Tag: financial results & corporate updates

Mindset Pharma Reports Fiscal Year 2021 Financial Results and Provides Corporate Update

Evolving Pipeline of Psychedelics Compounds Focused on Improved Efficacy and Safety

Advancing MSP-1014 as First Lead Drug Clinical Candidate to IND-Enabling Studies

Developing Robust Patent Portfolio for Next-Generation Compounds and Methods
—

TORONTO, Oct. 26, 2021 (GLOBE NEWSWIRE) — Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company”), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today provided a corporate update and reported financial results for its fiscal year ended June 30, 2021.

“During fiscal 2021 and subsequent months, our team made tremendous progress developing and advancing our vast library of next-generation psychedelic compounds as well as creating state-of-the-art, standard-setting processes for evaluating novel psychedelic drug candidates, which will prove valuable for the psychedelics industry at large. We complement our broad preclinical research with a strategic focus on intellectual property and filing patents to protect our growing new drug portfolio. Our overarching goal is to select the most promising clinical candidates from our ongoing discovery work, and advance them into the clinic as quickly as possible, either through partnerships or directly ourselves,” said James Lanthier, CEO of Mindset.

“The preclinical results from our compounds have meaningful clinical implications. Mindset’s next-generation psychedelic drug candidates can potentially offer a more scalable, safer and more convenient treatment for clinic-based mental health therapy programs due to optimization in duration, efficacy and safety. Our robust pipeline means that we have multiple ‘shots on goal’ to achieve a positive clinical outcome for patients. We have already identified four differentiated families of compounds and see an opportunity to expand further,” concluded Mr. Lanthier.

Corporate Highlights During and Subsequent to the Fiscal Year 2021

• Expanded Patent Portfolio: Filed four provisional patent applications bringing the total to eight provisional applications filed to-date. Mindset also has filed four final PCT applications, which cover a broad range of novel, next generation drugs inspired by psilocybin, DMT, & 5-MeO-DMT and a novel psilocybin synthesis and manufacturing method.
• Advanced First Lead Drug Candidate Toward Clinical Trials: Selected its first lead clinical candidate, MSP-1014, a differentiated psilocybin-based analog, to move forward into investigational new drug (IND)-enabling studies.
• Developed First-in-Class Benchmarking: Under the Cooperative Psychedelics Evaluation Platform (“COPE”) program, Mindset and its partner, InterVivo Solutions, continue to develop first-in-class benchmarking data across first-generation psychedelic drugs.
• Identified Technology Platform: Preclinical data generated across the four families of novel chemical entities resulted in the identification of a platform technology that enhances effect size and improves safety profiles of psychedelic drugs. A provisional patent application was filed in May of 2022.
• Enhanced Leadership and Advisory Teams: Appointed Dr. Malik Slassi as Senior Vice President of Innovation, Mr. Ian Dean as Director of Preclinical Development, and Drs. Michael Rogawski, Guy Higgins, Joseph Gabriele and Ishrat Husain to its Scientific Advisory Board (SAB).
• Dr. Slassi is a scientific co-founder and an originating member of Mindset’s SAB and is the architect of the Company’s intellectual property portfolio of novel and differentiated psychedelic drug families, along with the its patent pending psilocybin synthesis process.

• Mr. Dean is a seasoned toxicologist and pharmacology professional with over 40 years of intensive expertise in drug development.
• Dr. Rogawski is Professor of Neurology and Pharmacology at the University of California, Davis School of Medicine. Serves as lead of the University of California Drug Discovery Consortium and Member of board of directors of the American Epilepsy Society.
• Dr. Higgins brings more than three decades of expertise in the pharmaceutical industry as a drug developer and is a world renowned psychopharmacologist with greater than 180 peer reviewed publications in behavioural neuroscience.
• Dr. Gabriele is a molecular pharmacologist with extensive experience in product formulation and commercialization.
• Dr. Husain is a leading researcher in the neurobiology of depression and bipolar disorder, currently conducting clinical trials of emerging treatments for these conditions.
• Capital Markets: In December 2020, Mindset closed a $5.0 million gross proceeds private placement financing and subsequently listed its common shares on the Canadian Securities Exchange (CSE) under the ticker symbol “MSET.” In April 2021, Mindset closed an aggregate gross proceeds of $8.55 million bought deal public offering.

Pipeline Updates

To-date, Mindset has synthesized and screened over 100 compounds and run a battery of highly specialized in vitro and in vivo tests on its patent-pending novel compounds to select the optimal psychedelic drug candidates for progressing towards clinical trials. Preclinical results have demonstrated improved safety and efficacy across its four families of next-generation compounds when compared to their reference drugs, as well as a range of anticipated durations of action.

Family 1

• In June 2021, Mindset selected its first lead clinical candidate, MSP-1014, a differentiated psilocybin-based analog, to move forward into current good manufacturing practice (cGMP) compliant manufacturing and IND-enabling studies with a goal of reaching clinical stage in 2022.
• In September 2021, Mindset announced treatment-resistant depression and end of life cancer angst as initial indications for MSP-1014.

Family 2

In August 2021, Mindset announced its short-duration, psilocybin-based, analogs demonstrated superior efficacy and safety in head-to-head preclinical comparison to psilocin/psilocybin.

Family 3

In August 2021, Mindset’s long-acting, psilocybin-like, analogs demonstrated extended duration of action and decreased effect size at the 5-HT2A receptor. These results indicated a potentially significant improvement in the sustained efficacy and safety profile of current microdosing practices.

