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Earnings documents stored for KLRS.
Investor releaseQuarter not tagged2026-08-11Kalaris Reports Second Quarter 2026 Financial Results and Provides Business Updates
GlobeNewswire
Kalaris Reports Second Quarter 2026 Financial Results and Provides Business Updates
Patient dosing is ongoing in the Phase 1b/2 study of TH103; preliminary data anticipated in 1H 2027 Potential Phase 3 clinical trials remain on track for initiation by year-end 2027 $93.5 million in cash, cash equivalents and marketable securities as of June 30, 2026 is expected to fund operations into the fourth quarter of 2027 and through key clinical milestones BERKELEY HEIGHTS, N.J., Aug. 11, 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 second quarter ended June 30, 2026 and provided business updates. “We made significant advances over the second quarter,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “We successfully manufactured new batches of clinical material and are currently dosing patients in our Phase 1b/2 study of TH103 for neovascular Age-related Macular Degeneration. We recently released expanded Phase 1a data for TH103 which continues to strengthen our confidence in potential TH103 differentiation. The additional data is consistent with the initial structural, functional and pharmacokinetic findings and reinforces our belief that TH103 has the potential to offer a best-in-class treatment option for patients with neovascular AMD.” Business Updates Recently released Phase 1a data from expanded patient cohorts that reinforce the positive BCVA, OCT, pharmacokinetic and time-to-retreatment findings observed in the original patient cohorts. New manufacturing batch completed including process enhancements that have further reduced already low levels of process impurities. Kalaris is currently conducting a Phase 1b/2, multi-ascending dose, dose-finding study evaluating up to four monthly loading doses of TH103. The study aims to assess the safety and efficacy of repeat doses of TH103 at different dose levels and to identify the optimal dose and regimen for potential Phase 3 development. Preliminary data from the Phase 1b/2 study is expected in the first half of 2027. As previously announced, Kalaris expanded its leadership team with the hire of Liisa Bayko as Chief Financial Officer. Ms. Bayko brings more than two decades of experience in biotechnology finance, strategy, and capital markets, most recently serving a…Read full documentShow less
Patient dosing is ongoing in the Phase 1b/2 study of TH103; preliminary data anticipated in 1H 2027 Potential Phase 3 clinical trials remain on track for initiation by year-end 2027 $93.5 million in cash, cash equivalents and marketable securities as of June 30, 2026 is expected to fund operations into the fourth quarter of 2027 and through key clinical milestones BERKELEY HEIGHTS, N.J., Aug. 11, 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 second quarter ended June 30, 2026 and provided business updates. “We made significant advances over the second quarter,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “We successfully manufactured new batches of clinical material and are currently dosing patients in our Phase 1b/2 study of TH103 for neovascular Age-related Macular Degeneration. We recently released expanded Phase 1a data for TH103 which continues to strengthen our confidence in potential TH103 differentiation. The additional data is consistent with the initial structural, functional and pharmacokinetic findings and reinforces our belief that TH103 has the potential to offer a best-in-class treatment option for patients with neovascular AMD.” Business Updates Recently released Phase 1a data from expanded patient cohorts that reinforce the positive BCVA, OCT, pharmacokinetic and time-to-retreatment findings observed in the original patient cohorts. New manufacturing batch completed including process enhancements that have further reduced already low levels of process impurities. Kalaris is currently conducting a Phase 1b/2, multi-ascending dose, dose-finding study evaluating up to four monthly loading doses of TH103. The study aims to assess the safety and efficacy of repeat doses of TH103 at different dose levels and to identify the optimal dose and regimen for potential Phase 3 development. Preliminary data from the Phase 1b/2 study is expected in the first half of 2027. As previously announced, Kalaris expanded its leadership team with the hire of Liisa Bayko as Chief Financial Officer. Ms. Bayko brings more than two decades of experience in biotechnology finance, strategy, and capital markets, most recently serving as Managing Director and Senior Biotechnology Analyst at Evercore ISI, where she was consistently recognized as one of the industry’s top-ranked analysts covering small- and mid-cap biotechnology companies. As announced recently, Kalaris appointed Laurie Keating to its Board of Directors. Ms. Keating brings extensive experience as a biotechnology executive and board member to assist Kalaris in