1. Following a positive response by the FDA to the Company’s preIND submission, the Company continues to pursue multiple new sources of capital financing, as well as licensing and partnership agreements to provide working capital to support the progression of xB3001 as a treatment for HER2+ breast cancer and brain metastases.
2. Bioasis is also focused on the use of its technology to restore lysosomal function, reduce brain inflammation and offer disease modifying potential for neurodegenerative conditions. To this end, Bioasis has built an asset rich pipeline of innovative product candidates. The Company is currently pursuing further work on these pre clinical Pipeline Programs, including xB3004 (pain, CNS inflammation and neurodegeneration), xB3007 (Gaucher’s disease, Parkinson’s disease and Lewy Body Dementia) and xB3Progranulin for the treatment of Fronto Temporal Lobe Dementia, ALS and neuronal ceroid lipofusinosis, with the intention of strengthening our platform, creating greater value for our intellectual property and building stronger licensing partnerships.
3. We anticipate multiple, value accretive milestones from each of these programs in 2021 to drive shareholder value We further anticipate that there will be additional recognition of the strength of the Company’s intellectual property portfolio as the Company executes its strategy.
4. The Company continues to pursue and progress strategic partnering discussions for the xB3 platform. Building on our partnership with Chiesi Group in 2020, we anticipate that additional partnerships may be transacted in 2021, with funds from upfront payments being invested in the pipeline.
5. Commencing in November 2020, the Company began the process of filing the U.S. and foreign national stage patent applications of its PCT International Patent Application No. PCT/US2019/033012 directed to the treatment of Gaucher’s disease. It is anticipated that the filings will be completed by January 27, 2021. During the period from September 1, 2020 through November 22, 2020, Bioasis filed U.S. and foreign national stage patent applications for its International Patent Application No. PCT/US2019/023338 directed to bifunctional blood brain therapies. These applications are pending in the U.S., Australia, Canada, China, the European Patent Office (with an option to extend to Hong Kong), Israel, Japan, Korea and Saudi Arabia. On December 23, 2020, the Company received a Notice of Allowance from the U.S. Patent and Trademark Office for its Application Serial No. 15/943,160 which covers methods of treating Hunter disease. On September 15, 2020, the U.S. Patent and Trademark Office issued US Patent No. 10,772,939 to the Company. This patent is a further continuation covering the Company’s xB3 platform technology.
6. On December 8, 2020, the Company extended the original license option period for the Prothena License Agreement by three months from December 31, 2020 to March 31, 2021.
7. In December 2020, the Company accepted elections by warrant holders to exercise certain warrants issued in conjunction with the 7.5% Debentures in the aggregate amount of 3,480,759 shares for gross proceeds of $696,152.

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