KLRS on Nasdaq

Kalaris Therapeutics, Inc.

In its 2026 annual report the company says: “We are a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases with major unmet medical needs. We are developing TH103, a novel, clinical stage anti-vascular endothelial growth factor drug, specifically engineered to achieve extended intraocular retention with enhanced VEGF inhibition in patients with exudative and/or neovascular retinal diseases.”4 It is headquartered in Berkeley Heights, New Jersey.1 Its shares trade on Nasdaq under the symbol KLRS.1

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Last updated Oct 21, 2026.

Overview

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  • TickerKLRS on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersBerkeley Heights, New Jersey1
  • Incorporated inDE2
  • Business address400 Connell Drive, Suite 5500, Berkeley Heights, Nj 079222
  • Filer categoryNon-accelerated filer, Smaller reporting company2

We are a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases with major unmet medical needs.4 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 2019

-16182.4%Operating margin5
-14447.9%Net margin5
-$20.5MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2019

  • Research and development100¢$16.2M

Out of $165.0K in revenue.5 The company lost money this year.

Financial statements

Every line of the income statement as filed: the last 2 fiscal years, latest first.8

Period ending2025-12-312024-12-31
General and administrative (including $322 and $230 for a related party)$15.4M$6.7M
Total operating expenses$46.2M$51.7M
Loss from operations-$46.2M-$51.7M
Change in fair value of derivative liabilities (including $1,165 and $2,039 for a related party)$1.2M$2.1M
Interest expense (including $1,384 and $2,656 for a related party)-$1.4M-$2.7M
Loss on extinguishment and on issuance of convertible promissory notes (including $169 and $34,692 for a related party)-$186.0K-$38.0M
Other income, net$2.7M$188.0K
Total other income (expense), net$2.7M-$17.4M
Net loss-$43.4M-$69.2M
Net loss per share attributable to common stockholders - basic-$2.85-$51.77
Net loss per share attributable to common stockholders - diluted-$2.85-$51.77
Weighted-average shares outstanding - basic15.3M shares1.3M shares
Weighted-average shares outstanding - diluted15.3M shares1.3M shares
Unrealized gain on marketable securities, net of tax$6.0K$0
Total other comprehensive income$6.0K$0
Comprehensive loss-$43.4M-$69.2M
Research and development expenses$30.8M$45.0M
Change in fair value of tranche liability$365.0K$21.0M
Interest expense$1.4M$2.7M

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Corporate structure

Kalaris Therapeutics, Inc. sits at the top of its group. 4 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Kalaris Therapeutics, Inc.

  • Samsara BioCapital, L.P. Filed SCHEDULE 13D/A on Kalaris Therapeutics, Inc., latest May 22, 2026 (4 filings since Mar 25, 2025)
  • RTW INVESTMENTS, LP Filed SCHEDULE 13G on Kalaris Therapeutics, Inc., latest Feb 17, 2026
  • Invus Global Management, LLC Filed SCHEDULE 13G/A on Kalaris Therapeutics, Inc., latest Jul 29, 2025 (2 filings since Aug 2, 2024)
  • EcoR1 Capital, LLC Filed SCHEDULE 13G/A on Kalaris Therapeutics, Inc., latest May 15, 2025 (3 filings since Feb 1, 2024)
  • Gilead Sciences Filed SCHEDULE 13G/A on Kalaris Therapeutics, Inc., latest Mar 20, 2025 (3 filings since Aug 8, 2022)
  • Octagon Capital Advisors LP Filed SC 13G on Kalaris Therapeutics, Inc., latest Oct 11, 2024
  • Artal International S.C.A. Filed SC 13G/A on Kalaris Therapeutics, Inc., latest Feb 9, 2024 (2 filings since Aug 5, 2022)
  • FMR LLC Filed SC 13G/A on Kalaris Therapeutics, Inc., latest Feb 9, 2024 (3 filings since Feb 9, 2022)
  • John Robert Wilson Filed SC 13G/A on Kalaris Therapeutics, Inc., latest Jan 9, 2024 (2 filings since Jan 9, 2024)
  • ElevateBio, LLC Filed SC 13D/A on Kalaris Therapeutics, Inc., latest Aug 5, 2022
  • Globeways Holdings II Ltd Filed SC 13D on Kalaris Therapeutics, Inc., latest Aug 5, 2022
  • Kalaris Therapeutics, Inc. Berkeley Heights, New Jersey
    • AlloVir International Designated Activity Company Subsidiary · Ireland
    • AlloVir Italia S.R.L. Subsidiary · Italy
    • Kalaris Tx, Inc. Subsidiary · Delaware, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Kalaris Therapeutics, 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
Operating-lease assets (leased space)$1.5M8 Dec 31, 2025$08 Dec 31, 2024

