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HAVN Life to Be Featured on Viewpoint With Dennis Quaid

HAVN Life to Be Featured on Viewpoint With Dennis Quaid

The Company’s segment will be aired on public television networks across the U.S. starting in July, with interviews featuring CEO Tim Moore and the team leading HAVN Life’s Research and Development

Vancouver, BC – Havn Life Sciences Inc. (CSE: HAVN) (OTC: HAVLF) (FSE: 5NP) (the “Company” or “HAVN Life”) a biotechnology company pursuing standardized extraction of psychoactive compounds and the development of natural health products, is pleased to announce it will be featured in an upcoming Viewpoint with Dennis Quaid episode, airing in July. The episode of Viewpoint with Dennis Quaid will be distributed to more than 170 public television stations throughout the United States, reaching 60 million households throughout the year.

The segment includes an in-depth interview with HAVN Life CEO, Tim Moore, as well as clips from Chief Psychedelic Officer, Dr. Ivan Casselman, and Chief Research Officer, Alexzander Samuelsson, where they discuss the Company’s end-to-end research, extraction, formulation, and delivery of naturally derived psilocybin, and some of the strategic, research and supply partnerships HAVN Life has secured. They also touch on HAVN Life’s commitment to advancing psychedelic medicine through clinical research and therapeutic use as a ground-breaking medicine with the potential to provide better mental and cognitive health solutions at a global scale.

“We’re absolutely thrilled to be a part of the Viewpoint Project and in the illustrious company of previous guests including former U.S. Secretary of State, Colin Powell, Governor of Iowa Kim Reynolds and the 41st President of the United States, George H.W. Bush, among others,” says HAVN Life CEO, Tim Moore. “The format of the program provides a unique educational platform for the most talked about issues of the day, and we truly feel that psychedelics deserve such a platform. We are proud to be a part of the movement that is helping to redefine and rehabilitate psychedelics in the popular imagination,” he adds.

“From the very start, our mission has been to bring medicine to the people,” says HAVN Life Chief Psychedelic Officer, Dr. Ivan Casselman. “I am excited to see all the global momentum in psychedelic medicine – the future is bright,” he adds.

“As part of the evolving psychedelic industry, I’m proud of the way HAVN Life has been able to take a leading role in sharing information and perspectives on the history of psychedelics, its usage, and the huge potential that psilocybin-based therapies have to offer,” says Alexzander Samuelsson, Chief Research Officer at HAVN Life. “Through our work and partnerships, we are building a pathway to healing and relief for those suffering from mental health issues, which many people have been dealing with during the past two years of pandemic lockdowns, isolation, opportunity and personal losses,” he adds.

The HAVN Life segment on Viewpoint with Dennis Quaid will make its debut on public television in July. Additionally, a recently produced network-quality commercial featuring HAVN Life’s natural health products will debut twice during prime time on Fox Business in July. The commercials will continue to air up to 400 times during the year, reaching 84 million homes on networks such as CNBC, CNN Headline News, The Learning Channel, Discovery and Discovery Life, among others.

The Company also announces that on May 26, 2022, it granted 3,000,000 stock options to Tim Moore and 1,000,000 stock options to Gordon Clissold. The stock options are exercisable for a period of five (5) years at a price of $0.06 per common share.

###
On Behalf of The Board of Directors
Tim Moore
Chief Executive Officer

About HAVN Life Sciences Inc.
HAVN Life Sciences is a biotechnology company pursuing standardized extraction of psychedelic compounds for the creation of APIs, the development of natural health products, and innovative therapies to support brain health and enhance the capabilities of the mind.

Through its research division, HAVN Labs, the company has developed an end-to-end supply chain of GMP naturally derived psychedelic compounds for research that will define the future of modern medicine. With its new line of natural health products, HAVN Life offers a full range of high-quality mushroom and plant extracts that help boost immune function, reduce inflammation and support a healthy lifestyle.

Purchase our products and find out more at yourhavnlife.com, and follow us on Facebook, Twitter, Instagram and Youtube.

