KNE.V - Notable.


Kane Biotech Inc. (KNE.V) is a biotechnology company engaged in the research, development and commercialization of technologies and products that prevent and remove microbial biofilms. KNE.V has a portfolio of biotechnologies, intellectual property (52 patents and patents pending, trade secrets and trademarks) and products developed by the Company's own biofilm research expertise and acquired from leading research institutions.


StrixNB™, DispersinB®, Aledex™, bluestem™, bluestem®, silkstem™, goldstem™, coactiv+™, coactive+®, DermaKB™ and DermaKB Biofilm™ are trademarks of Kane Biotech Inc.


Thesis

Biofilm-related infections are notoriously hard to eradicate and have been the subject of intense scientific research over the past 30 years [6]. Examples of biofilm-associated infections include the colonization of implanted medical devices [39,40] such as central venous catheters, joint prostheses, urinary catheters, pacemakers, and mechanical heart valves; dental caries; lung infections in cystic fibrosis patients [41]; and chronic wounds [40]. The majority of human infections (60%–80%) are biofilm associated [42,43].


Biofilm-associated cutaneous diseases include burns, pressure ulcers, surgical site infections, and diabetic foot ulcers. Their annual incidence is 1.96 million cases in the United States, causing an estimated 268,000 deaths, and an estimated annual direct cost of $18 billion [44].


New Releases


Mar. 2 - Announces Grant of Stock Options. Granted an aggregate of 3,650,000 stock options ($0.18 cents) to certain directors, officers, employees and consultants of the Company.


Apr. 2 - Announces Fourth Quarter and Full Year 2019 Financial Results


May 12 - Reports Positive Results from Anti-Biofilm Shampoo Consumer Product Test


May 14 - Announces Further Extension of Warrants. Further amended the terms of its 34,504,997 common share purchase warrants issued on July 17, 2017 and August 17, 2017 pursuant to a private placement of units, by further extending the expiry thereof from July 17, 2020 to January 17, 2022. The Corporation previously extended the expiry of the Initial Closing Warrants and the Final Closing Warrants on November 12, 2018 for an additional 18 month term.


May 21 - Announces First Quarter 2020 Financial Results.

June 18 - Receives $2.7 Million USD United States Department of Defense Award for DispersinB®: Further to the releases of January 17, 2019 and December 4, 2019, the proposal entitled “DispersinB® the missing link in wound care – Clinical evaluation of DispersinB® to treat biofilm mediated antimicrobial resistance in non-healing chronic wound,” has received the U.S. Department of Defense’s Medical Technology Enterprise Consortium Research Project Award (“MTEC Award”).


The MTEC Award provide approximately $2.7 million USD in non-dilutive funding for the continued clinical development of the Company’s DispersinB® to treat biofilm-mediated antimicrobial resistance in non-healing chronic wounds.

MTEC’s mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting effective life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations.


June 24 - Receives New Funding from CanExport SMEs Program: Approved for up to $54,750 in funding from the Government of Canada’s CanExport SMEs program. KNE.V will use this funding to support the costs associated with the U.S. launch of its Human Health anti-biofilm shampoo and to support the growth of its Animal Health business.


Aug. 12 - Appoints Wound Care and Biofilms Expert, Dr. Gregory Schultz, as Scientific Advisor: Dr. Schultz is the Director of the Institute for Wound Research and Professor of Obstetrics and Gynecology at the University of Florida.


Dr. Schultz has co-authored 400 scientific publications that have been cited more than 19,000 times. He has received $38 million in grant support as a principal- or co-investigator and is an inventor on 34 patents. Dr. Schultz is also a consultant for multiple biotech, pharmaceutical, and medical device companies, and he is a co-founder of two successful biotech companies in the areas of antimicrobial coatings and anti-scarring drugs.


Aug. 20 - Announces Grant of Stock Options: Granted an aggregate of 2,310,555 stock options ($0.16 cents) to certain directors, officers, employees and consultants of the Company in accordance with the Company's stock option plan.

Aug. 27 - Announces Second Quarter 2020 Financial Results.


