$ANTB...Plan of Operation
In first half of calendar 2014, we successfully raised more than $11 million to fund our operations including hiring and retaining qualified
staff, leasing a manufacture and research facility and engaging third party advisors to assist in the AB101 development efforts. As of
September 30, 2014, we had $4.3 million cash on hand. Our general operating expenses average $350-$500 thousand per month and we
anticipate that our current cash would be sufficient to fund our operations well into 2
nd half of calendar 2015. However, our current cash is not
sufficient to fund the production of cGMP material required for AB101 clinical studies and it is insufficient to pay for our planned clinical
study in 2
nd half of 2015. In order to advance our clinical program for AB101, we believe that we require at least an additional $10 million of
cash.
Specifically, in order to produce cGMP material in our facility we will need to construct a manufacturing suite which we estimate will cost at
least $2.5 million and we expect that our first clinical study in 2
nd half of calendar 2015 will cost approximately $4 million. In addition,
following the move into our Louisville facility we discovered that some of the equipment required for the production of microspheres on our
platform is missing, broken or was managed by software which is outdated and unsupported and consequently we anticipate acquiring or
leasing additional equipment which may cost approximately $1 million.
17We believe that our current cash is sufficient to support the manufacture of fresh GLP AB101 material as well as to conduct studies in support
of our IND, including acute and sub-acute toxicity studies in at least two species (which are likely to be rodents and dogs), safety
pharmacology, and mutagenicity/genotoxicity studies.
We are also planning to conduct additional in vitro and in vivo pharmacology in the animal to demonstrate the promise of once weekly dosing
of basal insulin.
In our clinical studies our objective is to demonstrate that AB101 is safe and effective at the intended once weekly subcutaneous dosing
frequency and that it is non-inferior to current standard of care basal insulin therapies in controlling blood glucose without an undue risk of
hypoglycemia. After completion of additional IND-enabling work, we plan on filing an IND with the FDA in 2015, folowed by the initiation
of a clinical trial in the second half of 2015. The objectives of the Phase 1 program will be to assess the single and repeat (once weekly)
ascending dose safety, pharmacokinetics (PK), and pharmacodynamics (PD) in the target population with type 1 and type 2 diabetes, including
confirmation of the time action profile for glucose lowering (Phase 2a data). Following successful completion of the Phase 1/2a program,
Phase 2b trials in both populations will be conducted to obtain proof-of-concept for the intended once weekly dosing regimen, using the
accepted biomarker for glucose efficacy (hemoglobin A1c; HbA1c), compared to a standard of care basal insulin such as Lantus.
If proof-of-concept trials are successful, we would expand our clinical program to include Phase 3 registration trials in various jurisdictions
including the US and Europe, to obtain regulatory and marketing approval. The Phase 3 program would include studies in combination with
other injectable and oral glucose lowering therapies, and would be designed to meet regulatory guidelines for the development of therapies for
diabetes, while achieving an expanded label at the time of product launch.