About the Viewpoint Project
The goal of the Viewpoint Project is to enlighten the audience by delivering diverse informational and educational documentaries by covering a variety of issues and topics. Viewpoint Project is on the cutting edge of the television documentary industry, producing top quality programming for Public Television. Viewpoint Project is dedicated to the mission of developing and distributing social and educational programming about our neighbors, our community, and world. Each story has one thing in common – changing our lives for the better.

Contact:
Investor Relations: ir@havnlife.com
Media: savi@emergence-creative.com

Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable securities laws relating to statements regarding the Company’s feature on Viewpoint with Dennis Quaid, the Company’s work to build a pathway to healing and relief for those suffering from mental health issues, the Company’s business, products and future of the Company’s business. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking information. Such forward-looking statements are subject to risks and uncertainties that may cause actual results, performance and developments to differ materially from those contemplated by these statements depending on, among other things, the risk that the Company’s feature on Viewpoint with Dennis Quaid will not be completed as contemplated, or at all, risks that the Company’s work to build a pathway to healing and relief for those suffering from mental health issues will not be completed as contemplated, or at all, risks that the Company’s products and plan will vary from those stated in this news release and the Company may not be able to carry out its business plans as expected. Except as required by law, the Company expressly disclaims any obligation and does not intend to update any forward-looking statements or forward-looking information in this news release. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. The statements in this news release are made as of the date of this release.

The CSE has not reviewed, approved or disapproved the content of this press release.

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Pasithea Therapeutics Acquires Alpha-5 Integrin, LLC

Pasithea Therapeutics Acquires Alpha-5 Integrin, LLC

– Alpha-5 is a potentially first-in-class monoclonal antibody for the treatment of amyotrophic lateral sclerosis (ALS) and other neurological diseases –
– Expands pipeline across Pasithea’s core therapeutic areas to drive enhanced growth –
– Closing consideration of 3.26 million shares of Pasithea common stock –
– Pasithea to hold a webcast on June 22 at 9 a.m. ET to discuss the transaction –

MIAMI BEACH, Fla., June 22, 2022 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), today announced its acquisition of Alpha-5 integrin, LLC (“Alpha-5”), a privately-held preclinical-stage company developing a monoclonal antibody (mAbs) for the treatment of amyotrophic lateral sclerosis (“ALS”) and other neuroinflammatory disorders, such as Multiple Sclerosis (“MS”).

Alpha-5’s lead therapeutic candidate has a novel mechanism of action with the potential to improve clinical outcomes in patients with ALS, and is supported by post-mortem studies and with reproducible significant improvement in behavior and survival in the SOD1 mice model. The acquisition includes Alpha-5 proprietary antibodies with novel intellectual property and brings to Pasithea a group of seasoned scientists and a state-of-the-art laboratory.

The Company acquired all of the outstanding equity interests in Alpha-5 at an enterprise value for $3.75 million, payable in 3.26 million shares of Pasithea common stock, valued at $1.15 per share, an 11% premium to the closing price on June 21, plus 1 million warrants. An entity controlled by Paul B. Manning, Chairman and CEO of PBM Capital, a healthcare-focused investment firm, is Alpha-5’s majority owner and, following the transaction, will own approximately 10% of Pasithea common stock. Cassel Salpeter & Co. acted as financial advisor to the Company on this transaction.

“This agreement with Pasithea represents the culmination of years of work by Alpha-5 researchers, successfully leveraging their deep scientific expertise in the integrin space. We believe Pasithea will be well-positioned to apply its capabilities to move this asset forward and make an impact on ALS disease for the benefit of patients,” said Paul B. Manning.

“Treatments for ALS are extremely limited. Only two drugs are currently approved, with minimal impact on disease, and the majority of patients progress to death within a few years of symptom onset. The Alpha-5 acquisition is transformative for Pasithea, by adding a new drug with a novel mechanism of action to our pipeline, while preserving our strong cash position. In addition to the Alpha-5 development program, we will also acquire a wet lab and scientific team to develop our existing tolerizing vaccine and complementary program. Our plan is to file an Alpha-5 investigational new drug application (IND) with an orphan drug designation by the end of 2023,” stated Dr. Tiago Reis Marques, CEO of Pasithea.

