Kalaris Announces Closing of Merger with AlloVir
Kalaris Therapeutics (NASDAQ: KLRS) has completed its merger with AlloVir, with shares set to trade on Nasdaq from March 19, 2025. The company's focus is on developing TH103, a novel anti-VEGF treatment for retinal diseases, specifically engineered to address limitations in current neovascular Age-related Macular Degeneration (nAMD) therapies.
The clinical-stage biopharmaceutical company's lead candidate has shown promising preclinical results with potent anti-VEGF activity and sustained ocular residence time. Initial data from Part 1 of the ongoing Phase 1 trial in nAMD patients is expected in H2 2025.
Following the merger, Kalaris has approximately $100 million in cash and cash equivalents, projected to fund operations into Q4 2026, extending beyond the planned Phase 2 clinical trial initiation.
Kalaris Therapeutics (NASDAQ: KLRS) ha completato la sua fusione con AlloVir, con le azioni che inizieranno a essere scambiate su Nasdaq dal 19 marzo 2025. L'azienda si concentra sullo sviluppo di TH103, un nuovo trattamento anti-VEGF per le malattie retiniche, progettato specificamente per affrontare le limitazioni delle attuali terapie per la Degenerazione Maculare Neovascolare legata all'età (nAMD).
Il candidato principale della compagnia biopharmaceutica in fase clinica ha mostrato risultati preclinici promettenti con una potente attività anti-VEGF e un tempo di residenza oculare sostenuto. I dati iniziali della Parte 1 della fase 1 in corso sui pazienti con nAMD sono attesi nel secondo semestre del 2025.
Dopo la fusione, Kalaris dispone di circa $100 milioni in contante e equivalenti, previsti per finanziare le operazioni fino al quarto trimestre del 2026, oltre l'avvio previsto della fase 2 della sperimentazione clinica.
Kalaris Therapeutics (NASDAQ: KLRS) ha completado su fusión con AlloVir, con las acciones que comenzarán a cotizar en Nasdaq a partir del 19 de marzo de 2025. La empresa se centra en el desarrollo de TH103, un nuevo tratamiento anti-VEGF para enfermedades retinianas, diseñado específicamente para abordar las limitaciones de las terapias actuales para la Degeneración Macular Neovascular relacionada con la edad (nAMD).
El candidato principal de la compañía biofarmacéutica en etapa clínica ha mostrado resultados preclínicos prometedores con una potente actividad anti-VEGF y un tiempo de residencia ocular sostenido. Se esperan datos iniciales de la Parte 1 del ensayo clínico de fase 1 en pacientes con nAMD en la segunda mitad de 2025.
Tras la fusión, Kalaris tiene aproximadamente $100 millones en efectivo y equivalentes, proyectados para financiar operaciones hasta el cuarto trimestre de 2026, más allá del inicio previsto del ensayo clínico de fase 2.
칼라리스 테라퓨틱스 (NASDAQ: KLRS)가 알로비르와의 합병을 완료했으며, 주식은 2025년 3월 19일부터 나스닥에서 거래될 예정이다. 이 회사는 TH103의 개발에 집중하고 있으며, 이는 연령 관련 황반변성(nAMD) 치료의 한계를 해결하기 위해 특별히 설계된 새로운 항-VEGF 치료제이다.
임상 단계의 생물 제약 회사의 주요 후보는 강력한 항-VEGF 활성을 보이며 지속적인 안구 체류 시간을 가진 유망한 전임상 결과를 보여주었다. nAMD 환자에 대한 진행 중인 1상 시험의 1부에서 초기 데이터는 2025년 하반기에 예상된다.
합병 후, 칼라리스는 약 $100 백만의 현금 및 현금성 자산을 보유하고 있으며, 이는 2026년 4분기까지 운영 자금을 지원할 것으로 예상되며, 예정된 2상 임상 시험 개시를 넘어선다.
Kalaris Therapeutics (NASDAQ: KLRS) a finalisé sa fusion avec AlloVir, les actions devant être négociées sur le Nasdaq à partir du 19 mars 2025. L'entreprise se concentre sur le développement de TH103, un nouveau traitement anti-VEGF pour les maladies rétiniennes, spécialement conçu pour répondre aux limitations des thérapies actuelles pour la Dégénérescence Maculaire Neovasculaire liée à l'âge (nAMD).
Le candidat principal de l'entreprise biopharmaceutique en phase clinique a montré des résultats précliniques prometteurs avec une activité anti-VEGF puissante et un temps de résidence oculaire prolongé. Les données initiales de la Partie 1 de l'essai clinique de phase 1 en cours chez des patients atteints de nAMD sont attendues au second semestre 2025.
Suite à la fusion, Kalaris dispose d'environ $100 millions en liquidités et équivalents, prévus pour financer les opérations jusqu'au quatrième trimestre 2026, au-delà du début prévu de l'essai clinique de phase 2.
Kalaris Therapeutics (NASDAQ: KLRS) hat seine Fusion mit AlloVir abgeschlossen, und die Aktien werden ab dem 19. März 2025 an der Nasdaq gehandelt. Das Unternehmen konzentriert sich auf die Entwicklung von TH103, einer neuartigen anti-VEGF-Behandlung für Netzhauterkrankungen, die speziell entwickelt wurde, um die Einschränkungen der aktuellen Therapien für die neovaskuläre altersbedingte Makuladegeneration (nAMD) anzugehen.
Der Hauptkandidat des biopharmazeutischen Unternehmens in der klinischen Phase hat vielversprechende präklinische Ergebnisse mit starker anti-VEGF-Aktivität und langanhaltender okulärer Verweildauer gezeigt. Erste Daten aus Teil 1 der laufenden Phase-1-Studie bei nAMD-Patienten werden im zweiten Halbjahr 2025 erwartet.
Nach der Fusion verfügt Kalaris über etwa $100 Millionen an Bargeld und liquiden Mitteln, die voraussichtlich bis ins vierte Quartal 2026 für den Betrieb ausreichen werden, und dies über den geplanten Beginn der Phase-2-Studie hinaus.
- $100M cash position funds operations through Q4 2026
- Successful completion of merger with AlloVir
- Nasdaq listing secured under KLRS ticker
- Phase 1 trial actively enrolling patients
- Initial clinical data not available until H2 2025
- Early-stage company with no approved products
- Currently in Phase 1 trials only
Insights
The Kalaris-AlloVir merger marks a strategic move in the ophthalmology space, particularly for retinal disease treatments. Kalaris is developing TH103, a novel anti-VEGF therapy engineered to address treatment durability limitations in neovascular Age-related Macular Degeneration (nAMD).
The anti-VEGF market for retinal diseases is substantial but challenging, dominated by established therapies like Eylea, Lucentis, and newer entrants like Vabysmo. The key differentiator for TH103 appears to be its potential for longer-lasting activity, which directly addresses the treatment burden issue for patients who currently require frequent intravitreal injections.
Preclinical data showing "potent anti-VEGF activity and sustained ocular residence time" is promising but preliminary. The ongoing Phase 1 trial represents their first human data, with initial results expected in H2 2025. This timeline suggests a complete clinical development pathway extending several years before potential commercialization.
The ophthalmology development landscape demands significant investment, making their
This merger provides Kalaris with two critical resources: public market access and a
The transaction structure appears to be a reverse merger, allowing Kalaris to gain Nasdaq listing (KLRS) through AlloVir's existing infrastructure. While specific transaction terms aren't disclosed, this approach is typically more capital-efficient than traditional IPOs for biotech companies.
Investors should note the extended timeline to clinical validation. With initial Phase 1 data expected in H2 2025, meaningful efficacy signals remain over a year away. The cash runway into Q4 2026 suggests confidence in their ability to advance through early clinical development, but additional financing will likely be required before reaching commercialization.
The retinal therapeutics market represents a multi-billion dollar opportunity, particularly for treatments that can reduce injection frequency while maintaining efficacy. However, competition is intense with both established players and new entrants. The transaction provides necessary resources for development but success remains contingent on clinical data that won't materialize until late 2025.
Kalaris is focused on developing 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
Currently enrolling nAMD patients in a Phase 1 trial, with initial data from Part 1 of the trial expected in the second half of 2025
Post-transaction cash of approximately
operations into the fourth quarter of 2026
Shares expected to trade on Nasdaq under “KLRS”, effective March 19, 2025
PALO ALTO, Calif., March 18, 2025 (GLOBE NEWSWIRE) -- Kalaris Therapeutics, Inc. (Nasdaq: KLRS)(“Kalaris”), a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent diseases of the retina, today announced the completion of its previously announced merger with AlloVir, Inc. (“AlloVir”). The combined company will operate under the name Kalaris Therapeutics, Inc. and its shares are expected to begin trading on The Nasdaq Global Market on March 19, 2025 under the ticker symbol “KLRS.”
Kalaris is currently developing TH103, a novel, differentiated anti-vascular endothelial growth factor (“VEGF”) agent engineered to potentially provide longer-lasting and increased anti-VEGF activity to treat neovascular and exudative diseases of the retina. TH103 was specifically engineered to address the limitations of current neovascular Age-related Macular Degeneration (“nAMD”) therapies and has demonstrated both potent anti-VEGF activity and sustained ocular residence time in preclinical studies. Kalaris expects to report initial data from Part 1 of its ongoing Phase 1 clinical trial of TH103 in the second half of 2025.
The combined company’s cash and cash equivalents of approximately
About TH103 Phase 1 Clinical Trial
The ongoing Phase 1 open label clinical trial is evaluating TH103 in treatment-naïve nAMD patients. Enrollment in Part 1 of the trial began in August 2024, with initial data expected in the second half of 2025. The Phase 1 clinical trial is designed to evaluate safety, pharmacodynamics/pharmacokinetics, determine optimal dose, and assess preliminary evidence of treatment effect.
Transaction Details
Immediately following the closing of the merger, there are approximately 18,702,413 shares of the combined company’s common stock outstanding, with pre-merger Kalaris stockholders owning approximately
Leerink Partners acted as exclusive financial advisor to AlloVir, and Goodwin Procter LLP served as legal counsel to AlloVir. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Kalaris.
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, future financial position, projected costs, prospects, plans and objectives of management of Kalaris, including those relating to the merger, the therapeutic potential of TH103, the anticipated timeline for reporting data from the ongoing 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; 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’ period 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
+1 212 915 2577
cdavis@lifesciadvisors.com
FAQ
When will Kalaris (KLRS) report initial Phase 1 trial results for TH103?
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What is the therapeutic target of Kalaris's (KLRS) lead drug candidate TH103?
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