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Item 7. Management’s Discussion and Analysis

2021-02-25 compared with 2020-02-27 · 153 added, 190 removed, 90 unchanged (79% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

We are a clinical-stage, oncology therapeutics company, taking a Precision Cancer Medicine TM ("PCM TM ") approach to develop drugs that target mitosis (cell division) to treat various types of cancer, including prostate, colorectal and leukemia.

By integrating a biomarker strategy into our development programs, we will be able to identify patients more likely to respond to treatment.

On March 15, 2017, we announced that we licensed onvansertib, a PLK1 inhibitor, from Nerviano, pursuant to a license agreement with Nerviano dated March 13, 2017.

We are a clinical stage biotechnology company, developing new treatment options for cancer patients in indications with the greatest medical need.

Our goal is to overcome resistance, extend duration of response and increase overall survival.

We are developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 ("PLK1") inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics.

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

We licensed onvansertib from Nerviano Medical Sciences ("NMS") pursuant to a license agreement with NMS dated March 13, 2017.

This exclusive, world-wide license agreement includes 3 issued patents for onvansertib which cover composition of matter, salt forms of onvansertib and combination of onvansertib with other drugs.

Onvansertib was developed to have high selectivity to PLK1 (at low nanomolar IC 50 levels), to have ideal pharmacokinetics, including oral bioavailability and administration and a drug half-life of approximately 24 hours, allowing for flexible dosing and scheduling, and is well tolerated and safe with only mild to moderate side effects reported to-date.

A Phase 1 safety study of onvansertib has been successfully completed in patients with advanced metastatic solid tumors and published in 2017 in Investigational New Drugs.

We currently have three active clinical trials:

a Phase 2 open-label clinical trial of onvansertib in combination with abiraterone acetate (Zytiga ® ) and prednisone in patients with mCRPC, being conducted at Beth Israel Deaconess Medical Center ("BIDMC"), Dana-Farber Cancer Institute ("DFCI"), and Massachusetts General Hospital ("MGH");

a Phase 1b/2 open-label clinical trial of onvansertib in combination with FOLFIRI and Avastin ® in patients with mCRC with a KRAS mutation, being conducted at USC Norris Comprehensive Cancer Center and The Mayo Clinic;

and a Phase 1b/2 open-label clinical trial of onvansertib in combination with standard-of-care chemotherapy in patients with AML, being conducted at eight sites across the U.S.

Onvansertib is a first-in-class, third-generation, oral and highly-selective PLK1 inhibitor with demonstrated antitumor activity in different preclinical models.

Polo-like kinase family consists of 5 members (PLK1-PLK5) and they are involved in multiple functions in cell division, including the regulation of centrosome maturation, checkpoint recovery, spindle assembly, cytokinesis, apoptosis and many others.

PLK1 is essential for the maintenance of genomic stability during cell division.

The over-expression of PLK1 can lead to immature cell division followed by aneuploidy and cell death, a hallmark of cancer.

PLK1 is over-expressed in a wide variety of leukemias/lymphomas and solid tumor cancers, including acute myeloid leukemia, non-Hodgkin lymphoma, prostate, lung, breast, ovarian, colorectal and adrenocortical carcinoma.

In addition, several studies have shown that over-expression of PLK1 is associated with poor prognosis.

Blocking the expression of PLK1 by kinase inhibitors, such as onvansertib, can effectively inhibit growth of, and induce, tumor cell death.

Studies have shown that inhibition of polo-like-kinases can lead to tumor cell death, including a Phase 2 study in AML where response rates with a prior PLK inhibitor of up to 31% were observed when used in conjunction with a standard therapy for AML (low-dose cytarabine (“LDAC”)) versus a 13.3% response rate with LDAC alone.

We believe the more selective nature of onvansertib to PLK1, its 24-hour half-life and oral bioavailability, as well as its demonstrated safety and tolerability, with expected on-target, easy to manage and reversible side effects, may prove useful in addressing clinical therapeutic needs across a variety of cancers.

Onvansertib has been tested in-vivo in different xenograft and transgenic models suggesting tumor growth inhibition or tumor regression when used in combination with other therapies.

Onvansertib is highly potent against the PLK1 enzyme (concentration for 50% inhibition [IC 50 ] = 2nM), whereas low or no activity was observed on a panel of 63 kinases (IC 50 >500 nM), including the PLK members PLK2 and PLK3 (IC 50 >10 μM).

Onvansertib was developed to have ideal pharmacokinetics, including oral bioavailability and administration and a drug half-life of approximately 24 hours, allowing for flexible dosing and scheduling, and is well tolerated and safe with only mild to moderate side effects reported to-date.

A Phase 1 safety study of onvansertib was successfully completed in patients with advanced metastatic solid tumors and published in 2017 in Investigational New Drugs .

PLK1, a serine/threonine kinase, is a master regulator of mitotic progression with various roles and localizations during the different mitotic phases.

