YMAB Y mAbs Therapeutics Inc

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 8-K

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CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

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Date of report (Date of earliest event reported): August 12, 2024

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Y-MABS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

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230 Park Avenue

Suite 3350

New York, New York 10169

(Address of principal executive offices) (Zip Code)

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(646) 885-8505

(Registrant’s telephone number, include area code)

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N/A

(Former Name or Former Address, if Changed Since Last Report)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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Securities registered pursuant to Section 12(b) of the Act:

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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Emerging growth company  ☐

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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

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Item 2.02. Results of Operations and Financial Condition.

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On August 12, 2024, Y-mAbs Therapeutics, Inc., announced its financial results for the quarter ended June 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1.

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The information furnished pursuant to Item 2.02 on this Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

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Item 9.01. Financial Statements and Exhibits.

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(d) Exhibits

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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Exhibit 99.1

Y-mAbs Reports Second Quarter 2024 Financial Results and Recent Corporate Developments

New York, NY, August 12, 2024 (GLOBE NEWSWIRE) – Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today reported financial results for the second quarter ended June 30, 2024.

“We demonstrated commercial progress with DANYELZA in the second quarter of this year while continuing to advance our development pipeline,” said Mike Rossi, President and Chief Executive Officer. “Our dedicated U.S. sales team with deep neuroblastoma expertise continues to penetrate new centers with DANYELZA, a leading anti-GD2 therapy, added to two more hospital formularies in the second quarter of 2024, while our ex-U.S. distribution partners have gained traction in our Eastern Asia and Latin America markets. Additionally, we remain focused on advancing our novel Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy (“PRIT) technology platform and continue to evaluate potential expansion of indications for naxitamab in our mission of delivering better and safer therapies to patients. Looking ahead, we are on track to complete Part A of our GD2-SADA Phase 1 clinical trial in the fourth quarter of this year with a data readout to follow and are on track to dose the first patient in our CD38-SADA Phase 1 in Non-Hodgkin’s Lymphoma trial in the second half of this year.”

Second Quarter 2024 and Recent Corporate Highlights

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Financial Results

Revenues

Total net product revenues were $22.8 million and $42.2 million for the quarter and six months ended June 30, 2024, which represented an increase of 10% and 3%, respectively, over $20.8 million and $41.0 million in the comparable periods of 2023.

DANYELZA total net product revenues of $22.8 million in the second quarter of 2024, represented a 10% increase compared to the second quarter of 2023, primarily driven by increased international revenues. Y-mAbs’ international DANYELZA net product revenues were $7.6 million for the three months ended June 30, 2024, an increase of 55% over $4.9 million in the comparable period in 2023. The increase of net product revenue in the quarter ended June 30, 2024, compared to the quarter ended June 30, 2023, was a result of increased volume from Western Europe, as well as the commercial launch for Brazil and Mexico in Latin America. U.S. DANYELZA net product revenues were $15.2 million and $15.9 million for the three months ended June 30, 2024 and 2023, respectively, representing a 4% decline driven by a volume decrease due to the launch of competing therapy in another class of agents and some ongoing clinical trial activities.

The Company’s total net product revenue was $42.2 million for the six months ended June 30, 2024, as compared to $41.0 million in the comparable period in 2023. The 3% increase was primarily driven by a $1.2 million increase in the U.S. DANYELZA net product revenue in the six months ended June 30, 2024, while international net product revenue was relatively flat.

As of June 30, 2024, Y-mAbs has delivered DANYELZA to 65 centers across the U.S. since initial launch, with two new accounts added in the U.S. in the second quarter of 2024. During the quarter ended June 30, 2024, approximately 67% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center (“MSK”), compared to 60% in the first quarter ended March 31, 2024.

The Company did not have license revenue for the quarters ended June 30, 2024 and 2023. The Company had license revenues of $0.5 million for the six months ended June 30, 2024, from our distribution partner, Adium, related to our acceptance of the price for DANYELZA in Brazil from the Brazilian Medicines Market Regulation Chamber. There was no license revenue recorded for the six months ended June 30, 2023.

Operating Costs and Expenses

Cost of Goods Sold

Cost of goods sold was $3.0 million and $4.6 million for the quarter ended June 30, 2024 and 2023, respectively. Cost of goods sold was $5.1 million and $6.7 million for the six months ended June 30, 2024 and 2023, respectively. The Company defines gross margin as net product revenues less cost of goods sold divided by net product revenues. Our gross margins increased in the three and six months ended June 30, 2024, compared to the comparable periods in 2023, due to a favorable gross profit mix from lower vial volumes from our international regions.

Research and Development

Research and development expenses were $12.3 million for the quarter ended June 30, 2024, and relatively flat compared to $12.1 million for the quarter ended June 30, 2023. For the six months ended June 30, 2024 and 2023, research and development expenses were relatively flat at $25.6 million and $25.5 million, respectively.

Selling, General, and Administration

Selling, general, and administrative expenses were $17.2 million for the three months ended June 30, 2024, which was a $5.9 million increase compared to $11.3 million for the three months ended June 30, 2023. The increase was primarily attributable to a net impact of $3.6 million related to the Company’s settlement of a shareholder class-action lawsuit, which is the net impact of the Company’s $19.7 million accrued legal settlement, less the corresponding insurance recovery of $16.1 million and an additional legal settlement of $0.2 million in the three months ended June 30, 2024.

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For the six months ended June 30, 2024, selling, general, and administrative expenses were $28.7 million, an increase of $5.2 million for the six months ended June 30, 2023. The increase was primarily attributable to a net impact of $3.8 million related to the Company’s two legal settlements, as noted above.

Interest and Other Income

Interest and other income were $0.6 million for the three months ended June 30, 2024, as compared to $1.1 million for the three months ended June 30, 2023. The decrease of $0.5 million was primarily due to a $0.2 million gain from repayment of a secured promissory note in the three months ended June 30, 2023, and a $0.2 million increase in foreign currency transaction losses. The Company did not have the repayment of a secured promissory note in the three months ended June 30, 2024.

For the six months ended June 30, 2024 and 2023, the interest and other income was $1.1 million and $2.2 million, respectively. The decrease of $1.1 million was primarily due to a $0.8 million increase in foreign currency transaction losses related to the remeasurement of foreign currency denominated assets and liabilities.

Net Loss

Y-mAbs reported a net loss for the three months ended June 30, 2024, of $9.2 million, or ($0.21) per basic and diluted share, compared to net loss of $6.3 million, or ($0.14) per basic and diluted share, for the three months ended June 30, 2023. For the six months ended June 30, 2024, the Company reported a net loss of $15.9 million, or ($0.36) per basic and diluted share, as compared to net loss of $12.7 million, or ($0.29) per basic and diluted share, for the six months ended June 30, 2023. The increase in net loss for the three and six months ended June 30, 2024 was primarily driven by the net $3.8 million in charges related to the Company’s two legal settlements, as described above.

Cash and Cash Equivalents

As of June 30, 2024, Y-mAbs had approximately $77.8 million in cash and cash equivalents which, together with anticipated DANYELZA product revenues, is expected to support operations as currently planned into 2027. This estimate reflects the Company’s current business plan that is supported by assumptions that may prove to be inaccurate. Cash utilized in the first half year of 2024 was $0.8 million, which was favorable to internal company forecasts.

2024 Financial Guidance

Management updates its full year 2024 guidance:

Webcast and Conference Call

Y-mAbs will host a conference call on Monday, August 12, 2024, at 8:00 a.m. ET. To participate in the call, please use the following dial-in information:

Investors (domestic):(877) 407-0792

Investors (international):(201) 689-8263

To access the live webcast, please use this link. Prior to the call and webcast, a slide presentation pertaining to the Company’s quarterly earnings will be made available on the Investor Relations section of the Y-mAbs website, www.ymabs.com, shortly before the call begins.

About Y-mAbs

Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy Platform (“PRIT”) and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline

includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy.

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, statements about our business model, including financial outlook for 2024 and beyond, including estimated operating expenses, cash burn and DANYELZA product revenue and sufficiency of cash resources and related assumptions; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; the Company’s plans and strategies, development, commercialization and product distribution plans; expectations with respect to the Company’s products and product candidates, including potential territory and label expansion of DANYELZA and the potential market opportunity related thereto and potential benefits thereof, and the potential of the SADA PRIT Technology and potential benefits and applications thereof; the Company’s mission of delivering better and safer therapies to patients; expectations relating to key anticipated development milestones, including potential expansion and advancement of commercialization and development efforts, including potential indications, applications and geographies, and the timing thereof; expectations with respect to current and future clinical and pre-clinical studies and the Company’s research and development programs, including with respect to timing and results; expectations related to the timing of the initiation and completion of regulatory submissions; additional product candidates and technologies; expectations regarding collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of cash and cash equivalents, and the need for, timing and amount of any future financing transaction; expectations with respect to the Company’s future financial performance; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will,” ‘‘would’,’ “guidance,” “goal,” “objective,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company’s financial condition and need for additional capital; the risks that actual results of the Company’s restructuring plan and revised business plan will not be as expected; risks associated with the Company’s development work; cost and success of the Company’s product development activities and clinical trials; the risks of delay in the timing of the Company’s regulatory submissions or failure to receive approval of its drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of product candidates; development of sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for products; the risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture; the Company’s ability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s common stock, risks associated with macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, the state of war between Israel and Hamas and the related risk of a larger regional conflict, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in the Company’s Annual Report on Form 10 K for the fiscal year ended December 31, 2023, the Company’s Quarterly Report on Form 10 Q for the quarterly period ended March 31, 2024, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, and future filings and reports by the Company. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

DANYELZA® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc.

Investor Contact:

Courtney Dugan

VP, Head of Investor Relations

cdu@ymabs.com

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Y-MABS THERAPEUTICS, INC.

Consolidated Balance Sheets

(unaudited)

(In thousands, except share and per share data)

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Y-MABS THERAPEUTICS, INC.

Consolidated Statements of Net Loss and Comprehensive Loss

(unaudited)

(In thousands, except share and per share data)

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Y-MABS THERAPEUTICS, INC.

Consolidated Statements of Cash Flows

(unaudited)

(In thousands)

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