Kalaris Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 11, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 11, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001193125-26-219328
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001193125-26-344532
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 146 previous paragraphs and 149 current paragraphs.
109 unchanged; 29 reworded; 6 added; 7 removed; 1 previous and 5 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
In July 2026, we announced positive additional data from our Phase 1a single-ascending dose (“SAD”) clinical trial of TH103 for nAMD. The expanded Phase 1a SAD dataset included a total of 17 treatment-naive patients, as well as an additional three treatment-experienced patients which were included in the safety cohort. All 20 patients completed six months of follow-up. Consistent with the preliminary data from the Phase 1a clinical trial announced in December 2025, the additional data showed that TH103 was generally well tolerated and exhibited improvements on key functional and anatomical outcomes at 1-month post-dosing. Data from treatment-naive patients in the Phase 1a SAD trial (N=17) demonstrated a rapid, robust response on best corrected visual acuity (“BCVA”) and optical coherence tomography parameters across dose levels at one month following a single injection of TH103, including mean 9.2-letter BCVA improvement, mean 118μm improvement in central subfield thickness (“CST”), and mean 93% reduction in central subfield intraretinal fluid (“CSF”). 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 in treatment-naïve patients (N=17), 41% received a first retreatment at four months or later, 35% at five 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 treatment-experienced patients (N=3), time to retreatment was an average of two months longer than 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; one patient treated at the 5.0 mg dose experienced transient IOI that resolved without sequelae.
Current report
General and administrative expenses decreased by $0.4 million from $3.8 million for the three months ended June 30, 2025 to $3.4 million for the three months ended June 30, 2026. The decrease in general and administrative expenses was primarily attributable to a decrease of $0.3 million in legal, accounting and other professional fees.
Current report
Other income, net was $0.9 million for each of the three months ended June 30, 2026 and 2025 primarily consisted of interest income received from money market funds and U.S. government treasury securities.
Current report
Comparison of the Six Months Ended June 30, 2026 and 2025
Current report
Research and development expenses increased by $2.1 million, from $14.5 million for the six months ended June 30, 2025, to $16.6 million for the six months ended June 30, 2026.
Current report
Net cash used in operating activities was $22.6 million and $20.0 million for the six months ended June 30, 2026 and 2025, respectively.
Removed paragraphs (7)
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Other income, net
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Other income, net
Previous report
Net cash used in operating activities was $11.6 million and $7.4 million for the three months ended March 31, 2026 and 2025, respectively.
Reworded paragraphs (29)
Previous wording
We are developing TH103, a novel, clinical stage anti-vascular endothelial growth factor (“VEGF”) drug, specifically engineered to achieve extended intraocular retention with enhanced VEGF inhibition in patients with exudative and/or neovascular retinal diseases. TH103 is a fully humanized recombinant fusion protein, functioning as a “decoy receptor” (a VEGF trap), leveraging salient molecular properties of the human body’s native, highest affinity VEGF receptor 1. In head-to-head preclinical studies, TH103 showed more anti-VEGF activity and longer duration of activity compared to aflibercept, the current global market-leading anti-VEGF agent, which also functions as a decoy receptor VEGF trap but differs from TH103 in key molecular elements. Initial data from our Phase 1a single ascending dose (“SAD”) trial of TH103 in treatment-naïve neovascular Age-related Macular Degeneration (“nAMD”) patients showed that TH103 was generally well tolerated and exhibited improvements on functional and anatomical outcomes at 1-month post-dosing. Preliminary single dose pharmacokinetic data and retreatment results provide evidence that TH103 may offer extended treatment durability after a standard four-dose loading regimen.
Current wording
We are developing TH103, a novel, clinical stage anti-vascular endothelial growth factor (“VEGF”) drug, specifically engineered to achieve extended intraocular retention with enhanced VEGF inhibition in patients with exudative and/or neovascular retinal diseases. TH103 is a fully humanized recombinant fusion protein, functioning as a “decoy receptor” (a VEGF trap), leveraging salient molecular properties of the human body’s native, highest affinity VEGF receptor 1. In head-to-head preclinical studies, TH103 showed more anti-VEGF activity and longer duration of activity compared to aflibercept, the current global market-leading anti-VEGF agent, which also functions as a decoy receptor VEGF trap but differs from TH103 in key molecular elements. We are investigating TH103 as a treatment for patients with neovascular Age-related Macular Degeneration (“nAMD”), a leading cause of blindness in the United States and Europe that affects an estimated 1.6 million adults in the United States.
