Cartesian Therapeutics, Inc.
For the period ended Mar 31, 2026. Filed Apr 30, 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.
Mar 31, 2026 · Filed Apr 30, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001453687-25-000120
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-04-30.
0001453687-26-000082
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 120 previous paragraphs and 101 current paragraphs.
63 unchanged; 26 reworded; 12 added; 29 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 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 (12)
Current report
•advance Descartes-08 for myositis into Phase 2 development;
Current report
Collaboration and license revenue
Current report
Interest income
Current report
Gain on change in fair value of warrant liabilities
Current report
(Loss) gain on change in fair value of contingent value right liability
Current report
For the three months ended March 31, 2026, our general and administrative expenses were $7.1 million, compared to $8.3 million for the three months ended March 31, 2025, a decrease of $1.2 million. The decrease was primarily the result of lower professional and consulting fees.
Current report
Interest income
Current report
Gain on change in fair value of warrant liabilities
Current report
(Loss) gain on change in fair value of contingent value right liability
Current report
Other expense, net
Current report
“At the Market” Sales Agreement
Current report
During the three months ended March 31, 2026, the Company sold 2,270,712 shares of its common stock pursuant to the Sales Agreement for net proceeds of approximately $14.6 million after commissions and expenses. No shares were sold pursuant to the Sales Agreement during the three months ended March 31, 2025.
Removed paragraphs (29)
Previous report
Merger
Previous report
On November 13, 2023, the Company (formerly known as Selecta Biosciences, Inc., or Selecta) merged with the private Delaware corporation which, immediately prior to the Merger (as defined below), was known as Cartesian Therapeutics, Inc., or Old Cartesian, in accordance with the terms of an Agreement and Plan of Merger, or the Merger Agreement, by and among
Previous report
Selecta, Sakura Merger Sub I, Inc., a wholly owned subsidiary of Selecta, or First Merger Sub, Sakura Merger Sub II, LLC, a wholly owned subsidiary of Selecta, or Second Merger Sub, and Old Cartesian. Pursuant to the Merger Agreement, First Merger Sub merged with and into Old Cartesian, pursuant to which Old Cartesian was the surviving corporation and became a wholly owned subsidiary of Selecta, or the First Merger. Immediately following the First Merger, Old Cartesian merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity, or the Second Merger and, together with the First Merger, the Merger. In connection with the Second Merger, Old Cartesian changed its name to Cartesian Bio, LLC. In connection with the Merger and pursuant to the Merger Agreement, the Company changed its corporate name to Cartesian Therapeutics, Inc. See Note 4, “Merger” of the notes to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2024 for additional information regarding the Merger.
Previous report
Concurrently with the closing of the Merger, we entered into a securities purchase agreement, or the 2023 Securities Purchase Agreement, pursuant to which we agreed to issue 149,330.115 shares of Series A Non-Voting Convertible Preferred Stock, par value $0.0001 per share, or the Series A Preferred Stock, in exchange for aggregate gross proceeds of $60.25 million, or the 2023 Private Placement. We granted customary registration rights to investors in connection with the 2023 Private Placement.
Previous report
On July 2, 2024, we entered into a securities purchase agreement, or the 2024 Securities Purchase Agreement, for a private investment in public equity financing, or the 2024 Private Placement, which provided for the issuance of 3,563,247 shares of common stock and 2,937,903 shares of Series B Non-Voting Convertible Preferred Stock, par value $0.0001 per share, or the Series B Preferred Stock, each at a purchase price of $20.00 per share. The 2024 Private Placement resulted in gross proceeds of approximately $130.0 million before deducting placement agent fees and other offering expenses. We granted customary registration rights to investors in connection with the 2024 Private Placement.
Previous report
Research and development
Previous report
General and administrative
Previous report
Impairment of long-lived assets
Previous report
Impairment of long-lived assets consists of impairment charges on our long-lived assets.
Previous report
Change in fair value of forward contract liabilities
Previous report
The forward contract liabilities associated with the delayed issuance of the Series A Preferred Stock related to the Merger and 2023 Private Placement are remeasured quarterly and upon settlement at fair value with the change in fair value recognized as a component of earnings.