Stanford Professor Larry Steinman, Chairman of the Board and co-founder of Pasithea and a minority owner of Alpha-5 said, “My work has been instrumental for the discovery of natalizumab, an anti-alpha 4 integrin mAb. This was the first drug developed in the class of selective adhesion molecule inhibitors and a potent therapeutic for multiple sclerosis. We believe that alpha-5 integrin antibody can also be transformative in the treatment of other neurological disorders, such as ALS or MS. Post-mortem human studies and preclinical work conducted so far support this therapeutic target and we are excited to move it into clinical trials.” Professor Steinman recused himself from the vote to approve the transaction.

Transaction Details

At the closing of the transaction, the Company acquired all of Alpha-5’s issued and outstanding equity interests in exchange for 3,260,870 shares of Pasithea common stock plus warrants to acquire an additional 1,000,000 shares at an exercise price of $1.88 per share for a period of five years. The number of shares was calculated by dividing a $3.75 million enterprise value by $1.15 per share of Pasithea Common Stock, an 11% premium to the closing price on June 21. There are potential future earnouts based on net sales. There will be no post-closing adjustments for cash and working capital.

To further discuss the transaction, Pasithea´s management will host a webcast as follows:
   
Date: June 22, 2022
Time: 9 a.m. ET
URL: https://event.choruscall.com/mediaframe/webcast.html?webcastid=aph1RpCR
   
The webcast will be accessible on the Investors section of the website, www.ir.pasithea.com, and will be archived for 90 days following the event.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics Corporation is a U.S. biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of psychiatric and neurological disorders. Pasithea is also focused on addressing the needs of patients currently suffering with mental illness by providing access to IV ketamine infusions both in clinics and in-home settings.

About Amyotrophic Lateral Sclerosis

ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. It most commonly affects people between the ages of 40 and 70, with an average age of 55 at the time of diagnosis. It affects as many as 30,000 patients in the United States, with 5,000 new cases diagnosed each year. The average life expectancy after diagnosis is two to five years, but some patients may live for years or even decades. While 5-10% of cases are hereditary (familial ALS), the large majority of cases (90-95%) are not hereditary (Sporadic ALS). The cause of ALS is not completely understood and multiple complex factors may contribute to the death of motor neurons. Currently there is no known cure or treatment that halts or reverses the progression of ALS, and FDA only approved 2 medications so far for the treatment of this disorder, both shown to modestly slow the progression of ALS.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the SEC. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Corp. Company Contact

Dr. Tiago Reis Marques
Chief Executive Officer
E: tiago@pasithea.com

Pasithea Therapeutics Corp. Investor Relations

Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Primary Logo

Source: Pasithea

Released June 22, 2022

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MAVIRET® (glecaprevir/pibrentasvir) Approved by Health Canada for Pediatric Patients with Chronic Hepatitis C

MAVIRET® (glecaprevir/pibrentasvir) Approved by Health Canada for Pediatric Patients with Chronic Hepatitis C

  • MAVIRET can now be used as an 8-week, once-daily paediatric granule formulation option in treatment-naïve, without cirrhosis or with compensated cirrhosis, chronic Hepatitis C (HCV) paediatric patients aged 3 to <12 years with genotype (GT)1-6, weighing at least 12kg to less than 45kg
  • Health Canada’s decision makes MAVIRET the first pan-genotypic treatment option for treatment-naïve, compensated cirrhotic, chronic HCV patients as young as 3 years of age and weighing 12kg or more
  • This approval is supported by 98.4 per cent cure* rate across this group of patients who received the approved paediatric granule formulation