Upon PLK1 depletion in cancer cells by RNA interference ("RNAi"), inhibition of proliferation and decreased viability, resulting from cell cycle arrest with 4N DNA content followed by apoptosis, are observed.

PLK1 depletion also results in an increase in the number of cells containing abnormal spindle formation and misaligned chromosomes.

Expression of PLK1 is seen in all proliferating normal tissues, and PLK1 is overexpressed in a number of tumors (including breast, prostate, ovary, lung, gastric and colon cancers), as well as in hematologic cancers.

Onvansertib has been tested for antiproliferative activity on a panel of 148 tumor cell lines and appeared highly active with an IC 50 (a measure concentration for 50% target inhibition) below 100 nM in 75 cell lines and IC 50 values below 1 uM in 133 out of 148 cell lines.

Onvansertib also appears active in cells expressing multi-drug resistant (“MDR”) transporter proteins and we believe its apparent ability to overcome the MDR transporter resistance mechanism in cancer cells could prove useful in broader drug combination applications.

In in-vitro and in-vivo preclinical studies, synergy (interaction of discrete drugs such that the total effect is greater than the sum of the individual effects) has been demonstrated with onvansertib when used in combination with numerous different chemotherapies, including cisplatin, cytarabine, doxorubicin, gemcitabine and paclitaxel, as well as targeted therapeutics, such as abiraterone acetate (Zytiga ® ), histone deacetylase (“HDAC”) inhibitors, such as belinostat (Beleodaq ® ), quizartinib (AC220), a development stage FLT3 inhibitor, and bortezomib (Velcade ® ).

These therapies are used clinically for the treatment of leukemias, lymphomas and solid tumor cancers, including AML, Non-Hodgkin Lymphoma (“NHL”), mCRPC, mCRC, and Triple Negative Breast Cancer (“TNBC”).

We achieved a number of key milestones throughout 2019 and anticipate achieving additional milestones through the end of 2020:

Phase 2 Trial of Onvansertib in Combination with Abiraterone Acetate (Zytiga ® ) and Prednisone for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Initiated enrollment and evaluation of 3 safety lead-in patients in the second arm (2-week dosing schedule) with onvansertib at 18 mg/m 2 in combination with abiraterone acetate (Zytiga) and prednisone.

Provide safety and preliminary efficacy data of onvansertib in combination with abiraterone acetate (Zytiga ® ) and prednisone in patients treated through the end of 2019 and into 2020.

Presented data from the mCRPC trial at key oncology conferences throughout 2019, including the Asia-Pacific Prostate Cancer Conference ("APPC"), and first quarter of 2020 including ASCO-GU.

Phase 1b/2 Trial of Onvansertib in Combination with FOLFIRI and Bevacizumab (Avastin ® ) for Second-Line Treatment of Metastatic Colorectal Cancer with a KRAS Mutation

Completed enrollment and evaluation of the initial dose level cohort of onvansertib 12 mg/m 2 and fully enrolled the second dose level (onvansertib 15 mg/m 2 ) cohort.

Presented data from the mCRC trial at key oncology conferences throughout 2019, including the European Society for Medical Oncology (“ESMO”), and first quarter of 2020 including ASCO-GI.

Phase 1b/2 Trial of Onvansertib in Combination with Either Low-Dose Cytarabine or Decitabine for the Treatment of Acute Myeloid Leukemia

Completed Phase 1b dose escalation safety segment of trial, identified the recommended Phase 2 dose (“RP2D”) of onvansertib at 60mg/m 2 .

Initiated the Phase 2 segment of the AML trial, which will enroll approximately 32 patients, for continued evaluation of safety and efficacy of onvansertib in combination with decitabine.

Presented data from the AML trial at key oncology conferences, including the European Society for Medical Oncology ("ESMO") and the American Society of Hematology (“ASH”) annual meetings.

During 2019, we advanced our business with the following activities:

Announced positive data presented in an oral session at the American Society of Hematology (“ASH”) conference response to treatment in patients with acute myeloid leukemia.

On December 9, 2019, we announced the presentation of data demonstrating efficacy, durability of response and safety of onvansertib from the completed Phase 1b segment of the ongoing trial in acute myeloid leukemia, in an oral session at ASH.

Efficacy was observed in patients treated at onvansertib doses ranging from 27 to 90 mg/m 2 , with a complete response (CR) and CR with incomplete count recovery (Cri) rate of 31% (5 out of 16 patients).

Treatment was well tolerated;

adverse events related to onvansertib were primarily on-target hematological (based on mechanism of action) and were easily managed and reversible.

Biomarker positive patients showed a higher response to treatment;

67% (4 out of 6) patients had marked decreases in bone marrow blast cells vs only 18% (1 out of 11) biomarker negative patients.

Announced data showing the ability of onvanserib to rescue patients previously treated with, and resistant to, venetoclax in acute myeloid leukemia.

