ASIT biotech published its preliminary FY18 results in early April, including the cash position at the end of March 2019, and issued its FY18 report in May. The release of the balance of the FY18 financial statements resulted in no surprises, while the completion of the dosing phase of the Phase III study implies a safe and well-tolerated short-course allergy product.
We have updated our financial model for the 2018 annual report, which resulted in very minor, non-material changes to our numbers and valuation. Much more importantly, together with the announcement of Frank Hazevoets as its new CFO, ASIT has announced that dosing completed earlier than expected in the Phase III ABT-gpASIT011 study in 651 grass pollen allergy patients. Investors will remember that gp-ASIT+ is a short-course subcutaneous product given before the pollen season starts. The fact that the treatment phase has completed in all patients without major incident implies the product is safe and well tolerated.
For most of the northern hemisphere, the grass pollen allergy season is about to start and, while the conduct of the ABT-gpASIT011 Phase III clinical study of gpASIT+ for grass pollen allergies is dominating ASIT’s operations, there will be plenty of other newsflow from ASIT in 2019. First, confirmation of the amount raised by the €9–12m convertible note offering is expected to be announced by the end of Q219. Second, the H119 financial results release in September is likely to include an update on the progress of the ABT-gpASIT011 study and the out-licensing of ASIT’s portfolio. Then, in Q419, ASIT expects to announce the results of the Phase III ABT-gpASIT011 study. Investors will remember that this second Phase III study incorporates nine improvements made to the design of the first Phase III, which met one and missed one of its co-primary endpoints.
We have updated our valuation for the €5.9m end-March 2019 cash balance, the first tranche of the expected minimum €9m convertible note offering, which we assume will be received in H119, and exchange rates to leave our valuation unchanged at €119m or €6.4 per share.