Mydecine Reports Third Quarter 2021 Financial Results and Provides Business Update

Rhea-AI Summary

Mydecine Innovations Group (NEO: MYCO, OTC: MYCOF) reported Q3 2021 results, announcing a significant 5-year research agreement with Johns Hopkins University to advance smoking cessation studies using its lead candidate, MYCO-001. This agreement marks a historic moment as it's the first U.S. government-funded psychedelic study in over 50 years. The net loss for Q3 2021 was $4.5 million, significantly down from $17.4 million in Q3 2020. The company holds $1.6 million in cash and aims for FDA meetings in early 2022 to expedite treatment development for mental health issues.

Positive

• Entered a 5-year research agreement with Johns Hopkins University to explore multiple therapeutic molecules.
• Launching a seamless Phase 2/3 clinical trial for MYCO-001 for smoking cessation.
• Net loss decreased from $17.4 million in Q3 2020 to $4.5 million in Q3 2021.

Negative

• Current cash position of $1.6 million may raise concerns regarding funding for future trials.

--
To Launch Phase 2/3 Smoking Cessation Clinical Trial with Johns Hopkins University (JHU)

Signed 5-Year Research Agreement with JHU to Further Mydecine’s Research of Multiple Molecules for a Variety of Indications
--

DENVER, Nov. 16, 2021 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today reported its financial results for the third quarter ended September 30, 2021 and provided a business update.

“During the third quarter of 2021, we entered into a 5-year research agreement with Johns Hopkins University School of Medicine, one of the most experienced university departments in conducting clinical research related to the therapeutic use of psychedelics. In collaboration with JHU, we are rapidly progressing one of our lead candidates, MYCO-001, through clinical trials with the upcoming seamless Phase 2/3 smoking cessation clinical trial, and their NIDA grant-funded smoking cessation study which will use MYCO-001. This marks the first time in over 50 years that the U.S government has funded a study of a psychedelic compound for therapeutics,” stated Joshua Bartch, CEO of Mydecine. “As we prepare for the launch of these trials, we expect to meet with the FDA for Pre-Investigational New Drug Application (Pre-IND) meetings in early 2022, another step closer to bringing to market more effective treatments for today’s unmet needs in mental health and addiction.”

Business Highlights During and Subsequent to the Third Quarter 2021

Clinical Trials

• Prepared to supply its lead drug candidate, MYCO-001, for a JHU multi-site NIDA grant-funded smoking cessation study led by Dr. Matthew Johnson.
  
  
• Announced upcoming launch of seamless Phase 2/3 smoking cessation clinical trial studying the science and efficacy of MYCO-001.
  
  
• Signed a five-year research agreement with JHU School of Medicine to advance clinical trials and explore multiple molecules and medicines for a variety of indications.
  

IP Portfolio

• Filed final patent application for MYCO-003 with the United States Patent and Trademark Office and the World Intellectual Property Organization, which is being developed to offer enhanced treatment of anxiety and PTSD.
  
  
• Filed new patent for MDMA-like compounds further expanding its robust portfolio of novel compounds after MDMA-assisted psychotherapy received Breakthrough Therapy Designation from the Food and Drug Administration (FDA).
  
  
• Filed a technology patent that allows for the creation of formulations that utilize nanoemulsion technology to enhance, stabilize and make repeatable properties of ingredients from traditional medicine. The patent will cover formulations that are generally recognized as safe by FDA (GRAS-certified).
  
  
• Successfully synthesized a novel psilocin analogue with improved pharmaceutical properties to further expand its library of patent-pending tryptamines.
  

Technology

• Launched Mindleap 2.0, an updated version of its virtual health platform, providing improved infrastructure, better user experience, and expanded content. The 2.0 version also adds focus on the conscious and trustworthy adoption of psychedelics into the broader categories of mental health.
  
  
• Continued development of AI-driven drug discovery program, screening billions of new drug candidates and filtering them for their ability to modulate the activity of the psychedelic-related targets.
  

Corporate

• Completed its spin-out transaction of ALT House Cannabis Inc., which now holds the Company’s U.S. cannabis assets in order for the Mydecine Innovations Group's team to focus on the company's core drug development business.
  

Financial Results for the Third Quarter 2021

Net Loss: Net loss attributable to common stockholders was $4.5 million for the third quarter 2021, or a basic and diluted loss per share attributable to common stockholders of $0.02, as compared to a net loss attributable to common stockholders of $17.4 million for the third quarter 2020, or a basic and diluted loss per share attributable to common stockholders of $0.11.

Cash Position: As of September 30, 2021, the Company had cash and cash equivalents of $1.6 million.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group's business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we view mental health disorders. Mydecine Innovations Group's vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. 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, and LinkedIn.

For more information, please contact:

Media Contacts
Anne Donohoe / Nick Opich
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1265 / 1-212-896-1206

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

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.

