What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-05-02 compared with 2023-11-02 · 109 added, 85 removed, 95 unchanged (67% of the section changed)

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These forward-looking statements are subject to a number of risks, uncertainties and assumptions.

In addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 2, 2023.

Moreover, we operate in a very competitive and rapidly changing environment.

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Our goal is to target tumor vulnerabilities with treatment combinations of onvansertib, our oral and highly selective PLK1 inhibitor, and standard of care therapeutics.

We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC") and metastatic pancreatic ductal adenocarcinoma ("mPDAC"), as well as in investigator-initiated trials in small cell lung cancer ("SCLC") and triple negative breast cancer ("TNBC").

We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), and triple negative breast cancer ("TNBC").

Our clinical development programs incorporate tumor genomics and biomarker assays to refine assessment of patient response to treatment.

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Onvansertib is an oral, small molecule drug candidate that is highly specific for PLK1 inhibition with a 24-hour half-life.

We believe the attributes of onvansertib described below, as well as clinical evidence of favorable safety and efficacy, with expected on-target, easy to manage and reversible side effects, may prove beneficial in addressing clinical therapeutic needs across a variety of cancers:

We believe the attributes of onvansertib described below, as well as early clinical evidence of favorable safety and efficacy, with expected on-target, manageable and transient side effects, may prove beneficial in addressing clinical therapeutic needs across a variety of cancers:

• Onvansertib is highly potent and highly selective against the PLK1 enzyme (IC 50 = 2nM;

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In vitro studies have shown synergistic effects when onvansertib was administered in combination with different cytotoxic agents including microtubule-targeting agents, topoisomerase 1 inhibitors, antimetabolites, alkylating agents, proteasome inhibitors, kinase inhibitors, PARP inhibitors, BCL-2 inhibitors, and androgen biosynthesis inhibitors.

In addition, in vivo combination studies have confirmed the positive results obtained in vitro and synergistic effects have been observed in xenograft models of onvansertib in combination with irinotecan, 5-fluorouracil ("5-FU"), abiraterone, PARP inhibitors, venetoclax, and paclitaxel, while additive effects in combination with cytarabine or bevacizumab have been demonstrated.

In addition, in vivo combination studies have confirmed the positive results obtained in vitro and additive or synergistic effects on efficacy have been observed in xenograft models of onvansertib in combination with irinotecan, 5-fluorouracil ("5-FU"), abiraterone, PARP inhibitors, venetoclax, paclitaxel, or bevacizumab.

Combining onvansertib with standard of care cancer agents provides opportunities for synergy with many cancer therapies.

There are five ongoing and planned clinical trials of onvansertib:

one trial (CRDF-004) in first line treatment in patients with RAS-mutated mCRC, one trial (TROV-054) in second line treatment in patients with KRAS-mutated mCRC, one trial in second line treatment in patients with mPDAC, and two investigator-initiated trials in patients with relapsed extensive-stage SCLC and locally advanced or metastatic TNBC.

one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, one trial (CRDF-001) in second-line treatment in patients with mPDAC, and three investigator-initiated trials in first-line mPDAC, relapsed SCLC and unresectable locally advanced or metastatic TNBC.

Previously we reported data from two additional trials:

one trial (TROV-054) in second-line treatment in patients with KRAS-mutated mCRC, and one trial (CRDF-003), which we refer to as the ONSEMBLE trial, in second-line treatment in patients with RAS-mutated mCRC.

RAS-mutated mCRC Program:

CRDF-004 Clinical Trial in RAS-mutated mCRC

CRDF-004 Randomized Clinical Trial in First-Line RAS-mutated mCRC

CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial of onvansertib in combination with standard of care FOLFIRI and bevacizumab or FOLFOX and bevacizumab for the first-line treatment of patients with RAS-mutated mCRC.

The primary objectives of the CRDF-004 trial are to evaluate onvansertib’s safety and efficacy in combination with the standard of care, as well as to evaluate two doses of onvansertib, 20mg and 30mg, given in combination with standard of care, against standard of care alone.

The primary endpoint of the trial is objective response rate.

The primary endpoint of the trial is objective response rate ("ORR").