On December 4, 2019, we announced data showing the ability of onvansertib to rescue venetoclax-resistant AML patients.

Patients develop resistance to venetoclax in approximately 11 months following the start of treatment with no viable therapeutic options and a median survival of only 1.7 to 2.3 months and a poor prognosis.

Onvansertib as a single agent inhibits tumor growth in both venetoclax-resistant in-vitro and in-vivo AML models.

The combination of onvansertib and venetoclax is synergistic, which supports the addition of onvansertib to venetoclax in venetoclax-resistant AML patients.

Announced positive response to treatment in Phase 2 trial of onvansertib in patients with metastatic castration-resistant prostate cancer.

On November 14, 2019, we announced data demonstrating positive response to treatment in patients enrolled in our Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate) in patients with mCRPC.

72% of patients had decreases in PSA levels with the addition of onvansertib following 1 cycle of treatment.

60% of patients completing 3 months of treatment and evaluable for efficacy achieved the primary endpoint of disease control.

Announced positive response to treatment in Phase 1b/2 trial of onvansertib in patients with KRAS-mutated metastatic colorectal cancer.

On October 22, 2019, we announced data demonstrating positive response to treatment in patients enrolled in our Phase 1b/2 trial of onvansertib in combination with FOLFIRI and Avastin (bevacizumab) for second-line treatment of KRAS-mutated mCRC.

Decreases in tumor KRAS mutational burden in response to treatment with onvansertib was observed in all four patients who completed their first cycle of therapy, as measured by quantitative analysis of circulating tumor DNA (ctDNA).

Announced data presented at ESMO providing rationale for a clinical trial of onvansertib in subset of patients with Highly-Aggressive Triple Negative Breast Cancer (TNBC).

On October 2, 2019, we announced the presentation of data in a poster at ESMO demonstrating s ignificant tumor regression observed with onvansertib in combination with standard-of-care paclitaxel in models of p53-mutated TNBC.

Onvansertib preclinical data provides rationale for conducting a clinical trial targeting the 80% of TNBC that harbors the p53 mutation.

The combination has potential to address critical medical need to provide targeted treatment option to overcome resistance to paclitaxel as single agent therapy in TNBC.

Announced presentation of a poster at ESMO of Phase 1b/2 trial of onvansertib in patients with KRAS-mutated mCRC.

On October 1, 2019, we announced the presentation of a poster at ESMO providing an overview of our Phase 1b/2 trial in metastatic Colorectal Cancer, to assess the safety and efficacy of onvansertib in combination with FOLFIRI and Avastin ® (bevacizumab) in KRAS-mutated mCRC.

Approximately 50% of patients harbor the KRAS mutation;

current standard-of-care therapy has only a 5% response rate.

Biomarker data demonstrates ability to assess patient response to therapy within one week of treatment with onvansertib.

Announced oral presentation of positive data from Trovagene Phase 1b/2 AML Study of onvansertib at ESMO Conference.

On September 30, 2019, we announced positive data from our Phase 1b/2 trial in AML which was presented in an oral plenary session at the ESMO conference.

The data showed that administration of onvansertib in combination with standard-of-care chemotherapy is safe and well-tolerated and resulted in anti-leukemic activity that appears to be sustainable over time.

There is a strong correlation between biomarker positive patients and treatment response;

observed in 6 of 9 biomarker positive patients versus 1 of 11 biomarker negative patients.

Phase 2 is open to enrolling 32 patients for treatment with onvansertib at the recommended dose of 60 mg/m², in combination with decitabine, to further assess safety and efficacy of the regimen.

Announced Successful Completion of the AML Phase 1b Trial and Initiation of the Phase 2 Continuation Trial.

On September 19, 2019, we announced the successful completion of our Phase 1b trial in AML and the initiation of patient enrollment in Phase 2.

The Phase 1b dose escalation clinical trial confirmed safety, preliminary efficacy and identified the recommended phase 2 dose of onvansertib.

Complete response (CR + CRi) was achieved in 5 of 21 patients treated with onvansertib in combination with decitabine.

Phase 2 will treat 32 patients with onvansertib + decitabine;

eligible patients will have relapsed after receiving up to one prior therapy including patients who have developed resistance to first-line treatment with venetoclax.

Announced the Presentation of Positive Clinical Data from Ongoing Phase 2 Study of Onvansertib in mCRPC at the Asia-Pacific Prostate Cancer Conference.

On August 26, 2019, we announced findings from our Phase 2 trial in mCRPC that leads to the discovery that onvansertib stops the rise in PSA in patients with treatment-resistant, highly-aggressive and difficult-to-treat androgen-receptor variant 7 ("AR-V7") tumors.

Data demonstrates efficacy of onvansertib in patients showing early signs of resistance to androgen receptor signaling ("ARS") inhibitor, Zytiga ® .

