting Psychedelic Programs
SPL026 IM preclinical program has been completed. Phase I study is currently planned for H2 2022 to compare the treatment profile of intramuscular (“IM”) and IV modes of administration. SPL028, the Company’s deuterated DMT-assisted psychotherapy program was initiated with positive preclinical data of IM and IV formulations of SPL028. A Phase I clinical trial is planned for H2 2022. Intellectual Property
Continued to build upon its existing patent portfolio to a total of six granted patents (including two new Composition of Matter patents) and 74 patent applications pending across the Company’s psychedelic and non-psychedelic portfolio. Strengthening of Executive Team
Appointment of Dr. Alastair Riddell as Chief Operating Officer and Ms. Marie Layzell as Chief Manufacturing and Development Officer to support the growing pipeline of molecules as they progress into and through clinical trials. Peter Rands, Chief Executive Officer of Small Pharma, said:
“With depression cases on the rise globally and current antidepressants failing so many, there is a growing sense of urgency to develop entirely novel treatment approaches. This is the reason why the Company is taking a radically different approach to mental health treatment, but one that can be embedded into the current clinical setting. Short-acting psychedelics such as DMT may offer a practical and convenient treatment for patients, clinicians and health systems, and importantly one that has the potential to scale. As we advance our short-acting and ultra-short acting psychedelic programs, and with efficacy data for our lead DMT program on the horizon, it is an exciting time for the whole class of short-acting psychedelics.” Option Grants
The board of directors of the Company has granted options to purchase up to an aggregate of 6,300,000 common shares in the capital of the Company (the “Common Shares”) to certain directors and officers of the Company pursuant to the Company’s stock option plan. Each option is exercisable for one Common Share at a price equal to the greater of (i) $0.16 per Common Share; and (ii) the closing price of the Common Shares on Friday, June 10, 2022, being the first trading day after the release of the Company’s financial results. The options are exercisable for a period of ten years and are subject to certain vesting requirements.
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression. Small Pharma initiated a clinical program into DMT-assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside the development of a robust pipeline of proprietary preclinical assets.
About DMT
DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics. Small Pharma is advancing a pipeline of DMT-based therapies and is leading the most advanced clinical trial in commercial development for DMT-assisted psychotherapy in Major Depressive Disorder.
This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this news release include statements regarding the Company’s continued progression of Phase IIa clinical trials of SPL026 IV, including the expected timeline for completion of patient dosing; the Company’s preparation for the international multi-site Phase IIb clinical trial of SPL026; the Company’s plans, expectations, timelines and possible outcomes with respect to its anticipated drug interaction patient study assessing the impact of SSRIs; the Company’s plans, expectations, timelines and possible outcomes of the further Phase I study of SPL026 comparing IM versus IV modes of administration and Phase I clinical trial for the SPL028 deuterated DMT-assisted program; the expected roles of Mr. Riddell and Ms. Layzell as the Company progresses through clinical trials; the ability for short-acting psychedelics to provide mental health treatments and be scalable for patients; and the Company’s ability to develop solutions to effectively address depression through DMT-based therapies.
In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. 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 information. Such factors include but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting the Company’s business and results of operations; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.
Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The MHRA or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next generation psychoactive compounds. The efficacy of such therapies has not been confirmed by MHRA-approved research. There is no assurance that such DMT-assisted therapies and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy and safety of potential therapies do not imply that Small Pharma verified such in clinical trials or that Small Pharma will complete such trials. If Small Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Small Pharma’s performance and operations.
The TSX Venture Exchange (“TSXV”) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.
