ADDED
false --12-31 FY 2025 Like many companies, we face significant and persistent cybersecurity risks.
The small size of our organization and limited resources could exacerbate these risks.
However, we are committed to maintaining governance and oversight of these risks and to implementing standard operating procedures ( SOPs ) and training to help us assess, identify, monitor and respond to these risks.
Some examples of procedures implemented include an internal inventory of software and database exposures, a risk analysis of database vendors, and a review of vendor back-up, security and privacy measures.
In addition, we have issued a Board-approved internal cybersecurity policy which will be the basis for SOPs and training.
Our internal server includes a firewall and is scanned for malware several times a day, and the data are backed up in the Cloud for ease of restoration as needed.
Employees are trained to avoid phishing emails and our internal controls system is designed to mitigate the risk of payments of fraudulent invoices.
While we have not, as of the date of this Annual Report of Form 10-K, experienced any significant cybersecurity threats, including as a result of previous incidents, that we believe are reasonably likely to result in a material adverse impact to our business strategy, results of operations or financial condition, there can be no guarantee that we will not experience a material incident in the future.
Such incidents, whether successful or not, could impair our access to critical information including confidential operational and patient records and have the potential to be costly to effect remedies.
false We aim to incorporate industry best practices for companies of our size and financial strength throughout our cybersecurity program.
REMOVED
false --12-31 FY 2024 true false true true false false false false false false 0.001 0.001 40,000,000 40,000,000 6,102,560 6,102,560 2,980,900 2,980,900 98,230 107,806 1,489,702 2,621,880 14,338,403 0 6,102,560 0.00 25.00 25.01 50.00 50.01 75.00 75.01 100.00 800 Forfeited options represent unvested shares and vested, expired shares related to employee terminations.
43,523 options vest as follows: options to purchase 41,523 shares of the Company s common stock vest 6/48ths on the six-month anniversary of vesting commencement date and 1/48th per month thereafter; and options to purchase 2,000 shares of the Company s common stock vest monthly over one year.
Forfeitures only include known forfeitures to-date as the Company typically accounts for forfeitures as they occur due to a limited history of forfeitures.
The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant as of June 30, 2024 , was $ 6,413,187 based on the closing price reported for such date on the Nasdaq Capital Market.
Cautionary statements are disclosed in this Annual Report on Form 10-K, including without limitation statements in the section entitled Item 1A - Risk Factors, addressing forward-looking statements.
These risks include, among others, the following: We are a clinical stage biopharma company with a history of financial losses.
Although a completed pivotal Phase 3 trial with ALXN1840 met its primary endpoint as described in this report, Alexion Pharmaceuticals, Inc ( Alexion ) terminated the ALXN1840 program in Wilson disease based on a review of results from the Phase 2 mechanistic trials and discussions with the regulatory authorities.
In the near term, we will focus on assembling a regulatory package and submitting an NDA, all with uncertain outcomes.
Our business is highly dependent upon receiving marketing approvals from various U.S.
and international governmental agencies and would be severely harmed if we are not granted approvals to manufacture and sell our product candidates.