Previous report
For the three months ended September 30, 2025, our research and development expenses were $13.8 million, compared to $11.4 million for the three months ended September 30, 2024, an increase of $2.4 million. The increase was primarily due to an increase in expenses for Descartes-08 for MG, primarily related to the expenses for the ongoing Phase 3 AURORA trial, coupled with an increase in our research and development employee expenses and stock-based compensation expense, primarily the result of headcount growth, and an increase in expenses for early stage programs, primarily related to increased discovery expenses and manufacturing operations expenses. This increase was partially offset by a decrease in expenses for legacy Selecta programs, which were primarily related to expenses for Xork as a result of the termination of the License and Development Agreement, or the Astellas Agreement, with Audentes Therapeutics, Inc., doing business as Astellas Gene Therapies, or Astellas in 2024.
Previous report
For the three months ended September 30, 2025, our general and administrative expenses were $7.7 million, compared to $6.6 million for the three months ended September 30, 2024, an increase of $1.1 million. The increase in cost was primarily the result of increased facilities expenses and expenses incurred for stock-based compensation.
Previous report
Other income, net
Previous report
During the three months ended September 30, 2025, we recognized no other income, net, compared to $0.3 million other income, net for the three months ended September 30, 2024. The decrease was primarily due to a decrease in sublease income. The terms of our subleases expired during the year ended December 31, 2024.
Previous report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Previous report
During the nine months ended September 30, 2025, we recognized $0.4 million of collaboration and license revenue, compared to $39.1 million for the nine months ended September 30, 2024, a decrease of $38.7 million. The decrease was primarily due to a decrease in revenue recognized under the Sobi License resulting from the $30.0 million unconstrained development milestone recognized during the nine months ended September 30, 2024 and a decrease for revenue recognized under the Astellas Agreement upon notice of termination during the nine months ended September 30, 2024.
Previous report
During the nine months ended September 30, 2025, we recognized $1.5 million of grant revenue, compared to $0.6 million for the nine months ended September 30, 2024, an increase of $0.9 million. The increase was primarily due to increased expenses reimbursable under the grant from NINDS incurred during the nine months ended September 30, 2025, for which we received funding approval during the nine months ended September 30, 2024.
Previous report
For the nine months ended September 30, 2025, our general and administrative expenses were $23.3 million compared to $23.0 million for the nine months ended September 30, 2024, an increase of $0.3 million. The increase in cost was primarily the result of increased facilities expenses and expenses incurred for stock-based compensation, partially offset by decreased expenses incurred for personnel expenses and professional fees incurred in connection with the Merger.
Previous report
Interest income for the nine months ended September 30, 2025 was $5.3 million, compared to $4.9 million for the nine months ended September 30, 2024. The increase in interest income was due to increased cash and cash equivalents balance.
Previous report
For the nine months ended September 30, 2025, we recognized $18.7 million of income from the decrease in the fair value of the CVR liability, compared to $51.9 million of expense from the increase in the fair value of the CVR liability for the nine months ended September 30, 2024, a change of $70.6 million. The fair value of the CVR liability was determined utilizing a Monte Carlo simulation model. The decrease in the fair value of CVR liability in the current period was primarily due to changes in the timing of anticipated payments during the nine months ended September 30, 2025. The increase in the fair value of CVR liability in the prior period was primarily due to changes in the amount and timing of anticipated payments and the passage of time during the nine months ended September 30, 2024.
Previous report
Change in fair value of forward contract liability
Previous report
The remaining Series A Preferred Stock forward contract liability was settled during the nine months ended September 30, 2024. As such, no change in the fair value of the Series A Preferred Stock forward contract liability is reflected in our unaudited consolidated financial statements for the nine months ended September 30, 2025.
Previous report
Other (expense) income, net
Previous report
Net loss
Previous report
Net loss for the nine months ended September 30, 2025 was $37.7 million as compared to net loss of $67.2 million for the nine months ended September 30, 2024, a decrease of $29.5 million. The decrease in net loss was primarily due to higher income associated with the change in the fair value of the CVR liability, partially offset by increased research and development expenses and revenue recognized under the Sobi License during the nine months September 30, 2024.