The addition of onvansertib appears to extend the duration of response to ARS inhibitor therapy in this incurable and lethal cancer.

Announced research collaboration with Nektar Therapeutics to evaluate the efficacy of the combination of onvansertib and ONZEALD TM in models of colorectal cancer.

On May 23, 2019, we announced we entered into a research collaboration agreement with Nektar Therapeutics to explore the combination of our PLK1 inhibitor, onvansertib, and Nektar’s topoisomerase I inhibitor, ONZEALD, for the treatment of mCRC.

Under the collaboration, the two companies will evaluate the antitumor activity and tolerability of the combination of onvansertib and ONZEALD in two (HT29 - BRAF mutant and HCT-116 - KRAS mutant) preclinical tumor models of colorectal cancer.

Announced Data Demonstrating Significant Synergy of Onvansertib in Combination with Venetoclax in Cell Model of Venetoclax-Resistant AML.

On April 23, 2019, we announced preclinical data that evaluated the effect of combining onvansertib with venetoclax in an AML cell model known to be resistant to venetoclax (Venclexta ® - AbbVie).

This combination demonstrated synergy (the combined effect of the two drugs is greater than the sum of their individual effects) with a significant decrease in tumor cell viability.

This data provides support for clinical evaluation of onvansertib in combination with venetoclax in patients with difficult-to-treat relapsed/refractory AML, for which there are limited treatment options and the prognosis is poor.

Announced New Patent Issued for Combination of Onvansertib with Anti-Androgen Drugs to Treat Non-Metastatic and Metastatic Prostate Cancer.

On January 23, 2019, we announced the issuance of a new patent (10,155,006), entitled Combination Therapies and Methods of Use Thereof for Treating Cancer, by the U.S.

Patent and Trademark Office (“USPTO”).

This patent broadens previously issued patent (9,566,280), by expanding the use of onvansertib to encompass combination therapies with any anti-androgen and androgen antagonist drug, such as Zytiga ® , Xtandi ® and Erleada ® for the treatment of metastatic and non-metastatic castrate-resistant prostate cancer.

Additionally, onvansertib has been tested in in-vivo xenograft and transgenic models of different cancer types with the demonstration of tumor growth inhibition or tumor regression.

Onvansertib has been evaluated preclinically in combination with several different chemotherapies, including irinotecan, cisplatin, cytarabine, doxorubicin, gemcitabine and paclitaxel, and with targeted therapeutics such as abiraterone, histone deacetylase ("HDAC") inhibitors, fms-like tyrosine kinase 3 ("FLT3") inhibitors, and bortezomib.

These therapies are used clinically for the treatment of many hematologic and solid cancers, including acute myeloid leukemia ("AML"), non-Hodgkin’s lymphoma ("NHL"), metastatic CRC, metastatic castration resistant prostate cancer ("mCRPC"), adrenocortical carcinoma ("ACC"), triple negative breast cancer ("TNBC"), small cell lung cancer ("SCLC"), and ovarian cancer.

We believe the high-selectivity of onvansertib to PLK1, its 24-hour half-life and oral bioavailability, as well as its demonstrated safety and tolerability, with expected on-target, easy to manage and reversible side effects, may prove beneficial in addressing clinical therapeutic needs across a variety of cancers.

Clinical Program Updates

We currently have three active clinical trials:

• TROV-054 is a Phase 1b/2 open-label clinical trial of onvansertib in combination with FOLFIRI and bevacizumab ("Avastin ® ") for the second line treatment of patients with KRAS-mutated mCRC, which is being conducted at 6 clinical trial sites across the U.S.

- USC Norris Comprehensive Cancer Center, The Mayo Clinic Cancer Centers (Arizona, Minnesota and Florida), Kansas University Medical Center ("KUMC") and CARTI Cancer Center;

• TROV-053 is a Phase 2 open-label clinical trial of onvansertib in combination with abiraterone acetate (Zytiga ® ) and prednisone in patients with mCRPC, which is being conducted at Beth Israel Deaconess Medical Center ("BIDMC"), Dana-Farber Cancer Institute ("DFCI"), and Massachusetts General Hospital ("MGH");

• TROV-052 is a Phase 2 open-label clinical trial of onvansertib in combination with standard-of-care chemotherapy, decitabine, in patients with relapsed or refractory AML, which is being conducted at nine sites across the U.S.

The Phase 1b portion of the AML trial was completed in the fourth quarter of 2019 and enrollment in Phase 2 was completed in October 2020.

KRAS-mutated mCRC

TROV-054 is a Phase 1b/2 study of onvansertib for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer ("mCRC") in combination with standard-of-care FOLFIRI and bevacizumab (Avastin ® ).

The primary objective of this study is to evaluate the dose-limiting toxicities ("DLTs") and maximum tolerated dose ("MTD") or 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 (Phase 2).