Sept. 9 - To be Featured in Medtech Webinar Hosted by Alliance Global Partners.

Sept. 23 - Appoints New Advisor: Entered into an agreement with Harbor Access LLC to provide investor relations (North America, Europe). The initial term of the contract will be for four months on a monthly retainer of $8,500 USD.

Sept. 28 - Kane Biotech and Animalcare to Form Animal Health Company to Target Biofilm-Related Ailments: Entered into an agreement with UK-based veterinary products company, Animalcare Group PLC. Animalcare to Invest $5 million, Consisting of $3 million to Acquire One-Third Stake in STEM Animal Health, Kane Biotech’s New Animal Health Subsidiary, and $2 million for Rights to Commercialize Products in Global Veterinary Markets Outside of the Americas.


Animalcare will Launch Biofilm Oral Care Range for Companion Animals in European and Asian Markets.

Oct. 13 - STEM Animal Health Appoints New President and CEO: Kevin Cole will assume the role of President and CEO of STEM Animal Health Inc. (“STEM”), a subsidiary created from the recently formed joint venture with UK-based international veterinary products company, Animalcare Group PLC (AIM:ANCR) (“Animalcare”).


Kevin will focus on building STEM into a globally recognized name in biofilm-targeting technology with an emphasis on developing sales channels and penetrating the growing pet care sector, utilizing STEM’s expanding product lines.

Additionally, a new Board of Directors has been created to support STEM management. As such five new board members were appointed. Marc Edwards, currently President and CEO of Kane Biotech will assume the role of STEM Chairman. He will be joined by Ray Dupuis (Kane Biotech CFO), Georges Morin (Kane Biotech Board Member), Chris Brewster (Animalcare Group, CFO) and Martin Gore (Animalcare Group, Head of Commercial).


Oct. 24 - Builds upon successful results with launch of a US Consumer Test: Launched of a larger consumer product test to further prove the efficacy of the Company’s shampoo on dermatitis and dandruff . KNE.V's has been in development since December 2019 and has delivered positive results from each phase of testing.

This large-scale, multi-product test will focus on US consumers and has a similar design to the consumer trial that was launched earlier this year in Canada. The program is expected to last up to 9 weeks with approximately 3,000 participants. It will serve as both further proof of efficacy of the shampoo and as a customer acquisition strategy tool.


Nov. 5 - Enters into Credit Facility with Pivot Financial: Entered into a one year credit agreement with Pivot Financial Inc. for a non-revolving term loan in the aggregate amount of $1,480,000.00.


The Credit Facility shall be used for: (i) funding research and development relating to eligible government reimbursable expenditures; (ii) expenses related to STEM Animal Health Inc; and (iii) general working capital purposes.


This non-dilutive credit facility has been secured at an opportune time for Kane Biotech as it enters manufacturing, animal study and human study phases of its DispersinB® wound care program in the coming months. These phases of work will require significant cash outlays prior to funding being subsequently received from existing Western Economic Diversification Canada Business Scale-Up and Productivity and U.S. Department of Defense Medical Technology Enterprise Consortium Research Project Award funding programs.” - KNE.V's CFO.


Nov. 26 - Announces Third Quarter 2020 Financial Results.

Dec. 10 - Launch of New Human Health OTC DermaKB™ Product Line: Announce the commercial launch of its DermaKB™ shampoo, shampoo bar and scalp detoxifier as the first products in their new skin care line.

Derma KB products will be sold direct-to-consumer through Kane’s new online commerce site. The retail site will offer several shampoo products that contain Kane Biotech’s proprietary patented coactiv+™ technology. .


Dec. 10 - To Webcast Live at Life Sciences Investor Forum on December 17.


Feb. 24 - Announces New Chairman: Board member Mark Nawacki will take over as Chairman of the Board, and Philip Renaud will assume the role of Vice Chair.


Summary


Financing

In November 2020, KNE.V entered into a one year credit agreement with Pivot Financial Inc. for a non-revolving term loan for $1,48M. The purpose was to (i) fund R&D relating to eligible government reimbursable expenditures; (ii) expenses related to STEM Animal Health Inc; and (iii) general working capital purposes.


