Lexeo Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 12, 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 12, 2026
LXEO$2.89-0.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-11.
0001193125-26-215678
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-12.
0001193125-26-345724
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 116 previous paragraphs and 125 current paragraphs.
93 unchanged; 19 reworded; 10 added; 4 removed; 0 previous and 3 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 (10)
Current report
In August 2026, we announced that we received Regenerative Medicine Advanced Therapy, or RMAT, designation for LX2020 for the treatment of PKP2-ACM from the FDA based on recent interim data from our ongoing Phase I/II clinical trial in PKP2-ACM. RMAT designation provides opportunities for increased FDA interaction and may help expedite the development of LX2020.
Current report
Gain on long-term investment includes non-operating income related to an unrealized gain on convertible preferred stock received that was recorded at fair value to long-term investment.
Current report
The net increase of $4.3 million in research and development expenses for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was primarily due to a net increase in clinical trial expenses of $3.1 million, as well as an increase in stock-based compensation expense of $1.3 million primarily due to the achievement of performance metrics associated with Performance Restricted Stock Units, or PRSUs.
Current report
We recorded non-operating income of approximately $3.4 million during the three months ended June 30, 2025 related to an unrealized gain on convertible preferred stock received that was recorded at fair value to long-term investment.
Current report
Comparison of the six months ended June 30, 2026 and 2025
Current report
Research and development expenses
Current report
General and administrative expenses
Current report
The net decrease of $17.0 million in general and administrative expenses for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was primarily due to a decrease in third-party legal fees and associated costs of $20.4 million. This decrease was partially offset by an increase in professional service, consultant, and recruiting fees of $1.4 million including for preparatory commercial market research, business development, and other general and administrative activities, as well as an increase in stock-based compensation expense of $1.2 million primarily related to the achievement of performance metrics associated with PRSUs.
Current report
We recorded non-operating income of approximately $3.4 million during the six months ended June 30, 2025 related to an unrealized gain on convertible preferred stock received that was recorded at fair value to long-term investment.
Current report
During the six months ended June 30, 2025, net cash used in investing activities was $23.6 million and consisted primarily of purchases of investments in U.S. Treasury securities of $55.4 million, which was partially offset by $31.9 million of proceeds received upon sales or maturities of investments in U.S. Treasury securities.
Removed paragraphs (4)
Previous report
In February 2025, we announced further alignment on elements of the accelerated development pathway following a Type B Regenerative Medicine Advanced Therapy, or RMAT, meeting with the U.S. Food and Drug Administration, or FDA, including frataxin expression co-primary endpoint to be evaluated for any increase from baseline rather than numerical threshold.
Previous report
In October 2025, in response to our questions regarding the possibility of a faster path to a Biologics License Application, or BLA, the FDA indicated openness to a BLA submission for accelerated approval that includes clinical data from the ongoing Phase 1/2 studies of LX2006 pooled with new clinical data to be generated in the planned pivotal study. The FDA also previously agreed to evaluate the co-primary endpoint of LVMI at a time point earlier than 12 months. Collectively, we believe this regulatory feedback has the potential to reduce the size and length of the planned pivotal study, possibly accelerating the overall timeline to BLA submission. We plan to initiate the LX2006 pivotal study in the second quarter of 2026, pending finalization of the trial protocol.
Previous report
Interest income
Previous report
Interest income
Reworded paragraphs (19)
Previous wording
Our most advanced cardiovascular product candidate, LX2006 for the treatment of FA cardiomyopathy, is currently being evaluated in SUNRISE-FA, our ongoing Phase 1/2 clinical trial and in a Cornell investigator-initiated trial.
Current wording
Our most advanced cardiovascular product candidate is LX2006 for the treatment of FA cardiomyopathy.
Previous wording
In February 2026, we submitted the final registrational trial design and statistical analysis plan, or SAP, for the SUNRISE‑FA 2 pivotal study to the FDA following a Type B meeting. We are in contact with the FDA and are awaiting final feedback on the study protocol. We plan to provide an update when the protocol and SAP are finalized.