Family 4

• In September 2021, Mindset identified three pipeline opportunities from its DMT and 5-MeO-DMT-inspired novel drug candidates, MSP-4018, MSP-4019 and MSP-4020.
• In preclinical studies, MSP-4018, MSP-4019 and MSP-4020 demonstrated a significant decrease in signs of serotonergic toxicity, which is a considerable health risk associated with the first-generation psychedelic, 5-MeO-DMT.

Fiscal Year 2021 Financial Results

Mindset concluded fiscal year 2021 with approximately $6.6 million dollars in cash. The Company believes it is well capitalized for continued growth.

Net loss for the fiscal year ended June 30, 2021 and for the period from October 7, 2019 (date of incorporation) to June 30, 2020 was approximately $11.7 million and $0.5 million, respectively.

About Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds.

For further information on Mindset, please visit our website at www.mindsetpharma.com.

For more information, please contact:

Investor Contact:
Allison Soss/Tim Regan
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 212-896-1267/ 347-487-6788

Company Contact:
James Lanthier, CEO
Email: jlanthier@mindsetpharma.com

Jason Atkinson, VP, Corporate Development
Email: jatkinson@mindsetpharma.com
Phone: 416-479-4094

Forward-Looking Information

This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

Awakn Life Sciences Reports Second Quarter 2021 Financial Results and Business Highlights

TORONTO, CANADA, 15 SEPTEMBER 2021 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company with clinical operations developing and delivering psychedelic medicines to better treat Addiction, today is reporting its financial results and business highlights for the three and six months ended July 31, 2021. All results are reported under International Financial Reporting Standards (“IFRS”) and in Canadian dollars, unless otherwise specified.

We remain steadfast in our mission to fully integrate effective psychedelic-based treatments into mainstream healthcare to better treat

Addiction.”

Business and Operational Updates

• Filed provisional patent applications in the U.S. for two next-generation novel MDMA- derived new chemical entities, AWKN001 and AWKN002, further strengthening the Company’s intellectual property portfolio and pipeline for the treatment of a broad range of addictions, including, but not limited to alcohol, opioid and behavioural, such as gambling.
• Initiated a new chemical entity (NCE) drug discovery program to strengthen Awakn’s pipeline for the treatment of a broad range of substance and behavioral addictions. The program is led by Prof David Nutt. The first project in the program is a two stage ten month Hit to Lead (HtL) drug discovery program, with results from the first stage due in early Q4 2021.
• Initiated a Ketamine research program designed to demonstrate the effectiveness of ketamine-assisted psychotherapy against multiple addictions, initially focusing on treating AUD and gambling addiction.
• Signed a 10-year lease to open Awakn Clinics London, a psychedelic-focused therapy center to treat addition and other mental health conditions. Awakn Clinics London will be approximately 4,419 square-feet and will host eight treatment rooms.

Anthony Tennyson, Chief Executive Officer of Awakn Life Sciences, commented, “Our team has achieved many accomplishments in a short period of time since going public in June of 2021. We have continued to surround ourselves with experts in the psychedelic and addiction industries such as Prof. David Nutt, Prof. Celia Morgan and Prof. Barbara Mason. We have also made significant strides in the development and delivery of psychedelic therapeutics to treat Addiction

and continued to progress the opening of our first clinics.

• Established preclinical and clinical expert advisory boards by separating its current advisory board, while adding Prof. Stephen Husbands (University of Bath), Prof. Harriet de Wit (University of Chicago) and Prof Kevin Fone (University of Nottingham). Each of the two boards to be chaired by Professor David Nutt, Chief Research Officer.

Key Corporate Highlights and Developments:

• Announced Depository Trust & Clearing Corporation (“DTC”) eligibility, allowing Awakn’s shares to be electronically cleared and settled, which will streamline the process of trading, enhance liquidity, and provide direct access to investors in the U.S. OTC capital markets.
• Commenced trading on the OTC Market under the Symbol ‘AWKNF’. This additional capital markets exposure offers us greater visibility within the investment community in the U.S., which should enhance our liquidity and increase our access to institutional and retail investors.
• Commenced trading on the Neo Exchange under the symbol AWKN after completion of reverse takeover transaction and release from escrow of private placement proceeds. Key Financial Highlights: About Awakn Life Sciences Corp.
  Awakn Life Sciences is a biotechnology company with clinical operations, researching, developing, and delivering psychedelic medicine to better treat Addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat Addiction. Awakn will also deliver evidence backed psychedelic therapies for Addiction in clinics in the UK and Europe and through licencing partnerships globally. www.awaknlifesciences.com | Twitter | LinkedIn | Facebook 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

• Completed a $8.3 million financing at $2.50 per share in conjunction with the listing on

the Neo Exchange.

• Closed the quarter well capitalized with approximately $8.8 million of cash as on hand as

of July 31, 2021.

actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and 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: whether conditions to the listing on NEO will be satisfied; 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; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; 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.