Progression-free survival and duration of response will be secondary endpoints.

We expect to begin enrollment during the fourth quarter of 2023, with interim data anticipated in mid-2024.

Pfizer Ignite is responsible for the clinical execution of the trial and it is expected to enroll approximately 90 evaluable patients.

We anticipate releasing initial data from the CRDF-004 trial in the second half of 2024.

This trial is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies, and it is expected to enroll approximately 90 evaluable patients.

In February 2024 it was announced that the first patient dosed for this trial.

For more information, please visit NCT06106308 at www.clinicialtrials.gov .

Contingent upon the results of CRDF-004, Cardiff Oncology plans to initiate CRDF-005, a Phase 3, randomized trial with registrational intent.

The FDA has agreed that a seamless trial with objective response rate (ORR) at an interim point is an acceptable endpoint to pursue accelerated approval, with progression-free survival and trend in overall survival being the endpoints for full approval.

Phase 1b/2 Clinical Trial in KRAS-mutated mCRC

TROV-054 is a Phase 1b/2 open-label multi-center clinical trial of onvansertib in combination with standard-of-care FOLFIRI and bevacizumab for the second line treatment of patients with KRAS-mutated mCRC.

This trial completed enrollment in October 2022.

The primary objectives of this trial are to evaluate the Dose-Limiting Toxicities ("DLTs"), maximum tolerated dose ("MTD") and recommended Phase 2 dose ("RP2D") of onvansertib in combination with FOLFIRI and bevacizumab (Phase 1b) and to continue to assess the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab patients with KRAS-mutated mCRC (Phase 2).

Contingent upon the results of CRDF-004, we plan to initiate CRDF-005, a Phase 3, randomized trial with registrational intent.

The FDA has agreed that a seamless trial with ORR at an interim point is an acceptable endpoint to pursue accelerated approval, with progression-free survival and trend in overall survival being the endpoints for full approval.

Phase 1b/2 Clinical Trial in Second-Line KRAS-mutated mCRC

TROV-054, a Phase 1b/2 open-label multi-center clinical trial of onvansertib in combination with standard of care FOLFIRI and bevacizumab for the second-line treatment of patients with KRAS-mutated mCRC, completed enrollment in October 2022.

The primary objectives of this trial were to evaluate the Dose-Limiting Toxicities ("DLTs"), maximum tolerated dose ("MTD") and recommended Phase 2 dose ("RP2D") of onvansertib in combination with FOLFIRI and bevacizumab (Phase 1b) and to continue to assess the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab patients with KRAS-mutated mCRC (Phase 2).

For more information, please visit NCT03829410 at www.clinicialtrials.gov .

Data presented on August 7, 2023, provided an update of the ongoing TROV-054 Phase 1b/2 single arm clinical trial in KRAS-mutated metastatic colorectal cancer:

• Objective response rate ("ORR") across all evaluable patients was 29%, with 19 of 66 evaluable patients achieving an objective response.

• ORR across all evaluable patients was 29%, with 19 of 66 evaluable patients achieving an objective response.

Responses have been observed across multiple KRAS variants;

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Historical control trials of different drug combinations, including the standard-of-care of FOLFIRI with bevacizumab, in similar patient populations have shown ORR and mPFS of 5 – 13% and ~4.5 – 6.7 months, respectively.

• A subgroup analysis of patients who were bevacizumab naïve when they entered 2 nd line therapy vs patients who had received prior bevacizumab in 1 st line therapy showed that patients who were bevacizumab naïve (n=15) had an ORR of 73% and mPFS of 15 months, which is well above historical controls.

• A subgroup analysis of patients who were bevacizumab naïve when they entered second-line therapy vs.

patients who had received prior bevacizumab in first-line therapy showed that patients who were bevacizumab naïve (n=15) had an ORR of 73% and mPFS of 15 months, which is well above historical controls.

In contrast, patients previously treated with bevacizumab (n=51) had an ORR of 16% and mPFS of 7.8 months.

In reviewing the TROV-054 clinical data, we originally designed the ONSEMBLE trial (CRDF-003) as the next phase of our mCRC program.