Partnership with CRO Clerkenwell Health to design and deliver Psyence’s UK clinical trial progressing; exclusive licensing agreement with Filament Health
Clive Ward-Able has been appointed as Medical Director, Head of Research & Development and Early Commercialization for Psyence
ISO22000 certified commercial psilocybin production facility and lab upgraded
Received an import permit from Health Canada on behalf of Psilo Scientific
GOODMINDTM, functional mushroom product, launched online and in-store, sale through 300 stores of one of Africa’s largest coffee retail chains
CAD 1.273 million private placement received and being closed
Exploring capital market initiatives in UK, hires Investment Bank
TORONTO, ON/ June 02, 2022 / Psyence Group Inc. (CSE: PSYG | OTCQB: PSYGF) (“Psyence” or the “Company”) is pleased to provide the following corporate update on its three strategic focus areas namely: Psyence Therapeutics, Psyence Production and Psyence Function. The Psyence Group develops and provides innovative, safe, and effective psychedelic and nature-centered solutions for mental health and palliative care.
Psyence Therapeutics
Psyence is designing market-leading clinical trials in the field of palliative care, which will initially be conducted in the United Kingdom.
Psyence has partnered with a leading psychedelic Contract Research Organisation (CRO) Clerkenwell Health, to design and deliver the clinical trial, focused on assessing the safety and efficacy of psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to an incurable cancer diagnosis versus psychotherapy alone.
The UK’s “Guardian Online” reported on May 9, 2022 that Clerkenwell Health “hopes to “make the UK a world leader in psychedelics research and Europe’s first facility for psychedelic drug trials will open in London”. The article noted that “the first trials, planned in collaboration with the Toronto-based biotechnology company Psyence, will focus on the use of psilocybin for the treatment of adjustment disorder – an emotional or behavioural reaction to a stressful event in someone’s life – in people with terminal diagnoses.”
Psyence recently concluded an exclusive licensing agreement with Filament Health Corp, a clinical-stage natural psychedelic drug development company, in April 2022. Filament has previously received authorisation from the FDA and Health Canada to enter into Phase I and Phase II human clinical trials for this drug candidate, PEX010. Under the terms of the agreement, Filament will license its proprietary botanical drug candidate PEX010 (25mg), and the associated intellectual property, to Psyence for use in Psyence’s upcoming clinical trials. The license grants Psyence exclusivity in the UK for the indications of anxiety and depression, and associated ailments, within the context of palliative care.
In addition, Psyence appointed Dr. Clive Ward-Able as Medical Director, Head of Research & Development and Early Commercialization for Psyence in December 2021. Based in Toronto Canada, Dr. Ward-Able has degrees in both Pharmacy and Medicine and over thirty years’ experience in the pharmaceutical industry, within R&D, medical affairs, marketing and sales. The majority of his experience is in the medical aspects of the commercialization of a pharmaceutical product, with expertise and direct involvement in designing and conducting clinical trials.
Psyence operates one of the first and only federally licensed commercial psilocybin production facilities in the world. Its production facility, located in Southern Africa, is ISO22000 certified and is licensed to cultivate and export psilocybin mushrooms for the legal, global medical market and commercial medical research market.
In March 2022 Psyence received an import permit from Health Canada on behalf of Psilo Scientific and is preparing to send mushrooms to Canada for analysis and extraction. Psyence has also received an import permit from the Portuguese regulators for the Cooperativa de Ensino Superior Politécnico e Universitário (CESPU) in Portugal and will be providing mushrooms for their extraction methodology development. Psyence is in the process of obtaining the necessary permissions to commence with the export process to these partners.
Psyence has recently concluded an upgrade to its production facility. A new structure has expanded the overall controlled workspace and further secures the facility. The structure also serves to protect the current assets including the spore and substrate unit, laboratory and fruiting facility. The covering will help Psyence decrease its energy costs through providing better insulation. It has been designed to enable a more flexible and cost -effective expansion of the facility in the future to match the expected growth in demand for natural psilocybin.
The laboratory has also been expanded as part of this upgrade. This expansion enables Psyence to have the capability and equipment to undertake in-process testing on site, as well as to generate Certificates of Analysis (COAs) and undertake testing of the end product. It also provides the space for Psyence to undertake crude extraction and testing at the facility. Our extraction partners will then process the crude extract into an active pharmaceutical ingredient (API). There are multiple benefits to on-site extraction including increased product shelf life and reduced transport costs. Psyence mycologist, Neil Van Rij, and his Quality Assurance team are currently receiving training on the new equipment and expect to be fully functional by the end of June 2022.