Previous report
In January 2023, we entered into the Astellas Agreement with Astellas. Under this agreement, Astellas obtained the sole and exclusive right to commercialize Xork for use in Pompe disease in combination with an Astellas gene therapy investigational or authorized product, with a current focus on AT845. In connection with entry into this agreement, we received a $10.0 million upfront payment and were eligible to receive $340.0 million for certain additional development and commercial milestones plus royalties on any potential commercial sales where Xork is used as a pre-treatment for AT845. As a result of the sublicense of Xork to Astellas, we made a $4.0 million payment to Genovis in February 2023. The Astellas Agreement was terminated effective June 6, 2024. For further description of the Astellas Agreement, see Note 13, “Revenue Arrangements” to our unaudited consolidated financial statements included elsewhere in this Quarterly Report. Amounts paid and remaining obligations with regard to the Xork product candidate not reimbursed by Astellas through the Astellas Agreement were subject to potential reimbursement through deductions to CVR distributions as described in Note 7, “Fair Value Measurements” to our unaudited consolidated financial statements included elsewhere in this Quarterly Report and were reimbursed in the March 2025 CVR distribution.
Previous report
On July 2, 2024, we entered into the 2024 Securities Purchase Agreement for the 2024 Private Placement with certain institutional and accredited investors, or the Purchasers. In the 2024 Private Placement, we issued and sold an aggregate of 3,563,247 shares of common stock and 2,937,903 shares of Series B Preferred Stock for which we generated gross proceeds of approximately $130.0 million.
Previous report
On November 13, 2023, we entered into the 2023 Securities Purchase Agreement with (i) Dr. Timothy A. Springer, a member of our Board of Directors; (ii) TAS Partners LLC, an affiliate of Dr. Springer, and (iii) Seven One Eight Three Four Irrevocable Trust, a trust associated with Dr. Murat Kalayoglu, a co-founder and the former chief executive officer of Old Cartesian, who joined our Board of Directors effective immediately after the effective time of the Merger, providing for the 2023 Private Placement. In the 2023 Private Placement, we issued and sold an aggregate of 149,330.115 shares of Series A Preferred Stock for an aggregate purchase price of $60.25 million, of which 50,189.789 shares of Series A Preferred Stock were issued and sold in the year ended December 31, 2023 for gross proceeds of $20.25 million, and 99,140.326 shares of Series A Preferred Stock were issued and sold during the three months ended March 31, 2024 for gross proceeds of $40.0 million.
Reworded paragraphs (26)
Previous wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and related notes appearing elsewhere in this Quarterly Report and with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024, which we filed with the SEC on March 13, 2025. In addition, you should read the “Risk Factors” and “Information Regarding Forward-Looking Statements” sections of this Quarterly Report and our Annual Report on Form 10-K for the year ended December 31, 2024 for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Current wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and related notes appearing elsewhere in this Quarterly Report and with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025, which we filed with the Securities and Exchange Commission, or the SEC, on March 9, 2026. In addition, you should read the “Risk Factors” and “Information Regarding Forward-Looking Statements” sections of this Quarterly Report and our Annual Report on Form 10-K for the year ended December 31, 2025 for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Previous wording
We are a clinical-stage biotechnology company pioneering cell therapy for the treatment of autoimmune diseases. Unlike DNA cell therapies, our cell therapy method degrades naturally over time without integrating into the cell’s genetic material. Therefore, our cell therapy is distinguished by its capacity to be dosed repeatedly like conventional drugs, administered in an outpatient setting, and given without pre-treatment chemotherapy required with many conventional cell therapies. In our Phase 2b clinical trial in patients with myasthenia gravis, or MG, a chronic autoimmune disease that causes disabling muscle weakness and fatigue, we observed that our lead product candidate, Descartes-08, generated a deep and durable clinical benefit, with 83% of participants maintaining improvements in MG severity scales considered clinically meaningful by expert consensus at six months and sustained improvements in MG severity scales considered clinically meaningful by expert consensus at 12 months. Durability of response in MG is commonly measured over a period of 26 to 52 weeks, and maintenance of response over that period is considered durable.