Upon review of the clinical data from the bevacizumab naïve subgroup (those patients who did not receive bevacizumab in their 1 st line therapy), the preclinical data on the mechanism of action and the feedback from the FDA on our clinical development strategy, we made the decision to discontinue enrollment in the ONSEMBLE trial and to initiate the CRDF-004 clinical trial.

• Data on Treatment Emergent Adverse Events ("TEAEs") on the trial showed that onvansertib is well-tolerated when used in combination with FOLFIRI and bevacizumab.

The more severe, grade 4 TEAEs are either neutropenia or leukopenia, which are common events in patients treated with FOLFIRI and bevacizumab.

None of the patients with grade 4 TEAEs discontinued treatment due to their condition and all resolved without issue.

There were no major or unexpected toxicities seen in the trial.

• Data from the Phase 1b portion of this trial was published in the peer-reviewed journal Clinical Cancer Research, February 6, 2024 edition.

Based on the interim results of the TROV-054 trial, we previously designed the ONSEMBLE trial (CRDF-003) as the next phase of our mCRC program.

Upon further review of the clinical data from the bevacizumab naïve subgroup (those patients who did not receive bevacizumab in their first-line therapy), the preclinical data on the mechanism of action and the feedback from the FDA on our clinical development strategy, we made the decision to discontinue enrollment in the ONSEMBLE trial and to initiate the CRDF-004 clinical trial.

Phase 2 Clinical Trial in Second-Line RAS-mutated mCRC

The ONSEMBLE trial (CRDF-003) is a Phase 2 randomized, open-label multi-center clinical trial of onvansertib in combination with standard of care FOLFIRI and bevacizumab for the second-line treatment of patients with RAS-mutated mCRC.

The primary objectives of the ONSEMBLE trial are to evaluate onvansertib’s safety and efficacy in combination with FOLFIRI and bevacizumab, as well as to evaluate two doses of onvansertib, 20mg and 30mg, given in combination with FOLFIRI and bevacizumab, against FOLFIRI and bevacizumab alone.

The primary endpoint of the trial is ORR.

For more information, please visit NCT05593328 at www.clinicialtrials.gov .

The ONSEMBLE trial enrollment was closed in August 2023 as part of our shift to a first-line mCRC program, and the 23 patients enrolled continued treatment per protocol.

Data presented on February 29, 2024, provided the first update of the ongoing ONSEMBLE Phase 2 randomized clinical trial in RAS-mutated mCRC:

• ORR data for each arm of the trial and for the two experimental arms combined are shown in the table below.

The table also presents ORR data for two subgroups of patients:

those who were bevacizumab naïve when they entered second-line therapy vs.

patients who had received prior bevacizumab in first-line therapy.

Objective Response Rate

Bevacizumab Naïve Patients (1)

Bevacizumab Exposed Patients

FOLFIRI/bev (SoC alone);

Onvansertib 20 mg + SoC;

Onvansertib 30 mg + SoC;

Onvansertib (all doses) + SoC;

13% (2 of 15)

(1) The two partial responses were confirmed on the patients' subsequent scans.

• Data on TEAEs on the trial showed that onvansertib is well-tolerated when used in combination with FOLFIRI and bevacizumab.

No Grade 4 TEAEs were observed for the arms of FOLFIRI and bevacizumab alone and onvansertib 30 mg given in combination with FOLFIRI and bevacizumab.

Two Grade 4 TEAEs of neutropenia were seen in patients receiving 20 mg onvansertib given in combination with FOLFIRI and bevacizumab.

Both patients recovered within 7

and 10 days after withholding the study treatment and no dose reductions in subsequent treatment cycles were needed.

There were no major or unexpected toxicities seen in the trial.

The ORR data from the randomized ONSEMBLE trial validates the findings observed in our earlier single-arm Phase 1b/2 KRAS-mutated mCRC trial (TROV-054).

In the ONSEMBLE trial, objective responses were observed only in bevacizumab naïve patients versus bevacizumab exposed patients.