Phone: +1 (212) 896-1254

Awakn@KCSA.com

Investor Enquiries:

KCSA Strategic Communications

Valter Pinto / Tim Regan

Media Enquiries:

America and Canada: KCSA Strategic Communications

Anne Donohoe

Adonohoe@KCSA.com

Rest of World: ROAD Communications

Paul Jarman / Anna Ramsey

Awakn@roadcommunications.co.uk

Lobe Sciences Provides Corporate Update to Investors and Stakeholders

Vancouver, British Columbia–(Newsfile Corp. – September 13, 2021) – Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) (“Lobe” or the “Company“) is pleased to provide the following corporate update by CEO Philip Young, addressed to shareholders, investors and other stakeholders of the Company:

Dear Fellow Shareholders and Psychedelic Medicine Enthusiasts,

We are pleased to say that 2021 has been a busy and transformative year for the Company. During 2021, we have made significant progress on several fronts, and completed our transition to an integrated pharmaceutical development company. We have built the foundation of a drug development company and we are now following a path for the development of therapeutics for which we intend to seek FDA approval in the United States, and similar approvals internationally. Millions of people are experiencing the devastating, often long-term effects of mTBI (mild traumatic brain injury) and PTSD (post-traumatic stress disorder), with few, if any, effective treatments available. Our goal is to change that fact. We believe that psychedelic based therapeutics will bring a new era of treatment for many illnesses where current therapies are insufficient or unavailable. As such, we believe the Company is poised to lead the way in developing treatments for mTBI and PTSD, while altering the perception of psychedelic medicine as a treatment modality. Our entire team is dedicated to making a significant impact in this rapidly growing industry as we differentiate ourselves from other psychedelic medicine companies by executing our strategic plans and vision. The following is a brief review of the achievements we have made, laying the foundation for continued progress and milestones, which we believe will position the Company for long-term growth and success.

2021 Business Developments – the building blocks for our future

Our 2021 accomplishments spanned every aspect of our business as we executed our multi-prong strategy and vision for future developments. These accomplishments included: streamlining operations, enhancing our balance sheet, strengthening our intellectual property portfolio, further developing our medical devices, increasing our scientific breadth and reach by forming a world class scientific advisory board and entering into relationships with key organizations that promote mental health and wellness. Key accomplishments include:

Clinical and Scientific Developments and Operations:

Our pre-clinical study involving psilocybin and NAC (N-Acetylcysteine) led by Principal Investigator, Dr. Michael Hoffer of the University of Miami is progressing and in the process of analyzing the data. The Company continued to strengthen its overall product, device and intellectual property (“IP“) portfolio through acquisitions and our development efforts. Other key highlights include:

• On February 18, 2021 we announced the successful completion and testing of the proof of concept prototype of its proprietary nasal mist device;
• On April 27, 2021 we announced the Company entered into a joint venture agreement with Virtual Psychedelics Incorporated to design, develop and commercialize the Krysalis Pod, a state-of-the-art media device that will deliver immersive virtual experiences without a headset. (the “JV”);
• On April 29, 2021 we announced the filing of a PCT application entitled “Methods, Compositions and Devices for Treating Mild Traumatic Brain Injury”;
• On May 4, 2021 we announced the acquisition of the Vitamind line of functional mushroom wellness products; and
• On May 19, 2021 we announced entering into a production and supply agreement with HAVN Life Sciences Inc.

As announced on March 8, 2021, the Company completed the divestiture of the Washington State cannabis asset to Ionic Brands Corp. (“Ionic“), strengthening our balance sheet with a cash payment to the Company of $1,750,000, and receipt of 100,406,701 Series E shares of Ionic and 4,000,000 Ionic warrants.

Executive Team, Advisors and Industry Relationships:

In 2021, in addition to myself as CEO, we added Michael Petter, an accomplished businessman to our board of directors. We also assembled an accomplished Scientific Advisory Board (“SAB”), led by our CSO, Maghsoud Dariani, including Dr. Mark Geyer, Dr. Charles Grob, Dr. Benjamin Kelmendi, Dr. Michael Hoffer and Dr. Skip Rizzo, all regarded as leaders and innovators in their respective psychedelic and medical communities. We also leveraged our advisor network and partnered with the NFL Alumni Association and the World Boxing Association to investigate and develop plans for monitoring, mitigating and managing the consequences of mTBI and PTSD.

Looking Ahead: on-going corporate initiatives

The Company intends to leverage its 2021 accomplishments achieved to-date. Key milestones we anticipate working towards include the following items. The Company plans on completing these items by the end of calendar 2022, barring any unforeseen delays.

Clinical and Scientific Development and Regulatory

• Announce the results of the University of Miami Pre Clinical Study of the treatment of mTBI and PTSD
• Submit Pre Investigational New Drug (“IND“) meeting request to FDA
• Announce contract research organization (“CRO“) partner, finalize study protocol, select sites for first-in-man study with our combination therapeutics
• Finalize agreement with a cGMP manufacturing partner for clinical trial and commercial supplies of psilocybin and NAC (N-Acetylcysteine)
• Initiate the first human study with Lobe’s patent pending combination therapeutics of psilocybin and NAC (N-Acetylcysteine)
• Update on cGMP psilocybin production timing and availability
• File IND with FDA
• Update clinical trial enrolment progress
• Update IND plans based on feedback from FDA
• Finalize specifications for and design plan for nasal mist delivery device

Collaborations and Partnerships

• Update on Krysalis Pod design team and progress
• Launch the first products in the Vitamind product portfolio, subject to regulatory approval
• Update on Krysalis Pod design and tech stack development
• Expand Vitamind product offerings and launch in USA, subject to regulatory approval

Investment Conference Schedule:

