Item 1A. Risk Factors
ITEM 1A. RISK FACTORS
The following additional risk factor has been
identified since those presented under Part I, Item 1A of our Form 10-K for the year ended December 31, 2023.
RISKS RELATED TO OUR BUSINESS
There is doubt about our ability to continue
as a going concern.
As of September 30, 2024, the Company had an accumulated
deficit of $622,224,899. Losses have principally occurred as a result of the substantial resources required for research and development
of the Company’s product candidates which included the general and administrative expenses associated with its organization and
product development as well as the lack of sources of revenues until such time as the Company’s products are commercialized. These
factors raise substantial doubt about the Company’s ability to continue as a going concern for the 12 months from the issuance date
of these unaudited condensed consolidated financial statements for the quarter ended September 30, 2024. These financial statements do
not include any adjustments to reflect the possible future effect on the recoverability and classification of assets or the amounts and
classifications of liabilities that may result from the outcome of these uncertainties. Management intends to pursue additional funding
and implement its strategic plan to allow the opportunity for the Company to continue as a going concern, however, there cannot be any
assurance that we will be successful in doing so.
ITEM 2. UNREGISTERED SALES OF EQUITY
SECURITIES AND USE OF PROCEEDS.
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
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