Eledon Pharmaceuticals, Inc.
For the period ended Sep 30, 2025. Filed Nov 14, 2025.
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.
Sep 30, 2025 · Filed Nov 14, 2025
ELDN$2.61+5.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001193125-25-180906
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001193125-25-283275
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 152 previous paragraphs and 161 current paragraphs.
109 unchanged; 37 reworded; 10 added; 3 removed; 3 previous and 5 current paragraphs rearranged.
Tables are not compared: 7 previous and 7 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
At the time of the August 2025 update, which reported data as of July 2025, 32 patients undergoing kidney transplantation have been enrolled in the Phase 1b study. Updated data showed that kidney function, as assessed by eGFR, stabilized after the first month post-transplant and remained in the range of approximately 68 mL/min/1.73 m2 through 12 months for patients (n = 12) who remained on tegoprubart. Kidney function in the intention-to-treat population (n=15) was approximately 63 mL/min/1.73 m2 at 12 months. Data from historical studies using the standard of care, calcineurin inhibitor-based immunosuppression therapy, typically report aggregate mean eGFR of approximately 53 mL/min/1.73 m2 during the first year after kidney transplant. In addition, preliminary abbreviated iBox data was presented suggesting that tegoprubart may improve 5-year graft survival. Abbreviated iBox, a composite biomarker panel developed by the Paris Transplant Group, incorporates kidney function (eGFR, proteinuria) and immunologic response (donor-specific antibodies) parameters into a single prognostic score. Based on data collected as of July 2025, abbreviated iBox scores were -3.75 in the intention-to-treat population and -4.11 in the on-treatment population, which compare favorably to a -2.98 historical mean for calcineurin inhibitors. A difference in abbreviated iBox score of -0.40 at 12 months is considered predictive of a 4-5% difference in 5-year graft survival suggesting that tegoprubart may have a predicted 5-year allograft survival rate of over 96%. As of July 2025, there were six (18.8%) rejection episodes, and 75% of patients who experienced a rejection had received low-dose rabbit antithymocyte globulin (rATG) induction. All rejection episodes were successfully treated. Of the patients who experienced a rejection episode and completed a year in the study, three who remained on tegoprubart had a mean eGFR of approximately 73 mL/min/1.73 m2 at 12 months, indicating full recovery of kidney function, while the two patients who switched to standard of care tacrolimus had a mean eGFR of approximately 34 mL/min/1.73 m² at 12 months.
Current report
On November 6, 2025, we announced topline efficacy and safety data from the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of kidney transplant rejection. Safety and efficacy results supported the potential for tegoprubart to provide effective immunosuppression with a favorable safety and tolerability profile compared to tacrolimus. Safety findings underscore tegoprubart’s potential to maintain effective immunosuppression while minimizing the metabolic, neurologic, and cardiovascular toxicities characteristic of tacrolimus-based therapy. Notably, new-onset diabetes developed in approximately 1 in 6 patients receiving tacrolimus versus 1 in 47 receiving tegoprubart. Tremor was markedly higher in the tacrolimus group (25.0% vs. 1.6%) and cardiovascular effects, including hypertension (15.9% vs. 25.0%), hypertensive crisis (1.6% vs. 7.8%), and heart failure (0% vs. 4.7%) all favored tegoprubart. Delayed graft function occurred less often with tegoprubart and required shorter dialysis (14.3% vs. 25%; 4.6 days vs. 6.1 days) suggesting potential reductions of 115 days on dialysis post-transplant per 100 deceased donor kidney recipients on tegoprubart versus tacrolimus. Sepsis or bacteremia occurred more frequently in the tacrolimus arm (17.2% vs. 4.8%) and viral infection rates (CMV, BK, EBV, fungal) were similar across groups, with no cases of Post-Transplant Lymphoproliferative Disorder or Progressive Multifocal Leukoencephalopathy. Additionally, overall rates of serious adverse events were comparable between treatment arms. From an efficacy standpoint, tegoprubart achieved an eGFR of approximately 69 mL/min/1.73 m² (n=51) at 12 months compared to 66 mL/min/1.73 m² for tacrolimus (n=56). Although the primary endpoint did not reach statistical significance, tegoprubart maintained strong renal function, delivering what the Company believes is the highest mean eGFR level reported to date in kidney transplant clinical trials evaluating rejection prevention. Subgroup analyses showed higher eGFRs in nearly all tegoprubart subgroups compared to tacrolimus, particularly among living-related donor recipients (72 mL/min/1.73 m² vs. 62 mL/min/1.73 m²) and high Kidney Donor Profile Index (KDPI > 35) transplants (62 mL/min/1.73 m² vs. 53 mL/min/1.73 m²). In the deceased donor subgroup, tegoprubart achieved a mean eGFR of approximately 68 mL/min/1.73 m² at 12 months. The efficacy failure composite endpoint, comprising death, graft loss and biopsy proven acute rejection, is the approval endpoint currently recognized by the U.S. Food and Drug Administration. Efficacy failure composite endpoint was 22% in the tegoprubart group vs. 17% in the tacrolimus group, demonstrating non-inferiority for tegoprubart versus tacrolimus, using a 20% non-inferiority margin. The Company believes these results, if replicated in a Phase 3 study, would be sufficient to support tegoprubart’s approvability. The rate of acute rejection in all biopsies was 20.6% for tegoprub…
Excerpt shortened here; the source contains the full paragraph.