The Company will be sharing its vision and plans with investors as we attend several leading investment conferences and trade conventions including:

• HC Wainwright 23rd Global Investment Conference, September 13-15, 2021
• Maxim Group, Advances in Mental Health – Psychedelics and Non-Psychedelics Conference, September 22, 2021
• Benzinga Healthcare Small Cap Conference, September 29, 2021
• MoneyShow Virtual Expo, October 5-7, 2021
• BioFuture 2021, October 5-7, 2021
• LD Micro Main Event, October 12-14, 2021
• Q4 Investor Summit Virtual Conference, November 16-17, 2021
• JP Morgan Healthcare Conference, January 10-13, 2022

In summary, we believe the balance of 2021 and 2022 will bring exciting developments as we build on the foundation of our accomplishments. We are committed to creating effective therapies and treatments to better the lives of millions of people. We believe we have built a solid foundation and strategy that incorporates strong partnerships with recognized industry leaders, a world-class Scientific Advisory Board, a growing intellectual property portfolio, along with multiple products and devices under development.

Thank you for your continued commitment and support as we continue to execute our strategy to position the Company for long-term growth and success.

Philip Young
CEO and Director

* * *

About Lobe Sciences Ltd.

Lobe Sciences is a life sciences company focused on psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.

For further information please contact:

Lobe Sciences Ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623

THE CSE HAS NOT REVIEWED AND DOES NOT ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.

Disclaimer for Forward-Looking Statements

This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact included in this release, including statements made by our Chief Executive Officer and regarding the future plans and objectives of the Company; progression with nasal mist device engineering and commercialization; the pursuit of M&A initiatives, and the expected benefits to be derived from previous M&A initiatives; the development of effective delivery methods and commercialization potential of the nasal mist device, research and development using NAC and psilocybin and growth of the business; the Company’s expected attendance at various industry conferences; the timing of and results from the University of Miami pre-clinical study; expected timing to submit a pre IND meeting request to the FDA (and statements regarding FDA approvals generally); expected announcement and timing of a CRO partner, finalizing study protocol, and statements regarding a first-in-man study with our combination therapeutics; statements regarding expected development of the Krysalis Pod; anticipated timing and announcement of initiation of the first human study with Lobe’s patent pending combination therapeutics of psilocybin and NAC (N-Acetylcysteine); expected timing and occurrence of the launch of products in the Vitamind product portfolio, expansion of the Vitamind product line and receipt of regulatory approvals required for product launches; expected statements and timing regarding cGMP psilocybin production and availability; and the expected timing for the launch of new products and revenue-generating activities and expected completion of milestones by the end of calendar 2022, are all forward looking statements that involve risks and uncertainties. Forward-looking statements, by their very nature, require management to make assumptions and are subject to inherent risks and uncertainties, and while management of the Company believes the forward-looking statements contained herein have a reasonable basis, the possibility exists that our predictions, forecasts, projections, expectations or conclusions will not prove to be accurate. Material assumptions that underlie the forward-looking statements included in this news release include, without limitation, assumptions regarding: the outcomes of scientific studies showing the efficacy of psychedelic therapies on mTBI and PTSD, increasing acceptance in the medical community and among consumers for psychedelic therapies as an effective treatment modality; the Company having access to sufficient capital needed to support its various milestone objectives, expected synergies from M&A transactions and the timing of various milestone objectives, regulatory approvals and our ability to capitalize on business opportunities and develop revenue-generating activities; and the impact of COVID-19 on our business plans. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. As a result of the inherent uncertainty of forward-looking statements, 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, whether as a result of known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. Important risks and uncertainties that could cause actual results to differ materially from the Company’s expectations include without limitation risks relating to: that we may not have the capital needed or will not be able to raise sufficient capital to support our business activities or achieve our anticipated milestones; delays or stoppages in the Company’s business activities resulting from the COVID-19 pandemic; adverse or unexpected findings in scientific research; adverse changes to the regulatory environment in which we operate; regulatory delays or the failure to obtain required regulatory approvals; failure to capitalize on business opportunities and develop revenue-generating activities; contract counterparty risks; key personnel risk; business integration risks; risks inherent to equity and debt markets and their effects on our share price, and such other risks as may be detailed from time to time in the filings made by the Company pursuant to securities regulations, as well as other risks that may presently be unknown to us or which we consider to be immaterial at the time such forward-looking statements are made. As a result of these risks and uncertainties, the Company cannot guarantee that any forward-looking statement will materialize as expected, and the reader is therefore cautioned not to place undue reliance on any forward-looking statements contained in this news release. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement, are made only as of the date of this news release and the Company does not intend to update any of the forward-looking statements contained in this news release except as expressly required by applicable securities laws.

Blackhawk Growth’s SAC Pharma Announces Record August Revenue of CDN$460,000 and Includes Operational Update

Vancouver, British Columbia – TheNewswire – September 09, 2021 – Blackhawk Growth Corp. (CSE:BLR) (CNSX:BLR.CN) (Frankfurt:0JJ) (OTC:BLRZF) (the “Company”), is excited to announce the record unaudited revenue in the month of August for Sac Pharma Partners USA (“SAC Pharma”), its wholly owned subsidiary, of CDN$460,000. Sac Pharma continues to show strong revenue growth. Revenue for the 8 months ended August 31, 2021 is a company record of CDN$1,842,000. Sac Pharma has also continued to show strong gross margins of greater than 80% and positive cash flow for the year to date. These results are due to increasing facility yields, and the strong demand for Sac Pharma’s premium products.

Sac Pharma is also very excited to announce that the next of its proprietary strains, “Morada” has completed the R&D testing approvals and has shown very high producing yield. The robust profile, color and potency has enabled Sac Pharma to be able to have pre-sold the entire production run of the new Morado premium product.

“Blackhawk is thrilled with the operating results and the continued development of very desirable proprietary strains”, states Frederick Pels, CEO of Blackhawk. “We are very happy to have such a strong brand in our portfolio of companies.”

Sac Pharma is operating at near capacity and expansion planning has begun.

Sac Pharma’s signature products include the coveted Black Truffle, White Truffle strains, along with Bacio and Gelato.

The Company cautions that figures for revenue and margin generated by Sac Pharma have not been audited and are based on calculations prepared by management.  Actual results may differ from those reported in this release once these figures have been audited.

For more information on Blackhawk, please visit our website at:

https://www.blackhawkgrowth.com/

About Blackhawk Growth

Blackhawk is an investment holding looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods and MindBio Therapeutics. Blackhawk continues to bring its investments to cash flow and is growing at an exceeding pace.

The Company diligently posts updates through videos from the official company YouTube channel https://www.youtube.com/channel/UCs4f2tt3yAvOGhNLjgNOy-A

Please join the conversation on our Blackhawk group supporter’s telegram group at https://t.me/Blackhawkgrowthcorp and visit us online at https://www.blackhawkgrowth.com.

Frederick Pels, Chief Executive Officer

(403)-991-7737

fred@blackhawkgrowth.com

Cautionary Note Regarding Forward-Looking Statement

All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Company within the meaning of applicable securities laws, including with respect to the future prospects of the business of the Company and Sac Pharma USA. The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company’s public filings under the Company’s SEDAR profile at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The 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 unless required by law.

Silo Wellness Announces Filing of Subsidiary Interim Financial Statements

TORONTO, Sept. 08, 2021 (GLOBE NEWSWIRE) — Silo Wellness Inc. (“Silo Wellness” or the “Company”) (CSE: SILO) (OTCQB: SILFF) (FRA: 3K70), announces that further to a continuous disclosure review by staff of the Ontario Securities Commission, the Company is filing the interim financial statements of FlyOverture Equity, Inc., a wholly-owned subsidiary of the Company, for the three month period ended January 31, 2021.

ABOUT SILO WELLNESS 
Silo Wellness is a growth-oriented holding company focused on functional mushroom and psychedelic opportunities that benefit from a unified ecosystem and exceptional leadership. Founded in 2018 and headquartered in Toronto, Silo Wellness has operations in Jamaica and Oregon. Silo Wellness is a publicly-traded company on the Canadian (CSE: SILO) and Frankfurt (FRA: CK70) exchanges and trading on the OTCQB Venture Market (OTCQB: SILFF).

Silo Wellness offers a diverse and growing portfolio of functional mushroom products, psychedelic wellness retreats in Jamaica and Oregon, cultivation of psychedelic mushrooms and truffles in Jamaica, development of a brick-and-mortar smart shop in Jamaica, and intellectual property, focused initially on the commercialization of its metered-dosing psilocybin nasal spray.

In March 2021, Silo Wellness announced a multi-year licensing agreement with the family of legendary musician Bob Marley for the exclusive worldwide rights to brand, market and sell a distinct product line of functional and psychedelic mushrooms. The Marley One line of functional mushrooms is available at www.marley.one.

For more information about Silo Wellness, please visit www.silowellness.com.

For further information, please contact:

Silo Wellness Media Relations:
hello@trailblaze.co

Silo Wellness Investor Relations:
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION: This news release contains “forward-looking information” and “forward-looking statements”  (collectively, “forward-looking statements”) within the meaning of the applicable Canadian  securities legislation. All statements, other than statements of historical fact, are forward-looking  statements and are based on expectations, estimates, and projections as at the date of this news  release. Any statement that involves discussions with respect to 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 statements. In this news release, forward-looking statements  relate, among other things, to the business plans of Silo Wellness. Forward-looking statements are  necessarily based upon a number of estimates and assumptions that, while considered  reasonable, are subject to known and unknown risks, uncertainties, and other factors which may  cause the actual results and future events to differ materially from those expressed or implied by  such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties and the potential impact of COVID-19.  There can be no assurance that such statements will prove to be accurate, as actual results and  future events could differ materially from those anticipated in such statements. Readers should not place undue reliance on the forward-looking statements and information  contained in this news release. Silo Wellness assumes no obligation to update the forward-looking  statements of beliefs, opinions, projections, or other factors, should they change, except as  required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES  PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS  RELEASE. 

PharmaTher Provides Business Highlights and Releases Annual Financials for Fiscal Year Ended May 31, 2021

TORONTO, September 7, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today released business highlights and financial results for its fiscal year ended May 31, 2021.  Unless otherwise indicated, all amounts in this press release are in Canadian dollars. 
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “We had a tremendous year which focused on solidifying exclusive licenses for the development and commercialization of novel ketamine uses and formulations, as well as drug delivery technologies via a microneedle transdermal patch with the aim to change the way how ketamine and psychedelics are used to treat mental health, neurological and pain disorders.  In addition, we have strengthened our intellectual property portfolio and built a formidable clinical and scientific advisory team to support our research collaborations with leading research institutions and our clinical and commercial ambitions.  PharmaTher is now focused on completing its drug delivery research programs and clinical studies for the use of ketamine in Parkinson’s disease, depression, and ALS.  I like to thank the PharmaTher team, our Board of Directors and our shareholders for supporting our objective in unlocking the therapeutic potential of ketamine and psychedelics as next-generation pharmaceuticals for unmet medical needs.”

