Research and Development Agreements | 7. Research and Development Agreements Agreement Related to Intellectual Property Rights In July 2017, VSI, as “Licensee,” entered into a Patent License Agreement (the “Patent License Agreement”) with The U.S. Department of Health and Human Services, as represented by the National Institute on Alcohol Abuse and Alcoholism (“NIAAA”) and the National Institute on Drug Abuse (“NIDA”) of the National Institutes of Health (“NIH”), (collectively “Licensor”). In the course of conducting biomedical and behavioral research, the Licensor developed inventions that may have commercial applicability. The Licensee acquired commercialization rights to three patents covering a series of novel dual-action CB1 receptor inverse agonists, which includes MRI-1867, in order to develop processes, methods, or marketable products for public use and benefit. Pursuant to the terms of the Patent License Agreement, VSI is required to make minimum annual royalty payments on January 1 of each calendar year, which shall be credited against any earned royalties due for sales made in that year, throughout the term of the Patent License Agreement. The third annual payment of $25,000 was made in January 2021, of which the remaining $6,250 is included in “Prepaid expenses and other current assets” in the accompanying condensed consolidated balance sheets. For the three months ended September 30, 2021 and 2020, $6,250 of this prepaid royalty expense was recognized in each period in “Research and development” expenses in the accompanying condensed consolidated statements of comprehensive loss. For the nine months ended September 30, 2021 and 2020, $18,750 of this prepaid royalty expense was recognized in each period in “Research and development” expenses in the accompanying condensed consolidated statements of comprehensive loss. The Patent License Agreement also provides for payments from VSI to the Licensor upon the achievement of certain product development and regulatory clearance milestones, as well as royalty payments on net sales upon the commercialization of products developed utilizing the licensed patents. Through September 30, 2021, the Licensor has not achieved any milestones and therefore VSI has not made any milestone payments. VSI is obligated to pay earned royalties based on a percentage of net sales, as defined in the Patent License Agreement, of licensed product throughout the term of the Patent License Agreement. Since April 18, 2017 (inception) through September 30, 2021, there have been no sales of licensed products. In addition, VSI is also obligated to pay the Licensor additional sublicensing royalties on the fair market value of any consideration received for granting each sublicense. Through September 30, 2021, VSI has not entered into any sublicensing agreements and therefore no sublicensing consideration has been paid to Licensor. VSI is also obligated under the Patent License Agreement to reimburse Licensor for certain patent fees and expenses. Patent fee reimbursement under the Patent License Agreement was $5,017 and $15,050 for the three and nine months ended September 30, 2021, respectively. Patent fee reimbursement under the Patent license agreement was $6,680 and $20,040 for the three and nine months ended September 30, 2020, respectively. These costs are included in “Research and development” expenses in the accompanying condensed consolidated statements of comprehensive loss. Cooperative Research and Development Agreement Effective January 11, 2018, VSI signed a two-year Cooperative Research and Development Agreement (the “CRADA Agreement”) with the NIH for preclinical testing relating to the Patent License Agreement described above. Pursuant to the terms of the CRADA Agreement, each party will provide scientific staff and other support necessary to conduct the research and other activities described in the research plan. This agreement was subsequently amended to defer funding for year two subject to additional testing by NIH and approval of the results by VSI. On May 7, 2019, the Company made the first of two equal payments of $55,870 to NIH. As of September 30, 2021 and December 31, 2020, the second payment of $55,870, which is subject to delivery of final research results, is included in “Accounts payable and accrued expenses” on the accompanying condensed consolidated balance sheets. There were no expenses incurred in connection with the CRADA Agreement for the three months ended September 30, 2021 and 2020. Total expenses incurred in connection with the CRADA Agreement for the nine months ended September 30, 2021 and 2020 amounted to $0 and $31,039, respectively. These expenses are included in “Research and development” expenses in the accompanying condensed consolidated statements of comprehensive loss. 7. Research and Development Agreements (Continued) Memorandums of Understanding Effective July 28, 2018, SBI entered into two Memorandums of Understanding (“MOUs”) with Yissum Research Development Company (“Yissum”) of the Hebrew University of Jerusalem Ltd. (“Hebrew University”). Research under the Yissum MOUs was completed in December 2019 and March 2020, respectively, resulting in the license agreements below. There were no fees incurred in connection with these MOU’s for the three months ended September 30, 2021 and 2020. The fees incurred in connection with these MOU’s for the nine months ended September 30, 2021 and 2020 amounted to $0 and $29,457, respectively. These fees are included in “Research and development” expenses in the accompanying condensed consolidated statements of comprehensive loss. Effective March 5, 2019, the Company entered in a license agreement with Yissum with respect to the results of the research relating to the combination of cannabidiol with approved anesthetics as a potential treatment for the management of pain. Under the license agreement, the Company is obligated to pay earned royalties based on a percentage of net sales, as defined in the license agreement, including net sales generated from sub-licensees. In addition, the Company will be obligated to make payments upon the achievement of certain clinical development and product approval milestones. From March 5, 2019 through September 30, 2021, there have been no sales of licensed products by the Company nor has the Company entered into any sub-licensing agreements. Further, none of the milestones in the agreement have been reached and therefore as of September 30, 2021, there is no obligation to make any milestone payments. Effective August 8, 2019, the Company entered into a second license agreement with Yissum with respect to the research results relating to the synthesis of novel cannabinoid dual-action compounds and novel chemical derivatives of cannabigerol and tetrahydrocannabivarin. Under this license agreement, the Company is required to pay earned royalties based upon a percentage of net sales at one percentage for regulated products and a lesser percentage for non-regulated products. The Company is obligated to pay development milestone payments tied to regulated products totaling $1,225,000 in the aggregate and $100,000 for non-regulated products in the aggregate. None of the milestones in the agreement have been reached and therefore as of September 30, 2021 there is no obligation to make any milestone payments. CpG-STAT3siRNA License Agreement and Sponsored Research Agreement In June 2020, the Company entered into an exclusive, worldwide license agreement with City of Hope relating to CpG-STAT3siRNA (the “siRNA License Agreement”). In addition to the siRNA License Agreement, the Company also entered into a Sponsored Research Agreement (the “SRA”) relating to on-going research and development activities in collaboration with City of Hope relating to CpG-STAT3siRNA. The Company obtained the right to negotiate the siRNA License Agreement with City of Hope as part of the Bioscience Oncology acquisition in June 2020. Under the terms of the siRNA License Agreement, the Company is obligated to pay earned royalties based on a percentage of net sales, as defined in the siRNA License Agreement, including net sales generated from sub-licensees. In addition, the Company is obligated to make payments in cash upon the achievement of certain clinical development and product approval milestones totaling $3,525,000 in the aggregate. None of the milestones in the siRNA License Agreement have been reached and therefore as of September 30, 2021, there is no obligation to make any milestone payments. Pursuant to the terms of the SRA, the Company has committed to fund research and development at City of Hope for two years in accordance with a predetermined funding schedule. Total expenses incurred in connection with the siRNA License agreement and SRA were $70,000 and $210,000 for the three and nine months ended September 30, 2021 and $62,500 and $76,389 for the three and nine months ended September 30, 2020, respectively. These expenses are included in “Research and development” expenses in the accompanying condensed consolidated statements of comprehensive loss. 7. Research and Development Agreements (Continued) In March 2021, the Company paid to City of Hope approximately $1.2 million relating to the clinical lot manufacturing and IND preparation costs for CpG-STAT3siRNA and agreed to pay $10,000 per month to City of Hope for certain project management and regulatory services relating to the preparation of the IND for CpG-STAT3siRNA until such IND was filed with the FDA, which occurred in April 2021. Further, the Company incurred costs of approximately $10,010 and $0.3 million during the three and nine months ended September 30, 2021, respectively, pursuant to a clinical research support agreement (the “CRSA) relating to the Phase 1 clinical trial for CpG-STAT3siRNA to be conducted at City of Hope. These expenses are included in “Research and development” expenses in the accompanying condensed consolidated statements of comprehensive loss. In May 2021, the Company received United States Food and Drug Administration (“FDA”) approval of its IND application related to CpG-STAT3siRNA. Pursuant to the definitive agreement to acquire Bioscience Oncology, this approval satisfied a milestone that resulted in the issuance of approximately 1.3 million common shares of contingent consideration to the previous stockholders of Bioscience Oncology in June 2021 totaling approximately $5.1 million, based upon a value of $4.00 per share determined at the time of acquisition. The consideration was included in “Research and development” expenses in the accompanying condensed consolidated statements of comprehensive loss. Olimmune License Agreements On June 25, 2021, the Company completed the acquisition of Olimmune and Olimmune concurrently entered into two exclusive, worldwide license agreements with City of Hope relating to Olimmune’s drug candidates. The Company obtained the ASO Patent Rights license agreement and the Decoy Patent Rights license agreement (together, the “Olimmune License Agreements”) with City of Hope as part of the Olimmune acquisition in June 2021 (see Note 4). Under the terms of the Olimmune License Agreements, the Company is obligated to pay earned royalties based on a percentage of net sales, as defined in the Olimmune License Agreements, including net sales generated from sub-licensees. The Company incurred the upfront license fees of $385,622 in connection with these license agreements, of which $181,436 is included in accrued expenses at September 30, 2021. In addition, the Company is obligated to make payments in cash upon the achievement of certain clinical development and product approval milestones totaling $6,750,000 for each license |