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    BIOV   CA09076M1014

BIOVAXYS TECHNOLOGY CORP.

(BIOV)
Delayed CANADIAN NATIONAL STOCK EXCHANGE  -  03:50 2022-08-11 pm EDT
0.1300 CAD   +8.33%
08/09Biovaxys announces warrant extension
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08/04Biovaxys announces non-brokered private placement
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08/04BioVaxys Technology Corp. announced that it expects to receive CAD 1 million in funding
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BioVaxys Technology : MD&A for six months ended April 30, 2022

06/29/2022 | 10:12pm EDT

BioVaxys Technology Corp.

MANAGEMENT'S DISCUSSION AND ANALYSIS

For the six months ended April 30, 2022

As of June 29, 2022

This Management Discussion and Analysis ("MD&A") of BioVaxys Technology Corp. (the "Company") for the six months ended April 30, 2022 is performed by management using information available as of June 29, 2022. Management has prepared this MD&A with reference to National Instrument 51-102Continuous Disclosure Obligations of the Canadian Securities Administrators. This MD&A should be read in conjunction with the Company's unaudited condensed consolidated interim financial statements for six months ended April 30, 2022, the audited consolidated financial statements for the year ended October 31, 2021, and the related notes thereto. These are prepared in accordance with International Financial Reporting Standards ("IFRS"). All amounts are expressed in Canadian dollars, unless otherwise indicated.

This MD&A contains certain "forward-looking statements" and certain "forward-looking information" as defined under applicable Canadian securities laws that may not be based on historical facts, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect", "predict", "project", "potential", "continue", "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words and similar expressions. Forward-looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements in this MD&A include, but are not limited to, statements relating to:

  • estimates of the Company's future revenues, expenses and profits;
  • treatment under government regulatory and taxation regimes;
  • projections of market prices and costs, and the future market for the Company's products and conditions affecting same;
  • the ability to obtain and protect the Company's intellectual property and proprietary rights;
  • expectations regarding the Company's ability to raise capital;
  • timing and costs associated with completing research and development work relating to the Company's products;
  • the Company's strategies, objectives and plans to pursue the commercialization of its products;
  • the Company's ability to conduct all required clinical and non-clinical trials for its products, including the timing and result of such trials;
  • the Company's estimates of the size of the potential markets for its products and the rate and degree of market acceptance of such products;
  • statements and information concerning the Transaction;
  • statements relating to the business and future activities of, and developments related to the Company after the date of this MD&A and thereafter;
  • market position and future financial or operating performance of the Company; and
  • liquidity of the common shares of the Company.

BioVaxys Technology Corp. (formerly Lions Bay Mining Corp.)

Management's Discussion & Analysis

For the six months ended April 30, 2022

Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. All forward-looking statements, including those not specifically identified herein, are made subject to the cautionary language above and the Risks and Uncertainties section. Readers are advised to refer to the cautionary language when reading any forward-looking statements.

Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company, as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties, and contingencies.

In evaluating forward-looking statements, current and prospective shareholders should specifically consider various factors, including the risks outlined below under the headings Financial Instruments and Risks and Uncertainties.

BUSINESS OVERVIEW

The Company was incorporated on April 25, 2018 pursuant to the provisions of the Business Corporations Act of British Columbia and was a wholly owned subsidiary of Bearing Lithium Corp. Prior to the Transaction described below, the Company was a mineral exploration company. The Company's shares are traded on the Canadian Securities Exchange ("CSE") under the symbol "BIOV" and on OTCQB under the symbol "BVAXF". The registered and records office is located at Suite 503, 905 West Pender Street, Vancouver, British Columbia, V6C 1L6.

The Company is a leader in haptenized protein vaccines and immuno-diagnostics and is currently developing antiviral and anticancer vaccine platforms. The Company is evaluating BVX-0320, a potential SARS-CoV-2 vaccine based on its haptenized viral protein technology, and advancing a Phase I clinical trial in the European Union ("EU") to evaluate its haptenized cell vaccine for late-stage ovarian cancer. The Company is also developing a novel diagnostic platform, CoviDTH™, which screens for a protective, long-term,T-cell response in either patients exposed to SARS-CoV-2 or those who have been vaccinated and who are not sure of their immune status. The vaccines and CoviDTH™ are described in greater detail below.