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$98.1M8 Dec 31, 2025$1.6M8 Dec 31, 2024+5882.6%
Marketable securities, current$19.9M8 Dec 31, 2025$08 Dec 31, 2024

Properties, in its own words

We lease office space in Berkeley Heights, New Jersey under a lease agreement that is expected to terminate in December 2031, which serves as our corporate headquarters. We have the option to extend the lease term twice, each for an additional three years. We believe these facilities will be adequate for the foreseeable future and that suitable additional or substitute space will be available as and when needed.

Item 2 of the 10-K filed Mar 17, 2026.4

Leadership

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

Board members and other officers (26)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • AlloVir International Designated Activity Company Ireland3
  • AlloVir Italia S.R.L. Italy3
  • Kalaris Tx, Inc. Delaware3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • Allovir, Inc.May 22, 2019 to Mar 12, 20252
  • ViraCyte, Inc.Oct 2, 2018 to Oct 2, 20182

Timeline

  1. Aug 11, 20268-K Results of operations37
  2. Jul 20, 20268-K Executive or director change38
  3. Jul 17, 20268-K Regulation FD disclosure; Other events39
  4. Jul 6, 20268-K Executive or director change40
  5. Jun 4, 20268-K Shareholder vote41
  6. May 12, 20268-K Results of operations42
  7. Apr 10, 20268-K Executive or director change43
  8. Mar 17, 20268-K Results of operations44
  9. Mar 9, 20268-K Regulation FD disclosure45
  10. Dec 18, 20258-K Entered a material agreement; Unregistered sale of shares; Other events46
  11. Dec 17, 20258-K Regulation FD disclosure; Other events47
  12. Nov 12, 20258-K Results of operations48
  13. May 18, 2021New chief executive Diana Brainard becomes CEO10
  14. Jul 30, 2020New chief executive David Hallal becomes CEO11

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.64) a share, on Nov 12, 2025.49

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results37
  2. May 12, 2026Reported quarterly or annual results42
  3. Mar 17, 2026Reported quarterly or annual results44
  4. Nov 12, 2025Reported quarterly or annual results48
  5. Aug 13, 2025Reported quarterly or annual results50
  6. May 14, 2025Reported quarterly or annual results51
  7. Mar 18, 2025Reported quarterly or annual results52
  8. Nov 2, 2023Reported quarterly or annual results53

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

Filings

548 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 55 major events, 266 insider forms, 23 large holders, 183 other. The latest 20:

  1. Aug 28, 20264 EDGAR
  2. Aug 11, 202610-Q EDGAR
  3. Aug 11, 20268-K EDGAR
  4. Aug 3, 20264 EDGAR
  5. Aug 3, 20263 EDGAR
  6. Jul 27, 20263 EDGAR
  7. Jul 20, 20264 EDGAR
  8. Jul 20, 20263 EDGAR
  9. Jul 20, 20268-K EDGAR
  10. Jul 17, 20268-K EDGAR
  11. Jul 6, 20268-K EDGAR
  12. Jun 4, 20264 EDGAR
  13. Jun 4, 20264 EDGAR
  14. Jun 4, 20264 EDGAR
  15. Jun 4, 20264 EDGAR
  16. Jun 4, 20264 EDGAR
  17. Jun 4, 20264 EDGAR
  18. Jun 4, 20264 EDGAR
  19. Jun 4, 20268-K EDGAR
  20. May 22, 2026SCHEDULE 13D/A EDGAR

