Note: This is NOT an IPO. This offering is a unit public offering of stock and warrants – an uplisting to the NASDAQ from the OTC Pink Market in the U.S. The stock also trades on the Canadian Stock Exchange (CSE). 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 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.

Note: Net loss and revenue are for the year that ended Dec. 31, 2023. 

(Note: Asep Medical Holdings, Inc. filed its F-1 for its public offering – a NASDAQ uplisting from the OTC Pink Market – on May 29, 2024, without disclosing the terms. A confidential filing for this offering – which the company calls an IPO – was submitted to the SEC on June 30, 2023.)