Psyence Function
Psyence Function is focused on the development, distribution and sales of legal over-the-counter non-psilocybin containing functional mushroom nutraceuticals.
Psyence’s first non-psilocybin containing functional mushroom product, GOODMINDTM was launched online in 2021 through its South African based joint venture, Good Psyence. Good Psyence launched the GOODMINDTM product on the digital platform http://www.foragoodmind.com that was registered and developed by Psyence’s joint venture partner, Goodleaf, solely for the sale of such products. GOODMINDTM is also distributed through the digital platforms of Goodleaf, Takealot (South Africa’s leading online retailer) and Wellness Warehouse online as well as Wellness Warehouse stores. Wellness Warehouse is a leading distributor and retailer of natural and organic products in South Africa. GOODMINDTM’s water-soluble functional mushroom sachets, which blend with coffee and other beverages, are available for sale through 300 stores of one of Africa’s largest coffee retail chains, Vida e Caffè.
Corporate Update
The Company is pleased to announce that the non-brokered private placement as announced on December 2, 2021 has yielded approximately CAD 1.273 million of subscriptions and is in the process of closing.
The Company has identified the UK as an investor market for mental wellness and has engaged Hannam & Partners as Corporate Advisors in the UK to assist in exploring capital market opportunities to access a broader pool of UK and European investors. Hannam & Partners, our Corporate Advisors, are also working with Psyence to investigate a potential dual listing in the UK. As part of this dual listing exercise the Company conducted a thorough legal exercise. The Company obtained legal opinions from local counsel registered in each jurisdiction in which the Company currently operates for the purpose of confirming the lawfulness of the Company’s activities currently carried on in each jurisdiction. Each local legal adviser was required to address their legal opinion to UK legal counsel (having significant experience in proceeds of crime and anti-money laundering offences), for the purpose of confirming that such activities are suitable for investment by UK persons and such investment would be unlikely to amount to an offence in England under the Proceeds of Crime Act 2002 and relevant anti-money laundering legislation. Based upon the legal opinions obtained, including the opinion of UK legal counsel, the directors of the Company are satisfied that the current activities of the Group do not pose such a risk.
In light of the challenging small cap and global equity markets as a whole, the Company has put into place cash preservation strategies to reduce operational expenditure across the business, including executive remuneration reductions and accruals.
“Psyence’s progress continues to strengthen our company’s focused strategy,”says Dr. Neil Maresky, Psyence Chief Executive Officer. “As we execute on our plans as detailed in this corporate update, and continue to focus on operational efficiencies, we believe Psyence will achieve its milestones and in doing so deliver shareholder value.”
Psyence is a life science biotechnology company listed on the Canadian Securities Exchange (CSE: PSYG) and quoted on the OTCQB (OTCQB: PSYGF), with a focus on natural psychedelics. Psyence works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care. Our name “Psyence” combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research.
Informed by nature and guided by science, we built and operate one of the world’s first federally licensed commercial psilocybin mushroom cultivation and production facilities in Southern Africa. Our team brings international experience in both business and science and includes experts in mycology, neurology, palliative care, and drug development. We work to develop advanced natural psilocybin products for clinical research and development.
Our key divisions, Psyence Production, Psyence Therapeutics and Psyence Function, anchor an international collaboration, with operations in Canada, the United Kingdom, Southern Africa, and a presence in the United States and Australia.