Montreal, QC, June 22, 2022 – AbbVie (NYSE: ABBV) announced today that Health Canada has approved a change in the marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to include its use for the treatment in paediatric patients 3 to 12 years old, weighing at least 12kg to less than 45kg.1 MAVIRET is now approved as an 8-week, pan-genotypic (GT1-6) treatment for treatment-naïve, chronic HCV patients, without cirrhosis or with compensated cirrhosis in adults and children aged 3 years and older.1** “There is an estimated 250,000 people living in Canada with chronic hepatitis C including young children who I have witnessed first-hand at SickKids in need of treatment options,” said Dr. Simon Ling, MBChB, MRCP(UK), Division of Gastroenterology, Hepatology and Nutrition, SickKids Toronto. “The approval of MAVIRET® as a paediatric indication is a necessary step that will add a beneficial therapeutic option to treat HCV infection in children.” The label extension is supported by data from the phase 2/3, non-randomized, open-label, multicenter DORA Part 2 study evaluating the safety and efficacy of weight-based dosing of glecaprevir/pibrentasvir (G/P) granules for 8, 12 or 16 weeks in 80 children aged 3 years to less than 12 years with chronic HCV infection.1 Patients received a paediatric formulation of glecaprevir (GLE)/pibrentasvir (PIB), comprised of film-coated granules of GLE and PIB, in a sachet mixed together in a small amount of soft food for once-daily oral administration. The mixture of food and granules should be swallowed immediately; the granules should not be crushed or chewed.1 “With Canada’s commitment to eliminating viral hepatitis as a public health threat by 2030, the approval of MAVIRET ® for paediatric patients is a positive advancement in reaching our goals,” said Jennifer van Gennip, Executive Director, Action Hepatitis Canada. “Now with access to treatment of viral hepatitis amongst children, one more barrier to elimination is removed.” In DORA Part 2, the overall SVR12 rate for the subjects who received the final recommended dose was 98.4% (61/62)1 . No subject taking the final recommended dose experienced virologic failure1 . The adverse reactions observed in patients 3 less than 12 years of age were consistent with those observed in clinical trials of MAVIRET in adults with the exception of vomiting (occurring at approximately 8%), rash, and abdominal pain upper (each occurring at approximately 4%) which were observed more frequently than in adults.1 “MAVIRET has had a significant impact on the lives of people affected by chronic HCV, and we are pleased that pediatric patients are now also able to benefit from this treatment option,” said Tracey Ramsay, Vice-president and General Manager, AbbVie Canada. “We are committed to helping achieve the World Health Organization’s 2030 goal of HCV elimination and we believe Health Canada’s expanded approval for MAVIRET will help Canadians to get one step closer.” About the DORA part 2 Study2 The efficacy, safety and pharmacokinetics of G/P in children 3 years to less than 18 years old was demonstrated in an open-label study which was comprised of two parts, DORA Part 13 and Part 22 . DORA Part 2 evaluated the safety and efficacy of weight-based dosing of G/P granules for 8, 12 or 16 weeks in 80 children aged 3 years to less than 12 years. 18 subjects received the initial lower dose, and 62 subjects received the final recommended dose. The median age was 7 years (range: 3 to 11); 73% had HCV genotype 1, 3% had genotype 2, 23% had HCV genotype 3, 3% had HCV genotype 4; 55% were female; 4% were Black; 97.5% were HCV TN; 2.5% were treatment-experienced to interferon; 1% had HIV-coinfection; none had cirrhosis; the mean weight was 25 kg (range: 13 to 44). In DORA Part 2, the overall SVR12 rate for the subjects who received the final recommended dose was 98.4% (61/62). No subject taking the final recommended dose experienced virologic failure. One 9-year-old child with HCV GT3b infection, who had received the initial lower dose, experienced virologic failure. The child had K30R and V31M at baseline and treatment-emergent Y93H at relapse in NS5A; baseline or treatmentemergent substitutions were not detected in NS3. The pattern of adverse reactions observed was comparable with that observed in clinical studies of G/P film-coated tablets in adolescents and adults. About MAVIRET™ (glecaprevir/pibrentasvir)1,2 MAVIRET® is approved by Health Canada for the treatment of chronic hepatitis C virus (HCV) infection in adults and children 3 years and older across all major genotypes (GT1-6). MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets. The new paediatric formulation consists of MAVIRET coated granules in sachet. Each sachet contains 50mg of glecaprevir and 20mg of pibrentasvir. The recommended dosage in number of sachets is based on body weight for children1 . MAVIRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment**. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney1 disease (CKD). MAVIRET is a pangenotypic treatment approved for use in patients across all stages of CKD. Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in patients with moderate hepatic impairment (Child-Pugh B).1 For important safety information, please consult the MAVIRET Product Monograph at www.abbvie.ca. About Hepatitis C An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 40% are not aware that they have it.4 Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada.5 AbbVie supports a range of efforts to help elevate and prioritize HCV elimination because we know achieving the shared goal of elimination by 2030 will take more than medicine. It will take transparent and collaborative partnerships with all stakeholders – industry, healthcare providers, healthcare systems, patient groups and their support networks. Joint efforts and maximizing the time we have left will enable us to reach this goal. About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn. -30- Media: Muriel Haraoui AbbVie Canada 514-717-3764 muriel.haraoui@abbvie.com *Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. **The recommended duration of MAVIRET is 12 weeks in liver or kidney transplant recipients with or without cirrhosis. 1AbbVie Canada. Maviret Product Monograph. Retrieved https://www.abbvie.ca/content/dam/abbviedotcom/ca/en/documents/products/MAVIRET_PM_EN.pdf. April 2022. 2 Jonas MM et al. Pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir in children with chronic hepatitis C virus: part 2 of the DORA study. J Hepatol (2021) 3 Jonas, MM et al. Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Virus: Part 1 of the DORA Study. J Hepatol (2020) 4Canadian Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination efforts in Canada. https://www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf Accessed April 2022. 5Canadian Liver Foundation. How you advocate. https://www.liver.ca/how-you-help/advocate/ Accessed April 2022.

