Note: This IPO is part of a dual listing planned by Breathe BioMedical Inc. From the prospectus: “We intend to apply to list our common shares on the Nasdaq Capital Market under the symbol “BRTH.” We also intend to apply to list our common shares on a Canadian stock exchange (a “Canadian Exchange”) under the symbol “BRTH.” There can be no assurance that our common shares will be approved for listing on the Nasdaq Capital Market and/or on a Canadian Exchange. We will not complete this offering unless we receive approval for listing on the Nasdaq Capital Market.”

We are a medical technology company focused on developing a breath test to be used as an adjunctive test to mammography screening to detect early-stage breast cancer in women with dense breast tissue. (Incorporated in Canada) 

Breath analytics involves the collection, processing, and analysis of breath samples to identify biomarker patterns associated with specific diseases.

Our Vision: A new paradigm for early-disease detection that improves quality of life and saves lives.

Our Mission: Revolutionizing early-disease detection with our breath-based platform technology.

Our Focus: To develop a breath test to be used as an adjunctive test to mammography screening to detect early-stage breast cancer in women with dense breast tissue.

We believe breath analytics is an accessible, non-invasive, and convenient method for detecting disease. Breathe BioMedical’s platform technology consists of four components which we are developing to collect, process, and analyze breath samples effectively and efficiently. Each of the four components, discussed below, could be considered a device on its own. Our strategy is not focused on commercializing the four components individually. Rather, our focus is on commercializing the combination of the four components, which is the Breast Cancer Breath Test.

Breathe BioMedical is in the development stage of our Breast Cancer Breath Test, as an adjunct to mammography screening in women with dense breast tissue. Over the next two years we have verification and validation studies planned for the components and the Breast Cancer Breath Test, as well as a large multi-center clinical study planned to evaluate the safety and efficacy of the Breast Cancer Breath Test, subject to discussions with regulatory authorities, and build our machine learning model for breast cancer. We are currently conducting a proof-of-concept study which is discussed in detail in the Business section, under the “Breast Cancer Breath Test” heading. Data collection will be completed in 3Q2024. Data analysis will follow. We anticipate the completion of the components, the Breast Cancer Breath Test, and the verification and validation studies in 2025 with a pivotal trial in 2026 to support a marketing authorization application in the U.S. in 2027, subject to discussion with the FDA. We expect this could lead to FDA approval for our Breast Cancer Breath Test by 2027. There is no guarantee that we will meet these development milestones or be granted marketing authorization by 2027, if at all.

Note: Net loss is in U.S. dollars (converted from Canadian dolalrs) for the year that ended Dec. 31, 2023.

Note: Breathe BioMedical is based in New Brunswick, Canada; the company also maintains a U.S. headquarters office in Cambridge, Massachusetts, the prospectus says.

(Note: Breathe BioMedical Inc. increased the size of its IPO to 2.63 million shares (2,625,000 shares) and kept the price range at $4.00 to $6.00 to raise $13.13 million, according to an F-1/A filing dated July 26, 2024. Following up that filing: Breathe BioMedical amended its prospectus by adding the Canadian underwriter, Leede Financial,  as a book-runner – named alongside the U.S. book-runner, the Maxim Group – in an FWP filing dated July 30, 2024.) 

(Background: Breathe BioMedical Inc. disclosed the terms for its IPO in an F-1/A filing dated July 5, 2024: The company is offering 1.6 million shares at a price range of $4.00 to $6.00 to raise $8.0 million. Background: Breathe BioMedical Inc. filed its F-1/A on June 7, 2024, for its U.S. IPO, without disclosing terms.  Breathe BioMedical Inc. submitted a confidential IPO filing to the SEC on March 4, 2024.)