Artificial Intelligence
Mydecine Reports Financial Results for the Fiscal Year 2021 and Provides a Business Update
MYCO-001 Smoking Cessation Clinical Trial Moves Forward Following Conditional IRB Approval
Company Advances IP Portfolio With New Patent Applications Covering Novel Molecule Families
DENVER, March 31, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today reported financial results and provided a business update for the fiscal year ended December 31, 2021.
“Last year, Mydecine made significant strides toward creating and commercializing new treatments for mental health and addiction disorders,” said CEO Josh Bartch. “The conditional IRB approval we received is yet another positive signal that we will continue to advance our Phase 2b smoking cessation study, and we will hopefully receive full FDA IND approval in the second quarter of this year. We have been working hard to reduce our expenses and increase our efficiencies to continue progressing our clinical trials and expand our IP portfolio. I’d like to personally thank our shareholders, board members and highly dedicated team for enabling Mydecine to reach these significant milestones, and we look forward to another successful year.”
“In addition to our clinical trials, our research and development team has been making significant progress in our drug development program,” said Chief Scientific Officer Rob Roscow. “Over the last year, our new chemical entity (NCE) program has produced multiple patents covering several second-generation novel molecules that we believe will offer significant improvements over classic psilocybin and MDMA. We’re using a modular development approach to our patent strategy, which gives us the flexibility to license, partner or develop our lead drug candidates from our multiple families of NCEs, all wholly owned by Mydecine.”
Highlights of the Business for the Full Year 2021
Clinical Research
- Progressed Phase 2b smoking cessation study following a positive meeting with the Food and Drug Administration (FDA) to review Mydecine’s Investigational New Drug (IND) application. In Q2 2022, the company plans to file an IND and breakthrough status application and will begin patient recruitment upon receipt of FDA approval. The multi-site study’s lead investigator will be Johns Hopkins University.
- Agreed to supply MYCO-001 for Dr. Matthew Johnson’s multi-site NIDA grant-funded smoking cessation study. Johns Hopkins University, New York University, and the University of Alabama in Birmingham are the investigative sites conducting the research. The results from this study will support the safety profile of MYCO-001.
- Signed a five-year Master Collaboration Research Agreement with Johns Hopkins University School of Medicine, demonstrating the Company’s commitment to advancing psychedelic medicine by exploring multiple molecules and drugs for various indications.
Drug Development
- Filed several provisional and full patent applications for novel molecules that outperform first-generation compounds in safety, efficacy, stability, dosing and side effects. This year, the Company intends to file a number of new composition of matter patents supporting its NCE program.
- Patent applications include: novel MDMA analogs, improved psilocybin and other tryptamines (including a shorter duration with patch delivery), potentially heart-safe microdosing drugs, nanoemulsion technology, and technology patents covering the digital healthcare platform Mindleap.
- Unveiled an Artificial Intelligence (AI) drug discovery program that enables rapid screening of billions of compounds and will encourage near-term patent filings for novel molecules. Completed a 5-HT2A serotonin receptor model for Mydecine’s AI program with the intention to build the entire family of serotonin receptors to test its novel molecules against.
- Screened over 25 mushroom species, including various varieties of p. cubensis, and discovered and analyzed more than 40 unique compounds, with the majority appearing to be previously unreported.
Corporate
- Welcomed several new independent board members, including Gordon Neal, Josephine Wu, Dr. Saeid Babaei and Dr. Victoria Hale, who bring a wealth of experience in drug development, clinical trials and technology. The additions assist Mydecine in meeting anticipated capital markets initiatives for 2022.
- Listed on the NEO exchange and submitted an application to list on the NASDAQ.
- Completed the first international export of psilocybin mushrooms.
- Announced that Mydecine’s exclusive dealer was identified as a licensed psilocybin and MDMA supplier in Canada, allowing them to supply active pharmaceutical ingredients through Health Canada’s Special Access Program, which enables healthcare providers to request specific drugs for patients who have not responded well to other treatments.
- Successfully spun out the Company’s legacy cannabis assets to help satisfy certain requirements for a potential future uplisting.