Acquisition of BioVaxys Inc. (the "Transaction")

On June 2, 2020, the Company and BioVaxys Inc. ("BioVaxys"), an early-stage clinical biotechnology company developing antiviral and anticancer vaccines and immune-diagnostics, entered into a share exchange agreement ("Share Exchange Agreement"). Pursuant to the Share Exchange Agreement, the Company acquired all the issued and outstanding shares of BioVaxys by way of a share exchange with shareholders of BioVaxys on September 30, 2020. Specifically, each shareholder of BioVaxys transferred their shares of BioVaxys to the Company in exchange for fully paid and non-assessable common shares of the Company. As a result, the Company issued 31,100,000 common shares at an agreed price of $0.28 per share in exchange for all of the issued and outstanding securities of BioVaxys, which included 6,788,800 common shares issued to certain advisors and 1,160,000 common shares issued to Thomas Jefferson University ("TJU").

COVID-19

In March 2020, the World Health Organization ("WHO") declared coronavirus COVID-19 a global pandemic. This contagious disease outbreak, which has continued to spread, and any related adverse public health developments, has adversely affected workforces, economies and financial markets globally, potentially leading to an economic downturn. The extent to which the coronavirus may further impact the Company's business activities will depend on future developments, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions, business disruptions, and the effectiveness of actions taken in the United States (or "US"), Canada and other countries to contain and treat the disease. These events are highly uncertain and, as such, the Company cannot determine their financial impact at this time.

The Company has rapidly adapted to the needs of society and the demand from the market for coronavirus vaccine products. It has initiated the study and development of BVX-0320, its proprietary vaccine candidate for COVID-19. Refer to further discussion related to COVID-19 implication under the heading Risks and Uncertainties.

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BioVaxys Technology Corp. (formerly Lions Bay Mining Corp.)

