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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): November 8, 2024

Y-MABS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

    

001-38650

    

47-4619612

(State or other jurisdiction of
incorporation or organization)

 

(Commission
File Number)

 

(I.R.S. Employer
Identification No.)

230 Park Avenue

Suite 3350

New York, New York 10169

(Address of principal executive offices) (Zip Code)

(646) 885-8505

(Registrant’s telephone number, include area code)

N/A

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

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:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

Title of each class:

    

Trading Symbol

    

Name of each exchange on which registered:

Common Stock, $0.0001 par value

 

YMAB

 

NASDAQ Global Select Market

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).

Emerging growth company 

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.  

Item 2.02. Results of Operations and Financial Condition.

On November 8, 2024, Y-mAbs Therapeutics, Inc., announced its financial results for the quarter ended September 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1.

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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

    

Description

 

 

99.1

 

Press Release, dated November 8, 2024.

 

 

 

104

 

Interactive Data File (embedded within the Inline XBRL document).

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.

 

Y-MABS THERAPEUTICS, INC.

 

 

 

Date: November 8, 2024

By:

/s/ Michael Rossi

 

 

Michael Rossi

 

 

President and Chief Executive Officer

Exhibit 99.1

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

Reported Total DANYELZA net product revenues of $18.5 million for the third quarter of 2024
Entered into exclusive license and distribution agreement with Nobelpharma for DANYELZA in Japan recognizing an upfront payment of $2.0 million in the fourth quarter of 2024
Achieved extension of primary DANYELZA U.S. patent through February 2034
Continued geographic expansion of DANYELZA with new market revenues recorded in the third quarter from Turkey
Management reiterates Full Year 2024 guidance around Total Net Revenue, Operating Expenses, and Cash Flow Investment
The Company will host a conference call on Friday, November 8, 2024, at 8:00 a.m. ET

New York, NY, November 8, 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 third quarter ended September 30, 2024.

“The third quarter of this year was one of continued focus and execution across our DANYELZA commercial business and our novel SADA PRIT radiopharmaceutical platform development pipeline,” said Michael Rossi, President and Chief Executive Officer. “Physician usage of DANYELZA in the U.S. continues to remain very strong for patients with relapsed/refractory high-risk neuroblastoma. In addition, we continue to drive ex-U.S. market expansion with our new exclusive license and distribution agreement with Nobelpharma in Japan and the launch of our named patient program in Turkey. From a SADA PRIT pipeline standpoint, we expect to complete Part A of our GD2-SADA Phase 1 trial this year and present that data in the first quarter of next year.”

Third Quarter 2024 and Recent Corporate Highlights

Effective October 29, 2024, Y-mAbs entered into an exclusive license and distribution agreement with Nobelpharma for the development and commercialization of DANYELZA in Japan. Pursuant to the agreement, the Company recognized an upfront payment of $2.0 million in the fourth quarter of 2024. Y-mAbs is entitled to receive up to $31.0 million in product and commercial milestone payments in addition to profit sharing on the commercial sales of DANYELZA, if successfully approved and commercialized in Japan.
Y-mAbs received notification of the accepted patent extension for DANYELZA, US 9,315,585, through February 2034.
The Companys named patient program for DANYELZA launched in Turkey with partner TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm FZ-LLC.
Y-mAbs presented new clinical and preclinical data from studies evaluating anti-GD2 therapy naxitamab and the Companys first program from its Self-Assembly DisAssembly Radioimmunotherapy Technology Platform (SADA PRIT), GD2-SADA, respectively, in neuroblastoma in poster presentations at the American Academy of Cancer Research Special Conference in the Advanced in Pediatric Cancer Research on September 6-7, 2024 in Toronto, Canada.
The Company entered into a lease agreement for a term of ten years and nine months for office space in Princeton, New Jersey, where the Company plans to transition its headquarters in the first half of 2025 upon being provided access to the location.


Graphic

Financial Results

Revenues

Total net revenues for the quarter ended September 30, 2024 were $18.5 million, a 10% decline over total net revenues for the quarter ended September 30, 2023 of $20.5 million, which included $0.5 million in license revenue, primarily driven by decreased net product revenues in both U.S. and ex-U.S. markets.

Total net revenues for the nine months ended September 30, 2024 were relatively flat compared to the nine months ended September 30, 2023, at $61.2 million and $61.5 million, respectively. The slight decrease was driven by a $0.7 million decrease in ex-U.S. DANYELZA net product revenues in the nine months ended September 30, 2024, which was partially offset by increased net product revenues in the U.S.