Current report
2025 Underwritten Offering
Current report
On November 12, 2025, we entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners, LLC, as representative of the several underwriters named therein (the “Underwriters”), in connection with the underwritten public offering and sale by the Company (the “2025 Underwritten Offering”) of 15,152,485 shares of our common stock at a public offering price of $1.65 per share (the “Common Stock Purchase Price”), and pre-funded warrants (the “2025 Pre-Funded Warrants”) at a public offering price of $1.649 per 2025 Pre-Funded Warrant, which are exercisable to purchase up to 15,151,515 shares of common stock at an exercise price of $0.001 per share. In addition, pursuant to the Underwriting Agreement, we granted the Underwriters an option (the “Option”), exercisable for 30 days, to purchase up to 4,545,600 additional shares of common stock at the Common Stock Purchase Price less the underwriting discounts and commissions, which Option has been exercised in full by the Underwriters. The 2025 Underwritten Offering closed on November 13, 2025. The estimated net proceeds to the Company from the 2025 Underwritten Offering, after deducting the Underwriters’ discounts and commissions and our estimated offering expenses, was approximately $53.6 million, including net proceeds from the Underwriters exercise the Option.
Current report
an increase of $0.1 million in personnel-related expenses, primarily due to higher headcount; and
Current report
a decrease of $0.1 million in other expense, primarily due to lower general operating costs.
Current report
Other income for the three months ended September 30, 2025 was comparable to the three months ended September 30, 2024, with no significant variances.
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Current report
an increase of $0.2 million in other expense, primarily due to general operating costs associated with new headcount.
Current report
a decrease of $0.1 million in other expenses, primarily due to lower general operating costs.
Removed paragraphs (3)
Previous report
an increase of $0.1 million in personnel-related expenses, primarily due to increased headcount; and
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Previous report
Research and development expenses increased $16.3 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024. The increase was primarily attributable to the following:
Reworded paragraphs (37)
Previous wording
We reported interim safety and efficacy results from the Phase 1b clinical trial in March 2023, and provided updated data in November 2023 and June 2024. At the time of the June 2024 update, which reported data as of April 3, 2024, results from the 13 participants in the Phase 1b trial support tegoprubart’s potential to protect organs from rejection while improving renal function in patients undergoing kidney transplantation. As mentioned above, data from historical studies using standard of care, calcineurin inhibitor-based, immunosuppression therapy typically report aggregate mean estimated eGFRs of approximately 53 mL/min/1.73m² during the first year after kidney transplant. In the ongoing Phase 1b trial, as of April 3, 2024, mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant. Two participants completed 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m² at one-year post-transplant. The interim results demonstrated that tegoprubart is generally safe and well tolerated in patients undergoing de novo kidney transplantation. As of April 3, 2024, three subjects have discontinued the study due to hair loss and fatigue, viral infection, and rejection, respectively. There have been no cases of hyperglycemia, new onset diabetes, or tremor, all of which are side effects often associated with standard of care immunosuppression therapy. There have been no cases of graft loss or death.
