LICENSE AGREEMENTS AND COMMITMENTS | NOTE 9—LICENSE AGREEMENTS AND COMMITMENTS As of March 31, 2022, the Company has entered into two license agreements and certain other agreements with Memorial Sloan Kettering Cancer Center (“MSK”). The license agreements, as previously disclosed in our annual report on Form 10-K, are the MSK License and the CD33 License Agreement. In addition, the Company entered into the SADA Technology License Agreement, or the SADA License Agreement, with MSK and Massachusetts Institute of Technology (“MIT”) in 2020. Through a 2019 Settlement and Assumption and Assignment of the MSK License and Y-mAbs Sublicense Agreement (“SAAA”) with MabVax, Inc. (“MabVax”) and MSK, the Company has established a direct license with MSK relating to the GD2-GD3 Vaccine, which was originally sublicensed by the Company in 2018 from MabVax. These license agreements with MSK and MIT grant the Company certain patent rights and intellectual property rights, and in consideration thereof, the Company agreed to make certain payments and issue shares of the Company’s common stock to MSK and MIT. Certain of the payments are contingent milestone and royalty payments, as disclosed in the table below. Amounts disclosed for accrued milestone and royalty payments are inclusive of obligations under the MSK License, CD33 License Agreement, MabVax License Agreement, and SADA License Agreement, collectively. We have the following significant license agreements and related commitments which include all obligations that have been paid or are accrued as of and for the period ending March 31, 2022 (in thousands): Accrued Accrued Accrued Accrued Cash paid Cash paid Expense Expense liabilities liabilities liabilities liabilities Three months Three months Three months Three months Current Non-current Current Non-current ended ended ended ended as of as of as of as of March March March March March March December December Agreements 2022 2021 2022 2021 2022 2022 2021 2021 MSK $ - $ 450 $ 677 $ - $ 2,163 $ 1,650 $ 1,486 $ 1,650 CD33 — 100 — — — 450 — 450 MabVax — — — — — — — — SADA — — — — 1,605 — 1,605 — Minimum royalties and certain clinical and regulatory milestones that become due based upon the passage of time under the CD33 License Agreement, the SADA Agreement and the MabVax Agreement are excluded from the above table as the Company does not consider such obligations to be probable. The below table represents the maximum clinical, regulatory or sales-based milestones as reflected within the agreements, certain of which have been paid in prior periods or are accrued as presented in the table above (in thousands): Maximum Maximum Maximum Agreements Clinical Milestones Regulatory Milestones Sales-based milestones MSK $ 2,450 $ 9,000 $ 20,000 CD33 550 500 7,500 MabVax 200 1,200 — SADA 4,730 18,125 23,750 Research and development is inherently uncertain and as described above, should such research and development fail, the MSK License, the CD 33 License, and the SADA License are cancelable at the Company’s option. The Company will also consider the development risk and each party’s termination rights under the agreements when considering whether any clinical or regulatory based milestone payments, certain of which also contain time-based payment requirements, are deemed probable. The Company records milestones in the period in which the contingent liability is probable and the amount is reasonably estimable. The Company did not have an expense related to milestones under the SADA License Agreement in the first quarters of 2022 and 2021 and had $1,605,000 in accrued liabilities as of March 31, 2022 and 2021. This includes clinical-based milestones of Other agreements We have also entered into various other support agreements with MSK including a sponsored research agreement to provide research services related to the intellectual property licensed under the MSK License Agreement; a master data services agreement, for services provided by approximately five full time employees at MSK, who are engaged in transferring clinical data, databases, regulatory files and other know how included in the MSK License Agreement to the Company; a master clinical trial agreement pursuant to which we committed to fund certain clinical trials at MSK; two separate core facility service agreements pursuant to which we committed to obtaining certain laboratory services from MSK; and in October 2020 we entered into a SADA sponsored research agreement pursuant to which we agreed to pay MSK to provide research services over a period of three years related to the intellectual property licensed under the SADA License Agreement. For three months ended March 31, 2022 and 2021, we incurred research and development expenses of $697,000 and $948,000, respectively, under these agreements. Lease Agreements In July 2019, the Company entered a development, manufacturing and supply agreement with SpectronRx in South Bend, Indiana, to secure access to clinical and commercial scale radiolabeling capacity for omburtamab. Under the terms of the agreement, SpectronRx has agreed to establish a manufacturing unit designated for the Company within its existing facilities, at which both clinical and commercial supply of radiolabeled omburtamab can be produced. Since the Company possesses the right to substantially all the economic benefits and directs the use of the production area, the Company accounts for the payments related to the access to the manufacturing space under ASC 842 as an operating lease. The term of the lease is two years from the commencement date of August 31, 2020. Upon the lease commencement date, we recorded $3,617,000 as right-of-use asset and $2,680,000 as lease liability with the difference of $937,000 resulting from certain prepayments and other costs incurred. The Company pays equal monthly installments of approximately $117,000 per month in additional access fees through September 2022 resulting in total payments of $583,000 remaining under the agreement. There are no renewal options in this agreement. In February 2019, the Company entered into a lease agreement in connection with its 4,548 square feet laboratory in New Jersey. In December 2019, we expanded the space with an additional 235 square feet. The term of the lease is three years from the date the Company occupied the premises, with an option to extend for an additional two years which the Company expects to exercise and has included in the determination of the related lease liability. This lease will expire in the fourth quarter of 2023. Fixed rent payable under the lease is approximately $144,000 per annum and is payable in equal monthly installments of approximately $12,000. January 2018, the Company entered into a lease agreement in connection with its corporate headquarters in New York. The term of the lease is five years from the date the Company begins to occupy the premises. Fixed rent payable under the lease is approximately $384,000 per annum and is payable in equal monthly installments of approximately $32,000, which are recognized on a straight line basis. The Company entered a three-year lease agreement for the lease of certain office space in Denmark in February 2018, as amended in November 2018 and February 2019. Additionally, on September 26, 2021, the Company entered into a lease agreement in Denmark to expand the size of its current office space to a total of 29,288 square feet. The lease is payable in monthly installments of approximately $41,000, which are recognized on a straight line basis. The new lease is expected to last for 48 months and commenced on November 1, 2021 when we were provided access to the leased space. Total operating lease costs were $704,000 and $646,000 for the three months ended March 31, 2022 and 2021, respectively. During the three months ended March 31, 2022, the expenses were recorded as $638,000 in research and development expense and $66,000 in selling, general, and administrative expense. During the three months ended March 31, 2021, the expenses were recorded as $587,000 in research and development expense and $59,000 in selling, general, and administrative expense. Cash paid for amounts included in the measurement of lease liabilities for the three months ended March 31, 2022 and 2021 was $607,000 and $544,000, respectively, and was included in net cash used in operating activities in the Company’s Consolidated Statements of Cash Flows. Maturities of operating lease liabilities at March 31, 2022 were as follows (in thousands): Operating Leases at March 31, 2022 Remainder of 2022 $ 1,341 Years ending December 31, 2023 1,016 2024 540 2025 436 Total lease payments 3,333 Less: Imputed interest (284) Total operating lease liabilities at March 31, 2022 $ 3,049 Maturities of operating lease liabilities at December 31, 2021 were as follows (in thousands): Operating Leases Years ending December 31, at December 31, 2021 2022 $ 1,953 2023 1,025 2024 550 2025 445 Total lease payments 3,973 Less: Imputed interest (339) Total operating lease liabilities at December 31, 2021 $ 3,634 Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company uses its estimate of its incremental borrowing rate based on the information available at the lease commencement date. As of March 31, 2022, the weighted average remaining lease term is 2.54 years and the weighted average discount rate used to determine the operating lease liability was 6.5%. As of March 31, 2021, the weighted average remaining lease term is 1.97 years and the weighted average discount rate used to determine the operating lease liability was 7.6%. Legal Matters The Company has been named a nominal defendant in a lawsuit instigated by a stockholder against our Board Member and President, Interim Chief Executive Officer and Head of Business Development and Strategy, Mr. Thomas Gad, seeking to compel Mr. Gad to disgorge alleged short swing profits stemming from a certain transaction involving the Company’s common stock undertaken by Mr. Gad on March 10, 2021. The Company is of the opinion that the claim is without merit and intends to maintain this position in the proceedings. In addition, the Company had been informed by Mr. Gad that he also believes the claim is without merit, that he has strong defenses against such claim and that he intends to vigorously defend the action. The Company has assessed the proceedings and does not believe that it is probable that a gain or a liability will be realized by the Company. As a result, the Company did not record any loss or gain contingencies for this matter. |