Kalaris Reports Third Quarter 2026 Financial Results and Provides Business Update
Quarterly research and development spending fell, while nine-month spending on research and development increased.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Kalaris Therapeutics (Nasdaq: KLRS) reported third-quarter financial results and pushed preliminary TH103 trial data expectations to the second half of 2027. A pilot-manufacturing batch failed its aggregation release specification because of a batch-specific operational issue. Replacement material is expected in Q2 2027; the delayed Phase 1b/2 readout will include durability data from initial patient cohorts.
Technology transfer to KBI Biopharma is complete, with test batches meeting target specifications for Phase 3 development. Kalaris now expects potential Phase 3 initiation in 2028. The later timing extends its anticipated cash runway into 2028, beyond the preliminary readout. Cash, cash equivalents and marketable securities totaled $82.856 million at September 30, 2026, versus $117.982 million at December 31, 2025. Third-quarter net loss narrowed to $11.026 million from $11.894 million a year earlier.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointTechnology transfer to KBI Biopharma completed; test batches met target specifications for Phase 3 development.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Kalaris expects its cash runway to extend into 2028, beyond the preliminary Phase 1b/2 readout.
- Moderate pointThird-quarter net loss narrowed to $11.026 million from $11.894 million in 2025.
- Minor pointPhase 1b/2 enrollment and dosing continue in patients with neovascular age-related macular degeneration.
- Minor pointThird-quarter loss per share narrowed to $0.46 from $0.64 in 2025.
7 minor points
- Minor pointThird-quarter research and development expenses fell to $8.344 million from $9.126 million in 2025.
- Minor pointThird-quarter general and administrative expenses fell to $3.467 million from $3.615 million in 2025.
- Minor pointNine-month net loss narrowed to $33.397 million from $33.440 million in 2025.
- Minor pointNine-month loss per share narrowed to $1.40 from $2.41 in 2025.
- Minor pointNine-month general and administrative expenses fell to $11.096 million from $11.755 million in 2025.
- Minor pointNine-month total other income, net increased to $2.633 million from $1.911 million in 2025.
- Minor pointTotal liabilities declined to $41.601 million at September 30, 2026, from $42.922 million at December 31, 2025.
Negative
- Major point. Forward-looking: it has not happened yet and may not happen.TH103 supply interruption delays preliminary Phase 1b/2 data to 2H 2027; replacement material is expected in Q2 2027.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Potential Phase 3 initiation is now expected in 2028.
- Moderate pointCash, equivalents and marketable securities fell to $82.856 million from $117.982 million between December 2025 and September 2026.
- Minor pointNine-month research and development expenses rose to $24.934 million from $23.596 million in 2025.
- Minor pointThird-quarter total other income, net declined to $785,000 from $847,000 in 2025.
- Minor pointStockholders’ equity fell to $47.402 million at September 30, 2026, from $78.814 million at December 31, 2025.
Key Figures
- Cash and marketable securities
- $82.9 million
- As of September 30, 2026; compared with $118.0 million at December 31, 2025
- Cash runway
- Into 2028
- Based on current operating plans
- Net loss
- $11.0 million
- Third quarter ended September 30, 2026; compared with $11.9 million in Q3 2025
- Research and development expenses
- $8.3 million
- Third quarter ended September 30, 2026; compared with $9.1 million in Q3 2025
- Study size
- Approximately 60–80 patients
- Phase 1b/2 TH103 study in nAMD
- New material batch
- Q2 2027
- Expected after the prior batch did not meet the release specification for aggregation
- Preliminary study data
- 2H 2027
- Phase 1b/2 TH103 study; includes durability data from initial patient cohorts
- Potential Phase 3 initiation
- 2028
- Updated expected timing for a potential TH103 program
Previous Earnings Reports
-
Prior report expected TH103 data in 1H 2027 and runway into Q4 2027.
-
Prior KBI Biopharma CDMO agreement preceded current commercial-scale technology-transfer completion.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
intravitreal delivery medical
vascular endothelial growth factor medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
BERKELEY HEIGHTS, N.J., Nov. 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
Research and Development Expenses: Research and development expenses were
General and Administrative Expenses: General and administrative expenses were
Net Loss: For the quarter ended September 30, 2026, net loss was
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, | December 31, | |||||
| 2026 | 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 | ||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When does Kalaris expect preliminary TH103 trial data?
Kalaris now expects preliminary Phase 1b/2 data in 2H 2027, including durability data from initial patient cohorts. A clinical-supply batch failed its aggregation release specification because of a batch-specific operational issue, and new material is expected in Q2 2027.
How long does Kalaris expect its September 2026 cash to last?
Kalaris expects its September 30, 2026 cash, cash equivalents and marketable securities to fund operations into 2028, based on current operating plans. The anticipated runway extends beyond the preliminary Phase 1b/2 readout.
What is Kalaris testing in the TH103 Phase 1b/2 study?
The study evaluates the safety and efficacy of repeat TH103 doses in approximately 60-80 patients with neovascular age-related macular degeneration. It assesses up to four monthly loading doses at different dose levels and aims to identify an optimal dose for potential Phase 3 development.