Kalaris Therapeutics (KLRS) posts Q1 2026 loss with $104.9M cash to fund trials into 2027

Rhea-AI Filing Summary

Kalaris Therapeutics reported first‑quarter 2026 results and highlighted progress in its retinal disease program TH103. As of March 31, 2026, the company held $104.9 million in cash, cash equivalents and marketable securities and expects this to fund operations into the fourth quarter of 2027 and through key clinical milestones.

Research and development expenses rose to $7.6 million from $6.0 million a year earlier as additional clinical sites were opened and patients enrolled. General and administrative expenses were stable at $4.3 million. Net loss was $10.9 million, compared with $10.2 million in the prior‑year quarter, with no revenue reported.

The company has begun patient screening in its Phase 1b/2 trial of TH103 for neovascular age‑related macular degeneration and has manufactured new clinical material for upcoming dosing. It anticipates preliminary Phase 1b/2 data in the first half of 2027 and continues to plan Phase 3 trials targeted for initiation by year‑end 2027.

Insights

Biotech equity analyst

Solid cash runway supports advancing TH103, while losses remain typical for a clinical-stage biotech.

Kalaris Therapeutics ended March 31, 2026 with $104.9 million in cash, cash equivalents and marketable securities and expects this to fund operations into the fourth quarter of 2027. For a clinical‑stage company with no product revenue, this gives a multi‑year window to run trials without immediate financing.

Quarterly operating expenses totaled $11.8 million, driven mainly by research and development of TH103. R&D increased to $7.6 million from $6.0 million as the company opened more investigational sites and enrolled patients, while general and administrative costs were flat around $4.3 million. Net loss of $10.9 million is consistent with ongoing investment in trials.

Operationally, patient screening is underway in the Phase 1b/2 TH103 study, with new clinical batches prepared, and preliminary data are anticipated in the first half of 2027. Planned Phase 3 trials remain targeted for initiation by year‑end 2027. Actual value creation will depend on the quality of Phase 1b/2 data and the company’s ability to maintain timelines within its current cash runway.

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, and exhibit attachments filed with this report.

Key Figures

Cash, cash equivalents and marketable securities: $104.9 million Research and development expenses: $7.6 million General and administrative expenses: $4.3 million +5 more

8 metrics

Cash, cash equivalents and marketable securities $104.9 million As of March 31, 2026; expected to fund operations into Q4 2027

Research and development expenses $7.6 million Quarter ended March 31, 2026; up from $6.0 million in Q1 2025

General and administrative expenses $4.3 million Quarter ended March 31, 2026; flat versus Q1 2025

Net loss $10.9 million Quarter ended March 31, 2026; compared with $10.2 million in Q1 2025

Net loss per share $0.46 Basic and diluted, quarter ended March 31, 2026

Weighted-average shares outstanding 23,723,618 shares Basic and diluted, quarter ended March 31, 2026

Total assets $109.8 million As of March 31, 2026; from condensed consolidated balance sheet

Total stockholders’ equity $68.6 million As of March 31, 2026; from condensed consolidated balance sheet

Key Terms

Phase 1b/2 study, Phase 3 clinical trials, clinical-stage biopharmaceutical company, marketable securities, +2 more

6 terms

Phase 1b/2 study medical

"Patient screening now underway in the Phase 1b/2 study with the latest drug product batch..."

Phase 3 clinical trials medical

"Planned Phase 3 clinical trials remain on track for 2027 year-end initiation"

Phase 3 clinical trials are large, late-stage studies that test a drug or medical treatment in hundreds to thousands of patients to confirm it is safe and effective and to compare it with existing options. Investors care because positive results are a key step toward regulatory approval and commercial sales, reducing uncertainty much like a full dress rehearsal before a product launch; negative results can sharply reduce a program’s value.

clinical-stage biopharmaceutical company medical

"Kalaris Therapeutics, Inc. ... a clinical stage biopharmaceutical company dedicated to the development..."

