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Subsequent Events
12 Months Ended
Dec. 31, 2019
Subsequent Events  
Subsequent Events

16. Subsequent Events (in thousands)

Current Scientific Activity; Repurposing of NB-01

In light of the present business environment, including the impact of the COVID-19 disease that emerged in December 2019 as a global threat, the Company is currently conducting the scientific activities described below with a view toward conserving financial resources.

 

For NB-01, the Company has determined that any attempt to conduct Phase 3 clinical trials, as previously announced, would be difficult if not impossible in the short or medium term. Accordingly, in the first quarter of 2020, the Company directed its contract research organization (“CRO”) partners and other vendors working on the Phase 3 clinical trials of NB-01to cease all work and has terminated its existing contract arrangements with each of them.  In accordance with ASC 450, Contingencies, the Company has determined that it is probable and estimable that approximately $650 in termination penalties are owed to a vendor pursuant to the terms of the contract.  The Company has also determined for a second vendor the termination fees, while probable of occurring, are not currently estimable due to uncertainty within the terms of the contract governing termination and ongoing negotiations of the termination provision, but would be no more than $1,100. None of the termination fees associated with the reassessment of the Phase 3 clinical trials were accrued as of December 31, 2019.

 

 

The Company is currently devoting scientific resources to evaluating the potential to bring the NB-01 asset to the market through a different regulatory pathway. Development of NB-01 as an orphan drug is among the alternatives that the Company is considering, and the Company may conduct feasibility studies to identify a rare disease relevant to NB-01. Additionally, the Company is considering marketing NB-01 as a nutraceutical (non-pharmaceutical) product. There is no assurance that the Company will be able to pursue any of these alternatives for NB-01.

For NB-02, which is almost ready for the submission of an IND application to the FDA, the Company intends to postpone the first human clinical trials until global health and macroeconomic conditions improve.  The Company hopes to be in a position to commence commencing clinical trial activity in the first quarter of 2021, subject to availability of financing.

For Gemcabene, the Company will support activities related to getting the FDA to lift the partial clinical hold presently in effect on Gemcabene. In addition, the Company will engage in activities to support our partnership with Beijing SL with the possibility of advancing Gemcabene into trials in China.

Stock Option Grants

 

On January 13, 2020, each of the Company’s six non-employee directors was granted an option to purchase 60,000 shares of common stock, which vest in a series of 36 equal monthly installments, subject to the director’s continuous service through each monthly vesting date, and will vest in full upon the consummation of a corporate transaction (as defined in the 2019 Plan).

 

COVID-19

 

On March 11, 2020, the World Health Organization declared the outbreak of a novel coronavirus (COVID-19) as a global pandemic, which continues to spread throughout the United States and around the world. To date, except for the adjustments to scientific activity described under “Current Scientific Activity; Repurposing of NB-01” above, we have not experienced any significant changes in our business that would have a significant negative impact on our consolidated statements of position, operations or cash flows. There is uncertainty around when any disruption might occur, the duration and hence the potential impact. As a result, we are unable to estimate the potential impact on our business as of the date of this filing.