achieving its next phase of growth. Financial Results for the Second Quarter Ended June 30, 2026 Cash, Cash Equivalents and Marketable Securities: As of June 30, 2026, Kalaris had cash, cash equivalents and marketable securities of $93.5 million, compared with cash, cash equivalents and marketable securities of $118.0 million as of December 31, 2025. The decrease in cash, cash equivalents and marketable securities was primarily a result of cash used in operating activities during the period. Kalaris expects that its cash, cash equivalents and marketable securities as of June 30, 2026 will be sufficient to fund its operations into the fourth quarter of 2027. Research and Development Expenses: Research and development expenses were $9.0 million for the quarter ended June 30, 2026, compared with $8.4 million for the quarter ended June 30, 2025. The increase was primarily attributable to an increase in Contract Research Organization and other clinical expenses as Kalaris opened additional investigational sites and enrolled patients in its clinical program for TH103, offset by a decrease in expenses related to manufacturing and process development activities. General and Administrative Expenses: General and administrative expenses were $3.4 million for the quarter ended June 30, 2026, compared with $3.8 million for the quarter ended June 30, 2025. The decrease was primarily attributable to decreased legal, accounting, and other professional fees. Net Loss: For the quarter ended June 30, 2026, net loss was $11.5 million compared with a net loss of $11.4 million for the quarter ended June 30, 2025. The total number of shares of common stock outstanding as of June 30, 2026 was 23,804,981. 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 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; 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 [email protected]@kalaristx.com
Investor releaseQuarter not tagged2026-07-17Kalaris Therapeutics Reports Positive TH103 Phase 1a SAD Results from Expanded Neovascular AMD Cohorts
GlobeNewswire
Kalaris Therapeutics Reports Positive TH103 Phase 1a SAD Results from Expanded Neovascular AMD Cohorts
Data from the expanded cohorts reinforce the positive BCVA, OCT, pharmacokinetic and time-to-retreatment findings observed in the original cohorts Enrollment in the Phase 1b/2 multiple-ascending dose trial of TH103 continues, with preliminary data on track for 1H 2027 BERKELEY HEIGHTS, N.J., July 17, 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 positive additional data from its Phase 1a single ascending dose (SAD) trial of TH103 in neovascular age-related macular degeneration (AMD). Data from the expanded cohorts build on previously reported positive findings from the trial, with additional patients showing improvements in vision and retinal anatomy and further supporting the potential for extended treatment durability after a standard four-dose loading regimen. The updated SAD results will be presented today at 8:00 am EDT by Dr. Joel Pearlman, MD, PhD, at the American Society of Retina Specialists (ASRS) Annual Meeting. The expanded Phase 1a SAD dataset now includes a total of 17 treatment-naive patients, as well as an additional 3 treatment-experienced patients which were included in the safety cohort. All 20 patients completed six months of follow-up. Consistent with Kalaris’ previously reported findings, the expanded efficacy analysis, which includes the 17 treatment-naïve patients, continued to demonstrate robust structural and functional improvements. TH103 plasma pharmacokinetic findings continued to suggest greater intraocular retention, with 27- to 53-fold lower Cmax compared to current leading anti-VEGF agents on a molar equivalence basis. Additionally, the time to retreatment results further supported the hypothesis that increased intraocular retention may contribute to prolonged biological activity: following only a single TH103 injection, 41% of treatment-naïve patients (N=17) received a first retreatment at 4 months or later, 35% at 5 months or later, and 29% received no additional anti-VEGF treatment during the entire six-month follow-up period. Separately, after a single TH103 injection, time to retreatment in treatment-experienced patients (N=3) was extended by an average of 2 months compared with prior anti-VEGF treatment intervals. No cases of intraoc…Read full documentShow less