The 548 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

198 open-market trades by officers, directors and large owners since October 2021: 5 buys and 193 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 20, 2026Samsara BioCapital, L.P.10% ownerBuy244,300$4.83$1.2MForm 4
Mar 20, 2026Hagen Brett RChief Accounting OfficerSale1,915$6.72$12.9KForm 4
Dec 18, 2025Samsara Opportunity Fund, L.P.10% ownerBuy479,847$10.42$5.0MForm 4
Mar 26, 2025Hagen Brett RChief Accounting OfficerSale907$8.97$8.1KForm 4
Feb 21, 2025Sinha VikasSee RemarksSale303$10.08$3.1KForm 4
Feb 21, 2025Hagen Brett RChief Accounting OfficerSale96$10.08$968Form 4
Feb 21, 2025Miller EdwardGeneral CounselSale106$10.08$1.1KForm 4
Jan 23, 2025Miller EdwardGeneral CounselSale52$9.50$494Form 4
Jan 23, 2025Hagen Brett RChief Accounting OfficerSale36$9.50$342Form 4
Jan 23, 2025Sinha VikasSee RemarksSale129$9.50$1.2KForm 4
Jan 10, 2025Miller EdwardGeneral CounselSale409$0.44$180Form 4
Jan 10, 2025Hagen Brett RChief Accounting OfficerSale332$0.44$146Form 4
Jan 10, 2025Sinha VikasSee RemarksSale979$0.44$431Form 4
Nov 19, 2024Hagen Brett RChief Accounting OfficerSale554$0.55$305Form 4
Nov 19, 2024Sinha VikasSee RemarksSale3,186$0.55$1.8KForm 4
Nov 19, 2024Miller EdwardGeneral CounselSale432$0.55$238Form 4
Nov 19, 2024Brainard DianaChief Executive OfficerSale8,706$0.55$4.8KForm 4
Nov 5, 2024Brainard DianaChief Executive OfficerSale10,609$0.86$9.1KForm 4
Nov 5, 2024Miller EdwardGeneral CounselSale2,272$0.86$2.0KForm 4
Nov 5, 2024Hagen Brett RChief Accounting OfficerSale1,655$0.86$1.4KForm 4

All 198 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
2025Andrew Oxtoby52$537.7K$2.6M65
2025Chief Medical Officer$457.7K$1.7M65
2025Brett Hagen$397.3K$1.4M65
2025Vikas Sinha$81.1K$1.1M65
2025Former Chief Financial Officer$80.8K$1.1M65
2024President and Chief Executive Officer$394.2K$2.0M65
2024Chief Accounting Officer and AlloVir’s former Chief Accounting Officer$385.3K$796.3K65
2024AlloVir’s Former Chief Executive OfficerPresident and Chief Financial Officer$375.4K$544.4K65

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 57. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Samsara Biocapital, LLC12,881,175$52.4M4.3%−66,906
Rtw Investments, LP1,300,000$5.3M0.0%No change
Alyeska Investment Group, L.P.572,687$2.3M0.0%No change
Siren, L.L.C.435,798$1.8M0.0%No change
Vanguard Capital Management LLC398,712$1.6M0.0%+143,364
Ikarian Capital, LLC360,000$1.5M0.2%No change
UBS Group AG262,131$1.1M0.0%+255,947
Renaissance Technologies LLC149,351$607.9K0.0%+83,200
Marshall Wace, Llp139,201$566.5K0.0%+71,322
Geode Capital Management, LLC114,037$464.3K0.0%+26,492
Woodline Partners LP100,000$407.0K0.0%No change
ADAR1 Capital Management, LLC100,000$407.0K0.0%No change
WHI TRUST Co LLC97,493$396.8K0.3%No change
Raymond James Financial Inc97,164$395.5K0.0%−21,723
Citadel Advisors LLC95,772$389.8K0.0%New
Boothbay Fund Management, LLC92,261$375.5K0.0%No change
Verdad Advisers, LP80,297$326.8K0.3%New
Morgan Stanley72,326$294.4K0.0%+33,982
Vanguard Fiduciary Trust Co66,179$269.3K0.0%+29,462
BlackRock, Inc.54,442$221.6K0.0%+18,399
Belpointe Asset Management LLC40,000$162.8K0.0%No change
Fortis Capital Advisors, LLC40,000$162.8K0.0%No change
Pale Fire Capital SE39,626$161.3K0.0%New
Squarepoint Ops LLC38,775$157.8K0.0%−998
Bridgeway Capital Management, LLC32,500$132.3K0.0%+10,000

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

SEC filer profile

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

  • Name on EDGARKalaris Therapeutics, Inc.1
  • CIK0001754068
  • Employer ID (EIN)83-19710074
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • 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 address400 Connell Drive, Suite 5500, Berkeley Heights, NJ 079221
  • Phone650-249-27271
  • Shares outstanding23,804,981 as of Aug 4, 20267
  • Public float$12.6M as of Jun 30, 20254
  • AuditorDeloitte & Touche LLP, San Francisco, California PCAOB ID 34; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceOct 2, 20181
  • Filings698 in all: 4 (320), 144 (118), 8-K (71), 3 (35), 10-Q (19), CORRESP (13), 425 (11), SC 13G/A (8)1
    All 48 form types

    DEF 14A (7), SC 13G (7), UPLOAD (7), 10-K (6), DEFA14A (6), S-8 (6), 4/A (5), EFFECT (5), 424B3 (4), ARS (4), SCHEDULE 13G/A (4), 424B5 (3), S-3 (3), SCHEDULE 13D/A (3), 3/A (2), D (2), POS AM (2), PRE 14A (2), S-4/A (2), SC 13D (2), SEC STAFF LETTER (2), 10-K/A (1), 10-Q/A (1), 424B4 (1), 5 (1), 8-A12B (1), 8-A12B/A (1), CERT (1), DEL AM (1), DRS (1), POSASR (1), RW (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3ASR (1), S-4 (1), SC 13D/A (1), SCHEDULE 13D (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 17, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Aug 11, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareKLRSNasdaq

From the cover page of the 10-K filed Mar 17, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Kalaris Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 17, 2026: 72 risks under these headings, as written.4

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred significant losses since our inception. We expect to continue to incur significant expenses and operating losses for the foreseeable future, and may never achieve or maintain profitability.
  • We have never generated revenue from product sales and may never achieve or maintain profitability.
  • We are heavily dependent on the success of our lead product candidate, TH103, which will require significant clinical testing before we can seek marketing approval and potentially generate commercial sales. If TH103 does not receive marketing approval or is not successfully commercialized, or if there is significant delay in doing so, our business will be harmed.
  • We will need substantial additional funding for our continuing operations. If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • We have identified material weaknesses in our internal control over financial reporting and we may identify additional material weaknesses in the future or fail to maintain an effective system of internal control over financial reporting, which may result in material misstatements of our financial statements.
  • Our ability to use our net operating loss carryforwards (“NOLs”) and research and development tax credit carryforwards to offset future taxable income may be subject to certain limitations.
  • Risks Related to Research and Development of Our Product Candidates
  • We are early in our development efforts. If we are unable to commercialize TH103 or any product candidate we may develop or experience significant delays in doing so, our business will be materially harmed.
  • Drug development involves a lengthy and expensive process, with an uncertain outcome. The results of preclinical studies and early clinical trials may not be predictive of future results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of TH103 or any other product candidate we may develop.
The other 62 risks
  • We may conduct clinical trials at sites outside the United States. The Food and Drug Administration (the “FDA”) may not accept data from trials conducted in such locations, and the conduct of trials outside the United States could subject us to additional delays and expense.
  • The results of early-stage clinical trials and preclinical studies may not be predictive of future results. Initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials.
  • Interim and preliminary results from our clinical trials that we announce or publish from time to time may change as more participant data becomes available and are subject to audit and verification procedures, which could result in material changes in the final data.
  • If we experience delays or difficulties in the enrollment of patients in our clinical trials for TH103 or any other product candidate we develop, our receipt of necessary marketing approvals could be delayed or prevented.
  • If dose limiting toxicities, serious adverse events, undesirable side effects or unexpected characteristics are identified during the development of TH103 or any other product candidate we may develop, we may need to abandon or limit our further clinical development of those product candidates.
  • If TH103 or any other product candidate we may develop receives marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the drug could be compromised.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Risks Related to the Commercialization of Our Product Candidates
  • Even if TH103 or any other product candidate we may develop receives marketing approval, we may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, and the market opportunity for any of our product candidates, if approved, may be smaller than we estimate.
  • If we are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing our product candidates if and when they are approved.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do, thus rendering our products non-competitive, obsolete or reducing the size of the market for our products.
  • Clinical trial and product liability lawsuits against us could divert our resources and could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • Risks Related to Our Dependence on Third Parties
  • We rely, and expect to continue to rely, on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, which may prevent or delay our ability to seek or obtain marketing approval for or commercialize our product candidates or otherwise harm our business. If we are not able to maintain these third-party relationships or if these arrangements are terminated, we may have to alter our development and commercialization plans and our business could be adversely affected.
  • Manufacturing biologics is complex, and we may experience manufacturing problems that result in delays in our development or future commercialization programs.
  • We rely on third-party CDMOs for the manufacture of both drug substance and finished drug product of our product candidates for preclinical and clinical testing and expect to continue to do so for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.
  • We currently rely, and may in the future rely, on single-source suppliers for certain materials and components used in the manufacturing of our product candidates.
  • We may enter into collaborations with third parties for the research, development and commercialization of certain of our product candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates and our business could be adversely affected.
  • We may seek to establish additional collaborations. If we are not able to establish or maintain additional collaborations, on commercially reasonable terms, we may have to alter our development and commercialization plans and our business could be adversely affected.
  • Any acquisitions or in-license transactions that we complete could disrupt our business, cause dilution to our stockholders or reduce our financial resources.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain sufficient intellectual property protection for our technology, our product candidates, and product candidates we may develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully develop and, if approved, commercialize our product candidates may be adversely affected.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
  • We may become involved in third-party claims of intellectual property infringement, which may delay or prevent the development and commercialization of our current and any future product candidates.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property rights, or the patents or other intellectual property rights of any licensors, which could be expensive, time consuming, and unsuccessful, and could result in a court or administrative body finding our patents to be invalid or unenforceable.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • Changes in United States patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
  • 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, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties or claims asserting ownership of what we regard as our own intellectual property.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • If we fail to comply with our obligations under any license, collaboration or other agreements, such agreements may be terminated, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates.
  • We may not be able to license or acquire new or necessary intellectual property rights or technology from third parties.
  • Risks Related to Regulatory and Legal Compliance Matters
  • Even if we complete the necessary preclinical studies and clinical trials for our product candidates, the regulatory approval process is expensive, time-consuming and uncertain and we may not receive approvals for the commercialization of some or all of our product candidates in a timely manner, or at all.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent our medicines from being marketed in such jurisdictions and any of its medicines that are approved for marketing in such jurisdiction will be subject to risk associated with foreign operations.
  • Any of our product candidates for which we obtain marketing approval in the future may be subject to post-marketing regulatory requirements and could be subject to post-marketing restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products following approval.
  • 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, it may become subject to significant liability.
  • If approved, our product candidates that are licensed and regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • Our relationships with healthcare providers, physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.
  • Recently enacted and future legislation may increase the difficulty and cost for us to commercialize our product candidates, if approved, and affect the prices we may obtain.
  • The insurance coverage and reimbursement status of newly approved products is uncertain. Product candidates, if approved, may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain coverage and adequate reimbursement for any product candidates for which we obtain approval could limit our ability to market those products and decrease our ability to generate revenue.
  • The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if and when approved.
  • We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • Changes in and uncertainty surrounding U.S. and internal trade policy could have a material adverse impact on our business, financial condition and results of operations.
  • Risks Related to Employee Matters and Managing Growth
  • Our future success depends on our ability to retain key executives and experienced scientists and to attract, retain and motivate qualified personnel.
  • We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our internal computer systems, or those of our collaborators, vendors, suppliers, contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
  • Our employees, independent contractors, including principal investigators, consultants and vendors and any third parties we may engage in connection with research, development, regulatory, manufacturing, quality assurance and other pharmaceutical functions and commercialization may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
  • Risks Related to the Ownership of Our Common Stock
  • The market price of our common stock has been and is expected to continue to be volatile.
  • We incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.
  • We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control, which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • Our amended and restated bylaws designates certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
  • We do not anticipate paying any cash dividends in the foreseeable future.
  • We do not know whether an active, liquid and orderly trading market will develop for our common stock or what the market price of our common stock will be and, as a result, it may be difficult for our stockholders to sell shares of our common stock.
  • Transfers of our securities utilizing Rule 144 of the Securities Act may be limited.
  • Our possible disposal of certain of AlloVir’s historical assets and operations, the discontinuation of AlloVir’s product development programs and the Merger made AlloVir subject to the SEC requirements applicable to reporting shell company business combinations. As a result, we are subject to more stringent reporting requirements, offering limitations and resale restrictions.
  • Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to the 2020 Plan or the 2019 Plan, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
  • Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
  • Our executive officers, directors and principal stockholder, Samsara LP, have the ability to control or significantly influence all matters submitted to our stockholders for approval.
  • Samsara LP, our principal stockholder, beneficially owns greater than 50% of our outstanding shares of capital stock, which has caused us to be deemed a “controlled company” under the rules of Nasdaq.