Contact Information
Katherine Murphy, Investor Relations Email: ir@psyence.com Media Inquiries: media@psyence.com General Information: info@psyence.com
FORWARD LOOKING STATEMENTS:
Certain statements in this news release related to Psyence Group Inc and its subsidiaries (collectively the “Company“) are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regardingthe approval of clinical trial applications by the relevant regulatory authorities, the receipt of all regulatory approvals for the Company’s import and export activities, the appetite for investment into the psychedelic and mental wellness sector by UK and European investors, the fulfilment of the conditions required to achieve Company milestones, the effectiveness of the Company’s operational efficiency measures and the resultant creation of shareholder value. These forward-looking statements are based on a number of assumptions, including the assumptions that the Company’s applications will be successful, the Company’s research and development efforts will yield favourable results sufficient for product commercialisation and that there will be demand in the market for the Company’s current product offering internationally. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information. These risks and uncertainties include demand for the Company’s securities being less than anticipated, fluctuations in the price the Company’s common shares, and the Company not raising the amount expected, or any funds at all. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend to update these forward-looking statements.
The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, 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, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company 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 the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.
CHICAGO and TORONTO, May 31, 2022 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc.(“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms today, has today announced its first quarter 2022 financial results.
Q1 2022 Highlights
Delivered findings indicating psilocybin potentiates impact of anti-depressant
Received positive feedback from pre-Investigational New Drug (“IND”) meeting with U.S. Food and Drug Administration (“FDA”) on SANA-013
Announced positive findings from Animal Study on Novel Depression Treatment Protocol Combining Psilocybin and Cannabidiol
Record Q1 2022 operating results at Wesana Clinics
Opening of third Wesana Clinic in May 2022
Launched strategic Review of Care Delivery Assets
Select Consolidated Financial Information
The following table sets forth selected financial information derived from the Company’s unaudited interim combined and consolidated financial statements and notes thereto for the three-months ended March 31, 2022. The following information should be read in conjunction with the financial statements and the accompanying management’s discussion and analysis (“MD&A”), which are available on the Company’s website at www.wesanahealth.com and under the Company’s SEDAR profile at www.sedar.com.
For the three months ended ($USD)
Mar 31, 2022
Dec 31, 2021
Change
Cash Balance
3,193,371
6,576,088
(3,382,717
)
Total Assets
6,577,392
9,741,602
(3,164,210
)
Total Equity
4,001,782
7,714,585
(3,712,803
)
Weighted Average Shares Outstanding
33,312,555
23,152,729
10,159,826
Fully Diluted Shares Outstanding (as converted*)
41,593,023
41,387,743
205,280
*The number is presented assuming all of the Company’s outstanding Proportionate Subordinate Voting Shares and Super Voting Shares as at March 31, 2022 are converted into Subordinate Voting Shares in accordance with their terms and all of the Company’s other outstanding convertible, exchangeable and exercisable securities as at March 31, 2022 are converted, exchanged or exercised in accordance with their terms.
Business Updates and Highlights
“We are delighted with our progress on SANA-013 and our accelerated pathway toward development,” said Wesana CEO and Chairman, Daniel Carcillo. “Our shift in focus to our drug development program will be instrumental in working toward the Company’s goal of FDA approval for SANA-013.”
New Findings Indicating Psilocybin Potentiates Impact of an Anti-Depressant
On March 22, 2022, Wesana delivered data from an animal study, conducted by an independent global laboratory services provider in a validated model of depression. Results of the study showed that administration of imipramine given three weeks following a psilocybin loading dose provided an additional 39% improvement in depressive behaviors from that of psilocybin loading dose alone. Furthermore, a second administration of imipramine given four weeks after a psilocybin loading dose provided an even greater reduction (45%) in depressive behaviors.
Positive Feedback from Pre-IND Meeting with FDA on SANA-013
On March 14, 2022, Wesana reported it received a full written response from the FDA regarding their pre-IND meeting for the novel therapy and proprietary protocol of SANA-013 for the treatment of Traumatic Brain Injury (“TBI”) related MDD.
The Company received positive written responses from the FDA on March 11th outlining the requirements to open the IND and commence clinical studies for SANA-013. The written response provides a path to agreements on IND-enabling studies and validates the team’s recent effort and accomplishments. The FDA response also provided important insights pertaining to advancing SANA-013 as a potential treatment for TBI-related MDD. Wesana intends to initiate its in-human clinical study program in late 2022.