Data from the expanded cohorts reinforce the positive BCVA, OCT, pharmacokinetic and time-to-retreatment findings observed in the original cohorts Enrollment in the Phase 1b/2 multiple-ascending dose trial of TH103 continues, with preliminary data on track for 1H 2027 BERKELEY HEIGHTS, N.J., July 17, 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 positive additional data from its Phase 1a single ascending dose (SAD) trial of TH103 in neovascular age-related macular degeneration (AMD). Data from the expanded cohorts build on previously reported positive findings from the trial, with additional patients showing improvements in vision and retinal anatomy and further supporting the potential for extended treatment durability after a standard four-dose loading regimen. The updated SAD results will be presented today at 8:00 am EDT by Dr. Joel Pearlman, MD, PhD, at the American Society of Retina Specialists (ASRS) Annual Meeting. The expanded Phase 1a SAD dataset now includes a total of 17 treatment-naive patients, as well as an additional 3 treatment-experienced patients which were included in the safety cohort. All 20 patients completed six months of follow-up. Consistent with Kalaris’ previously reported findings, the expanded efficacy analysis, which includes the 17 treatment-naïve patients, continued to demonstrate robust structural and functional improvements. TH103 plasma pharmacokinetic findings continued to suggest greater intraocular retention, with 27- to 53-fold lower Cmax compared to current leading anti-VEGF agents on a molar equivalence basis. Additionally, the time to retreatment results further supported the hypothesis that increased intraocular retention may contribute to prolonged biological activity: following only a single TH103 injection, 41% of treatment-naïve patients (N=17) received a first retreatment at 4 months or later, 35% at 5 months or later, and 29% received no additional anti-VEGF treatment during the entire six-month follow-up period. Separately, after a single TH103 injection, time to retreatment in treatment-experienced patients (N=3) was extended by an average of 2 months compared with prior anti-VEGF treatment intervals. No cases of intraocular inflammation (IOI) were observed among the six patients treated at the 2.5 mg dose using product manufactured following process adjustments to reduce impurities. As previously reported, one patient treated at the 5 mg dose experienced transient IOI that resolved without sequelae. “The expanded Phase 1a SAD dataset continues to strengthen our confidence in potential TH103 differentiation,” said Andrew Oxtoby, CEO of Kalaris Therapeutics. “The consistency of the structural, functional and pharmacokinetic findings reinforces our belief that TH103 has the potential to offer a best-in-class treatment option for patients with neovascular AMD.” Building on these findings, Kalaris is actively enrolling and dosing patients in its ongoing Phase 1b/2 study aimed at evaluating a standard four-dose loading regimen of TH103 in treatment-naïve patients using an ascending-dose design. The study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of repeated TH103 intravitreal injections as well as time to retreatment following a complete loading course. Study results will inform dose selection for potential future Phase 3 trials of TH103, and Kalaris remains on track to share initial data from the Phase 1b/2 study in the first half of 2027. About TH103 TH103 is a potential best-in-class, investigational dual-targeting biologic 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 AMD, diabetic eye disease and retinal vein occlusion. TH103 is currently being investigated in a Phase 1b/2 clinical trial in patients with neovascular Age-related Macular Degeneration (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, prospects, 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; plans to advance TH103 into Phase 3 clinical trials and to develop TH103 for additional indications, plans to improve the manufacturing process for 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. 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; 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; 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 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, LLC+1 212 915 [email protected] [email protected]
Investor releaseQuarter not tagged2026-05-12Kalaris Reports First Quarter 2026 Financial Results and Provides Business Updates
GlobeNewswire
Kalaris Reports First Quarter 2026 Financial Results and Provides Business Updates
Patient screening now underway in the Phase 1b/2 study with the latest drug product batch on track to be available to support upcoming dosing; preliminary data anticipated in 1H 2027 Planned Phase 3 clinical trials remain on track for 2027 year-end initiation $104.9 million in cash, cash equivalents and marketable securities as of March 31, 2026 is expected to fund operations into the fourth quarter of 2027 and through key clinical milestones BERKELEY HEIGHTS, N.J., May 12, 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 first quarter ended March 31, 2026 and provided business updates. “I am happy to report that new batches of clinical material have been manufactured and are undergoing packaging and labeling, and we are currently screening patients for dosing in our Phase 1b/2 study of TH103 for neovascular Age-related Macular Degeneration,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “Our Phase 1b/2 multiple ascending dose trial is designed to accelerate TH103’s clinical development and inform dose selection for potential future Phase 3 development, and we look forward to sharing data from this ongoing trial in the first