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XFOR on Nasdaq

X4 Pharmaceuticals, Inc

In its 2026 annual report the company says: “We are a biopharmaceutical company developing and commercializing novel therapeutics for the treatment of rare hematology diseases. Our primary asset is mavorixafor, a small molecule delivered in a capsule for oral dosing as a selective antagonist of the chemokine receptor, CXCR4.”5 It is headquartered in Cambridge, United States.2 Its shares trade on Nasdaq under the symbol XFOR.2

$2.56 up 0.12 (4.69%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

Compare with C4 Therapeutics (United States), Precision BioSciences or Scholar Rock Holding Corp, or pick any stock.

  • TickerXFOR on Nasdaq2
  • IndustryBiological Products, (No Diagnostic Substances)2
  • HeadquartersCambridge, United States2
  • Incorporated inDE4
  • Business address61 North Beacon Street, 4Th Floor, Boston, Ma 021344
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • Legal formCorporation2
  • LEI549300R0UFVPXWP86U942
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 48519822

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We are a biopharmaceutical company developing and commercializing novel therapeutics for the treatment of rare hematology diseases. Our goal is to build a profitable company by generating income from products we develop and commercialize, either alone or with partners.5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-247.4%Operating margin6
-225.6%Net margin6
1273.2%Revenue growth, 20256
-42.5%Return on equity6
0.40×Debt to equity6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

License and Other Revenue brought in 81% of the revenue X4 Pharmaceuticals, Inc broke down this way in fiscal 2025.

  1. License and Other Revenue$28.6M681%
  2. Product$6.5M619%up 155% from 2024
Products and services by year
Products and services202320242025
License and Other Revenue$0$0$28.6M
Product$0$2.6M$6.5M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue7¢$5.8M
  • Research and development93¢$72.7M
  • Income tax0¢$41.0K

Out of $35.1M in revenue.6 The company lost money this year.

Financial statements

Revenue7896$35.1M in 2025
0$10.0M$20.0M$30.0M$40.0M2019: $0$020192020: $3.0M$3.0M20202021: $0$020212022: $0$020222023: $0$020232024: $2.6M$2.6M20242025: $35.1M$35.1M2025+1273%
Operating income781096-$86.9M in 2025+68% since 2019
-$150.0M-$100.0M-$50.0M02019: -$51.7M-$51.7M20192020: -$59.9M-$59.9M2020+16%2021: -$85.1M-$85.1M2021+42%2022: -$87.6M-$87.6M2022+3%2023: -$107.5M-$107.5M2023+23%2024: -$36.4M-$36.4M2024−66%2025: -$86.9M-$86.9M2025+139%
Net income781096-$79.2M in 2025+50% since 2019
-$150.0M-$100.0M-$50.0M02019: -$52.8M-$52.8M20192020: -$62.1M-$62.1M2020+18%2021: -$88.7M-$88.7M2021+43%2022: -$93.9M-$93.9M2022+6%2023: -$101.2M-$101.2M2023+8%2024: -$37.5M-$37.5M2024−63%2025: -$79.2M-$79.2M2025+111%

Every line of the income statement as filed: the last 3 fiscal years, latest first.6

Period ending2025-12-312024-12-312023-12-31
Total revenue$35.1M$2.6M$0
Cost of revenue$5.8M$797.0K$0
Research and development$72.7M$81.6M$72.0M
General and administrative$43.5M$61.5M$35.5M
Gain on sale of non-financial asset$0-$105.0M$0
Total operating expense$122.0M$39.0M$107.5M
Loss from operations-$86.9M-$36.4M-$107.5M
Interest income$4.6M$5.8M$4.6M
Interest expense-$8.9M-$8.8M-$5.8M
Change in fair value of warrant liability$12.8M$1.9M$7.1M
Other (expense) income, net-$753.0K$332.0K$554.0K
Total other income (expense), net$7.7M-$739.0K$6.4M
Loss before provision for income taxes-$79.2M-$37.1M-$101.1M
Provision for income taxes$41.0K$310.0K$78.0K
Net loss-$79.2M-$37.5M-$101.2M
Net loss per share attributable to common stockholdersbasic-$1.87-$5.59-$17.07
Weighted average shares of common stock outstandingbasic42.3M shares6.7M shares5.9M shares
Net loss per share attributable to common stockholdersdiluted-$1.87-$5.59-$17.07
Weighted average shares of common stock outstandingdiluted42.3M shares6.7M shares5.9M shares
Change in net unrealized gains on marketable debt securities$13.0K-$3.0K$0
Comprehensive loss-$79.2M-$37.5M-$101.2M

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Corporate structure

X4 Pharmaceuticals, Inc sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of X4 Pharmaceuticals, Inc

  • X4 Pharmaceuticals, Inc Cambridge, Massachusetts, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What X4 Pharmaceuticals, Inc reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$1.4M6 Dec 31, 2025$2.7M6 Dec 31, 2024−47.2%
Accumulated depreciation$1.2M6 Dec 31, 2025$1.9M6 Dec 31, 2024−35.3%
Property and equipment, net$182.0K6 Dec 31, 2025$776.0K6 Dec 31, 2024−76.5%
Operating-lease assets (leased space)$1.4M6 Dec 31, 2025$4.1M6 Dec 31, 2024−65.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$217.0M6 Dec 31, 2025$55.7M6 Dec 31, 2024+289.7%
Debt securities available for sale$35.9M6 Dec 31, 2025$46.4M6 Dec 31, 2024−22.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$17.4M6 Dec 31, 2025$17.4M6 Dec 31, 20240%
Finite-lived intangibles, gross$10.5M6 Dec 31, 2025$10.5M9 Dec 31, 20240%
Accumulated amortization$1.3M6 Dec 31, 2025$500.0K9 Dec 31, 2024+160.0%
Finite-lived intangibles, net$9.2M6 Dec 31, 2025$10.0M6 Dec 31, 2024−7.5%

Inventory

ItemLatestA year beforeChange
Inventory, total$2.8M9 Dec 31, 2024$09 Dec 31, 2023
Raw materials$1.4M6 Dec 31, 2025$1.5M6 Dec 31, 2024−9.6%
Work in process$2.5M6 Dec 31, 2025$608.0K6 Dec 31, 2024+314.1%
Finished goods$579.0K6 Dec 31, 2025$680.0K6 Dec 31, 2024−14.9%

Properties, in its own words

We lease approximately 28,000 square feet of office space at 61 North Beacon Street, 4th Floor, Boston, Massachusetts, which serves as our corporate headquarters. The lease expires on November 30, 2026. The base monthly payment on the lease is approximately $96 thousand as of December 31, 2025, not including operating expenses, certain utilities, taxes and insurance for which we are responsible. We have the right to sublease the premises, subject to landlord consent.

Item 2 of the 10-K filed Mar 17, 2026.5

Leadership

Who has led X4 Pharmaceuticals, Inc, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Rene Russo2018
  2. Paula Ragan2019–now

Chair

  1. Adam R. Craig2025–now

President

  1. Rene Russo2018
  2. Paula Ragan2019–2025
  3. John Volpone2025–now

Chief financial officer

  1. Adam S. Mostafa2019–2025
  2. David Kirske2025–now

Chief operating officer

  1. Mary Dibiase2021–now
20202025
Board members and other officers (31)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorFrancoise J. De Craecker named Jul 19, 2022 to Aug 25, 202551

Former names

  • Arsanis, Inc.Sep 24, 2010 to Mar 13, 20194

Timeline

  1. Oct 8, 20268-K Entered a material agreement; Ended a material agreement; New debt or obligation52
  2. Sep 9, 20268-K Other events53
  3. Sep 8, 20268-K Other events54
  4. Jul 1, 20268-K Executive or director change; Regulation FD disclosure55
  5. May 13, 20268-K Executive or director change; Shareholder vote56
  6. May 12, 20268-K Executive or director change; Shareholder vote57
  7. Nov 5, 20258-K Results of operations58
  8. Oct 27, 20258-K Entered a material agreement59
  9. Sep 17, 20258-K Exit or restructuring costs; Executive or director change; Regulation FD disclosure60
  10. Aug 25, 20258-K Executive or director change61
  11. Aug 13, 20258-K Entered a material agreement; Unregistered sale of shares; Other events62
  12. Aug 12, 20258-K Entered a material agreement; Unregistered sale of shares; Executive or director change63
  13. Mar 14, 2019New chief executive Paula Ragan becomes CEO15
  14. Mar 9, 2018New chief executive Rene Russo becomes CEO16

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.69) a share, on Nov 5, 2025.64

When it reported results

  1. Nov 5, 2025Reported quarterly or annual results58
  2. May 1, 2025Reported quarterly or annual results65
  3. Mar 25, 2025Reported quarterly or annual results66
  4. Nov 13, 2024Reported quarterly or annual results67
  5. Aug 8, 2024Reported quarterly or annual results68
  6. May 7, 2024Reported quarterly or annual results69
  7. Mar 21, 2024Reported quarterly or annual results70
  8. Nov 9, 2023Reported quarterly or annual results71

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

436 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 85 major events, 154 insider forms, 62 large holders, 3 private raises, 112 other. The latest 20:

  1. Oct 8, 20268-K EDGAR
  2. Oct 7, 2026SCHEDULE 13G/A EDGAR
  3. Oct 5, 20264 EDGAR
  4. Oct 1, 2026144 EDGAR
  5. Sep 21, 2026SCHEDULE 13G EDGAR
  6. Sep 9, 20268-K EDGAR
  7. Sep 8, 20268-K EDGAR
  8. Aug 14, 2026SCHEDULE 13G/A EDGAR
  9. Aug 14, 2026SCHEDULE 13G/A EDGAR
  10. Aug 13, 2026144 EDGAR
  11. Aug 13, 20264 EDGAR
  12. Aug 13, 20264 EDGAR
  13. Aug 13, 2026144 EDGAR
  14. Aug 6, 202610-Q EDGAR
  15. Jul 30, 2026SCHEDULE 13G EDGAR
  16. Jul 1, 20264 EDGAR
  17. Jul 1, 20264 EDGAR
  18. Jul 1, 20263 EDGAR
  19. Jul 1, 20268-K EDGAR
  20. May 15, 2026SCHEDULE 13G/A EDGAR

The 436 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

75 open-market trades by officers, directors and large owners since October 2021: 5 buys and 70 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 12, 2026Volpone JohnPresidentSale24,576$4.44$109.1KForm 4
Aug 12, 2026Craig Adam RExecutive ChairmanSale47,436$4.44$210.6KForm 4
Jun 30, 2026KIRSKE DAVIDChief Financial OfficerSale8,543$4.26$36.4KForm 4
May 12, 2026KIRSKE DAVIDChief Financial OfficerSale16,961$4.29$72.8KForm 4
Oct 23, 2025Craig Adam RExecutive ChairmanBuy86,206$2.90$250.0KForm 4
May 16, 2025Baldry MarkChief Commercial OfficerBuy1,032$2.48$2.6KForm 4
Jan 24, 2025Ragan PaulaPresident and CEOSale76,473$0.45$34.4KForm 4
Jan 24, 2025Mostafa Adam S.Chief Financial OfficerSale74,773$0.45$33.6KForm 4
Jan 24, 2025Baldry MarkChief Commercial OfficerSale29,159$0.45$13.1KForm 4
Jan 24, 2025DiBiase MaryChief Operating OfficerSale22,258$0.45$10.0KForm 4
Jan 24, 2025Arbet-Engels ChristopheChief Medical OfficerSale11,624$0.45$5.2KForm 4
Nov 15, 2024Baldry MarkChief Commercial OfficerBuy13,404$0.34$4.6KForm 4
Nov 15, 2024Ragan PaulaPresident and CEOSale31,897$0.39$12.4KForm 4
Oct 15, 2024Ragan PaulaPresident and CEOSale31,897$0.56$17.9KForm 4
Oct 7, 2024Mostafa Adam S.Chief Financial OfficerSale230,645$0.55$126.9KForm 4
Oct 7, 2024Baldry MarkChief Commercial OfficerSale11,127$0.58$6.5KForm 4
Oct 7, 2024Ragan PaulaPresident and CEOSale239,436$0.55$131.7KForm 4
Oct 7, 2024DiBiase MaryChief Operating OfficerSale67,695$0.57$38.6KForm 4
Oct 7, 2024Taveras ArthurChief Scientific OfficerSale76,920$0.56$43.1KForm 4
Sep 9, 2024DiBiase MaryChief Operating OfficerSale2,642$0.66$1.7KForm 4

All 75 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Adam R. CraigM.D., Ph.D., M.B.A. Executive Chairman$179.6K$6.7M95
2025John VolponeM.B.A., President and Chief Operating Officer51$176.5K$6.7M95
2025David KirskeChief Financial Officer, Treasurer and Corporate Secretary72$194.2K$4.6M95
2025Paula Ragan, Ph.D.Former President and Chief Executive Officer$420.2K$2.6M95
2024Paula Ragan, Ph.D.Former President and Chief Executive Officer$654.2K$2.1M95

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Aug 13, 2025Raised $85 million in a private offering of equity Form D: 18 investors so far Form D
  2. May 18, 2023Raised $65 million in a private offering of equity Form D: $65 million offered in all Form D
  3. Jul 6, 2022Raised $55.7 million in a private offering of equity Form D: $111.5 million offered in all Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 88. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Morgan Stanley9,461,279$44.2M0.0%−5,713
Fmr LLC8,321,657$38.9M0.0%+218,257
Bain Capital Life Sciences Investors, LLC7,967,454$37.2M2.2%No change
Perceptive Advisors LLC7,933,491$37.0M0.6%+1,195,843
Kalehua Capital Management LLC7,445,680$34.8M11.1%No change
Saturn V Capital Management LP6,973,343$32.6M4.7%+516,697
Empery Asset Management, LP6,930,591$32.4M37.4%−2,013,527
Deep Track Capital, LP5,878,757$27.5M0.4%−460,778
BlackRock, Inc.5,554,906$25.9M0.0%+4,343,112
Nantahala Capital Management, LLC4,898,936$22.9M0.7%+2,449,468
Vanguard Capital Management LLC3,715,859$17.4M0.0%+218,247
Rosalind Advisors, Inc.3,214,766$15.0M5.6%No change
Braidwell LP2,922,754$13.6M0.5%−350,200
Blackstone Inc.2,681,922$12.5M0.0%No change
Trails Edge Capital Partners, LP2,571,478$12.0M1.9%No change
Bvf Inc/il2,233,742$10.4M0.3%No change
Geode Capital Management, LLC2,098,047$9.8M0.0%+1,158,321
Venrock Adviser, LLC1,934,253$9.0M0.3%+1,603,728
Samsara Biocapital, LLC1,395,587$6.5M0.5%−436,979
State Street Corp1,296,017$6.1M0.0%+892,483
Woodline Partners LP1,001,095$4.7M0.0%No change
Goldman Sachs Group Inc916,536$4.3M0.0%+34,402
Northern Trust Corp652,849$3.0M0.0%+474,614
Vanguard Fiduciary Trust Co572,038$2.7M0.0%+91,305
Vanguard Portfolio Management LLC542,128$2.5M0.0%New

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How X4 Pharmaceuticals, Inc is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARX4 Pharmaceuticals, Inc1
  • CIK0001501697
  • Employer ID (EIN)27-31816085
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address61 North Beacon Street, 4Th Floor, Boston, MA 021341
  • Phone857-529-83001
  • Shares outstanding99,146,743 as of Jul 31, 202612
  • Public float$14.9M as of Jun 30, 20255
  • AuditorPricewaterhouseCoopers LLP, Boston, Massachusetts, US PCAOB ID 2385
  • On EDGAR sinceSep 24, 20101
  • Filings815 in all: 4 (255), 8-K (141), 3 (59), 144 (42), SC 13G/A (37), 10-Q (26), SC 13G (22), CORRESP (19)1
    All 43 form types

    S-8 (17), UPLOAD (17), 4/A (14), EFFECT (14), SCHEDULE 13G/A (14), SCHEDULE 13G (13), 424B5 (12), S-3 (12), DEF 14A (11), DEFA14A (11), D (10), 10-K (9), 424B3 (7), SC 13D (7), SC 13D/A (7), 8-K/A (6), 425 (5), ARS (3), PRE 14A (3), CT ORDER (2), D/A (2), FWP (2), S-1/A (2), SCHEDULE 13D (2), SCHEDULE 13D/A (2), 424B1 (1), 8-A12B (1), CERTNAS (1), DRS (1), DRS/A (1), DRSLTR (1), S-1 (1), S-3/A (1), S-4 (1), S-4/A (1)

  • Latest filingsAnnual report (10-K) Mar 17, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Mar 20, 2026
    Latest 8-K (8-K) Oct 8, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareXFORThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 17, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks X4 Pharmaceuticals, Inc names in Item 1A of its 10-K filed Mar 17, 2026: 65 risks under these headings, as written.5

  • Risks Related to Our Financial Position and Need for Additional Capital
  • Until we achieve profitability, our operations will require substantial additional funding. Our history of recurring losses and anticipated future expenditures could raise substantial doubts about our ability to continue as a going concern. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate any product development programs or commercialization efforts.
  • We have incurred significant losses and have not generated significant revenue from product sales since our inception. We expect to continue to incur losses for the foreseeable future and we may never achieve or maintain profitability.
  • Raising additional capital may cause dilution to our investors, restrict our operations or require us to relinquish rights to our technologies or product candidates. Future debt obligations may expose us to risks that could adversely affect our business, operating results and financial condition and may result in further dilution to our stockholders.
  • Changes in estimates regarding fair value of intangible assets may result in an adverse impact on our results of operations.
  • Risks Related to Development of Our Product Candidates
  • We have not generated significant revenues from product sales since inception and may never become profitable. We may never be able to generate meaningful revenues from sales of our product candidates and approved commercial products at levels or on timing necessary to support our investment and goals.
  • If the commercial opportunity for mavorixafor in chronic neutropenic disorders is smaller than we anticipate, our potential future revenue from mavorixafor for the treatment of any of these diseases may be adversely affected and our business may suffer.
  • We depend almost entirely on the success of our future product candidate, mavorixafor. We cannot be certain that we will be able to obtain regulatory approval for, or successfully commercialize, mavorixafor for disorders other than WHIM, including CN, or any other product candidate.
  • We may develop mavorixafor, and future product candidates, in combination with other therapies, which could expose us to additional risks.
  • The regulatory review and approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, including additional indications for mavorixafor, our business will be substantially harmed.
  • We depend on license agreements with Genzyme and others to permit us to use patents and patent applications. Termination of these rights or the failure to comply with obligations under these agreements could materially harm our business and prevent us from developing or commercializing our product candidates.
The other 55 risks
  • The results of clinical trials may not support our product candidate claims.
  • Product development involves a lengthy and expensive process, with uncertain outcomes. Delays in or failure to complete any of our clinical trials may lead to a delay in the submission of our marketing approval application and jeopardize our ability to potentially receive approvals and generate revenues from the sale of our products.
  • Product candidates may cause undesirable side effects that could delay or prevent their marketing approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any, including marketing withdrawal.
  • We may fail to enroll a sufficient number of patients in our clinical trials in a timely manner, which could delay or prevent clinical trials of our product candidates.
  • Results of earlier clinical trials may not be predictive of the results of later-stage clinical trials.
  • Interim top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Risks Related to the Marketing and Commercialization of Our Product Candidates
  • Our product candidates that have received regulatory approval may still face future development and regulatory difficulties and any approved products will be subject to extensive post-approval regulatory requirements. Additionally, our approved product, XOLREMDI, and future approved products, if any, could be subject to marketing restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability.
  • Our commercial success depends upon attaining significant market acceptance of our approved product or product candidates, if approved, among hospitals, physicians, patients and healthcare payors.
  • If we are unable to maintain effective sales and marketing capabilities or to selectively enter into agreements with third parties to sell and market our product or product candidates, we may not be successful in commercializing our product candidates that have been approved.
  • We face substantial competition that may result in others discovering, developing or commercializing products before or more successfully than we do.
  • Even though we have obtained FDA approval for one of our product candidates, we may never obtain approval for our product candidates outside of the United States, which would limit our market opportunities and could harm our business.
  • Significant political, trade, regulatory developments, economic downturns, inflation, increases in interest rates, natural disasters, public health crises, geopolitical events, such as the war in Ukraine and in Gaza and other circumstances beyond our control, could have a material adverse effect on our business, financial condition or results of operations.
  • If we seek approval to commercialize our product candidates outside of the United States, a variety of risks associated with international operations could harm our business.
  • Any products that we commercialize may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which would harm our business.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit the commercialization of any product candidates we may develop.
  • Risks Related to Government Regulation
  • Our relationships with customers and third-party payors are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to significant penalties, including administrative, civil and criminal penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product or product candidates and affect the prices we may obtain.
  • We are subject to anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses, which could adversely affect its business, results of operations and financial condition.
  • Risks Related to Our Dependence on Third Parties
  • We have limited experience manufacturing our product or product candidates on a large clinical or commercial scale and
  • have no manufacturing facility. We are currently dependent on a single third-party manufacturer for the manufacture of the API for mavorixafor, and a single manufacturer of mavorixafor finished drug product capsules. If we experience problems with these third parties, the manufacturing of mavorixafor could be delayed, which could harm our results of operations.
  • We rely on third-party CROs to conduct our preclinical studies and clinical trials. If these CROs do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
  • Disruptions in our supply chain could delay the commercial sale of our product.
  • Our employees, principal investigators, CROs, CMOs and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
  • We have established, and may seek to selectively establish in the future, collaborations, and, if we are unable to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • We may depend on such collaborations for the development and commercialization of our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of our product candidates.
  • Risks Related to Our Intellectual Property
  • Recent laws and rulings by U.S. courts make it difficult to predict how patents will be issued or enforced in our industry.
  • If we are unable to protect our intellectual property rights, our competitive position could be harmed.
  • We could be required to incur significant expenses to obtain our intellectual property rights, and we cannot ensure that we will obtain meaningful patent protection for our product candidates.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.
  • From time to time, we may need to rely on licenses to proprietary technologies, which may be difficult or expensive to obtain or we may lose certain licenses which may be difficult to replace.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • Our trade secrets are difficult to protect and if we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Our Business Operations, Employee Matters and Managing Growth
  • Our future success depends on our ability to retain executives and to attract, retain and motivate key personnel in a competitive environment for skilled biotechnology personnel.
  • We may experience difficulties in managing the reduction in size of our organization due to our restructuring activities, and we may not achieve the expected benefits of such activities.
  • The pharmaceutical industry is highly competitive and is subject to rapid and significant technological change, which could render our technologies and products obsolete or uncompetitive.
  • Our internal information technology systems and infrastructure, or those of our contractors, consultants, or other third parties, may be subject to cyber attacks, or data breaches, compromises, or other security incidents, which could result in additional costs, loss of revenue, significant liabilities, harm to our reputation, and disruption of our development programs and operations.
  • Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.
  • We may be subject to adverse legislative or regulatory changes in tax laws that could negatively impact our financial condition.
  • Our term loan contains restrictions that limit our flexibility in operating our business.
  • Risks Related to Ownership of Our Common Stock
  • Although we are currently in compliance with the Nasdaq continued listing requirements, if we are unable to maintain compliance with Nasdaq’s listing requirements, our securities could be delisted, which could affect our common stock’s market price and liquidity and reduce our ability to raise capital.
  • Our stock price has been and is likely to continue to be volatile and fluctuate substantially.
  • “Penny stock” rules may make buying or selling our securities difficult which may make our stock less liquid and make it harder for investors to buy and sell our securities.
  • If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.
  • We do not anticipate that we will pay any cash dividends in the foreseeable future.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to decline.
  • We are a “smaller reporting company” and cannot predict if the reduced reporting requirements applicable to smaller reporting companies will make our securities less attractive to investors.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Legal proceedings

From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceedings against us that we believe could have a material adverse effect on our business, operating results or financial condition.

The opening of Item 3, Legal Proceedings.5

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