Current wording
In February 2026, we submitted the final registrational trial design and statistical analysis plan, or SAP, for the SUNRISE‑FA 2 pivotal study to the FDA following a Type B meeting. In June 2026, we announced that we have finalized the SUNRISE-FA 2 pivotal study protocol and SAP for LX2006, each incorporating the FDA's feedback to date and intended to support a BLA submission to the FDA in the first half of 2028 under the accelerated approval pathway. The SUNRISE-FA 2 study was initiated in June 2026. We are continuing to engage with the FDA regarding the confirmatory evidence strategy for the SUNRISE-FA 2 study.
Previous wording
Increases in PKP2 protein expression versus baseline at three months in all participants that had undergone cardiac biopsies (n=7) assessed by western blot. Dose-dependent increases observed, with mean increase of 93% in the low-dose cohort (n=2) and 162% mean increase in the high-dose cohorts (n=5).
Current wording
Increases in PKP2 protein expression versus baseline at three months in all participants that had undergone cardiac biopsies (n=7) assessed by western blot. Dose-dependent increases observed, with mean increase of 90% (previously reported 93% due to a calibration error) in the low-dose cohort (n=2) and 162% mean increase in the high-dose cohorts (n=5).
Previous wording
To date, we have funded our operations primarily through proceeds from the sale of shares of our convertible preferred stock, common stock, and pre-funded warrants and warrants to purchase our common stock. As of March 31, 2026, we had $227.6 million of cash, cash equivalents, and investments in U.S. Treasury securities. We have incurred significant operating losses since the commencement of our operations. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current gene therapy candidates or any future gene therapy candidates. Our net losses for the three months ended March 31, 2026 and the year ended December 31, 2025 were $20.2 million and $100.0 million, respectively, and our accumulated deficit was $400.3 million at March 31, 2026. We expect to continue to incur significant losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, continue to build our operations and operate as a public company.
Current wording
To date, we have funded our operations primarily through proceeds from the sale of shares of our convertible preferred stock, common stock, and pre-funded warrants and warrants to purchase our common stock. As of June 30, 2026, we had $234.2 million of cash, cash equivalents, and investments in U.S. Treasury securities, and in July 2026, we sold 3,109,103 shares of our common stock under the ATM Program for net proceeds of approximately $14.1 million after transaction costs. We have incurred significant operating losses since the commencement of our operations. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current gene therapy candidates or any future gene therapy candidates. Our net losses for the six months ended June 30, 2026 and the year ended December 31, 2025 were $46.1 million and $100.0 million, respectively, and our accumulated deficit was $426.2 million at June 30, 2026. We expect to continue to incur significant losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, continue to build our operations and operate as a public company.
Previous wording
General and administrative expenses consist primarily of personnel expenses, including salaries, benefits and stock-based compensation expense for personnel in executive, accounting, business development, legal, human resources and administrative functions. General and administrative expenses also include corporate facility costs not otherwise included in research and development expenses, depreciation, and other expenses, which include direct or allocated expenses for rent and maintenance of facilities and insurance, not otherwise included in research and development expenses, as well as professional fees for legal, consulting, investor and public relations, accounting and audit services.
Current wording
General and administrative expenses consist primarily of personnel expenses, including salaries, benefits and stock-based compensation expense for personnel in executive, accounting, business development, legal, human resources and administrative functions. General and administrative expenses also include corporate facility costs not otherwise included in research and development expenses, depreciation, and other expenses, which include direct or allocated expenses for rent and maintenance of facilities and insurance, not otherwise included in research and development expenses, as well as professional fees for legal, consulting, investor and public relations, tax and audit services.
Previous wording
We expect that in the near to medium term future our general and administrative expenses may increase relative to those incurred during the three months ended March 31, 2026 on a quarterly basis and on an annualized basis, due to anticipated sales and marketing costs as we approach expected commercialization of our product candidates, if approved, while supporting the continued research and development of our programs and the growth of our business.
Current wording
We expect that in the near to medium term future our general and administrative expenses may increase relative to those incurred during the three and six months ended June 30, 2026 on a quarterly basis and on an annualized basis, due to anticipated sales and marketing costs as we approach expected commercialization of our product candidates, if approved, while supporting the continued research and development of our programs and the growth of our business.
Previous wording
Interest income is primarily related to interest earned from our investments in U.S. government money market funds and interest earned from our investments in U.S. Treasury securities, as well as interest earned on interest-bearing demand deposit cash accounts and a cash collateral account.
