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X4 Pharmaceuticals Reports First-Quarter 2024 Financial Results and Provides Corporate Updates

U.S. launch underway for XOLREMDI™ (mavorixafor) in WHIM syndrome

XOLREMDI Phase 3 4WHIM clinical trial data published online in Blood, the journal of the
American Society of Hematology

Presentation of interim clinical data from the ongoing mavorixafor Phase 2 trial in chronic neutropenia expected at a planned company investor event in June 2024

Conference call to be hosted today at 8:30 a.m. ET

BOSTON, May 07, 2024 (GLOBE NEWSWIRE) — X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the first quarter ended March 31, 2024 and highlighted key recent and upcoming expected milestones.

“With the recent U.S. approval of our first commercial product, XOLREMDI (mavorixafor) in WHIM syndrome, we are now deploying our experienced rare disease field force, engaging with payers to communicate the XOLREMDI value proposition, and, most importantly, enabling patient access to treatment as quickly as possible,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. “Concurrent with this approval, we received a Rare Pediatric Disease Priority Review Voucher, which we intend to monetize. In addition, we look forward to sharing data in June from our ongoing Phase 2 clinical trial exploring the use of mavorixafor in certain chronic neutropenic disorders.”

Recent and Key Anticipated Upcoming Milestones

First-Quarter 2024 Results

First-quarter 2024 expenses included greater costs due to commercial and medical team expansions as well as launch preparations across the commercial and medical organizations.

Conference Call and Webcast
The company will host a conference call and webcast today at 8:30 a.m. ET. The conference call can be accessed by dialing 1-877-451-6152 from the United States or 1-201-389-0879 internationally, followed by the conference ID: 13745487. The live webcast will be accessible through the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com. Following the completion of the call, a webcast replay will be available on the website.

About X4 Pharmaceuticals
X4 is delivering progress for patients by developing and commercializing innovative therapies for those with rare diseases of the immune system and significant unmet needs. Leveraging our expertise in CXCR4 and immune system biology, we have successfully developed mavorixafor, which has received U.S. approval as XOLREMDI™ (mavorixafor) capsules in its first indication. We are also evaluating the use of mavorixafor in additional potential indications. X4 corporate headquarters are in Boston, Massachusetts and our research center of excellence is in Vienna, Austria. For more information, please visit our website at www.x4pharma.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target,” or other similar terms or expressions that concern X4’s expectations, strategy, plans, or intentions. Forward-looking statements include, without limitation, statements regarding X4’s plans with respect to the potential to monetize the Priority Review Voucher; X4’s expected cash runway; X4’s commercialization plans and ongoing efforts with respect to XOLREMDI and the expected timing thereof; and other statements regarding X4’s future operations, financial performance, financial position, prospectus, objectives and other future events. Any forward-looking statements in this press release are based on management’s current expectations and beliefs. Actual events or results may differ materially from those expressed or implied by any forward-looking statements contained herein, including, without limitation, unanticipated costs and expenses may be greater than anticipated; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; delays, interruptions or failures in the manufacture and supply of our products; and the company’s ability to obtain additional funding to support its clinical development and commercial programs; and other risks and uncertainties, including those described in the section entitled “Risk Factors” in X4’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 21, 2024, and in other filings X4 makes with the SEC from time to time. X4 undertakes no obligation to update the information contained in this press release to reflect new events or circumstances, except as required by law.

X4 PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
     
    Three Months Ended
    March 31,
      2024       2023  
Operating expenses:        
Research and development   $ 19,854     $ 22,063  
Selling, general and administrative     17,435       7,241  
Total operating expenses     37,289       29,304  
Loss from operations     (37,289 )     29,304  
Other (expense) income, net     (14,458 )     5,288  
Loss before provision for income taxes     (51,747 )     (24,016 )
Provision for income taxes     19       4  
Net loss   $ (51,766 )   $ (24,020 )
Net loss per share attributable to common stockholders- basic and diluted   $ (0.26 )   $ (0.16 )
Weighted average common shares outstanding-basic and diluted     199,992       145,967  
                 
X4 PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
       
  March 31, 2024   December 31,
2023
Current assets:      
Cash and cash equivalents $ 60,493   $ 99,216
Marketable securities   20,376     15,000
Research and development incentive receivable   702     562
Prepaid expenses and other current assets   5,762     7,298
Total current assets   87,333     122,076
Property and equipment, net   742     745
Goodwill   17,351     17,351
Right-of-use assets   5,264     5,650
Other assets   1,492     1,436
Total assets $ 112,182   $ 147,258
Current liabilities:      
Accounts payable $ 8,935   $ 8,947
Accrued expenses   13,473     12,816
Current portion of lease liability   1,133     1,099
Total current liabilities   23,541     22,862
Long-term debt, including accretion, net of discount   54,824     54,570
Lease liabilities   2,318     2,612
Warrant liability   29,438     15,683
Other liabilities   1,025     432
Total liabilities   111,146     96,159
Total stockholders’ equity   1,036     51,099
Total liabilities and stockholders’ equity $ 112,182   $ 147,258
           

Company Contact:
José Juves
Head of Corporate & Patient Affairs
jose.juves@x4pharma.com

Investor Contact:
Daniel Ferry
Managing Director, LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576


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