LICENSE AGREEMENTS AND COMMITMENTS | NOTE 9—LICENSE AGREEMENTS AND COMMITMENTS The Company has entered into three license agreements and certain other agreements with Memorial Sloan Kettering Cancer Center (“MSK”). The license agreements are the MSK License Agreement, dated August 20, 2015, between the Company and MSK (the “MSK License”), the License Agreement, dated November 13, 2017, between the Company and MSK (the “CD33 License Agreement”), and the License Agreement, dated April 15, 2020, between the Company, MSK and Massachusetts Institute of Technology (“MIT”) (the “SADA License Agreement”). Through the Settlement and Assumption and Assignment of the MSK License and Y-mAbs Sublicense Agreement, dated December 2, 2019, among MabVax Therapeutics Holdings, Inc. and MabVax Therapeutics, Inc., (together “MabVax”), the Company and MSK (the “SAAA”), 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. In addition, the Company entered the SADA License Agreement with MSK and Massachusetts Institute of Technology (“MIT”) in 2020. 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 payments are contingent milestone and royalty payments, as disclosed in the table below. Amounts disclosed in NOTE 8—ACCRUED LIABILITIES In the past, the Company had defined MSK as a related-party under the Company’s related-party policy. During the three months ended June 30, 2023, the Company updated the related-party policy to remove MSK as a related-party as MSK does not participate on the Company’s Board of Directors, does not have a significant ownership in the Company and MSK is not in a position to exert decision making power. The Company has entered into several agreements with MSK, which include the MSK License Agreement, the SADA License Agreement, the CD33 License Agreement, and the MabVax Agreement, all as noted above. The Company’s material license agreements are detailed in N ote 9—License Agreements and Commitments MSK License Agreement The MSK License relates to intellectual property for DANYELZA and requires the Company to pay to MSK mid to high single-digit royalties based on annual net sales of licensed products or the performance of licensed services by the Company and the Company’s affiliates and sublicensees. The Company is required to pay annual minimum royalties of $80,000 over the royalty term, which amounts are non-refundable but are creditable against royalty payments otherwise due thereunder. The Company is also obligated to pay to MSK certain clinical, regulatory and sales-based milestone payments under the MSK License, which payments become due upon achievement of the related clinical, regulatory or sales-based milestones. As product candidates developed using technology from the MSK License progress through clinical development, and potential regulatory approval and commercialization, certain of these clinical and regulatory milestone payments become due at the earlier of completion of the related milestone activity or the date indicated in the MSK License. In addition to any milestone payments, to the extent the Company enters into sublicense arrangements, the Company is required to pay to MSK a percentage of certain payments that the Company receives from sublicensees of the rights licensed to the Company by MSK under the MSK License, which percentage will be based upon the achievement of certain clinical milestones. The Company has entered into sublicenses and distribution agreements related to DANYELZA and omburtamab under the MSK License with Takeda Israel, Swixx BioPharma AG and SciClone in 2020, with Adium in 2021, and with WEP in 2022. The MSK License will expire, on a country-by-country basis, and on a licensed-product by licensed-product or licensed-service by licensed-service basis, on the later of (i) the expiration of the last to expire of the patents and patent applications covering such licensed product or service in such country, (ii) the expiration of any market exclusivity period granted by a regulatory authority for such licensed product or service in such country, or (iii) 15 years from the first commercial sale of such licensed product or service in such country. MSK may terminate the MSK License upon prior written notice in the event of the Company’s uncured material breach, or upon prior written notice if such breach is of a payment obligation. MSK may also terminate the MSK License upon written notice in the event of the Company’s bankruptcy or insolvency or the Company’s conviction of a felony relating to the licensed products, or if the Company challenges the validity or enforceability of any licensed patent right. In addition, the Company has the right to terminate the MSK License in its entirety at will upon prior written notice to MSK, but if the Company has commenced the commercialization of licensed products and/or licensed services the Company can only terminate at will if the Company ceases all development and commercialization of such licensed products and/or licensed services. The Company’s failure to meet certain conditions under the MSK License could cause the license related to such licensed product to be canceled and could result in termination of the MSK License by MSK. SADA License Agreement Pursuant to the SADA License Agreement, the Company was granted an exclusive worldwide, sublicensable license to MSK’s and MIT’s rights to certain patent and intellectual property to develop, make, and commercialize licensed products and to perform services for all therapeutic and diagnostic uses in the field of cancer diagnostics and cancer treatments using the SADA-BiDE Pre-targeted Radioimmunotherapy Platform (“SADA Technology”). At the time of entering into the arrangement, the Company assessed the licensing and other rights acquired and given the lack of outputs upon acquisition and that no employees were acquired, among other factors, the Company has concluded that the licensing rights represented an asset acquisition. The Company concluded that the technology acquired under the licensing arrangement had no alternative future use. This conclusion was based on consideration of the rights conveyed under the agreement, extent of further development necessary and presence of uncertainty prior to obtaining regulatory approval for any product. The SADA License Agreement requires the Company to pay to MSK and MIT mid to high single-digit royalties based on annual net sales of licensed products or the performance of licensed services by the Company and its affiliates and sublicensees. The Company is obligated to pay annual minimum royalties of $40,000, increasing to $60,000 once a patent has been issued, over the royalty term, commencing on the tenth anniversary of the license agreement. These amounts are non-refundable but are creditable against royalty payments otherwise due under the SADA License Agreement. The Company is also obligated to pay MSK and MIT certain clinical, regulatory and sales-based milestone payments under the SADA License Agreement. As product candidates developed using technology from the SADA License Agreement progress through clinical development, and potential regulatory approval and commercialization, certain of these clinical and regulatory milestone payments become due at the earlier of completion of the related milestone activity or the date indicated in the SADA License Agreement. In addition to any milestone payments, to the extent the Company enters into sublicense arrangements, it is obligated to pay to MSK and MIT a percentage of certain payments received from sublicensees of the rights licensed to it by MSK and MIT, which percentage will be based upon the achievement of certain clinical milestones. The Company has not entered into any sublicenses related to the SADA License Agreement. For each of the constructs previously generated by MSK using the SADA Technology and sold for the Company by a sublicensee, the Company may pay sales milestones up to $60,000,000, in total, based on the achievement of various levels of cumulative net sales made by the sublicensee. Failure by the Company to meet certain conditions under the arrangement could cause the related license to such licensed products to be canceled and could result in termination of the entire arrangement with MSK and MIT. In addition, the Company may terminate the SADA License Agreement with prior written notice. Summary of Significant License Agreements and Related Commitments The Company has the following significant license agreements and related commitments which include all obligations that have been paid or accrued for the three and six months ended June 30, 2023 and 2022, and as of June 30, 2023 and December 31, 2022 (in thousands): Cash paid Cash paid Expense Expense Expense Expense Accrued Accrued Accrued Accrued Six Six Three Six Three Six liabilities liabilities liabilities liabilities months months months months months months Current Non-current Current Non-current ended ended ended ended ended ended as of as of as of as of June 30, June 30, June 30, June 30, June 30, June 30, June 30, June 30, December 31, December 31, Agreements 2023 2022 2023 2023 2022 2022 2023 2023 2022 2022 MSK $ 3,245 $ 1,263 $ 1,479 $ 2,702 $ 1,083 $ 1,760 $ 2,777 $ 1,950 $ 3,397 $ 1,950 CD33 — — — — — — — 300 — 300 MabVax — — — — — — — — — — SADA 605 1,000 — — — — — — 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/MSK License Agreement are excluded from the above table as the Company does not consider such obligations to be probable as of June 30, 2023. 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 Clinical Regulatory Sales-based Agreements Milestones Milestones 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 as well as the MabVax/Y-mAbs Sublicense 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. The Company did not recognize any expense related to milestones under the SADA License Agreement during the three and six months ended June 30, 2023 and 2022, as no additional milestones were determined to be probable. The Company had $605,000, in accrued liabilities as of December 31, 2022, which was accrued upon entry into the arrangement in 2020. The Company made a payment of $605,000 in the quarter ended June 30, 2023 related to achievement of the milestone for dosing the first patient in the Phase 1 trial of GD2-SADA in April 2023, and did not have any accrued liabilities as of June 30, 2023 related to milestones under SADA License Agreement. During the second half of 2023, the Company anticipates having the necessary data for a further assessment of clinical progress to determine whether any other milestones under the agreement are deemed probable. The Company did not consider any other milestones under the SADA License Agreement to be probable as of June 30, 2023 and December 31, 2022. 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 had established a manufacturing unit designated for the Company within its existing facilities, at which both clinical and commercial supply of radiolabeled omburtamab could be produced. Since the Company possessed the right to substantially all the economic benefits and directs the use of the production area, the Company accounted 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 Company entered into an additional one-month extension that terminated in January 2023 for a de minimis cost. 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 was to expire in January 2024, which the Company exercised and had included in the determination of the related lease liability. In July 2023, the Company entered into a lease amendment to extend the term to February 2025. Fixed rent payable under the lease is approximately $177,000 per annum and is payable in equal monthly installments of approximately $15,000 per month. In January 2018, the Company entered into a lease agreement in connection with its corporate headquarters in New York. The term of the lease was six years from the date the Company began to occupy the premises and the lease was to expire 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 is recognized on a straight-line basis. In January 2023, the Company notified the landlord of its intention to reduce the leased premise as a result of the Company’s strategic restructuring, which was approved by the Company’s Board of Directors on January 4, 2023. The lease modification resulted in an immaterial charge in the six months ended June 30, 2023. Total operating lease costs were $220,000 and $701,000 for the three months ended June 30, 2023 and 2022, respectively. Total operating lease costs were $560,000 and $1,406,000 for the six months ended June 30, 2023 and 2022, respectively. The decrease in operating lease costs in three and six months ended June 30, 2023 compared to the same periods in 2022 was due to the SpectronRx lease which we terminated in January 2023 as discussed above. For the three months ended June 30, 2023, the operating lease expenses were recorded as $163,000 in research and development expense and $57,000 in selling, general and administrative expense. For the three months ended June 30, 2022, the expenses were recorded as $641,000 in research and development expense and $60,000 in selling, general and administrative expense. For the six months ended June 30, 2023, the expenses were recorded as $446,000 in research and development expense and $114,000 in selling, general and administrative expense. For the six months ended June 30, 2022, the expenses were recorded as $1,279,000 in research and development expense and $127,000 in selling, general and administrative expense. Cash paid for amounts included in the measurement of lease liabilities for the three and six months ended June 30, 2023, was $266,000 and $525,000, respectively, and cash paid for amounts included in the measurement of lease liabilities for the three and six months ended June 30, 2022, was $601,000 and $1,208,000, 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 at June 30, 2023, were as follows (in thousands): Operating Leases at June 30, 2023 Remainder of 2023 $ 531 Years ending December 31, 2024 477 2025 369 Total lease payments 1,377 Less: Imputed interest (132) Total operating lease liabilities at June 30, 2023 $ 1,245 Maturities of operating leases liabilities as of December 31, 2022, were as follows (in thousands): Operating Leases Years ending December 31, at December 31, 2022 2023 $ 997 2024 490 2025 419 Total lease payments 1,906 Less: Imputed interest (139) Total operating lease liabilities at December 31, 2022 $ 1,767 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 June 30, 2023, the weighted average remaining lease term is 1.98 years and the weighted average discount rate used to determine the operating lease liability was 8.4%. As of December 31, 2022, the weighted average remaining lease term was 2.36 years and the weighted average discount rate used to determine the operating lease liability was 8.3%. 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 Juan Møller San Pedro 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 $1,589,000, which included salary and certain benefits continuation. All of the cash compensation had been paid as of June 30, 2023. Also, under terms of the equity award agreement, Dr. Møller’s outstanding stock option awards will continue to vest as scheduled and become exercisable when vested. This resulted in a non-cash share-based compensation charge of $9,286,000 in the three and six months ended June 30, 2022, as there is no longer a service condition related to such awards. The total charge of $10,875,000 related to executive management change was recorded in selling, general and administrative expenses during the three and the six months ended June 30, 2022. There was no financial impact in the three and six months ended June 30, 2023. Legal Matters Donoghue vs. Y-mAbs Therapeutics, Inc., and Gad The Company has 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 the Company’s stockholders, Deborah Donoghue (Case No. 1:21-cv-07182). The suit names the Company’s President, Interim Chief Executive Officer and Head of Business Development and Strategy, and member of the Company’s board of directors, Mr. Thomas Gad as an additional defendant, and it seeks 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 together with appropriate interest and costs of the lawsuit. On December 17, 2021, Mr. Gad filed a Motion to Dismiss the lawsuit. On August 8, 2022, the Court denied Mr. Gad’s Motion to Dismiss the lawsuit. The parties have completed documentary discovery and depositions and the action is currently stayed through August 22, 2023. 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 has 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. In re Y-mAbs Therapeutics, Inc. Securities Litigation On January 18, 2023, a putative class-action lawsuit was filed against the Company and certain of its current and former officers for alleged violations of the U.S. federal securities laws in the United States District Court, Southern District of New York (Case No.: 1:23-cv-00431). The amended complaint filed on May 23, 2023, asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, on behalf of a proposed class consisting of those who acquired the Company’s common stock between October 6, 2020 and October 28, 2022. The amended complaint alleges that there were material misrepresentations and/or omissions regarding the FDA’s consideration of the Company’s BLA for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma firstly submitted in 2020 and resubmitted in 2022. The amended complaint seeks unspecified damages, and costs and expenses, including attorneys’ fees. On April 4, 2023, the Court appointed a lead plaintiff for the putative class. On July 11, 2023, the defendants filed a motion to dismiss the amended complaint. The plaintiff has until August 29, 2023 to file his opposition to the motion to dismiss. The Company believes that these claims are without merit and intends to vigorously defend against these claims. The Company has not established a liability for this claim as of June 30, 2023 as the Company does not consider the loss on the claim to be probable. Hazelton vs. Y-mAbs Therapeutics Inc., and Gad, et al. The Company has been named a nominal defendant in a lawsuit filed in the Court of Chancery of the State of Delaware, on February 8, 2023, by a purported stockholder, Jeffrey Hazelton (Case No. 2023-0147-LWW). The amended complaint filed on May 12, 2023, purports to bring claims on behalf of the Company against current and former members of the Company’s board of directors for allegedly awarding themselves excessive compensation for fiscal years 2020 and 2021. The amended complaint seeks, among other things, recovery of alleged excessive compensation, an order directing the Company to undertake certain corporate governance reforms, and an award of costs and expenses, including attorneys’ fees. On June 22, 2023, the defendants filed a motion to dismiss the amended complaint. The plaintiff has until August 11, 2023, to file his opposition to the motion to dismiss. The Company is of the opinion that the claims are without merit and intends to maintain this position in the proceedings. The Company has not established a liability for this claim as of June 30, 2023 as the Company does not consider the loss on the claim to be probable. |