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Mydecine Reports Third Quarter 2021 Financial Results and Provides Business Update

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  • MYCOF

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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
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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


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