Business Highlights:

• Solidified four exclusive license agreements, including the University of Arizona for the development and commercialization of ketamine in the treatment of Parkinson’s disease; BioRAE, Inc. for the development and commercialization of a novel biocompatible and biodegradable gelatin methacryloyl microneedle delivery technology developed at the University of California, Los Angeles (UCLA) for use with psychedelic pharmaceuticals (i.e. psilocybin, MDMA, LSD, DMT); National Health Research Institutes for the development and commercialization of a patented combination formulation of ketamine and betaine (KETABET™); The Queen’s University of Belfast for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to deliver ketamine and KETABET™; and The University of Kansas for the development and commercialization of ketamine in the treatment amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.

• Formed essential research and development collaborations, including a sponsored research agreement with the Terasaki Institute to develop a novel microneedle patch that aims to deliver psilocybin, MDMA, LSD and DMT; a sponsored research agreement with The Queen’s University of Belfast for the development of a patented hydrogel-forming microneedle patch to deliver ketamine and PharmaTher’s proprietary ketamine formulation, KETABET™; a collaboration agreement with MediSynergics, LLC. to develop patented ketamine derivatives and to investigate drug discovery and development of next-generation psychedelic derivatives; and a co-development agreement with TSRL, Inc. to jointly develop a microneedle array patch with the aim to control the manufacturing and supply of microneedle patches for the Company’s clinical and commercial drug programs.

• Closed the sale of PharmaTher’s intellectual property pertaining to psilocybin, via an asset purchase agreement with Revive Therapeutics Ltd. (CSE: RVV, USA: RVVTF), for consideration of up to $10 million satisfied as follows: (i) $3 million in cash (ii) $4 million through the issuance of securities in the capital of Revive and (iii) up to $3 million, in either cash or securities in the capital of Revive for future milestones.

• Strengthened the Company’s clinical and scientific advisory team with the addition of Maurizio Fava, MD, Psychiatrist-in-Chief in the Department of Psychiatry at Massachusetts General Hospital; Dr. Robert A. Hauser, MD, MBA, Professor of Neurology and Director of the University of South Florida Parkinson’s Disease and Movement Disorders Center; Dr. Alberto J. Espay, MD, MSc, FAAN, Professor and Endowed Chair of the University of Cincinnati James J. and Joan A. Gardner Family Center for Parkinson’s Disease and Movement Disorders; and Professor Matthew Macaluso, D.O., Bee McWane Reid Professor for the Department of Psychiatry and Behavioral Neurobiology in the School of Medicine at The University of Alabama at Birmingham (UAB) and Clinical Director of the UAB Depression and Suicide Center.

• Announced the FDA approved the Company’s Investigational New Drug application to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.

Financial Highlights
·      Cash and cash equivalents ($2,778,081) and Investment ($3,100,000) for a total of $5,878,081 as of May 31, 2021.
·      Net loss was $2,664,196 for the financial year ended May 31, 2021.
For further information, please refer to the Company’s audited annual financial statements prepared in accordance with International Financial Reporting Standards and the related management’s discussion and analysis for the financial year ended May 31, 2021, which are available under the Company’s profile on SEDAR at www.sedar.com.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Red Light Closes Acquisition of Mera Life Sciences and Files Quarterly Financial Statements

Toronto, Ontario–(Newsfile Corp. – August 31, 2021) – Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) (“Red Light Holland” or the “Company”), an Ontario-based corporation engaged in the production, growth and sale of a premium brand of magic truffles, is pleased to announce that its financial results for the quarter ended June 30, 2021 (“Q1FY22”) have been filed on SEDAR. Separately, the Company has closed its previously announced acquisition of Mera Life Sciences (“Mera”).

Financial Statements

The Company is pleased to announce that its annual financial statements for the quarter ended June 30, 2021 are now available on SEDAR and highlights key data points below:

– Q1 FY22 revenue grew 521% over Q4 FY2, to $595,137

– Cash balance remains healthy, in excess of $29 million

– Company remains committed to identifying and executing M&A transactions within psychedelics and recreational THC markets

“I’m so proud of our team for another great quarter. This is the second quarter in a row we have grown revenues by over 500%, and growing our revenues on a quarterly basis remains a core focus of our business in becoming a revenue focused Psychedelic Company,” said Todd Shapiro, CEO and Director of Red Light Holland. “As well, our team remains razor focused on identifying and executing additional M&A transactions in both the psychedelics and recreational THC sectors, and we hope to bring additional deals to the market over the coming months with counterparties that exhibit material revenue capabilities and cautious spending habits.”

Mera Life Sciences

Shapiro added: “Separately, we have also completed the acquisition of Mera and its coveted psychedelic licenses in St. Vincent and the Grenadines. We have renamed Mera to Scarlette Lillie Science and Innovation, which allows for us to carefully pursue financially disciplined high quality psychedelic product research and development, open up treatment clinics, cultivate, extract and process, and export not just Psilocybin, but other compounds such as Ayahuasca, MDMA, DMT, Peyote, Ketamine and many other natural based plants. Red Light Holland can now explore the inner molecular worlds of multiple plant species, including a variety of psychedelics potentially putting us in a position to discover novel clinical applications for a variety of natural psychedelics. We hope to be on the frontier of natural plant based drug discovery while being in control of the inner workings including staffing, budgeting and a synergistic company culture.”