Previous wording
We are investigating TH103 as a treatment for patients with nAMD, a leading cause of blindness in the United States and Europe that affect an estimated 1.6 million adults in the United States. We are currently conducting a Phase 1b/2 multiple ascending dose clinical trial of TH103 in patients with nAMD, which is intended to build upon our ongoing Phase 1a single ascending dose clinical trial. The Phase 1b/2 dose-finding trial is designed to evaluate multiple dose levels of TH103 in approximately 60 to 80 nAMD patients. In the trial, patients are expected to receive four initial monthly intravitreal injections of TH103 and assessments are expected to include safety and preliminary efficacy with a primary time point for analysis at one month following the last injection. Patients will then be followed in an extension phase of the study. Following the implementation of additional manufacturing process refinements, new batches of clinical trial material were manufactured and scheduled to be delivered to trial sites in mid-May 2026 for our ongoing Phase 1b/2 multiple ascending dose study, and we are actively screening patients in anticipation of receiving the new batches and resuming dosing. Enrolled patients will receive four monthly loading doses of TH103 at a dose of 1.0 mg followed by dose escalation in subsequent cohorts per protocol. We expect to report preliminary data from the Phase 1b/2 clinical trial in the first half of 2027. Assuming successful completion of the ongoing Phase 1b/2 clinical trial of TH103, and subject to the favorable results from such trial and discussions with regulators, we intend to initiate Phase 3 clinical trials of TH103 for nAMD by year-end 2027. We also plan to expand the development of TH103 beyond nAMD into other prevalent VEGF-mediated retinal diseases, such as Diabetic Macular Edema (“DME”), diabetic retinopathy (“DR”), and Retinal Vein Occlusion (“RVO”).
Current wording
We are currently conducting a Phase 1b/2 multiple ascending dose clinical trial of TH103 in patients with nAMD, which is intended to build upon our Phase 1a single ascending dose clinical trial. The Phase 1b/2 dose-finding trial is designed to evaluate multiple dose levels of TH103 in up to 80 nAMD patients. In the trial, patients are expected to receive up to four monthly loading doses of intravitreally administered TH103 at a range of dose levels. Assessments are expected to include safety and preliminary efficacy with a primary time point for analysis at one month following the last TH103 injection. Patients will then be followed in an extension phase of the study. Following the implementation of additional manufacturing process refinements, patients in the Phase 1b/2 multiple ascending dose study are now receiving new batches of clinical trial material with lower levels of impurities. We expect to report preliminary data from the Phase 1b/2 clinical trial in the first half of 2027.
Previous wording
Since our inception in September 2019, we have devoted substantially all of our resources to organizing and staffing, business planning, raising capital, acquiring technology, establishing our intellectual property portfolio and performing research and development of our product candidate. We do not have any products approved for sale and have not generated any revenue from product sales or otherwise. We have incurred significant losses and negative cash flows from operations since our inception. Our net losses were $10.9 million and $10.2 million for the three months ended March 31, 2026 and 2025, respectively. Our negative cash flows from operations were $11.6 million and $7.4 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $170.9 million. To date, we have funded our operations primarily from sales of our redeemable convertible preferred stock, issuances of convertible promissory notes and a simple agreement for future equity (“SAFE”), from cash and cash equivalents of AlloVir, Inc. (“AlloVir”) received in the Merger (as defined below), and from proceeds from the 2025 Private Placement (as defined below).
Current wording
Since our inception in September 2019, we have devoted substantially all of our resources to organizing and staffing, business planning, raising capital, acquiring technology, establishing our intellectual property portfolio and performing research and development of our product candidate. We do not have any products approved for sale and have not generated any revenue from product sales or otherwise. We have incurred significant losses and negative cash flows from operations since our inception. Our net losses were $22.4 million and $21.5 million for the six months ended June 30, 2026 and 2025, respectively. Our negative cash flows from operations were $22.6 million and $20.0 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $182.4 million. To date, we have funded our operations primarily from sales of our redeemable convertible preferred stock, issuances of convertible promissory notes and a simple agreement for future equity (“SAFE”), from cash and cash equivalents of AlloVir, Inc. (“AlloVir”) received in the Merger (as defined below), and from proceeds from the 2025 Private Placement (as defined below).