Current wording
We are a late clinical-stage biotechnology company pioneering cell therapy for the treatment of autoimmune diseases. We leverage our proprietary technology and manufacturing platform to introduce mRNA into cells to provide a therapeutic effect to patients suffering from a variety of autoimmune conditions. Unlike DNA, mRNA degrades naturally over time without integrating into the cell’s genetic material. Our cell therapies are designed to be dosed repeatedly like conventional drugs, administered in an outpatient setting, and given without pre-treatment chemotherapy, which is required with many conventional cell therapies.
Previous wording
We have incurred significant operating losses since our inception. We incurred a net loss of $37.7 million and $67.2 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $729.8 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we:
Current wording
We incurred net losses of $39.2 million and $17.7 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $861.6 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we:
Previous wording
•continue to advance Descartes-08 for MG through Phase 3 development;
Current wording
•continue to advance Descartes-08 for myasthenia gravis, or MG, through Phase 3 development;
Previous wording
We believe that our existing cash, cash equivalents, and restricted cash as of September 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of these financial statements. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
Current wording
We believe that our existing cash, cash equivalents, and restricted cash as of March 31, 2026 will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
Previous wording
Additionally, we generate grant revenue which consists of funding received to perform specific research and development services under grant arrangements.
Current wording
We generate grant revenue, which consists of funding received to perform specific research and development services under grant arrangements.
Previous wording
During the three months ended September 30, 2025, we recognized $0.5 million of grant revenue, compared to $0.4 million for the three months ended September 30, 2024, an increase of $0.1 million. The increase was primarily due to increased expenses reimbursable under the grant from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health, or NINDS, incurred during the three months ended September 30, 2025.
Current wording
During the three months ended March 31, 2026, we recognized $0.1 million of grant revenue, compared to $0.7 million for the three months ended March 31, 2025, a decrease of $0.6 million. The decrease was primarily due to decreased expenses reimbursable under the grant from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health, or NINDS, incurred during the three months ended March 31, 2026.
Previous wording
For the nine months ended September 30, 2025, our research and development expenses were $43.3 million, compared to $33.8 million for the nine months ended September 30, 2024, an increase of $9.5 million. The increase was primarily due to an increase in expenses for Descartes-08 for MG, primarily related to the expenses for the ongoing Phase 3 AURORA trial, coupled with an increase in our research and development employee expenses and stock-based compensation expense, primarily as the result of headcount growth, and an increase in expenses for early stage program, primarily related to increased discovery expenses and manufacturing operations expenses. These increases were partially offset by a decrease in expenses for legacy Selecta programs, primarily related to decreased expenses for Xork as a result of the termination of the Astellas Agreement in 2024.
Current wording
For the three months ended March 31, 2026, our research and development expenses were $19.5 million, compared to $14.7 million for the three months ended March 31, 2025, an increase of $4.8 million. The increase was primarily due to an increase in expenses for Descartes-08 for MG, primarily related to the expenses for the ongoing Phase 3 AURORA trial. This increase was partially offset by a decrease in expenses for early stage programs, primarily related to our decision to no longer pursue development of Descartes-08 in systemic lupus erythematosus.
Previous wording
Interest income for the three months ended September 30, 2025 was $1.5 million, compared to $2.6 million for the three months ended September 30, 2024, a decrease of $1.1 million. The decrease in interest income was due to decreased cash and cash equivalents balance.
Current wording
Interest income for the three months ended March 31, 2026 was $1.0 million, compared to $2.0 million for the three months ended March 31, 2025, a decrease of $1.0 million. The decrease in interest income was due to decreased cash and cash equivalents balance.
Previous wording
For the three months ended September 30, 2025, we recognized $0.5 million of income from the decrease in the fair value of warrant liabilities, compared to $5.7 million of income from the decrease in the fair value of warrant liabilities for the three months ended September 30, 2024, a decrease of $5.2 million. Fair value of warrant liabilities was determined utilizing the Black-Scholes valuation methodology. The decrease in warrant value was primarily driven by a decrease in the per-share price of our common stock and the expiration of the warrants we issued in 2019, or the 2019 Warrants, during the year ended December 31, 2024.
