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Kalaris Reports Third Quarter 2025 Financial Results and Provides Business Updates Phase 1a Single Ascending Dose trial remains on track for initial clinical data to be reported by year end 2025 Phase 1b/2 Multiple Ascen

Key Takeaway: Kalaris Therapeutics reported its financial results for Q3 2025, highlighting significant corporate milestones and progress in clinical trials. The Phase 1a Single Ascending Dose trial remains on schedule for initial data by year's end, while the Phase 1b/2 trial is currently enrolling participants. The company has substantial cash reserves of $77 million, projected to fund operations into 2027 even as R&D expenses reflect past obligations. Despite a notable net loss, the company is advancing its investigational treatment TH103 aimed at retinal diseases.

Market Sentiment Analysis

POSITIVE FACTORS

  • Phase 1a Single Ascending Dose trial is on track for initial data by year-end 2025.
  • Cash, cash equivalents and short-term investments of $77 million expected to fund operations into 2027.
  • Enrolled in Phase 1b/2 trial aimed at dose selection for potential Phase 3 development.

CONCERNS & RISKS

  • Net loss for Q3 2025 was $11.9 million, reducing from $38.1 million in Q3 2024.
  • R&D expenses decreased significantly due to previous high royalty obligations.

Full Press Release Details

Kalaris Reports Third Quarter 2025 Financial Results and Provides Business Updates
Phase 1a Single Ascending Dose trial remains on track for initial clinical data to be reported by
Phase 1b/2 Multiple Ascending Dose trial currently enrolling, intended to inform dose selection
for potential Phase 3 development program; initial clinical data expected in 2H 2026
Recent significant corporate milestones include
the selection of a CDMO, CFO hire, and opening of corporate headquarters
Cash, cash equivalents and short-term investments of $77.0M
as of September 30, 2025, expected to fund operations into 2027
Kalaris is currently evaluating TH103, a dual-targeting
biologic designed to achieve superior VEGF inhibition and extended intraocular durability through optimized binding to VEGF receptor 1 ligands and concurrent heparan sulfate proteoglycan (HSPG) anchoring
BERKELEY HEIGHTS, N.J., November 12, 2025 (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, 2025, and provided business updates.
"The third quarter marked an important inflection point for Kalaris," said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics.
"Most importantly, we began enrolling our Phase 1b/2 multiple ascending dose trial of TH103 in neovascular age-related Macular Degeneration (nAMD). This Phase 1b/2 trial is designed to build on our
ongoing Phase 1a single ascending dose trial; we look forward to reporting initial clinical data from our Phase 1a trial by the end of this year, including safety, preliminary efficacy (e.g., visual acuity and lesion morphology), and
In addition to progressing TH103's clinical development program, Kalaris also entered a formal agreement with KBI
Biopharma for clinical supply manufacturing. Mr. Oxtoby stated, "Working with KBI is an important step as we progress into a later stage biotech company. Our decision to work with KBI reflects their deep technical expertise to support
continued development of TH103." Katie Edgar, Chief Business Officer of KBI Biopharma, said, "We look forward to applying our scientific and regulatory acumen to helping progress Kalaris' exciting product candidate. Our agreement
with Kalaris reflects our shared commitment to patient impact."
Financial Results for the Third Quarter Ended September 30, 2025
Cash, Cash Equivalents and Short-Term Investments: As of September 30, 2025, Kalaris had cash, cash equivalents and short-term investments of
$77.0 million, compared with cash and cash equivalents of $1.6 million as of December 31, 2024. The increase in cash and cash equivalents was primarily a result of the completion of its merger with AlloVir in Q1 2025. Kalaris expects
that its cash, cash equivalents and short-term investments as of September 30, 2025 will be sufficient to fund its operations into 2027.
and Development Expenses: Research and development expenses were $9.1 million for the quarter ended September 30, 2025, compared with $36.0 million for the quarter ended September 30, 2024. The decrease
quarter-over-quarter was primarily attributable to a $32.0 million royalty obligation expense for a Royalty agreement entered into with Samsara in July 2024, offset by an increase in costs related to the outsourcing of manufacturing and
clinical-related costs to support the ongoing Phase 1a and the newly initiated Phase 1b/2 clinical trial.
General and Administrative
Expenses: General and administrative expenses were $3.6 million for the quarter ended September 30, 2025, compared with $1.8 million for the quarter ended September 30, 2024. The increase quarter-over-quarter was
primarily attributable to an increase in insurance, legal, accounting, and professional fees and personnel related costs to support operating as a public company.
Net Loss: For the quarter ended September 30, 2025, net loss was $11.9 million compared with a net loss of $38.1 million for the quarter
ended September 30, 2024. The total number of shares of common stock outstanding as of September 30, 2025 was 18,702,418.
Kalaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent
retinal diseases with major unmet medical needs. 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 such as neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
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, prospects, plans and objectives of management of Kalaris, including the therapeutic potential of TH103 for nAMD and other exudative and neovascular retinal diseases, the anticipated timelines for reporting clinical data
from the Phase 1a and Phase 1b/2 clinical trials of TH103, 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; 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; potential adverse reactions or changes to
business relationships resulting from the completion of the merger with AlloVir, Inc.; risks associated with the possible failure to realize, or that it may take longer to realize than expected, certain anticipated benefits of the merger, including
with respect to future financial and operating results; the risk of involvement in current and future litigation, including securities class action 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:
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,
2025 2024 2025 2024
Operating expenses
Research and development $ 9,126 $ 36,020 $ 23,596 $ 41,192
General and administrative 3,615 1,829 11,755 3,407
Total operating expenses 12,741 37,849 35,351 44,599
Loss from operations (12,741 ) (37,849 ) (35,351 ) (44,599 )
Total other income (expense), net 847 (235 ) 1,911 (2,542 )
Net loss $ (11,894 ) $ (38,084 ) $ (33,440 ) $ (47,141 )
Net loss per share, basic and diluted $ (0.64 ) $ (28.16 ) $ (2.41 ) $ (35.44 )
Weighted-average shares outstanding, basic and diluted 18,701,708 1,352,265 13,872,369 1,330,255
Kalaris Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(unaudited, in thousands)
September 30, 2025 December 31, 2024
Assets
Current assets
Cash, cash equivalents and short-term investments $ 76,999 $ 1,639
Other current assets 1,184 967
Total current assets 78,183 2,606
Other assets 2,992 3,556
Total assets $ 81,175 $ 6,162
Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)
Current liabilities $ 6,065 $ 24,703
Long-term liabilities 33,245 32,076
Total liabilities 39,310 56,779
Redeemable convertible preferred stock - 45,999
Total stockholders' equity (deficit) 41,865 (96,616 )
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) $ 81,175 $ 6,162

Frequently Asked Questions

What is the purpose of the Phase 1b/2 trial for TH103?

The Phase 1b/2 trial aims to inform dose selection for potential Phase 3 development.

How much cash does Kalaris have as of September 30, 2025?

Kalaris has cash, cash equivalents, and short-term investments totaling $77.0 million.

What is TH103 designed to inhibit?

TH103 is a biologic designed to achieve superior VEGF inhibition.

Who is Kalaris' Chief Executive Officer?

Andrew Oxtoby serves as the Chief Executive Officer of Kalaris Therapeutics.

When will initial clinical data for Phase 1a trial be reported?

Initial clinical data from the Phase 1a trial is expected by the end of this year.

Last updated: Nov 12, 2025