Previous wording
As of March 31, 2026, we had $104.9 million in cash, cash equivalents and marketable securities. Based on our current operating plans, our management expects that our cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2027. However, management has based these estimates on assumptions that may prove to be wrong, and our operating plans may change as a result of many factors currently unknown to us. In addition, changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more than currently expected because of circumstances beyond our control. As a result, we could deplete our capital resources sooner than we currently expect.
Current wording
As of June 30, 2026, we had $93.5 million in cash, cash equivalents and marketable securities. Based on our current operating plans, our management expects that our cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2027. However, management has based these estimates on assumptions that may prove to be wrong, and our operating plans may change as a result of many factors currently unknown to us. In addition, changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more than currently expected because of circumstances beyond our control. As a result, we could deplete our capital resources sooner than we currently expect.
Previous wording
Additionally, in the spring of 2025, the U.S. government initiated a series of tariff-related actions against U.S. trading partners. Although several countries have threatened or imposed retaliatory measures in response, the U.S. reached agreements with a number of trading partners. The reciprocal tariffs and the fentanyl tariffs were imposed pursuant to the International Emergency Economic Powers Act, or the IEEPA. These tariffs were found to be unconstitutional by multiple federal courts in the spring and summer of 2025. However, the Trump Administration imposed a new 10% global tariff under Section 122 of the Trade Act of 1974, effective February 24, 2026. Tariff-related actions are likely to remain a prominent part of U.S. economic policy for the foreseeable future, which may introduce uncertainty in international trade, including impacts to the costs of materials and production processes, supply chain stability, and other factors. While we have not experienced, and do not currently expect to experience, any direct impact from these tariffs and retaliatory measures, the full extent of the future impact of these and other threatened measures remains uncertain. We continue to monitor these tariffs and retaliatory measures and their possible effects on our business.
Current wording
Additionally, in 2025, the U.S. government initiated a series of tariff-related actions against U.S. trading partners, described below under the heading, “Changes in and uncertainty surrounding U.S. and international trade policy could have a material adverse impact on our business, financial condition and results of operations” in Part II, Item 1A of this Quarterly Report . Tariff-related actions are likely to remain a prominent part of U.S. economic policy for the foreseeable future, which may introduce uncertainty in international trade, including impacts to the costs of materials and production processes, supply chain stability, and other factors. While we have not experienced, and do not currently expect to experience, any direct impact from these tariffs and retaliatory measures, the full extent of the future impact of these and other threatened measures remains uncertain. We continue to monitor these tariffs and retaliatory measures and their possible effects on our business.
Previous wording
We recognized $0.03 million and $0.1 million in patent reimbursement costs for the three months ended March 31, 2026 and 2025, respectively. We made a payment of $0.1 million in connection with our achievement of the first development milestone related to the dosing of the first patient in our Phase 1a clinical trial in August 2024. No other milestones were achieved or probable through March 31, 2026 and, therefore, for the three months ended March 31, 2026, no milestone expense was recognized.
Current wording
Patent reimbursement costs were immaterial for the three and six months ended June 30, 2026. We recognized an immaterial amount and $0.1 million in patent reimbursement costs for the three and six months ended June 30, 2025, respectively. We made a payment of $0.1 million in connection with our achievement of the first development milestone related to the dosing of the first patient in our Phase 1a clinical trial in August 2024. No other milestones were achieved or probable through June 30, 2026 and, therefore, for the three and six months ended June 30, 2026, no milestone expense was recognized.
Previous wording
Once royalty payments to Samsara are deemed probable and estimable, and if such amounts exceed the initially recorded royalty obligation balance, we will impute interest to accrete the liability on a prospective basis based on such estimates. If and when we make royalty payments under the Royalty Agreement, the royalty obligation balance will be reduced. As of March 31, 2026, royalty payments were not probable and estimable and, therefore, for the three months ended March 31, 2026, no interest expense was recognized for the royalty liability.