Financial Results for the Fiscal Year 2021
Net Loss: The net loss attributable to common stockholders was $28.9 million, which consisted of $5.3 million loss from discontinued operations, for the fiscal year ended December 31, 2021, or a basic and diluted loss per share attributable to common stockholders of ($0.12). This is compared to a net loss attributable to common stockholders of $26.9 million, which consisted of $0.1 million loss from discontinued operations, for the fiscal year ended December 31, 2020, or a basic and diluted loss per share attributable to common stockholders of ($0.24).
Cash Position: The Company had $1.5 million in cash and cash equivalents as of December 31, 2021. Subsequent to the year end, the Company secured additional funding and is moving forward with clinical trials and projects to expand its IP portfolio.
MYDECINE INNOVATIONS GROUP INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(EXPRESSED IN CANADIAN DOLLARS)
| As at, | December 31, 2021 $ |
December 31, 2020 $ |
|||
| Current assets | |||||
| Cash | 1,495,311 | 2,190,702 | |||
| Accounts receivable | 3,856 | 27,746 | |||
| Inventory | – | 47,262 | |||
| Sales tax receivable | 201,060 | 13,734 | |||
| Prepaids and deposits | 3,521,125 | 216,003 | |||
| Total current assets | 5,221,352 | 2,495,447 | |||
| Non-current assets | |||||
| Prepaids and deposits | 1,793,894 | – | |||
| Investment in joint venture | – | 303,982 | |||
| Loan receivable, net | – | 316,110 | |||
| Investment in associate | – | 4,481,988 | |||
| Right-of-use asset | 130,546 | 223,645 | |||
| Investment properties | – | 1,418,345 | |||
| Property and equipment | 434,910 | 291,614 | |||
| Total assets | 7,580,702 | 9,531,131 | |||
| Current liabilities | |||||
| Accounts payable and accrued liabilities | 1,587,238 | 1,187,486 | |||
| Convertible debentures, net | – | 2,959,755 | |||
| Derivative liabilities | 1,280,294 | 1,586,744 | |||
| Lease liability – current portion | 79,728 | 69,329 | |||
| Total current liabilities | 2,369,383 | 5,803,314 | |||
| Non-current liabilities | |||||
| Convertible debentures, net | 4,354,302 | – | |||
| Lease liability | 67,821 | 167,118 | |||
| Total liabilities | 7,369,383 | 5,970,432 | |||
| Shareholders’ equity | |||||
| Share capital | 107,349,388 | 85,298,435 | |||
| Contributed surplus | 17,536,315 | 12,734,636 | |||
| Equity portion of convertible debentures | 240,756 | 254,690 | |||
| Accumulated other comprehensive loss | – | (444,803 | ) | ||
| Deficit | (124,915,140 | ) | (94,282,259 | ) | |
| Total shareholders’ equity | 211,319 | 3,560,699 | |||
| Total liabilities and shareholders’ equity | 7,580,702 | 9,531,131 | |||
MYDECINE INNOVATIONS GROUP INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(EXPRESSED IN CANADIAN DOLLARS)
| For the years ended, | |||||
| December 31, 2021 |
December 31, 2020 |
||||
| Sales | 7,493 | 2,617 | |||
| Cost of goods sold | – | – | |||
| Gross margin | 7,493 | 2,617 | |||
| Expenses | |||||
| Finance cost | 205,267 | 182,866 | |||
| Corporate development | 3,401,645 | 2,259,956 | |||
| Depreciation | 235,177 | 57,080 | |||
| Consulting fees | 5,220,556 | 3,381,726 | |||
| Director and management fees | 1,346,468 | 539,347 | |||
| Foreign exchange loss | 355,671 | 111,251 | |||
| Insurance | 511,501 | – | |||
| Office and miscellaneous | 925,568 | 292,070 | |||
| Professional fees | 2,216,950 | 934,135 | |||
| Regulatory and filing fees | 349,777 | 201,818 | |||
| Research and development | 3,960,232 | 1,290,548 | |||
| Salaries | 1,424,012 | 17,584 | |||
| Share-based payments | 3,099,743 | 2,487,509 | |||
| Total expenses | 23,252,567 | 11,755,890 | |||
| Other income (expenses) | |||||
| Change in fair value of derivative liabilities | 43,688 | 545,194 | |||
| Consideration paid in excess of net assets acquired from acquisition | – | (10,645,239 | ) | ||
| Impairment of goodwill and intangible assets | – | (5,031,967 | ) | ||
| Impairment of loan receivable | (382,902 | ) | – | ||
| Other expenses | – | (24,025 | ) | ||
| Gain on settlement of debt | 1,377 | 33,304 | |||
| Total other income (expenses) | (337,837 | ) | (15,122,733 | ) | |
| Loss from continuing operations | (23,582,911 | ) | (26,876,006 | ) | |
| Loss from discontinued operations | (5,314,488 | ) | (72,939 | ) | |
| Net loss for the year | (28,897,399 | ) | (26,948,945 | ) | |
| Foreign currency translation adjustment | – | (382 | ) | ||
| Net loss and comprehensive loss for the year | (28,897,399 | ) | (26,949,327 | ) | |
| Net loss per share – Basic and diluted from continuing operations | (0.12 | ) | (0.24 | ) | |
| Weighted average number of shares outstanding – Basic and diluted | 234,086,043 | 113,714,260 | |||
About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.