Positive Findings from Animal Study on Novel Depression Treatment Protocol Combining Psilocybin and Cannabidiol
On January 18, 2022, Wesana shared positive results of an animal study on a novel depression treatment protocol. Combining psilocybin and cannabidiol, the animal study, conducted by an independent global laboratory services provider, demonstrated considerable and sustained improvement in depressive behaviors.
Wesana’s novel and proprietary depression treatment protocol includes a single high dose of psilocybin followed by a maintenance regimen of a microdose of psilocybin combined with cannabidiol. In a validated pre-clinical animal model of depression, the maintenance regimen demonstrated up to 64% further improvement than those observed with a single high dose of psilocybin alone.
Furthermore, the maintenance regimen provided a sustained antidepressant effect after the single high dose of psilocybin. Wesana’s proprietary treatment protocol is currently being evaluated for the treatment of multiple mental health conditions including major depressive disorder associated with traumatic brain injury.
Strategic Rationale for Clinics and Other Care Delivery Asset Review:
Feedback from the FDA validates the Company’s strategic plan for simplification and growth. Given the clarity provided by FDA in the pre-IND meeting, and the Company’s increased focus on drug development, Wesana has commenced a strategic review of the Company’s assets with a focus on reviewing Wesana’s care delivery division. The Company is reviewing strategic alternatives including, but not limited to, a sale of all the assets under the care delivery division, including:
Wesana Clinics – a network of psychiatrist-led mental health clinics focused on serving the community through the delivery of personalized innovative psychiatric care, inclusive of ketamine therapy, medication management, psychotherapy, cognitive testing, and pharmacogenetic testing.
Wesana Solutions – a medical-grade clinical SaaS platform focused on improving mental healthcare through facilitating access to leading edge clinical protocols and tracking their efficacy. In concert with EMRs and practice management systems, Wesana Solutions is intended to be used in clinics delivering psychedelics and related therapies, targeting the developing international psychiatric clinic and research market.
PsyTech Connect – a leading community for the clinical use of psychedelics with over 8,000 actively engaged professionals.
Management Changes
Wesana today announced that, as part of a Board of Directors transition, Chad Bronstein has tendered his resignation as Executive Chairman, effective immediately, to pursue other professional opportunities. In connection with Mr. Bronstein’s resignation, the Company is pleased to announce the Company’s Board of Directors’ appointment of Daniel Carcillo as Chairman.
“I am incredibly proud of the Company that we have built and the progress we have made to date,” commented Mr. Bronstein, “and I look forward to seeing the continued evolution of Wesana under Daniel’s leadership as the Company moves towards advancing its clinical development program and human clinical trials in the coming months later this year.”
Bronstein was instrumental in the founding of the Company as well as in its first years of growth. His commitment to Wesana over the past two years helped the Company go-public on the Canadian Securities Exchange and raise $17 million in capital, to initiate the FDA drug development and approval process.
“On behalf of everyone at Wesana, I would like to express my heartfelt gratitude to Chad for his support and guidance through Wesana’s early growth. Chad was a visionary leader who provided excellent stewardship as we navigated the going-public and related capital raise process. As we position ourselves for our next phase of growth, we will continue on the path Chad and I set to develop and deliver life-changing medicine to those in need,” said Daniel Carcillo, Wesana’s Founder and CEO.
About Wesana Health
Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and patent-pending protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.
Cautionary Note Regarding Forward-Looking Information
This news release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the initiation of Phase 1 clinical trials in late 2022, exploration of MDD as the lead indication for SANA-013, and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. 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”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.
Certain assumptions that influence successfully initiating its clinical development program in late 2022 include: (i) third parties who assisted the Company with the pre-IND submissions will continue to satisfy deadlines on deliverables within anticipated timeframes; (ii) the pre-IND guidance will continue to support that a drug development plan and future clinical trials are going to be acceptable to the FDA; (iii) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests as they may arise during the course of their review following the filing of submissions; (iv) additional pre-clinical studies will be commenced and completed on a timely basis and results will be supportive and as anticipated; (v) the Company’s pre-clinical studies (animal pharmacology and toxicology testing) generate data and analyses to support an FDA decision that it is safe to proceed with human trials of the Company’s formulation; and (vi) the Company is able to maintain a GMP supply source necessary to conduct in-human clinical trials.