Current wording
Once royalty payments to Samsara are deemed probable and estimable, and if such amounts exceed the initially recorded royalty obligation balance, we will impute interest to accrete the liability on a prospective basis based on such estimates. If and when we make royalty payments under the Royalty Agreement, the royalty obligation balance will be reduced. As of June 30, 2026, royalty payments were not probable and estimable and, therefore, for the three and six months ended June 30, 2026, no interest expense was recognized for the royalty liability.
Previous wording
Other income, net includes interest income received from money market marketable securities, U.S. government treasury securities, and bank deposits, the amortization of premiums and accretion of discounts on U.S. government treasury securities, and realized and unrealized foreign currency gains (losses).
Current wording
Other income, net includes interest income received from money market funds, U.S. government treasury securities, and bank deposits, the amortization of premiums and accretion of discounts on U.S. government treasury securities, and realized and unrealized foreign currency gains (losses).
Previous wording
Research and development expenses increased by $1.5 million, from $6.0 million for the three months ended March 31, 2025, to $7.6 million for the three months ended March 31, 2026.
Current wording
Research and development expenses increased by $0.6 million, from $8.4 million for the three months ended June 30, 2025, to $9.0 million for the three months ended June 30, 2026.
Previous wording
CDMO, CRO and other third-party preclinical studies, clinical trials and consulting costs increased by $1.4 million as we initiated our Phase 1a clinical trial in TH103 in June 2024 and our Phase 1b/2 clinical trial in the third quarter of 2025. This was primarily driven by an increase of $1.8 million in CRO and other clinical expenses as we opened additional investigational sites and enrolled patients in our clinical program.
Current wording
CDMO, CRO and other third-party clinical trials and consulting costs increased by $0.5 million. This was primarily driven by an increase of $1.5 million in CRO and other clinical expenses as we opened additional investigational sites and enrolled patients in our clinical program, offset by a decrease of $1.0 million in CDMO manufacturing and process development activities.
Previous wording
Personnel related costs (including stock-based compensation) increased by $0.2 million due to hiring in our research and development organization to support our clinical trials and manufacturing.
Current wording
Personnel related costs (including stock-based compensation) increased by $0.3 million due to hiring in our research and development organization to support our clinical trials and manufacturing.
Previous wording
General and administrative expenses was $4.3 million for each of the three months ended March 31, 2026 and 2025. The immaterial decrease in general and administrative expenses was primarily attributable to a decrease of $1.3 million in directors’ and officers’ insurance due to a $1.5 million charge for directors' and officers' insurance for AlloVir, Inc. (“AlloVir”) following the closing of the Merger, offset by an increase of $0.8 million in personnel related expenses (including stock-based compensation) to support operating as a public company.
Current wording
General and administrative expenses decreased by $0.5 million, from $8.1 million for the six months ended June 30, 2025 to $7.6 million for the six months ended June 30, 2026. The decrease in general and administrative expenses was primarily attributable to a decrease of $1.3 million in directors’ and officers’ insurance due to a $1.5 million charge for directors' and officers' insurance for AlloVir, Inc. (“AlloVir”) following the closing of the Merger offset by an increase of $1.0 million in personnel related expenses (including stock-based compensation) to support operating as a public company.
Previous wording
For the three months ended March 31, 2025, we recognized a $0.4 million gain related to the changes in the fair value of tranche liability. The convertible promissory notes issued in the Convertible Note Financing in October and November 2024 and amended in November 2024 included three subsequent tranches for the issuance of convertible promissory notes at the predetermined conversion price that were concluded to be liabilities and are accounted for at fair value until the tranches’ expiration or settlement. In January 2025, as part of the first tranche of the Additional Permitted Bridge Financing, we issued additional convertible promissory notes for $3.75 million and one of three tranches was settled. In March 2025, we and other noteholders entered into an acknowledgment of conversion and termination agreement to cancel all unfunded tranches and the tranche liability expired unexercised.
