UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
Kalaris Therapeutics, Inc.
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
Not applicable
(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 |
Name of each exchange | ||
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 May 12, 2026, Kalaris Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and 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 filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filling.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release issued by Kalaris Therapeutics, Inc. on May 12, 2026 | |
| 104 | Cover Page 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.
| KALARIS THERAPEUTICS, INC. | ||||||
| Date: May 12, 2026 | By: | /s/ Andrew Oxtoby | ||||
| Name: | Andrew Oxtoby | |||||
| Title: | Chief Executive Officer | |||||
Exhibit 99.1
Kalaris Reports First Quarter 2026 Financial Results and Provides Business Updates
Patient screening now underway in the Phase 1b/2 study with the latest drug product batch on track to be
available to support upcoming dosing; preliminary data anticipated in 1H 2027
Planned Phase 3 clinical trials remain on track for 2027 year-end initiation
$104.9 million in cash, cash equivalents and marketable securities as of March 31, 2026 is expected to fund
operations into the fourth quarter of 2027 and through key clinical milestones
BERKELEY HEIGHTS, N.J., May 12, 2026 (GLOBE NEWSWIRE)—Kalaris Therapeutics, Inc. (Nasdaq: KLRS) (“Kalaris”), a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases, today announced financial results for the first quarter ended March 31, 2026 and provided business updates.
“I am happy to report that new batches of clinical material have been manufactured and are undergoing packaging and labeling, and we are currently screening patients for dosing in our Phase 1b/2 study of TH103 for neovascular Age-related Macular Degeneration,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “Our Phase 1b/2 multiple ascending dose trial is designed to accelerate TH103’s clinical development and inform dose selection for potential future Phase 3 development, and we look forward to sharing data from this ongoing trial in the first half of 2027.”
Q1 2026—Business Updates
| • | On February 26th, Dean Eliott, MD, presented previously shared positive initial Phase 1a data at the 49th Annual Meeting of the Macula Society. |
| • | New manufacturing batch completed including process enhancements that have further reduced already low levels of process impurities. |
| • | Kalaris is currently conducting a Phase 1b/2, multi-ascending dose, dose-finding study evaluating four monthly loading doses of TH103. The study aims to assess the safety and efficacy of repeat doses of TH103 at different dose levels and to identify the optimal dose and regimen for potential Phase 3 development. |
| • | Preliminary data from the Phase 1b/2 study is expected in the first half of 2027. |
Financial Results for the First Quarter Ended March 31, 2026
Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026, Kalaris had cash, cash equivalents and marketable securities of $104.9 million, compared with cash and cash equivalents of $118.0 million as of December 31, 2025. The decrease in cash, cash equivalents and marketable securities was primarily a result of cash used in operating activities during the period. Kalaris expects that its cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund its operations into the fourth quarter of 2027.
Research and Development Expenses: Research and development expenses were $7.6 million for the quarter ended March 31, 2026, compared with $6.0 million for the quarter ended March 31, 2025. The increase was primarily attributable to an increase in CRO and other clinical expenses as Kalaris opened additional investigational sites and enrolled patients in our clinical program.
General and Administrative Expenses: General and administrative expenses were $4.3 million for the quarter ended March 31, 2026, compared with $4.3 million for the quarter ended March 31, 2025.
Net Loss: For the quarter ended March 31, 2026, net loss was $10.9 million compared with a net loss of $10.2 million for the quarter ended March 31, 2025. The total number of shares of common stock outstanding as of March 31, 2025 was 22,992,291.
About Kalaris
Kalaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases. Founded by renowned scientist Dr. Napoleone Ferrara, whose pioneering research led to the development of anti-VEGF therapy, the company is committed to advancing novel therapeutic approaches for patients with sight-threatening retinal conditions with major unmet medical needs.
For more information, visit www.kalaristx.com.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this press release, including statements regarding the strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management of Kalaris; the therapeutic potential of TH103 for neovascular Age-related Macular Degeneration and other exudative and neovascular retinal diseases; the anticipated timeline for reporting data from the ongoing Phase 1b/2 clinical trial of TH103 and initiating Phase 3 clinical trials; plans to advance TH103 into Phase 3 clinical trials and to develop TH103 for additional indications; the sufficiency of Kalaris’ cash resources for the period anticipated, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are based on current expectations and beliefs of the management of Kalaris as well as assumptions made by, and information currently available to, the management of Kalaris and are subject to risks and uncertainties. There can be no assurance that future developments affecting Kalaris will be those that it has anticipated. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: risks associated with the clinical development and regulatory approval of TH103, including potential delays in the completion of clinical trials; expectations regarding the therapeutic benefits, clinical potential and clinical development of TH103; the timing of and Kalaris’ ability to enroll patients in clinical trials; whether results from preclinical studies and initial data from early clinical trials will be predictive of the final results of the clinical trials or future trials; dependence on third parties for the development and manufacture of TH103; risks related to the inability of Kalaris to obtain sufficient additional capital to
continue to advance its product candidate; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from any product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; the ability to obtain, maintain, and protect intellectual property rights related to product candidates; changes in regulatory requirements and government incentives; Kalaris’ competitive position and expectations regarding developments and projections relating to its competitors and any competing therapies that are or become available; the risk of involvement in current and future litigation; and such other factors as are set forth in Kalaris’ public filings with the SEC, including, but not limited to, those described under the heading “Risk Factors”. Kalaris may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release, and Kalaris does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Kalaris Therapeutics Investor Contact:
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com
ir@kalaristx.com
Kalaris Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
| Three Months Ended March 31, |
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| 2026 | 2025 | |||||||
| Operating expenses |
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| Research and development |
$ | 7,572 | $ | 6,030 | ||||
| General and administrative |
4,261 | 4,324 | ||||||
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| Total operating expenses |
11,833 | 10,354 | ||||||
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| Loss from operations |
(11,833) | (10,354) | ||||||
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| Total other income, net |
977 | 158 | ||||||
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| Net loss |
$ | (10,856) | $ | (10,196) | ||||
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| Net loss per share, basic and diluted |
$ | (0.46) | $ | (2.52) | ||||
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| Weighted-average shares outstanding, basic and diluted |
23,723,618 | 4,053,140 | ||||||
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Kalaris Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(unaudited, in thousands)
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Assets |
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| Current assets |
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| Cash, cash equivalents and short-term marketable securities |
$ | 97,215 | $ | 117,982 | ||||
| Other current assets |
1,250 | 827 | ||||||
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| Total current assets |
98,465 | 118,809 | ||||||
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| Long-term marketable securities |
7,654 | — | ||||||
| Other assets |
3,686 | 2,927 | ||||||
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| Total assets |
$ | 109,805 | $ | 121,736 | ||||
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| Liabilities and stockholders’ equity |
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| Current liabilities |
$ | 8,079 | $ | 9,714 | ||||
| Long-term liabilities |
33,169 | 33,208 | ||||||
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| Total liabilities |
41,248 | 42,922 | ||||||
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| Total stockholders’ equity |
68,557 | 78,814 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 109,805 | $ | 121,736 | ||||
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