Avivagen Inc. Announces Results for Fiscal Year Ending October 31, 2021

Research, News, and Market Data on Avivagen

OTTAWA, Ontario, January 19, 2022–(BUSINESS WIRE)–Avivagen Inc. (TSXV:VIV) (“Avivagen” or the “Company”) today reported its audited financial results for the year ended October 31, 2021. Unless otherwise noted, all figures are in Canadian currency.

The Corporation’s Audited Financial Statements for the year ended October 31, 2021, and the accompanying Management’s Discussion and Analysis have been filed on the System for Electronic Document Analysis and Retrieval and are available via its website (www.sedar.com). The financial information for the year ended October 31, 2021, should be read in conjunction with the Corporation’s Financial Statements as well as its Management’s Discussion and Analysis for the year ended October 31, 2021.

“2021 has been an important year for Avivagen as we continued to establish ourselves and our OxC-beta™ product in a growing number of markets worldwide, with OxC-beta™ now approved for sale in seven countries. The AB Vista-distribution agreement (US, Brazil and Thailand), increased product use by Philippines distributor UNAHCO, first commercial use of OxC-beta in sows (new product application), and becoming the cornerstone ingredient in a top selling premium brand of pet food in Taiwan highlight the progress achieved in 2021. Unfortunately, the ongoing Covid-19 pandemic with accompanying disruptions in the global supply chain and continued outbreaks of African Swine Fever (ASF) in Southeast Asia have led to an extremely challenging economic environment for all businesses, including many of Avivagen’s current customers. As a direct result of this, previously announced contracts with Melder and Transformadora have been pushed back. During this same period, potential new customers have completed numerous successful animal trials, with the expectation of new additional sales with our Mexican customers to follow,” says Kym Anthony, Chief Executive Officer.

Throughout this challenging period, Avivagen has continued to set a foundation for strong growth in 2022 and beyond. Initiatives include investment in a major toxicology study which is near completion, investment in additional inventory and further progress on obtaining our non-objection letter from the U.S. Food and Drug Administration (“FDA”), activities which we expect to contribute to future growth. Looking ahead, the Company expects to make further inroads in existing and new markets in Asia and the Americas in the coming year, progressing our relationships with customers in a number of key markets and continuing to grow many of the early-stage customer and partner relationships we successfully established in 2021 which are substantially additive as our customers have displayed growing and recurring revenue models.

Previously announced agreements with AB Vista and UNAHCO to supply OxC-beta™ to feed producers in the United States, Brazil, Thailand and the Philippines are expected to result in recognized revenue beginning in the early part of 2022. The Company is also expecting to receive regulatory approval for the use of OxC-beta™ in a number of large and important Asian feed production markets in the coming year.

The Company reported revenues of $1,295,991 ($1,177,857 in the year ending October 31, 2020) and a comprehensive loss of $(6,394,159) for the year ended October 31, 2021. This compares to a comprehensive loss in the year ending October 31, 2020 of $(4,751,287). As at October 31, 2021, the Company reported total assets of $3,477,774 (current assets of $3,216,022), total liabilities of $7,430,439, and shareholders’ deficit of ($3,952,665).

About Avivagen

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock

Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to Avivagen’s expectations as to future growth and results, expectation as to the completion of toxicology studies, the anticipated continuation of shipments to customers based on recurring orders, timing of future shipments and revenue recognition, expectations as to additional regulatory approvals, and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, sales and use of Avivagen’s products may not grow in the manner anticipated, toxicology studies may not be completed in the time frames expected, initial orders may not result in recurring or repeat orders for Avivagen’s products, despite receipt of the purchase order timing, delivery or fulfilment of orders of product could be delayed for a number of reasons, some of which are outside of Avivagen’s control, which could result in anticipated revenues from such sales being delayed or in the most serious cases eliminated, actions taken by Avivagen’ s customers and factors affecting the business and financial viability of Avivagen’ s customers can have a negative impact on the expectation of future sales and revenues, customer plans may change due to many reasons, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics in livestock feeds, in each case due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Contacts

Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com

ProMIS Neurosciences Announces Antibody Program for Schizophrenia Therapy and Recruitment of Dr. Carsten Korth to its Scientific Advisory Board

News and Market Data on ProMIS Neurosciences

TORONTO, Ontario and CAMBRIDGE, Mass., Jan. 18, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers implicated in the development of neurodegenerative diseases, announced today that it has initiated a program to develop monoclonal antibodies to treat schizophrenia and other chronic mental illnesses. Schizophrenia is a clinical term for a severely disabling neuropsychiatric disease that disrupts employment, families and communities, and likely has heterogenous biological origins.

The biomedical literature has implicated protein misfolding as one cause of schizophrenia. A candidate for a key misfolding protein in schizophrenia was first identified in a Scottish family with a neurodevelopmental syndrome including schizophrenia, such that the gene was named “disrupted in schizophrenia” (DISC1). DISC1, and its genetically-linked protein interactors in the brain, represent a new platform target for ProMIS, given its outstanding track record of predicting and validating misfolding-specific epitopes using proprietary computational approaches.

Dr. Carsten Korth, biological psychiatrist and pioneer on the role of DISC1 in chronic mental illness, has been recruited to the ProMIS Scientific Advisory Board to share his expertise and scientific acumen on this subject. Dr. Korth, a board-certified psychiatrist and Professor of Molecular Neuropathology at University of Dusseldorf, has found that DISC1 pathological aggregates can be detected in the brains of persons dying with sporadic schizophrenia, and that overexpression of human DISC1 leading to DISC1 aggregates in a rat model leads to signs of mental illness similar to those seen in human patients. “ProMIS is now digging deep into the biological basis and treatment for these psychotic scourges of mankind; it is a pleasure to participate and advise on such an effort,” stated Dr. Korth.

“We now have tools – including ProMIS’ proprietary computational algorithms – to approach schizophrenia and related diseases for druggable misfolded protein targets,” stated Dr. Neil Cashman, ProMIS’ Chief Scientific Officer. “This represents a true confluence of opportunity for ProMIS in psychiatric diseases, just like we have accomplished for neurodegenerative diseases.”

About ProMIS Neuroscience
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting misfolded proteins such as toxic misfolded oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary computational modeling techniques. The Company applies its molecular dynamics, computational discovery platform -ProMIS™ and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF
Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: ProMIS Neurosciences Inc.

Neovasc Announces Case Series of First U.S. Reducer Implants Published In Peer-Reviewed Journal

Research, News, and Market Data on Neovasc

VANCOUVER and MINNEAPOLIS – ( NewMediaWire ) – January 18, 2022 –  Neovasc Inc. (Neovasc or the Company) ( NASDAQ , TSX : NVCN) today announced the publication of a case series in the journal Cardiovascular Revascularization Medicine describing successful uses of the Neovasc Reducer™ (Reducer) under a compassionate use protocol in the United States.The patients were treated under the care of Ryan Gindi, M.D., and the procedures were performed by Gerald Koenig, M.D., Ph.D, both from the Division of Cardiology, Henry Ford Hospital, Detroit. Following the commencement of the COSIRA-II Trial in the United States, qualifying patients are now eligible to be treated in a clinical trial for the device.

We are pleased to publish the one-year outcomes of the first two patients treated with the Reducer device in the United States, stated Dr. Gindi. As a clinical cardiologist in a large metropolitan practice, I am confronted with the challenges of treating patients with refractory angina every day. Its gratifying to see the positive impact the Reducer device has had on our patients.

The first patient treated with the Reducer is a 59-year-old male with diabetes suffering from severe coronary artery disease and debilitating refractory angina. The patient had a history of multiple stenting procedures, radiation therapy to treat blocked stents, and extensive medications to treat his chest pain. Despite all efforts to alleviate his anginal symptoms, he lived a significantly restricted lifestyle because of his chest pain. After implantation of the Reducer device, the patient became largely asymptomatic and did not require any further interventional therapy. He described walking several miles around Washington, D.C. without angina.

The second patient is another 59-year-old male with an extensive history of coronary artery disease who previously suffered multiple heart attacks, underwent coronary artery bypass surgery and had multiple stenting procedures to control his symptoms. Despite all efforts and extensive medications, he remained severely restricted by his angina, and was subsequently treated with the Reducer device. A year following the procedure, he described being able to ride a bicycle 35 miles on hilly terrain without angina.

It’s encouraging to see such positive results on the first two patients treated with the Reducer in the United States,” said Dr. Koenig. I have seen first-hand the positive impact that it can have on patients, and we are excited to participate in the COSIRA-II clinical trial at Henry Ford Hospital.

COSIRA-II is a clinical trial designed to evaluate the safety and effectiveness of the Reducer in treating patients suffering from refractory angina. The randomized, double blinded, placebo-controlled trial will enroll approximately 380 patients in the United States and Canada at as many as 50 investigational sites. The primary endpoint of the trial is the change in exercise tolerance testing time measured at six months via a treadmill test.

Now that the COSIRA-II clinical study is underway, we have the opportunity to bring the Reducer therapy to patients suffering from refractory angina in the United States, commented Fred Colen, Chief Executive Officer at Neovasc. It is rewarding to see such positive results on the early US patients treated under compassionate use.

About Reducer

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms.

While the Reducer is not approved for commercial use in the United States, the FDA has granted Breakthrough Device designation to the Reducer. This designation is granted by the FDA to prioritize review of subsequent regulatory submissions for a device that demonstrates compelling potential to provide a more effective treatment of a life-threatening or irreversibly debilitating disease, represents breakthrough technology for which no approved alternatives exist or offers significant advantages over existing alternatives, and the availability of which is in the best interest of patients.

Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.

Contacts

Investors:
Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com

Media:
Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.Leous@westwicke.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, potential benefits of the Reducer, details of the COSIRA-II trails, the opportunity to bring the Reducer therapy to patients suffering from refractory angina in the United States, the growing incidence of refractory angina and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and nine months ended September 30, 2021 (copies of which may be obtained at www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law. www.sedar.com or www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law.

Tuesday, January 18, 2022

Stem Holdings (STMH)(STEM:CA)
Reports Full Year FY2021 Results

Stem Holdings Inc is engaged in the purchasing, improving, and leasing of properties and finance assets which are operated by third parties and are used for the cultivation and retail sale of marijuana. Its properties includes 42nd Street, and Mulino Farm which are used for agriculture. The company generates its revenue in the form of rental income from tenants.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

FY2021 Results. Stem reported net revenue of revenue of $35.8 million compared to $14.0 million last year. Excluding the subsequently divested Driven operations, net revenue totaled $20.9 million, up 49% y-o-y. Adjusted EBITDA loss for the year totaled $5.8 million, compared to a loss of $5.4 million in fiscal 2020. Stem reported a net loss of $64.6 million for the year, including $52.3 million of non-cash impairment charges. Reported EPS loss was $0.40.


FY4Q21.  Although Stem did not disclose fourth quarter 2021 results, by our calculations net revenue was $9.2 million, up from $5.2 million in the year ago period but down from the $10.6 million in the fiscal third quarter. Driven results are included for the full quarter. Reflecting the Driven impairment charge, net loss was $55.2 million, or $0.23 per share …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision.