As filed with the U.S. Securities and Exchange Commission on August 9, 2024

Registration No. 333-279801

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Amendment No. 1 to

FORM F-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

ASEP MEDICAL HOLDINGS INC.

(Exact Name of Registrant as Specified in Its Charter)

Not Applicable

(Translation of Registrant’s Name into English)

420 – 730 View Street

Victoria, BC V8W 3Y7

Canada

Tel: 778-600-0509

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

Clark Wilson LLP

Suite 900 - 885 West Georgia St

Vancouver, BC, V6C 3H1

604-687-5700

(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)

Copy to:

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box: ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Commission acting pursuant to said Section 8(a) may determine.

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.

Units, each Unit consisting of

One Common Share or One Pre-Funded Warrant to Purchase One Common Share, and

One Common Warrant to purchase One Common Share

Up to               Common Shares underlying the Pre-Funded Warrants, and

Up to               Common Shares underlying the Common Warrants

This is an initial public offering in the United States of up to        units (“Units”) of ASEP Medical Holdings Inc., with each Unit consisting of one common share no par value (“common share”), and one warrant to purchase one common share (each a “common warrant”), based on an assumed initial public offering price of $          per Unit, the midpoint of the range discussed below. Our common shares are currently quoted on the Canadian Stock Exchange under the trading symbol “ASEP” and on the OTC Pink operated by the OTC Markets Group Inc. (the “OTC Pink”) under the trading symbol “SEPSF”. On May 28, 2024, the closing price of our common shares on CSE was CAD 0.1850 and the last reported sale price for our common shares on the OTC Pink was $0.05.

We anticipate that the initial public offering price of each Unit will be between $[__] and $[__] per Unit. We are offering all Units offered by this prospectus. This prospectus also covers the common shares issuable upon exercise of the Pre-Funded Warrants, and the common warrants.

We are also offering to each purchaser of Units that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our common shares outstanding immediately following the consummation of this offering, the opportunity to purchase Units consisting of one pre-funded warrant (in lieu of one common share, each a “Pre-Funded Warrant”), and one common warrant. Subject to limited exceptions, a holder of Pre-Funded Warrants will not have the right to exercise any portion of its Pre-Funded Warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of the holder, such limit may be increased to up to 9.99%) of the number of common shares outstanding immediately after giving effect to such exercise. Each Pre-Funded Warrant will be exercisable for one common share. The purchase price of each Unit including a Pre-Funded Warrant will be equal to the price per Unit that includes one common share, minus $0.0001, and the remaining exercise price of each Pre-Funded Warrant will equal $0.0001 per share. The Pre-Funded Warrants will be immediately exercisable (subject to the beneficial ownership cap) and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. For each Unit including a Pre-Funded Warrant we sell (without regard to any limitation on exercise set forth therein), the number of Units including a share of common stock we are offering will be decreased on a one-for-one basis. The Pre-Funded Warrant may be exercised on a cashless basis.

The Units have no stand-alone rights and will not be certificated or issued as stand-alone securities. The common shares and Pre-Funded Warrants can each be purchased in this offering only with the accompanying common warrants, as part of a Unit, but the components of the Unit are immediately separable and will be issued separately in this offering. See “Description of Securities” in this prospectus for more information.

We have applied to list the common shares on The Nasdaq Stock Market LLC under the symbol “SEPS”. No assurance can be given that our application will be approved. Completion of this offering is contingent on the approval of our listing application for trading of our common shares on the Nasdaq Capital Market. There is no established trading market for any of our common shares, Pre-Funded Warrants, or common warrants. We do not expect a market to develop for our Pre-Funded Warrants or our common warrants, neither do we intend to apply for a listing of any Pre-Funded Warrants, or common warrants on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the Pre-Funded Warrants and the common warrants will be limited.

We are both an “emerging growth company” and a “foreign private issuer” as defined under the U.S. federal securities laws and, as such, may elect to comply with certain reduced public company reporting requirements for this and future filings. See “Prospectus Summary — Implications of Being an Emerging Growth Company” and “Prospectus Summary — Implications of Being a Foreign Private Issuer.”

An investment in our securities is highly speculative, involves a high degree of risk and should be considered only by persons who can afford the loss of their entire investment. See “Risk Factors” beginning on page 9 of this prospectus.

We have granted the underwriter an option, exercisable for forty-five (45) days from the closing of the offering, to purchase up to an additional [__] common shares and/or Pre-Funded Warrants and [ ] common warrants (equal to fifteen percent (15%) of the total number of Units to be offered by us in this offering) on the same terms as the common shares, Pre-Funded Warrants, and common warrants being purchased by the underwriter from us. For a description of the other compensation to be received by the underwriter, see “Underwriting.”

The underwriter expects to deliver the securities comprising the Units against payment in U.S. dollars on or about [___], 2024.

THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

Sole Book – Running Manager

Aegis Capital corp.

The date of this prospectus is ,          2024.

TABLE OF CONTENTS

ABOUT THIS PROSPECTUS

This prospectus is part of a registration statement on Form F-1 that we filed with the U.S. Securities and Exchange Commission (the “SEC”). You should read this prospectus and the information and documents incorporated herein by reference carefully. Such documents contain important information you should consider when making your investment decision. See “Where You Can Find Additional Information” and “Incorporation of Certain Documents by Reference” in this prospectus.

You should rely only on the information contained in or incorporated by reference into this prospectus. We have not authorized anyone to provide you with information different from, or in addition to, that contained in or incorporated by reference into this prospectus. This prospectus is an offer to sell only the securities offered hereby but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in or incorporated by reference into this prospectus is current only as of their respective dates or on the date or dates that are specified in those documents. Our business, financial condition, results of operations and prospects may have changed since those dates.

Unless the context otherwise requires the terms “ASEP Medical Holdings Inc.,” “ASEP,” “we,” “us,” “our,” the “Company,” and “our business” refer to ASEP Medical Holdings Inc., a Canadian public company together with its subsidiaries.

We are not offering to sell or seeking offers to purchase these securities in any jurisdiction where the offer or sale is not permitted. We have not done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the jurisdiction of the United States who come into possession of this prospectus are required to inform themselves about and to observe any restrictions relating to this offering and the distribution of this prospectus applicable to that jurisdiction.

TRADEMARKS AND TRADENAMES

All service marks, trademarks and trade names referred to in this prospectus are the property of their respective owners. Solely for convenience, the trademarks and trade names in this prospectus are referred to without the ®, © and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

PRESENTATION OF FINANCIAL INFORMATION

We publish our consolidated financial statements in Canadian dollars as of April 29, 2024. In this prospectus, unless otherwise specified, all references to “C$” and “CAD$” means Canadian dollars and all references to “$”and “dollars” mean United States dollars.

This prospectus includes our audited annual consolidated financial statements, or the “Financial Statements.” Our audited consolidated financial statements for the years ended December 31, 2023 and December 31, 2022 were prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB, the independent, private-sector body that develops and approves IFRS, and Interpretations issued by the International Financial Reporting Interpretations Committee, or IFRIC. None of the financial statements were prepared in accordance with generally accepted accounting principles in the United States.

INDUSTRY AND MARKET DATA

This prospectus includes statistical, market and industry data and forecasts which we obtained from publicly available information and independent industry publications and reports that we believe to be reliable sources. These publicly available industry publications and reports generally state that they obtain their information from sources that they believe to be reliable. Although we are responsible for all of the disclosures contained in this prospectus, including such statistical, market and industry data, we have not independently verified any of the data from third-party sources, nor have we ascertained the underlying economic assumptions relied upon therein. In addition, while we believe the market opportunity information included in this prospectus is generally reliable and is based on reasonable assumptions, such data involves risks and uncertainties, including those discussed under the heading “Risk Factors.”

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

We have made statements in this prospectus, including under “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Our Business” and elsewhere that constitute forward-looking statements. Forward-looking statements involve risks and uncertainties, such as statements about our plans, objectives, expectations, assumptions or future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “we believe,” “we intend,” “may,” “should,” “will,” “could” and similar expressions denoting uncertainty or an action that may, will or is expected to occur in the future. These statements involve estimates, assumptions, known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from any future results, performances or achievements expressed or implied by the forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements about the following:

● our prospects, including our future business, revenues, expenses, net income, earnings per share, gross margins, profitability, cash flows, cash position, liquidity, financial condition and results of operations, backlog of orders and revenue, our targeted growth rate, our goals for future revenues and earnings, and our expectations about realizing the revenues in our backlog and in our sales pipeline;

● the potential impact of COVID-19 on our business and results of operations;

● the effects on our business, financial condition and results of operations of current and future economic, business, market and regulatory conditions, including the current economic and market conditions and their effects on our customers and their capital spending and ability to finance purchases of our products, services, technologies and systems;

● the effects of fluctuations in sales on our business, revenues, expenses, net income, earnings per share, margins, profitability, cash flows, capital expenditures, liquidity, financial condition and results of operations;

● our products, services, technologies and systems, including their quality and performance in absolute terms and as compared to competitive alternatives, their benefits to our customers and their ability to meet our customers’ requirements, and our ability to successfully develop and market new products, services, technologies and systems;

● our markets, including our market position and our market share;

● our ability to successfully develop, operate, grow and diversify our operations and businesses;

● our business plans, strategies, goals and objectives, and our ability to successfully achieve them;

● the sufficiency of our capital resources, including our cash and cash equivalents, funds generated from operations, availability of borrowings under our credit and financing arrangements and other capital resources, to meet our future working capital, capital expenditure, lease and debt service and business growth needs;

● the value of our assets and businesses, including the revenues, profits and cash flows they are capable of delivering in the future;

● the effects on our business operations, financial results, and prospects of business acquisitions, combinations, sales, alliances, ventures and other similar business transactions and relationships;

● industry trends and customer preferences and the demand for our products, services, technologies and systems; and

● the nature and intensity of our competition, and our ability to successfully compete in our markets.

These statements are necessarily subjective, are based upon our current plans, intentions, objectives, goals, strategies, beliefs, projections and expectations, and involve known and unknown risks, uncertainties and other important factors that could cause our actual results, performance or achievements, or industry results, to differ materially from any future results, performance or achievements described in or implied by such statements. Actual results may differ materially from expected results described in our forward-looking statements, including with respect to correct measurement and identification of factors affecting our business or the extent of their likely impact, the accuracy and completeness of the publicly-available information with respect to the factors upon which our business strategy is based, or the success of our business. Furthermore, industry forecasts are likely to be inaccurate, especially over long periods of time.

Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of whether, or the times by which, our performance or results may be achieved. Forward-looking statements are based on information available at the time those statements are made and management’s belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that may cause actual results, our performance or achievements, or industry results to differ materially from those contemplated by such forward-looking statements include, without limitation, those discussed under the caption “Risk Factors” in this prospectus as well as other risks and factors identified from time to time in our SEC filings.

PROSPECTUS SUMMARY

This summary highlights information that we present more fully in the rest of this prospectus. This summary does not contain all of the information you should consider before buying common shares in this offering. This summary contains forward-looking statements that involve risks and uncertainties, such as statements about our plans, objectives, expectations, assumptions or future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “we believe,” “we intend,” “may,” “should,” “will,” “could,” and similar expressions denoting uncertainty or an action that may, will or is expected to occur in the future. These statements involve estimates, assumptions, known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from any future results, performances or achievements expressed or implied by the forward-looking statements. You should read the entire prospectus carefully, including the “Risk Factors” section and the financial statements and the notes to those statements.

Business Overview

We are focused on combating global health issues through diagnostic and therapeutic solutions by acquiring assets, technologies and/or businesses in the areas of life sciences and medical diagnostics. Currently, we are focused on the issue of antibiotic failure, which encompasses the widespread and deadly crises of sepsis and biofilm infections. Antibiotic failure occurs when an infection is not responsive to antibiotics. Per year, there are estimated to be over 49 million cases of sepsis and more than 11 million deaths due to sepsis¹. Since the major front line treatment for sepsis is potent antibiotics, this high death rate represents antibiotic failure. Furthermore, severe COVID-19, caused by infection with a coronavirus (SARS-CoV-2), is severe sepsis and caused a further 6-18 million deaths to date. In the U.S., 65% of all infections are due to biofilms that are highly resistant to antibiotics, which is estimated to cost global health care $368 billion dollars annually.²

Sepsis and antibiotic resistant infections impose significant burdens on healthcare systems and create the need for new diagnostics and therapeutics. In 2020, the global sepsis diagnostic market was valued at $569.49 million and is projected to reach $1.2 billion by 2030, based on a compound annual growth rate (“CAGR”) of 7.8% from 2021 to 2030.³ Our therapeutic anti-biofilm products are directed at wound care, oral health care and sinusitis, which have global markets of $22.5 billion (CAGR 4.1%), 2.8 billion (CAGR 3.5%) and $33.7 billion (CAGR 6.4%) respectively.⁵ The global antibiotic market is $40.9 billion and has a CAGR of 3.7%.⁵

Our fight against sepsis and antibiotic failure has two fronts, diagnostic and therapeutic. Our diagnostic product consists of a novel assay that is intended to provide earlier, faster risk assessment/diagnosis to enable informed treatment of sepsis. Based on data from published clinical research studies with more than 700 patients our diagnostic technology is designed to detect sepsis based on whether a patient has unique molecular signatures of sepsis specific to their immune response instead of detecting the presence of a pathogen, and, as such, does not differentiate between bacterial and viral sepsis. Furthermore, although sepsis is the body’s response to an infection, not all patients with sepsis have an identifiable pathogen associated with sepsis development. Conventional sepsis diagnoses can take approximately 13 to 48 hours, but our technology has the potential to provide results in approximately 1 hour after a blood draw in the emergency room or intensive care unit. Our diagnostic technology has been developed using data acquired in a large clinical study performed by our founding scientists.

Our therapeutic product consists of patented pharmaceutical peptides that target presently untreatable biofilm infections and the associated pathology caused by inflammation. Currently, 65% of all infections are caused by biofilms and there are no approved drugs to fight them. Our technology involves small potent broad-spectrum anti-biofilm and anti-inflammatory peptides⁶. Our therapeutic products are directed against wound, oral and sinusitis biofilm infections. Our peptides have been optimized using a combination of conventional structure-activity relationship studies and artificial intelligence (AI) aided discovery. The AI studies have employed neural networks to relate structural descriptors, based on the primary sequences of the peptides, to activity, and predict the activities of computationally-generated peptide sequences^6a. We are increasingly employing generative and explainable AI methods to generate further improved peptides. Proceeds from this offering will be applied to further develop therapeutic product candidates in these areas in addition to sepsis diagnostics.

Our peptides have not been shown to be safe and effective in humans. Statements related to safety and efficacy are within the sole authority of the FDA. Indeed, we have not performed human clinical studies to formally demonstrate a safety profile for our therapeutic candidates that is consistent with our animal model results, which are not pre-clinical studies and cannot support an investigational new drug (“IND”) application, and play no part in the regulatory approval process. Pre-clinical studies must be conducted to enable the Company to perform human clinical trials. Currently, we do not have any commercial products that compete in the markets for sepsis diagnostics and anti-infective therapeutics. Further, none of our products have yet been approved by the Food and Drug Administration or other regulators as safe and effective. Almost all funding obtained by the Company to date has gone towards product development and associated activities and thus represents a loss of $5,757,286 for the year ended December 31, 2022, and $2,343,563 for the period from January 20, 2021 (incorporation) to December 31, 2021; we anticipate that we will require future funding for these activities. As of the date of this prospectus, our auditor has included an explanatory paragraph in their opinion that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2022, indicating that our current liquidity position raises substantial doubt about our ability to continue as a going concern. Please see “Risks Associated with Our Business” in this summary on page 6 and the section entitled “Risk Factors” for a description of the risks and limitations we may face.

¹ Rudd, K.E., Johnson, S.C., Agesa, K.M., Shackelford, K.A., Tsoi, D., Kievlan, D.R., Colombara, D.V., Ikuta, K.S., Kissoon, N., Finfer, S., Fleischmann-Struzek, C (2020). Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global Burden of Disease Study. The Lancet. 395(10219), 200-11.

² Cámara et al. (2022) Economic significance of biofilms: a multidisciplinary and cross-sectoral challenge. NPJ Biofilms and Microbiomes 8:42.

³ https://www.globenewswire.com/news-release/2022/10/18/2536561/0/en/Global-Sepsis-Therapeutics-Market-to-Reach-435-9-Billion-by-2027.html

⁴ https://www.globenewswire.com/news-release/2022/10/18/2536561/0/en/Global-Sepsis-Therapeutics-Market-to-Reach-435-9-Billion-by-2027.html

⁵ https://www.globenewswire.com/en/news-release/2023/04/06/2642247/0/en/Antibiotics-Market-Size-58-4-Bn-by-2032-at-3-7-CAGR-Global-Analysis-by-Market-us.html; https://www.grandviewresearch.com/industry-analysis/wound-care-market; https://www.businessresearchinsights.com/market-reports/sinusitis-drugs-market-101686; https://www.grandviewresearch.com/industry-analysis/oral-care-market

⁶ Fuente-NúñezC, REW Hancock et al. 2014. Broad-spectrum anti-biofilm peptide that targets a cellular stress response. PLoS Pathogens 10(5):e1004152; Fuente-Núñez C, REW Hancock et al. 2015. D-enantiomeric peptides that eradicate wild-type and multi-drug resistant bacterial biofilms and protect against lethal Pseudomonas aeruginosa infections. Chem. Biol. 22:196–205; Pletzer, D., S.C. Mansour, and R.E.W. Hancock. 2018. Synergy between conventional antibiotics and anti-biofilm peptides in a murine,sub-cutaneous abscess model caused by recalcitrant ESKAPE pathogens. PLoS Pathogens 14(6):e1007084; Reffuveille F, C. REW Hancock et al. 2014. A broad-spectrum anti-biofilm peptide enhances antibiotic action against bacterial biofilms. Antimicrob. Agents Chemother. 58:5363-5371; Zhang, T., L.Xia, Z. Wang, R.E.W. Hancock, and M. Haapasalo. 2021. Recovery of oral in vitro biofilms after exposure to peptides and chlorhexidine. J. Endodontics 47:466-471; Alford, M.A., K.-Y.G. Choi, M.J. Trimble, H. Masoudi, P. Kalsi, D. Pletzer, R.E.W. Hancock. 2021. Murine models of sinusitis infection for screening antimicrobial and immunomodulatory therapies. Frontiers Cell. Infect. Microbiol. 11:621081; Wu, B.C., A.H. Lee, and R.E.W. Hancock. 2017. Mechanisms of the innate defense regulator peptide-1002 anti-inflammatory activity in a sterile inflammation mouse model. J. Immunol. 199:3592-3603.

^6a. Cherkasov, A., K. Hilpert, H. Jenssen, C.D. Fjell, M. Waldbrook, S.C. Mullaly, R. Volkmer and R.E.W. Hancock. 2009. Use of artificial intelligence in the design of small peptide antibiotics effective against a broad spectrum of highly antibiotic resistant Superbugs. ACS Chemical Biol. 4:65-74.

Haney, E.F., Y. Brito-Sánchez, M.J. Trimble, S.C. Mansour, A. Cherkasov, and R.E.W. Hancock. 2018. Computer-aided discovery of peptides that specifically attack bacterial biofilms. Sci. Reports 8:1871 .

Company History and Development

On January 20, 2021, we were incorporated under the British Columbia Business Corporations Act (“BCBCA”) under the name Trenchant Life Sciences Investment Corp. On November 9, 2021, we changed our name to ASEP Medical Holdings Inc.

On November 22, 2021, we commenced trading on the Canadian Securities Exchange (“CSE”) as a life sciences issuer under the trading symbol “ASEP”. On April 19, 2022, we commenced trading on the OTCQB under the trading symbol “SEPSF”, although we currently trade on the OTC Pink. On November 10, 2022, we commenced trading on the Frankfurt Stock Exchange (“FSE”) under the trading symbol “FSX:JJ8”.

Since our inception in 2021, ASEP has been a committed innovator within the medical industry. We strive to mitigate the global crisis of antibiotic failure by improving patients’ odds of survival and quality of life. Currently, we are developing therapeutic and diagnostic products through two of our subsidiaries. As of the date of this prospectus, we have the following subsidiaries:

(1) Pursuant to the Start-Up License Agreement (as defined herein), UBC and certain inventors will collectively own 12% of the total issued and outstanding common shares of SafeCoat following the issuance of the consideration shares. As at the date of this Registration Statement, the consideration shares have not yet been issued and ASEP owns 100% of SafeCoat. ASEP will own 88% of SafeCoat, with UBC and inventors receiving a total of 12% of shares as a requirement of the licensing agreement with UBC.

# Our subsidiary ABT owns 100% of ABT Peptides Inc, an inactive company incorporated in British Columbia, Canada.

* Our subsidiary OHP is inactive.

ABT Innovations Inc.

ABT was incorporated on July 3, 2015 pursuant to the provisions of the BCBCA under the name “ABT Innovations Inc.” for the purpose of ensuring the commercialization of the broad peptide technology developed by its founder, Dr. Robert E.W. Hancock. ABT’s peptide technology covers a broad range of therapeutic applications including bacterial biofilm infections. Bacterial biofilms are serious global health concern due to their abilities to shelter bacteria from antibiotics and host defense during infection. Therefore, biofilms contribute to persistent chronic infections; they play a significant role in human infections as diverse as medical device infections, chronic infections, lung, bladder, wound, dental, skin, ear-nose and throat, sinusitis, orthopedic, etc., representing two thirds of all infections.⁷ Our technology also includes anti-inflammatories, anti-infective immune-modulators and vaccine adjuvants.

Sepset Biosciences Inc.

Sepset was incorporated on April 23, 2015 pursuant to the provisions of the BCBCA under the name “Sepset Biosciences Inc.” for the purpose of ensuring the commercialization of a diagnostic kit for predicting the onset of severe sepsis and organ failure that was developed by its founder, Dr. Robert E.W. Hancock. The Sepset diagnostic technology involves a patient gene expression signature predictive of the development of severe sepsis and organ failure. The Sepset^ER test involves drawing a small amount of a patient’s blood and determining whether the patient presents with the sepsis markers in their gene expression profiles as assessed by nucleic acid amplification technologies. The Sepset^ER diagnostic technology differs from current diagnostic tests by enabling diagnosis of severe sepsis within 1-2 hours of first clinical presentation (i.e., in the emergency room), while other diagnostics only provide definitive diagnosis after 13-48 hours of first clinical presentation. We believe this will enable critical early decisions to be made by physicians regarding appropriate therapies leading to reduced overall morbidity and mortality due to sepsis.

SafeCoat Medical Inc.

On December 1, 2022, we entered into a definitive Earn-In and Option Agreement with SafeCoat Medical Inc. (“SafeCoat”) and the security holders of SafeCoat, whereby we acquired a 50.1% equity interest of SafeCoat and were granted the option to acquire the remaining common shares of SafeCoat from the securityholders, such that, subject to any future ownership interest of the University of British Columbia (“UBC”), we would own 100% of common shares of SafeCoat, free and clear of all liens. On December 12, 2022, we exercised the option and completed our 100% acquisition of SafeCoat. On July 31, 2023, ASEP, through SafeCoat, entered into an exclusive worldwide license agreement with UBC for the use, development and commercialization of medical device coating technology. Through this agreement, UBC and certain inventors of the technology will hold 12% of SafeCoat while ASEP will hold 88% following the issuance of the consideration shares. Pursuant to the Start-Up License Agreement (as defined herein), UBC and certain non-waiving inventors (namely Dr. Jayachandran Kizhakkedathu, Dr. Dirk Lange, Dr. Robert Hancock, and Dr. Kai Yu) will collectively own 12% (8% to UBC and 1% to each of the non-waiving inventors) of the total issued and outstanding common shares of SafeCoat following the issuance of the consideration shares. As at the date of this Registration Statement, the consideration shares have not yet been issued and ASEP owns 100% of SafeCoat. Following such issuance, ASEP will own 88% of SafeCoat, with UBC and the non-waiving inventors receiving a total of 12% of shares (as further described above) as a requirement of the licensing agreement with UBC.

SafeCoat’s technology provides coatings for medical devices that are non-fouling (i.e. do not readily bind live or dead bacteria) and are protected by a peptide coating that kills bacteria. This product addresses the definitive risk of infection of medical devices including prosthetics, implants, catheters and stents, etc. Indeed, over half of the nearly 2 million healthcare-associated infections in the U.S. annually can be attributed to indwelling medical devices.⁸

ASEP’s head office is located at 420 – 730 View Street, Victoria, BC V8W 3Y7 and its registered office is located at 800 – 885 West Georgia Street, Vancouver, BC V6C 3H1. Our main telephone number is 778-600-0509.

Emerging Growth Company Status

As a company with less than $1.235 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, enacted in April 2012, and may take advantage of reduced reporting requirements that are otherwise applicable to public companies. These provisions include, but are not limited to:

⁷ Sharma, D., Misba, L. & Khan, A.U. 2019. Antibiotics versus biofilm: an emerging battleground in microbial communities. Antimicrob. Resist. Infect. Control 8, 76.

⁸ VanEpps J.S. & Younger J.G. 2016. Implantable device related infection. Shock. 46(6):597-608.

We may take advantage of these provisions until the last day of our fiscal year following the fifth anniversary of the date of the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act of 1933, as amended (the “Securities Act”). However, if certain events occur before the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.235 billion or we issue more than $1.00 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company before the end of such five-year period.

In addition, Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. We have elected to take advantage of the extended transition period for complying with new or revised accounting standards and acknowledge such election is irrevocable pursuant to Section 107 of the JOBS Act.

We have elected to take advantage of certain of the reduced disclosure obligations regarding executive compensation in this prospectus and, as long as we continue to qualify as an emerging growth company, we may elect to take advantage of this and other reduced burdens in future filings. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.

Competitive Market Conditions

The pharmaceutical and biotechnology industries are intensely competitive. We compete directly and indirectly with other pharmaceutical companies, biotechnology companies and academic and research organizations in developing therapies to treat diseases and antibiotic resistance. There is no strong evidence that any of our competitors in the therapeutics space are developing products that work against a broad spectrum of bacterial biofilms or have conjoint anti-inflammatory activity. As for the sepsis diagnostics, our competitive edge lies in the timeframe required to identify patients who might develop severe sepsis as well as our ability to provide a binary (sepsis or not) risk assessment. As mentioned earlier, conventional sepsis diagnoses can take approximately 13 to 48 hours whereas Sepset^ER results should be available within approximately 1 hour.

Foreign Private Issuer Status

We are a “foreign private issuer,” as defined in Rule 405 under the Securities Act and Rule 3b-4(c) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As a result, we are not subject to the same requirements as U.S. domestic issuers. Under the Exchange Act, we will be subject to reporting obligations that, to some extent, are more lenient and less frequent than those of U.S. domestic reporting companies. For example, we will not be required to issue quarterly reports or proxy statements. We will not be required to disclose detailed individual executive compensation information. Furthermore, our directors and executive officers will not be required to report equity holdings under Section 16 of the Exchange Act and will not be subject to the insider short-swing profit disclosure and recovery regime.

As an exempted Canadian company to be listed on The Nasdaq Stock Market (“Nasdaq”), we will be subject to Nasdaq’s corporate governance listing standards. However, Nasdaq rules permit a foreign private issuer like us to follow the corporate governance practices of its home country. Certain corporate governance practices in Canada, which is our home country, may differ significantly from Nasdaq corporate governance listing standards.

Currently, as a Canadian company, we intend to rely on home country practice with respect to our corporate governance. A description of the significant ways in which our governance practices currently differ from those followed by domestic companies pursuant to the Rule 5600 series of the Nasdaq Stock Market Rules is set out below:

Risks Associated with Our Business

Our ability to execute our business strategy is subject to numerous risks, as more fully described in the section captioned “Risk Factors” immediately following this prospectus summary. You should read these risks before you invest in our securities. In particular, risks associated with our business include, but are not limited to, the following:

THE OFFERING

SUMMARY CONSOLIDATED FINANCIAL DATA

The following tables summarize our historical financial data. The summary consolidated statements of operation for the year ended December 31, 2023 and the summary consolidated balance sheets as of December 31, 2023 have been derived from our consolidated financial statements included elsewhere in this prospectus. The following summary financial data should be read in conjunction with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results that may be expected in the future.

The following table presents our summary consolidated statements of operation for the year ended December 31, 2023:

The following table presents our summary consolidated balance sheet data as of December 31, 2023:

RISK FACTORS

Investing in our securities is speculative and involves a high degree of risk. You should consider carefully the following risk factors, as well as the other information in this prospectus, including our consolidated financial statements and notes thereto, before you decide to purchase our securities. If any of the following risks actually occur, our business, financial condition, results of operations and prospects could be materially adversely affected, the value of our common shares could decline, and you may lose all or part of your investment. This prospectus also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in the forward-looking statements as a result of a number of factors, including the risks described below. See “Cautionary Note Regarding Forward-Looking Statements.”

Risks Related to Our Business

If ABT or Sepset experience delays or difficulties in the enrollment of volunteers or patients in the clinical trials, receipt of necessary regulatory approvals could be delayed or prevented.

Clinical trials for treatment candidates require identification and enrollment of a large number of volunteers or eligible patients. ABT or Sepset may not be able to enroll sufficient volunteers or eligible patients to complete clinical trials in a timely manner or at all. Patient enrollment is a function of many factors, including the following: design of the protocol, size of the patient population, eligibility criteria for the study in question, perceived risks and benefits of the product under study, availability of competing therapies, efforts to facilitate timely enrollment in clinical trials, patient referral practices of physicians, and availability of clinical trial sites. If ABT or Sepset have difficulty enrolling sufficient volunteers or patients to conduct its clinical trials as planned, they may need to delay, forego or terminate ongoing clinical trials, which could have a material adverse effect on the Company’s financial condition or results of operations.

The commercialization of certain technology is dependent on the Hancock License Agreement and the UBC License Agreement.

The Sepset^ER technology is covered by two separate filed and issued patents. The first patent is owned by Dr. Robert E.W. Hancock together with other inventors. Dr. Robert E.W. Hancock is also one of three inventors for the technology underlying the second patent. However, the second patent has been assigned to UBC, who provided an exclusive license to Sepset. Sepset has been granted an exclusive and worldwide license for the use and sublicense of the Sepset technology as well as any improvements, variations, updates, modifications, and enhancements made and/or acquired thereon, and to manufacture, have made, distribute and sell products made from or based upon the Sepset technology pursuant to the terms of the Hancock License Agreement. In the event the Hancock License Agreement is terminated prior to the expiration of its term, the ability of Sepset to achieve its stated business objectives and milestones would be severely impacted.

UBC has licensed to ABT pursuant to the terms and conditions of the University of British Columbia License Agreement the patents found in “Business- Intellectual Property- ABT Innovations Inc” of this prospectus. UBC may, at its option, immediately terminate the UBC License Agreement by giving notice to ABT under certain circumstances, including insolvency, breach of contract, winding up, liquidation or other termination of the existence of ABT. Either party may terminate this Agreement for any breach which is not remedied after proving notice to the party in breach. In the event the UBC License Agreement is terminated prior to the expiration of its term, the ability of ABT to achieve its stated business objectives and milestones could be impacted.

Probable lack of business diversification.

Because the Company will be focused on developing its business ancillary to the life sciences industry, and potentially directly in the life sciences industry, the prospects for the Company’s success will be dependent upon the future performance and market acceptance of the Company’s intended products, processes, and services. Unlike certain entities that have the resources to develop and explore numerous product lines, operating in multiple industries or multiple areas of a single industry, the Company does not anticipate the ability to immediately diversify or benefit from the possible spreading of risks or offsetting of losses. Again, the prospects for the Company’s success may become dependent upon the development or market acceptance of a very limited number of products, processes or services.

The Company’s officers and directors may be engaged in a range of business activities that could result in conflicts of interest.

Certain of the directors and officers of the Company may also serve as directors and/or officers of other companies involved in the industries in which the Company may operate and consequently there exists the possibility for such directors and officers to be in a position of conflict. For example, Dr. Hancock currently holds a position as a faculty member at UBC, where he runs a research and development laboratory. Additionally, Dr. Hancock holds 23% of ABT, 31.5% of Sepset and holds several other positions with other life sciences companies. Dr. Hancock is one of the non-waiving University of British Columbia (UBC) inventors of the technology in-licensed by SafeCoat Medical. He was not involved in any of the discussions regarding the licencing. However, as a result of his involvement as an inventor, he will receive one quarter of the inventor’s shares, representing 12.5% of the SafeCoat shares to be issued to UBC and Inventors. He will receive 1.5% of total SafeCoat shares. Any decision made by any of such directors and officers will be made in accordance with their duties and obligations to deal fairly and in good faith with a view to the best interests of the Company and its shareholders. In addition, each director is required to declare and refrain from voting on any matter in which such director may have a conflict of interest in accordance with the procedures set forth in applicable laws.

Competition.

An increase in other companies competing in the industry could limit the ability of the Company’s potential of expanding its operations. Current and new competitors may have better capitalization, a longer operating history, more expertise and able to develop higher quality equipment or products, at the same or a lower cost. The Company will not be able to provide assurances that we will be able to compete successfully against current and future competitors. Competitive pressures that the Company may face could have a material adverse effect on our business, operating results and financial condition.

Risks Related to Government Regulation

If the Company fails to comply with extensive regulations of United States and foreign regulatory agencies, the commercialization of our products could be delayed or prevented entirely.

The Company’s future product candidates and research and development activities are subject to extensive government regulations related to its development, testing, manufacturing and commercialization in the United States and other countries. The determination of when and whether a product is ready for large-scale purchase and potential use in the United States will be made by the United States government through consultation with a number of governmental agencies, including the Food and Drug Administration (“FDA”), the National Institutes of Health and the Centers for Disease Control and Prevention. The Company’s products have not received regulatory approval from the FDA, or any foreign regulatory agencies, to be commercially marketed and sold. The process of obtaining and complying with FDA and other governmental regulatory approvals and regulations in the United States and in foreign countries is costly, time consuming, uncertain and subject to unanticipated delays. Obtaining such regulatory approvals, if any, can take several years. Despite the time and expense exerted, regulatory approval is never guaranteed. The Company is also subject to the following risks and obligations, among others:

Failure to comply with these or other regulatory requirements may subject the Company to administrative or judicially imposed sanctions, including:

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in other jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.

Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or to receive applicable marketing approvals, our future target market could be reduced and our ability to realize the full market potential of our future product candidates could be harmed.

If the Company fails to comply with laws and regulations, it could be subject to regulatory actions, which could affect its ability to develop, market and sell its product candidates and any other future product candidates and may harm its reputation.

If the Company fails to comply with applicable federal, state or foreign laws or regulations, the Company could be subject to regulatory actions, which could affect its ability to successfully develop, market and sell any future product candidates under development and could harm its reputation and lead to reduced or non-acceptance of its proposed product candidates by the market. Technical recommendations or evidence provided by the FDA through letters, site visits, and overall recommendations to academia or biotechnology companies may also make the manufacturing of a clinical product extremely labor intensive or expensive, making the product candidate no longer viable to manufacture in a cost-efficient manner. The mode of administration or the required testing of the product candidate may make that candidate no longer commercially viable. The FDA, or a clinical trial site’s Institutional Review Board or Institutional Biosafety Committee, may not agree with the proposed clinical trials, which may delay or make impossible the clinical testing of a product candidate. For example, the Institutional Review Board for a clinical trial may request to stop a trial or deem a product candidate unsafe to continue testing. This would have a material adverse effect on the value of the product candidate and the Company’s business, results of operations and financial condition.

United States legislative or FDA regulatory reforms may make it more difficult and costly for the Company to obtain regulatory approval of its product candidates and to manufacture, market and distribute its products after approval is obtained.

From time to time, legislation is drafted and implemented that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect the Company’s business and its products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of future products or impose changes on other products already on the market. It is impossible to predict whether legislative changes will be enacted, or FDA regulations, guidance or interpretations will be changed, and what the impact of such changes, if any, may be on the Company’s new product development efforts.

Current and future legislation may increase the difficulty and cost of commercializing our drug candidates and may affect the prices we may obtain if our drug candidates are approved for commercialization.

In the U.S. and some foreign jurisdictions, there have been a number of adopted and proposed legislative and regulatory changes regarding the healthcare system that could prevent or delay regulatory approval of our drug candidates, restrict or regulate post-marketing activities and affect our ability to profitably sell any of our drug candidates for which we obtain regulatory approval.

In the U.S., the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, changed the way Medicare covers and pays for pharmaceutical products. Cost reduction initiatives and other provisions of this legislation could limit the coverage and reimbursement rate that we receive for any of our future approved products. While the MMA only applies to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private payors.