In addition, these objective responses were present only in bevacizumab naïve patients randomized to the experimental arms of onvansertib in combination with FOLFIRI and bevacizumab versus bevacizumab naïve patients randomized to the FOLFIRI and bevacizumab alone control arm.

mDPAC Program:

Phase 2 Investigator-Initiated Clinical Trial in First-Line mPDAC

A two-cohort, non-randomized Phase 2 trial of onvansertib in combination with first-line standard of care Gemzar ® and Abraxane ® will be conducted at the OHSU Knight Cancer Institute.

The enrollment criteria includes patients who are treatment-naïve with an ECOG performance status of 0 to 1, and with unresectable, locally advanced, or metastatic pancreatic cancer with measurable disease per RECIST 1.1.

The first cohort of patients will receive ten days of monotherapy as a lead-in.

After the lead-in period, patients will then move to receive a combination regimen of standard of care chemotherapy and onvansertib.

The second cohort of patients will not receive the onvansertib monotherapy lead-in, but will move straight to the combination regimen.

This combination regimen consists of Gem-Abraxane on days 1, 8 and 15 of a four-week cycle.

Patients will receive daily onvansertib with chemotherapy on days 1 through 5, days 8 through 12, and days 15 through 19.

Patients will be monitored with bloodwork on a weekly basis.

The primary endpoint of this trial will be ORR, disease control rate ("DCR") at 16 weeks.

Secondary endpoint will be DoR and PFS.

Phase 2 Clinical Trial in mPDAC

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– The Mayo Clinic Cancer Centers (Arizona, Minnesota, and Florida), Kansas University Medical Center, Inova Schar Cancer Institute, and the University of Nebraska Medical Center.

The first patient was dosed in June 2021.

Enrollment for this trial closed in October 2023.

The objective of this trial is to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide ® ), 5-FU and leucovorin as a 2 nd line treatment in patients with mPDAC who have failed 1 st line gemcitabine-based therapy.

For more information, please visit NCT04752696 at www.clinicialtrials.gov .

Preliminary data presented on September 26, 2023 provided an update of the ongoing CRDF-001 Phase 2 open label clinical trial in mPDAC:

• Preliminary data from 21 patients evaluable for radiographic response showed 1 patient achieving a confirmed partial response (“PR”) and 3 patients achieving a partial response that are awaiting confirmatory scans;

• 19% objective response rate (“ORR”) achieved compared to historical control of 7.7% in 2nd line setting;

• Preliminary data from 21 patients evaluable for radiographic response showed 1 patient achieving a confirmed partial response (“PR”) and 3 patients achieving unconfirmed partial response that were awaiting confirmatory scans;

• 19% objective response rate (“ORR”) achieved compared to historical control of 7.7% in second-line setting;

• 5.0 months median progression-free survival (“mPFS”) achieved compared to historical control of 3.1 months with standard of care (“SoC”);

mPDAC biomarker discovery trial

The investigator-initiated biomarker discovery trial is exploring the impact of onvansertib 10-day monotherapy on tumors in mPDAC patients, and is currently enrolling at the Oregon Health & Science University (OHSU) Knight Cancer Institute.

Two patients have been enrolled as of September 13, 2023.

Preliminary data were presented on September 26, 2023.

One patient demonstrated an 86% decrease in Ki67, a well-established biomarker of tumor proliferation, and a 28% decrease in CA 19-9, a clinically-used biomarker to monitor treatment response.

An update provided on February 29, 2024 indicated 3 of the 4 PRs are confirmed PRs and 1 of the 4 PRs did not confirm on their subsequent scan.

Other Clinical Programs:

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An examination of the safety data from the first six patients by the institutional review board confirmed the trial can continue to enroll as planned.

Preliminary efficacy data for seven patients presented on September 26, 2023, showed 1 confirmed partial response (“PR”), three stable disease (“SD”) and three progressive disease (“PD”).

The disease control rate, including PR and SD, is 57% (4 of 7 patients).

Preliminary efficacy data for seven patients presented on September 26, 2023, showed one confirmed partial response (“PR”), three stable disease (“SD”) and three progressive disease (“PD”).

The disease control rate (“DCR”), including PR and SD, is 57% (4 of 7 patients).

Phase 1b/2 Investigator-Initiated Clinical Trial in TNBC

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Our accounting policies are described in ITEM 7.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS of our Annual Report on Form 10-K as of and for the year ended December 31, 2022, filed with the SEC on March 2, 2023.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS of our Annual Report on Form 10-K as of and for the year ended December 31, 2023, filed with the SEC on February 29, 2024.

There have been no changes to our critical accounting policies since December 31, 2023.

RESULTS OF OPERATIONS

Three Months Ended September 30, 2023 and 2022

Total revenues were $141,000 for the three months ended September 30, 2023, as compared to $93,000 for the prior period.

Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib.

Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.

Research and Development Expenses

Research and development expenses consisted of the following:

Three Months Ended September 30,

(in thousands) 2023 2022 Increase (Decrease)

Salaries and staff costs $ 1,615 $ 1,000 $ 615

Stock-based compensation 294 286 8

Clinical trials, outside services, and lab supplies 5,603 4,279 1,324

Facilities and other 510 444 66

Total research and development $ 8,022 $ 6,009 $ 2,013

Research and development expenses increased by $2.0 million for the three months ended September 30, 2023, compared to the same period in 2022.

The overall increase in expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib.

The increase in salaries and staff costs from additional hires in senior management and our clinical operations team (research and development average headcount grew by 50% over the comparative period).

Selling, General and Administrative Expenses

Selling, general and administrative expenses consisted of the following:

Three Months Ended September 30,

(in thousands) 2023 2022 Increase (Decrease)

Salaries and staff costs $ 731 $ 808 $ (77)

Stock-based compensation 661 751 (90)

Outside services and professional fees 1,011 840 171

Facilities and other 536 678 (142)

Total selling, general and administrative $ 2,939 $ 3,077 $ (138)

Selling, general and administrative expenses decreased by $0.1 million for the three months ended September 30, 2023, compared to the same period in 2022.

Salary and staff costs and stock-based compensation decreased due to lower headcount.

Facilities and other costs were lower as a result of a reduction of insurance costs compared to the prior period.

The increase in outside services and professional fees was due mainly to additional legal fees for contract reviews.

Interest Income, Net

Interest income, net was $1.1 million for the three months ended September 30, 2023 as compared to $0.5 million for the same period of 2022.

The increase in interest income was primarily due to higher interest rates on our short-term investments portfolio for the three months ended September 30, 2023 as compared to the same period of 2022.

Nine Months Ended September 30, 2023 and 2022

Total revenues were $332,000 for the nine months ended September 30, 2023, as compared to $258,000 for the same period in 2022.

Three Months Ended March 31, 2024 and 2023

Total revenues were $205,000 for the three months ended March 31, 2024, as compared to $83,000 for the same period in 2023.

Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib.

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Research and development expenses consisted of the following:

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands) 2024 2023 Increase (Decrease)

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Total research and development $ 8,008 $ 9,052 $ (1,044)

Research and development expenses increased by $4.4 million for the nine months ended September 30, 2023, compared to the same period in 2022.

The overall increase in expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib.

Salaries and staff costs increased primarily from additional hires in senior management and our clinical operations team (research and development average headcount grew by 37% over the comparative period).

The increase in facilities and other costs is primarily due to increased allocation of facilities cost resulting from headcount growth compared to the prior period.

Research and development expenses decreased by $1.0 million for the three months ended March 31, 2024, compared to the same period in 2023.

The overall decrease in clinical trials and outside services expenses was primarily due to a reduction in chemistry, manufacturing and control costs compared to the prior period.

Salaries and staff costs increased primarily from additional hires (research and development average headcount grew by 36% over the comparative period).

Selling, General and Administrative Expenses

Selling, general and administrative expenses consisted of the following:

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands) 2024 2023 Increase (Decrease)

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Total selling, general and administrative $ 3,130 $ 3,083 $ 47

Selling, general and administrative expenses increased by $0.2 million for the nine months ended September 30, 2023, compared to the same period in 2022.

Salaries and staff costs increased due to an employee severance agreement.

Selling, general and administrative expenses increased by $47,000 for the three months ended March 31, 2024, compared to the same period in 2023.

Salaries and staff costs increased due to adjustments to our bonus accrual compared to the prior period.