Certain assumptions that influence successfully expanding the lead indication for SANA-013 to MDD include all of the assumptions in the above and (i) the board of directors of the Company (the “Board”) continues to determine and approve, based on the readiness of the overall research and development plan, capital resources and internal procedures of the Company, the expansion of the lead indication to MDD; (ii) the Company’s current capital will be sufficient for developing the updated IND submission package and updated IND enabling studies; (iii) the broadened indication and the future clinical trials are going to be acceptable to the FDA; (iv) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests as they may arise resulted from the broaden indication; and (v) additional pre-clinical studies required for MDD will be commenced and completed on a timely basis and results will be supportive and as anticipated.
Any patent efforts of the Company remain at the application stage and there is no assurance that the Company will file additional patent applications or in what jurisdictions they may be filed, if any. Furthermore, while the PCT application has been filed, there is no assurance that a patent(s) will be granted or will be granted in a form that will be sufficient to protect the Company’s proprietary therapies or protocols or enable it to gain or keep any competitive advantage that it may have.
Although management believes that the anticipated future results, performance or achievements expressed or implied by the forward-looking statements are based upon reasonable assumptions and expectations, the reader should not place undue reliance on forward-looking statements because they involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. Certain risk factors include but are not limited to there being no assurance as to the Company’s ability to continue as a going concern; there being no assurance that the strategic review of the Company’s care and delivery division will result in any viable alternatives or a definitive transaction; there being no assurance that the net proceeds of the recently completed private placement will be used as currently contemplated by the Company, the allocation and use of which is at the discretion of the Company, or that the Company will achieve the results from the use of such proceeds as currently targeted; the detrimental impact of future losses and negative cash flow from operations; requirements for additional capital; lack of product or service revenue; research and development of drugs targeting the central nervous system being particularly difficult; failure to comply with health and data protection laws and regulations; delays in pre-clinical and clinical testing resulting in delays in commercializing; inability to file investigational new drug applications or clinical trial applications to commence clinical trials in a timely manner; difficulty enrolling patients in clinical trials; competition from other biotechnology and pharmaceutical companies; violations of laws and regulations resulting in repercussions; psychedelic inspired drugs possibly never being approved as medicines; regulatory or political change; reliance on third parties to plan, conduct and monitor preclinical studies and clinical trials; requirements of commercial scale and quality manufactured drug supply; negative results from pre-clinical and clinical trials or studies of others; unfavourable publicity or consumer perception; not achieving publicly announced milestones; reliance on the capabilities and experience of key executives and scientists; disruptions due to acquisitions or collaborations; risk of product liability claims; COVID-19; litigation; conflicts of interest; limited operating history; general economic, market and business conditions and other risk factors including those found in the MD&A and the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.
Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.
Record high quarterly revenue of $3,227,352, +32% over the previous quarter
Growth driven by Arizona acquisition, expanding clinic network to eight total locations
Numinus to acquire Novamind, creating a preeminent North American platform, spanning 13 wellness clinics, four research sites and one bioanalytical laboratory
TORONTO, ON / May 31, 2022 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2) (“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, reported its financial results for the three and nine months ended March 31, 2022 (“Fiscal Q3 2022”). All results are reported under International Financial Reporting Standards (“IFRS”) and in Canadian dollars, unless otherwise specified.
Novamind CEO, Yaron Conforti, commented, “Once again, we’re pleased to report record-high revenue this quarter. Growth was driven by our recent expansion to Arizona in addition to the continued progress of our Utah operations. With the anticipated shareholder approval of the acquisition of Novamind by Numinus in June, the Company is well-positioned to continue this record growth in pursuit of its mission to responsibly reintroduce psychedelic therapy to mental healthcare.”