The rationale for this clinical trial is based on three key principles including synthetic lethality, synergy and proof-of-concept clinical benefit.

Synthetic lethality arises when a combination of deficiencies in the expression of two genes leads to cell death, whereas a deficiency in only one of these genes does not.

The deficiencies can arise through mutations, epigenetic alterations or inhibitors of the protein encoded by one of the genes.

In reference to onvansertib, CRC tumor cells harboring KRAS mutations are more vulnerable to cell death with PLK1 inhibition versus KRAS wild-type isogenic cells.

Synergy occurs when the combination of two drugs results in an unexpected greater activity than an expected additive effect of the two drugs.

Onvansertib in combination with irinotecan and 5-FU (components of FOLFIRI) demonstrate synergy in colorectal cancer cell lines and the combination has demonstrated significantly greater tumor growth inhibition than either drug alone.

Proof-of-concept clinical response has been demonstrated in a previously completed Phase 1 trial in solid tumors in which 3 of 5 patients showing stable disease had a KRAS mutation;

2 in colorectal cancer and 1 in pancreatic cancer.

Data presented on January 15, 2021, at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (“ASCO-GI”), demonstrated the safety and efficacy of onvansertib.

Of the 12 patients evaluable for efficacy, 5

(42%) achieved a partial response (PR);

4 patients had a confirmed PR;

1 patient went on to curative surgery;

1 patient with a non-confirmed PR went off study due to an unrelated event prior to their 16-week confirmatory scan.

8 (67%) patients showed a durable response to treatment of >6 months with a range from 6.1 to 13.7 months.

Time to achieving a PR ranges from 2 to 6 months in patients on treatment.

10 of 12 patients had a KRAS variant detected by ddPCR at baseline (all had a KRAS mutation detected by NGS).

Clinical responses were observed across different KRAS variants, including the 3 most common in CRC.

The greatest decreases in KRAS mutant allelic frequency (MAF) after 1 cycle of treatment were observed in patients achieving a PR (ranging from -78% to -100%), while the 2 patients who progressed showed a more modest reduction in KRAS MAF (-55% and -26%).

Patients with PR and stable disease (SD) tended to have lower on-treatment KRAS MAF than patients with early progressive disease (PD).

Onvansertib in combination with FOLFIRI/bevacizumab is safe and well tolerated with only 9% of all adverse events (AEs) being grade 3 or 4.

Grade 4 adverse events were attributed to the 5-FU bolus component of the combination regimen, which was eliminated in subsequent cycles of treatment per protocol and institutional guidelines.

The only G3/G4 AEs reported in ≥2 patients were neutropenia (n=8), which were managed by dose delay, growth factor therapy and/or discontinuation of the 5-FU bolus;

no patients went off trial due to neutropenia.

No major or unexpected toxicities were attributed to onvansertib.

Key News Releases

On January 15, 2021, we announced an electronic poster presentation of clinical data further demonstrating the clinical benefit of onvansertib in KRAS-mutate mCRC and initial findings from our Expanded Access Program (EAP) in mCRC.

On September 17, 2020, we announced an electronic poster presentation of clinical data further demonstrating the safety, efficacy and durability of response of onvansertib in KRAS-mutated mCRC patients at the European Society of Medical Oncology ("ESMO") Virtual Congress 2020.

On June 9, 2020, we announced the initiation of our Expanded Access Program ("EAP") for onvansertib, in combination with standard-of-care FOLFIRI and bevacizumab, for second-line treatment of patients with KRAS-mutated mCRC.

This announcement followed the FDA granting Fast Track Designation for onvansertib in KRAS-mutated mCRC.

TROV-053 is a Phase 2 study of onvansertib in combination with Zytiga ® (abiraterone) and prednisone for the treatment of patients with metastatic castration resistant prostate cancer ("mCRPC").

The primary objective of this study is to observe the effects of onvansertib in combination with abiraterone and prednisone on disease control as assessed by prostate specific antigen ("PSA") decline or stabilization after 12 weeks of study treatment in patients with mCRPC showing early signs of resistance to abiraterone.

The rationale for this trial is based on the mechanism of action ("MOA") of onvansertib and Zytiga ® and the synergy of these two drugs when used in combination.

Onvansertib inhibits tumor cell division (mitosis) by inducing G2/M arrest of tumor cells and the combination of onvansertib and Zytiga ® significantly increases mitotic arrest and is synergistic when used in combination.

Additionally, PLK1 inhibition appears to enhance the efficacy of androgen signaling blockade in castration-resistant prostate cancer.

Data presented on February 11, 2021, at the American Society of Clinical Oncology Genitourinary Cancers Symposium (“ASCO-GU”) demonstrated safety and efficacy of onvansertib in combination with abiraterone.

Arms A (n=17) and B (n=12) showed similar efficacy with 29% and 25% of patients achieving the primary endpoint and 53% and 42% of patients with SD at 12 weeks, respectively.