Current wording
Interest income is primarily related to interest earned from our investments in U.S Treasury securities and U.S. government money market funds, as well as interest earned on interest-bearing demand deposit cash accounts and a cash collateral account.
Previous wording
The net decrease of $10.0 million in general and administrative expenses for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to decreases in (i) third-party legal fees and associated costs of $10.5 million, and (ii) employee and stock-based compensation expenses of $0.4 million primarily due to decreased headcount. These decreases were partially offset by increased professional services and consultant expenses of $0.4 million.
Current wording
The net decrease of $7.0 million in general and administrative expenses for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was primarily due to a decrease in third-party legal fees and associated costs of $9.7 million. This decrease was partially offset by an increase in stock-based compensation expense of $1.3 million primarily due to the achievement of performance metrics associated with PRSUs, as well as an increase in professional services costs of $0.8 million primarily associated with preparatory commercial market research activities.
Previous wording
We recognized interest income of $2.1 million and $1.2 million for the three months ended March 31, 2026 and March 31, 2025, respectively, primarily related to interest earned on our investments in U.S. government money market funds, our investments in U.S Treasury securities, and our interest-bearing demand deposit cash accounts, with the increase due to higher invested balances, which was partially offset by lower interest rates.
Current wording
We recognized interest income of $2.2 million and $1.3 million for the three months ended June 30, 2026 and June 30, 2025, respectively, primarily related to interest earned on our investments in U.S Treasury securities and U.S. government money market funds, with the increase due to higher invested balances, which was partially offset by lower interest rates.
Previous wording
The net decrease of $1.5 million in total research and development expenses for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to decreases in (i) employee and stock-based compensation expenses of $1.5 million primarily due to decreased headcount, (ii) CMC expenses of $0.8 million, and (iii) preclinical and quality expenses of $0.4 million. These decreases were primarily offset by increases in (i) clinical trial expenses of $0.5 million, (ii) milestone expenses of $0.4 million associated with our LX1001 program, and (iii) program and portfolio management expenses of $0.3 million.
Current wording
The net increase of $2.8 million in research and development expenses for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was primarily due to increases in (i) clinical trial expenses of $3.6 million, (ii) program and portfolio management expenses of $0.5 million, (iii) stock-based compensation expense of $0.5 million primarily due to the achievement of performance metrics associated with PRSUs partially offset by forfeitures due to employee separations, and (iv) milestone expenses of $0.4 million associated with our LX1001 program. These increases were partially offset by a net decrease in CMC expenses of $1.3 million, as well as a decrease in non-stock based compensation expenses of $0.6 million due to employee separations.
Previous wording
Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates. Since our inception through March 31, 2026, we funded our operations primarily through proceeds from the sale of shares of our convertible preferred stock, common stock, and pre-funded warrants and warrants to purchase our common stock. As of March 31, 2026 and December 31, 2025, we had cash, cash equivalents, and investments in U.S. Treasury Securities of $227.6 million and $246.6 million, respectively.
Current wording
Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates. Since our inception through June 30, 2026, we funded our operations primarily through proceeds from the sale of shares of our convertible preferred stock, common stock, and pre-funded warrants and warrants to purchase our common stock. As of June 30, 2026 and December 31, 2025, we had cash, cash equivalents, and investments in U.S. Treasury Securities of $234.2 million and $246.6 million, respectively.
Previous wording
As of March 31, 2026, we had not sold any shares of common stock pursuant to the ATM Program. In April 2026, we sold 4,424,778 shares of our common stock under the ATM Program for net proceeds of $23.6 million after transaction costs.
Current wording
During the three and six months ended June 30, 2026, we sold 4,424,778 shares of our common stock under the ATM Program for net proceeds of approximately $23.6 million after transaction costs, and in July 2026, we sold 3,109,103 shares of our common stock under the ATM Program for net proceeds of approximately $14.1 million after transaction costs.