Management's Discussion & Analysis

For the six months ended April 30, 2022

RECENT HIGHLIGHTS

  • On November 6, 2021, the Company announced that results from its in vivo animal research study support the safety and tolerability of CoviDTHTM at two intradermal dose levels across a battery of clinical pathology, immunology and histopathology evaluations. The objective of the study was to determine the potential toxicity and toxicokinetic profile of SARS-CoV-2 spike protein when administered two times via intradermal injection in a rabbit model, and to determine the persistence or reversibility of any toxic effects over a one-week recovery period. Conducted together with global contract research organization Inotiv, Inc. ("Inotiv"), the Good Laboratory Practice ("GLP") study successfully met all objectives and demonstrated the safety, tolerability and lack of toxicity of the purified recombinant SARS-CoV-2s-protein that is a principal constituent of CoviDTHTM. The highest dose tested in the study was 5x-10x higher than the probable dose in humans, with no adverse effects, except some mild localized redness.
  • On November 18, 2021, the Company announced that its Chief Medical Officer, David Berd, MD, has been invited by the Editorial Board of Therapeutic Advances in Vaccines and Immunotherapy to submit a scientific review article based on his speaking engagement entitled Haptenized Protein Vaccines for Viral Diseases and Cancer on December 1 at the World Vaccine & Immunotherapy Congress in San Diego, California.
  • On December 7, 2021, the Company announced that it has entered into a major sponsored research collaboration with Ohio State University ("OSU") to further develop BioVaxys' haptenized viral antigen platform to create a broadly reactive pan-sarbecovirus vaccine. This is the second research collaboration in the SARS- CoV-2 field between BioVaxys and OSU, a leading global academic research institute in the fight against SARS- CoV-2. OSU's Wexner Medical Center serves as a site for SARS-CoV-2 multicenter clinical trials.
  • On February 16, 2022, the Company announced that studies on BVX-0320 demonstrate that the vaccine does not bind to the Angiotensin Converting Enzyme-2 ("ACE2") receptor. The finding suggests that the Company's haptenized SARS-CoV-2 spike protein vaccine may not lead to the unusual, but serious, myocarditis observed with mRNA vaccines. Previous studies in mice have shown that BVX-0320 stimulates a robust antibody and T- cell response, and was safe and well tolerated.
  • On March 17, 2022, the Company announced that it has entered into an agreement with Millipore-Sigma ("Millipore") a global Contract Development and Manufacturing Research Organization ("CDMO"), to manufacture a supply of GLP-gradeBVX-1021, the Company's newly developed vaccine ("BVX-1021") for the strain of coronavirus that causes Severe Acute Respiratory Syndrome ("SARS1"), the respiratory illness responsible for the deadly 2002-2004 pandemic. There are no vaccines approved for SARS1. BVX-1021is the subject of the ongoing research collaboration between The Ohio State University ("Ohio State") and BioVaxys, announced December 7th, 2021, that is evaluating the Company's novel approach for a "universal vaccine" that can treat a broad range of sarbecoviruses ("pan-sarbecovirusvaccine"). Sarbecoviruses are a family of viruses that include SARS-CoV-2and all current 'Variants of Concern' such as Delta and Omicron (as well as at least ten additional variants that are currently being monitored), SARS1, and a broad range of other potentially dangerous zoonotic viruses.
  • On March 30, 2022, the Company announced the expansion of its cancer vaccine platform with BVX-0922, its autologous haptenized tumor vaccine for colorectal cancer ("CRC"). The Company plans to advance an Investigator-Sponsored Clinical Trial Application ("CTA") in the EU with the European Medicines Agency ("EMEA") this year for BVX-0922. An Investigator Sponsored CTA is submitted to regulatory authorities by a clinical investigator who both initiates and conducts an initial clinical study of a new drug or procedure, and under whose immediate direction the investigational drug is administered.
  • On April 25, 2022, the Company announced that it has entered into an agreement with the Deaconess Research Institute ("DRI") to supply BioVaxys with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients undergoing treatment at Deaconess Health System ("Deaconess"). DRI, based in Evansville, Indiana, is the clinical studies arm of Deaconess, a premier regional provider of health care services in the United States. Access to ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918, the Company's autologous haptenized tumor cell vaccine for late-stage ovarian cancer.
  • On April 29, 2022, the Company announced that Mr. Anthony Dutton has been appointed as a director. Anthony is currently President and CEO of Delu Ltd. and provides corporate finance and strategic advisory services to earlier stage growth firms. He was also Co-Founder, CEO and a director of Cannex Capital, a pioneering US cannabis company, before its 2019 acquisition of 4Front Holdings Ltd. to create 4Front Ventures, a large multi-

3

BioVaxys Technology Corp. (formerly Lions Bay Mining Corp.)

Management's Discussion & Analysis

For the six months ended April 30, 2022

state cannabis operator. Prior to Cannex, Anthony was a Co-Founder, CEO and director of IBC Advanced Alloys, a leading manufacturer of high-performance alloys serving global manufacturing and aerospace contractors. He currently serves on the board of Sanatana Resources Inc. Anthony has a BA (Econ) from UBC, a M. Arch. From Dalhousie and a joint MBA from the Cranfield School of Management, UK and the Ecole Superieure de Commerce in Lyon, France.