Legal proceedings

From time to time, we may become subject to arbitration, litigation or claims arising in the ordinary course of business.

Litigation Related to the Merger

Two complaints have been filed by purported AlloVir stockholders as individual actions against AlloVir and the members of its board of directors in the Supreme Court of the State of New York, New York County, captioned Keller v. AlloVir, Inc. et al., No. 650989/2025 (N.Y. Sup. Ct. Feb. 20, 2025), and Morgan v. AlloVir, Inc. et al., No. 650965/2025 (N.Y. Sup. Ct. Feb. 19, 2025) (the “Complaints”). The Complaints allege that the proxy statement/prospectus describing the transaction between Legacy Kalaris and AlloVir misrepresented and/or omitted certain purportedly material information, and assert claims for negligent misrepresentation and concealment and negligence under New York common law. The Complaints seek various remedies including, among other things, an order enjoining the consummation of the merger, requiring the defendants to file an amended proxy statement/prospectus, rescinding the merger or granting rescissory damages, and awarding costs, including plaintiff’s attorneys’ fees and experts’ fees, and other relief the court may deem just and proper. AlloVir and Legacy Kalaris deny the allegations in the Complaints and deny that any further disclosure beyond that already contained in the proxy statement/prospectus was required under applicable law.

The opening of Item 3, Legal Proceedings.4

Sources

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