half of 2027.” Q1 2026 - Business Updates On February 26th, Dean Eliott, MD, presented previously shared positive initial Phase 1a data at the 49th Annual Meeting of the Macula Society. New manufacturing batch completed including process enhancements that have further reduced already low levels of process impurities. Kalaris is currently conducting a Phase 1b/2, multi-ascending dose, dose-finding study evaluating four monthly loading doses of TH103. The study aims to assess the safety and efficacy of repeat doses of TH103 at different dose levels and to identify the optimal dose and regimen for potential Phase 3 development. Preliminary data from the Phase 1b/2 study is expected in the first half of 2027. Financial Results for the First Quarter Ended March 31, 2026 Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026, Kalaris had cash, cash equivalents and marketable securities of $104.9 million, compared with cash and cash equivalents of $118.0 million as of December 31, 2025. The decrea…Read full documentShow less
Patient screening now underway in the Phase 1b/2 study with the latest drug product batch on track to be available to support upcoming dosing; preliminary data anticipated in 1H 2027 Planned Phase 3 clinical trials remain on track for 2027 year-end initiation $104.9 million in cash, cash equivalents and marketable securities as of March 31, 2026 is expected to fund operations into the fourth quarter of 2027 and through key clinical milestones BERKELEY HEIGHTS, N.J., May 12, 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 first quarter ended March 31, 2026 and provided business updates. “I am happy to report that new batches of clinical material have been manufactured and are undergoing packaging and labeling, and we are currently screening patients for dosing in our Phase 1b/2 study of TH103 for neovascular Age-related Macular Degeneration,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “Our Phase 1b/2 multiple ascending dose trial is designed to accelerate TH103’s clinical development and inform dose selection for potential future Phase 3 development, and we look forward to sharing data from this ongoing trial in the first half of 2027.” Q1 2026 - Business Updates On February 26th, Dean Eliott, MD, presented previously shared positive initial Phase 1a data at the 49th Annual Meeting of the Macula Society. New manufacturing batch completed including process enhancements that have further reduced already low levels of process impurities. Kalaris is currently conducting a Phase 1b/2, multi-ascending dose, dose-finding study evaluating four monthly loading doses of TH103. The study aims to assess the safety and efficacy of repeat doses of TH103 at different dose levels and to identify the optimal dose and regimen for potential Phase 3 development. Preliminary data from the Phase 1b/2 study is expected in the first half of 2027. Financial Results for the First Quarter Ended March 31, 2026 Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026, Kalaris had cash, cash equivalents and marketable securities of $104.9 million, compared with cash and cash equivalents of $118.0 million as of December 31, 2025. The decrease in cash, cash equivalents and marketable securities was primarily a result of cash used in operating activities during the period. Kalaris expects that its cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund its operations into the fourth quarter of 2027. Research and Development Expenses: Research and development expenses were $7.6 million for the quarter ended March 31, 2026, compared with $6.0 million for the quarter ended March 31, 2025. The increase was primarily attributable to an increase in CRO and other clinical expenses as Kalaris opened additional investigational sites and enrolled patients in our clinical program. General and Administrative Expenses: General and administrative expenses were $4.3 million for the quarter ended March 31, 2026, compared with $4.3 million for the quarter ended March 31, 2025. Net Loss: For the quarter ended March 31, 2026, net loss was $10.9 million compared with a net loss of $10.2 million for the quarter ended March 31, 2025. The total number of shares of common stock outstanding as of March 31, 2025 was 22,992,291. 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, projected costs, prospects, 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; 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; 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 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 [email protected] [email protected]
Investor releaseQuarter not tagged2026-03-17Kalaris Reports Full Year 2025 Financial Results and Provides Business Updates
GlobeNewswire
Kalaris Reports Full Year 2025 Financial Results and Provides Business Updates