Current wording
For the three months ended March 31, 2026, we recognized $0.1 million of income from the decrease in the fair value of warrant liabilities, compared to $1.8 million of income from the decrease in the fair value of warrant liabilities for the three months ended March 31, 2025, a decrease of $1.7 million. Fair value of warrant liabilities was determined utilizing the Black-Scholes valuation methodology. The decrease in warrant value was primarily driven by a decrease in the per-share price of our common stock and a decrease in the remaining expected life of the warrants.
Previous wording
For the three months ended September 30, 2025, we recognized $16.9 million of expense associated with the increase in the fair value of the CVR liability, compared to $15.1 million of expense associated with the increase in the fair value of the CVR liability for the three months ended September 30, 2024, an increase of $1.8 million. The fair value of the CVR liability was determined utilizing a Monte Carlo simulation model. The increase in both periods in the fair value of the CVR liability was primarily due to a decrease in interest rates and the passage of time.
Current wording
For the three months ended March 31, 2026, we recognized $13.8 million of expense associated with the increase in the fair value of the CVR liability, compared to $0.3 million of income from the decrease in the fair value of the CVR liability for the three months ended March 31, 2025, an increase of $14.1 million. The fair value of the CVR liability was determined utilizing a Monte Carlo simulation model. The increase in the fair value of the CVR liability was primarily due to the passage of time.
Previous wording
During the nine months ended September 30, 2025, we recognized less than $0.1 million of other expense, net, compared to $1.1 million other income, net for the nine months ended September 30, 2024, a change of $1.1 million. The change was primarily due to a decrease in sublease income. The terms of our subleases expired during the year ended December 31, 2024.
Current wording
During the three months ended March 31, 2026, we recognized immaterial other expense, net, compared to no other expense, net for the three months ended March 31, 2025.
Previous wording
Net loss for three months ended September 30, 2025 was $35.9 million as compared to net loss of $24.2 million for the three months ended September 30, 2024, an increase of $11.7 million. The increase in net loss was primarily due to lower income from the change in the fair value of the warrant liabilities, an increase in research and development expenses and higher expense from the change in the fair value of the CVR liability during the three months ended September 30, 2025.
Current wording
Net loss for three months ended March 31, 2026 was $39.2 million as compared to net loss of $17.7 million for the three months ended March 31, 2025, an increase of $21.5 million. The increase in net loss was primarily due to higher expense from the change in the fair value of the CVR liability, an increase in research and development expenses and lower revenue and interest income the three months ended March 31, 2026.
Previous wording
Our cash, cash equivalents, and restricted cash were $145.1 million as of September 30, 2025, of which $1.7 million was restricted cash related to lease commitments.
Current wording
Our cash, cash equivalents, and restricted cash were $120.4 million as of March 31, 2026, of which $1.7 million was restricted cash related to lease commitments.
Previous wording
The liability associated with the contingent value rights agreement, or CVR Agreement, entered into on December 6, 2023, will be settled solely through cash flow received under the Sobi License and any other Gross Proceeds (as such term is defined in the CVR Agreement) net of certain agreed deductions. Under the CVR Agreement, 100% of all milestone payments, royalties, and other amounts paid to us or our controlled entities under the Sobi License, and any other Gross Proceeds, in each case net of certain agreed deductions, will be distributed to holders of the CVRs. There is no contractual obligation for us to fund any amount related to the CVR liability.
Current wording
The liability associated with the contingent value rights agreement, or CVR Agreement, entered into on December 6, 2023, will be settled solely through cash flow received under the Sobi License (as defined below) and any other Gross Proceeds (as such term is defined in the CVR Agreement) net of certain agreed deductions. Under the CVR Agreement, 100% of all milestone payments, royalties, and other amounts paid to us or our controlled entities under the Sobi License, and any other Gross Proceeds, in each case net of certain agreed deductions, will be distributed to holders of the CVRs. There is no contractual obligation for us to fund any amount related to the CVR liability.
Previous wording
In June 2020, we entered into the Sobi License. Sobi paid us a one-time, upfront payment of $75 million, and upon the closing of a private placement of our common stock to Sobi at a price of $138.468 per share, we received an additional $25 million from Sobi. We are eligible to receive $630.0 million in milestone payments upon the achievement of various development and regulatory milestones and sales thresholds for annual net sales of SEL-212, and tiered royalty payments ranging from the low double digits on the lowest sales tier to the high teens on the highest sales tier. Sobi has agreed to fund the Phase 3 clinical program of SEL-212, which commenced in September 2020. In July 2022, we received $10.0 million for the completion of the enrollment of the DISSOLVE II trial. In July 2024, we received $30.0 million for the milestone associated with the initiation of a rolling biologics license application to the FDA for SEL-212 for the potential treatment of chronic refractory gout by Sobi. Proceeds from milestone payments and royalties on sales of SEL-212, if any, are required to be distributed, net of certain agreed deductions, to holders of the CVRs. For further description of the Sobi License, see Note 13, “Revenue Arrangements” to our unaudited consolidated financial statements included elsewhere in this Quarterly Report.
Current wording
In June 2020, we entered into a License and Development Agreement, or as so amended, the Sobi License, with Swedish Orphan Biovitrum AB (publ.), or Sobi. Sobi paid us a one-time, upfront payment of $75 million, and upon the closing of a private placement of our common stock to Sobi at a price of $138.468 per share, we received an additional $25 million from Sobi. We are eligible to receive $630.0 million in milestone payments upon the achievement of various development and regulatory milestones and sales thresholds for annual net sales of Nanoecapsulated Sirolimus plus Pegadricase, or NASP, and tiered royalty payments ranging from the low double digits on the lowest sales tier to the high teens on the highest sales tier. Sobi has agreed to fund the Phase 3 clinical program of NASP, which commenced in September 2020. In July 2022, we received $10.0 million for the completion of the enrollment of the DISSOLVE II trial. In July 2024, we received $30.0 million for the milestone associated with the initiation of a rolling biologics license application to the FDA for NASP for the potential treatment of chronic refractory gout by Sobi. Proceeds from milestone payments and royalties on sales of NASP, if any, are required to be distributed, net of certain agreed deductions, to holders of the CVRs. For further description of the Sobi License, see Note 11, “Revenue Arrangements” to our unaudited consolidated financial statements included elsewhere in this Quarterly Report.
Previous wording
On December 13, 2024, we and Leerink Partners LLC entered into a Sales Agreement, or the Sales Agreement. Under the Sales Agreement, we may issue and sell shares of our common stock, from time to time, through Leerink Partners LLC or aggregate gross sales proceeds of up to $100.0 million. During the nine months ended September 30, 2025, we sold no shares of our common stock pursuant to the Sales Agreement.
Current wording
On December 13, 2024, the Company entered into a Sales Agreement, or the Sales Agreement, with Leerink Partners LLC to sell shares of the Company’s common stock, from time to time, through an “at the market” equity offering program under which Leerink Partners LLC acts as sales agent. The shares of common stock sold pursuant to the Sales Agreement will be issued pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-283803), filed on December 13, 2024 with the SEC and related prospectus supplement, filed on January 8, 2025 with the SEC, for aggregate gross sales proceeds of up to $100.0 million.
Previous wording
As of September 30, 2025, we had an accumulated deficit of $729.8 million. We anticipate operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of our product candidates, conducting preclinical studies and clinical trials, and our administrative organization. We will require substantial additional financing to fund our operations and to continue to execute our strategy, and we will pursue a range of options to secure additional capital.
Current wording
As of March 31, 2026, we had an accumulated deficit of $861.6 million. We anticipate operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of our product candidates, conducting preclinical studies and clinical trials, and our administrative organization. We will require substantial additional financing to fund our operations and to continue to execute our strategy, and we will pursue a range of options to secure additional capital.
Previous wording
We believe that our existing cash, cash equivalents, and restricted cash as of September 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of these financial statements. We may pursue additional cash resources through public or private equity or debt financings, by establishing collaborations with other companies or through the monetization of potential royalty and/or milestone payments pursuant to our existing collaboration and license arrangements. Management’s expectations with respect to our ability to fund current and long-term planned operations are based on estimates that are subject to risks and uncertainties. If actual results are different from management’s estimates, we may need to seek additional strategic or financing opportunities sooner than would otherwise be expected. However, there is no guarantee that any of these strategic or financing opportunities will be executed on favorable terms, and some could be dilutive to existing stockholders. If we are unable to obtain additional funding on a timely basis, we may be forced to significantly curtail, delay, or discontinue one or more of our planned research or development programs or be unable to expand our operations, meet long-term obligations or otherwise capitalize on our commercialization of our product candidates.
Current wording
We believe that our existing cash, cash equivalents, and restricted cash as of March 31, 2026 will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. We may pursue additional cash resources through public or private equity or debt financings, by establishing collaborations with other companies or through the monetization of potential royalty and/or milestone payments pursuant to our existing collaboration and license arrangements. Management’s expectations with respect to our ability to fund current and long-term planned operations are based on estimates that are subject to risks and uncertainties. If actual results are different from management’s estimates, we may need to seek additional strategic or financing opportunities sooner than would otherwise be expected. However, there is no guarantee that any of these strategic or financing opportunities will be executed on favorable terms, and some could be dilutive to existing stockholders. If we are unable to obtain additional funding on a timely basis, we may be forced to significantly curtail, delay, or discontinue one or more of our planned research or development programs or be unable to expand our operations, meet long-term obligations or otherwise capitalize on our commercialization of our product candidates.
Previous wording
We are under agreement to lease approximately 32,294 square feet of laboratory and office space in Watertown, Massachusetts through May 2028. Remaining lease payments from September 30, 2025 through the end of the lease term total approximately $7.6 million. Payments made and remaining obligations on this lease liability were subject to potential reimbursement through deductions to CVR distributions as described in Note 7, “Fair Value Measurements” to our unaudited consolidated financial statements included elsewhere in this Quarterly Report and were reimbursed in the March 2025 CVR distribution.
Current wording
We are under agreement to lease approximately 32,294 square feet of laboratory and office space in Watertown, Massachusetts through May 2028. Remaining lease payments from March 31, 2026 through the end of the lease term total approximately $6.1 million. Payments made and remaining obligations on this lease liability are subject to potential reimbursement through deductions to CVR distributions as described in Note 5, “Fair Value Measurements” to our unaudited consolidated financial statements included elsewhere in this Quarterly Report and were reimbursed in the March 2025 CVR distribution.
Previous wording
In November 2023, in connection with the Merger, we acquired two leases for office and laboratory space in Gaithersburg, Maryland, which expire in January 2027. Annualized rent is approximately $0.3 million and remaining lease payments from September 30, 2025 through the end of the lease term total approximately $0.4 million.
Current wording
In November 2023 we acquired two leases for office and laboratory space in Gaithersburg, Maryland, which expire in January 2027. Annualized rent is approximately $0.3 million and remaining lease payments from March 31, 2026 through the end of the lease term total approximately $0.3 million.
Previous wording
In February 2024, we entered into an agreement to lease approximately 19,199 square feet of integrated manufacturing and office space in Frederick, Maryland. In May 2024, we entered into an amendment to lease an additional approximately 7,842 square feet at the same site. In August 2024, we entered into a second amendment to lease an additional approximately 2,009 square feet at the same site. In March 2025, we entered into a third amendment to lease an additional approximately 6,439 square feet at the same site. The leases expire coterminously in June 2031. Annualized base rent under the leases is approximately $1.2 million and is subject to annual increases in accordance with the terms of the lease agreement. The leases provide for a tenant improvement allowance of $0.8 million. Remaining lease payments total $9.1 million through the end of the lease term.
Current wording
In February 2024, we entered into an agreement to lease approximately 19,199 square feet of integrated manufacturing and office space in Frederick, Maryland. In May 2024, we entered into an amendment to lease an additional approximately 7,842 square feet at the same site. In August 2024, we entered into a second amendment to lease an additional approximately 2,009 square feet at the same site. In March 2025, we entered into a third amendment to lease an additional approximately 6,439 square feet at the same site. The leases expire coterminously in June 2031. Annualized base rent under the leases is approximately $1.4 million and is subject to annual increases in accordance with the terms of the lease agreement. The leases provide for a tenant improvement allowance of $0.8 million. Remaining lease payments total $8.4 million through the end of the lease term.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2025 was $56.2 million compared to $16.7 million for the nine months ended September 30, 2024. The increase in cash used in operating activities of $39.5 million was primarily due to $48.2 million of net loss, adjusted for non-cash items, and $8.0 million of cash used in changes in operating assets and liabilities, in each case during the nine months ended September 30, 2025 compared to $4.0 million of net loss, adjusted for non-cash items, and $12.7 million of cash used in changes in operating assets and liabilities during the nine months ended September 30, 2024.
Current wording
Net cash used in operating activities for the three months ended March 31, 2026 was $22.1 million compared to $23.1 million for the three months ended March 31, 2025. The decrease in cash used in operating activities of approximately $1.0 million was primarily due to $22.2 million of net loss, adjusted for non-cash items, and $0.1 million of cash provided by changes in operating assets and liabilities, in each case during the three months ended March 31, 2026 compared to $16.0 million of net loss, adjusted for non-cash items, and $7.1 million of cash used in changes in operating assets and liabilities during the three months ended March 31, 2025.
Previous wording
Net cash used in investing activities for the nine months ended September 30, 2025 was $5.0 million compared to $8.4 million in the same period in 2024, a decrease of $3.4 million. The net cash used in investing activities for the nine months ended September 30, 2025 and 2024 consisted of purchases of property and equipment.
Current wording
Net cash used in investing activities for the three months ended March 31, 2026 was immaterial compared to $1.1 million for the three months ended March 31, 2025, a decrease of approximately $1.1 million. The net cash used in investing activities for the three months ended March 31, 2026 and 2025 consisted of purchases of property and equipment.
Previous wording
Net cash used in financing activities for the nine months ended September 30, 2025 was $8.0 million compared to net cash provided by financing activities of $167.6 million for the nine months ended September 30, 2024, a decrease of $175.6 million. The net cash used in financing activities in the nine months ended September 30, 2025 was primarily the result of payments for the CVR distribution. The net cash provided by financing activities in the nine months ended September 30, 2024 was primarily the result of proceeds of the 2023 Private Placement and the 2024 Private Placement.
Current wording
Net cash provided by financing activities for the three months ended March 31, 2026 was $15.7 million compared to net cash used in financing activities of $8.0 million for the three months ended March 31, 2025, an increase of approximately $23.7 million. The net cash provided by financing activities in the three months ended March 31, 2026 was primarily from $15.4 million in proceeds from sales of our common stock pursuant to the Sales Agreement, net of commissions and expenses. The net cash used in financing activities in the three months ended March 31, 2025 was primarily the result of payments for the CVR distribution.
Previous wording
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities in our consolidated financial statements. Actual results may differ from these estimates under different assumptions or conditions. During the three and nine months ended September 30, 2025, there were no material changes to our critical accounting policies from those described in our Annual Report on Form 10-K for the year ended December 31, 2024.
Current wording
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities in our consolidated financial statements. Actual results may differ from these estimates under different assumptions or conditions. During the three months ended March 31, 2026, there were no material changes to our critical accounting policies from those described in our Annual Report on Form 10-K for the year ended December 31, 2025.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
The following is a comparison of research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands, except percentages):
Previous report — wording carried elsewhere
For the nine months ended September 30, 2025, we recognized $3.0 million of income from the decrease in the fair value of warrant liabilities, compared to $2.8 million of income from the decrease in the fair value of warrant liabilities for the nine months ended September 30, 2024, an increase of $0.2 million. Fair value of warrant liabilities was determined utilizing the Black-Scholes valuation methodology. The decrease in warrant value was primarily driven by a decrease in the per-share price of our common stock and the expiration of the 2019 Warrants during the year ended December 31, 2024.