The more continuous dosing schedule of Arm C (n=8) has shown a higher response rate with 63% of patients, to-date, achieving the primary endpoint and 75% with SD at 12 weeks.

Efficacy was observed in patients harboring AR alterations across all 3 arms.

ctDNA analysis revealed differences in baseline genomic profiles of patients achieving SD at 12 weeks vs patients progressing before or at 12 weeks.

Mutations exclusively present in patients with SD were associated with cell cycle and DNA repair pathways that may result in increased sensitivity to onvansertib and efficacy of the combination.

Onvansertib + abiraterone has demonstrated safety across all 3 dosing schedules.

Key News Releases

On February 11, 2021, we announced an electronic poster presentation of clinical data further demonstrating the safety, efficacy and durability of response in patient with mCRPC at the American Society of Clinical Oncology Genitourinary Cancers Symposium (“ASCO-GU”).

TROV-052 is a Phase 2 Study of onvansertib in combination with standard-of-care chemotherapy, decitabine, for the treatment of patients with relapsed or refractory acute myeloid leukemia ("AML").

The Phase 1b portion of this trial was completed in the fourth quarter of 2019.

The objective of this trial is to evaluate the DLTs and MTD or RP2D of onvansertib (Phase 1b – completed in October 2019).

In Phase 2, the objective is to assess the safety, tolerability and preliminary efficacy of the combination of onvansertib at the RP2D and decitabine in patients with relapsed or refractory AML (Phase 2 enrollment completed in October 2020).

Additionally, as a correlative objective, this trial is evaluating potential pharmacodynamic ("PD") and diagnostic biomarkers of onvansertib in patients with AML.

We were granted Orphan Drug Designation ("ODD") for onvansertib for the treatment of AML from the FDA and the European Commission.

Data presented on December 6, 2020 at the 62 nd American Society of Hematology ("ASH") conference, demonstrated the safety, tolerability and anti-leukemic activity of onvansertib in combination with decitabine in patients with difficult-to-treat relapsed/refractory AML.

Nine of 45 (20%) patients achieved a complete remission with or without hematologic count recovery (CR/CRi – 5 in Phase 1b and 4 in Phase 2);

55% of responders had a mutation in a splicing factor.

Two patients proceeded to transplant following CR and four patients remain on treatment with duration of response of 9, 10, 17 and 20 months, respectively.

Together with data demonstrating the safety and tolerability of the combination therapy, these findings highlight onvansertib’s potential to address critical unmet needs in hematologic malignancies.

Key News Releases

On December 6, 2020, we announced an electronic poster presentation of data from the Phase 1b/2 trial in AML demonstrating the safety and efficacy of onvansertib in relapsed or refractory patients at the annual American Society of Hematology (“ASH”) conference.

Financial and Company Updates

On September 29, 2020 we announced pricing of an underwritten public offering of 6,500,000 shares of our common stock at a price of $13.50 per share.

The underwriters had an option to purchase an additional 975,000 shares, which was exercised in full.

The offering was completed on October 2, 2020 and the gross proceeds were $100.9 million.

On December 21, 2020 we announced that Dr.

Thomas Adams has stepped down from his positions as Executive Chairman and Chairman of the Board of Directors and will continue to serve as a Director.

Rodney Markin was appointed by the Board of Directors as our new Chairman of the Board.

On May 8, 2020 we changed our company name from Trovagene, Inc.

to Cardiff Oncology, Inc., and our Nasdaq ticker symbol to ‘CRDF.’ The web address for the Cardiff Oncology website is www.cardiffoncology.com.

On May 8, 2020 Mark Erlander, PhD, assumed the role of Chief Executive Officer and Thomas Adams, PhD, transitioned from Chief Executive Officer and Chairman to Executive Chairman.

On April 22, 2020, we announced the election of three new independent Directors to our Board of Directors;

James Armitage, Dr.

Gary Pace and Ms.

Each new Director brings extensive and relevant experience to our company.

Our accumulated deficit through December 31, 2020 is $231,495,279.

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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 drugs.

The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses, and competing technologies being developed by organizations with significantly greater resources.

research and development expenses, and competing technologies being developed by organizations with significantly greater resources.

Critical Accounting Policies

Financial Reporting Release No.

60 requires all companies to include a discussion of critical accounting policies or methods used in the preparation of financial statements.

Our accounting policies are described in Part II, Item 8.

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We believe that the following discussion represents our critical accounting policies.

Royalty and License Revenues

We license and sublicense our patent rights to healthcare companies, medical laboratories and biotechnology partners.

These agreements may involve multiple elements such as license fees, royalties and milestone payments.

Revenue is recognized when the criteria described above have been met as well as the following:

• Up-front nonrefundable license fees pursuant to agreements under which we have no continuing performance obligations are recognized as revenues on the effective date of the agreement and when collection is probable.

• Minimum royalties are recognized as earned, and royalties are earned based on the licensee’s use.