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Cybin Inc. Reports Fiscal Year 2022 Financial Results and Recent Business Highlights

Cybin Inc. Reports Fiscal Year 2022 Financial Results and Recent Business Highlights

– 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.

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Nova Mentis to Present at the H.C. Wainwright Mental Health Conference

Nova Mentis to Present at the H.C. Wainwright Mental Health Conference

Vancouver, British Columbia – June 22, 2022 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders is pleased to announce that it will be presenting at the H.C. Wainwright 1st Annual Mental Health Conference: Neuropsychiatry, Psychedelics, and Beyond on June 27, 2022.

The NOVA presentation is titled: A Novel Psilocybin Microdose Treatment of Fragile X Syndrome.

NOVA has filed a patent to protect the novel psilocybin microdose therapeutic approach to treatment of autism spectrum disorder (ASD) and especially fragile X syndrome (FXS), the largest genetic cause of ASD. This breakthrough psilocybin treatment preclinical data will be presented at the HCW conference.

The Company’s patent is titled: Diagnosing, Monitoring and Treating Neurological Diseases with Psychoactive Tryptamine Derivativesm; RNA Diagnostic Index to Measure Drug Treatment Response.

“NOVA is looking forward to advancing the discussion around the therapeutic potential of oral microdose psilocybin for the treatment of autism spectrum disorder (ASD) and fragile X syndrome (FXS),” says Dr. Marvin S. Hausman, Chairman of NOVA’s Scientific Advisory Board. “Future government regulatory plans, based on our proprietary psilocybin drug (NM-1001) positive preclinical study data, will also be discussed.”

Dr. Hausman’s presentation will be available on-demand starting at 7:00 a.m. EST on June 27, 2022. Click here to register for the conference and schedule a one-on-one meeting with Dr. Hausman.


About Nova Mentis Life Science Corp.

Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS).

Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.

For further information on the Company, please visit www.novamentis.ca or email info@novamentis.ca.

On Behalf of the Board

Will Rascan, President & CEO
Nova Mentis Life Science Corp.

Phone: 778-819-0244
Toll Free: 1-833-542-5323

Twitter: @novamentislsc

Instagram: @novamentislsc

Facebook: @novamentislsc

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur.

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Numinus Applies for International Patent Filing of Psychedelics Production Process

Numinus Applies for International Patent Filing of Psychedelics Production Process

Filing would offer added protection to IP already submitted to USPTO

VANCOUVER, BC, June 22, 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 that its subsidiary Numinus Bioscience Inc. (“Numinus Bioscience”) has 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.

“The WIPO is an important global forum that provides reassurance to the patent offices of member states. Numinus is confident that the robust evidence supporting the production process will further inform regulators as they consider policy changes to make psychedelic-assisted therapies and products more accessible,” said Sharan Sidhu, VP, Scientific Research, Innovation & Laboratory Operations, Numinus. “We look forward to advancing current research and paving the way for eventual commercialization and mainstream access.”

The purpose of the process is to significantly increase production of therapeutics for use in psychedelic-assisted therapy, while reducing product variability, increasing production efficiency and ultimately reducing commercialization costs. Since the initial filing, data-sets validating the process for additional fungi specifies have been completed, broadening its potential application and scope from psilocybin to other active compounds.

“This application is part of Numinus’ long-term IP strategic focus on scalable and sustainable production that advances research, development and delivery of innovative psychedelic-derived formulations in North America and beyond,” said Payton Nyquvest, Founder and CEO, Numinus.About Numinus

Numinus Wellness 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. 

Learn more at numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.

Disclaimer

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

Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “expect” and “intend” and statements that an event “may”, “will”, “should”, “could” or “might” occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. The Company does not undertake any obligation to update forward-looking statements even if circumstances or management’s estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.

SOURCE Numinus Wellness Inc.

For further information: Investor Contact: Jamie Kokoska, Vice President, Investor Relations & Communications, jamie.kokoska@numinus.com; Media Contact: May Lee, Communications Manager, may.lee@numinus.com

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Pasithea Therapeutics Acquires Alpha-5 Integrin, LLC

Pasithea Therapeutics Acquires Alpha-5 Integrin, LLC

– Alpha-5 is a potentially first-in-class monoclonal antibody for the treatment of amyotrophic lateral sclerosis (ALS) and other neurological diseases –
– Expands pipeline across Pasithea’s core therapeutic areas to drive enhanced growth –
– Closing consideration of 3.26 million shares of Pasithea common stock –
– Pasithea to hold a webcast on June 22 at 9 a.m. ET to discuss the transaction –

MIAMI BEACH, Fla., June 22, 2022 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), today announced its acquisition of Alpha-5 integrin, LLC (“Alpha-5”), a privately-held preclinical-stage company developing a monoclonal antibody (mAbs) for the treatment of amyotrophic lateral sclerosis (“ALS”) and other neuroinflammatory disorders, such as Multiple Sclerosis (“MS”).

Alpha-5’s lead therapeutic candidate has a novel mechanism of action with the potential to improve clinical outcomes in patients with ALS, and is supported by post-mortem studies and with reproducible significant improvement in behavior and survival in the SOD1 mice model. The acquisition includes Alpha-5 proprietary antibodies with novel intellectual property and brings to Pasithea a group of seasoned scientists and a state-of-the-art laboratory.

The Company acquired all of the outstanding equity interests in Alpha-5 at an enterprise value for $3.75 million, payable in 3.26 million shares of Pasithea common stock, valued at $1.15 per share, an 11% premium to the closing price on June 21, plus 1 million warrants. An entity controlled by Paul B. Manning, Chairman and CEO of PBM Capital, a healthcare-focused investment firm, is Alpha-5’s majority owner and, following the transaction, will own approximately 10% of Pasithea common stock. Cassel Salpeter & Co. acted as financial advisor to the Company on this transaction.

“This agreement with Pasithea represents the culmination of years of work by Alpha-5 researchers, successfully leveraging their deep scientific expertise in the integrin space. We believe Pasithea will be well-positioned to apply its capabilities to move this asset forward and make an impact on ALS disease for the benefit of patients,” said Paul B. Manning.