Current wording
For the six months ended June 30, 2025, we recognized a $0.4 million gain related to the changes in the fair value of tranche liability. The convertible promissory notes issued in the Convertible Note Financing in October and November 2024 and amended in November 2024 included three subsequent tranches for the issuance of convertible promissory notes at the predetermined conversion price that were concluded to be liabilities and are accounted for at fair value until the tranches’ expiration or settlement. In January 2025, as part of the first tranche of the Additional Permitted Bridge Financing, we issued additional convertible promissory notes for $3.75 million and one of three tranches was settled. In March 2025, we and other noteholders entered into an acknowledgment of conversion and termination agreement to cancel all unfunded tranches and the tranche liability expired unexercised.
Previous wording
For the three months ended March 31, 2025, we recognized a $1.2 million gain related to the changes in the fair value of derivative liabilities embedded into convertible promissory notes issued to Samsara and other investors. All outstanding convertible promissory notes, other than the AlloVir Note, were converted into either shares of redeemable convertible preferred stock or common stock and the derivative liability expired in connection with the closing of the Merger on March 18, 2025.
Current wording
For the six months ended June 30, 2025, we recognized a $1.2 million gain related to the changes in the fair value of derivative liabilities embedded into convertible promissory notes issued to Samsara and other investors. All outstanding convertible promissory notes, other than the AlloVir Note, were converted into either shares of redeemable convertible preferred stock or common stock and the derivative liability expired in connection with the closing of the Merger on March 18, 2025.
Previous wording
For the three months ended March 31, 2025, we recognized $1.4 million of interest expense, which included the accrued interest and amortization of debt discount related to issued and outstanding convertible promissory notes issued to Samsara and other investors. All outstanding convertible promissory notes, other than the AlloVir Note, were converted into either shares of redeemable convertible preferred stock or common stock and the derivative liability expired in connection with the closing of the Merger on March 18, 2025.
Current wording
For the six months ended June 30, 2025, we recognized $1.4 million of interest expense, which included the accrued interest and amortization of debt discount related to issued and outstanding convertible promissory notes issued to Samsara and other investors. All outstanding convertible promissory notes, other than the AlloVir Note, were converted into either shares of redeemable convertible preferred stock or common stock and the derivative liability expired in connection with the closing of the Merger on March 18, 2025.
Previous wording
For the three months ended March 31, 2025, we recognized $0.2 million of loss on extinguishment and on issuance of convertible promissory notes to Samsara and other investors. All outstanding convertible promissory notes, other than the AlloVir Note, were converted into either shares of redeemable convertible preferred stock or common stock and the derivative liability expired in connection with the closing of the Merger on March 18, 2025.
Current wording
For the six months ended June 30, 2025, we recognized $0.2 million of loss on extinguishment and on issuance of convertible promissory notes to Samsara and other investors. All outstanding convertible promissory notes, other than the AlloVir Note, were converted into either shares of redeemable convertible preferred stock or common stock and the derivative liability expired in connection with the closing of the Merger on March 18, 2025.
Previous wording
Other income, net increased by $0.8 million from $0.2 million for the three months ended March 31, 2025 to $1.0 million for the three months ended March 31, 2026. This increase was primarily attributable to interest income received from money market marketable securities and U.S. government treasury securities as a result of our increased cash position following the Merger and the 2025 Private Placement.
Current wording
Other income, net increased by $0.7 million from $1.1 million for the six months ended June 30, 2025 to $1.9 million for the six months ended June 30, 2026. This increase was primarily attributable to interest income received from money market funds and U.S. government treasury securities as a result of our increased cash position following the Merger and the 2025 Private Placement.
Previous wording
From inception through March 31, 2026, we have received gross proceeds of $67.5 million from sales of redeemable convertible preferred stock, issuances of convertible promissory notes and a SAFE, we received cash and cash equivalents of AlloVir of approximately $102.1 million in the Merger, and we received aggregate gross proceeds of $50.0 million from the 2025 Private Placement. As of March 31, 2026, we had $104.9 million in cash, cash equivalents and marketable securities.
Current wording
From inception through June 30, 2026, we have received gross proceeds of $67.5 million from sales of redeemable convertible preferred stock, issuances of convertible promissory notes and a SAFE, we received cash and cash equivalents of AlloVir of approximately $102.1 million in the Merger, and we received aggregate gross proceeds of $50.0 million from the 2025 Private Placement. As of June 30, 2026, we had $93.5 million in cash, cash equivalents and marketable securities.
Previous wording
On April 3, 2026, we filed the Shelf Registration Statement with the SEC, which was declared effective on April 13, 2026. Under the Shelf Registration Statement, we may offer and sell up to $350.0 million of a variety of securities including common stock, preferred stock, debt securities, subscription rights, warrants or units during the three-year period that commenced upon the Shelf Registration Statement becoming effective. Pursuant to the Sales Agreement with TD Cowen which we may issue and sell, from time to time, up to an aggregate of $100.0 million of our common stock in the At-the-Market Offering through TD Cowen, as sales agent. As of March 31, 2026, we had capitalized $0.4 million of deferred transaction costs related to the At-the-Market Offering. We have not sold any shares of our common stock pursuant to the At-the-Market Offering.
Current wording
On April 3, 2026, we filed the Shelf Registration Statement with the SEC, which was declared effective on April 13, 2026. Under the Shelf Registration Statement, we may offer and sell up to $350.0 million of a variety of securities including common stock, preferred stock, debt securities, subscription rights, warrants or units during the three-year period that commenced upon the Shelf Registration Statement becoming effective. Pursuant to the Sales Agreement with TD Cowen which we may issue and sell, from time to time, up to an aggregate of $100.0 million of our common stock in the At-the-Market Offering through TD Cowen, as sales agent. As of June 30, 2026, we had capitalized $0.5 million of deferred transaction costs related to the At-the-Market Offering. We have not sold any shares of our common stock pursuant to the At-the-Market Offering.
Previous wording
We have incurred significant losses and negative cash flows from operations since our inception. As of March 31, 2026, we had an accumulated deficit of $170.9 million. Based on our current operating plans, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2027. However, we have based these estimates on assumptions that may prove to be wrong, and our operating plans may change as a result of many factors currently unknown to us. In addition, changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more than currently expected because of circumstances beyond our control. As a result, we could deplete our capital resources sooner than we currently expect.
Current wording
We have incurred significant losses and negative cash flows from operations since our inception. As of June 30, 2026, we had an accumulated deficit of $182.4 million. Based on our current operating plans, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2027. However, we have based these estimates on assumptions that may prove to be wrong, and our operating plans may change as a result of many factors currently unknown to us. In addition, changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more than currently expected because of circumstances beyond our control. As a result, we could deplete our capital resources sooner than we currently expect.
Previous wording
Cash used in operating activities for the three months ended March 31, 2026, was primarily due to a net loss of $10.9 million, offset by non-cash charges of $0.4 million and further offset by net changes in net operating assets and liabilities of $1.1 million. Non-cash charges primarily consist of $0.6 million in stock-based compensation expense and $0.2 million in accretion of discounts on marketable securities. The unfavorable net change in net operating assets and liabilities was primarily due to an increase in other non-current assets of $0.8 million and a decrease in accounts payable of $0.4 million.
Current wording
Cash used in operating activities for the six months ended June 30, 2026, was primarily due to a net loss of $22.4 million, offset by non-cash charges of $1.0 million and further offset by net changes in net operating assets and liabilities of $1.3 million. Non-cash charges primarily consist of $1.2 million in stock-based compensation expense offset by $0.3 million in accretion of discounts on marketable securities. The unfavorable net change in net operating assets and liabilities was primarily due to an increase in prepaid expenses and other current assets of $1.0 million and an increase in other non-current assets of $0.8 million, offset by an increase in accrued expenses and other current liabilities of $0.9 million.
Previous wording
Cash used in operating activities for the three months ended March 31, 2025, was primarily due to a net loss of $10.2 million, reduced by non-cash charges of $0.4 million and further reduced by net changes of $2.3 million in the net operating assets and liabilities. Non-cash changes primarily consist of a $0.4 million stock-based compensation expense, a gain of $1.2 million related to the change in fair value of derivative liabilities, a gain of $0.4 million related to the change in fair value of tranche liability, non-cash interest expense of $1.4 million and loss on issuance of convertible promissory notes of $0.2 million. The change in net operating assets and liabilities was primarily due to a decrease in prepaid expenses and other current assets of $1.4 million, an increase in accounts payable of $0.9 million, an increase in accrued research and development expenses of $1.2 million due to the timing of receipt of invoices from vendors, an increase in accrued expenses and other current liabilities of $0.2 million, partially offset by a decrease of $1.4 million in accrued compensation.
Current wording
Cash used in operating activities for the six months ended June 30, 2025, was primarily due to a net loss of $21.5 million, reduced by non-cash charges of $1.0 million and further reduced by net changes of $0.6 million in the net operating assets and liabilities. Non-cash changes primarily consist of a $1.0 million stock-based compensation expense, a gain of $1.2 million related to the change in fair value of derivative liabilities, a gain of $0.4 million related to the change in fair value of tranche liability, non-cash interest expense of $1.4 million and loss on issuance of convertible promissory notes of $0.2 million. The change in net operating assets and liabilities was primarily due to an increase in prepaid expenses and other current assets of $0.6 million, an increase in other non-current assets of $0.3 million, an increase in accounts payable of $2.2 million, and a decrease in accrued expenses and other current liabilities of $0.8 million.
Previous wording
Net cash used in investing activities for the three months ended March 31, 2026 was $50.4 million, which primarily consisted of $70.4 million in purchases of marketable securities offset by $20.0 million in proceeds from maturities of marketable securities. There was no cash used in investing activities for the three months ended March 31, 2025.
Current wording
Net cash used in investing activities for the six months ended June 30, 2026 was $30.2 million, which primarily consisted of $70.2 million in purchases of marketable securities offset by $40.0 million in proceeds from maturities of marketable securities. There was no cash used in investing activities for the six months ended June 30, 2025.
Previous wording
Net cash used in financing activities for the three months ended March 31, 2026 was $1.7 million, which consisted of $1.8 million in payments of issuance costs related to the 2025 Private Placement and deferred transaction costs related to the At-the-Market Offering, offset by $0.1 million in proceeds from the exercise of stock options.
Current wording
Net cash used in financing activities for the six months ended June 30, 2026 was $2.1 million, which consisted of $2.2 million in payments of issuance costs related to the 2025 Private Placement and deferred transaction costs related to the At-the-Market Offering, offset by $0.1 million in proceeds from the exercise of stock options.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2025 was $107.3 million, which consisted of $102.1 million of cash and cash equivalents of AlloVir received in the Merger, proceeds from the issuance of a convertible promissory note of $7.5 million, partially offset by payments of transaction costs related to the Merger of $2.3 million.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2025 was $107.3 million, which consisted of $102.1 million of cash and cash equivalents of AlloVir received in the Merger, proceeds from the issuance of a convertible promissory note of $7.5 million, partially offset by payments of transaction costs related to the Merger of $2.3 million.
Previous wording
We enter into contracts in the normal course of business with CDMOs for clinical supply manufacturing, with CROs for clinical trials and with other vendors for preclinical studies, supplies and other products and services for operating purposes. These agreements generally provide for termination at the request of either party generally with less than one-year notice and, therefore, our management believes that non-cancellable obligations under these agreements are not material. We do not currently expect any of these agreements to be terminated and did not have any non-cancellable obligations under these agreements as of March 31, 2026 and December 31, 2025.
Current wording
We enter into contracts in the normal course of business with CDMOs for clinical supply manufacturing, with CROs for clinical trials and with other vendors for clinical studies, supplies and other products and services for operating purposes. These agreements generally provide for termination at the request of either party generally with less than one-year notice and, therefore, our management believes that non-cancellable obligations under these agreements are not material. We do not currently expect any of these agreements to be terminated and did not have any non-cancellable obligations under these agreements as of June 30, 2026 and December 31, 2025.
Previous wording
We are required to pay certain milestone payments contingent upon the achievement of specific development and regulatory events in accordance with the UCSD Agreement. Refer to Note 7, Significant Agreements, in our condensed consolidated financial statements included elsewhere in this Quarterly Report for additional details. As of March 31, 2026 and December 31, 2025, we recognized $0.1 million and $0.03 million related to the UCSD Agreement in accrued expenses and other current liabilities in the condensed consolidated balance sheets, respectively. Over the life of the agreement through March 31, 2026, development milestones totaling $0.1 million have been achieved and incurred as research and development expenses. We did not achieve any development milestones and did not incur any related milestone expense during the three months ended March 31, 2026. We are required to pay royalties on sales of products developed under the UCSD Agreement. Our product candidate was in development as of March 31, 2026 and December 31, 2025, and no such royalties were due.