We estimate and record licensee’s sales based on historical usage rate and collectability.

• For sales-based royalties, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

Payment terms and conditions vary by contracts, although terms generally include a requirement of payment within 30 to 45 days after invoice.

Minimum royalties are generally due quarterly or annually.

Accrued Clinical Trial Expenses

We expense research and development expenditures as incurred, which include costs related to clinical trial activities.

We accrue costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by the clinical research organizations (CROs), investigators, professional service providers, and other vendors providing clinical trial services (collectively, the “service providers”).

As of December 31, 2020 our clinical trial accrual balance of $1,683,195 is included in accrued liabilities and other liabilities.

Our related 2020 clinical trial expenses are included in research and development expense of $11,235,396.

Certain accrued clinical trial expenses are released from service receivables classified within equity as clinical trial services are performed.

Derivative Financial Instruments—Warrants

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Changes in fair value of derivative liabilities are recorded in the statement of operations under the caption “gain (loss) from changes in fair value of derivative financial instruments — warrants.”

The fair value of warrants is determined using the Black-Scholes option-pricing model using assumptions regarding the historical volatility of Trovagene’s common stock price, the remaining life of the warrants, and the risk-free interest rates at each period end.

The fair value of warrants is determined using the Black-Scholes option-pricing model using assumptions regarding the historical volatility of Cardiff Oncology’s common stock price, the remaining life of the warrants, and the risk-free interest rates at each period end.

Accordingly, the fair value of the warrants is sensitive to changes in these estimates.

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Total revenues $ 365,993 $ 244,632 $ 121,361

The decrease in service revenue for the year ended December 31, 2019 as compared to the prior period is primarily from the disposition of our CLIA laboratory.

We expect our royalties to fluctuate as the royalties are sales-based or usage-based royalties on our intellectual property license.

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

Cost of Revenue

Our total cost of revenue was $0 in the year ended December 31, 2019 , as compared to $597,457 in the year ended December 31, 2018 .

Cost of revenues relates to the costs of our service revenues.

The decrease in cost of revenues compared to the same period of last year is mainly due to the disposition of our CLIA laboratory.

We do not expect any cost of revenue based on our current business model.

The increase in revenues for the year ended December 31, 2020 as compared to the prior period is primarily from fluctuations of 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

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Total research and development expenses $ 11,235,396 $ 11,162,236 $ 73,160

Research and development expenses increase d by $2,998,225 to $11,162,236 for the year ended December 31, 2019 from $8,164,011 for the year ended December 31, 2018 .

The overall increase in research and development expenses was primarily due to the increased clinical trials and outside service costs for three ongoing clinical trials related to the development of our drug candidate, onvansertib.

We expect an increase in research and development costs as we advance the development of onvansertib.

Research and development expenses increased by $73,160 to $11,235,396 for the year ended December 31, 2020 from $11,162,236 for the year ended December 31, 2019.

The increase in salaries and staff costs is primarily due to promotions, merit increases and increased headcount.

The increase in costs associated with clinical programs and outside service costs is primarily related to assay development and recruiting fees.

Facilities and other decreased primarily due to decreased travel and conference expenses to present data related to our drug candidate, onvansertib.

Due to COVID-19 presentation of data has transitioned to virtual conferences.

Selling, General and Administrative Expenses

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Total selling, general and administrative $ 8,216,471 $ 5,760,890 $ 2,455,581

Selling, general and administrative expenses decrease d by $2,244,693 to $5,760,890 for the year ended December 31, 2019 , from $8,005,583 for the year ended December 31, 2018 .

The significant components of the decrease were primarily due to the decrease in salaries and staff costs, stock-based compensation, and facilities costs.

The decreased salaries and staff costs for the year ended December 31, 2019 as compared to the same period of 2018, was due to decreased headcount in 2019, and a one-time executive severance expense occurring in the second quarter of 2018.

The decreased stock-based compensation

related to one-time employee stock option grants in lieu of cash bonuses occurring in January 2018, these options were immediately expensed.

Our selling, general and administrative costs may increase in future periods in order to support financing and general business activities as we continue to develop and introduce new product offerings.

Restructuring

In May 2018, we closed our CLIA laboratory operations in order to streamline our business model.

The loss recognized from disposition of the CLIA laboratory was reported as restructuring charges in the December 31, 2018 financial statements.

For the year ended December 31, 2018, we recorded total restructuring charges of approximately $664,000, the majority of which was related to loss on sublease of office and laboratory space.

Interest Income and Expense

Selling, general and administrative expenses increased by $2,455,581 to $8,216,471 for the year ended December 31, 2020, from $5,760,890 for the year ended December 31, 2019.

The increase of stock-based compensation expense and salaries and staff costs is primarily related to the Separation Agreement with Thomas Adams which includes accelerated vesting of

stock options of approximately $583,000 and a one-time severance payment of $300,000.

