Commitments and Contingencies | . Commitments and Contingencies Operating Leases The Company has operating leases for approximately 12,250 square feet of space located in Miramar, Florida. The leases have a two-year term which commenced on March 1, 2022 and will terminate on February 29, 2024 . Upon the commencement of the leases, the Company used its incremental borrowing rate of 6.0 % to determine the amounts to recognize for a ROU asset and a lease liability. There are no obligations under finance leases. The components of the lease expense for the three and six months ended June 30, 2023 were as follows: For the Three Months For the Six Months Ended June 30, 2023 Operating lease cost $ 42,413 $ 84,825 Supplemental cash flow information related to lease for the six months ended June 30, 2023 was as follows: For the Six Months Ended June 30, 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 84,040 Right-of-use assets obtained in exchange for lease obligations: Operating lease $ 80,036 As of June 30, 2023, the supplemental balance sheet information related to leases was as follows: As of June 30, 2023 Operating lease right-of-use assets $ 110,561 Operating lease liabilities, current $ 112,232 As of June 30, 2023, the remaining lease payments were as follows: 2023 $ 85,661 2024 28,693 Total future minimum lease payments $ 114,354 For the three months ended June 30, 2022 and 2023, rent expense recognized by the Company was $ 49,996 and $ 40,875 , respectively, of which $ 25,149 and $ 22,212 , respectively, is included in research and development in the accompanying condensed statements of operations. For the six months ended June 30, 2022 and 2023, rent expense recognized by the Company was $ 77,139 and $ 84,825 , respectively, of which $ 32,834 and $ 44,424 , respectively, is included in research and development in the accompanying condensed statements of operations. Contractual Commitments The Company entered into an agreement with a third-party global contract development and manufacturer of biologics for the manufacture of the Company’s proprietary molecules for use in clinical trials. At December 31, 2022 and June 30, 2023, future payment obligations under such agreements were $ 406,000 and $ 2.2 million, respectively. In addition, as of December 31, 2022, the Company committed to purchase upstream processing and fluid management equipment for $ 1.6 million, and it advanced $ 495,000 for this purchase as of June 30, 2023. Project Financing On April 21, 2023, the Company entered into a secured Development Line of Credit Agreement (the "2023 Loan Agreement") with Prime Capital Ventures, LLC ("Prime"), pursuant to which Prime will advance loans to the Company in a principal amount not to exceed $ 26.3 million with a scheduled maturity of April 20, 2028 (the "Prime Maturity Date"). The Company has the option to prepay the balance of the loan prior to the Prime Maturity date without penalty. The note issued pursuant to the 2023 Loan Agreement bears interest at a fixed rate equal to 7.00 % per annum, due monthly in arears on the first day of each month. The primary purpose of the loan is to provide the funding required to complete the buildout of the Company's new headquarters, including improved research laboratories and a vivarium to support the Company's pre-clinical research efforts, and a manufacturing facility to produce GMP material to support the Company's clinical development as well as produce material to support the clinical development of its licensee, Wugen. Under the 2023 Loan Agreement, the Company was required to fund an interest reserve bank account controlled by Prime in the amount of $ 5.3 million to fund the interest payments due on outstanding principal amounts under the 2023 Loan Agreement. The balance of the reserve account is presented in Deposit for interest reserve in noncurrent assets on the accompanying condensed balance sheet. As of June 30, 2023, the Company had no outstanding borrowings under the 2023 Loan Agreement. The initial advance is contingent upon the Company's receipt of all necessary permits and approvals to begin construction. On August 10, 2023, the Company obtained construction permits required to begin the buildout of its new headquarters. This satisfies the final condition precedent to accessing the $26.3 million line of credit. The Company will incur $ 1.8 million in debt issuance costs in connection to the Prime loan, which will be earned and payable upon the first draw down. Legal From time to time, the Company is a party to or otherwise involved in legal proceedings, including suits, assessments, regulatory actions and investigations generally arising out of the normal course of business. In addition, the Company enters into agreements that may include indemnification provisions, pursuant to which the Company agrees to indemnify, hold harmless and defend the indemnified parties for losses suffered or incurred by the indemnified party. When the Company believes that the outcome of such a matter will result in a liability that is probable to be incurred and result in a potential loss, or range of loss, that can be reasonably estimated, the Company will accrue a liability and make the appropriate disclosure in the footnotes to the financial statements. On December 23, 2022, Altor BioScience, LLC and NantCell, Inc. (“Altor/NantCell”) initiated an arbitration against Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in California alleging breach of contract and fiduciary duty, among other claims. On that same date, Altor/NantCell filed a lawsuit against the Company in federal court alleging misappropriation of trade secrets, inducement of breach of contract and breach of fiduciary duty, among other claims against the Company. On January 31, 2023, the Company filed a motion to compel arbitration, a motion for the stay of the litigation, and a motion to dismiss the complaint (“motion to compel”). On April 18, 2023, the U.S. District Court for the Southern District of Florida (the “Court”) heard oral argument on the Company’s motion to compel and ordered the parties to provide supplemental briefing by April 28, 2023. Before the Court ruled on the Company’s motion to compel, on April 26, 2023, the parties stipulated that Altor/NantCell’s action against the Company would be consolidated with the Altor/NantCell arbitration demand against Dr. Wong. On April 27, 2023, the Court approved the parties’ stipulation and ordered the parties to arbitration. On May 1, 2023, Altor/NantCell filed a demand against the Company before JAMS. On May 3, 2023, Altor/NantCell dismissed the federal court action without prejudice and the Court ordered the case dismissed without prejudice and closed the case. Altor/NantCell’s proceeding against the Company is now proceeding in arbitration before JAMS. Inflationary Cost Environment, Geopolitical Risks and Other Macroeconomic Factors The operations have been affected by many headwinds, including inflationary pressures, rising interest rates, ongoing global supply chain disruptions resulting from increased geopolitical tensions such as the war between Russia and Ukraine, Chinese aggression towards Taiwan, financial market volatility and currency movements. Further, there have been lingering, long-term effects of COVID-19 that continue to directly or indirectly impact the Company’s business, results of operations and financial condition, particularly related to staffing at clinical sites. The Company may be impacted by inflation when procuring materials required for the buildout of our new headquarters, the costs for recruiting and retaining employees and other employee-related costs. The Company uses a number of strategies to effectively navigate these issues, including product redesign, alternate sourcing, and establishing contingencies in budgeting and timelines. Future developments in these and other areas present material uncertainty and risk with respect to the Company's clinical trials, IND-enabling activities, buildout of the new headquarters, as well as the Company's financial condition and results of operations. The extent and duration of such events and conditions, and resulting disruptions to our operations, are highly unpredictable. |