The decrease in facilities and other costs was primarily due to reduced insurance costs compared to the prior period.

Interest Income, Net

Interest income, net was $3.1 million for the nine months ended September 30, 2023 as compared to $0.8 million for the same period of 2022.

The increase in interest income was primarily due to higher interest rates on our short-term investments portfolio for the nine months ended September 30, 2023 as compared to the same period of 2022.

Interest income, net was $0.9 million for the three months ended March 31, 2024 as compared to $0.9 million for the same period of 2023.

Interest income, net is primarily earned from our short-term investment portfolio and money market accounts.

LIQUIDITY AND CAPITAL RESOURCES

Net cash used in operating activities for the nine months ended September 30, 2023, was $23.7 million, compared to $24.4 million for the nine months ended September 30, 2022.

Our use of cash was primarily a result of the net loss of $32.1 million for the nine months ended September 30, 2023, adjusted for non-cash items related to stock-based compensation of $3.6 million.

The net change in our operating assets and liabilities decreased cash used in operations by $5.2 million.

At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years.

Net cash provided by investing activities was $22.6 million primarily related to sales and maturities in excess of purchases of marketable securities for the nine months ended September 30, 2023, compared to net cash provided by investing activities of $31.1 million primarily related to sales and maturities in excess of purchases of marketable securities during the same period in 2022.

Net cash provided in financing activities was $0 for the nine months ended September 30, 2023, compared to net cash provided by financing activities of $0.1 million during the same period of 2022.

As of September 30, 2023, and December 31, 2022, we had working capital of $74.9 million and $103.5 million, respectively.

As of March 31, 2024, and December 31, 2023, we had working capital of $58.1 million and $67.0 million, respectively.

We have incurred net losses since our inception and have negative operating cash flows.

As of September 30, 2023, we had $81.4 million in cash, cash equivalents and short-term investments and we believe we have sufficient cash to meet our funding requirements for at least the next 12 months following the issuance date of this Quarterly Report on Form 10-Q.

Based on our current projections we expect that our capital resources are sufficient to fund our operations into 2025.

As of March 31, 2024, we had $67.2 million in cash, cash equivalents and short-term investments and we believe we have sufficient cash to meet our funding requirements for at least the next 12 months following the issuance date of this Quarterly Report on Form 10-Q.

Based on our current projections we expect that our capital resources are sufficient to fund our operations into the third quarter of 2025.

Our drug development efforts are in their early stages, and we cannot make estimates of the costs or the time that our development efforts will take to complete, or the timing and amount of revenues related to the sale of our drug candidates.

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To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience additional dilution.

Cash Flow Summary

Three Months Ended March 31,

(in thousands) 2024 2023

Net cash used in operating activities $ (7,740) $ (8,659)

Net cash provided by investing activities 4,636 7,329

Net cash provided by financing activities 107 —

Net change in cash and equivalents $ (2,997) $ (1,330)

Operating Activities

Net cash used in operating activities for the three months ended March 31, 2024, was $7.7 million.

Our primary use of cash was from our net loss of $10.0 million, adjusted for non-cash items of $1.1 million primarily related to stock-based compensation.

The net change in our operating assets and liabilities decreased cash used in operations by $1.2 million.

Net cash used in operating activities for the three months ended March 31, 2023, was $8.7 million.

Our primary use of cash was from our net loss of $11.2 million, adjusted for non-cash items of $1.0 million primarily related to stock-based compensation.

The net change in our operating assets and liabilities decreased cash used in operations by $1.6 million.

At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years.

Investing Activities

Net cash provided by investing activities for the three months ended March 31, 2024 was $4.6 million, primarily related to maturities in excess of purchases of marketable securities.

Net cash provided by investing activities for the three months ended March 31, 2023 was $7.3 million, primarily related to sales and maturities in excess of purchases of marketable securities.

Financing Activities

Net cash provided by financing activities for the three months ended March 31, 2024 was $0.1 million, from employee stock options exercises.

Net cash provided by financing activities for the three months ended March 31, 2023 was $0.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

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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-Q

Item 2. Management’s Discussion and Analysis