Kalaris Therapeutics expects TH103 data in 2H 2027

Kalaris expects its September cash balance to fund operations into 2028, while preliminary TH103 data are now expected in 2H 2027.

Available on EDGAR 11/10/2026 - 07:42 AM EST Accepted by SEC EDGAR 11/10/2026 - 07:42 AM EST Learn about SEC filing dates

Rhea-AI Filing Summary

Kalaris Therapeutics, Inc. reported a third-quarter 2026 net loss of $11.0 million, compared with $11.9 million in the prior-year quarter. Research and development expense was $8.3 million versus $9.1 million, and general and administrative expense was $3.5 million versus $3.6 million. Basic and diluted net loss per share was $0.46, compared with $0.64.

Cash, cash equivalents and marketable securities were $82.9 million as of September 30, 2026, versus $118.0 million as of December 31, 2025; the decrease primarily reflected cash used in operating activities. Based on current operating plans, Kalaris expects its September 30 balance to fund operations into 2028. Preliminary data from the ongoing Phase 1b/2 TH103 study in neovascular age-related macular degeneration are now expected in 2H 2027. The company completed technology transfer from a pilot to a commercial-scale manufacturer, with initial test batches meeting target specifications.

For the nine months ended September 30, 2026, net loss was $33.397 million, compared with $33.440 million for the same period of 2025.

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• Moderate pointQuarterly net loss: $11.0 million versus $11.9 million a year earlier.

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• None.

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: $82.9 million Cash, cash equivalents and marketable securities: $118.0 million Research and development expenses: $8.3 million +5 more

8 metrics

Cash, cash equivalents and marketable securities $82.9 million As of September 30, 2026

Cash, cash equivalents and marketable securities $118.0 million As of December 31, 2025

Research and development expenses $8.3 million Quarter ended September 30, 2026; $9.1 million in the quarter ended September 30, 2025

General and administrative expenses $3.5 million Quarter ended September 30, 2026; $3.6 million in the quarter ended September 30, 2025

Net loss $11.0 million Quarter ended September 30, 2026; $11.9 million in the quarter ended September 30, 2025

Basic and diluted net loss per share ($0.46) Quarter ended September 30, 2026; ($0.64) in the quarter ended September 30, 2025

Expected timing of preliminary TH103 data 2H 2027 Ongoing Phase 1b/2 study in nAMD

Common stock outstanding 23,804,981 shares As of September 30, 2026

Key Terms

marketable securities, Phase 1b/2, neovascular Age-related Macular Degeneration (nAMD), heparan sulfate proteoglycan (HSPG) anchoring

4 terms

marketable securities financial

"cash, cash equivalents and marketable securities"

Marketable securities are financial assets — such as publicly traded stocks, bonds, and short-term government bills — that a company can quickly sell for cash at a known price. Investors watch them because they show how much ready cash a company can access without selling core operations, like keeping money in a highly liquid savings account versus being tied up in a house, and they affect short-term risk, financial flexibility, and balance-sheet strength.

Phase 1b/2 medical

"ongoing Phase 1b/2 study of TH103 in nAMD"

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 (nAMD) medical

"such as neovascular Age-related Macular Degeneration (nAMD)"

Neovascular age-related macular degeneration (nAMD) is an eye disease in older adults where abnormal blood vessels grow under the retina and leak fluid or blood, damaging central vision used for reading and recognizing faces. For investors it matters because treatments and clinical trials for nAMD can drive significant medical spending and company revenue, similar to a large, recurring market for devices or drugs that slow or reverse vision loss.

heparan sulfate proteoglycan (HSPG) anchoring technical

"concurrent heparan sulfate proteoglycan (HSPG) anchoring"

Earnings Snapshot

Net loss: $11.0 million · Guidance included

Three months ended September 30, 2026

Net loss $11.0 million Compared with $11.9 million for the quarter ended September 30, 2025

Research and development expenses $8.3 million Compared with $9.1 million for the quarter ended September 30, 2025

General and administrative expenses $3.5 million Compared with $3.6 million for the quarter ended September 30, 2025

Basic and diluted net loss per share ($0.46) Compared with ($0.64) for the quarter ended September 30, 2025

Guidance

Based on current operating plans, Kalaris expects cash, cash equivalents and marketable securities as of September 30, 2026 to fund operations into 2028; preliminary data from the ongoing Phase 1b/2 TH103 study in nAMD are now expected in 2H 2027.

FAQ

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

How much cash did KLRS have at September 30, 2026?

As of September 30, 2026, Kalaris had $82.9 million in cash, cash equivalents and marketable securities, compared with $118.0 million as of December 31, 2025. Based on current operating plans, it expects the September balance to fund operations into 2028.

When are preliminary TH103 data expected?

Preliminary data from Kalaris' ongoing Phase 1b/2 study of TH103 in nAMD are now expected in 2H 2027. Kalaris said it continues to enroll and dose patients in the study.

What drove KLRS's lower research and development expenses?

Research and development expenses were $8.3 million for the third quarter of 2026, versus $9.1 million a year earlier. The decrease primarily reflected lower manufacturing and process development activities, partly offset by higher contract research organization and other clinical expenses as additional sites opened and patients enrolled.

