LICENSE AGREEMENTS AND COMMITMENTS | NOTE 9—LICENSE AGREEMENTS AND COMMITMENTS 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 the Company’s Annual Report on Form 10-K, are the MSK License Agreement and the CD33 License Agreement. In addition, the Company entered into the SADA License Agreement with MSK and Massachusetts Institute of Technology (“MIT”) in 2020. Through a 2019 Settlement and Assumption and Assignment Agreement and Y-mAbs Sublicense Agreement (“SAAA”) with MabVax, Inc. (“MabVax”) and MSK, the Company has established a direct license (“MabVax Agreement”) 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 in NOTE 8—ACCRUED LIABILITIES The Company has the following significant license agreements and related commitments which include all obligations that have been paid or accrued as of and for the three and nine months ended September 30, 2022 and 2021, and as of December 31, 2021 (in thousands): Accrued Accrued Accrued Accrued Cash paid Cash paid Expense Expense Expense Expense liabilities liabilities liabilities liabilities Nine months Nine months Three months Nine months Three months Nine months Current Non-current Current Non-current ended ended ended ended ended ended as of as of as of as of September September September September September September September September December December Agreements 2022 2021 2022 2022 2021 2021 2022 2022 2021 2021 MSK $ 2,871 $ 1,480 $ 753 $ 2,513 $ 321 $ 531 $ 828 $ 1,950 $ 1,486 $ 1,650 CD33 — 100 — — — — 150 300 — 450 MabVax — 10 10 10 — 10 10 — — — SADA 1,000 1,000 — — — — 605 — 1,605 — 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 should such research and development fail the MSK License Agreement, the CD33 License Agreement, the SADA License Agreement and the MabVax Agreement are cancelable at the Company’s option. The Company will also consider the development risk and each party’s termination rights under the respective agreement when considering whether any clinical or regulatory based milestone payments, certain of which also contain time-based payment requirements, are probable. The Company records milestones in the period in which the contingent liability is probable and the amount is reasonably estimable. With respect to the SADA License Agreement, all time-based milestones coming due within 36 months of the effective date of the agreement, totaling $605,000, have been accrued, as this continues to represent the time period the Company expects will be required to gather necessary clinical data to determine which patent rights to further pursue, if any, under the SADA License Agreement. Other Agreements The Company has 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 the Company committed to fund certain clinical trials at MSK; two separate core facility service agreements pursuant to which the Company committed to obtaining certain laboratory services from MSK; and in October 2020 the Company entered into a SADA sponsored research agreement pursuant to which the Company 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 the three months ended September 30, 2022 and 2021, the Company incurred research and development expenses of $458,000 and $833,000, respectively, under these agreements. For the nine months ended September 30, 2022 and 2021, the Company incurred research and development expenses of $1,505,000 and $2,728,000, 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 established 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 original term of the lease was two years from the commencement date of August 31, 2020, which was subsequently extended to December 2022. The extension resulted in an immaterial impact to the underlying right of use asset and lease liability. Upon the lease commencement date, the Company recorded $3,617,000 as right of use asset and $2,679,000 as lease liability 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, the Company expanded the space with an additional 235 square feet. The original term of the lease was three years from the date the Company occupied the premises, with an option to extend for an additional two years which expires in January 2024, which the Company exercised and has included in the determination of the related lease liability. Fixed rent payable under the lease is approximately $144,000 per annum and is payable in equal monthly installments of approximately $12,000. In January 2018, the Company entered into a lease agreement in connection with its corporate headquarters in New York. The term of the lease is six years from the date the Company began to occupy the premises and expires in April 2024. 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. In February 2018, the Company entered into a lease agreement for certain office space in Denmark, which has been amended several times. The lease was renewed on November 1, 2021 with a four year term that expires in November 2025. The lease is payable in monthly installments of approximately $41,000, which are recognized on a straight-line basis. Total operating lease costs were $721,000 and $644,000 for the three months ended September 30, 2022 and 2021, respectively, and $2,127,000 and $1,936,000 for the nine months ended September 30, 2022 and 2021, respectively. For the three months ended September 30, 2022, the operating lease expenses were recorded as $657,000 in research and development expense and $64,000 in general and administrative expense. For the three months ended September 30, 2021, the expenses were recorded as $584,000 in research and development expense and $60,000 in general and administrative expense. For the nine months ended September 30, 2022, the expenses were recorded as $1,937,000 in research and development expense and $190,000 in general and administrative expense. For the nine months ended September 30, 2021, the expenses were recorded as $1,758,000 in research and development expense and $178,000 in general and administrative expense. Cash paid for amounts included in the measurement of lease liabilities for the three and nine months ended September 30, 2022 was $481,000 and $1,689,000, respectively, and cash paid for amounts included in the measurement of lease liabilities for the three and nine months ended September 30, 2021 was $548,000 and $1,641,000, respectively. These payments were included in net cash used in operating activities in the Company’s Consolidated Statements of Cash Flows. Maturities of operating lease liabilities as of September 30, 2022 were as follows (in thousands): Operating Leases at September 30, 2022 Remainder of 2022 $ 554 Years ending December 31, 2023 958 2024 482 2025 383 Total lease payments 2,377 Less: Imputed interest (158) Total operating lease liabilities as of September 30, 2022 $ 2,219 Maturities of operating leases as of 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 as of 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 September 30, 2022, the weighted average remaining lease term is 2.18 years and the weighted average discount rate used to determine the operating lease liability was 6.8%. As of December 31, 2021, the weighted average remaining lease term was 2.62 years and the weighted average discount rate used to determine the operating lease liability was 6.5%. Former Chief Executive Officer Contractual Severance Related Benefits On April 27, 2022, the Company announced certain executive management changes. Effective April 22, 2022, Dr. Claus Møller stepped down from his positions as Chief Executive Officer and as a member of the Company’s Board of Directors. There were no disagreements with the Company expressed by Dr. Møller on any matters relating the Company’s operations, policies or practices. Dr. Møller’s contractual severance related benefits provided for cash compensation of Legal Matters We have been named a nominal defendant in a lawsuit filed in the U.S. District Court, Southern District of New York, on August 25, 2021, by one of our stockholders, Deborah Donoghue and in a related lawsuit filed in the U.S. District Court, Southern District of New York, on October 10, 2022 by one of our stockholders, Mark Rubenstein. The suits name our President, Interim Chief Executive Officer and Head of Business Development and Strategy, and member of our board of directors, Mr. Thomas Gad as an additional defendant, and they seek to compel Mr. Gad to disgorge alleged short swing profits stemming from a certain transaction involving our common stock undertaken by Mr. Gad on March 10, 2021 together with appropriate interest and costs of the lawsuit. On December 17, 2021, Mr. Gad filed a Motion to Dismiss the lawsuit by Ms. Donoghue. On August 8, 2022, the Court denied Mr. Gad’s Motion to Dismiss the lawsuit. As a result, the lawsuit by Ms. Donoghue has entered the discovery phase. Mark Rubenstein is represented by the same lawfirm as was Ms. Donoghue. Mr. Rubenstein had sought to intervene to continue the litigation instigated by Ms. Donahue on her passing, but was denied by the court. We are of the opinion that the claims are without merit and intend to maintain this position in the proceedings. In addition, we have been informed by Mr. Gad that he also believes the claims are without merit, that he has strong defenses against such claims and that he intends to vigorously defend the actions. We have assessed the proceedings and do not believe that it is probable that a gain or a liability will be realized by us. As a result, we did not record any loss or gain contingencies for this matter. |