Intrinsic Medicine, Inc.
(Note: Intrinsic Medicine, Inc. withdrew its IPO plans in an SEC filing dated July 25, 2022. The preclinical therapeutics company had filed to go public on April 8, 2022.)
We are a preclinical-stage therapeutics company leveraging synthetic biology-manufactured human identical milk oligosaccharide, or HiMO, molecules as new medicines to treat large patient populations underserved by current treatment options. In the first half of 2023, we plan to initiate a Phase 2 clinical trial under an approved protocol in Australia to test our lead drug candidate in over 400 patients with the constipation-dominant form of irritable bowel syndrome, or IBS-C, which is estimated to affect approximately 5 million patients in the United States alone. On this basis, we anticipate disclosing top-line data from this study in the first half of 2024. Our initial drug candidates are based on bioactive oligosaccharides naturally produced in human milk, called human milk oligosaccharides, or HMOs, which modulate both the bacteria in the gut, or the gut microbiome, and human cells. We believe HMOs exert beneficial effects through multiple mechanisms of action. In particular, HMOs beneficially shift the composition of the gut microbiome, increase the microbiome’s production of beneficial metabolites, and directly modulate the immune system. HMOs are the third most abundant solid component of human milk after fats and lactose, and over 200 distinct HMOs have been identified by the scientific community to date. Because HMOs have been selected and conserved over millions of years of mammalian evolution, with all human beings exposed before birth and during early life development, we believe HiMO drugs can have a favorable toxicity and tolerability profile in the therapeutic context.
Our pipeline currently consists of HiMO drug candidates we call OMs based on some of the most abundant and well-characterized HMOs, including OM001 (HiMO 3’sialyllactose), or 3’SL, OM002 (HiMO 2’-fucosyllactose), or 2’FL, and OM003 (HiMO 6’-sialyllactose), or 6’SL, each of which we believe has the potential to treat gut-brain axis disorders, or GBA, and certain inflammatory disorders. We selected these drug candidates based on published third-party clinical, preclinical and toxicology data indicating the potential for disease-modifying HMO bioactivity combined with a low risk of dose-limiting toxicity.
Our OMs are produced via synthetic biology and are identical in chemical structure to their equivalent HMOs. Therefore, we believe our OMs will reproduce the multiple beneficial effects observed with HMOs and have the potential to affect multiple pathways implicated in GBA disorders and certain inflammatory disorders. These disorders are complex and often involve multiple pathways involving the central nervous system, or CNS, and the enteric nervous system controlling the gut, or ENS, as well as other organ systems including the immune, endocrine and autonomic systems. We initially intend to target GBA disorders and certain inflammatory disorders, such as irritable bowel syndrome, or IBS, inflammatory bowel disease, or IBD, rheumatoid arthritis, or RA, oligoarticular juvenile idiopathic arthritis, or oJIA, atopic dermatitis, or AD, and autism spectrum disorder, or ASD. We plan to prioritize the development of our drug candidates for disorders where available treatment options are inadequately serving patients due to safety or tolerability issues, where regulators have indicated that medical foods and supplements cannot be legally marketed for disease or symptom treatment, and where we have the potential to redefine the standard of care. We continuously evaluate expansion opportunities for our pipeline including new indications and new HiMO drug candidates. We believe HiMO-based medicines are a novel treatment approach to diseases which are being more frequently classified as GBA disorders by the scientific and medical communities because they operate via diverse mechanisms affecting gut somatic cells, the microbiome and the human immune system. To our knowledge, there have been no therapeutic compounds to date that have been approved to treat GBA through this multifaceted mechanistic approach.
In addition to our plan to initiate our first clinical trial in Australia, in accordance with the feedback we received during a pre-investigational new drug, or IND, interaction with the U.S. Food and Drug Administration, or the FDA, Division of Gastroenterology, we plan to undertake a confirmatory, IND-enabling toxicology study, to be commenced following the closing of this offering, prior to expanding this clinical trial under an IND from the FDA in the United States. The FDA provided us guidance related to the third-party published toxicology studies, suggesting that we must conduct our own confirmatory toxicology studies under Good Laboratory Practices, or GLP, to include in our IND, which indicates that they consider HiMOs as new molecular entities, or NMEs, when being developed as therapeutics. Subsequently, we plan to evaluate OM002 for the treatment of the diarrhea-predominant form of IBS, or IBS-D. We believe the clinical, preclinical and toxicology third-party published data on 2’FL, which reports both preclinical and exploratory clinical data in infants, healthy volunteers and IBS patients, support our therapeutic rationale for the clinical development of OM002 as a potential new medicine for the treatment of both IBS-C and IBS-D. To date, there has been no reported toxicities in human and animal studies of 2’FL.
We believe OM002 has the potential to be the first drug, if approved, to treat both IBS-C and IBS-D, which, based on the estimated adult population reported in the 2020 U.S. Census and an approximately 5.0% prevalence rate among adults, is estimated to affect over 10 million patients in the United States, alone.
Note: Revenue and net loss figures are for the year ended Dec. 31, 2021.
(Note: Intrinsic Medicine, Inc., set terms for its IPO – 4.17 million shares (4,166,667 shares) – at a price range of $5.00 to $7.00 – to raise $25.02 million, according to its S-1/A filing dated May 4, 2022. Intrinsic Medicine filed its S-1 (prospectus) on April 8, 2022 – following a confidential filing to go public in SEC documents dated Dec. 30, 2021.)
|Industry:||Biological Products (No Diagnostic Substances)|
|Address||500 Yale Avenue North Seattle, WA 98109|
|Phone Number||(206) 426-3624|
|View Prospectus:||Intrinsic Medicine, Inc.|
|Revenues||$0 mil (last 12 months)|
|Net Income||$-11.95 mil (last 12 months)|
|Price range||$5.00 - $7.00|
|Est. $ Volume||$25.0 mil|
|Manager / Joint Managers||Spartan Capital Securities/ Revere Securities|
|Expected To Trade:|
|Quiet Period Expiration Date:||Available only to Subscribers|
|Lock-Up Period Expiration Date:||Available only to Subscribers|
|SCOOP Rating||Available only to Subscribers|
|Rating Change||Available only to Subscribers|