“Treatments for ALS are extremely limited. Only two drugs are currently approved, with minimal impact on disease, and the majority of patients progress to death within a few years of symptom onset. The Alpha-5 acquisition is transformative for Pasithea, by adding a new drug with a novel mechanism of action to our pipeline, while preserving our strong cash position. In addition to the Alpha-5 development program, we will also acquire a wet lab and scientific team to develop our existing tolerizing vaccine and complementary program. Our plan is to file an Alpha-5 investigational new drug application (IND) with an orphan drug designation by the end of 2023,” stated Dr. Tiago Reis Marques, CEO of Pasithea.

Stanford Professor Larry Steinman, Chairman of the Board and co-founder of Pasithea and a minority owner of Alpha-5 said, “My work has been instrumental for the discovery of natalizumab, an anti-alpha 4 integrin mAb. This was the first drug developed in the class of selective adhesion molecule inhibitors and a potent therapeutic for multiple sclerosis. We believe that alpha-5 integrin antibody can also be transformative in the treatment of other neurological disorders, such as ALS or MS. Post-mortem human studies and preclinical work conducted so far support this therapeutic target and we are excited to move it into clinical trials.” Professor Steinman recused himself from the vote to approve the transaction.

Transaction Details

At the closing of the transaction, the Company acquired all of Alpha-5’s issued and outstanding equity interests in exchange for 3,260,870 shares of Pasithea common stock plus warrants to acquire an additional 1,000,000 shares at an exercise price of $1.88 per share for a period of five years. The number of shares was calculated by dividing a $3.75 million enterprise value by $1.15 per share of Pasithea Common Stock, an 11% premium to the closing price on June 21. There are potential future earnouts based on net sales. There will be no post-closing adjustments for cash and working capital.

To further discuss the transaction, Pasithea´s management will host a webcast as follows:
   
Date: June 22, 2022
Time: 9 a.m. ET
URL: https://event.choruscall.com/mediaframe/webcast.html?webcastid=aph1RpCR
   
The webcast will be accessible on the Investors section of the website, www.ir.pasithea.com, and will be archived for 90 days following the event.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics Corporation is a U.S. biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of psychiatric and neurological disorders. Pasithea is also focused on addressing the needs of patients currently suffering with mental illness by providing access to IV ketamine infusions both in clinics and in-home settings.

About Amyotrophic Lateral Sclerosis

ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. It most commonly affects people between the ages of 40 and 70, with an average age of 55 at the time of diagnosis. It affects as many as 30,000 patients in the United States, with 5,000 new cases diagnosed each year. The average life expectancy after diagnosis is two to five years, but some patients may live for years or even decades. While 5-10% of cases are hereditary (familial ALS), the large majority of cases (90-95%) are not hereditary (Sporadic ALS). The cause of ALS is not completely understood and multiple complex factors may contribute to the death of motor neurons. Currently there is no known cure or treatment that halts or reverses the progression of ALS, and FDA only approved 2 medications so far for the treatment of this disorder, both shown to modestly slow the progression of ALS.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the SEC. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Corp. Company Contact

Dr. Tiago Reis Marques
Chief Executive Officer
E: tiago@pasithea.com

Pasithea Therapeutics Corp. Investor Relations

Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Primary Logo

Source: Pasithea

Released June 22, 2022

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What machine learning tells us about microdosing

Natural language signatures of psilocybin microdosing

The benefits of microdosing can be so subtle that they’re hard to measure in clinical settings, which is why this study turned to machine learning and natural language processing.

Essentially, patients were asked a series of subjective questions following psilocybin microdoses or placebo doses, and the interviews were analyzed with AI.

The key takeaways?

  1. A “sentiment analysis” measured the connotation of each word as positive, negative, or neutral. Sentiment scores increased while microdosing, suggesting that psilocybin has a positive effect on mood and subjective well-being.
  2. Verbosity (length of responses in number of words) increased for all questions when microdosing, which may reflect increased enthusiasm, motivation, and energy.
  3. Semantic variability (how much the meaning of consecutive words changed) was not affected by microdosing. This implies that microdosing does not lead to incoherent speech and might not enhance creativity like many believe. 