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

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false 0001754068 0001754068 2026-11-10 2026-11-10

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): November 10, 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 November 10, 2026, Kalaris Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 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 filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release issued by Kalaris Therapeutics, Inc. on November 10, 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: November 10, 2026				By:		/s/ Andrew Oxtoby
				Name:		Andrew Oxtoby
				Title:		Chief Executive Officer

Exhibit 99.1

Kalaris Reports Third Quarter 2026 Financial Results and Provides Business Update

Preliminary data from the ongoing Phase 1b/2 study of TH103 in nAMD is now expected in 2H 2027

Recently completed technology transfer from pilot to commercial-scale manufacturer with test batches meeting target specifications

$82.9 million in cash, cash equivalents and marketable securities as of September 30, 2026 now expected to fund operations into 2028

BERKELEY HEIGHTS, N.J., November 10, 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 third quarter ended September 30, 2026 and provided a business update.

Business Updates

• Kalaris continues to enroll a Phase 1b/2, multiple-ascending dose, dose-finding study evaluating up to four monthly loading doses of TH103 in patients with neovascular age-related macular degeneration (nAMD). The study aims to assess the safety and efficacy of repeat doses of TH103 in approximately 60-80 patients at different dose levels and to identify the optimal dose for potential Phase 3 development.

• In the third quarter, the pilot manufacturer for clinical supply of TH103 produced a batch that did not meet the applicable release specification for aggregation due to a batch-specific operational issue. A new batch of material is now expected in Q2 2027.

• As a result of this supply interruption, data from the Phase 1b/2 study is now expected in 2H 2027, which will include durability data from initial patient cohorts.

• Kalaris has now successfully completed the technology transfer from the pilot manufacturer to KBI Biopharma, the drug substance manufacturer selected to deliver the planned commercial-scale supply. Test batches achieved the target specifications required for Phase 3 clinical development.

• Potential initiation of a Phase 3 program is now expected in 2028, resulting in an extension of the anticipated cash runway into 2028 and beyond the preliminary Phase 1b/2 data readout.

“Kalaris made meaningful progress in the third quarter,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “We continue to enroll and dose nAMD patients in the ongoing Phase 1b/2 study. In addition to progressing the clinical trial, we have successfully completed the tech transfer to a new commercial-scale manufacturer, with initial test batches achieving the target specifications. Given the paramount importance of ensuring critical quality attributes at the scale required for Phase 3 and commercial supply, this was a significant accomplishment in Q3 and strengthens our confidence in our future clinical supply.”

Financial Results for the Third Quarter Ended September 30, 2026

Cash, Cash Equivalents and Marketable Securities: As of September 30, 2026, Kalaris had cash, cash equivalents and marketable securities of $82.9 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. Based on its current operating plans, Kalaris expects that its cash, cash equivalents and marketable securities as of September 30, 2026 will be sufficient to fund its operations into 2028.

Research and Development Expenses: Research and development expenses were $8.3 million for the quarter ended September 30, 2026, compared with $9.1 million for the quarter ended September 30, 2025. The decrease was primarily attributable to a decrease in manufacturing and process development activities, partially offset by an increase in contract research organization and other clinical expenses as Kalaris opened additional investigational sites and enrolled patients in its Phase 1b/2 clinical trial of TH103.

General and Administrative Expenses: General and administrative expenses were $3.5 million for the quarter ended September 30, 2026, compared with $3.6 million for the quarter ended September 30, 2025. The decrease was primarily attributable to a decrease in professional services, consulting and other general and administrative expenses, partially offset by an increase in personnel-related costs.

Net Loss: For the quarter ended September 30, 2026, net loss was $11.0 million compared with a net loss of $11.9 million for the quarter ended September 30, 2025. The total number of shares of common stock outstanding as of September 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, Kalaris’ expectations regarding the anticipated timeline for obtaining a new batch of TH103 for use in its Phase 1b/2 clinical trial, Kalaris’ expectations regarding the ability of its new commercial-scale drug substance manufacturer to supply sufficient TH103 drug substance meeting the quality standards and applicable regulatory requirements for clinical development 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 and their ability to supply sufficient TH103 drug substance meeting the quality standards and applicable regulatory requirements for clinical development; 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 September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Operating expenses
Research and development		$	8,344			$	9,126			$	24,934			$	23,596
General and administrative			3,467				3,615				11,096				11,755
Total operating expenses			11,811				12,741				36,030				35,351
Loss from operations			(11,811	)			(12,741	)			(36,030	)			(35,351	)
Total other income, net			785				847				2,633				1,911
Net loss		$	(11,026	)		$	(11,894	)		$	(33,397	)		$	(33,440	)
Net loss per share, basic and diluted		$	(0.46	)		$	(0.64	)		$	(1.40	)		$	(2.41	)
Weighted-average shares outstanding, basic and diluted			23,804,981				18,701,708				23,775,600				13,872,369

Kalaris Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(unaudited, in thousands)

		September 30, 2026				December 31, 2025
Assets
Current assets
Cash, cash equivalents and marketable securities		$	82,856			$	117,982
Other current assets			2,320				827
Total current assets			85,176				118,809
Other assets			3,827				2,927
Total assets		$	89,003			$	121,736
Liabilities and stockholders’ equity
Current liabilities		$	8,514			$	9,714
Long-term liabilities			33,087				33,208
Total liabilities			41,601				42,922
Total stockholders’ equity			47,402				78,814
Total liabilities and stockholders’ equity		$	89,003			$	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 17.6 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.0 KB