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, collectively the PPACA, was enacted. The PPACA was intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. The PPACA increased manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate amount for both branded and generic drugs and revised the definition of “average manufacturer price,” or AMP, which may also increase the amount of Medicaid drug rebates manufacturers are required to pay to states. The legislation also expanded Medicaid drug rebates and created an alternative rebate formula for certain new formulations of certain existing products that is intended to increase the rebates due on those drugs. The Centers for Medicare & Medicaid Services, or CMS, which administers the Medicaid Drug Rebate Program, also has proposed to expand Medicaid rebates to the utilization that occurs in the territories of the U.S., such as Puerto Rico and the Virgin Islands. Further, beginning in 2011, the PPACA imposed a significant annual fee on companies that manufacture or import branded prescription drug products and required manufacturers to provide a discount, equal to 70% off, effective as of 2019, the negotiated price of prescriptions filled by beneficiaries in the Medicare Part D coverage gap, referred to as the “donut hole.” Legislative and regulatory proposals have been introduced at both the state and federal level to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery models, such as bundled payment models. In addition, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under government payor programs, and review the relationship between pricing and manufacturer patient programs. We also expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for our future drug candidates, if approved for commercialization.

In Europe, the United Kingdom withdrew from the European Union on January 31, 2020, and entered into a transition period that expired on December 31, 2020. A significant portion of the previous regulatory framework in the United Kingdom was derived from the regulations of the European Union. In 2021, the United Kingdom’s Medicines and Healthcare products Regulatory Agency, or MHRA, and the European Medicines Agency, or EMA, released guidance explaining the new regulatory framework. We cannot predict the consequences or impact that the new regulatory framework would have on our future operations, if any, in these jurisdictions.

In addition, on August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022, which, among other things, includes policies that are designed to have a direct impact on drug prices and reduce drug spending by the federal government, which shall take effect in 2023. Under the Inflation Reduction Act, Congress authorized Medicare beginning in 2026 to negotiate lower prices for certain costly single-source drug and biologic products that do not have competing generics or biosimilars. This provision is limited in terms of the number of pharmaceuticals whose prices can be negotiated in any given year and it only applies to drug products that have been approved for at least 9 years and biologics that have been licensed for 13 years. Drugs and biologics that have been approved for a single rare disease or condition are categorically excluded from price negotiation. Further, the new legislation provides that if pharmaceutical companies raise prices in Medicare faster than the rate of inflation, they must pay rebates back to the government for the difference. The new law also caps Medicare out-of-pocket drug costs at an estimated $4,000 a year in 2024 and, thereafter beginning in 2025, at $2,000 a year.

Our future clinical trials may fail to demonstrate substantial evidence of the safety and effectiveness of future product candidates that we may identify and pursue, which would prevent, delay or limit the scope of regulatory approval and commercialization.

In the United States, we would be able to begin marketing a product after we receive approval from the FDA, or, in any foreign countries, when we receive the requisite approval from those countries. Before obtaining regulatory approvals for the commercial sale of any product candidate for a target indication, we must demonstrate with evidence gathered in preclinical and well-controlled clinical trials, and, with respect to approval in the United States, to the satisfaction of the FDA and, with respect to approval in other countries, similar regulatory authorities in those countries, that the product candidate is safe and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate. Our failure to adequately demonstrate the safety and effectiveness of any of our products or product candidates for the treatment of particular diseases may delay or prevent our receipt of the FDA’s and foreign regulatory authorities’ approval and, ultimately, may prevent commercialization of our products and product candidates for those diseases. The FDA and foreign regulatory authorities have substantial discretion in deciding whether, based on the benefits and risks in a particular disease, any of our products or product candidates should be granted approval for the treatment of that particular disease. Even if we believe that a clinical trial or trials has demonstrated the safety and statistically significant efficacy of any of our products or product candidates for the treatment of a disease, the results may not be satisfactory to the FDA or foreign regulatory authorities. Preclinical and clinical data can be interpreted by the FDA and foreign regulatory authorities in different ways, which could delay, limit or prevent regulatory approval.

Additionally, clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization. We have limited experience in designing clinical trials and may be unable to design and execute a clinical trial to support marketing approval.

We cannot be certain that any clinical trials will be successful. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same therapeutic candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants.

Even if any of our future products obtain regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expenses. Additionally, any such products, if approved, could be subject to labeling and other restrictions and market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with any of our future products.

If Health Canada (“HC”), the FDA, the European Commission (“EC”) and the European Medicines Agency (“EMA”) or a comparable foreign regulatory authority approves any of our future products, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with current good manufacturing practice (“cGMP”) and with good clinical practice (“GCP”) for any clinical trials that we conduct post-approval, all of which may result in significant expense and limit our ability to commercialize such therapies. Later discovery of previously unknown problems with any approved product, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

In addition, any regulatory approvals that we receive for our future products may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including clinical trials, and surveillance to monitor the safety and efficacy of such products.

If there are changes in the application of legislation, regulations or regulatory policies or if we or one of our distributors, licensees or co-marketers fails to comply with regulatory requirements, the regulatory agencies/bodies could take various actions. In such a case, the Company may be subject to fines, manufacturing or distribution restrictions or limitations, product recalls or removal of the product from the market, including marketing authorization suspension or withdrawal. The Company may also be subject to additional clinical trial requirements, product labeling changes or marketing authorization resubmissions. If any of these events occurs, our ability to sell such therapy may be impaired, and we may incur substantial additional expense to comply with regulatory requirements, which could materially adversely affect our business, financial condition and results of operations.

The results of preclinical studies and early-stage clinical trials of our products may not be predictive of the results of later stage clinical trials. Initial success in our ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials.

Our products in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. Furthermore, there can be no assurance that any of our clinical trials will ultimately be successful or support further clinical development of any of our future products. There is a high failure rate for products proceeding through clinical trials. A number of companies in the medical industry have suffered significant setbacks in clinical development even after achieving promising results in earlier studies.

The commercial success of our products will depend on the degree of market access and acceptance of our products among healthcare professionals, patients, healthcare payors, health technology assessment bodies and the medical community at large.

Our products may not achieve an adequate level of acceptance by payors, health technology assessment bodies, healthcare professionals, patients and the medical community at large, and we may not become profitable. The level of acceptance we ultimately achieve may be affected by negative public perceptions. Because of this history, efforts to educate the medical community and third-party payors and health technologies assessment bodies on the benefits of our products may require significant resources and may never be successful, which would prevent us from generating significant revenue or becoming profitable. Market acceptance of our products by healthcare professionals, patients, healthcare payors and health technology assessment bodies will depend on a number of factors, many of which are beyond our control, including, but not limited to, the following:

If our future products fail to gain market access and acceptance, this will have a material adverse impact on our ability to generate revenue to provide a satisfactory, or any, return on our investments. Even if some products achieve market access and acceptance, the market may prove not to be large enough to allow us to generate significant revenue.

We must comply with Health Information Privacy and Security Standards.

The privacy regulations Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) contains detailed requirements concerning the use and disclosure of individually identifiable patient health information by various healthcare providers, such as medical groups. HIPAA covered entities must implement certain administrative, physical, and technical security standards to protect the integrity, confidentiality and availability of certain electronic health information received, maintained, or transmitted. HIPAA also implemented standard transaction code sets and standard identifiers that covered entities must use when submitting or receiving certain electronic healthcare transactions, including billing and claim collection activities. Violations of the HIPAA privacy and security rules may result in civil and criminal penalties, including a tiered system of civil money penalties that range from $100 to $50,000 per violation, with a cap of $1.5 million per year for identical violations. A HIPAA covered entity must also promptly notify affected individuals where a breach affects more than 500 individuals and report breaches affecting fewer than 500 individuals annually. State attorneys general may bring civil actions on behalf of state residents for violations of the HIPAA privacy and security rules, obtain damages on behalf of state residents, and enjoin further violations.

Failure to comply with health and data protection laws and regulations could lead to U.S. federal and state government enforcement actions, including civil or criminal penalties, private litigation, and adverse publicity and could negatively affect our operating results and business.

We and any potential collaborators may be subject to U.S. federal and state data protection laws and regulations, such as laws and regulations that address privacy and data security. In the United States, numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws, govern the collection, use, disclosure, and protection of health-related and other personal information. In addition, we may obtain health information from third parties, including research institutions from which we obtain clinical trial data, which are subject to privacy and security requirements under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”). To the extent that we act as a business associate to a healthcare provider engaging in electronic transactions, we may also be subject to the privacy and security provisions of HIPAA, as amended by HITECH, which restricts the use and disclosure of patient-identifiable health information, mandates the adoption of standards relating to the privacy and security of patient-identifiable health information, and requires the reporting of certain security breaches to healthcare provider customers with respect to such information. Additionally, many states have enacted similar laws that may impose more stringent requirements on entities like ours. Depending on the facts and circumstances, we could be subject to significant civil, criminal, and administrative penalties if we obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

Compliance with U.S. and foreign privacy and data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions. Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business. Moreover, clinical trial subjects, employees and other individuals about whom we or our potential collaborators obtain personal information, as well as the providers who share this information with us, may limit our ability to collect, use and disclose the information. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business. Please also refer to risk factor, “A failure of one or more of our key IT systems, networks, processes, associated sites or service providers could have a material adverse impact on business operations, and if the failure is prolonged, our financial condition.”

We will be subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities which may adversely affect our business and financial condition.

Our operations, including our research, development, testing and manufacturing activities, will be subject to numerous foreign, federal, state and local environmental, health and safety laws and regulations. These laws and regulations govern, among other things, the controlled use, manufacture, handling, release and disposal of and the maintenance of a registry for, hazardous materials, such as chemical solvents, human cells, carcinogenic compounds, mutagenic compounds and compounds that have a toxic effect on reproduction, laboratory procedures and exposure to blood-borne pathogens.

We may incur significant costs to comply with these current or future environmental and health and safety laws and regulations. Furthermore, if we fail to comply with such laws and regulations, we could be subject to fines or other sanctions.

Risks Related to Our Financial Position and Need for Capital

We have only a limited history upon which an evaluation of our prospects and future performance can be made and have no history of profitable operations.

We commenced operations in 2021 and have a limited history upon which an evaluation of our prospects and future performance can be made. We may sustain losses in the future as we implement our business plan. We do not have a history of profitable operations and we may not achieve profitable operations.

We will require additional financing in the future to fund our operations.

We will need additional capital in the future to continue to execute our business plan. Therefore, we will be dependent upon additional capital in the form of either debt or equity to continue our operations. Our ability to obtain additional financing will be subject to a number of factors, including market conditions, our operating performance and investor sentiment. We cannot assure that additional financing will be available to us on acceptable terms or at all. If additional capital is either unavailable or cost prohibitive, our operations and growth may be limited, and we may need to change our business strategy to slow the rate of, or eliminate, our expansion or to reduce or curtail our operations. Also, any additional financing we undertake could impose covenants upon us that restrict our operating flexibility, and, if we issue equity securities to raise capital, our existing shareholders may experience dilution and the new securities may have rights, preferences and privileges senior to those of our common shares.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish certain rights.

We may seek additional capital through a combination of equity offerings, debt financings, strategic collaborations and alliances or licensing arrangements. To the extent that we raise additional capital through the sale of equity, convertible debt securities or other equity-based derivative securities, your ownership interest will be diluted and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. Any indebtedness we incur could involve restrictive covenants, such as limitations on our ability to incur additional debt, acquire or license intellectual property rights, declare dividends, make capital expenditures and other operating restrictions that could adversely impact our ability to conduct our business. Furthermore, the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our common stock to decline. If we raise additional funds through strategic collaborations and alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to future candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects. Adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our future therapeutic candidates that we would otherwise prefer to develop and market ourselves.

We may not be able to consummate proposed acquisitions or divestitures successfully or integrate acquired businesses successfully.

From time to time, we acquire businesses, assets or securities of companies that we believe will provide a strategic fit with our business. We integrate acquired businesses with our existing operations; our overall internal control over financial reporting processes; and our financial, operations and information systems. If the financial performance of our business, as supplemented by the assets and businesses acquired, does not meet our expectations, it may make it more difficult for us to service our debt obligations and our results of operations may fail to meet market expectations. We may not effectively assimilate the business or product offerings of acquired companies into our business or within the anticipated costs or timeframes, retain key customers and suppliers or key employees of acquired businesses or successfully implement our business plan for the combined business. In addition, our final determinations and appraisals of the estimated fair value of assets acquired and liabilities assumed in our acquisitions may vary materially from earlier estimates and we may fail to realize fully anticipated cost savings, growth opportunities or other potential synergies. We cannot assure that the fair value of acquired businesses or investments will remain constant.