Fiscal Q3 2022 Operating Highlights and Subsequent Events
The Company entered into a definitive arrangement agreement (the “Arrangement”) pursuant to which Numinus Wellness (“Numinus”), will acquire Novamind in an all-share transaction
Pending shareholder approval, holders of Novamind common shares (“Novamind Shareholders”) will receive 0.84 of a common share of Numinus for each Novamind share held
The Arrangement values Novamind at $26.2 million on a fully diluted in-the-money basis, representing a premium of 51% to Novamind’s 20-day volume-weighted average price on the Canadian Securities Exchange as of April 8, 2022
A special meeting of the Company’s shareholders will be held on June 8, 2022, to approve the proposed acquisition of Novamind by Numinus
Closed the acquisition of Arizona-based Foundations for Change, Inc., a mental health practice specialized in ketamine-assisted psychotherapy
Opened the Company’s eighth integrative psychiatry clinic, located in Phoenix, Arizona
Launched Groups by Novamind, an expansion of the Company’s clinical care model focused on increasing patient access to mental health treatments
Novamind’s strategic partner, Bienstar Wellness Corp., signed a letter of intent to acquire BRC Saude Mental E Terapias Assistidas Ltda., a leader in specialized ibogaine treatments for substance use disorder based in Sao Paolo, Brazil
Contracted to provide clinical research services for the following clinical trials:
A phase IIb randomized clinical trial investigating lysergic acid diethylamide (LSD) for generalized anxiety disorder in adults, sponsored by MindMed
A phase II clinical trial investigating psilocybin for major depressive disorder, sponsored by the Usona Institute
A phase II clinical trial investigating ketamine-assisted psychotherapy for adults with life-threatening illnesses, sponsored by the Ketamine Research Foundation
A phase I clinical trial investigating the safety and efficacy of ketamine-assisted psychotherapy combined with Mindfulness-Oriented Recovery Enhancement therapy for the treatment of adults with opioid use disorder
A phase II clinical trial investigating an antidepressant medication for adults with major depressive disorder and PTSD, sponsored by Alto Neuroscience
A phase II randomized clinical study for the acute treatment of social anxiety disorder, sponsored by Bionomics
Fiscal Q3 2022 Financial Highlights
Total revenue $3,227,352, +32% over the previous quarter
Total working capital of $3,928,642 to fund operations
Closed a $5,000,000 private placement with an institutional investor
The following table presents selected financial information from Novamind’s reviewed condensed interim financial statements for the three and nine months ended March 31, 2022. The following information should be read in conjunction with the financial statements and management’s discussion and analysis, which are available under Novamind’s SEDAR profile at www.sedar.com.
Supplemental Disclosure for Circular Novamind confirms that the management information circular dated May 6, 2022 (the “Circular”), form of proxy and other materials with respect to the Company’s Arrangement with Numinus have been mailed to Novamind Shareholders of record as of May 2, 2022.
The Company wishes to provide the following additional disclosure to supplement and amend the disclosure in the Circular. Capitalized terms not otherwise defined below shall have the meanings ascribed to such terms in the Circular.
The Company confirms that the Novamind Board, other than Yaron Conforti, who abstained from voting on the Arrangement, has determined that the Arrangement is fair to Novamind Shareholders, that the Arrangement is in the best interests of Novamind and unanimously recommends that Novamind Shareholders vote FOR the Arrangement Resolution. Mr. Conforti abstained from voting on the Arrangement on the basis that he will receive a change of control payment in connection with the Arrangement, as described in more detail in the Circular under “The Arrangement – Interests of Certain Persons in the Arrangement – Change in Control Payment”.
The Company also wishes to advise that the definition of Supporting Shareholders referenced on pages 17 and 24 of the Circular misstated that Support Agreements were entered into with directors and officers of Novamind and “a certain Novamind Shareholder”. The Company clarifies that only certain directors and officers of Novamind entered into Support Agreements, and no non-director or officer Novamind Shareholders entered into a Support Agreement. Copies of the Support Agreements have been uploaded to the Company’s SEDAR profile.
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 integrative mental health clinics and operates a full-service contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. 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.
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