MYDECINE INNOVATIONS GROUP INC.
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
UNAUDITED
(EXPRESSED IN CANADIAN DOLLARS)

As at,		September 30, 2021 $		December 31, 2020 (audited) $
Current assets
Cash		1,593,516		2,190,702
Rent and other receivable		135,674		27,746
Inventory		41,268		47,262
Sales tax receivable		73,632		13,734
Prepaids and deposits		3,782,180		216,003
Total current assets		5,626,270		2,495,447
Non-current assets
Prepaids and deposits		1,922,559		-
Investment in joint venture		158,432		303,982
Note receivable		327,536		316,110
Investment in associate		233,579		4,481,988
Right-of-use asset		154,347		223,645
Investment properties		1,419,347		1,418,345
Property and equipment		521,867		291,614
Total assets		10,363,937		9,531,131
Current liabilities
Accounts payable and accrued liabilities		1,315,927		1,187,486
Convertible debentures		272,740		2,959,755
Derivative liabilities		837,207		1,586,744
Lease liability – current portion		76,969		69,329
Total current liabilities		2,502,843		5,803,314
Non-current liabilities
Long-term portion of lease liability		94,515		167,118
Total liabilities		2,597,358		5,970,432
Shareholders’ equity
Share capital		105,648,795		85,298,435
Contributed surplus		14,848,383		12,734,636
Equity portion of convertible debentures		17,190		254,690
Accumulated other comprehensive loss		(449,317	)	(444,803	)
Deficit		(112,298,472	)	(94,282,259	)
Total shareholders’ equity		7,766,579		3,560,699
Total liabilities and shareholders’ equity		10,363,937		9,531,131

        

             
MYDECINE INNOVATIONS GROUP INC.
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
UNAUDITED
(EXPRESSED IN CANADIAN DOLLARS)

		For the three-month period ended,				For the nine-month period ended,
		September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
Sales		73		17,158		21,278		43,391
Cost of goods sold		(35	)	(21,153	)	(10,032	)	(31,829	)
Gross margin		38		(3,995	)	11,246		11,562
Expenses
Finance cost		22,995		19,151		146,692		19,151
Corporate development		410,424		325,038		2,838,317		1,099,728
Amortization		47,572		61,886		126,767		128,926
Consulting fees		1,617,184		461,623		3,835,207		1,744,009
Director and management fees		454,215		186,520		1,286,723		367,622
Foreign exchange loss (gain)		(65,862	)	(21,233	)	249,746		(158,014	)
Insurance		171,704		-		324,927		-
Office and miscellaneous		427,486		113,441		648,961		170,235
Share of losses (income) from investment in Joint Venture		28,503		-		136,604		-
Share of (income) from investment in Associate		45,056		(7,470	)	86,808		(15,411	)
Professional fees		179,130		43,255		1,529,599		143,088
Regulatory and filing fees		7,879		12,644		185,791		27,091
Research and development		1,265,610		433,408		2,587,740		434,791
Salaries		311,355		-		545,686		-
Share-based payments		-		3,715,421		-		4,725,174
Total expenses		(4,923,251	)	(5,343,684	)	(14,529,568	)	(8,686,360	)
Other income (expenses)
Change in fair value of derivative liabilities		353,612		(740,434	)	575,505		(740,434	)
Impairment of investment in associate		-		-		(4,169,616	)	-
Consideration paid in excess of net assets acquired from acquisition		-		(10,645,239	)	-		(10,645,239	)
Write-off of inventory		-		(458,921	)	-		(458,921	)
Other income		-		35		-		35
Rental income		33,073		45,293		98,539		141,715
Gain (loss) on settlement of debt		-		21,879		(2,319	)	33,304
Total other income (expenses)		386,685		(11,777,387	)	(3,497,891	)	(11,669,540	)
Net loss for the period		(4,536,528	)	(17,125,066	)	(18,016,213	)	(20,344,338	)
Foreign currency translation adjustment		44,114		(279,811	)	(4,514	)	(152,659	)
Net loss and comprehensive loss for the period		(4,492,414	)	(17,404,877	)	(18,020,727	)	(20,496,997	)
Net loss per share – Basic and diluted		(0.02	)	(0.11	)	(0.08	)	(0.22	)
Weighted average number of shares outstanding – Basic and diluted		240,222,065		152,596,239		228,662,632		95,039,381

FAQ

What are the financial results for Mydecine Innovations Group for Q3 2021?

Mydecine reported a net loss of $4.5 million for Q3 2021, down from $17.4 million in Q3 2020.

What new research agreements has Mydecine entered into?

Mydecine has signed a 5-year research agreement with Johns Hopkins University to advance its smoking cessation studies.

What is MYCO-001 and its significance in Mydecine’s research?

MYCO-001 is Mydecine's lead drug candidate being studied for smoking cessation in collaboration with Johns Hopkins University.

When does Mydecine expect to meet with the FDA regarding their clinical trials?

Mydecine anticipates meeting with the FDA for Pre-Investigational New Drug Application meetings in early 2022.

What is the cash position of Mydecine Innovations Group as of September 30, 2021?

As of September 30, 2021, Mydecine had cash and cash equivalents of $1.6 million.