Previous wording
The following table summarizes our sources and uses of cash for the three months ended March 31, 2026 and March 31, 2025 (in thousands):
Current wording
The following table summarizes our sources and uses of cash for the six months ended June 30, 2026 and June 30, 2025 (in thousands):
Previous wording
During the three months ended March 31, 2026, net cash used in operating activities consisted primarily of our net loss of $20.2 million and $4.2 million of net cash used in changes in operating assets and liabilities, which were partially offset by $2.8 million of stock-based compensation expense and $0.5 million of depreciation expense and amortization of operating and finance right-of-use assets.
Current wording
During the six months ended June 30, 2026, net cash used in operating activities was $38.7 million and consisted primarily of our net loss of $46.1 million and net cash used in changes in operating assets and liabilities of $2.2 million, which were partially offset by $8.4 million of stock-based compensation expense and $1.1 million of depreciation expense and amortization of operating and finance right-of-use assets.
Previous wording
During the three months ended March 31, 2025, net cash used in operating activities consisted primarily of our net loss of $32.7 million, which was partially offset by $6.7 million of net cash provided by changes in operating assets and liabilities, $3.7 million of stock-based compensation expense, and $0.5 million of depreciation and amortization of operating and finance right-of-use assets.
Current wording
During the six months ended June 30, 2025, net cash used in operating activities was $48.9 million and consisted primarily of our net loss of $58.8 million, which included an unrealized gain of $3.4 million recorded to other non-operating income upon receipt of our long-term investment in convertible preferred stock, and which was partially offset by $6.8 million of stock-based compensation expense, $5.4 million of net cash provided by changes in operating assets and liabilities, and $1.0 million of depreciation and amortization of operating and finance right-of-use assets.
Previous wording
During the three months ended March 31, 2026 and March 31, 2025, net cash provided by investing activities was $27.5 million and $15.6 million, respectively, and consisted primarily of proceeds from sales or maturities of investments.
Current wording
During the six months ended June 30, 2026, net cash provided by investing activities was $41.7 million and consisted primarily of proceeds from sales or maturities of investments in U.S. Treasury securities of $53.7 million, which was partially offset by $12.0 million of purchases of investments in U.S. Treasury securities.
Previous wording
During the three months ended March 31, 2025, net cash provided by financing activities consisted of proceeds received from common stock issuances under the 2023 ESPP of $0.2 million, which was partially offset by $0.2 million of principal payments made on equipment finance leases.
Current wording
During the six months ended June 30, 2026, net cash provided by financing activities was $26.9 million and consisted primarily of proceeds received from the sale of shares of our common stock under the ATM Program of $24.2 million net of $0.8 million of related transaction costs paid during the period, the exercise of common warrants of $2.4 million, and common stock issuances under the 2023 ESPP of $0.1 million, which were partially offset by $0.3 million of principal payments made on equipment finance leases.
Previous wording
During the three months ended March 31, 2026, net cash provided by financing activities consisted primarily of proceeds received from the exercise of common warrants of $2.4 million, as well as proceeds received from common stock issuances under the 2023 ESPP of $0.1 million, which were partially offset by $0.1 million of principal payments made on equipment finance leases.
Current wording
During the six months ended June 30, 2025, net cash provided by financing activities was $73.0 million and consisted primarily of the net proceeds received from the May 2025 Private Placement offering of $73.1 million, as well as proceeds received from the common stock issuances under the 2023 ESPP of $0.2 million, which were partially offset by $0.3 million of principal payments made on equipment finance leases.
Previous wording
Other than as disclosed in Note 2 to the condensed financial statements included in this Quarterly Report on Form 10-Q, there have been no significant changes to our critical accounting estimates from those described in our audited financial statements as of and for the year ended December 31, 2025 included in our Annual Report on Form 10-K, filed with the SEC on March 30, 2026.
Current wording
Other than as disclosed in Note 2 to the unaudited condensed financial statements included in this Quarterly Report on Form 10-Q, there have been no significant changes to our critical accounting estimates from those described in our audited financial statements as of and for the year ended December 31, 2025 included in our Annual Report on Form 10-K, filed with the SEC on March 30, 2026.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses incurred for the six months ended June 30, 2026 and 2025 (in thousands):
Current report — wording carried from elsewhere
We recognized interest income of $4.3 million and $2.5 million for the six months ended June 30, 2026 and June 30, 2025, respectively, primarily related to interest earned on our investments in U.S Treasury securities and U.S. government money market funds, which was partially offset by lower interest rates.