Kalaris Reports Second Quarter 2025 Financial Results and Provides Business Updates
Kalaris Therapeutics (NASDAQ:KLRS), a clinical-stage biopharmaceutical company focusing on retinal diseases, reported Q2 2025 financial results and provided business updates. The company continues enrolling patients in its Phase 1 trial of TH103, a novel anti-VEGF treatment for neovascular Age-related Macular Degeneration (nAMD), with initial clinical data expected in Q4 2025.
Financial highlights include cash position of $88.4 million as of June 30, 2025, expected to fund operations into Q4 2026. Q2 2025 resulted in a net loss of $11.4 million ($0.61 per share). The company strengthened its leadership team with the addition of Kristine Curtiss as SVP of Clinical, bringing 25 years of ophthalmology expertise.
Kalaris Therapeutics (NASDAQ:KLRS), una società biofarmaceutica in fase clinica specializzata nelle malattie retiniche, ha reso noti i risultati finanziari del secondo trimestre 2025 e fornito aggiornamenti aziendali. L'azienda continua a reclutare pazienti per la fase 1 del trial di TH103, un nuovo trattamento anti‑VEGF per la degenerazione maculare neovascolare legata all'età (nAMD), con i primi dati clinici attesi nel quarto trimestre 2025.
I punti finanziari evidenziano una posizione di cassa di 88,4 milioni di dollari al 30 giugno 2025, considerata sufficiente a finanziare le operazioni fino al quarto trimestre 2026. Il Q2 2025 si è chiuso con una perdita netta di 11,4 milioni di dollari (0,61 dollari per azione). L'azienda ha inoltre rafforzato il management con l'ingresso di Kristine Curtiss come SVP Clinical, che porta con sé 25 anni di esperienza in oftalmologia.
Kalaris Therapeutics (NASDAQ:KLRS), una compañía biofarmacéutica en fase clínica centrada en enfermedades de la retina, informó los resultados financieros del segundo trimestre de 2025 y dio actualizaciones sobre el negocio. La compañía sigue reclutando pacientes en su ensayo de fase 1 de TH103, un nuevo tratamiento anti‑VEGF para la degeneración macular neovascular relacionada con la edad (nAMD), y espera los primeros datos clínicos en el cuarto trimestre de 2025.
Entre los aspectos financieros destaca una posición de efectivo de 88,4 millones de dólares al 30 de junio de 2025, que se espera financie las operaciones hasta el cuarto trimestre de 2026. El 2T 2025 registró una pérdida neta de 11,4 millones de dólares (0,61 dólares por acción). La empresa también reforzó su equipo directivo incorporando a Kristine Curtiss como SVP of Clinical, con 25 años de experiencia en oftalmología.
Kalaris Therapeutics (NASDAQ:KLRS), 망막 질환에 주력하는 임상 단계의 바이오제약사로서 2025년 2분기 재무실적과 사업 현황을 발표했습니다. 회사는 신생혈관성 연령 관련 황반변성(nAMD)을 치료하는 새로운 항‑VEGF 제제인 TH103의 1상 시험에서 환자 등록을 계속하고 있으며, 초기 임상 데이터는 2025년 4분기에 예상됩니다.
재무 핵심 사항으로는 2025년 6월 30일 기준 현금 보유액 $88.4 million으로, 이는 2026년 4분기까지 운영 자금을 충당할 것으로 예상됩니다. 2025년 2분기 순손실은 $11.4 million(주당 $0.61)였습니다. 또한 임상 부문 수석 부사장(SVP of Clinical)으로 Kristine Curtiss를 영입해 25년의 안과(ophthalmology) 경력을 더했습니다.
Kalaris Therapeutics (NASDAQ:KLRS), une société biopharmaceutique en phase clinique spécialisée dans les maladies rétiniennes, a publié ses résultats financiers du deuxième trimestre 2025 et des mises à jour opérationnelles. La société poursuit le recrutement des patients pour l'essai de phase 1 de TH103, un nouveau traitement anti‑VEGF pour la dégénérescence maculaire néovasculaire liée à l'âge (nAMD), et prévoit des premières données cliniques au quatrième trimestre 2025.
Les points financiers comprennent une trésorerie de 88,4 millions de dollars au 30 juin 2025, censée couvrir les opérations jusqu'au quatrième trimestre 2026. Le T2 2025 s'est soldé par une perte nette de 11,4 millions de dollars (0,61 dollar par action). L'entreprise a par ailleurs renforcé son équipe dirigeante en nommant Kristine Curtiss en tant que SVP Clinical, qui apporte 25 ans d'expérience en ophtalmologie.
Kalaris Therapeutics (NASDAQ:KLRS), ein klinisch tätiges Biopharmaunternehmen mit Fokus auf Netzhauterkrankungen, berichtete über die Finanzergebnisse des zweiten Quartals 2025 und gab Geschäfts-Updates bekannt. Das Unternehmen rekrutiert weiterhin Patienten für die Phase‑1‑Studie von TH103, eine neuartige Anti‑VEGF‑Therapie zur Behandlung der neovaskulären altersbedingten Makuladegeneration (nAMD); erste klinische Daten werden für das vierte Quartal 2025 erwartet.
Zu den finanziellen Eckdaten gehört eine Barmittelposition von 88,4 Millionen US‑Dollar zum 30. Juni 2025, die voraussichtlich die Geschäftstätigkeit bis ins vierte Quartal 2026 finanzieren wird. Das zweite Quartal 2025 schloss mit einem Nettoverlust von 11,4 Millionen US‑Dollar (0,61 US‑Dollar je Aktie). Zudem hat das Unternehmen das Führungsteam mit der Ernennung von Kristine Curtiss zur SVP Clinical verstärkt; sie bringt 25 Jahre Erfahrung in der Augenheilkunde mit.
- Strong cash position of $88.4M, up from $1.6M in December 2024
- Cash runway extended into Q4 2026
- Addition of experienced SVP of Clinical with 25 years of ophthalmology expertise
- Phase 1 trial progressing with initial data expected in Q4 2025
- Increased net loss to $11.4M from $5.7M year-over-year
- R&D expenses increased significantly to $8.4M from $3.2M year-over-year
- G&A expenses jumped to $3.8M from $1.0M year-over-year
Insights
Kalaris reports increasing R&D spend as Phase 1 TH103 trial progresses, with $88.4M cash providing runway into Q4 2026.
Kalaris Therapeutics' Q2 2025 results highlight the company's healthy cash position of
The clinical progress of TH103, their novel anti-VEGF agent for neovascular Age-related Macular Degeneration (nAMD), remains on track with initial data expected in Q4 2025. This upcoming data readout represents a critical catalyst that will offer the first human efficacy signals for their differentiated approach to retinal disease treatment.
Financial metrics show R&D expenses increased to
The net loss widened to
The addition of Kristine Curtiss as SVP of Clinical strengthens their leadership team with valuable ophthalmology expertise as they advance their clinical program. Her 25 years of experience in ophthalmology-focused biotech companies should bolster their clinical development capabilities at this crucial stage.
Kalaris' TH103 for nAMD nears key Q4 2025 data readout, potentially offering longer duration than current anti-VEGF therapies.
Kalaris Therapeutics is advancing TH103, a differentiated anti-VEGF therapy engineered to address key limitations in current neovascular Age-related Macular Degeneration (nAMD) treatments. The ongoing Phase 1 single ascending dose trial is specifically enrolling treatment-naïve nAMD patients, which allows for cleaner efficacy signals without the confounding effects of prior therapy resistance or tachyphylaxis.
The company's focus on longer-lasting and increased anti-VEGF activity directly addresses one of the most significant unmet needs in retinal care - reducing treatment burden. Current standard-of-care anti-VEGF agents like aflibercept and ranibizumab typically require frequent intravitreal injections, creating substantial treatment burden for elderly patients.
TH103's differentiated preclinical profile suggests potential advantages in both efficacy and duration compared to approved therapies. The upcoming Q4 2025 data readout will provide crucial insights into dose-response relationships across multiple dose levels, safety profile, and early efficacy signals. This will be particularly important for determining whether the preclinical durability advantages translate to human subjects.
The strategic hiring of Kristine Curtiss as SVP of Clinical brings valuable ophthalmology-specific expertise to oversee the development program. Her extensive experience across ophthalmology clinical programs will be essential as Kalaris navigates the complex landscape of retinal disease trials, which require specialized imaging endpoints and careful patient selection.
The current cash position provides runway beyond the critical Phase 1 data readout and likely into potential Phase 2 studies, allowing the company to adapt their development strategy based on initial human data without immediate financing pressure.
Continuing to enroll nAMD patients in a Phase 1 trial of TH103, a novel, differentiated anti-VEGF agent engineered to potentially provide longer-lasting and increased anti-VEGF activity to treat neovascular and exudative diseases of the retina; initial clinical data is expected in Q4 2025
Cash and cash equivalents of
PALO ALTO, Calif., Aug. 13, 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 second quarter ended June 30, 2025, and provided a business update.
“We continued to enroll treatment-naïve nAMD patients in our open-label Phase 1 clinical trial of TH103 in the second quarter of 2025” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “TH103 has exhibited differentiated anti-VEGF properties in multiple preclinical studies, and we believe it has the potential to improve efficacy and extend treatment duration compared to currently approved agents. We look forward to reporting initial clinical data later this year which will provide an initial read of safety and efficacy data of TH103 at multiple dose levels and help inform the next stage of our clinical development program.”
Business Updates
- Kalaris is currently enrolling a Phase 1, single ascending dose trial to assess the safety, pharmacokinetics, and preliminary treatment effect of TH103 in neovascular Age-related Macular Degeneration (nAMD) patients. Initial clinical data is expected in the fourth quarter of 2025.
- Kalaris recently expanded its leadership team with the hire of Kristine Curtiss, Senior Vice President of Clinical. Ms. Curtiss has over 25 years of clinical research and operations experience in ophthalmology-focused biotech companies, overseeing programs and building departments.
Financial Results for the Second Quarter Ended June 30, 2025
Cash and Cash Equivalents: As of June 30, 2025, Kalaris had cash and cash equivalents 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 June 30, 2025, net loss was
About Kalaris
Kalaris is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases. The company is focused on development of TH103, a novel, differentiated anti-VEGF investigational therapy. Developed by Dr. Napoleone Ferrara, TH103 is a fully humanized, recombinant fusion protein that acts against VEGF as a decoy receptor and has been specifically engineered for potentially improved VEGF inhibition and longer retention in the retina. TH103 is currently being evaluated in an ongoing, Phase 1 clinical trial for the treatment of neovascular Age-related Macular Degeneration (nAMD), with plans to develop TH103 for additional neovascular and exudative diseases of the retina such as Diabetic Macular Edema (DME), and Retinal Vein Occlusion (RVO).
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, the anticipated timeline for reporting initial clinical data from the Phase 1 clinical trial of TH103, 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. Forward-looking statements include, but are not limited to, statements concerning the following: the future operations of Kalaris, including research and development activities; the nature, strategy and focus of Kalaris; the development and commercial potential and potential benefits of any product candidate of Kalaris, including expectations around intellectual property protection; anticipated clinical drug development activities and related timelines, including the expected timing for announcement of data and other clinical results; the uncertainties associated with Kalaris’ product candidate, as well as risks associated with the clinical development and regulatory approval of its product candidate, 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, that could divert the attention of the management of Kalaris, harm Kalaris’ business and for which Kalaris may not have sufficient insurance coverage to cover all costs and damages; 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. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Kalaris makes. 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
| Kalaris Therapeutics, Inc. Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Operating expenses | |||||||||||||||
| Research and development | $ | 8,440 | $ | 3,211 | $ | 14,470 | $ | 5,172 | |||||||
General and administrative | 3,816 | 976 | 8,140 | 1,578 | |||||||||||
Total operating expenses | 12,256 | 4,187 | 22,610 | 6,750 | |||||||||||
Loss from operations | (12,256 | ) | (4,187 | ) | (22,610 | ) | (6,750 | ) | |||||||
Total other income (expense), net | 906 | (1,463 | ) | 1,064 | (2,307 | ) | |||||||||
| Net loss | $ | (11,350 | ) | $ | (5,650 | ) | $ | (21,546 | ) | $ | (9,057 | ) | |||
| Net loss per share, basic and diluted | $ | (0.61 | ) | $ | (4.26 | ) | $ | (1.89 | ) | $ | (6.87 | ) | |||
| Weighted-average shares outstanding, basic and diluted | 18,701,286 | 1,325,706 | 11,417,677 | 1,319,129 | |||||||||||
| Kalaris Therapeutics, Inc. Condensed Consolidated Balance Sheets (unaudited, in thousands) | |||||||
| June 30, | December 31, | ||||||
| 2025 | 2024 | ||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 88,426 | $ | 1,639 | |||
| Other current assets | 3,225 | 967 | |||||
| Total current assets | 91,651 | 2,606 | |||||
| Other assets | 1,191 | 3,556 | |||||
| Total assets | $ | 92,842 | $ | 6,162 | |||
| Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | |||||||
| Current liabilities | $ | 7,651 | $ | 24,703 | |||
| Long-term liabilities | 32,076 | 32,076 | |||||
| Total liabilities | 39,727 | 56,779 | |||||
| Redeemable convertible preferred stock | — | 45,999 | |||||
| Total stockholders’ equity (deficit) | 53,115 | (96,616 | ) | ||||
| Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | $ | 92,842 | $ | 6,162 | |||
FAQ
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