It’s important to note that the microdose were fairly large – 500 mg of dried mushrooms. It would be interesting to see how a 100 or 200 mg dose compares.

PDF of article

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Yale’s Department of Psychiatry Chair to Join Clearmind Medicine

Yale’s Department of Psychiatry Chair to Join Clearmind Medicine

Dr. John H. Krystal, world-leading expert in alcoholism and depression, will serve on scientific advisory board

VANCOUVER, June 21, 2022 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF, FSE: CWY0) (“Clearmind” or the “Company“), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major undertreated health problems, today announced the appointment to its Scientific Advisory Board of John Krystal, Chair of the Psychiatry Department at Yale University’s School of Medicine.

A leading expert on alcoholism, post-traumatic stress disorder, schizophrenia, and depression, Dr. Krystal’s work links psychopharmacology, neuroimaging, molecular genetics, and computational neuroscience to study the neurobiology and treatment of these disorders. He is best known for leading the discovery of the rapid antidepressant effects of ketamine.

“We are truly honored to add Dr. Krystal, one of the world’s most recognized experts in alcoholism, to our Scientific Advisory Board,” said Dr. Adi Zuloff-Shani, Clearmind’s Chief Executive Officer. “Clearmind has emphasized collaboration with scientists and clinicians at ​​the very best academic, medical and research institutions in the world, helping us bring innovative expertise to bear on some of the most pressing global health needs.”

Dr. Krystal is a Professor of Translational Research; Psychiatry, Neuroscience, and Psychology; he chairs the Department of Psychiatry at Yale University; and he is Chief of Psychiatry and Behavioral Health at Yale-New Haven Hospital. He is a graduate of the University of Chicago and the Yale University School of Medicine

Among many other positions he holds or has held, Dr. Krystal is the Director of the NIAAA Center for the Translational Neuroscience of Alcoholism and the Clinical Neuroscience Division of the VA National Center for PTSD, co-director of the Neuroscience Forum of the U.S. National Academies of Sciences, Engineering, and Medicine; and editor of Biological Psychiatry (IF=12.1). He is a member of the U.S. National Academy of Medicine and a Fellow of the American Association for the Advancement of Science.

“We believe that the scientists on our Scientific Advisory Board, working closely with us to challenge, validate and guide our scientific agenda for developing breakthrough therapies that improve human mental-health at scale, increase access to care, reduce suffering and improve health outcomes around the world,” said Zuloff-Shani.

About Clearmind Inc. (CSE: CMND), (OTC: CMNDF), (FSE: CWY0)

Clearmind is a new biotech company focused on the discovery and development of safe and novel psychedelic-derived therapeutics to treat alcohol use disorder and other pressing health challenges.

The Israeli Canadian company holds several patents for the non-hallucinogenic compound MEAI (5-methoxy-2-aminoindane, a novel psychoactive substance). The company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Clearmind has established a research collaboration with the Hebrew University of Jerusalem and Bar Ilan University. The partnerships aim to expand its R&D capabilities and discover new candidate treatments for other mental health issues.

For further information, please contact:

Investor Relations

invest@clearmindmedicine.com

Telephone: (604) 260-1566

General Inquiries

Info@Clearmindmedicine.com

www.Clearmindmedicine.com

FORWARD-LOOKING STATEMENTS:

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Such statements include submission of the relevant documentation within the required timeframe to the satisfaction of the relevant regulators and raising sufficient financing to complete the Company’s business strategy. There is no certainty that any of these events will occur. Although such statements are based on management’s reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances.

Investing into early-stage companies inherently carries a high degree of risk, and investment into securities of the Company shall be considered highly speculative.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities in any province in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under the Private Placement have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Neither the Canadian Securities Exchange (the “CSE”) nor its Regulation Services Provider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.