Learn more at: https://www.mydecine.com and follow us on Twitter, LinkedIn, YouTube and Instagram.
For more information, please contact:
Media Contact
Morgan Kervitsky, Director of Marketing
[email protected]
Investor Relations
Morgan Kervitsky, Director of Marketing
[email protected]
On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
[email protected]
For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.
This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause 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 information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.
Artificial Intelligence
J.P. Morgan Life Sciences Private Capital, Blue Horizon Advisors and United Al Saqer Announce Winner of Inaugural 2024 Life Sciences Innovation Summit
In conjunction with Abu Dhabi Global Healthcare Week 2024
ABU DHABI, UAE, May 17, 2024 /PRNewswire/ — J.P. Morgan Life Sciences Private Capital, Blue Horizon Advisors and United Al Saqer Group announced today Rayees Rahman of Harmonic Discovery as the winner of the inaugural J.P. Morgan Asset Management: Life Sciences Innovation Summit. Harmonic Discovery is a precision pharmacology company applying its generative chemistry platform to advance next-generation kinase inhibitors.
In partnership with the Department of Health – Abu Dhabi (DoH), the Summit took place on May 14-15, 2024 at Cleveland Clinic Abu Dhabi and showcased the 11 innovative finalists, as well as highlighted existing innovators and opportunities in the Emirate of Abu Dhabi. The event also featured keynote speeches from Dr. Laurie Glimcher of Dana-Farber Cancer Institute, Dr. Shahrukh Hashmi of the Department of Health – Abu Dhabi, and Dr. David Ho of Columbia University Medical Center and provided attendees networking opportunities to gain valuable insights into the future of life sciences innovation.
In addition, the jury designated Chun-Hao Huang of Algen Biotechnologies as honourable mention. Algen Biotechnologies is a platform therapeutics and drug discovery company using world-leading CRISPR and AI to find treatments for cancer, inflammation and metabolic diseases.
The winners were selected by an esteemed, international panel of judges, which included:Laurie Glimcher, MD, President and CEO at Dana-Farber Cancer InstituteJorge Guzman, MD, CEO at Cleveland Clinic Abu DhabiProf. Shahrukh Khurshid Hashmi, MD, Director of Research, Department of Health, Abu DhabiYasmine Hayek Kobeissi, PhD, CQF, BSc., Executive Director at Blue Horizon AdvisorsAnya Schiess, Managing Partner at J.P. Morgan Life Sciences Private CapitalWalid Zaher, PhD, Co-Founder and CEO, Carexso
Dr. Asma Al Mannaei, Executive Director of the Research and Innovation Centre at the Department of Health – Abu Dhabi said: “Under the directives of the UAE’s wise leadership, and renowned for its world-leading medical infrastructure, Abu Dhabi stands at the forefront of healthcare excellence, offering an unparalleled opportunity for advancement in healthcare for global partners. It was our utmost pleasure hosting the J.P. Morgan Asset Management Life Sciences Innovation Summit 2024 on the sidelines of Abu Dhabi Global Healthcare Week and we commend the winners for their pioneering efforts in driving impactful advancements in healthcare; their dedication to innovation not only transforms the landscape of medicine, but also holds the promise of improving lives worldwide.”
Stephen Squinto, PhD, Chief Investment Officer, J.P. Morgan Life Sciences Private Capital said: “We are thrilled with the level of biotech passion and innovation that we observed at this year’s Summit in Abu Dhabi. The energy was truly palpable we are thrilled to announce Rayees Rahman as the winner of our first Life Sciences Innovation Summit. Harmonic Discovery’s approach embodies the next generation of drug discovery and development. We appreciate the time and effort of all participants and cannot wait for our next event in the region.”