Positive initial data reported from Phase 1a Single Ascending Dose study in nAMD in December 2025; preliminary data from ongoing Phase 1b/2 study expected in 1H 2027 Intend to initiate Phase 3 clinical trials by year-end 2027 Completed oversubscribed $50.0 million private placement in December 2025 $118.0 million in cash, cash equivalents and marketable securities as of December 31, 2025 is expected to fund operations into the fourth quarter of 2027 and through key clinical milestones BERKELEY HEIGHTS, N.J., March 17, 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 full year ended December 31, 2025 and provided business updates. “This past year was truly transformational for Kalaris,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “Following our initial listing as a public company in March 2025, we continued to advance our clinical program for TH103 throughout the year, culminating with the disclosure of positive initial Phase 1a single ascending dose data and concurrent oversubscribed private placement. In Q3 2025, we began to enroll patients in our Phase 1b/2 multiple ascending dose trial which is designed to accelerate TH103’s clinical development and inform dose selection for potential future Phase 3 development.” Q4 2025 - Business Updates Positive initial Phase 1a data reported in December 2025. The Phase 1a study evaluated a single intravitreal injection of TH103 at three dose levels (0.5 mg, 1.5 mg, 2.5 mg) in treatment-naïve nAMD patients. Thirteen patients completed 6 months of follow-up. Results demonstrated clinical activity on visual acuity and retinal anatomy, as well as pharmacokinetic data that support TH103’s molecular design and preclinical profile, including: Mean 10-letter best corrected visual acuity (BCVA) improvement Mean 129μm improvement in central subfield thickness (CST) Mean ~95% reduction in central subfield intraretinal fluid 27 to 51-fold lower mean plasma Cmax than current leading approved anti-VEGF agents TH103 was generally well-tolerated and that data supported further dose escalation. No dose-limiting toxicities or treatment-related serious adverse events were observed in the Phase 1a study.…Read full documentShow less
Positive initial data reported from Phase 1a Single Ascending Dose study in nAMD in December 2025; preliminary data from ongoing Phase 1b/2 study expected in 1H 2027 Intend to initiate Phase 3 clinical trials by year-end 2027 Completed oversubscribed $50.0 million private placement in December 2025 $118.0 million in cash, cash equivalents and marketable securities as of December 31, 2025 is expected to fund operations into the fourth quarter of 2027 and through key clinical milestones BERKELEY HEIGHTS, N.J., March 17, 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 full year ended December 31, 2025 and provided business updates. “This past year was truly transformational for Kalaris,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “Following our initial listing as a public company in March 2025, we continued to advance our clinical program for TH103 throughout the year, culminating with the disclosure of positive initial Phase 1a single ascending dose data and concurrent oversubscribed private placement. In Q3 2025, we began to enroll patients in our Phase 1b/2 multiple ascending dose trial which is designed to accelerate TH103’s clinical development and inform dose selection for potential future Phase 3 development.” Q4 2025 - Business Updates Positive initial Phase 1a data reported in December 2025. The Phase 1a study evaluated a single intravitreal injection of TH103 at three dose levels (0.5 mg, 1.5 mg, 2.5 mg) in treatment-naïve nAMD patients. Thirteen patients completed 6 months of follow-up. Results demonstrated clinical activity on visual acuity and retinal anatomy, as well as pharmacokinetic data that support TH103’s molecular design and preclinical profile, including: Mean 10-letter best corrected visual acuity (BCVA) improvement Mean 129μm improvement in central subfield thickness (CST) Mean ~95% reduction in central subfield intraretinal fluid 27 to 51-fold lower mean plasma Cmax than current leading approved anti-VEGF agents TH103 was generally well-tolerated and that data supported further dose escalation. No dose-limiting toxicities or treatment-related serious adverse events were observed in the Phase 1a study. TH103’s initial pharmacokinetic profile aligns with the molecule's engineered properties and preclinical data demonstrating prolonged intraocular residence time. Based on the positive Phase 1a data, Kalaris is currently conducting a Phase 1b/2, multi-ascending dose, dose-finding study evaluating four monthly loading doses of TH103. The study aims to assess the safety and efficacy of repeat doses of TH103 at different dose levels and to identify the optimal dose and regimen for potential Phase 3 development. Preliminary data from the Phase 1b/2 study is expected in the first half of 2027. As announced in December 2025, Kalaris completed a private placement for aggregate gross proceeds of $50.0 million. Financial Results for the Year Ended December 31, 2025 Cash, Cash Equivalents and Marketable Securities: As of December 31, 2025, Kalaris had cash, cash equivalents and marketable securities of $118.0 million, compared with cash and cash equivalents of $1.6 