Form 8-K
8-K — Kalaris Therapeutics, Inc.
Accession: 0001193125-26-343477
Filed: 2026-08-11
Period: 2026-08-11
CIK: 0001754068
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — d114296d8k.htm (Primary)
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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): August 11, 2026
KALARIS THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware
001-39409
83-1971007
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
Kalaris Therapeutics, Inc.
400 Connell Drive, Suite 5500
Berkeley Heights, New Jersey 07922
(Address of principal executive offices, including zip code)
(650) 249-2727
(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
Symbol(s)
Name of each exchange
on which registered
Common Stock, $0.0001 par value per share
KLRS
The Nasdaq Global 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 August 11, 2026, Kalaris Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended June 30, 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 August 11, 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: August 11, 2026
By:
/s/ Andrew Oxtoby
Name:
Andrew Oxtoby
Title:
Chief Executive Officer
EX-99.1
EX-99.1
Filename: d114296dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
Kalaris Reports Second Quarter 2026 Financial Results and Provides Business Updates
Patient dosing is ongoing in the Phase 1b/2 study of TH103; preliminary data anticipated in 1H 2027
Potential Phase 3 clinical trials remain on track for initiation by year-end 2027
$93.5 million in cash, cash equivalents and marketable securities as of June 30, 2026 is expected to fund operations into the
fourth quarter of 2027 and through key clinical milestones
BERKELEY HEIGHTS, N.J., August 11, 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 second quarter ended
June 30, 2026 and provided business updates.
“We made significant advances over the second quarter,” said Andrew Oxtoby, Chief Executive
Officer of Kalaris Therapeutics. “We successfully manufactured new batches of clinical material and are currently dosing patients in our Phase 1b/2 study of TH103 for neovascular Age-related Macular
Degeneration. We recently released expanded Phase 1a data for TH103 which continues to strengthen our confidence in potential TH103 differentiation. The additional data is consistent with the initial structural, functional and pharmacokinetic
findings and reinforces our belief that TH103 has the potential to offer a best-in-class treatment option for patients with neovascular AMD.”
Business Updates
•
Recently released Phase 1a data from expanded patient cohorts that reinforce the positive BCVA, OCT,
pharmacokinetic and time-to-retreatment findings observed in the original patient cohorts.
•
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 up to 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.
•
As previously announced, Kalaris expanded its leadership team with the hire of Liisa Bayko as Chief Financial
Officer. Ms. Bayko brings more than two decades of experience in biotechnology finance, strategy, and capital markets, most recently serving as Managing Director and Senior Biotechnology Analyst at Evercore ISI, where she was consistently
recognized as one of the industry’s top-ranked analysts covering small- and mid-cap biotechnology companies.
•
As announced recently, Kalaris appointed Laurie Keating to its Board of Directors. Ms. Keating brings
extensive experience as a biotechnology executive and board member to assist Kalaris in achieving its next phase of growth.
Financial Results for the Second Quarter Ended June 30, 2026
Cash, Cash Equivalents and Marketable Securities: As of June 30, 2026, Kalaris had cash, cash equivalents and marketable securities of
$93.5 million, compared with cash, cash equivalents and marketable securities 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 June 30, 2026 will be sufficient to fund its operations into the fourth quarter of 2027.
Research and Development Expenses: Research and development expenses were $9.0 million for the quarter ended June 30, 2026, compared
with $8.4 million for the quarter ended June 30, 2025. The increase was primarily attributable to an increase in Contract Research Organization and other clinical expenses as Kalaris opened additional investigational sites and enrolled
patients in its clinical program for TH103, offset by a decrease in expenses related to manufacturing and process development activities.
General and
Administrative Expenses: General and administrative expenses were $3.4 million for the quarter ended June 30, 2026, compared with $3.8 million for the quarter ended June 30, 2025. The decrease was primarily attributable
to decreased legal, accounting, and other professional fees.
Net Loss: For the quarter ended June 30, 2026, net loss was $11.5 million
compared with a net loss of $11.4 million for the quarter ended June 30, 2025. The total number of shares of common stock outstanding as of June 30, 2026 was 23,804,981.
About TH103
TH103 is an investigational
dual-targeting biologic with the potential to be best-in class for neovascular and exudative retinal diseases. TH103 was engineered by VEGF scientific discoverer Dr. Napoleone Ferrara to achieve extended
intraocular retention with enhanced VEGF inhibition through optimized binding to VEGF receptor 1 ligands and concurrent heparan sulfate proteoglycan (HSPG) anchoring. It is a fully humanized, recombinant fusion protein designed for intravitreal
delivery, with potential applications as a treatment for exudative and/or neovascular retinal diseases, such as neovascular Age-related Macular Degeneration (nAMD), diabetic eye disease and retinal vein
occlusion. TH103 is currently being investigated in a Phase 1b/2 clinical trial in patients with nAMD.
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, 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 and 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 Securities and Exchange Commission, 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, LLC
+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
June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
Operating expenses
Research and development
$
9,018
$
8,440
$
16,590
$
14,470
General and administrative
3,368
3,816
7,629
8,140
Total operating expenses
12,386
12,256
24,219
22,610
Loss from operations
(12,386
)
(12,256
)
(24,219
)
(22,610
)
Total other income, net
871
906
1,848
1,064
Net loss
$
(11,515
)
$
(11,350
)
$
(22,371
)
$
(21,546
)
Net loss per share, basic and diluted
$
(0.48
)
$
(0.61
)
$
(0.94
)
$
(1.89
)
Weighted-average shares outstanding, basic and diluted
23,797,306
18,701,286
23,760,665
11,417,677
Kalaris Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(unaudited, in thousands)
June 30,
December 31,
2026
2025
Assets
Current assets
Cash, cash equivalents and marketable securities
$
93,538
$
117,982
Other current assets
2,383
827
Total current assets
95,921
118,809
Other assets
3,618
2,927
Total assets
$
99,539
$
121,736
Liabilities and stockholders’ equity
Current liabilities
$
8,738
$
9,714
Long-term liabilities
33,129
33,208
Total liabilities
41,867
42,922
Total stockholders’ equity
57,672
78,814
Total liabilities and stockholders’ equity
$
99,539
$
121,736
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