Nabil Kobeissi, Chief Executive Officer of Blue Horizon Advisors, said: “As the main sponsor, we are committed to nurturing and fostering the growth of all 11 finalists in this vibrant biotech ecosystem. This Summit marks the beginning of a transformative journey, and we are confident that it will pave the way for a flourishing hub in the region. We are also pleased to announce that we will commit to invest in and partner with the winner, Harmonic Discovery, to support its future growth in the region.”
Sponsors for the event included J.P. Morgan Life Sciences Private Capital, J.P. Morgan Commercial Bank, Blue Horizon Advisors, United Al Saqer Group, Thermo Fisher Scientific, and Salam Capital. The Summit organisation, logistics and finalist recruitment were facilitated by Lyfebulb.
Of importance, at the Summit, Mr. Mohamed Al Breiki, Executive Director of Sustainable Development at Masdar City, announced that Masdar City Free Zone would award all 11 Finalists complimentary business licenses to further support their establishment in the region. Masdar City is one of the world’s most sustainable urban developments and innovation hubs with a growing focus on life science entrepreneurship in Abu Dhabi.
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Artificial Intelligence
Congregating in the Lion City for a Win-Win Future of Intelligent Computing at the Global Data Center Facility Summit 2024
SINGAPORE, May 17, 2024 /PRNewswire/ — On May 17, 2024, the Global Data Center Facility Summit 2024 was held in Singapore with the theme of “Power the Digital Era Forward.” At the summit, over 600 data center industry leaders, technical experts, and ecosystem partners gathered to discuss new trends and opportunities of the global data center industry in the intelligent computing era. The attendees also got to experience all-scenario, all-ecosystem, and all-service end-to-end (E2E) solutions, share innovative practices of green data centers in the Asia Pacific and Europe, and experience the exhibition vehicle to unveil the mystery of Outdoor PowerPOD that features one power system per container. By fully embracing the intelligent computing era, Huawei strives to power the digital era forward.
Seizing Opportunities Brought by AI and Jointly Building Green & Reliable Computing Infrastructure
At the opening speech, Charles Yang, Senior Vice President of Huawei and President of Marketing, Sales and Services, Huawei Digital Power, noted that since ChatGPT ushered in the AI era, large models keep pushing the limits of computing power and the intelligent computing industry is witnessing an unprecedented construction boom. As predicted, 100 GW will be added to the global data center installed capacity and the market value will exceed US$600 billion in the next five years.
According to Charles, with opportunities come challenges. The primary challenge concerning the data center industry is reliability and electricity. Data centers are scaling up from the MW-level to the GW-level. E2E reliability of data centers is becoming even more important than ever. In response to the opportunities, Huawei will work with customers and partners to expand the industry space.
Steering Data Centers to the AI Era with Product + Service + Ecosystem
During the summit, Sun Xiaofeng, President of Huawei Data Center Facility & Critical Power Business, delivered a speech titled “Power the Digital Era Forward. ” He stated that as AI large models are penetrating, the surging compute demands drive the expansive growth in data center.
To address the challenges, Huawei strives to build product + service + ecosystem E2E data center solutions that feature fast deployment, flexible cooling, green energy, and ultimate reliability.
Fast deployment: Data centers are fully modularized and prefabricated to ensure high quality and efficient construction.Flexible cooling: Air-liquid fusion and integrated cooling source emerges as the optimal cooling architecture for intelligent computing.Green energy: New generation-grid-load-storage integrated solution is built to ensure the sound operations of intelligent computing centers.Ultimate reliability: Data centers are safeguarded through reliable products and preventive protection.Currently, Huawei’s global service network covers more than 170 countries with over 1800 professional engineers, providing 24/7 technical support. With N+ flagship service centers, Huawei has built a one-hour service radius for its customers.
The ecosystem is a key part for a win-win future of intelligent computing. Huawei works with partners to develop comprehensive E2E solutions and provide customers with one-stop data center services.
During the summit, Huawei and the ASEAN Centre for Energy released a white paper on “Building Next Generation Data Center Facility in ASEAN.” The document provides insights into the status quo, challenges, and trends of data centers in the ASEAN region, and emphasizes that efficient and energy-saving products and solutions should be applied. It also proposes future-oriented policy recommendations for data center markets.