“Working through the Mera acquisition with the various stakeholders involved has been a really fantastic experience,” said William Lay, EVP and Chief Strategy Officer of Red Light Holland. “I’m really excited for Red Light to take advantage of such a comprehensive applied science landscape to further its initiatives within the Scarlette Lillie Sciences and Innovation division, and to continue pursuing attractive M&A opportunities.”

Hon. Minister Saboto Ceasar, Minister of Agriculture, Forestry, Fisheries, Rural Transformation Industry and Labor of St. Vincent and the Grenadines added: “We welcome Red Light Holland and Scarlette Lillie Sciences and Innovation as one of the Pioneer Licensees in St. Vincent and the Grenadines’ modern medicinal wellness industry. Our mantra is that this industry ‘begins and ends with science’. This important event demonstrates that our legal framework and wide range of protocols will make St Vincent and the Grenadines an enviable business and research destination for serious scientists and psychedelics companies. Red Light Holland is a world-class, professional organization that patiently worked through all details required to ensure a successful and profitable venture. Their CEO Todd Shapiro has invested and established roots here in our country that will flourish into a special partnership. We are excited to work with the entire team as they continue their march forward.”

The Acquisition was completed pursuant to the terms of the definitive agreement (the “Acquisition Agreement”) dated July 29, 2021, pursuant to which Red Light Holland acquired 100% of the issued and outstanding shares of Mera for $2,450,000. The consideration will be comprised of up to 7,000,000 common shares of the Company (the “Red Light Shares”), with each Red Light Share priced at $0.35, representing a 35% premium to the closing price of the Red Light Shares on the Canadian Securities Exchange immediately prior to the closing of the Acquisition. Upon closing of the transaction, the Company issued 700,000 Red Light Shares to the vendor of Mera.

The remaining 6,300,000 Red Light Shares will be released to the vendors based on the achievement of several milestones, which include: the importation of 15,000 grams of iMicrodose truffles to St. Vincent and the Grenadines (“SVG”), governmental authority to rename Mera to Scarlette Lillie Sciences and Innovation, the successful prescription and sale of iMicrodose truffles to at least five patients in SVG or the successful administration of iMicrodose truffles to at least five participants in a scientific study or trial in SVG, the extraction and testing of the iMicrodose truffles, the successful export of iMicrodose truffles from SVG to another jurisdiction, and the final implementation of SVG’s regulatory framework for the psychedelics industry.

Mera currently holds a Medicinal Industry Development License (the “License“) issued by the SVG Bureau of Standards, which permits the research, cultivation, production, development and extraction, import and export, clinical treatment facilities, and prescribed patient access in specifically licensed clinical treatment facilities. The License applies to the following compounds: Tumeric, Aloe Vera, Papaya, Arrowroot, Soursop, Coconut, Ginger, Moringa, Ayahuasca, Mushroom, Iboga, Sassafras, Peyote, Psilocybin, Ibogaine, Dimethyltryptamine (DMT), Mescaline, Ketamine, 3-4 Methylenedioxy – Methamphetamine (MDMA), Lysergic Acid Diethylamide (LSD), 5-Methoxy-N,N-Dimethyltrypotomine (5-MeO-DMT). The Company has worked closely with the SVG government over the last 6 months to assist in the development of the final regulatory framework which will govern the Company’s expected activities in SVG, and has been informed by the SVG government that it expects these regulations, which are in substantially final form, to be signed into law in the near future.

Mera has been renamed Scarlette Lillie Science and Innovation (“SLSI”) and will serve as a key growth driver with respect to its ability to engage in various research and applied science applications.

About Red Light Holland

Red Light Holland is an Ontario-based corporation engaged in the production, growth and sale (through existing Smart Shops operators and an advanced e-commerce platform) of a premium brand of magic truffles.

For additional information on the Company:
Todd Shapiro
Chief Executive Officer & Director
Tel: 647-204-7129
Email: todd@redlighttruffles.com
Website: https://redlighttruffles.com/

Forward-Looking Statements

This press release contains certain “forward-looking information” within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company’s beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company’s control.

Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may contain statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “will continue”, “will occur” or “will be achieved”. The forward-looking information and forward- looking statements contained herein include but are not limited to: identify and executing M&A transactions within psychedelics and recreational THC markets; the completion of the conditions with respect to the 6,300,000 Red Light Holland Shares; the signing of the regulations developed in conjunction with the SVG government into law; and the ability of SLSI to drive growth.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s ability to continue as a going concern; the continued commercial viability and growth in popularity of functional mushrooms and/or magic truffles; continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; and the ability of the Company to fulfil the listing requirements of the CSE.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the risks associated with the psychedelics industry in general such as operational risks in growing, competition, incorrect assessment of the value and potential benefits of various transactions; the inability of the Company to identify and execute M&A transactions within psychedelics and recreational THC markets; the non-completion of the conditions with respect to the 6,300,000 Red Light Holland Shares; the refusal of the SVG government to sign the regulations developed with the Company into law the inability of SLSI to drive growth; the diversion of management time on transaction-related issues; expectations regarding future investment, growth and expansion of the operations of the businesses; regulatory and licensing risks; changes in general economic, business and political conditions, including changes in the financial and stock markets; risks related to infectious diseases, including the impacts of the COVID-19 pandemic; legal and regulatory risks inherent in the cannabis and magic psychedelics industries, including the global regulatory landscape and enforcement related to cannabis and psychedelics, political risks and risks relating to regulatory change; risks relating to anti-money laundering laws; compliance with extensive government regulation and the interpretation of various laws regulations and policies; public opinion and perception of the cannabis and psychedelics industries; and such other risks contained in the public filings of the Company filed with Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof, and thus are subject to change thereafter. Red Light Holland disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Braxia Scientific Reports First Quarter 2022 Financial Results; Company Achieves 80% Revenue Growth from Expanding Clinic Patient Base

Seelos Therapeutics Announces Mid-Year 2021 Business and Clinical Update

NEW YORK, Aug. 9, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced its mid-year 2021 business and clinical update.

“In the first half of 2021, the Seelos team continued to execute at a very high level. Part 1 of the SLS-002 study demonstrated rapid antidepressant and anti-suicidal effects with a well-tolerated safety profile. We have begun the placebo-controlled Part 2 of this registration directed study and plan to enroll in up to 30 sites,” said Raj Mehra Ph.D., Chairman and CEO of Seelos. “The SLS-005 IV trehalose program’s pivotal study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, plans to commence dosing patients in the third quarter as well. We have begun additional in vivo studies with our gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression targeting Parkinson’s disease, and we continue to evaluate additional indications for both SLS-002 and SLS-005.”

In the first half of 2021, Seelos achieved several major clinical and financial milestones and continued to make progress on its multiple clinical stage development programs.

Seelos Business Update

As of the end of Q2, Seelos had $87.2mm of cash. It currently has no outstanding debt.

In January, Seelos raised $33.5 million in net proceeds in an offering of common stock. The company raised an additional $65 million in net proceeds in another offering of common stock. Proceeds were used for the full repayment of Seelos’ prior convertible promissory notes and the remainder is for general corporate purposes and to advance the development of its product candidates.

Also in January, Seelos was selected as one of 17 companies included in the world’s first psychedelic Exchange Traded Fund (ETF), the Horizons Psychedelic Stock Index Fund, which trades on Canada’s NEO exchange and, in June, Seelos was included in the Defiance Next Gen Altered Experience ETF, the first U.S. listed Exchange Traded Fund (ETF) focused on psychedelics, which began trading on May 28^th.

In February, Seelos announced an amendment of its agreement with Vyera Pharmaceuticals AG for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash 9% of the royalties payable on any future net sales of SLS-002.

In April, Seelos announced a Strategic Device Partnership with AptarGroup, Inc. for the co-exclusive use and supply of Aptar Pharma’s Bidose (BDS) Liquid System device for SLS-002 in the investigational development programs for the treatment of suicidality, depression, and Post-Traumatic Stress Disorder (PTSD) and under the terms of the agreement, Seelos has certain rights to add other undisclosed indications to the Strategic Device Partnership.

Seelos was added to the Russell 2000^®, Russell 3000^®, and Russell Microcap^® Indexes at the end of June, as part of the 2021 Russell US Indexes Reconstitution.

Seelos Clinical Update

SLS-002 (intranasal racemic ketamine)

• Data for Part 1, the open-label cohort, of the registration directed study for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder demonstrated a significant treatment effect plus a well-tolerated safety profile.
• In early July, dosing of Part 2, the double-blind, placebo-controlled cohort of the study commenced. A super-majority of the trial sites are in various stages of onboarding.
• On June 15^th, Seelos completed a Type C meeting with the FDA to discuss the regulatory pathway for the SLS-002 program.

SLS-005 (IV trehalose)

• Seelos was issued a patent from the Australian Patent Office covering the parenteral administration of SLS-005  in multiple neurodegenerative indications.
• A Notice of Allowance was received from the Japanese Patent Office covering the parenteral administration of SLS-005 in treating oculopharyngeal muscular dystrophy (OPMD).
• SLS-005 received European Orphan Drug designation for ALS.
• In the third quarter, Seelos is expected to commence dosing of a pivotal Phase IIb/III trial in amyotrophic lateral sclerosis (ALS) as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital at several dozen trial sites across the U.S.

SLS-004 (Parkinson’s disease gene therapy programs)

• In vivo data was released in early July demonstrating down-regulation of SNCA mRNA and protein-expression from a study of SLS-004 in an in-vivo rodent model utilizing CRISPR-dCas9 gene therapy technology.
• Additional studies have commenced to explore efficacy of SLS-004 in the induced Parkinsonism in an in vivo rodent model.

If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding enrollment in Seelos’ Part 2 of the SLS-002 registration directed study focused on patients with major depressive disorder (the “SLS-002 Study”), and the planned dosing of patients in the SLS-005 IV trehalose program’s pivotal study in ALS (with SLS-002 Study, collectively, the “Studies”). These statements are based on Seelos’ current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, or continuing the Studies, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from the Studies are not replicated, or the risk that the clinical results from the SLS-002 Study are materially different from the topline clinical results of Part I of the SLS-002 Study), the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

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

SOURCE Seelos Therapeutics, Inc.

Related Links

https://seelostherapeutics.com