Options & Warrants

On May 2020, 34.5M Warrants ($0.18 cents) were extended to January & February 2022. Meanwhile in March 2020, 3.6M options were granted at $0.18 cents and another 2.3M options were granted in August 2020, at $0.16 cents.


Insider Activity

Looking in the past year, insiders have purchased stocks at the open market for about $60,000.


Appointment

In late June 2020, Wound Care and Biofilms Expert, Dr. Gregory Schultz was appointed a as Scientific Advisor

He also happens to be a co-author of this article: Microbial Biofilms and Chronic Wounds.


In October 2020, Stem Animal Health (STEM) appointed Kevin Cole as President and CEO to focus on building STEM into a leading name in biofilm-targeting technology by developing sales channels and penetrating the pet care sector.


In February 2021, Mark Nawacki was appointed to chairman of the board.


AnimalCare & STEM Animal Health

In late September 2020, AnimalCare invested 5$ million in KNE.V. Specifically, $3 million to Acquire One-Third Stake in STEM Animal Health (STEM), Kane Biotech’s New Animal Health Subsidiary, and $2 million for Rights to Commercialize Products in Global Veterinary Markets Outside of the Americas (i.e. European and Asian Markets).


DermaKB

Since December 2019, KNE.V has conducted consumer multi-product tests in Canada and the US which have culminated to the launch of DermaKB product line in December 2020.


MTEC Award

In June 2020, U.S. Department of Defense’s Medical Technology Enterprise Consortium Research (MTEC) awarded a $2.7M USD grant to KNE.V to work on the evaluation of DispersinB® to treat biofilm mediated antimicrobial resistance in non-healing chronic wound. The project is expected to take three years and is in cooperation with Charles Rivers Laboratories, Southwest Regional Wound Care Center (SRWCC).

Project Objective: The objective of the proposed project is to evaluate the stability, preclinical safety, clinical safety, efficacy and usability of the DispersinB® wound gel prototype. The specific aims of this project are:


1. Stability studies: Kane Biotech will conduct stability studies (accelerated and real time) on the final DispersinB® gel, examining the stability of the prototype across a range of temperatures for a minimum of 12 months.

2. Pre-clinical studies: Studies examining biocompatibility and toxicity of the DispersinB® prototype both in vitro and in vivo will be conducted by Charles Rivers Laboratories.

3. Proof of Concept study: Studies examining the efficacy, safety (pharmacokinetics) of DispersinB® gel in a chronic wound pig model will be conducted by Charles Rivers Laboratories

4. Clinical safety study: A human safety study will monitor safety following the application of DispersinB® gel on multiple chronic wound types. This will be a randomized open label study, conducted at the SRWCC.

5. Usability study: A human usability study will examine the ease of using/applying/wearing the DispersinB® topical gel for end users (clinicians and wound care patients). This study will be conducted in conjunction with the safety study at the Southwest Regional Wound Care Center.


Earnings

As displayed below, earnings tend to be lumpy. However, by Q2 2020, KNE.V revenue already exceeded FY 2018 and depending on Q4 2020, it might be able to match FY 2019.

Both STEM and DermaKB revenues are still in early days and expected to grown in Q4 2020 and beyond.


In short

KNE.V appears to be at an inflection point in terms of commercialization of its intellectual properties. The AnimalCare investment In STEM and the introduction of DermaKB product lines represents significant milestones.

However, the MTEC award and the possible imminent commercialization of DispersinB® are indeed notable.


DISCLAIMER: The work included in this article is based on current events, technical charts, and the author’s opinions. It may contain errors, and you shouldn’t make any investment decision based solely on what you read here. This publication contains forward-looking statements, including but not limited to comments regarding predictions and projections. Forward-looking statements address future events and conditions and therefore involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. The content of rally is provided for informational and entertainment purposes only and is not a recommendation to buy or sell any security. Always thoroughly do your own due diligence and talk to a licensed investment adviser prior to making any investment decisions - rally cannot take responsibility for your investment decisions.

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