million as of December 31, 2024. The increase in cash, cash equivalents and marketable securities was primarily a result of the completion of its merger with AlloVir in March 2025 and the closing of its private placement in December 2025. Kalaris expects that its cash, cash equivalents and marketable securities as of December 31, 2025 will be sufficient to fund its operations into the fourth quarter of 2027. Research and Development Expenses: Research and development expenses were $30.8 million for the year ended December 31, 2025, compared with $45.0 million for the year ended December 31, 2024. The decrease was primarily attributable to a $32.0 million royalty obligation expense for a Royalty agreement that Kalaris entered into with Samsara BioCapital, LP in July 2024, offset by an increase in costs related to the outsourcing of manufacturing and clinical-related costs to support the Phase 1a and Phase 1b/2 clinical trials. General and Administrative Expenses: General and administrative expenses were $15.4 million for the year ended December 31, 2025, compared with $6.7 million for the year ended December 31, 2024. The increase was primarily attributable to an increase in insurance, legal, accounting, and other professional fees and personnel related costs to support operating as a public company. Net Loss: For the year ended December 31, 2025, net loss was $43.4 million compared with a net loss of $69.2 million for the year ended December 31, 2024. The total number of shares of common stock outstanding as of December 31, 2025 was 22,902,418. 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, projected costs, prospects, 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; plans to advance TH103 into Phase 3 clinical trials and to develop TH103 for additional indications; plans to improve the manufacturing process for TH103; 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; 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 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 [email protected] [email protected]
Investor releaseQuarter not tagged2025-12-18Kalaris Posts Positive Results from Macular Degeneration Drug Trial
MT Newswires
Kalaris Posts Positive Results from Macular Degeneration Drug Trial
Kalaris Therapeutics (KLRS) reported late Wednesday positive initial data from its Phase 1a trial of
Investor releaseQuarter not tagged2025-11-12Kalaris Reports Third Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
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 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., 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." Bus…Read full documentShow less
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 $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., 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 $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. Research 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. 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 [email protected] [email protected]
Investor releaseQuarter not tagged2025-08-13Kalaris Reports Second Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
Kalaris Reports Second Quarter 2025 Financial Results and Provides Business Updates
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 $88.4M as of June 30, 2025, expected to fund operations into Q4 2026 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 $88.4 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. Research and Development Expenses: Research and development expe…Read full documentShow less
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 $88.4M as of June 30, 2025, expected to fund operations into Q4 2026 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 $88.4 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. Research and Development Expenses: Research and development expenses were $8.4 million for the quarter ended June 30, 2025, compared with $3.2 million for the quarter ended June 30, 2024. The increase quarter-over-quarter was primarily attributable to an increase in costs related to the outsourcing of manufacturing and clinical-related costs as Kalaris initiated its Phase 1 clinical trial in June 2024. General and Administrative Expenses: General and administrative expenses were $3.8 million for the quarter ended June 30, 2025, compared with $1.0 million for the quarter ended June 30, 2024. The increase quarter-over-quarter was primarily attributable to an increase in insurance, legal, accounting, and professional fees associated with operating as a public company. Net Loss: For the quarter ended June 30, 2025, net loss was $11.4 million or $0.61 per share, compared with a net loss of $5.7 million or $4.26 per share for the quarter ended June 30, 2024. The total number of shares of common stock outstanding as of June 30, 2025 was 18,702,418. 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 [email protected] [email protected]
Investor releaseQuarter not tagged2025-05-14Kalaris Reports First Quarter 2025 Financial Results and Provides Business Highlights
GlobeNewswire
Kalaris Reports First Quarter 2025 Financial Results and Provides Business Highlights
Actively enrolling 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 $101M as of March 31, 2025, expected to fund operations into Q4 2026 PALO ALTO, Calif., May 14, 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 financial results for the first quarter ended March 31, 2025 and provided a business update. “We are excited by our progress in 2025,” said Andrew Oxtoby, Chief Executive Officer of Kalaris. “We recently completed our merger with Allovir, and our Phase 1 trial investigating TH103 for nAMD is well underway. TH103 was engineered by VEGF pioneer, Napoleone Ferrara, MD, to address the limitations of current nAMD therapies and has demonstrated both potent anti-VEGF activity and sustained ocular residence time in preclinical studies. TH103 has the potential to provide longer-lasting and increased anti-VEGF activity to treat neovascular and exudative diseases of the retina. We look forward to reporting the initial clinical data from our Phase 1 trial in the fourth quarter of this year.” Business Highlights Kalaris is currently enrolling a Phase 1, single ascending dose trial to assess the safety, pharmacokinetics, and preliminary treatment effect of TH103 in nAMD patients. Initial clinical data is expected in the fourth quarter of 2025. As previously announced, Kalaris completed its merger with AlloVir in March 2025. As recently announced, Kalaris therapeutics had expanded its Board of Directors with the appointment of Leone Patterson as a director and Chair of the Audit Committee. Financial Results for the First Quarter Ended March 31, 2025 Cash and Cash Equivalents: As of March 31, 2025, Kalaris had cash and cash equivalents of $101.0 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. Research and Development Expenses: Research and development expenses were $6.0 million for…Read full documentShow less
Actively enrolling 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 $101M as of March 31, 2025, expected to fund operations into Q4 2026 PALO ALTO, Calif., May 14, 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 financial results for the first quarter ended March 31, 2025 and provided a business update. “We are excited by our progress in 2025,” said Andrew Oxtoby, Chief Executive Officer of Kalaris. “We recently completed our merger with Allovir, and our Phase 1 trial investigating TH103 for nAMD is well underway. TH103 was engineered by VEGF pioneer, Napoleone Ferrara, MD, to address the limitations of current nAMD therapies and has demonstrated both potent anti-VEGF activity and sustained ocular residence time in preclinical studies. TH103 has the potential to provide longer-lasting and increased anti-VEGF activity to treat neovascular and exudative diseases of the retina. We look forward to reporting the initial clinical data from our Phase 1 trial in the fourth quarter of this year.” Business Highlights Kalaris is currently enrolling a Phase 1, single ascending dose trial to assess the safety, pharmacokinetics, and preliminary treatment effect of TH103 in nAMD patients. Initial clinical data is expected in the fourth quarter of 2025. As previously announced, Kalaris completed its merger with AlloVir in March 2025. As recently announced, Kalaris therapeutics had expanded its Board of Directors with the appointment of Leone Patterson as a director and Chair of the Audit Committee. Financial Results for the First Quarter Ended March 31, 2025 Cash and Cash Equivalents: As of March 31, 2025, Kalaris had cash and cash equivalents of $101.0 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. Research and Development Expenses: Research and development expenses were $6.0 million for the quarter ended March 31, 2025, compared with $2.0 million for the quarter ended March 31, 2024. The increase quarter-over-quarter was primarily attributable to an increase in costs related to the outsourcing of manufacturing and clinical-related costs as Kalaris initiated its Phase 1 clinical trial in June 2024. General and Administrative Expenses: General and administrative expenses were $4.3 million for the quarter ended March 31, 2025, compared with $0.6 million for the quarter ended March 31, 2024. The increase quarter-over-quarter was primarily attributable to a one-time charge for AlloVir’s directors and officers’ liability insurance and an increase in legal, accounting, and professional fees associated with operating as a public company. Net Loss: For the quarter ended March 31, 2025, net loss was $10.2 million or $2.52 per share, compared with a net loss of $3.4 million or $2.60 per share for the quarter ended March 31, 2024. The total number of shares of common stock outstanding as of March 31, 2025 was 18,702,418. 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 trial of TH103 in nAMD, 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 [email protected] [email protected] Kalaris Therapeutics, Inc. Condensed Consolidated Balance Sheets (unaudited, in thousands)

