Kalaris posts Q2 2026 loss and extends cash runway

Kalaris Therapeutics, Inc. reported second quarter 2026 results and provided updates on its lead retinal therapy candidate TH103.

Rhea-AI Filing Summary

Kalaris Therapeutics, Inc. reported second quarter 2026 results and provided updates on its lead retinal therapy candidate TH103. Patient dosing is ongoing in a Phase 1b/2 trial in neovascular age-related macular degeneration, with preliminary data anticipated in the first half of 2027, and potential Phase 3 trials remain on track for initiation by year-end 2027.

As of June 30, 2026, Kalaris held $93.5 million in cash, cash equivalents and marketable securities, which it expects will fund operations into the fourth quarter of 2027 and through key clinical milestones. For the quarter ended June 30, 2026, research and development expenses were $9.0 million and general and administrative expenses were $3.4 million. Net loss for the quarter was $11.5 million, or $0.48 per share, compared with a net loss of $11.4 million, or $0.61 per share, for the same period in 2025.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Cash, cash equivalents and marketable securities: $93.5 million Research and development expenses: $9.0 million General and administrative expenses: $3.4 million +5 more

8 metrics

Cash, cash equivalents and marketable securities $93.5 million As of June 30, 2026; expected to fund operations into Q4 2027

Research and development expenses $9.0 million Quarter ended June 30, 2026; compared with $8.4 million in Q2 2025

General and administrative expenses $3.4 million Quarter ended June 30, 2026; compared with $3.8 million in Q2 2025

Net loss $11.5 million Quarter ended June 30, 2026; compared with $11.4 million in Q2 2025

Net loss per share $0.48 Basic and diluted for quarter ended June 30, 2026; $0.61 in Q2 2025

Weighted-average shares outstanding 23,797,306 shares Basic and diluted for quarter ended June 30, 2026

Total assets $99.5 million As of June 30, 2026; compared with $121.7 million at December 31, 2025

Stockholders’ equity $57.7 million As of June 30, 2026; compared with $78.8 million at December 31, 2025

Key Terms

Phase 1b/2, neovascular Age-related Macular Degeneration, intravitreal delivery, heparan sulfate proteoglycan (HSPG) anchoring, +1 more

5 terms

Phase 1b/2 medical

"Patient dosing is ongoing in the Phase 1b/2 study of TH103"

Phase 1b/2 is a combined early-stage human study that first checks a drug’s safety and side effects in a small group and then expands to test whether it shows signs of working in patients. Think of it as a product test that first confirms it’s safe to use, then looks for early evidence of benefit; positive results can significantly reduce clinical risk and increase a company’s value, while negative results raise the opposite.

neovascular Age-related Macular Degeneration medical

"TH103 for neovascular Age-related Macular Degeneration"

A progressive eye disease in older adults where abnormal blood vessels grow beneath the central retina and leak fluid or blood, quickly damaging sharp central vision used for reading and recognizing faces. For investors, it matters because it creates ongoing demand for medical treatments, diagnostics and follow-up care, and outcomes hinge on clinical trial results, regulatory approvals and reimbursement decisions that can sharply affect the value of companies developing therapies — like a chronic market need driven by a high-impact illness.

intravitreal delivery medical

"designed for intravitreal delivery, with potential applications"

Injection of a drug directly into the vitreous humor, the gel-like space inside the eyeball, so the medicine reaches the retina and other internal eye tissues. It matters to investors because this route affects how often a treatment must be given, the complexity of clinical trials and regulatory review, and the costs and logistics of manufacturing and administration—similar to choosing whether to send a package to a central mailbox or hand-deliver it to the recipient’s door.

heparan sulfate proteoglycan (HSPG) anchoring medical

"concurrent heparan sulfate proteoglycan (HSPG) anchoring"

forward-looking statements regulatory

"This press release contains “forward-looking statements” within the meaning"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

Earnings Snapshot

Net loss: $11.5 million · Guidance included

Quarter ended June 30, 2026

Net loss $11.5 million Compared with net loss of $11.4 million in Q2 2025

R&D expenses $9.0 million Compared with $8.4 million in Q2 2025

Cash, cash equivalents and marketable securities $93.5 million Compared with $118.0 million at December 31, 2025

Guidance

Kalaris expects its cash, cash equivalents and marketable securities as of June 30, 2026 to be sufficient to fund operations into the fourth quarter of 2027.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Kalaris Therapeutics (KLRS) key clinical updates in Q2 2026?

Kalaris reported ongoing patient dosing in its Phase 1b/2 TH103 trial for neovascular AMD, expects preliminary data in 1H 2027, and indicated potential Phase 3 trials remain on track to start by year-end 2027.

How much cash did Kalaris Therapeutics (KLRS) have as of June 30, 2026?

As of June 30, 2026, Kalaris had $93.5 million in cash, cash equivalents and marketable securities. The company expects this balance to fund operations into the fourth quarter of 2027 and through key clinical milestones.

What was Kalaris Therapeutics (KLRS) net loss for Q2 2026?

For the quarter ended June 30, 2026, Kalaris reported a net loss of $11.5 million, or $0.48 per share, compared with a net loss of $11.4 million, or $0.61 per share, for the same quarter in 2025.

How did Kalaris Therapeutics (KLRS) R&D and G&A expenses change in Q2 2026?

In Q2 2026, research and development expenses were $9.0 million versus $8.4 million in Q2 2025, while general and administrative expenses were $3.4 million versus $3.8 million, reflecting higher clinical activity and lower professional fees.

What is TH103, Kalaris Therapeutics (KLRS) lead candidate?

TH103 is an investigational dual-targeting biologic designed for intravitreal delivery, aiming to treat neovascular and exudative retinal diseases such as neovascular age-related macular degeneration, diabetic eye disease and retinal vein occlusion.

What were Kalaris Therapeutics (KLRS) total assets and equity at June 30, 2026?

At June 30, 2026, Kalaris reported total assets of $99.5 million and stockholders’ equity of $57.7 million, compared with total assets of $121.7 million and stockholders’ equity of $78.8 million at December 31, 2025.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 08/11/2026 - 08:06 AM Accepted by SEC EDGAR 08/11/2026 - 08:05 AM Learn about SEC filing dates

false 0001754068 0001754068 2026-08-11 2026-08-11

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

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

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 48.4 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.1 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 18.3 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.4 KB