In the ecosystem exhibition area, Huawei showcased scenario-based solutions for large-, medium-, and small-sized data centers, and demonstrated data center consulting, design, integrated development, and delivery capabilities with dozens of ecosystem partners including CIMC, Weichai, CSCEC, and Huashi.
On a special note, the Huawei Outdoor PowerPOD exhibition vehicle made its global debut. The Huawei Outdoor PowerPOD features one power system per container, outdoor deployment, plug-and-play, and high protection rating and reliability. It has become the preferred choice for decoupling the power supply architecture.
A single tree cannot make a forest.
AI is presenting great opportunities. By delving into the industry, aggregating partner ecosystems, and making innovations applicable to transformations, Huawei will continue to help customers build reliable computing infrastructure, accelerating the industry to embrace AI and powering the digital era forward.
Photo – https://mma.prnewswire.com/media/2415818/Global_Data_Center_Facility_Summit_2024.jpg
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Artificial Intelligence
HOYA Group Company, PENTAX of America, Inc. and MAGENTIQ EYE Ltd. Announce their Intention to Form a Distribution Partnership for the U.S Market
WASHINGTON D.C., May 17, 2024 /PRNewswire/ — HOYA Group Company, PENTAX of America, Inc. (PENTAX Medical) and MAGENTIQ-EYE Ltd., an AI medical device company, announced today their intention to form a partnership in the field of AI in Gastroenterology and to examine further collaboration and strategic partnerships.
Pending field trials and customer demonstrations to be conducted over the next several months, the companies expect to formalize an agreement as a first step in this partnership, by which PENTAX Medical will distribute the MAGENTIQ-COLO™ AI-assisted lesion detection device in the U.S.A. beginning October 1st, 2024. The system will be demonstrated at the upcoming Digestive Disease Week (DDW) in Washington D.C., U.S.A.
MAGENTIQ-COLO™ is a cutting-edge system for the detection of gastrointestinal lesions in colonoscopies. Successfully validated in an international multicenter, randomized, controlled trial (RCT) with 950 enrolled patients at 10 hospitals in Europe, United States and Israel, its outstanding diagnostic capabilities are setting new standards in endoscopic AI.
“We are excited to bring the MAGENTIQ-COLO™ device to the GI community in the U.S. Together with PENTAX Medical’s product portfolio, we are confident to provide a smart solution in colonoscopy and contribute further to colorectal cancer prevention”, says David Harrison, President PENTAX of America, Inc.
“Partnering with PENTAX Medical is an important milestone for us, as it opens new opportunities to introduce our game changing product to the U.S. market, benefiting doctors and their patients and saving more lives”, says Dror Zur, Founder & CEO of MAGENTIQ-EYE.
About MAGENTIQ-EYE Ltd.Founded in 2014, MAGENTIQ-EYE offers a groundbreaking AI-aided colonoscopy solution that offers one of the best performances known today. With worldwide recognition from the gastroenterology community, and dozens of procedures performed every day with the assistance of MAGENTIQ-COLO™, we are setting the new standard of colonoscopy, and saving more and more lives. www.magentiq.com
About PENTAX Medical
PENTAX Medical is a division of HOYA Group. The company’s mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. PENTAX Medical strives to align with the healthcare community’s Triple Aim goals through transparent partnerships with its customers and by providing the highest quality solutions to help them reach their goals, including enabling customers to improve patient outcomes by offering evidence-based solutions across the continuum of care; ensuring value by supporting the customers to improve their efficiency and minimize their healthcare costs; and enriching patient and provider’s experience by empowering every member of the care team to achieve optimal outcomes through products, education, and support. Focused on the outcome instead of technological features, PENTAX Medical listens to the healthcare community and their patients, understands their daily obstacles and helps improve endoscopy with smart innovations.
For more information: https://www.pentaxmedical.com
About HOYA
Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med-tech company and a leading supplier of innovative high-tech and medical products. HOYA is active in the fields of lifecare and information technology, providing eyeglasses, medical endoscopes, intraocular lenses, optical lenses, as well as key components for semiconductor devices, LCD panels, and hard disk drives. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 36,000 people. For more information, please visit: https://www.hoya.com/en/
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