  • On May 2, 2022, the Company announced that it has continued to expand the patent coverage for its cancer vaccine platform by filing an international patent application through the Patent Cooperation Treaty ("PCT") for broad geographic market coverage outside the US for cervical cancer.
  • On May 18, 2022, the Company announced that Hospices Civils de Lyon, France ("HCL") has agreed to serve as a clinical study site for the Phase I study of BVX-0918, the Company's autologous haptenized tumor cell vaccine for late-stage ovarian cancer. HCL has further agreed to supply BioVaxys with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients undergoing treatment at the hospital to permit the Company to perform manufacturing tests.
  • On June 3, 2022, the Company announced that The Ohio State University ("Ohio State"), its research collaborator that is jointly evaluating the Company's novel approach for a "universal vaccine" that can treat a broad range of sarbecoviruses ("pan-sarbecovirus vaccine"), has completed preparation of the surrogate virus neutralization assays for the SARS-CoV-2 variants, as well as Pangolin-Cov-GD1 and Bat-CoV-RaTG13 sarbecoviruses. The next step will be immunizing the test animals with BVX-1021, BioVaxys' "booster" vaccine to be administered with current SARS-CoV-2 vaccines, to target sarbecoviruses.
  • On June 8, 2022, the Company announced that its Lyon, France-based bioproduction partner, BioElpida, has completed the creation of multiple OVCAR-3 cell banks as the next step in the GMP manufacturing process development for BVX-0918, BioVaxys' vaccine for treatment of platinum-resistant ovarian cancer. The OVCAR- 3 cell line is mandatory for creating the identity assays that will have to be performed on every batch of ovarian cancer vaccine. This assay is required by regulatory bodies in the EU and United States. The cell line is derived from a human ovarian adenocarcinoma, established from a patient refractory to cisplatin, a chemotherapeutic agent used in late-stage ovarian cancer. Patients whose tumors are innately cisplatin-resistant at the time of initial treatment generally have poor prognosis, which is the patient population target for BVX-0918.
  • On June 15, 2022, the Company announced that its clinical study collaborator HCL has surgically excised the first ovarian cancer tumors from cancer patients to be used by the Company for process development and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production of the Company's ovarian cancer vaccine.

PRODUCTS AND DEVELOPMENT

Haptenized Vaccines Platform

The Company's vaccine platform is based on the concept of haptenization. Haptenization is based on the established immunological concept that modifying surface proteins, whether they are viral or tumor, with simple chemicals called haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient's immune system to recognize and make target proteins more "visible", thereby stimulating a T-cell mediated immune response. This is critical for fighting viral pathogens or cancer cells, as T-cells directly battle viruses or tumors by targeting and destroying infected or cancerous cells. Haptenization is based on proven science and extensive clinical data. There is also growing evidence that it can be used for many viruses and any resectable (i.e., surgically removable) solid tumors. The Company is building a pipeline of vaccine products that are based on this proprietary technology platform of hapentizing antigens to elicit a robust immune response. Current development programs target ovarian cancer, cervical cancer, Human papillomavirus, SARS-CoV-2 and pan-sarbecoviruses.

SARS-CoV-2 Vaccine Candidate (BVX-0320)

BVX-0320 is the Company's Investigational New Drug ("IND") stage vaccine candidate for SARS-CoV-2. The vaccine is the recombinant S1 subunit of the spike protein of SARS-CoV-2 that has been modified with a chemical called a hapten, specifically, dinitrophenyl. The Company has developed a simple, low-cost procedure for manufacturing its vaccines, and BVX-0320 can be stored in a universally available freezer.

4

BioVaxys Technology Corp. (formerly Lions Bay Mining Corp.)

Management's Discussion & Analysis

For the six months ended April 30, 2022

The Company believes that by utilizing a process called haptenization, the S-spike antigens are changed so that they become visible to the patient's immune system. This allows the immune system to mount a response against the S-spike antigen that results in the loss of ability of the virus to attach to human cells.

Studies (May 14, 2020, Cell) have demonstrated that patients recovering from SARS-CoV-2 carried helper T-cells that recognized the SARS-CoV-2S-spike protein; virus-specific killer T-cells were detected in 70% of the test subjects. As haptenized proteins are known to induce potent T-cell responses, the Company believes BVX-0320 will have an advantage over other developing COVID-19 vaccines.

In December 2020, the Company completed its preclinical program for BVX-0320, which was the Murine Model Study that evaluated in vivo immune response, T-cell activation and tolerability of BVX-0320, which were studies suggested by the US Department of Health and Human Services, US Food and Drug Administration ("FDA") and Center for Biologics Evaluation and Research ("CBER") in their published Guidance on Development and Licensure of Vaccines to Prevent COVID-19 (the "Guidance"). The Guidance is intended to assist in the clinical development and licensure of vaccines for the prevention of COVID-19 and reflects the FDA's current thinking on the issue.

Conducted by Charles River Laboratories, Inc. ("CRL"), under contract with the Company, the preclinical program, which began in September 2020, evaluated the anti-virus immune response elicited by BVX-0320 in the Murine Model Study by measuring the development of antibodies to the protein that binds the virus to human cells. Following two injections of BVX-0320, together with QS-21, to 28 mice at four dosage levels, 96.4% developed positive antibody responses at week 6. The Company also found that BVX-0320 activated CD4+ helper T-cells and CD8+ killer T-cells that express the activation markers, CD69 and CD25. This result indicates that immunization with BVX-0320 at two different dose levels of 3μg or 10μg stimulated CD4+ helper T-cells and CD8+ killer T-cells. CD4+ helper T-cells are crucial in achieving a regulated effective immune response to viral pathogens and are central to adaptive immune responses. Generated following an immune response, memory CD4+ helper T-cells retain information about the virus, which enables them to respond rapidly after viral exposure. CD8+ killer T-cells have the capacity to kill cells infected by the virus, thereby stopping viral replication in those cells.

BVX-0320 also elicits a neutralizing antibody response against SARS-CoV-2, as evidenced by further analysis of sera samples from the Murine Model Study. Under a Company research collaboration, OSU researchers observed in a pooled sample that BVX-0320 elicited the production of neutralizing antibodies to SARS-CoV-2. The findings were obtained from a Plaque Reduction Neutralization Test, where the endpoint is reduction of plaques by 50%, after using available remaining mouse sera from the immune response assay. Plaques are produced by infection of cultured human cells by a live SARS-CoV-2 virus.

On February 16, 2022, the announced that studies on BVX-0320 conducted by Millipore demonstrate that the vaccine does not bind to the ACE2 receptor. The finding suggests that the Company's haptenized SARS-CoV-2 spike protein vaccine may not lead to the unusual, but serious, myocarditis observed with mRNA vaccines. Previous studies in mice have shown that BVX-0320 stimulates a robust antibody and T-cell response and was safe and well tolerated.

BVX-1021

On March 17, 2022, the Company announced that it has entered into an agreement with Millipore-Sigma ("Millipore") a global Contract Development and Manufacturing Research Organization ("CDMO"), to manufacture a supply of GLP-gradeBVX-1021, the Company's newly developed vaccine ("BVX-1021") for the strain of coronavirus that causes Severe Acute Respiratory Syndrome ("SARS1"), the respiratory illness responsible for the deadly 2002-2004 pandemic. There are no vaccines approved for SARS1. BVX-1021is the subject of the ongoing research collaboration between The Ohio State University ("Ohio State") and BioVaxys, announced December 7th, 2021, that is evaluating the Company's novel approach for a "universal vaccine" that can treat a broad range of sarbecoviruses ("pan- sarbecovirus vaccine"). Sarbecoviruses are a family of viruses that include SARS-CoV-2and all current 'Variants of Concern' such as Delta and Omicron (as well as at least ten additional variants that are currently being monitored), SARS1, and a broad range of other potentially dangerous zoonotic viruses.

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Disclaimer

Biovaxys Technology Corp. published this content on 30 June 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 June 2022 02:11:08 UTC.


© Publicnow 2022
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Financials
Sales 2021 - - -
Net income 2021 -6,46 M -5,06 M -5,06 M
Net cash 2021 0,59 M 0,47 M 0,47 M
P/E ratio 2021 -4,75x
Yield 2021 -
Capitalization 13,4 M 10,5 M 10,5 M
EV / Sales 2020 -
EV / Sales 2021 -
Nbr of Employees -
Free-Float 74,1%
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Managers and Directors
James Christopher Passin Chief Executive Officer & Director
Kenneth E. Kovan President & Chief Operating Officer
Lachlan McLeod Chief Financial Officer & Secretary
David Berd Chief Medical Officer
David Wang Director
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