A clinical-stage biopharmaceutical company develops drugs or medical therapies that are being tested in people in formal clinical trials but do not yet have any approved, marketed products. For investors, these firms behave like prototype makers: their value depends heavily on trial results and regulatory decisions, so they can swing widely on a single study, consume cash while testing, and offer either large upside if trials succeed or big downside if they fail.

marketable securities financial

"$104.9 million in cash, cash equivalents and marketable securities as of March 31, 2026"

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.

net loss per share, basic and diluted financial

"Net loss per share, basic and diluted | | $ | (0.46) | | | $ | (2.52)"

forward-looking statements regulatory

"This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995..."

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: $10.9 million · Guidance included

Quarter ended March 31, 2026

Net loss $10.9 million vs $10.2 million net loss in the quarter ended March 31, 2025

Research and development expenses $7.6 million vs $6.0 million in the quarter ended March 31, 2025

General and administrative expenses $4.3 million vs $4.3 million in the quarter ended March 31, 2025

Cash, cash equivalents and marketable securities $104.9 million as of March 31, 2026, expected to fund operations into Q4 2027

Guidance

Kalaris expects its cash, cash equivalents and marketable securities as of March 31, 2026 to be sufficient to fund operations into the fourth quarter of 2027.

Understanding 8-K Material Events →

false 0001754068 0001754068 2026-05-12 2026-05-12

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): May 12, 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 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 26^th, 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,
		2026				2025
Operating expenses
Research and development		$	7,572			$	6,030
General and administrative			4,261				4,324
Total operating expenses			11,833				10,354
Loss from operations			(11,833)				(10,354)
Total other income, net			977				158
Net loss		$	(10,856)			$	(10,196)
Net loss per share, basic and diluted		$	(0.46)			$	(2.52)
Weighted-average shares outstanding, basic and diluted			23,723,618				4,053,140

Kalaris Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(unaudited, in thousands)

		March 31,				December 31,
		2026				2025
Assets
Current assets
Cash, cash equivalents and short-term marketable securities		$	97,215			$	117,982
Other current assets			1,250				827
Total current assets			98,465				118,809
Long-term marketable securities			7,654				—
Other assets			3,686				2,927
Total assets		$	109,805			$	121,736
Liabilities and stockholders’ equity
Current liabilities		$	8,079			$	9,714
Long-term liabilities			33,169				33,208
Total liabilities			41,248				42,922
Total stockholders’ equity			68,557				78,814
Total liabilities and stockholders’ equity		$	109,805			$	121,736

FAQ

How much cash does Kalaris Therapeutics (KLRS) have after Q1 2026?

Kalaris reported $104.9 million in cash, cash equivalents and marketable securities as of March 31, 2026. The company expects this balance to fund operations into the fourth quarter of 2027 and support key clinical milestones for its retinal drug candidate TH103.

What was Kalaris Therapeutics’ net loss in the first quarter of 2026?

Kalaris reported a net loss of $10.9 million for the quarter ended March 31, 2026, compared with a net loss of $10.2 million in the same period of 2025. The loss reflects higher research and development spending as clinical activities for TH103 expanded.

How are Kalaris Therapeutics’ R&D expenses changing year over year?

Research and development expenses were $7.6 million in Q1 2026, up from $6.0 million in Q1 2025. The increase mainly reflects higher contract research organization and clinical costs as Kalaris opened additional investigational sites and enrolled patients into its TH103 clinical program.

What is the status of Kalaris Therapeutics’ TH103 clinical program?

Kalaris is screening patients in a Phase 1b/2 study of TH103 for neovascular age‑related macular degeneration. New clinical material batches are prepared for dosing, with preliminary Phase 1b/2 data anticipated in the first half of 2027 and Phase 3 trials planned to start by year‑end 2027.

How long does Kalaris Therapeutics expect its cash to last?

Kalaris expects its $104.9 million in cash, cash equivalents and marketable securities as of March 31, 2026 to fund operations into the fourth quarter of 2027. This runway is expected to cover key milestones, including preliminary data from the ongoing Phase 1b/2 TH103 trial.

Did Kalaris’ general and administrative expenses change in Q1 2026?

General and administrative expenses were $4.3 million for the quarter ended March 31, 2026, unchanged from $4.3 million in the prior‑year quarter. This indicates stable overhead costs while the company increased research and development spending on its TH103 clinical program.

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 40.6 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