Current wording
At the time of the June 2024 update, which reported data as of April 3, 2024, results from the 13 participants in the Phase 1b trial support tegoprubart’s potential to protect organs from rejection while improving renal function in patients undergoing kidney transplantation. As mentioned above, data from historical studies using standard of care, calcineurin inhibitor-based, immunosuppression therapy typically report aggregate mean estimated eGFRs of approximately 53 mL/min/1.73m² during the first year after kidney transplant. In the ongoing Phase 1b trial, as of April 3, 2024, mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant. Two participants completed 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m² at one-year post-transplant. The interim results demonstrated that tegoprubart is generally safe and well tolerated in patients undergoing de novo kidney transplantation. As of April 3, 2024, three subjects discontinued the study due to hair loss and fatigue, viral infection, and rejection, respectively. There have been no cases of hyperglycemia, new onset diabetes, or tremor, all of which are side effects often associated with standard of care immunosuppression therapy. There have been no cases of graft loss or death.
Previous wording
In July 2022, we received Investigational New Drug (“IND”) application clearance from the FDA for our controlled, Phase 2 BESTOW trial of tegoprubart for the prevention of transplant rejection in persons receiving a kidney transplant. The BESTOW study is a multi-center, two-arm, active comparator, head-to-head superiority clinical study, and will enroll approximately 120 participants undergoing kidney transplantation in the U.S. and other countries to evaluate the safety, pharmacokinetics, and efficacy of tegoprubart compared to the calcineurin inhibitor tacrolimus. The study’s primary objective is to assess graft function as measured by estimated eGFR at 12 months post-transplant in participants treated with tegoprubart compared to tacrolimus. Secondary objectives will include assessment of graft survival, biopsy-proven acute rejection, and the incidence of new onset diabetes mellitus after transplant. The BESTOW study is running in parallel to the ongoing Phase 1b clinical trial of tegoprubart in kidney transplantation. The first subject in the BESTOW study was dosed in August 2023. On September 4, 2024, we announced the completion of enrollment in the BESTOW study. We expect the last patient to be dosed in September 2025 and anticipate presenting topline results from the BESTOW study in November 2025.
Current wording
In July 2022, we received Investigational New Drug (“IND”) application clearance from the FDA for our controlled, Phase 2 BESTOW trial of tegoprubart for the prevention of transplant rejection in persons receiving a kidney transplant. The BESTOW study is a multi-center, two-arm, active comparator, head-to-head superiority clinical study, with approximately 120 participants undergoing kidney transplantation in the U.S. and other countries to evaluate the safety, pharmacokinetics, and efficacy of tegoprubart compared to the calcineurin inhibitor tacrolimus. The study’s primary objective is to assess graft function as measured by estimated eGFR at 12 months post-transplant in participants treated with tegoprubart compared to tacrolimus. Secondary objectives will include assessment of graft survival, biopsy-proven acute rejection, and the incidence of new onset diabetes mellitus after transplant. The BESTOW study is running in parallel to the ongoing Phase 1b clinical trial of tegoprubart in kidney transplantation. The first subject in the BESTOW study was dosed in August 2023. On September 4, 2024, we announced the completion of enrollment in the BESTOW study.
Previous wording
To date, tegoprubart has been used as a key component of the immunosuppression regimen in four xenotransplantation procedures: three involving genetically modified pig kidneys and one involving a genetically modified pig heart. Two of the kidney transplant recipients remains alive with ongoing graft function.
Current wording
To date, tegoprubart has been used as a key component of the immunosuppression regimen in four xenotransplantation procedures: three involving genetically modified pig kidneys and one involving a genetically modified pig heart. Two of the kidney transplant recipients remain alive. One continues to maintain kidney function with the transplanted pig kidney, while the other had the graft removed on day 271 and has since returned to dialysis.
Previous wording
On April 28, 2023, we entered into a Securities Purchase Agreement (the “2023 Securities Purchase Agreement”) with certain institutional and accredited investors, pursuant to which we agreed to issue and sell to the investors in a private placement (the “2023 Private Placement”) (i) in an initial closing, (a) an aggregate of 15,151,518 shares (the “Shares”) of our common stock, $0.001 par value per share, or pre-funded warrants in lieu thereof (the “Pre-Funded Warrants”), and (b) common stock warrants exercisable into an aggregate of 15,151,518 shares of common stock (or Pre-Funded Warrants in lieu thereof) (the “Common Warrants” and, together with the Pre-Funded Warrants, the “Warrants”); (ii) in a second closing (the “Second Closing”), upon the satisfaction or waiver of specified conditions set forth in the 2023 Securities Purchase Agreement, an aggregate of 20,202,024 shares of common stock (or Pre-Funded Warrants); and (iii) in a third closing (the “Third Closing”), upon the satisfaction or waiver of specified conditions set forth in the 2023 Securities Purchase Agreement, an aggregate of 25,252,530 shares of common stock (or Pre-Funded Warrants), in each case subject to customary adjustments as provided in the 2023 Securities Purchase Agreement, Pre-Funded Warrant or Common Warrant, as applicable. Each Common Warrant has an exercise price of $3.00 per share and expires five years after issuance. The Pre-Funded Warrants are exercisable immediately and until exercised in full, with an exercise price of $0.001 per share. The Pre-Funded Warrants and Common Warrants are subject to specified beneficial ownership limitations, which are generally set at 9.99% of the total common stock then issued and outstanding immediately following the exercise of such warrants, and provided that any beneficial ownership limitation may not exceed 19.99% unless otherwise permitted. The Shares, the Warrants, and the shares of common stock issuable upon the exercise of the Warrants, have not been registered under the Securities Act of 1933, as amended, and were offered pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act of 1933, as amended, and Rule 506(b) promulgated thereunder.
Current wording
Pre-Funded Warrants in lieu thereof) (the “Common Warrants” and, together with the Pre-Funded Warrants, the “Warrants”); (ii) in a second closing (the “Second Closing”), upon the satisfaction or waiver of specified conditions set forth in the 2023 Securities Purchase Agreement, an aggregate of 20,202,024 shares of common stock (or Pre-Funded Warrants); and (iii) in a third closing (the “Third Closing”), upon the satisfaction or waiver of specified conditions set forth in the 2023 Securities Purchase Agreement, an aggregate of 25,252,530 shares of common stock (or Pre-Funded Warrants), in each case subject to customary adjustments as provided in the 2023 Securities Purchase Agreement, Pre-Funded Warrant or Common Warrant, as applicable. Each Common Warrant has an exercise price of $3.00 per share and expires five years after issuance. The Pre-Funded Warrants are exercisable immediately and until exercised in full, with an exercise price of $0.001 per share. The Pre-Funded Warrants and Common Warrants are subject to specified beneficial ownership limitations, which are generally set at 9.99% of the total common stock then issued and outstanding immediately following the exercise of such warrants, and provided that any beneficial ownership limitation may not exceed 19.99% unless otherwise permitted. The Shares, the Warrants, and the shares of common stock issuable upon the exercise of the Warrants, have not been registered under the Securities Act of 1933, as amended, and were offered pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act of 1933, as amended, and Rule 506(b) promulgated thereunder.
Previous wording
On September 20, 2024, we entered into an Open Market Sale Agreement (the “Sales Agreement”) with Guggenheim Securities, LLC (“Guggenheim Securities”) to sell shares of our common stock, having aggregate sales proceeds of up to $75.0 million, from time to time, through an “at the market” equity offering program under which Guggenheim Securities will act as sales agent. In connection with the Sales Agreement, we filed on September 20, 2024 a registration statement on Form S-3 containing a prospectus and prospectus supplement (the “Shelf Registration Statement”) with the SEC. The Shelf Registration Statement became effective on October 2, 2024. As of June 30, 2025, we have not sold any shares under the Sales Agreement.
Current wording
Guggenheim Securities will act as sales agent. In connection with the Sales Agreement, we filed on September 20, 2024 a registration statement on Form S-3 containing a prospectus and prospectus supplement (the “Shelf Registration Statement”) with the SEC. The Shelf Registration Statement became effective on October 2, 2024. Through September 30, 2025, we have not sold any shares under the Sales Agreement.
Previous wording
Our management’s discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amount of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities as of the date of the financial statements. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions. In Part II, Item 7 of the Amended Form 10-K, we disclosed our critical accounting estimates, which are those estimates made in accordance with GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operation. There have been no significant changes in our critical accounting estimates during the six months ended June 30, 2025, as compared to those disclosed in the Amended Form 10-K.
Current wording
Our management’s discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amount of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities as of the date of the financial statements. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions. In Part II, Item 7 of the Amended Form 10-K, we disclosed our critical accounting estimates, which are those estimates made in accordance with GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operation. There have been no significant changes in our critical accounting estimates during the nine months ended September 30, 2025, as compared to those disclosed in the Amended Form 10-K.
Previous wording
an increase of $8.1 million in expenses related to Tegoprubart - kidney transplantation programs, primarily driven by external CRO costs associated with increased activities in our Phase 1b, Phase 2 BESTOW, and Phase 2 open-label extension trials;
Current wording
a decrease of $0.8 million in expenses related to tegoprubart - kidney transplantation programs, primarily driven by lower external CRO costs associated with decreased activities in our Phase 1b, Phase 2 BESTOW, and Phase 2 open-label extension trials;
Previous wording
an increase of $5.7 million in manufacturing expenses, primarily with contract manufacturing organizations, for the increased production of drug substance and drug product clinical trial supply;
Current wording
a decrease of $2.5 million in manufacturing expenses, primarily with contract manufacturing organizations, for the production of drug substance and drug product clinical trial supply;
Previous wording
an increase of $2.0 million in personnel-related expenses. primarily due to increased headcount to support ongoing clinical development programs;
Current wording
an increase of $1.1 million in personnel-related expenses, primarily due to higher headcount to support ongoing clinical development programs;
Previous wording
an increase of $0.9 million in stock-based compensation expense, primarily attributable to new time-based restricted stock unit and stock option grants; and
Current wording
an increase of $0.7 million in stock-based compensation expense, primarily attributable to new time-based restricted stock unit and stock option grants; and
Previous wording
General and administrative expenses increased by $0.1 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. The decrease was primarily attributable to the following:
Current wording
General and administrative expenses increased by $0.1 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. The increase was primarily attributable to the following:
Previous wording
an increase of $0.6 million in professional and consulting expenses, primarily driven by increased audit and legal services;
Current wording
an increase of $0.1 million in professional and consulting expenses, primarily driven by increased audit and legal services;
Previous wording
For the three months ended June 30, 2025, the fair value of warrant liabilities decreased by $12.3 million, reflecting a decline in the Company’s stock price during the period. This decrease was driven primarily by a reduction in the fair value of the Common Warrants, with the total warrant liability declining from $34.8 million as of March 31, 2025 to $22.5 million as of June 30, 2025.
Current wording
For the three months ended September 30, 2025, the fair value of warrant liabilities decreased by $0.6 million, primarily reflecting a decline in the Company’s stock price during the period. This decrease was driven primarily by a reduction in the fair value of the Common Warrants, with the total warrant liability declining from $22.5 million as of June 30, 2025 to $21.9 million as of September 30, 2025.
Previous wording
By comparison, for the three months ended June 30, 2024, the fair value of the Common Warrants increased by $31.3 million, primarily due to an increase in the Company’s stock price. The warrant liability increased from $89.5 million as of March 31, 2024 to $120.8 million as of June 30, 2024.
Current wording
By comparison, for the three months ended September 30, 2024, the fair value of the Common Warrants decreased by $96.4 million, primarily due to the reversal of $94.5 million in warrant liabilities associated with the Subsequent Closing Warrants that expired July 8, 2024 and September 30, 2024. The warrant liability decreased from $120.8 million as of June 30, 2024 to $24.0 million as of September 30, 2024.
Previous wording
The following table provides comparative unaudited results of operations for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table provides comparative unaudited results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
Research and development expenses increased $10.2 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. The increase was primarily attributable to the following:
Current wording
Research and development expenses increased $14.7 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024. The increase was primarily attributable to the following:
Previous wording
an increase of $4.1 million in expenses related to Tegoprubart - kidney transplantation programs, primarily driven by external CRO costs associated with increased activities in our Phase 1b, Phase 2 BESTOW, and Phase 2 open-label extension trials;
Current wording
an increase of $7.3 million in expenses related to tegoprubart - kidney transplantation programs, primarily driven by higher external CRO costs associated with increased activities in our Phase 1b, Phase 2 BESTOW, and Phase 2 open-label extension trials;
Previous wording
an increase of $4.8 million in manufacturing expenses, primarily with contract manufacturing organizations, for the increased production of drug substance and drug product clinical trial supply;
Current wording
an increase of $3.2 million in manufacturing expenses, primarily with contract manufacturing organizations, for the increased production of drug substance and drug product clinical trial supply;
Previous wording
an increase of $1.3 million in personnel-related expenses, primarily due to increased headcount to support ongoing clinical development programs; and
Current wording
an increase of $3.1 million in personnel-related expenses, primarily due to higher headcount to support ongoing clinical development programs;
Previous wording
an increase of $0.3 million in stock-based compensation expense, primarily attributable to new time-based restricted stock unit and stock option grants.
Current wording
an increase of $1.6 million in stock-based compensation expense, primarily attributable to new time-based restricted stock unit and stock option grants; and
Previous wording
General and administrative expenses increased by $1.0 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024. The decrease was primarily attributable to the following:
Current wording
General and administrative expenses increased by $1.1 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024. The decrease was primarily attributable to the following:
Previous wording
an increase of $0.9 million in professional and consulting expenses, primarily driven by increased audit and legal services;
Current wording
an increase of $1.0 million in professional and consulting expenses, primarily driven by increased audit and legal services;
Previous wording
an increase of $0.3 million in personnel-related expenses, primarily due to increased headcount; and
Current wording
an increase of $0.3 million in personnel-related expenses, primarily due to higher headcount;
Previous wording
a decrease of $0.6 million in stock-based compensation expense, primarily attributable to performance-based stock options granted in 2024.
Current wording
a decrease of $0.2 million in stock-based compensation expense, primarily attributable to performance-based stock options granted in 2024; and
Previous wording
The $1.2 million increase in other income, net was primarily due to an increase in interest income, driven by higher balances of our cash and cash equivalents and short-term investments during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024.
Current wording
The $1.2 million increase in other income, net was primarily due to an increase in interest income, driven by higher balances of our cash and cash equivalents and short-term investments during the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024.
Previous wording
For the six months ended June 30, 2025, the fair value of warrant liabilities decreased by $22.4 million. This change was primarily driven by a decrease in the fair value of the Common Warrants, reflecting a decline in the Company’s stock price during the period. The warrant liability declined from $44.9 million as of December 31, 2024 to $22.5 million as of June 30, 2025.
Current wording
For the nine months ended September 30, 2025, the fair value of warrant liabilities decreased by $22.9 million. This change was primarily driven by a decrease in the fair value of the Common Warrants, reflecting a decline in the Company’s stock price during the period. The warrant liability declined from $44.9 million as of December 31, 2024 to $21.9 million as of September 30, 2025.
Previous wording
In contrast, for the six months ended June 30, 2024, the fair value of the Common Warrants increased by $44.6 million, primarily due to an increase in the Company’s stock price. The warrant liability increased from $76.2 million as of December 31, 2023 to $120.8 million as of June 30, 2024.
Current wording
In contrast, for the nine months ended September 30, 2024, the fair value of the Common Warrants decreased by $51.8 million, primarily due to the reversal of $58.7 million in warrant liabilities associated with the Subsequent Closing Warrants that expired on July 8, 2024 and September 30, 2024 and primarily offset by an increase in fair value of the Common Warrants, reflecting an increase in the Company's stock price during the period. The warrant liability decreased from $76.2 million as of December 31, 2023 to $24.0 million as of September 30, 2024.
Previous wording
As of June 30, 2025, the Company had cash and cash equivalents and short-term investments of $107.6 million, working capital of $97.7 million and an accumulated deficit of $373.3 million.
Current wording
As of September 30, 2025, the Company had cash and cash equivalents and short-term investments of $93.4 million, working capital of $82.0 million and an accumulated deficit of $390.8 million.
Previous wording
We do not have any approved products for commercial sale and have never generated revenue from product sales and have incurred significant net losses since our inception and expect to continue to incur net operating losses for the foreseeable future. We do not expect to receive any revenue from any product candidates that we develop unless and until we obtain regulatory approval and commercialize our product candidates or enter into collaborative arrangements with third parties. We currently have no credit facility or committed sources of capital. To date, our operations have been financed primarily by net proceeds from the sale of preferred and common stock, and the sale of warrants. Additionally, in view of our expectation to incur significant losses for the foreseeable future we will be required to raise additional capital resources in the future in order to fund our operations, although the availability of, and our access to, such resources is not assured.
Current wording
We do not have any approved products for commercial sale and have never generated revenue from product sales and have incurred significant net losses since our inception and expect to continue to incur net operating losses for the foreseeable future. We do not expect to receive any revenue from any product candidates that we develop unless and until we obtain regulatory approval and commercialize our product candidates or enter into collaborative arrangements with third parties. We currently have no credit facility or committed sources of capital.
Previous wording
Conditions in the financial and credit markets may also limit the availability of funding or increase the cost of funding. As a result of any of the foregoing factors, adequate additional funding may not be available to us on acceptable terms on a timely basis, or at all. The severity and duration of any such impacts cannot be predicted. Any such failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies or cause us to delay our clinical development plans, research and development programs or commercialization efforts, out-license intellectual property rights to our product candidates or sell unsecured assets, or a combination of the above. Any of these actions could materially harm our business. The issuance of shares of common stock in the 2023 Private Placement, the 2024 Private Placement and the 2024 Underwritten Offering diluted the ownership interests of our existing stockholders, and to the extent that we raise additional capital through the sale of additional equity, including through our “at the market” equity offering program, or convertible debt securities in the future, our stockholders’ ownership interests may be further diluted, and the terms of these securities may also include liquidation or other preferences that adversely affect our stockholders’ rights. Debt financing, if available, would result in fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. If we raise funds through collaborations, licenses and other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. Please see Part II, Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q for additional risks associated with our substantial capital requirements and the challenges we may face in raising capital.
Current wording
Conditions in the financial and credit markets may also limit the availability of funding or increase the cost of funding. As a result of any of the foregoing factors, adequate additional funding may not be available to us on acceptable terms on a timely basis, or at all. The severity and duration of any such impacts cannot be predicted. Any such failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies or cause us to delay our clinical development plans, research and development programs or commercialization efforts, out-license intellectual property rights to our product candidates or sell unsecured assets, or a combination of the above. Any of these actions could materially harm our business. The issuance of shares of common stock in the 2023 Private Placement, the 2024 Private Placement, the 2024 Underwritten Offering and the 2025 Underwritten Offering diluted the ownership interests of our existing stockholders, and to the extent that we raise additional capital through the sale of additional equity, including through our “at the market” equity offering program, or convertible debt securities in the future, our stockholders’ ownership interests may be further diluted, and the terms of these securities may also include liquidation or other preferences that adversely affect our stockholders’ rights. Debt financing, if available, would result in fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. If we raise funds through collaborations, licenses and other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. Please see Part II, Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q for additional risks associated with our substantial capital requirements and the challenges we may face in raising capital.
Previous wording
The following table provides a summary of our net cash flow activity for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table provides a summary of our net cash flow activity for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
For the six months ended June 30, 2025, operating activities used $33.8 million in cash, primarily reflecting our net loss of $17.7 million. Operating activities included adjustments for certain non-cash charges, including $22.4 million due to changes in warrant liabilities, and $1.1 million from accretion of investment discounts. These were partially offset by $5.6 million in stock-based compensation, and $0.2 million in non-cash lease expense. Net operating assets and liabilities changed by $1.7 million, driven by a $2.1 million increase in accounts payable and accrued expenses, a $0.3 million increase in prepaid expenses and other assets, and a $0.2 million decrease in operating lease liabilities.
Current wording
For the nine months ended September 30, 2025, operating activities used $48.3 million in cash, primarily reflecting our net loss of $35.2 million. Operating activities included adjustments for certain non-cash charges, including $22.9 million due to changes in warrant liabilities, and $1.4 million from accretion of investment discounts. These were partially offset by $8.0 million in stock-based compensation, and $0.2 million in non-cash lease expense. Net operating assets and liabilities changed by $3.0 million, driven by a $2.6 million increase in accounts payable and accrued expenses, a $0.5 million decrease in prepaid expenses and other assets, and a $0.2 million decrease in operating lease liabilities.
Previous wording
For the six months ended June 30, 2024, operating activities used $16.5 million in cash, primarily reflecting our net loss of $68.5 million. Operating activities include adjustments for certain non-cash charges including $44.6 million due to changes in warrant liabilities, $4.8 million in stock-based compensation, and $0.2 million in non-cash lease expense, partially offset by $1.0 million in accretion of investment discounts and gain on lease termination. Net operating assets and liabilities changed by $3.4 million, primarily driven by a $2.2 million increase in accounts payable and accrued expenses, a $1.3 million decrease in prepaid expenses and other assets, and a $0.1 million decrease in operating lease liabilities.
Current wording
For the nine months ended September 30, 2024, operating activities used $28.3 million in cash, primarily reflecting our net loss of $8.4 million. Operating activities include adjustments for certain non-cash charges including $51.8 million due to changes in warrant liabilities and $1.9 million in accretion of investment discounts. These were partially offset by $6.5 million in stock-based compensation and $0.3 million in non-cash lease expense. Net operating assets and liabilities changed by $10.2 million, primarily driven by a $8.8 million increase in accounts payable and accrued expenses, a $1.7 million decrease in prepaid expenses and other assets, and a $0.2 million decrease in operating lease liabilities.
Previous wording
Net cash provided by investing activities for the six months ended June 30, 2025 was $18.9 million. This consisted of $78.1 million in proceeds from maturity of available-for-sale short-term investments, partially offset by $59.3 million used to purchase available-for-sale short-term investments.
Current wording
Net cash provided by investing activities for the nine months ended September 30, 2025 was $31.2 million. This consisted of $123.2 million in proceeds from maturity of available-for-sale short-term investments, partially offset by $91.9 million used to purchase available-for-sale short-term investments.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2024 was $10.1 million. This consisted of $49.2 million used to purchase available-for-sale short-term investments, partially offset by $39.1 million in proceeds from maturity of available-for-sale short-term investments.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2024 was $22.9 million. This consisted of $83.4 million used to purchase available-for-sale short-term investments, partially offset by $60.4 million in proceeds from maturity of available-for-sale short-term investments.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2025 consisted of $0.1 million from exercise of stock options.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2025 consisted of $0.1 million from exercise of stock options.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2024 consisted of the 2024 Private Placement, totaling $48.1 million in net proceeds from the sale of 13.1 million shares of common stock and 8.0 million pre-funded warrants to purchase common stock.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2024 consisted of the 2024 Private Placement, totaling $48.1 million in net proceeds from the sale of 13.1 million shares of common stock and 8.0 million pre-funded warrants to purchase common stock; $2.0 million in net proceeds from the Second Closing, involving the sale of 909,088 shares of commons stock; and $3.3 million in net proceeds from the Third Closing, involving the sale of 1.5 million shares of common stock.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
We reported interim safety and efficacy results from the Phase 1b clinical trial in March 2023, and provided updated data in November 2023, June 2024 and August 2025.
Current report — wording carried from elsewhere
On April 28, 2023, we entered into a Securities Purchase Agreement (the “2023 Securities Purchase Agreement”) with certain institutional and accredited investors, pursuant to which we agreed to issue and sell to the investors in a private placement (the “2023 Private Placement”) (i) in an initial closing, (a) an aggregate of 15,151,518 shares (the “Shares”) of our common stock, $0.001 par value per share (“common stock”), or pre-funded warrants in lieu thereof (the “Pre-Funded Warrants”), and (b) common stock warrants exercisable into an aggregate of 15,151,518 shares of common stock (or
Current report — wording carried from elsewhere
On September 20, 2024, we entered into an Open Market Sale Agreement (the “Sales Agreement”) with Guggenheim Securities, LLC (“Guggenheim Securities”) to sell shares of our common stock, having aggregate sales proceeds of up to $75.0 million, from time to time, through an “at the market” equity offering program (the “ATM Program”) under which
Current report — wording carried from elsewhere
Research and development expenses decreased $1.6 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. The decrease was primarily attributable to the following:
Current report — wording carried from elsewhere
To date, our operations have been financed primarily by net proceeds from the sale of preferred and common stock, and the sale of warrants. Additionally, in view of our expectation to incur significant losses for the foreseeable future we will be required to raise additional capital resources in the future in order to fund our operations, although the availability of, and our access to, such resources is not assured.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
$0.3 million in expenses related to Tegoprubart - other development programs incurred in the three months ended June 30, 2024 that were not incurred in the three months ended June 30, 2025, due to the termination of our IgAN program in 2023;
Previous report — wording carried elsewhere
The $0.4 million increase in other income, net was primarily due to an increase in interest income, driven by higher balances of our cash and cash equivalents and short-term investments during the three months ended June 30, 2025 as compared to the three months ended June 30, 2024.
Previous report — wording carried elsewhere
a decrease of $0.1 million in stock-based compensation expense, primarily attributable to performance-based stock options granted in 2024.