By John Vandermosten, CFA
READ THE FULL MDXG RESEARCH REPORT
_span_style3d_22_text-decoration3a_ _underline3b_22_=””>Last Patients, Last Visits in Late-stage Trials
On April 19, 2021, MiMedx Group, Inc. (NASDAQ:MDXG) announced that three late stage trials in MiMedx’ pipeline had recently achieved important milestones. All patients in the Phase III studies for AmnioFix Injectable in plantar fasciitis (PF) and Achilles tendonitis (AT) have completed their last clinical visits. The Phase IIb trial for AmnioFix Injectable in knee osteoarthritis (KOA) has completed the recording of all clinical effectiveness endpoints. Next steps for the programs include a planned review and statistical analysis of data for all three trials.
The PF, AT and KOA trials are evaluating AminoFix Injectable, which uses MiMedx’ micronized dehydrated Human Amnion Chorion Membrane (mdHACM). Following completion of the planned review and statistical analysis of data, MiMedx expects to share top-line data this summer and will begin planning a Phase III in KOA assuming data are supportive. A biologics license application (BLA) is expected to be submitted for PF in 1H:22; however, due to trial design, a BLA for AT is not expected. Data from the AT trial will be used to support safety of the product. Next steps for the PF program include:
➣ Closing sites
➣ Cleaning the data
➣ Locking database
➣ Conducting statistical analysis
➣ Meeting with the FDA
➣ BLA submission
Prescience Point Capital Management Board Nominations
Prescience Point Capital Management recently announced that it will nominate four directors to MiMedx board at the 2021 Annual Meeting. The Louisiana-based asset manager owns ~8.1% of the shares outstanding. When accounting for the Series B Convertibles and adjusting for their ultimate conversion to equity, ownership drops to ~6.6%. Prescience contends that EW Healthcare’s interests may conflict with those of other shareholders and that MiMedx management has not provided sufficient information regarding the opportunities for AmnioFix in Knee Osteoarthritis.
We remind investors that data is not yet available for the Phase II study in KOA and that even if favorable information is generated and AmnioFix progresses to Phase III, there remain