Kalaris Reports Third Quarter 2025 Financial Results and Provides Business Updates
Kalaris (Nasdaq: KLRS) reported Q3 2025 results and business updates on Nov 12, 2025. The company had $77.0M in cash, cash equivalents and short-term investments as of Sep 30, 2025, which it expects will fund operations into 2027. Clinical progress includes a Phase 1a single ascending dose trial with initial data expected by year-end 2025 and a newly initiated Phase 1b/2 multiple ascending dose trial enrolling up to 80 nAMD patients with initial data expected in 2H 2026. Kalaris entered a formal CDMO agreement with KBI Biopharma, hired a new CFO, and opened headquarters in Berkeley Heights, NJ. Q3 net loss was $11.9M; shares outstanding were 18,702,418.
Kalaris (Nasdaq: KLRS) ha riportato i risultati del Q3 2025 e aggiornamenti aziendali il 12 novembre 2025. L'azienda disponeva di 77.0M USD in contanti, equivalenti e investimenti a breve termine al 30 settembre 2025, che prevede finanzieranno le operazioni fino al 2027. I progressi clinici includono uno studio di fase 1a a dose singola in salita con dati iniziali attesi entro la fine del 2025 e un nuovo studio di fase 1b/2 a dosi multiple che arruola fino a 80 pazienti nAMD con dati iniziali previsti nel secondo semestre del 2026. Kalaris ha stipulato un accordo CDMO formale con KBI Biopharma, ha assunto un nuovo CFO e ha aperto la sede a Berkeley Heights, NJ. La perdita netta del Q3 è stata di $11.9M; le azioni in circolazione erano 18,702,418.
Kalaris (Nasdaq: KLRS) informó resultados del tercer trimestre de 2025 y actualizaciones comerciales el 12 de noviembre de 2025. La empresa tenía $77.0M en efectivo, equivalentes de efectivo e inversiones a corto plazo al 30 de septiembre de 2025, de los cuales espera financiar las operaciones hasta 2027. El progreso clínico incluye un ensayo de dosis única de fase 1a con datos iniciales esperados para finales de 2025 y un nuevo ensayo de fase 1b/2 de dosis múltiples que recluta hasta 80 pacientes nAMD con datos iniciales esperados en la segunda mitad de 2026. Kalaris cerró un acuerdo formal de CDMO con KBI Biopharma, contrató a un nuevo CFO y abrió la sede en Berkeley Heights, NJ. La pérdida neta del Q3 fue de $11.9M; las acciones en circulación eran 18,702,418.
Kalaris (Nasdaq: KLRS)은 2025년 11월 12일 2025년 3분기 실적 및 사업 업데이트를 발표했습니다. 2025년 9월 30일 기준 현금, 현금성 자산 및 단기 투자액은 77.0M 달러였으며, 이는 2027년까지 운영 자금을 조달할 것으로 예상됩니다. 임상 진전으로는 단일 상승 용량 1a상 시험의 초기 데이터가 2025년 말까지 기대되고, 새로운 다중 상승 용량 1b/2상 시험이 80명 nAMD 환자를 모집하며 초기 데이터는 2026년 하반기에 예상됩니다. Kalaris는 KBI Biopharma와 형식적인 CDMO 계약을 체결했고, 새로운 CFO를 채용했으며 뉴저지주 버클리 히츠에 본사를 열었습니다. 3분기 순손실은 11.9M 달러였고, 발행 주식 수는 18,702,418주였습니다.
Kalaris (Nasdaq : KLRS) a publié les résultats du troisième trimestre 2025 et des mises à jour commerciales le 12 novembre 2025. L'entreprise disposait de 77,0 M$ en liquidités, équivalents de liquidités et investissements à court terme au 30 septembre 2025, qu'elle prévoit financer ses opérations jusqu'en 2027. Les progrès cliniques comprennent un essai de phase 1a à dose unique en escalade avec des données initiales attendues d'ici la fin de 2025 et un nouvel essai de phase 1b/2 à doses multiples recrutant jusqu'à 80 patients nAMD avec des données initiales prévues au cours du 2e semestre 2026. Kalaris a conclu un accord CDMO formel avec KBI Biopharma, a nommé un nouveau directeur financier et a ouvert le siège à Berkeley Heights, NJ. La perte nette du T3 était de 11,9 M$; le nombre d'actions en circulation était de 18 702 418.
Kalaris (Nasdaq: KLRS) berichtete am 12. November 2025 über die Ergebnisse des dritten Quartals 2025 und Geschäftsupdates. Das Unternehmen verfügte zum 30. September 2025 über 77,0 Mio. USD an Bargeld, Zahlungsmitteln und kurzfristigen Investitionen, von denen es erwartet, die Operationen bis 2027 zu finanzieren. Der klinische Fortschritt umfasst eine Phase-1a-Studie mit aufsteigenden Einzeldosen, deren erste Daten bis Ende 2025 erwartet werden und eine neu gestartete Phase-1b/2-Studie mit Mehrfachdosen, die bis zu 80 nAMD-Patienten einschließt, mit ersten Daten in der 2. Hälfte 2026. Kalaris schloss eine formelle CDMO-Vereinbarung mit KBI Biopharma, stellte einen neuen CFO ein und eröffnete die Zentrale in Berkeley Heights, NJ. Die Nettoverlust im Q3 betrug 11,9 Mio. USD; die Anzahl der umlaufenden Aktien lag bei 18.702.418.
Kalaris (ناسداك: KLRS) أبلغت عن نتائج الربع الثالث من 2025 وتحديثات الأعمال في 12 نوفمبر 2025. كانت لدى الشركة 77.0 مليون دولار من النقد وما يعادله والاستثمارات قصيرة الأجل حتى 30 سبتمبر 2025، والتي تتوقع أن تمول العمليات حتى 2027. يشمل التقدم السريري تجربة من المرحلة 1a بجرعة مفردة في التصاعد مع بيانات أولية متوقعة بحلول نهاية 2025 وتجربة جديدة من المرحلة 1b/2 بجرعات متعددة تُسجل حتى 80 مريضًا بمرض AMD-n مع توقع بيانات أولية في النصف الثاني من 2026. دخلت Kalaris في اتفاق CDMO رسمي مع KBI Biopharma، وتعيين مدير مالي جديد، وفتح المقر الرئيسي في Berkeley Heights، NJ. كانت الخسارة الصافية للربع الثالث 11.9 مليون دولار؛ وكانت الأسهم القائمة 18,702,418.
- $77.0M cash and short-term investments (Sep 30, 2025)
- Cash runway expected into 2027
- Phase 1a initial clinical data expected by year-end 2025
- Phase 1b/2 dose-finding trial enrolling up to 80 patients
- Signed CDMO agreement with KBI Biopharma for clinical supply
- Q3 net loss of $11.9M (Sep 30, 2025)
- R&D expenses fell to $9.1M from $36.0M YoY due to prior-period $32.0M royalty charge
- Clinical program value dependent on upcoming Phase 1a/1b/2 readouts (data by YE 2025 and 2H 2026)
Insights
Kalaris advances TH103 trials, secures manufacturing and funding that should support operations into
Kalaris is progressing a Phase 1a single ascending dose study with initial clinical readout expected by year end
Key dependencies and risks are explicit and limited to facts disclosed: initial Phase 1a data timing, successful enrollment and execution of the Phase 1b/2 protocol, and manufacturing supply continuity with KBI. Cash resources of
Watch for the Phase 1a initial dataset by year end
Phase 1a Single Ascending Dose trial remains on track for initial clinical data to be reported
by year end 2025
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
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., Nov. 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 pharmacokinetics.”
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."
Business Updates
- Initial clinical data from the Phase 1a clinical trial expected by year end 2025. The single ascending dose trial followed patients after a single injection of TH103 to assess the safety, pharmacokinetics, and preliminary treatment effect of TH103 in treatment naïve nAMD patients.
- Newly initiated Phase 1b/2 dose-finding clinical trial is designed to evaluate multiple dose levels of TH103 in up to 80 nAMD patients. Patients are expected to receive 4 initial monthly intravitreal injections of TH103. Study assessments are expected to include safety and preliminary efficacy with a primary time point for analysis at one-month following the last injection with patients followed thereafter in an extension phase.
- KBI Biopharma, based in North Carolina, selected as Kalaris’ Contract Development and Manufacturing Organization (CDMO) for clinical supply manufacturing of TH103.
- As previously announced, Kalaris expanded its leadership team with the hire of Matthew Gall, Chief Financial Officer. Mr. Gall has over 20 years of corporate finance experience, including business development transactions and financial operations and strategy for both small and large biopharmaceutical companies.
- New corporate headquarters opened in Berkeley Heights, New Jersey.
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
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, 2025, net loss was
About Kalaris
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:
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
| 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, | December 31, | ||||||
| 2025 | 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 | |||
FAQ
When will Kalaris (KLRS) report initial Phase 1a clinical data for TH103?
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What is the design and size of Kalaris' Phase 1b/2 TH103 trial (KLRS)?
Did Kalaris (KLRS) secure a CDMO for TH103 manufacturing?
What were Kalaris' (KLRS) Q3 2025 R&D and net loss figures?
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