We are a life sciences company focused on the development of liquid biopsy tests based on the mitochondrial genome. A liquid biopsy offers the opportunity to diagnose disease earlier without the risks of a traditional biopsy, which include infection. Our product candidates are:
*Mitomic Prostate Test (MPT™) is currently in development and is being designed as a blood-based assay that quantifies the level of the 3.4kb mitochondrial DNA deletion. Published analytical data for the 3.4kb mitochondrial DNA deletion associated with prostate cancer, suggests the 3.4kb mitochondrial DNA deletion may be able to identify clinically significant prostate cancer for men in the prostate-specific antigen (PSA) grey zone (PSA < 10ng/ml) and if proven through ongoing clinical study, the 3.4kb mitochondrial DNA deletion may be able to aid in the decision to biopsy.
*Mitomic Endometriosis Test (MET™) is currently in development and is being designed as a blood-based assay that quantifies the level of one or more mitochondrial DNA deletions which published analytical data suggest are associated with endometriosis – a condition affecting approximately 1 in 10 women according to Endometriosis World and the World Health Organization. The Mitomic Endometriosis Test is intended for use in females of child-bearing age who present symptoms of endometriosis to determine whether medical or surgical intervention is warranted.
Endometriosis occurs when the tissue of the uterus (endometrium) grows on areas where it does not belong, most often on the ovaries, fallopian tubes, outer surface of the uterus, and tissues holding the uterus, but can be found almost anywhere in the body. Endometriosis is challenging to identify, and on average takes nine years to diagnose.
We have discovered novel biomarkers and designed laboratory assays, which we refer to as our Mitomic Technology, that are intended to use mitochondrial DNA (mtDNA) to detect cancer earlier, more accurately, and less invasively than traditional methods. Though we have no commercially available FDA or foreign regulator approved products, we have licensed our intellectual property related to the Mitomic prostate cancer biomarker through a license and distribution agreement (the “Labcorp Agreement”) with Laboratory Corporation of America Holdings (“Labcorp”), a national U.S. commercial Clinical Laboratory Improvement Amendments (“CLIA”) lab in the United States. We also have licensed distribution rights through various agreements with international business partners to commercialize our Mitomic Technology, should Mitomic tests be successfully developed and successfully approved by the FDA or a foreign regulator. We believe our biomarker portfolio covers many high-clinical need cancers, with potential applications outside oncology.
We have a state-of-the-art clinical laboratory in Newcastle upon Tyne in the UK for research and development (“R&D”) on mitochondrial DNA and development of Mitomic liquid biopsy tests. This laboratory is an ISO 15189:2012 accredited medical testing laboratory – the highest international standard for medical testing, used by medical testing regulators worldwide and has capability for COVID-19 related tests and services for employers, schools, sports teams, and organizations in the UK and internationally.
MDNA’s Mitomic Technology targets mutations in mitochondrial DNA to detect disease. Every human cell is home to multiple copies of mitochondrial DNA, some of which become mutated beyond repair when cells are stressed by diseases such as cancer. Though further technical development and clinical validation is required to determine efficacy, Mitomic tests are being designed to detect this mutated DNA, which can accumulate from the very early stages of a disease. If the development of Mitomic tests is successful and if Mitomic tests can achieve their still unproven objective of early disease detection, our Mitomic Technology presents an opportunity to detect disease before it presents clinically.
**Note: Revenue and net loss figures are for the year ended Sept. 30, 2022.
(Note: MDNA Life Sciences Inc. postponed its IPO on May 12, 2023, due to general market conditions. Background: MDNA Life Sciences Inc. adjusted its unit IPO’s terms in an S-1/A filing dated April 20, 2023, by trimming the number of units to 2.45 million units (2,454,545 units) – down from 2.64 million units – and changing the price range to $5.00 to $6.00 – from $4.125 to $6.125 – to raise $13.5 million. Each unit consists of one share of common stock and one redeemable warrant to buy one share of stock. The proposed symbol for the stock is “MDLS” and the proposed symbol for the warrant is “MDLSW” – for listing on NASDAQ. **Note: The change – effective in the S-1/A filing on April 20, 2023 – was the second revision in the deal’s terms during the week of April 17, 2023. Background: In the April 17, 2023, filing with the SEC, MDNA Life Sciences Inc. increased the size of its unit IPO to 2.64 million units – up from 2.1 million units – and raised the price range to $4.125 to $6.125 – up from $4.00 to $6.00 – to raise $13.53 million. The new terms increased the IPO’s size by 29 percent.)
(More background: MDNA Life Sciences, Inc. revised its IPO again – back to its original structure as a unit offering of stock and warrants – in an S-1/A filing dated March 15, 2023: 2.1 million units at $4.00 to $6.00 to raise $10.5 million. Look back to the fall of 2022: In an Oct. 20, 2022, S-1/A filing, the IPO was changed to a stock-only offering of 2.1 million shares at $4.00 to $6.00. MDNA Life Sciences, Inc. filed its S-1 on Aug. 5, 2022; it filed confidential IPO paperwork with the SEC on April 8, 2022.)