We may also divest ourselves of businesses, assets or securities of companies that we believe no longer provide a strategic fit with our business. We may provide various indemnifications in connection with the divestiture of businesses or assets. Divestitures of portions of our business may also result in costs stranded in our remaining business. Delays in developing or implementing plans to address such costs could delay or prevent the accomplishment of our financial objectives.

In addition, our continued success depends, in part, on our ability to develop new products. The launch and ongoing success of new products are inherently uncertain, especially with respect to consumer appeal. A new product launch can give rise to a variety of costs. An unsuccessful launch, among other things, can affect consumer perception of existing brands and our reputation. Unsuccessful implementation or short-lived popularity of our product innovations may result in inventory write-offs and other costs.

We cannot assure that we will realize the expected benefits of acquisitions, divestitures or investments. We also cannot assure that our acquisitions, investments, or joint ventures will be profitable, that forecasts regarding our acquisitions, divestitures, or investment activities will be accurate or that the internal control over financial reporting of entities which we must consolidate as a result of our investment activities will be as robust as the internal control over financial reporting for our wholly-owned entities. Our failure to adequately manage the risks associated with acquisitions or divestitures, or the failure of an entity in which we have an equity or membership interest, could have a material adverse effect on our business, liquidity, financial condition and/or results of operations.

We may not be able to retain and recruit executive management or build morale and performance amongst our workforce.

Our success depends upon the efforts and abilities of our executive management team, key senior management, and a high-quality employee base, as well as our ability to attract, motivate, reward and retain them. If one of our executive officers or critical senior management terminates his or her employment, we may not be able to replace their expertise, fully integrate new personnel or replicate the prior working relationships. The loss of critical employees might significantly delay or prevent the achievement of our business objectives. Qualified individuals with the breadth of skills and experience in our industry that we require are in high demand and we may incur significant costs to attract them. Difficulties in hiring or retaining key executive or employee talent or the unexpected loss of experienced employees could have an adverse impact on our business performance. In addition, we could experience business disruption and/or increased costs related to organizational changes, reductions in workforce, or other cost-cutting measures.

If we are not able to successfully execute on our future operating plans and objectives, our financial condition, and results of operation may be materially adversely affected, and we may not be able to continue as a going concern.

It is important that we meet our future sales goals and increase sales going forward. If we do not meet our sales goals, our available cash and working capital will decrease and our financial condition will be negatively impacted.

In order to be successful, we believe that we must, among other things:

We may not be able to meet these objectives, which could have a material adverse effect on our results of operations. We have incurred significant operating expenses in the past and may do so again in the future and, as a result, will need to commence revenues in order to improve our results of operations. Our ability to increase sales will depend primarily on success in expanding our current markets, improving our distribution base, entering into depository trust company (“DTC”) arrangements with national accounts, and introducing new products or product extensions to the market. Our ability to successfully enter new distribution areas and obtain new accounts will, in turn, depend on various factors, many of which are beyond our control, including, but not limited to, the continued demand for our brands and products in target markets, the ability to price our products at competitive levels, the ability to establish and maintain relationships with distributors in each geographic area of distribution and the ability in the future to create, develop and successfully introduce one or more new brands, products, and product extensions.

Although our financial statements have been prepared on a going concern basis, we must raise additional capital to fund our operations in order to continue as a going concern.

Manning Elliott LLP, our independent registered public accounting firm for the fiscal year ended December 31, 2023, has included an explanatory paragraph in their opinion that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2023, indicating that our current liquidity position raises substantial doubt about our ability to continue as a going concern. If we are unable to improve our liquidity position we may not be able to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments that might result if we are unable to continue as a going concern and, therefore, be required to realize our assets and discharge our liabilities other than in the normal course of business which could cause investors to suffer the loss of all or a substantial portion of their investment.

Based on the Company’s financial position as at December 31, 2023, the available funds are not considered adequate to meet requirements for the estimated operations and development activities on the Company’s technologies in the coming twelve-month period. These requirements may be adversely impacted by an absence of normal available financing due to the continued uncertainty in the markets. To address its financing requirements, the Company will seek financing through and not limited to debt financing, equity financing and strategic alliances. However, there is no assurance that such financing will be available. This material uncertainty casts significant doubt upon the Company’s ability to continue as a going concern. If the going concern assumption were not appropriate for these financial statements, then adjustments would be necessary to the carrying values of assets, liabilities, the reported income and expenses and the consolidated statement of financial position classifications used. Such adjustments could be material.

We may be unable to adequately protect our proprietary and intellectual property rights

Our ability to compete may depend on the superiority, uniqueness and value of any intellectual property and technology that it may develop or license. To the extent we are able to do so, to protect any proprietary rights of the Company, we intend to rely on a combination of patent, trademark, copyright and trade secret laws, confidentiality agreements with its employees and third parties, and protective contractual provisions. Despite these efforts, any of the following occurrences may reduce the value of any of the Company’s intellectual property:

Volatility in the price or availability of the inputs we depend on, including raw materials, packaging, energy, and labor, could adversely impact our financial results upon commercialization.

The principal raw materials we use include peptides, nucleic acids and enzymes. These costs are subject to fluctuation. Substantial increases in the prices of our raw materials and packaging materials, to the extent that they cannot be recouped through increases in the prices of finished products, would increase our operating costs and could reduce our profitability upon commercialization. If our supply of these raw materials is impaired or if prices increase significantly, it could affect the affordability of our products and reduce sales.

If we are unable to secure sufficient ingredients or raw materials and other key supplies, we might not be able to satisfy demand on a short-term basis.

Operational disruptions could cause delays in our production.

As our operations are concentrated in a limited number of production and distribution facilities, we are more likely to experience a significant operational disruption or catastrophic loss in any one location from acts of war or terrorism, fires, floods, earthquakes, severe winter storms, hurricanes, pandemics, labor strike, or other labor activities, cyber-attacks, and other attempts to penetrate our information technology systems or the information technology used by our employees who work from home during the COVID-19 pandemic, unavailability of raw or packaging materials, or other natural or man-made events. If a significant operational disruption or catastrophic loss were to occur, we could breach agreements, our reputation could be harmed, and our business, liquidity, financial condition, and/or results of operations could be adversely affected due to higher maintenance charges, unexpected capital spending, or product supply constraints.

Our insurance policies do not cover certain types of catastrophes and may not cover certain events such as pandemics. Economic conditions and uncertainties in global markets may adversely affect the cost and other terms upon which we are able to obtain property damage and business interruption insurance. If our insurance coverage is adversely affected, or to the extent we have elected to self-insure, we may be at greater risk that we may experience an adverse impact to our business, liquidity, financial condition, and/or results of operations.

A security incident may allow unauthorized access to our systems, networks, or data, harm our reputation, create additional liability, and harm our financial results.

Increasingly, companies are subject to a wide variety of attacks on their systems on an ongoing basis. In addition to threats from traditional computer “hackers,” malicious code (such as malware, viruses, worms, and ransomware), employee theft or misuse, password spraying, phishing, credential stuffing, and denial-of-service attacks, we may also face threats from sophisticated organized crime, nation-state, and nation-state supported actors who engage in attacks (including advanced persistent threat intrusions) that add to the risks to our internal systems. Third parties may attempt to fraudulently induce employees, users, or organizations into disclosing sensitive information or otherwise compromise the security of our internal electronic systems, networks, and/or physical facilities in order to gain access to our data, which could result in significant legal and financial exposure, a loss of confidence in us, interruptions or malfunctions in our operations, and, ultimately, harm to our future business prospects and revenue. The Company is in the process of engaging an information technology company, which will ensure appropriate security systems are in place to mitigate the risk of attacks on the Company’s system.

Failure to obtain satisfactory performance from our suppliers or loss of our existing suppliers could harm our business and as a result, our operations could suffer upon commercialization

Currently, we do not have long-term, written agreements with any of our suppliers. Upon commercialization, the termination of our relationships or an adverse change in the terms of these arrangements could have a negative impact on our business. If our suppliers increase their prices, we may not be able to secure alternative suppliers, and may not be able to raise the prices of our products to cover all or even a portion of the increased costs. Also, our future suppliers’ failure to perform satisfactorily or handle increased orders, delays in shipments of products from suppliers or the loss of our existing suppliers, especially our key suppliers, could cause us to fail to meet orders for our products, lose sales, incur additional costs and/or expose us to product quality issues. In turn, upon commercialization, this could cause us to lose credibility in the marketplace and damage our relationships with distributors, ultimately leading to a decline in our business and results of operations. If we are not able to renegotiate these contracts on acceptable terms or find suitable alternatives, our business, financial condition, or results of operations could be negatively impacted.

If our third-party service providers and business partners do not satisfactorily fulfill their commitments and responsibilities, our financial results could suffer.

In the conduct of our business, we rely on relationships with third parties, including manufacturers, consultants, service providers, and other external business partners, for certain functions or for services in support of key portions of our operations. These third-party service providers and business partners are subject to similar risks as we are, relating to cybersecurity, privacy violations, business interruption, and systems and employee failures, and are subject to legal, regulatory, and market risks of their own. Our third-party service providers and business partners may not fulfill their respective commitments and responsibilities in a timely manner and in accordance with the agreed-upon terms. In addition, while we have procedures in place for selecting and managing our relationships with third-party service providers and other business partners, we do not have control over their business operations or governance and compliance systems, practices and procedures, which increases our financial, legal, reputational, and operational risk. If we are unable to effectively manage our third-party relationships, or for any reason our third-party service providers or business partners fail to satisfactorily fulfill their commitments and responsibilities, our financial results could suffer.

Pandemics, such as the current global COVID-19 pandemic, outbreaks of communicable infections or diseases, or other public health concerns in the markets in which our employees live and/or in which we or our distributors, retailers, and suppliers operate may damage our business and disrupt our operations.

Disease outbreaks and other public health conditions could result in disruptions and damage to our business caused by potential disruption to our supply chains, production processes, and operations. Supply disruption may result from restrictions on the ability of employees and others in the supply chain to travel and work, caused by quarantine or individual illness, or which may result from border closures imposed by governments to deter the spread of communicable infection or disease, or determinations by us or our suppliers or distributors to temporarily suspend operations in affected areas, or other actions which restrict the ability to distribute our products or which may otherwise negatively impact our ability to produce, bottle, and ship our product, for our distributors to distribute our products, or for our suppliers to provide us our raw materials. Ports or channels of entry may be closed or operate at only a portion of capacity, or transportation of products within a region or country may be limited, if workers are unable to report to work due to travel restrictions or personal illness. Our operations and the operations of our suppliers may become less efficient or otherwise become negatively impacted if our executive leaders or other personnel critical to our operations are unable to work or if a significant percentage of the workforce is unable to work or is required to work from home. Our cyber-security could be compromised if persons who are forced to work from home do not maintain adequate information security. A prolonged quarantine or border closure could result in temporary or longer-term disruptions of sales patterns, consumption and trade patterns, supply chains, production processes, and operations. A widespread health crisis, such as the COVID-19 pandemic, could negatively affect the economies and financial markets of many countries resulting in a global economic downturn, which could negatively impact demand for our products and our ability to borrow money. Any of these events could have a material adverse effect on our business, liquidity, financial condition, and/or results of operations.

A failure of one or more of our key IT systems, networks, processes, associated sites or service providers could breach HIPAA, patient privacy, and/or have a material adverse impact on business operations, and if the failure is prolonged, our financial condition.

We rely on IT systems, networks, and services, including internet sites, data hosting and data processing facilities and tools, hardware (including laptops and mobile devices), software and technical applications and platforms, some of which are managed, hosted, provided and used by third-parties or their vendors, to assist us in the management of our business. The various uses of these IT systems, networks and services include, but are not limited to: hosting our internal network and communication systems; collecting and storing employee, shareholder, and other data; processing transactions; summarizing and reporting results of operations; hosting, processing and sharing confidential and proprietary research, business plans and financial information; complying with regulatory, legal or tax requirements; providing data security; and handling other processes necessary to manage our business.

The proper functioning of our own information technology (“IT”) infrastructure is critical to the efficient operation and management of our business. We may not have the necessary financial resources to update and maintain our IT infrastructure, and any failure or interruption of our IT system could adversely impact our operations. In addition, our IT is vulnerable to cyber-attacks, computer viruses, worms and other malicious software programs, physical and electronic break-ins, sabotage and similar disruptions from unauthorized tampering with our computer systems. We believe that we have adopted appropriate measures to mitigate potential risks to our technology infrastructure and our operations from these IT-related and other potential disruptions. However, given the unpredictability of the timing, nature, and scope of any such IT failures or disruptions, we could potentially be subject to downtimes, transactional errors, processing inefficiencies, operational delays, other detrimental impacts on our operations or ability to provide products to our customers, the compromising of confidential or personal information, destruction or corruption of data, security breaches, other manipulation or improper use of our systems and networks, financial losses from remedial actions, loss of business or potential liability, and/or damage to our reputation, any of which could have a material adverse effect on our cash flows, competitive position, financial condition, or results of operations. In any of these events, we could be required to spend significant financial and other resources to remedy the damage caused by a security breach or to repair or replace networks and IT systems.

Our operations, products, data and intellectual property are inherently at risk of loss, inappropriate access, or tampering by both insider threats and external bad actors. In particular, our operations face various cyber and other security threats, including attempts to gain unauthorized access to sensitive information, intellectual property, mission operations, systems and networks. Our systems (internal, customer and partner systems) and assets may also be subject to damage or interruption from natural and other disaster events or disruptions including hurricanes, floods, earthquakes, fires, other extreme weather conditions, epidemics or pandemics, acts of terrorism, power shortages and blackouts, aging infrastructures and telecommunications failures. In addition, insider threats, threats to the safety of our directors and employees, threats to the security of our facilities, infrastructure and supply chain and threats from terrorist acts or other acts of aggression could have a material adverse impact on our business.

Our partners (including our supply chain) face similar threats. Partner proprietary, classified, or sensitive data and information transmitted to, from, or stored on our networks are at risk. Assets and intellectual property and products in partner environments are also at risk. We also have risk where we have access to partner networks and face risks of breach, disruption or loss as well.

While we have implemented reasonable measures consistent with government regulations aimed at reducing the risk of cyber threats as well as to help thwart bad actors and protect our data and our systems and assets, the techniques used to gain unauthorized access are constantly evolving, and we may be unable to anticipate or prevent all unauthorized access, disruption, loss, or harm. Because of our desired data and intellectual property we (and/or partners we use) may be an attractive target for such attacks. We cannot offer assurances, however, that future attacks will not materially adversely affect our business or reputation.

Litigation and litigation risks may have an adverse impact on our operations, business, and reputation.

From time to time, we may become involved in various litigation matters and claims, including employment, regulatory proceedings, administrative proceedings, governmental investigations, and contract disputes. We could face potential claims or liability for, among other things, breach of contract, defamation, libel, fraud, or negligence. We may also face employment-related litigation, including claims of age discrimination, sexual harassment, gender discrimination, immigration violations, or other local, state, and federal labor law violations. Because of the uncertain nature of litigation and insurance coverage decisions, the outcome of such actions and proceedings cannot be predicted with certainty and an unfavorable resolution of one or more of them could have a material adverse effect on our business, financial condition, results of operations, cash flows, reputation, brand identity, and the trading price of our securities. Any such litigation, with or without merit, could also result in substantial expenditures of time and money, and divert attention of our management team from other tasks important to the success of our business.

In the future, if we were to encounter product recalls or other product quality issues, our business may suffer.

Any future product quality issues, real or imagined, or allegations of product contamination, even when false or unfounded, could tarnish our image and could cause consumers to choose other products. In addition, because of changing government regulations or implementation thereof, or allegations of product contamination, we could be required from time to time to recall products entirely or from specific markets. Any future product recalls could affect our profitability and could negatively affect brand image.

International operations, worldwide and domestic economic trends, and financial market conditions, geopolitical uncertainty, changes to international trade agreements and tariffs, import and excise duties, other taxes, or other governmental rules and regulations could have a material adverse effect on our business and operations.

Risks associated with international operations, any of which could have a material adverse effect on our business, liquidity, financial condition, and/or results of operations, include:

Unfavorable global or regional economic conditions, including economic slowdown and the disruption, volatility, and tightening of credit and capital markets, as well as unemployment, tax increases, governmental spending cuts, or a return of high levels of inflation, could affect consumer spending patterns and purchases of our products. These could also create or exacerbate credit issues, cash flow issues, and other financial hardships for us and our suppliers, distributors, retailers, and consumers. The inability of suppliers, distributors, and retailers to access liquidity could impact our ability to produce and distribute our products.

We are also exposed to risks associated with interest rate fluctuations. We could experience changes in our ability to manage fluctuations in interest rates and, accordingly, there can be no assurance that we will be successful in reducing those risks.

We could also be affected by nationalization of our international operations, unstable governments, unfamiliar or biased legal systems, intergovernmental disputes or animus against the U.S. Any determination that our operations or activities did not comply with applicable U.S. or foreign laws or regulations could result in the imposition of fines and penalties, interruptions of business, terminations of necessary licenses and permits, and other legal and equitable sanctions.

We will be subject to risks inherent in sales of products in international markets.

There can be no assurance that future products that we manufacture, distribute, or sell will be accepted or be successful in any particular foreign market, due to local or global competition, product price, cultural differences, consumer preferences, or otherwise. There are many factors that could adversely affect demand for our products in foreign markets, including our inability to attract and maintain key distributors in these markets; volatility in the economic growth of certain of these markets; changes in economic, political or social conditions; the status and renegotiations of the North American Free Trade Agreement; imposition of new or increased labeling, product or production requirements, or other legal restrictions; restrictions on the import or export of our products or ingredients or substances used in our products; inflationary currency, devaluation or fluctuation; and increased costs of doing business due to compliance with complex foreign and U.S. laws and regulations. If we are unable to effectively operate or manage the risks associated with operating in international markets, our business, financial condition, or results of operations could be adversely affected.

Damage to our reputation could harm our future business and cause a decline in our future sales.

Our future sales’ success, in part, depends upon the positive image that consumers have of our products and maintaining a good reputation is critical to selling our future products. Our reputation could also be impacted negatively by public perception, adverse publicity (whether or not valid, such as the similarity of the name of certain of our brands or trademarks and a type of virus), negative comments in social media, or our responses relating to:

Failure to comply with federal, state, or local laws and regulations, maintain an effective system of internal controls, provide accurate and timely financial statement information, or protect our information systems against service interruptions, misappropriation of data, or breaches of security, could also hurt our reputation. Damage to our reputation or loss of consumer confidence in our future products for any of these or other reasons could result in decreased demand for our future products and could have a material adverse effect on our business, liquidity, financial condition, and/or results of operations, as well as require additional resources to rebuild our reputation, competitive position, and brand equity and renew investor confidence.

Our intangible assets, such as goodwill and trademarks, could have a material adverse effect in the event of a write-down of the assets.

We have a significant amount of intangible assets such as goodwill and trademarks and may acquire more intangible assets in the future. Intangible assets are subject to a periodic impairment evaluation under applicable accounting standards. The write-down of any of these intangible assets could have a material adverse effect on our business, liquidity, financial condition, and/or results of operations.

Any changes to existing accounting pronouncements or taxation rules or practices may affect how we conduct business.

New accounting pronouncements, taxation rules and varying interpretations of accounting pronouncements or taxation rules have occurred in the past and may occur in the future. The change to existing rules, future changes, if any, or the need for the Company to modify a current tax position may adversely affect the way we conduct business.

We may be required in the future to record a significant charge to earnings if our intangible assets become impaired.

Under International Financial Reporting Standards (“IFRS”), we are required to review our intangible assets for impairment when events or changes in circumstances indicate the carrying value may not be recoverable. Factors that may be considered a change in circumstances indicating that the carrying value of our intangible assets may not be recoverable include, declining or slower than anticipated growth rates for certain of our existing products, a decline in stock price and market capitalization, and slower growth rates in our industry. We may be required in the future to record a significant charge to earnings during the period in which we determine that our intangible assets have been impaired. Any such charge would adversely impact our results of operations. As of December 31, 2023, our intangible assets totaled C$22,949,560.

Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters could significantly affect our financial results.

IFRS with regard to a wide variety of matters that are relevant to our business, such as, but not limited to, fair value measurement for financial instruments and the recoverability, share-based compensation and deferred tax assets are highly complex and involve many subjective assumptions, estimates, and judgments by our management. Changes to these standards or changes in underlying assumptions, estimates or judgments by our management could significantly change our reported results.

If we are unable to maintain effective disclosure controls and procedures and internal control over financial reporting, our stock price and investor confidence could be materially and adversely affected.

We are required to maintain both disclosure controls and procedures and internal control over financial reporting that are effective. Because of their inherent limitations, internal control over financial reporting, however well designed and operated, can only provide reasonable, and not absolute, assurance that the controls will prevent or detect misstatements. Because of these and other inherent limitations of control systems, there is only the reasonable assurance that our controls will succeed in achieving their goals under all potential future conditions. The failure of controls by design deficiencies or absence of adequate controls could result in a material adverse effect on our business and financial results, which could also negatively impact our stock price and investor confidence.

Our business operations may be adversely affected by social, political, and economic conditions affecting market risks and the demand for and pricing of our products.

These risks include:

Uncertainty in the financial markets and other adverse changes in general economic or political conditions in any of the major countries in which we do business could adversely affect our industry, business and results of operations.

Global economic uncertainties, including foreign currency exchange rates, affect businesses such as ours in a number of ways, making it difficult to accurately forecast and plan our future business activities. There can be no assurance that economic improvements will occur, or that they would be sustainable, or that they would enhance conditions in markets relevant to us.

An investment in our common shares, Pre-Funded Warrants and common warrants is speculative and there can be no assurance of any return on any such investment.

An investment in our common shares, Pre-Funded Warrants and common warrants is speculative and there is no assurance that investors will obtain any return on their investment. Investors will be subject to substantial risks involved in an investment in the Company, including the risk of losing their entire investment.

Future sales of common shares, or the perception of such future sales, by some of our existing shareholders could cause our share price to decline.

The market price of our common shares could decline as a result of sales of a large number of our common shares in the market or the perception that these sales may occur. These sales, or the possibility that these sales may occur, also might make it more difficult for us to sell shares in the future at a time and at a price that we deem appropriate.

From time to time, certain of our shareholders may be eligible to sell all or some of their common shares by means of ordinary brokerage transactions in the open market pursuant to Rule 144 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), subject to certain limitations. In general, pursuant to Rule 144, non-affiliate shareholders may sell freely after six months subject only to the current public information requirement. Affiliates may sell after six months subject to the Rule 144 volume, manner of sale (for equity securities), and current public information and notice requirements.

We do not expect to pay dividends and investors should not buy our common shares expecting to receive dividends.

We do not anticipate that we will declare or pay any dividends in the foreseeable future. Consequently, you will only realize an economic gain on your investment in our common shares if the price appreciates. You should not purchase our common shares expecting to receive cash dividends. Since we do not pay dividends, and if we are not successful in establishing an orderly trading market for our shares, then you may not have any manner to liquidate or receive any payment on your investment. Therefore, our failure to pay dividends may cause you to not see any return on your investment even if we are successful in our business operations. In addition, because we do not anticipate that we will pay dividends, we may have trouble raising additional funds which could affect our ability to expand our business operations.

There can be no assurances that our common shares once listed on Nasdaq will not be subject to potential delisting if we do not continue to maintain the listing requirements of Nasdaq.

We intend to apply to list the shares of our common shares on The Nasdaq Stock Market, under the symbol “SEPS.” An approval of our listing application by Nasdaq will be subject to, among other things, our fulfilling all of its listing requirements. In addition, Nasdaq has rules for continued listing, including, without limitation, minimum market capitalization and other requirements. Failure to maintain our listing (i.e., being de-listed from Nasdaq), would make it more difficult for shareholders to sell our common shares and more difficult to obtain accurate price quotations on our common shares. This could have an adverse effect on the price of our common shares. Our ability to issue additional securities for financing or other purposes, or otherwise to arrange for any financing we may need in the future, may also be materially and adversely affected if our common shares is not traded on a national securities exchange.

Our common shares could be further diluted as the result of the issuance of additional common shares, convertible securities, options, or warrants.

Our issuance of additional common shares, convertible securities, options, and warrants could affect the rights of our shareholders, result in a reduction in the overall percentage holdings of our shareholders, could put downward pressure on the market price of our common shares, could result in adjustments to conversion and exercise prices of outstanding notes and warrants, and could obligate us to issue additional common shares to certain of our shareholders.

Our formation documents permit us to issue an unlimited number of the common shares without additional shareholder approval.

Our formation documents permit us to issue an unlimited number of common shares. The Company may, from time to time, issue additional Common Shares in the future. Subject to the requirements of Nasdaq and the TSX, the Company will not be required to obtain the approval of shareholders for the issuance of additional common shares. Any further issuances of common shares will result in immediate dilution to existing shareholders and may have an adverse effect on the value of their shareholdings.

There is no established public trading market for the Pre-Funded Warrants or the common warrants being offered in this offering, and we do not expect a market to develop for either the Pre-Funded Warrants or the common warrants.

There is no established public trading market for the Pre-Funded Warrants, or the common warrants being offered in this offering, and we do not expect a market to develop. In addition, we do not intend to apply to list either the Pre-Funded Warrants or the common warrants on any national securities exchange or other nationally recognized trading system. Without an active market, the liquidity of the Pre-Funded Warrants and the common warrants will be limited. Further, the existence of the Pre-Funded Warrants or the common warrants may act to reduce both the trading volume and the trading price of our common shares.

Except as otherwise provided in the Pre-Funded Warrants or the common warrants, holders of the Pre-Funded Warrants or the common warrants purchased in this offering will have no rights as shareholders until such holders exercise their Pre-Funded Warrants or the common warrants and acquire our common shares.

Except as otherwise provided in the Pre-Funded Warrants or the common warrants, until holders of the Pre-Funded Warrants or the common warrants acquire common shares upon exercise of the Pre-Funded Warrants or the common warrants, holders of the respective warrants will have no rights with respect to the common shares underlying such Pre-Funded Warrants or common warrants. Upon exercise of the Pre-Funded Warrants or the common warrants, the holders will be entitled to exercise the rights of a holder of our common shares only as to matters for which the record date occurs after the exercise date.

Since the common warrants are executory contracts, they may have no value in a bankruptcy or reorganization proceeding.

In the event a bankruptcy or reorganization proceeding is commenced by or against us, a bankruptcy court may hold that any unexercised common warrants are executory contracts that are subject to rejection by us with the approval of the bankruptcy court. As a result, holders of the common warrants may, even if we have sufficient funds, not be entitled to receive any consideration for their common warrants or may receive an amount less than they would be entitled to if they had exercised their common warrants prior to the commencement of any such bankruptcy or reorganization proceeding.

Our articles of incorporation provide that a quorum for the transaction of business at a meeting of shareholders is one or more persons present in person or by proxy and we do not require shareholder approval before certain issuances of shares other than public offerings.

Our articles of incorporation provide that a quorum for the transaction of business at a meeting of shareholders is one or more persons present in person or by proxy and we do not require shareholder approval before an issuance of securities in connection with the acquisition of the stock or assets of another company; equity-based compensation of officers, directors, employees, or consultants; and transactions other than public offerings. This could result in dilution to existing shareholders and may have an adverse effect on shareholder value.

We are an “emerging growth company,” and any decision on our part to comply with certain reduced disclosure requirements applicable to emerging growth companies could make the common shares less attractive to investors.

We are an “emerging growth company” as defined in the JOBS Act, and, for as long as we continue to be an emerging growth company, we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, not being required to comply with any new requirements adopted by the Public Company Accounting Oversight Board, or the PCAOB, requiring mandatory audit firm rotation or a supplement to the auditor’s report in which the auditor would be required to provide additional information about the audit and the financial statements of the issuer, not being required to comply with any new audit rules adopted by the PCAOB after April 5, 2012 unless the SEC determines otherwise, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. We could remain an emerging growth company until the earlier of: (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of our first sale of common equity securities pursuant to an effective registration statement; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer. We cannot predict if investors will find our common shares less attractive if we choose to rely on these exemptions. If some investors find our common shares less attractive as a result of any choices to reduce future disclosure, there may be a less active trading market for our common shares and our share price may be more volatile. Further, as a result of these scaled regulatory requirements, our disclosure may be more limited than that of other public companies and you may not have the same protections afforded to shareholders of such companies.

Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (the “Securities Act”), for complying with new or revised accounting standards. We have opted for taking advantage of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the Jobs Act.

Unstable market and economic conditions caused by the ongoing conflict between the Ukraine and Russia, as well as the ongoing COVID-19 pandemic, could have adverse consequences on our business, financial condition and results of operations.

The global economy, including credit and financial markets, has experienced extreme volatility and disruptions as a result of the ongoing conflict between the Ukraine and Russia, as well as challenges arising from the ongoing COVID-19 pandemic, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, increases in inflation rates and uncertainty about economic stability. We could suffer inflationary pressure in our business such as through the increased costs of the supplies that we use to manufacture our products and distributing our products to all our customers where we do business. Any such volatility and disruptions could have adverse consequences on us or the third parties upon whom we rely.

You should consult your independent tax advisor regarding any tax matters arising with respect to our common shares, including the possibility that we may be classified as a passive foreign investment company (as discussed below under “Certain Material United States Federal Income Tax Considerations”).

All prospective purchasers of our common shares are advised to consult their own tax advisors regarding the U.S. federal, state, local and non-U.S. tax consequences relevant to the purchase, ownership, and disposition of our common shares.

CURRENCY AND EXCHANGE RATE INFORMATION

The following table sets forth, for each period indicated, the period-end and the high and low exchange rate for U.S. dollars expressed in Canadian dollars, and the average exchange rate for the periods indicated. These rates are based on the noon buying rate certified for custom purposes by the U.S. Federal Reserve Bank of New York set forth in the H.10 statistical release of the Federal Reserve Board. These rates are provided solely for your convenience and are not necessarily the exchange rates that we used in this prospectus or will use in the preparation of any other reports or information to be provided to you. We make no representation that any Canadian dollar or U.S. dollar amounts referred to in this prospectus could have been or could be converted into U.S. dollars or Canadian dollars, as the case may be, at any particular rate or at all. We have presented our results of operations in Canadian dollars.

On February 26, 2024, the noon buying rate was US$1.00 = C$1.352422.

USE OF PROCEEDS

We estimate that the net proceeds to us from the sale of our [__] Units in this offering will be approximately [$_________], after deducting the underwriting discounts and commissions and the estimated offering expenses payable by us (including the offering expenses that have been committed to be paid), and assuming no exercise of the over-allotment option by the Underwriter, and no exercise of the common warrants.

We intend to use net proceeds from this offering for working capital and general corporate purposes, including product development other than as set forth, we do not anticipate requiring any material amounts of other funds to accomplish the specified purposes. Of the net proceeds from this offering, 85% will go towards product development and associated activities, with 35% going to Sepset, 40% to ABT and 10% to SafeCoat. The majority of Sepset funding will go towards completing 510(k) filings for clearance of early diagnostics for severe sepsis and severe Covid with follow-up filings for regulatory approval in Europe, China and Bahrain. ABT funding will focus on completing a clinical study of high-end dental mouth rinse and obtaining regulatory clearance in Europe and China. The SafeCoat funding will be used for development and testing of a prototype medical device (e.g., contact lenses) with our proprietary coating. Other activities will depend on the amount of proceeds raised. If sufficient, we will further develop and test our diagnostic for sepsis mechanism (endotypes) in patients enabling personalized treatments in preparation, and perform advance development of enhanced bandages, treatments for chronic rhinosinusitis and other oral therapies/preventatives, preparing for device or Investigational New Drug applications. We believe that the net proceeds from this offering and our existing cash will be sufficient to fund our operations through at least the next 24 months. This expected use of the net proceeds from the offering represents our intentions based upon our current plans and business conditions. We cannot specify with certainty all of the particular uses of the net proceeds that we will receive from this offering, or the amounts that we will actually spend on the uses set forth above. We may find it necessary or advisable to use the net proceeds for other purposes, and we will have broad discretion in using these proceeds. Investors will be relying on our judgment regarding the use of the net proceeds from this offering.

The expected use of net proceeds of this offering represents our current intentions based upon our present plan and business conditions. As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering. We will have broad discretion in the application of the net proceeds in the category of “for general corporate purposes,” and investors will be relying on our judgment regarding the application of the proceeds of this offering. Depending on the outcome of our business activities and other unforeseen events, our plans and priorities may change and we may apply the net proceeds of this offering in different proportions than we currently anticipate.

MARKET FOR COMMON EQUITY AND RELATED SHAREHOLDER MATTERS

Market Information for Common Shares

Our common shares are currently quoted on the Canadian Stock Exchange (“CSE”) under the trading symbol “ASEP”, the OTC Pink under the trading symbol “SEPSF” and on the Frankfurt Stock Exchange (“FSE”) under the trading symbol “FSX:JJ8”. On May 28, 2024, the closing price of our common shares on CSE was CAD 0.1850 and the last reported sale price on the OTC Pink was $0.05. We do not intend to apply for the listing of the Pre-Funded Warrants or the common warrants that are part of this offering on any national securities exchange.

Holders

As at December 31, 2023, the registrar and transfer agent for our common shares reported that there were 74,184,087 common shares issued and outstanding. Of these, 71,093,882 were registered to Canadian residents, including 60,538,587 shares registered to CDS & Co., which is a nominee of the Canadian Depository for Securities Limited. The 71,093,882 shares were registered to 145 shareholders in Canada, one of which is CDS & Co. 3,090,205 of our shares were registered to residents of the United States, including 1,000 shares registered to CEDE & Co., which is a nominee of Depository Trust Company. The 3,090,205 shares were registered to 9 shareholders in the United States, one of which is CEDE & Co. None of our shares were registered to residents of other foreign countries.

Dividends

We have not declared any common share dividends to date. We have no present intention of paying any cash dividends on our common shares in the foreseeable future, as we intend to use earnings, if any, to generate growth. The payment by us of dividends, if any, in the future, is within the discretion of our board of directors and will depend upon, among other things, our earnings, capital requirements and financial condition, as well as other relevant factors. There are no material restrictions in our articles that restrict us from declaring dividends.

DILUTION

If you invest in our common shares and/or Pre-Funded Warrants, your interest will be diluted for each common share you purchase to the extent of the difference between the public offering price per common share, included as part of the Units (without assigning any value to the common warrants) and our net tangible book value per common share after this offering. Dilution results from the fact that the public offering price per common share is substantially in excess of the net tangible book value per common share attributable to the existing shareholders for our presently outstanding common shares.

Our net tangible book value as of December 31, 2023, was [___], or [__] per common share. Net tangible book value represents the amount of our total consolidated tangible assets, less the amount of our total consolidated liabilities. Dilution is determined by subtracting the net tangible book value per common share (as adjusted for the offering) from the initial public offering price per common share and after deducting the estimated underwriting discounts and the estimated offering expenses payable by us.

After giving effect to our sale of [__] Units offered in this offering based on the assumed public offering price of $[__] per Unit, which is the midpoint of the estimated range of the public offering price shown on the front cover of this prospectus, after deduction of the estimated underwriting discounts and the estimated offering expenses payable by us, and assuming no Pre-Funded Warrants are issued, our as adjusted net tangible book value as of [__], would have been $[__], or $[__] per outstanding common share. This represents an immediate increase in net tangible book value of $[__] per common share to the existing shareholders, and an immediate dilution in net tangible book value of $[__] per common share to investors purchasing common shares included in the Units sold in this offering. The as adjusted information discussed above is illustrative only.

A $1.00 change in the assumed public offering price of $[__] per Unit would, in the case of an increase, increase and, in the case of a decrease, decrease our pro forma net tangible book value after giving effect to the offering by $[__] million, the pro forma net tangible book value per common share after giving effect to this offering by $[__] and the dilution in pro forma net tangible book value per common share included in the Units sold to new investors in this offering by $[__] assuming no change to the number of common share included in the Units offered by us as set forth on the cover page of this prospectus, and after deducting underwriting discounts and estimated offering expenses. The pro forma information discussed above is illustrative only. Our net tangible book value following the completion of this offering is subject to adjustment based on the actual initial public offering price of our common shares included in the Units and other terms of this offering determined at pricing.

The following table illustrates the estimated net tangible book value per share after this offering and the per share dilution to persons purchasing common shares included in the Units in this offering based on the foregoing offering assumptions:

The following tables summarize, on a pro forma as adjusted basis as of [___], the differences between existing shareholders and the new investors with respect to the number of common shares included in the Units purchased from us, the total consideration paid and the average price per common share before deducting the estimated underwriting discounts and the estimated offering expenses payable by us. The table below assumes no exercise of the Underwriter’s over-allotment option

To the extent that our outstanding options, warrants or subscription investment units are exercised, investors in this offering may suffer additional dilution.

The pro forma as adjusted information as discussed above is illustrative only. Our net tangible book value following the completion of this offering is subject to adjustment based on the actual initial public offering price of our common shares and other terms of this offering determined at the pricing.

CAPITALIZATION

The following table sets forth our cash and our capitalization as of December 31, 2023:

The pro forma information below is illustrative only and our capitalization following the completion of this offering is subject to adjustment based on the public offering price of our common shares and other terms of this offering determined at pricing. You should read this capitalization table together with our consolidated financial statements and the related notes appearing elsewhere in this prospectus and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section and other financial information included elsewhere in this prospectus.

A $1.00 increase (decrease) in the assumed public offering price of $[__] per Unit would increase (decrease) the pro forma net tangible book value per share by approximately $[__] and the dilution in pro forma net tangible book value per share to investors participating in this offering by $[__] per share, assuming that the number of Units offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions, non-accountable expense allowance, and offering expenses payable by us.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL

CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our results of operations and financial condition should be read in conjunction with our audited consolidated financial statements for the years ended December 31, 2023 and December 31, 2022 (our “Audited Financial Statements”), which are included elsewhere in this registration statement. Our financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) and all amounts are expressed in Canadian dollars unless otherwise noted. Our accounting policies are described in note 3 of our Audited Financial Statements.

Our Business

ASEP is in the business of acquiring assets, technologies and/or businesses in area of life sciences and medical diagnostics.

Year ended December 31, 2023 compared to year ended December 31, 2022

A summary of the Company’s operating results for the years ended December 31, 2023 and December 31, 2022 are as follows:

The net loss attributable to the shareholders for the year ended December 31, 2023 amounted to $8,227,328 compared to a net loss for the comparative period of $4,524,981 . Current year results included borrowing costs of $270 (2022: $814), a foreign exchange loss of $4,116 (2022: $2,399 ), loss on debt settlement of $429,864 (2022: $Nil) and SafeCoat Medical Inc. acquisition expense of $1,275,000 (2022: $400,521 ) and a deferred tax recovery of $Nil (2022: $89,100).

The loss on debt settlement resulted from the issue of 2,105,000 shares and 2,105,000 warrants with an estimated fair value of $850,864 to settle debt totaling $421,000.

Details of the SafeCoat acquisition expense are as follows:

Revenue

The Company recorded an investment in SepSMART of $2,375,000 on the vend in of certain patents licensed to the associate. The revenue from the license is being recognized over the license term of 8 years commencing December 5, 2023. In the current year, revenues of $21,140 have been recorded and the balance of the revenues of $2,353,860 to be recognized over the remaining term of the licenses are disclosed as deferred revenues in the consolidated statement of financial position.

Operating expenses

Operating expenses totaled $7,742,403 for the year ended December 31, 2023 compared to $5,442,653 for the comparative prior period.

Significant factors that contributed to the variances are discussed below:

The Company recorded amortization of $1,294,266 for the year ended December 31, 2023 (2022: $1,282,394) on intangible assets, lab equipment and computer equipment. During the year ended December 31, 2023, the Company acquired an additional license ($596,591) included in Intellectual Property resulting in an increase in the amortization expense in the current financial year.

Breakdown of amortization expenses for the respective years are as follows:

The Company incurred board advisory fees of $230,673 for the year ended December 31, 2023 (2022: $79,887). In prior comparative period, the Company had one board advisor who was receiving monthly compensation of US$5,000. In March 2023, the Company appointed new members to the advisory board, three of whom are receiving monthly compensation of $5,000 for their services, which are being settled through the issue of shares on a quarterly basis.

The Company recorded compensation expense of $782,301 for 2 employees of Asep, 3 employees of ASEP Medical Inc. and 2 employees of Sepset for the year ended December 31, 2023 (2022: $556,550). One full time employee was hired October 1, 2022 at a monthly rate of $15,000 and an additional employee was hired January 1, 2024 at a monthly rate of $9,200.

The Company incurred consulting costs of $514,478 (2022: $246,946) for the year ended December 31, 2023, which is related to the services provided by the Company’s COO, CFO, Medical Director and external consultants for regulatory advisory services. In the prior year, consulting fees included the CEO up to the date of his resignation in June 2022, the COO from date of his appointment in July 2022 and the CFO from date of appointment in October 2022 and financial advisory services.

The Company incurred $222,903 of general & administrative costs during the year ended December 31, 2023 compared to $139,718 for the year ended December 31, 2022. The current year’s expense includes travel, occupancy, IT support services and insurance costs. In the prior comparative period, there were no external IT support services and lower corporate activity.

For the year ended December 31, 2023, the Company has incurred investor relations costs of $1,110,409 (2022: $845,950). The Company has engaged the services of numerous consultants to assist in

The Company incurred 134,880 (2022: $155,401) in patent fees related to patent filings and maintenance fees incurred by ABT and Sepset.

The Company incurred $760,006 in professional fees for the year ended December 31, 2023, which included legal, audit and accounting fees. Professional fees for the prior comparative period totalled $284,606. The increase is a result of increased corporate activity (SafeCoat License Agreement, Joint Venture Contract and supplemental agreements SepSMART, RSU Plan, Life Offering, Debt Settlement, general corporate matters and preparation of the draft registration statement on Form F-1 filed on a confidential basis with the U.S. Securities and Exchange Commission (July 2023).

The Company incurred research & development costs of $678,543 for the year ended December 31, 2023 (2022: $615,040) related to the collaborative research agreements with the University of British Columbia (UBC). The current period expense is net of a SR&ED refund of $45,439 received by ABT for the claim made for the period from January 1, 2021 to November 9, 2021.

Details are as follows:

The collaborative research agreement between UBC and ABT Innovations Inc. is for activities related to the development of the Company’s proprietary peptide technology. These include evaluating the antibiofilm and immunomodulatory activity of several lead peptide molecules as they relate to the various biofilm-associated infections being targeted by the company such as chronic sinusitis, biofilm-infected wounds and oral health.

The collaborative research agreement between UBC and Sepset Biosciences Inc. is to experimentally test and validate the components of the diagnostic assays for sepsis that are designed and developed by Sepset employees. This includes activities related to the nucleic acid isolation procedures as well as testing the performance of the various components of the quantitative polymerase chain reaction assay.

The Company recognized share-based compensation of $1,952,054 (2022: $1,119,072) related to stock options and restricted stock units (“RSUs) that were granted to certain directors, officers, employees and consultants and vested during the year ended December 31, 2023. Stock options are granted to directors, officers, employees and consultants pursuant to employment, consulting or board advisory agreements, collectively referred to as service agreements, as part of the remuneration package to the respective party, as set out in their respective service agreement. RSUs are rewarded to directors, officers, employees, consultants and advisory board members to promote the long-term success of the Company and the creation of shareholder value by: (i) encouraging the attraction and retention; (ii) encouraging such to directors, officers, employees and consultants to focus on critical long-term objectives; and (iii) promoting greater alignment of the interests of such to directors, officers, employees and consultants with the interests of the Company.

Details are as follows:

The following table details the Company’s quarterly results:

There are no meaningful trends evident from analysis of the summary of quarterly financial information.

Factors that can cause significant fluctuations in the Company’s quarterly results include share-based compensation:

Significant items contributing to the loss incurred during the fourth quarter ended December 31, 2023 and 2022 are as follows

Details are as follows:

The collaborative research agreement between UBC and ABT Innovations Inc. is for activities related to the development of the company’s proprietary peptide technology. These include evaluating the antibiofilm and immunomodulatory activity of several lead peptide molecules as they relate to the various biofilm-associated infections being targeted by the company such as chronic sinusitis, biofilm-infected wounds and oral health.

The collaborative research agreement between UBC and Sepset Biosciences Inc. is to experimentally test and validate the components of the diagnostic assays for sepsis that are designed and developed by Sepset employees. This includes activities related to the nucleic acid isolation procedures as well as testing the performance of the various components of the quantitative polymerase chain reaction assay.

Details are as follows:

Liquidity and Capital Resources

The following table summarizes our cash flow data as of:

Operating Activities

Net cash used in operating activities consists of net loss adjusted for non cash items, including amortization, borrowing costs, consulting fees, loss on debt settlement, revenue, SafeCoat acquisition expense, shares issued for services and share-based compensation and for impact of changes in working capital. Net cash used in operations for the year ended December 31, 2023 was $2,712,598 representing a decrease of $901,878 compared to net cash used in operation of $3,614,476 for the year ended December 31, 2022.

Investing Activities

During the year ended December 31, 2023, the Company purchased computer equipment ($1,227) and incurred costs in registering trademarks ($3,244). Net cash provided by investing during the year ended December 31, 2022 was provided by the cash acquired on the acquisition of SafeCoat ($125,231) offset by the cost incurred in registering trademarks ($435).

Financing Activities

During the year ended December 31, 2023, the Company completed a Life Offering for gross proceeds of $587,000 and received loan proceeds of $20,000. Additionally, 200,000 stock options were exercised for proceeds of $60,000. During the year ended December 31, 2022, the Company completed a debt financing for proceeds of $330,000.

Cash Resources and Capital Resources

We have no revenue generating operations from which we can internally generate funds. To date the Company’s ongoing operations have been funded through debt and equity financings. The Company believes that it will be able to secure additional debt financings, private placements and public financings in the future, although it can not predict the size or pricing of any such financings. This situation is unlikely to change until such time as the Company commences profitable operations from the sale of its products. When acquiring technologies through purchase or option, the Company will sometimes issue common shares to the vendor or optioned of the technology as partial or full consideration for the technology in order to preserve cash.

As at December 31, 2023, the Company had cash and cash equivalents of $64,721, other current assets of $186,222 and current liabilities of $995,587, compared to cash and cash equivalents of $2,130,390, other current assets of $1,268,255 and current liabilities of $528,161as at December 31, 2022.

As of December 31, 2023, the Company had working capital (deficit) of $(744,644) (December 31, 2022 –$2,870,484 ). The Company estimates that it does not have available funds to meet requirements for the coming twelve months based on current estimated expenditures for operations and development of its technologies. These uncertainties cast significant doubt on the ability of the Company to continue as a going concern. As at December 31, 2023, the consolidated financial statements were prepared on a going concern basis which contemplates the realization of assets and the settlement of liabilities in the normal course of operations. Management is working with its financial advisors to determine the best manner of raising capital over the next number of months. Management is considering an equity raise as well as, in the right circumstances and the right terms, a debt financing.

The ability of the Company to carry out its planned business objectives is dependent on its ability to raise adequate capital funds including and not limited to grants, strategic alliances, debt financing and equity financing. If adequate financing is not available, the Company may be required to delay, reduce the scope of, or eliminate one or more development activities. There is no assurance that Company will be able to obtain financing in the future or that such financing will be on terms acceptable to Company.

Material Accounting Policies

A summary of material accounting policies of Asep Medical Holdings Inc. is presented in note 3 of our Audited Financial Statements. The financial statements and notes are representations of the Company’s management, which is responsible for their integrity and objectivity. These accounting policies conform too accounting principles under IFRS and have been consistently applied in the preparation of financial statements.

Basis of presentation

These consolidated financial statements have been prepared on an accrual basis and on a historical cost basis. The preparation of the consolidated financial statements in compliance with IFRS requires management to make certain critical accounting estimates. It also requires management to exercise judgment in applying the Company’s accounting policies. The areas involving a higher degree of judgment of complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed in note 3. These consolidated financial statements are prepared in Canadian dollars, with all amounts rounded to the nearest dollar, unless otherwise stated.

Consolidation

These consolidated financial statements include the accounts of the Company and its subsidiaries. Subsidiaries are all entities over which the Company has control. The Company controls an entity when the Company is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. Subsidiaries are consolidated from the date on which control is transferred to the Company and are deconsolidated from the date that control ceases.

All intercompany transactions, balances and unrealized gains and losses from intercompany transactions in Canada are eliminated on consolidation. The functional and presentation currency of the Company and its subsidiaries is the Canadian dollar. The principal subsidiaries of ASEP and their geographic locations at December 31, 2023, are as follows: