What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-19 compared with 2025-03-20 · 78 added, 84 removed, 231 unchanged (41% of the section changed)

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The next and final analysis will be conducted once 80 events (deaths) are reached.

We anticipate that 80 events will be reached this year.

In December 2025, we announced that our contract research organization informed us that the pooled number of events was 72 as of December 26, 2025.

We remain blinded to all efficacy and survival data outcomes and, as no outcomes analyses were performed and no statistical penalty has been incurred, this one-time update on the aggregate number of events does not impact future statistical analyses.

Because the final analysis is event driven, it is difficult to predict with any certainty and it may occur at a different time than currently expected.

We will announce the 80th event when it occurs.

In December 2020, we entered into an exclusive license agreement, or the 3D Medicines Agreement, with 3D Medicines Inc., or 3D Medicines, a China-based biopharmaceutical company developing next-generation immuno-oncology drugs, for the development and commercialization of GPS, as well as the Company’s next generation heptavalent immunotherapeutic GPS+, which is at preclinical stage, across all therapeutic and diagnostic uses in mainland China, Hong Kong, Macau and Taiwan, which we refer to as Greater China.

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Although the REGAL study has completed enrollment as announced in March 2024, in accordance with the predetermined statistical analysis plan, 3D Medicines may still enroll patients in mainland China.

The timing of such participation and patient enrollment by 3D Medicines, if at all, cannot be predicted with certainty.

As of March 15, 2025, we have received an aggregate of $10.5 million in upfront and milestone payments under our license agreement with 3D Medicines, or the 3D Medicines Agreement, and a total of $191.5 million in potential future development, regulatory and sales milestones, not including future royalties, remains under the license agreement, which milestones are variable in nature and not under our control.

The timing of such participation and patient enrollment by 3D Medicines, if at all,

cannot be predicted with certainty.

As of December 31, 2025, we have received an aggregate of $10.5 million in upfront and milestone payments under our license agreement with 3D Medicines, or the 3D Medicines Agreement, and a total of $191.5 million in potential future development, regulatory and sales milestones, not including future royalties, remains under the license agreement, which milestones are variable in nature and not under our control.

In December 2023, we announced that we had commenced a binding arbitration proceeding against 3D Medicines to resolve a dispute regarding, among other things, the trigger and payment of relevant milestone payments due to us under the 3D Medicines Agreement.

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In October 2024, the FDA granted Rare Pediatric Disease, or RPD, designation to GPS for the treatment of pediatric AML.

SLS009, or Tambiciclib:

Highly Selective Next Generation CDK9 Inhibitor

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We completed a Phase 1 dose-escalating clinical trial in the United States and China for SLS009 in mid-2023 and reported positive safety and efficacy data for both patient cohorts, that is relapsed and/or refractory AML and refractory lymphoma.

We also established in the trial a recommended Phase 2 dose, or RP2D, of 60 mg once weekly for AML and 100 mg once weekly for lymphomas.

We also established in the trial a recommended Phase 2 dose, or RP2D, of 60 mg once weekly or 30 mg twice weekly for AML and 100 mg once weekly for lymphomas.

In the second quarter of 2023, we commenced an open label, single arm, multi-center Phase 2a clinical trial with SLS009 in combination with venetoclax and azacitidine, or aza/ven, in patients with AML who failed or did not respond to treatment with venetoclax-based therapies.

The trial is evaluating safety, tolerability, and efficacy at two dose levels of SLS009, 45 mg once weekly, and 60 mg once weekly or 30 mg twice a week, in combination with aza/ven.

In addition to safety and tolerability of SLS009 in combination with aza/ven, the efficacy endpoints are complete response composite rate and duration of response.

Additional endpoints include event free survival, overall survival, and pharmacokinetic and pharmacodynamic assessments.

In the fourth quarter of 2023, we completed enrollment in the 45 mg (safety) dose cohort in the Phase 2a study and reported positive initial topline data.

At that time, we also commenced enrollment in the 60 mg dose cohort with patients randomized to one of two groups, 60 mg fixed dose once weekly or 30 mg fixed twice weekly.

Each group was planned to enroll five to 10 patients.

During the trial we identified 30 mg fixed twice weekly as our optimal dose level.

During the trial, we identified potential biomarkers currently undergoing testing as predictive markers in the most recent portion of the study.

In May 2024, we announced additional preliminary data from the Phase 2a trial of SLS009 in r/r AML and successful filing of a provisional patent application around the ASXL1 mutation and SLS009, including all CDK9 inhibitor drugs.

ASXL1 mutations are associated with poor prognosis in all myeloid diseases, owing to the reduced response to the current treatment options.

We observed a high rate of responses in patients with myelodysplasia-related molecular mutations (AML MR), as defined by the World Health Organization, and patients with the ASXL1 gene mutation accounted for the most responders across all dose cohorts.

We expanded the ongoing study to include two additional cohorts, one with ASXL1 mutated AML patients and one with patients with myelodysplasia-related molecular abnormalities other than ASXL1 at the optimal dose level of 30 mg fixed twice weekly.

In December 2024, we announced positive data from the first 3 cohorts in the Phase 2a trial and the trial remains ongoing with additional data expected from the expansion cohorts in the first half of 2025.

Our partner, GenFleet, is focusing on lymphoma indications with SLS009 in its Greater China market.

In March 2024, we announced that GenFleet initiated a study of SLS009 in combination with zanubrutinib (Brukinsa®), a BTK inhibitor, in r/r diffuse large B-cell lymphoma, or DLBCL, and the first patient was dosed in the trial.

The study is funded and sponsored by GenFleet and is being conducted in China only.

In February 2025, we announced positive data from the Phase 2a study evaluating SLS009 in combination with zanubrutinib.

In December 2024, we announced positive data from the first 3 cohorts in the Phase 2a trial.

In July 2025, we announced that the Phase 2 trial of SLS009 in r/r AML met all primary endpoints and received FDA guidance to advance into a first-line therapy study.

The overall response rate, or ORR, in 54 evaluable patients was 33% across all cohorts and dose levels, 40% for the 30 mg BIW dose level, and 44% in the 30 mg BIW dose among patients with myelodysplasia-related molecular mutations, or AML MR, all exceeding the pre-specified ORR threshold of 20%.

The highest efficacy was observed among patients with ASXL1 mutations, with an ORR of 50% (9/18) at 30 mg BIW dose levels, and AML MR with Myelomonocytic/Myelomonoblastic markers, or M4/M5 per FAB classification, patients with an ORR of 50% (6/12).

The median overall survival, or mOS, reached 8.9 months in patients with AML MR and 8.8 months in patients r/r to venetoclax-based regimens at a 30 mg BIW dose level, surpassing the historical benchmark of ~2.4 months.

SLS009 was well-tolerated with no new safety signals observed.

No dose-limiting toxicities were observed across all dose levels.

Following a productive end of Phase 2 meeting, the FDA recommended that we proceed into a clinical trial to include newly diagnosed, first-line AML patients eligible for aza/ven therapy, where the FDA noted clinical benefit might be greatest.

The randomized 80-patient Phase 2 clinical trial is currently ongoing and began enrollment in the first quarter of 2026.

The clinical trial will include two groups:

predictive biomarker cohort (newly diagnosed patients unlikely to benefit from standard aza/ven therapy based on molecular profiling) and early venetoclax resistance cohort (patients who initiate treatment with aza/ven, but demonstrate confirmed lack of any response after two treatment cycles).

In January 2026, we announced that we entered into an agreement with IMPACT-AML, a European collaborative initiative dedicated to advancing innovative treatments for patients with AML.

Under the agreement,

the IMPACT-AML network will conduct a clinical study evaluating SLS009, enabling access to multiple European clinical sites and patients.

IMPACT-AML is a pan-European project and builds an inclusive clinical network (STREAM platform) that connects patients, clinicians, and researchers to test novel AML therapies and improve patient outcomes.

It is part of the prestigious EU Mission Cancer program and a top-tier scientific cluster.

The IMPACT-AML project is led by a consortium of major research and clinical institutions in Europe, including IRST (IRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori”), the University of Bologna, IIS LA FE (Health Research Institute Hospital La Fe), several European AML collaborative groups, and supranational organizations under the umbrella of the European Leukemia Net (ELN), as well as various university hospitals across Europe.

By leveraging IMPACT-AML’s existing infrastructure and expertise, we expect to expand European patient access to SLS009 in a highly cost-efficient manner while supporting broader participation across the clinical program.

In November 2024, we announced data from preclinical studies identifying ASXL1 mutation as key predictor of SLS009 in response to solid cancers.

SLS009 is also currently being evaluated in pediatric solid tumors and leukemia models through the NCI Pediatric Preclinical in Vivo Testing, or PIVOT, program.

Studies are supported through cooperative agreement grants from the NCI to the PIVOT research centers performing the testing in pediatric tumor models and a centralized coordinating center.

We expect to report relevant data from the program in the first half of 2025.

In May 2025, we announced data for pediatric acute lymphoblastic leukemia, or ALL, patients derived xenografts, or PDX.

The experiment conducted and funded by the National Institute of Health, or NIH, through through the NCI Pediatric Preclinical in Vivo Testing, or PIVOT, program, included 27 patient-derived ALL tumors from pediatric patients.

Tumors were xenografted in mice in two groups, vehicle control arm and SLS009 arm.

Mice were treated with a fractionated dose once per week for six consecutive weeks.

Treatment was well tolerated.

For all models, median survival was approximately tripled in the SLS009 arm, compared to vehicle control arm.

SLS009 demonstrated delayed progression in 25/27 (93%) models and more than two times longer time to progression in 15/27 (56%) of ALL models.

In addition, there were complete responses, or CR, in two models and in one of the two models CR was maintained after the treatment had been completed until the end of the study (four months).

Among seven KMT2A rearranged models, time to progression was extended in all seven models, and in six out of seven (86%) time to progression was more than doubled.

For SLS009, the FDA granted Orphan Drug Product designations in AML and peripheral T-cell lymphoma, or PTCL, and Fast Track designations for r/r AML and r/r PTCL.

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At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or when, if ever, material net cash inflows may commence from, any current or future product candidates.

This uncertainty is due to the numerous risks and uncertainties associated with the duration and cost of our clinical trials, which vary significantly over the life of a project as a result of many factors, including:

This uncertainty is due to the numerous risks and uncertainties associated with the

duration and cost of our clinical trials, which vary significantly over the life of a project as a result of many factors, including:

• the number and geographical location of clinical sites included in the trials;

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Oncology product candidates in the later stages of clinical development generally have higher development costs than those in the earlier stages of clinical development, primarily due to the increased size and duration of the later-stage clinical trials.

We expect our

research and development expenses to increase for the foreseeable future as we conduct and complete our ongoing early and late-stage clinical trials, initiate additional clinical trials, and expand regulatory activities associated with the preparation and submission of regulatory filings.

We expect our research and development expenses to increase for the foreseeable future as we conduct and complete our ongoing early and late-stage clinical trials, initiate additional clinical trials, and expand regulatory activities associated with the preparation and submission of regulatory filings.

Our expenditures are subject to additional uncertainties, including the terms and timing of regulatory approvals.

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Non-Operating Income

Non-operating income consists of changes in fair value of our warrant liability and interest income.

Interest income primarily reflects the interest earned from our cash and cash equivalents.

Non-operating income consists of interest income.

Interest income primarily reflects interest earned from our cash and cash equivalents.

Results of Operations for the Years Ended December 31, 2025 and 2024

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The following table summarizes our research and development expenses for the years ended December 31, 2025 and 2024 (amounts in thousands):

For Year ended December 31,

Year ended December 31,

2025 2024 Change

External clinical trial expenses:

GPS 4,257 6,669 (2,412)

SLS009 3,486 4,469 (983)

Employee related expenses 3,045 2,808 237

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The decrease in research and development expenses of approximately $3.1 million was primarily attributable to the following:

• $2.2 million of decreased clinical and regulatory consultant costs primarily driven by the completion of enrollment in the REGAL study in the first quarter of 2024;

• $1.5 million of decreased manufacturing costs and clinical drug supply purchases primarily driven by the completion of enrollment in the REGAL study in the first quarter of 2024;

• $0.6 million of decreased employee related expenses due to a decrease in headcount;

• $0.6 million of decreased external clinical trial expenses primarily driven by the completion of enrollment in REGAL.

We anticipate that our research and development expenses will increase in the future as we continue to advance the development of GPS and SLS009.

• $2.4 million of decreased external clinical trial expenses related to GPS primarily driven by the completion of enrollment in the REGAL study in the first quarter of 2024;

• $1.0 million of decreased external clinical trial expenses related to SLS009 primarily driven by the completion of enrollment in our Phase 2a trial in the current period;

• $0.5 million of decreased clinical consulting costs driven by the completion of enrollment in the REGAL study in the first quarter of 2024;

partially offset by

• $0.4 million of increased manufacturing costs as we prepare for a potential BLA filing for GPS following final analysis of the REGAL study;

• $0.4 million of increased employee related expenses, stock-based compensation, and facilities and other research and development costs combined.

We anticipate that our research and development expenses will increase in the future as we continue to prepare for a potential BLA filing for GPS following the upcoming final analysis of the REGAL study and proceed into a randomized Phase 2 clinical trial to include newly diagnosed, front-line AML patients for SLS009.

General and Administrative

General and administrative expenses were $12.3 million for the year ended December 31, 2025 compared to $12.4 million for the year ended December 31, 2024.

The $1.5 million decrease was primarily attributable to a $1.5 million decrease in employee related expenses, including a $0.5 million decrease in non-cash stock-based compensation, primarily due to a decrease in headcount, a $0.7 million decrease in outside services and public company costs, and a $0.6 million decrease in insurance premiums, which were partially offset by the initial recognition of a $1.1 million one-time severance charge during the current period and a $0.2 million increase in legal fees.

The $0.1 million decrease was primarily attributable to a $0.8 million decrease in employee related expenses which was driven by the recognition of a $1.1 million one-time severance charge in the prior period partially offset by a $0.3 million increase in non-cash stock-based compensation and a $0.7 million increase in legal fees.

Non-Operating Income

Non-operating income for the years ended December 31, 2024 and 2023 was as follows (in thousands):

Year ended December 31,

2024 2023 Change

Change in fair value of warrant liability $ — $ 4 $ (4)

Interest income 632 525 107

Total non-operating income $ 632 $ 529 $ 103

The increase in our non-operating income during the year ended December 31, 2024 compared to the year ended December 31, 2023 was primarily due to a $0.1 million increase in interest income earned from our cash and cash equivalents.

Non-operating income of $1.4 million and $0.6 million for the years ended December 31, 2025 and 2024, respectively, was related to interest income earned from our cash and cash equivalents.

Liquidity and Capital Resources

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Sources of Liquidity

On January 29, 2025, we consummated a registered direct offering with an institutional investor priced at-the-market under Nasdaq rules, or the January 2025 Registered Direct Offering, pursuant to which we agreed to issue and sell 8,200,000 shares of common stock and 11,485,040 pre-funded warrants exercisable for shares of common stock, together with accompanying warrants to purchase up to 19,685,040 shares of common stock.

On October 24, 2025, we entered into a Warrant Inducement Agreement, or the October 2025 Inducement, with an institutional investor and holder of certain existing warrants to cash exercise (i) warrants to purchase 6,514,658 shares of common stock at an exercise price of $1.535 per share, previously issued in March 2024, or the March 2024 Warrants, and (ii) warrants to purchase 15,849,056 shares of common stock at an exercise price of $1.325 per share, previously issued in August 2024, or the August 2024 Warrants.

The March 2024 Warrants and the August 2024 Warrants were exercised at their original issuance exercise price plus $0.125 per share of common stock in accordance with Nasdaq rules.

In consideration of the investor's agreement to exercise the March 2024 Warrants and the August 2024 Warrants, we agreed to issue new warrants to the investor to purchase up to 22,363,714 shares of common stock at an exercise price of $2.00 per share, or the October 2025 Warrants, which are exercisable immediately and will expire on the five year anniversary of issuance.

The net proceeds to us from the October 2025 Inducement were approximately $29.1 million, after deducting financial advisory fees and related transaction expenses.

On September 10, 2025, we entered into a Warrant Inducement Agreement, or the September 2025 Inducement, with an institutional investor and holder of certain existing warrants to cash exercise warrants to purchase 19,685,040 shares of common stock, previously issued in January 2025, or the January 2025 Warrants, at the original issuance exercise price of $1.20 per share.

In consideration of the investor’s agreement to exercise the January 2025 Warrants, we agreed to issue new warrants to the Investor to purchase up to 19,685,040 shares of common stock at an exercise price of $1.88 per share, or the September 2025 Warrants, which are exercisable immediately and will expire on the five and one half anniversary of issuance.

The net proceeds to us from the September 2025 Inducement were approximately $22.0 million, after deducting financial advisory fees and related transaction expenses.

On January 29, 2025, we consummated a registered direct offering, or the January 2025 Registered Direct Offering, with an institutional investor priced at-the-market under Nasdaq rules, pursuant to which we agreed to issue and sell 8,200,000 shares of common stock and 11,485,040 pre-funded warrants exercisable for shares of common stock, together with accompanying warrants to purchase up to 19,685,040 shares of common stock.

Each share of common stock and accompanying common warrant were sold together at a combined offering price of $1.27, and each pre-funded warrant and accompanying common warrant were sold together at a combined offering price of $1.2699.

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The net proceeds to us from the January 2025 Registered Direct Offering were approximately $23.1 million, after deducting the placement agents' fees and related offering expenses.

On August 1, 2024, we consummated a registered direct offering with an institutional investor priced at a premium to market, or the August 2024 Registered Direct Offering, pursuant to which we agreed to issue and sell 6,370,070 shares of common stock and 9,478,986 pre-funded warrants exercisable for shares of common stock, together with accompanying warrants to purchase 15,849,056 shares of common stock.

Each share of common stock and accompanying common warrant were sold together at a combined offering price of $1.325, and each pre-funded warrant and accompanying common warrant were sold together at a combined offering price of $1.3249.

The common warrants have an exercise price of $1.20 per share.

The net proceeds to us from the August 2024 Registered Direct Offering were approximately $19.5 million, after deducting the placement agent's fees and related offering expenses.

On March 19, 2024, we consummated a registered direct offering with two institutional investors priced at-the-market under Nasdaq rules, or the March 2024 Registered Direct Offering, pursuant to which the Company agreed to issue and sell 11,000,000 shares of its common stock and 2,029,316 pre-funded warrants exercisable for shares of common stock.

Each share of common stock was sold at a purchase price of $1.535 and each pre-funded warrant was sold at a purchase price of $1.5349.

The net proceeds to us from the March 2024 Registered Direct Offering were approximately $18.5 million, after deducting the placement agent's fees and related offering expenses.

In a concurrent private placement, we agreed to issue to the two institutional investors exercisable for up to an aggregate of 13,029,316 shares of common stock warrants at an exercise price of $1.41 per share.

Subsequent to the closing of the March 2024 Registered Direct Offering, all of the pre-funded warrants issued in the March 2024 Registered Direct Offering have been exercised for shares of common stock.

On January 8, 2024, we consummated a public offering on a "reasonable best efforts" basis, or the January 2024 Offering, issuing 10,130,000 shares of common stock and an aggregate of 1,870,000 pre-funded warrants exercisable for shares of common stock, together with accompanying warrants to purchase an aggregate of 12,000,000 shares of common stock.

Each share of common stock and accompanying common warrant were sold together at a combined offering price of $0.75, and each pre-funded warrant and accompanying common warrant were sold together at a combined offering price of $0.7499.

The net proceeds to us from the January 2024 Offering were approximately $8.2 million, after deducting the placement agent's fees and related offering expenses.

Subsequent to the closing of the January 2024 Offering, all of the pre-funded warrants issued in the January 2024 Offering have been exercised for shares of common stock.

During the year ended December 31, 2025, the Company received approximately $12.6 million in proceeds from the exercise of 16.8 million warrants exercisable for shares of common stock at an exercise price of $0.75 per share.

Subsequent to December 31, 2025, the Company received an additional $42.6 million in proceeds from the exercise of 26.4 million warrants at a weighted-average exercise price of approximately $1.61 per share.

In December 2020, together with our wholly-owned subsidiary, SLSG Limited, LLC, we entered into the 3D Medicines Agreement pursuant to which we granted 3D Medicines a sublicensable royalty-bearing license under certain intellectual property owned or controlled by us, to develop, manufacture and have manufactured, and commercialize GPS and heptavalent GPS product candidates for all therapeutic and other diagnostic uses in the 3DMed Territory.

To date, we have received $10.5 million in upfront payments and certain technology transfer and regulatory milestones.

As of December 31, 2025, we have received $10.5 million in upfront payments and certain technology transfer and regulatory milestones.

A total of $191.5 million in potential future development, regulatory, and sales milestones, not including future royalties, remains under the 3D Medicines Agreement as of December 31, 2025, which milestones are all variable in nature and not under our control.

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As of December 31, 2025, we had an accumulated deficit of $275.0 million, cash and cash equivalents of $71.8 million and restricted cash and cash equivalents of $0.1 million.

In addition, we had current liabilities of $9.5

million as of December 31, 2024.

We expect that our cash and cash equivalents will not be sufficient to fund our current planned operations for at least the next twelve months from the date of issuance of these financial statements.

These conditions give rise to a substantial doubt over our ability to continue as a going concern.

This going concern assumption is based on management’s assessment of the sufficiency of our current and future sources of liquidity and whether it is probable we will be able to meet our obligations as they become due for at least one year from the date our consolidated financial statements are available to be issued, and if not, whether our liquidation is imminent.

Our consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

We anticipate incurring additional losses until such time, if ever, that we can generate significant sales of any current or future product candidates in development.

We will require substantial additional financing to develop any current or future product candidates.

If we are unable to obtain additional funding on a timely basis, we will be required to scale back our plans and place certain activities on hold.

We currently do not have any commitments to obtain additional funds.

Our management continues to evaluate different strategies to obtain the required funding for future operations.

These strategies may include public and private placements of equity and/or debt securities, as well as payments from potential strategic research and development collaborations or licensing and/or marketing arrangements with pharmaceutical companies.

Additionally, we continue to pursue discussions with global and regional pharmaceutical companies for licensing and/or co-development rights to our product candidates.

There can be no assurance that these future funding efforts will be successful.

In addition, we had current liabilities of $7.0 million as of December 31, 2025.

We expect that our cash and cash equivalents, together with the $42.6 million in proceeds from warrant exercises received subsequent to December 31, 2025, will be sufficient to fund our current planned operations for at least the next twelve months from the date of issuance of these financial statements, although we may pursue additional capital resources through public or private equity or debt financings or by entering into additional license agreements or collaborations with other companies.

Management's expectations with respect to its ability to fund current planned operations is 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.

There is no guarantee that any of these strategic or financing opportunities will be executed or 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 its planned research and development programs or be unable to expand our operations or otherwise prepare for the potential regulatory approval and commercialization of its product candidates, assuming positive data.

Our future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of any additional financings, (ii) our ability to complete revenue-generating partnerships with pharmaceutical and biotechnology companies, (iii) the success of our research and development activities, (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies, and, ultimately, (v) regulatory approval and market acceptance of our product candidates.

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Operating activities $ (28,389) $ (35,402)

Investing activities — (5,500)

Financing activities 86,296 46,758

Net increase (decrease) in cash, cash equivalents, restricted cash, and restricted cash equivalents $ 11,356 $ (14,595)

Net increase in cash, cash equivalents, restricted cash, and restricted cash equivalents $ 57,907 $ 11,356

Net Cash Used in Operating Activities

Net cash used in operating activities of $28.4 million during the year ended December 31, 2025 was primarily attributable to our net loss of $26.9 million and a $4.1 million change in our operating assets and liabilities, partially offset by non-cash charges of $2.6 million.

The net change in our operating assets and liabilities is due to a decrease in accounts payable and accrued expenses and other current liabilities of approximately $2.5 million, an increase in prepaid expenses and other assets of approximately $1.0 million, and a decrease in operating lease liabilities of approximately $0.6 million.

Non-cash charges were driven by approximately $2.0 million in non-cash stock-based compensation expense and $0.6 million in non-cash lease expense.

Net cash used in operating activities of $35.4 million during the year ended December 31, 2024 was primarily attributable to our net loss of $30.9 million and a $6.6 million change in our operating assets and liabilities, partially offset by various net non-cash charges of $2.1 million.

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Net non-cash charges were driven by approximately $1.5 million in non-cash stock-based compensation expense and $0.6 million in non-cash lease expense.

Net cash used in operating activities of $31.4 million during the year ended December 31, 2023 was primarily attributable to our net loss of $37.3 million, and partially offset by a change in our operating assets and liabilities of $3.3 million and various net non-cash charges of $2.6 million.

The net change in our operating assets and liabilities is due to an increase in accounts payable of $2.3 million, an increase in accrued expenses and other current liabilities of $1.4 million, and a decrease in prepaid expenses and other assets of $0.1 million, which was partially offset by a decrease in operating lease liabilities of $0.5 million.

Net non-cash charges were driven by $2.1 million in non-cash stock compensation expense and $0.5 million in non-cash lease expense.

Net Cash Used in Investing Activities

There was no cash used in investing activities during the year ended December 31, 2024.

Net cash used in investing activities of $5.5 million during the year ended December 31, 2023 related to license payments made for the acquisition of in-process research and development under the GenFleet License Agreement.

Net Cash Flow from Financing Activities

We generated $86.3 million of net cash from financing activities for the year ended December 31, 2025, which was due to $51.0 million in aggregate net proceeds received from the September 2025 Warrant Inducement and October 2025 Warrant Inducement, $23.1 million in net proceeds received from the January 2025 Registered Direct Offering, $12.6 million in proceeds received from the exercise of warrants, and $0.1 million in proceeds received from the issuance of common stock under our employee stock purchase plan, partially offset by $0.5 million to satisfy tax withholding on vesting of restricted stock units.

We generated $46.8 million of net cash from financing activities for the year ended December 31, 2024, which was due to $46.2 million in aggregate net proceeds received from the January 2024 Offering, the March 2024 Registered Direct Offering, and the August 2024 Registered Direct Offering, and $0.6 million in proceeds received from the exercise of warrants, $0.1 million in aggregate net proceeds received from the issuance of common stock under our employee stock purchase plan, partially offset by $0.1 million to satisfy tax withholding on vesting of restricted stock units.

We generated $22.3 million of net cash from financing activities during the year ended December 31, 2023, which was due to $21.9 million in aggregate net proceeds received from the February 2023 Offering, $0.3 million in aggregate net proceeds received from the issuance of common stock under a Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co., or the Sales Agreement, and $0.1 million in aggregate net proceeds received from the issuance of common stock under our employee stock purchase plan.

In January 2024, we mutually agreed with Cantor Fitzgerald & Co.

to terminate the Sales Agreement.

Contractual Obligations and Other Commitments

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Other Commitments

We acquire product candidates still in development and enter into research and development arrangements with third parties that often require milestone and royalty payments to the third-party contingent upon the occurrence of certain future events linked to the success of the product candidate in development.

occurrence of certain future events linked to the success of the product candidate in development.

Milestone payments may be required, contingent upon the successful achievement of an important point in the development life-cycle of the pharmaceutical product (e.g., approval of the product for marketing by a regulatory agency).

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At the inception of each arrangement that includes regulatory or development milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method.

If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price.

If it is probable that a significant revenue

reversal would not occur, the associated milestone value is included in the transaction price.

Milestone payments that are not within the control of us or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis