The Company views COVID-19 as a diseases that could potentially transform from a pandemic to an endemic, due to the combination of the vaccine’s efficacy being less than 100% and the refusal of certain populations to get vaccinated. This could potentially result in continuous appearances of various SARS-2 mutations, that in turn may be less responsive to existing vaccines. In its endemic state, COVID-19 could remain for many years to come, and under these conditions the Company expects a demand for safe and effective therapies for the severe/critical patient populations, that may be under-served by existing therapeutics. The Company believes that AllocetraTM, upon regulatory approval, could potentially serve as a “last line” therapy for this patient population.

On February 4th, 2021, the Company reported positive top-line results from Phase II clinical trial that evaluated AllocetraTM in severe and critical COVID-19 patients and provided a program update.

  • Phase II + Ib (21 patients treated, 11/21 (52%) with severe illness, 10/21 (48%) with critical illness)
  • 0/21 (0%) mortality on day-28
  • 19/21 (90.5%) patients recovered and were discharged from the hospital by day-28
  • Average duration of hospitalization post administration of AllocetraTM for discharged patients was 5.6 days
  • 2/21 (9.5%) patients, both of whom had critical illness at the time of AllocetraTM treatment, were hospitalized in the ICU on a respirator on day-28

Data from the investigator-initiated Phase II trial, as well as an audited analysis of the Phase Ib trial are shown below:

Clinical Trial # Patients Enrolled Disease Severity Clinical Outcome Hospitalization
Discharged patients, post Administration of AllocetraTM
Recovered
Day 28
Mortality
Day 28
Discharged Duration
(days, avg.)
Phase Ib 5 2 Severe
3 Critical
5/5 (100%) 0/5 (0%) 5/5 (100%) 6.6
Phase II 16 9 Severe
7 Critical
14/16 (87.5%) 0/16 (0%) 14/16 (87.5%) 5.3
Total 21 11 Severe
10 Critical
19/21 (90.5%) 0/21 (0%) 19/21 (90.5%) 5.6

AllocetraTM is being developed
to treat cytokine storms and multiple organ failure in sepsis patients and in COVID-19 patients

The Company expects to initiate a Phase III clinical trial ofAllocetraTM in COVID-19 patients with severe or critical illness by mid 2021.