The Company’s U.S. DANYELZA net product revenues were $15.3 million and $16.1 million for the three months ended September 30, 2024 and 2023, respectively, representing a 5% decline, primarily due to an unfavorable price mix, partially offset by increased volume of 5% vial growth over the same time period.

Y-mAbs’ ex-U.S. DANYELZA net product revenues for the quarter ended September 30, 2024 were $3.1 million, a 19% decline from $3.9 million in the comparable period in 2023, primarily driven by decreased volume from Western Europe partially offset by volume increases in the remaining ex-U.S. territories.

As of September 30, 2024, Y-mAbs had delivered DANYELZA to 68 centers across the U.S. since initial launch, with three new accounts added in the U.S. in the third quarter of 2024. During the quarter ended September 30, 2024, approximately 65% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center (“MSK”), compared to 67% in the second quarter ended June 30, 2024.

The Company did not have license revenue for the quarter ended September 30, 2024. The Company had license revenues of $0.5 million for the nine months ended September 30, 2024, from its Latin America distribution partner, Adium, related to price approval for DANYELZA in Brazil from the Brazilian Medicines Market Regulation Chamber. The Company had license revenues of $0.5 million for the quarter and nine months ended September 30, 2023 from Adium, recognized upon the September 2023 achievement of marketing authorization for DANYELZA in Mexico.

Operating Costs and Expenses

Cost of Goods Sold

Cost of goods sold were $2.3 million and $2.6 million for the quarter ended September 30, 2024 and 2023, respectively. Cost of goods sold were $7.4 million and $9.3 million for the nine months ended September 30, 2024 and 2023, respectively. Cost of goods sold included lower vial volumes of 1% and 37% in the three and nine months ended September 30, 2024, compared to the same periods in 2023, respectively. Cost of goods sold also included $0.4 million and $0.8 million inventory write-downs in the three and nine months ended September 30, 2023, respectively.

The Company defines gross margin as net product revenues less cost of goods sold divided by net product revenues. The Company’s gross margins was relatively unchanged in the quarter ended September 30, 2024, compared to the comparable periods in 2023. The Company’s gross margins increased in the nine months ended September 30, 2024, compared to the comparable period in 2023, due to a favorable gross profit mix from revenue in international regions, particularly Eastern Asia that had an inventory stocking order in the nine months ended September 30, 2024, and inventory write-downs during the comparable periods in 2023, as noted above.

Research and Development

Research and development expenses were $11.2 million for the quarter ended September 30, 2024, a decrease of $4.2 million when compared with the same period in 2023. The decrease in research and development expenses was primarily attributable to the recognition of $4.1 million of milestone and license acquisition costs related to the Company’s SADA license agreement during the three months ended September 30, 2023, as certain time-based clinical milestones within the agreement were determined to be probable based on the availability of necessary data and the assessment of clinical progress in the third quarter of 2023.


Graphic

For the nine months ended September 30, 2024, research and development expenses were $36.8 million, a decrease of $4.0 million when compared with the same period in 2023. The decrease in the research and development expenses was primarily attributable to recognition of $4.1 million of milestone and license acquisition costs related to the Company’s SADA license agreement during the nine months ended September 30, 2023, as noted above.

Selling, General, and Administrative

Selling, general, and administrative expenses were $13.6 million and $10.2 million for the quarters ended September 30, 2024 and 2023, respectively. The $3.4 million increase in the selling, general and administrative expenses was primarily attributable to a $1.2 million increase related to the Company’s former Chief Financial Officer’s separation and consulting agreements, $1.1 million increase in personnel cost, inclusive of stock-based compensation and $0.5 million in professional and consulting fees.

For the nine months ended September 30, 2024, selling, general, and administrative expenses were $42.3 million, an increase of $8.5 million compared with the same period in 2023. The increase was primarily attributable to a net impact of $3.6 million related to the settlement of a shareholder class-action lawsuit in the nine months ended September 30, 2024, and an additional legal settlement of $0.2 million in the nine months ended September 30, 2024. The increase also includes a $1.2 million increase related to our former Chief Financial Officer’s separation and consulting agreements, $1.1 million increase in personnel cost inclusive of stock-based compensation and $0.8 million in professional and consulting fees.

Interest and Other Income

Interest and other income were $1.9 million for the quarter ended September 30, 2024, as compared to $0.2 million for the quarter ended September 30, 2023. The increase of $1.7 million was primarily due to a $1.9 million of foreign currency transactional gains in the three months ended September 30, 2024, partially offset by a $0.2 million decrease in interest earned on the Company’s cash and cash equivalents.

For the nine months ended September 30, 2024 and 2023, the interest and other income was $3.0 and $2.4 million, respectively. The increase of $0.6 million was primarily due to $1.1 million of foreign currency transactional gains, partially offset by a $0.3 million decrease in interest earned on the Company’s cash and cash equivalents.

Net Loss

Y-mAbs reported a net loss for the quarter ended September 30, 2024, of $7.0 million, or ($0.16) per basic and diluted share, compared to a net loss of $7.7 million, or ($0.18) per basic and diluted share, for the quarter ended September 30, 2023. The decrease in net loss for the quarter ended September 30, 2024 was primarily driven by decreased operating expenses and foreign currency transactional gains, partially offset by decreased net product revenue.

For the nine months ended September 30, 2024, the Company reported a net loss of $22.9 million, or ($0.52) per basic and diluted share, as compared to net loss of $20.4 million, or ($0.47) per basic and diluted share, for the nine months ended September 30, 2023. The increase in net loss for the nine months ended September 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 September 30, 2024, Y-mAbs had approximately $68.1 million in cash and cash equivalents. Cash utilized in the first three quarters of 2024 was $10.5 million, which was favorable relative to the Company’s internal forecasts, and is on track to meet its corporate guidance for the full year 2024.

2024 Financial Guidance

Management reiterates its full year 2024 guidance:

Anticipated Total Net Revenues expected to be between $87 million and $95 million;
Anticipated Operating Expenses expected to remain between $115 million and $120 million;
Anticipated Total Annual Cash Investment expected to remain between $15 million and $20 million; and
Cash and Cash Equivalents anticipated to continue to support operations as currently planned into 2027.

Graphic

Webcast and Conference Call

Y-mAbs will host a conference call on Friday, November 8, 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, use of cash and cash equivalents and DANYELZA product revenue and sufficiency of cash resources and related assumptions; expectations with respect to the Company’s future financial performance; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; expectations with respect to the Company’s plans and strategies, development, regulatory, commercialization and product distribution plans, including the timing thereof; 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; 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 regarding collaborations or strategic partnerships and the potential benefits thereof; 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 or its partners’ 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; risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture as well as regulatory submissions; the Company’s ability to enter into new partnerships or to recognize the anticipated benefits from its existing partnerships; 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


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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, and the Company’s Quarterly Report on Form 10-Q for the quarterly periods ended March 31, 2024, and September 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


Graphic

Y-MABS THERAPEUTICS, INC.

Consolidated Balance Sheets

(unaudited)

(In thousands, except share and per share data)

September 30, 

    

December 31, 

2024

2023

ASSETS

 

  

 

  

CURRENT ASSETS

 

  

 

  

Cash and cash equivalents

$

68,122

$

78,637

Accounts receivable, net

19,916

22,454

Inventories

9,557

5,065

Other current assets

 

1,462

 

4,955

Total current assets

 

99,057

 

111,111

Property and equipment, net

 

53

 

224

Operating lease right-of-use assets

1,075

1,412

Intangible assets, net

2,366

2,631

Other assets

 

18,366

 

12,491

TOTAL ASSETS

$

120,917

$

127,869

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

  

 

  

LIABILITIES

 

  

 

  

Accounts payable

$

7,878

$

6,060

Accrued liabilities

 

16,638

 

13,166

Operating lease liabilities, current portion

776

902

Total current liabilities

 

25,292

20,128

Accrued milestones

 

2,000

 

5,375

Operating lease liabilities, long-term portion

299

517

Other liabilities

897

864

TOTAL LIABILITIES

28,488

26,884

 

  

 

  

STOCKHOLDERS’ EQUITY

 

  

 

  

Preferred stock, $0.0001 par value, 5,500,000 shares authorized and none issued at September 30, 2024 and December 31, 2023

 

 

Common stock, $0.0001 par value, 100,000,000 shares authorized at September 30, 2024 and December 31, 2023; 44,766,802 and 43,672,112 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively

 

4

 

4

Additional paid-in capital

 

572,807

 

558,002

Accumulated other comprehensive income

 

(36)

 

449

Accumulated deficit

 

(480,346)

 

(457,470)

TOTAL STOCKHOLDERS’ EQUITY

 

92,429

 

100,985

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

120,917

$

127,869


Graphic

Y-MABS THERAPEUTICS, INC.

Consolidated Statements of Net Loss and Comprehensive Loss

(unaudited)

(In thousands, except share and per share data)

Three months ended September 30, 

    

Nine months ended September 30, 

2024

2023

    

2024

2023

REVENUES

Product revenue, net

$

18,461

$

19,954

$

60,690

$

60,956

License revenue

500

500

500

Total revenues

18,461

20,454

61,190

61,456

OPERATING COSTS AND EXPENSES

 

 

  

 

  

 

 

Cost of goods sold

2,248

2,595

7,359

9,327

License royalties

 

 

50

 

50

 

50

Research and development

11,168

15,358

36,776

40,831

Selling, general, and administrative

 

13,613

 

10,200

 

42,270

 

33,721

Total operating costs and expenses

 

27,029

 

28,203

 

86,455

 

83,929

Loss from operations

 

(8,568)

 

(7,749)

 

(25,265)

 

(22,473)

OTHER INCOME, NET

 

  

 

  

 

  

 

  

Interest and other income

 

1,916

 

189

 

2,995

 

2,400

LOSS BEFORE INCOME TAXES

(6,652)

(7,560)

(22,270)

(20,073)

Provision for income taxes

346

187

606

366

NET LOSS

$

(6,998)

$

(7,747)

$

(22,876)

$

(20,439)

Other comprehensive income/(loss)

 

  

 

  

 

  

 

  

Foreign currency translation

 

(1,083)

 

806

 

(485)

 

518

COMPREHENSIVE LOSS

$

(8,081)

$

(6,941)

$

(23,361)

$

(19,921)

Net loss per share attributable to common stockholders, basic and diluted

$

(0.16)

$

(0.18)

$

(0.52)

$

(0.47)

Weighted average common shares outstanding, basic and diluted

 

44,626,943

 

43,620,532

 

44,145,183

 

43,651,536


Graphic

Y-MABS THERAPEUTICS, INC.

Consolidated Statements of Cash Flows

(unaudited)

(In thousands)

Nine months ended September 30, 

2024

2023

CASH FLOWS FROM OPERATING ACTIVITIES

 

  

 

  

 

Net loss

$

(22,876)

$

(20,439)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

  

Depreciation and amortization

 

433

 

574

Stock-based compensation

 

11,480

 

11,330

Foreign currency and other transactions

 

(456)

 

(369)

Changes in assets and liabilities:

 

 

Accounts receivable, net

2,538

(6,343)

Inventories

(4,492)

(411)

Other current assets

 

3,493

 

2,671

Other assets

 

(5,875)

 

(3,735)

Accounts payable

 

2,274

 

(6,196)

Accrued liabilities and other

 

(363)

 

3,722

NET CASH USED IN OPERATING ACTIVITIES

 

(13,844)

 

(19,196)

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

  

 

  

Proceeds from exercised stock options

3,325

NET CASH PROVIDED BY FINANCING ACTIVITIES

 

3,325

 

Effect of exchange rates on cash and cash equivalents

 

4

 

5

NET DECREASE IN CASH AND CASH EQUIVALENTS

 

(10,515)

 

(19,191)

Cash and cash equivalents at the beginning of period

 

78,637

 

105,762

Cash and cash equivalents at the end of period

$

68,122

$

86,571

SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES

 

  

 

  

Right-of-use assets obtained in exchange for lease obligations

$

320

$

636

Acquisition of treasury shares upon repayment of secured promissory note

$

$

480


v3.24.3
Document and Entity Information
Nov. 08, 2024
Document and Entity Information [Abstract]  
Document Type 8-K
Document Period End Date Nov. 08, 2024
Entity File Number 001-38650
Entity Registrant Name Y-MABS THERAPEUTICS, INC.
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 47-4619612
Entity Address State Or Province NY
Entity Address, Address Line One 230 Park Avenue
Entity Address, Adress Line Two Suite 3350
Entity Address, City or Town New York
Entity Address, Postal Zip Code 10169
City Area Code 646
Local Phone Number 885-8505
Title of 12(b) Security Common Stock, $0.0001 par value
Trading Symbol YMAB
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001722964
Amendment Flag false
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false

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