On January 4, 2023 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported a strategic restructuring plan designed to extend its cash runway and prioritize resources on the commercialization and potential label extension of DANYELZA and development of the SADA (Self-Assembly DisAssembly ("SADA") PRIT 2-STEP) technology platform (Press release, Y-mAbs Therapeutics, JAN 4, 2023, View Source [SID1234625829]). The Company plans to discuss omburtamab at its upcoming Type A meeting with the FDA; however, the Company has assumed a deprioritization of the omburtamab program, including all indications, in designing its restructuring plan and in its estimates for 2023. In addition, the Company plans to deprioritize other pipeline programs, including activities relating to GD2-GD3 Vaccine and CD33 bispecific antibody constructs, as part of the restructuring plan.
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"We believe that this restructuring of the organization aligns our resources to efficiently leverage both the DANYELZA franchise and support development activities for our highly differentiated novel SADA platform, which we view as the key near and long-term potential growth drivers of Y-mAbs. We believe this sharpened focus should propel us through key anticipated milestones, including continuation and potential expansion of the commercialization of DANYELZA for neuroblastoma patients and potential indication expansion," said Thomas Gad, founder, President, and Interim CEO. "We also look forward to potentially dosing the first patient with GD2-SADA and generating data that we believe could potentially represent a transformative therapeutic option for patients based on the novel mechanism of action of our SADA constructs. We also expect to submit the IND for CD38-SADA targeting non-Hodgkin’s lymphoma. We are excited for 2023 and aim at further de-risking our SADA platform while continuing to grow our top line revenue for DANYELZA in the U.S. and adding ex-U.S. sales as we are excited about the potential launch in China after SciClone Pharmaceuticals received an approval late last year. Additionally, we anticipate a Type A meeting with the FDA in January 2023 to discuss the future of omburtamab."
Mr. Gad continued, "We expect the reduction in our workforce and our revised business plan to result in a reduction in operating expenses and extension of our cash runway into Q1 2026. I want to extend my sincere appreciation and gratitude to all of our colleagues for the work that has brought us to this point, and for their dedication and service to Y-mAbs while striving to develop new treatments for patients with cancer."
Strategic Objectives for 2023 and Beyond
Aiming to drive growth for our commercial drug, DANYELZA in the US through market growth and potential label expansion to target an estimated US market opportunity of $400 million for high-risk neuroblastoma and osteosarcoma alone
Seeking initial validation of the tumor binding capability of our novel SADA platform in solid tumors in the GD2-SADA multicenter trial through the collection of imaging data in patients with small-cell lung cancer, sarcoma, and malignant melanoma
Targeting an IND submission in Q2 2023 for CD38-SADA construct against non-Hodgkin’s lymphoma to potentially validate SADA in blood cancers
Seeking partnerships based on the SADA technology platform
Discussing potential regulatory pathway for omburtamab at Type A meeting with the FDA
2023 Financial Outlook
The restructuring plan announced today is expected to result in a reduction of Y-mAbs workforce by approximately 35% by the end of May 2023
Operating expenses, including restructuring costs which are expected to be recognized in Q1 2023, are expected to decrease by approximately 28% to $115-120 million, compared to previously announced 2022 guidance for operating expenses of $162-167 million
As a result of the estimated decrease in operating expenses, we estimate that our cash and cash equivalents should support our operations as currently planned, taking into account the restructuring plan, into the first quarter of 2026
The total cash burn for the 2023 fiscal year is expected to be in the range of $50-55 million, which is based on an expected 2022 year-end cash position of approximately $106 million
Estimated DANYELZA net product revenues for the 2023 fiscal year are expected to be between $60-65 million, compared to approximately $47-48 million expected for fiscal year 2022
Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.
Preliminary Financial Results
The preliminary financial results pertaining to expected cash and cash equivalents as of December 31, 2022 and DANYELZA net product revenues for fiscal year 2022 set forth above are unaudited and based on management’s initial review of the Company’s results as of and for the year ended December 31, 2022, and are subject to revision based upon the Company’s year-end closing procedures and the completion of the audit by the Company’s external auditors of the Company’s December 31, 2022 financial statements. Actual results may differ materially from these preliminary results as a result of the completion of year-end closing procedures, final adjustments, and other developments arising between now and the time that the Company’s financial results are finalized. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results as of and for the year ended December 31, 2022, should not be viewed as a substitute for complete financial statements prepared in accordance with U.S. generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.
About DANYELZA (naxitamab-gqgk)
DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.