Business 4 1A. Risk Factors 21 1B. Unresolved Staff Comments 50 2. Exhibits, Financial Statement Schedules 65 16. Lenabasum reduces inflammation and limits fibrosis, without immunosuppression. These biologic effects have been demonstrated in cells, animal models, and humans. The DETERMINE Study is fully enrolled with 176 patients. 5 Phase 2 Dermatomyositis Study* *Data on file. A CB1 agonist is a compound that initiates a pharmacologic response when it binds to CB1. Day 0 = start of investigational compound dosing. * Presented at New York Academy of Sciences Webinar on January 27, 2021. About 80,000 individuals in the U.S., Europe and Japan suffer from dermatomyositis. 10,154,986 to the Company with claims covering pharmaceutical compositions of lenabasum. On November 27, 2017, the USPTO issued U.S. Patent No. Similar filings are required in other countries. Orphan product designation must be requested before submitting an NDA. 18 Individual states have also established controlled substance laws and regulations. We believe our relations with our employees are good. Our drug candidates are in various stages of preclinical and clinical testing. Preclinical tests can last years. Similar requirements exist in many of these areas in other countries. Such efforts are subject to significant uncertainty. Conflicts may arise in connection with these indemnification obligations. In order to reduce costs, we may need to develop and implement process improvements. In certain circumstances, violations could lead to criminal proceedings. However, trade secrets are difficult to protect. Litigation may be necessary to defend against these claims. As of December 31, 2020, we had 76 full-time employees. We intend to obtain product liability insurance covering our clinical trials. The lack of an active market may also reduce the fair market value of your shares. Future sales of shares by existing stockholders could cause our stock price to decline. In this event, you could lose some or all of your investment. 51 Our pipeline includes the following programs: 1. In March 2019, Kaken made an upfront payment to us of $27 million. For non-employee options, the expected term is the contractual term. Interest accrues on this loan at an annual rate of 4.89%. Funding may not be available when needed, at all, or on terms acceptable to us. 23.1 Consent of EisnerAmper LLP.* 101.PRE XBRL Taxonomy Extension Presentation Linkbase Document.* The Company has also agreed to reimburse Jefferies for certain specified expenses. Actual results could differ from those estimates and changes in estimates may occur. Marketable investments are those with original maturities in excess of three months. At December 31, 2020 and 2019, cash equivalents were comprised of money market funds. The fair value recorded for the derivative liability varies from period to period. The ROU asset also includes any lease payments made and excludes lease incentives. No impairment charges were recorded for the years ended December 31, 2020 and 2019. The standard will be adopted upon the effective date for us beginning January 1, 2021. Interest expense for the year ended December 31, 2020 was approximately $1,126,534. The Company's payment obligations survive the termination of the Investment Agreement. The CFF Warrant expires on January 26, 2025. J7^SK#AC90!?X1Y8R:/[-L@ MWEC %\'-3[?U]X3^M3?V M98$$"T@VC[S6*/[.L.&-E !_" WHI!WI: "BBB@ HHHH **** "BBB@ H\'2CM0.E ! H^RV__ #PC_P"^ M14FQ?[H_*C8O]T?E0!\']EM_^$
