Ann: Positive AD-214 Phase I extension study results, page-114

The issue with the share price correlates to the fact that their Phase I extension trial was delayed by two years and now that they will be moving onto Phase 2 with an intended strategic partner would be the most feasible aspect. The derailment of the share price and the company at large was due in part to the change in mode of delivery from intravenous to inhalation to now resorting back to the IV route. Management is a highly academic based team led largely by a sense of scientific methodology and years of expertise. However, the company continues to focus on the IPF indication as this is the most advanced study. A large pharmaceutical company will only come on board once they have assessed the credentials of how well the AD-214 works: based on the three findings
1) Receptor occupancy (CXCR4 which is part of the GPCR - G-couple protein receptor family) is involved in the pathway of IPF, the AD-214 engages with CXCR4 and in turn inhibits its expression leading to improved efficacy.
2) The 10mg/kg dose is the identified and safe dose to be utilised for the study pertaining to the above as it continues to demonstrate the required pharmacokinetics and pharmacodynamics.
3) Again, the meticulous work of the team has also identified the anti drug antibody (ADA) development upon the introduction of the therapeutic protein, and how its minimal aggregation is seen as favourable for the overall efficacy as well as the minimal side effects.

Strategically, given the current market a milestone based collaboration with a big pharmaceutical company would be the only way AdAlta can survive, they intend on either out-licensing or developing it in conjunction with a bio pharmaceutical company.