I just invested because I'm excited about your potential. Great team with terrific experience, and the Mayo Clinic is impressive and lends tremendous credibility. I have just a couple of questions before I possibly do more: 1. Can you describe your IP and the barriers to entry...

Hi Alan, Thank you for your investment and the thoughtful and highly relevant questions. 1. Regarding IP, we have just recently converted our provisional patent filing to a non-provisional application. Our submission covers the formula, but also the application of multi-omics to produce phenotypic sub-classifications of diseases. We believe the strength of our IP is not necessarily just the weights applied to variables within the formula (those could be improved over time), but rather the com...

Your timeline states start selling in 45 states in q2 of 2019. Do you plan to, and if so when will you start partnering with clinicians? Also the CLIA sounds straight forward, but does the team have experience meeting these requirements, are there any backup plans if this is n...

Hi Gentry, great question! The test will be a physician-ordered product and regulations specify that clinical testing for humans must be performed in a CLIA-registered, certified, or accredited laboratory. CLIA is a federal mandate (carried out through CMS), but a handful of states such as CA, PA, MD, RI, and NY have enacted additional registration procedures specific for samples tested from their states. To address those specific requirements (for the former 4), it is best to achieve CAP-acc...

Hi Ross, big supporter of Mayo and place a lot of trust in any originated research growing up in Rochester so I have a lot of trust in the science and management team here and believe this product is well positioned. I am also an early adopter (~3yrs ago) of 23&Me and DNAF...

Hi Nicolas, thank you for your questions and for your support of our organization! 1. At the present time, we are planning to raise Series A before the maturity date of the note. The amount of equity you would receive upon a conversion event will be based on the Series A valuation (TBD), the discount rate (20%) and valuation cap (9.6M). 2. Regarding ongoing research and IP: Both Dr. Acosta and Dr. Camilleri are well-funded by NIH, foundations, and industry partners to continue their research....

Any updates on the lab retrofitting?

Hi Nick! Sorry for the delay getting back to you. The retrofitting of the space is nearly complete and we are being told that we can begin occupancy on or around February 1, 2019! We are taking a hardhat tour next week and will be sure to post some pictures of the progress!

I’m looking to invest but I have a few questions. 1. What type of approval will you need from the FDA? 2. Have you thought of expanding internationally? 3. With the Series A can you give me a rough estimate when you expect to start it?

Hi Carlos, Thanks for your questions and interest in Phenomix! 1. Physician ordered tests developed within a specific lab such as ours (called "Lab Developed Tests") are presently regulated through CLIA standards (with oversight from CMS and/or deemed accrediting agencies such as the College of American Pathologists). The FDA has expressed interest in assuming this oversight authority in the future, which if approved by congress, would likely occur over a 5-10 year transition period. For now,...

Phenomix Sciences

Mayo Clinic startup personalizing weight loss

phenomixsciences.com

Rochester, MN

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