Current wording
We are required to pay certain milestone payments contingent upon the achievement of specific development and regulatory events in accordance with the UCSD Agreement. Refer to Note 7, Significant Agreements, in our condensed consolidated financial statements included elsewhere in this Quarterly Report for additional details. As of June 30, 2026 and December 31, 2025, we recognized an immaterial amount related to the UCSD Agreement in accrued expenses and other current liabilities in the condensed consolidated balance sheets. Over the life of the agreement through June 30, 2026, development milestones totaling $0.1 million have been achieved and incurred as research and development expenses. We did not achieve any development milestones and did not incur any related milestone expense during the three and six months ended June 30, 2026. We are required to pay royalties on sales of products developed under the UCSD Agreement. Our product candidate was in development as of June 30, 2026 and December 31, 2025, and no such royalties were due.
Previous wording
We are obligated to pay royalties to Samsara under the Royalty Agreement. Refer to Note 7, Significant Agreements, in our condensed consolidated financial statements included elsewhere in this Quarterly Report for additional details. We recognized an initial royalty liability in the amount of $32.1 million, which was based on its estimated fair value at the effective date of the Royalty
Current wording
We are obligated to pay royalties to Samsara under the Royalty Agreement. Refer to Note 7, Significant Agreements, in our condensed consolidated financial statements included elsewhere in this Quarterly Report for additional details. We recognized an initial royalty liability in the amount of $32.1 million, which was based on its estimated fair value at the effective date of the Royalty Agreement. Once royalty payments to Samsara are deemed probable and estimable, and if such amounts exceed the royalty liability balance, we will impute interest to accrete the royalty liability on a prospective basis based on such estimates. As of June 30, 2026 these royalties were not probable and estimable.
Previous wording
In February 2025, we entered into an operating lease agreement for office space in Berkeley Heights, New Jersey. The lease commenced in September 2025 and is expected to terminate in December 2031. We can extend the lease term twice for an additional three years and can terminate the lease after four years and four months after the lease commencement date with a termination penalty of $0.3 million. Total remaining undiscounted payments under this lease are approximately $2.0 million. In addition to the base rent, we will pay our share of operating expenses and taxes. The lessor provided a tenant improvement allowance of up to $0.4 million, which we fully utilized in 2025.
Current wording
In February 2025, we entered into an operating lease agreement for office space in Berkeley Heights, New Jersey. The lease commenced in September 2025 and is expected to terminate in December 2031. We can extend the lease term twice for an additional three years and can terminate the lease after four years and four months after the lease commencement date with a termination penalty of $0.3 million. Total remaining undiscounted payments under this lease are approximately $1.9 million. In addition to the base rent, we will pay our share of operating expenses and taxes. The lessor provided a tenant improvement allowance of up to $0.4 million, which we fully utilized in 2025.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
Assuming successful completion of the ongoing Phase 1b/2 clinical trial of TH103, and subject to the favorable results from such trial and discussions with regulators, we intend to initiate Phase 3 clinical trials of TH103 for nAMD by year-end 2027. We also plan to expand the development of TH103 beyond nAMD into other prevalent VEGF-mediated retinal diseases, such as Diabetic Macular Edema (“DME”), diabetic retinopathy (“DR”), and Retinal Vein Occlusion.
Current report — wording carried from elsewhere
The following table summarizes our results of operations (in thousands):
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses (in thousands):
Current report — wording carried from elsewhere
CDMO, CRO and other third-party clinical trials and consulting costs increased by $1.9 million. This was primarily driven by an increase of $3.3 million in CRO and other clinical expenses as we opened additional investigational sites and enrolled patients in our clinical program, offset by a decrease of $ 1.5 million in CDMO manufacturing and process development activities.
Current report — wording carried from elsewhere
Personnel related costs (including stock-based compensation) increased by $0.5 million due to hiring in our research and development organization to support our clinical trials and manufacturing.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Agreement. Once royalty payments to Samsara are deemed probable and estimable, and if such amounts exceed the royalty liability balance, we will impute interest to accrete the royalty liability on a prospective basis based on such estimates. As of March 31, 2026 these royalties were not probable and estimable.