The increase in outside services and professional fees is primarily related to legal and patent fees to analyze our competitive landscape and evergreen patent strategy.

The increase in facilities and other cost was due to a decrease in sublease income, an increase in Delaware franchise tax and an increase in insurance costs.

Interest Income

Interest income was $89,809 and $234,169 for the years ended December 31, 2020 and 2019, respectively.

The increase of interest income is primarily due to a higher average money market fund balance and higher average interest rates during 2019 as compared to 2018.

Interest expense was $0 and $25,409 for the years ended December 31, 2019 and 2018 , respectively.

The decrease of interest expense is resulting from pay-off of our Equipment Line of Credit.

The decrease of interest income is due to significantly lower average interest rates during 2020 as compared to 2019.

Change in Fair Value of Derivative Financial Instruments—Warrants

We have issued warrants to purchase shares of our common stock that are accounted for as derivative liabilities.

As of December 31, 2019 , the derivative financial instruments—warrants liabilities related to securities issued, and were revalued to $4,127 , resulting in a decrease in fair value of $28,188 from December 31, 2018 based primarily upon the change in our stock price from $3.15 at December 31, 2018 to $1.24 at December 31, 2019 , and the changes in the expected term, volatility and risk-free interest rates for the expected term.

The decrease in value was recorded as non-operating gain for the year ended December 31, 2019 .

As of December 31, 2020, the derivative financial instruments—warrants liabilities related to securities issued were revalued to $284,971, resulting in a increase in fair value of $280,844 from December 31, 2019 based primarily upon the change in our stock price from $1.24 at December 31, 2019 to $17.99 at December 31, 2020, and the changes in the expected term, volatility and risk-free interest rates for the expected term.

The increase in value was recorded as non-operating loss for the year ended December 31, 2020.

Net loss and per share amounts were as follows:

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2020 2019 Increase/(Decrease)

Net loss $ (19,306,672) $ (16,414,159) $ 2,892,513

Preferred stock dividend (24,240) (24,240) —

Deemed dividend on preferred stock (3,266,484) (268,269) 2,998,215

Net loss attributable to common stockholders $ (22,597,396) $ (16,706,668) $ 5,890,728

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Weighted-average shares outstanding — basic and diluted 20,874,665 5,973,906 14,900,759

The $2,548,283 decrease in net loss attributable to common shareholders was primarily the result of a decrease in Series B deemed dividend expense of $2,769,533, and a decrease in operating expenses of $508,611 offset by a decrease in gain from change in fair value of derivative financial instruments-warrants of $588,884 for the for the year ended December 31, 2019 as compared to the same period of 2018.

The $5.46 decrease in basic and diluted net loss per share was impacted by the decrease in net loss attributable to shareholders and the increase in basic weighted average shares outstanding resulting primarily from the sales of approximately 3.9 million shares of common stock and common stock equivalents through public and direct offerings, issuance of approximately 0.5 million shares of common stock upon exercise of warrants, and 0.3 million shares of common stock upon conversion of Series C Convertible Preferred Stock.

The increase of $5,890,728 net loss attributable to common stockholders is primarily related to an increase of deemed dividends on preferred stock of $2,998,215, related to the beneficial conversion upon issuance of preferred stock and an increase of net loss of $2,892,513.

The increase of 14,900,759 basic and diluted weighted-average shares outstanding primarily resulting from the sales of common stock through public and direct offerings and the issuance of common stock upon exercise of warrants.

The $1.72 decrease in basic and diluted net loss per share was impacted by the increase in net loss attributable to shareholders and the increase in basic and weighted average shares outstanding.

Liquidity and Capital Resources

The COVID-19 outbreak in the United States has caused business disruptions.

The extent of the impact of COVID-19 on our operational and financial performance will depend on certain developments, including the duration and spread of the outbreak, and impact on our clinical trials, employees and vendors, all of which are uncertain and cannot be predicted.

The economic effects of the outbreak could also have an adverse effect on our ability to raise additional capital.

At this point, the extent to which COVID-19 may impact our future financial condition or results of operations is uncertain.

There has not been a material impact on the Company's financial statements for the twelve months ended December 31, 2020.

As of December 31, 2020, we had $130,980,681 in cash and cash equivalents.

Net cash used in operating activities for the year ended December 31, 2020 was $16,314,962, compared to $13,267,500 for the year ended December 31, 2019.

Our use of cash was primarily a result of the net loss of $16,414,159 for the year ended December 31, 2019 , adjusted for items mainly related to stock-based compensation of $884,943 , release of clinical trial funding commitment of $703,327 , and depreciation and amortization of $494,232 .

The changes in our operating assets and liabilities consisted primarily of higher accounts payable and accrued expenses.

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

As of December 31, 2019 and 2018 , we had working capital of $6,571,985 and $9,841,947 , respectively.

The decrease in working capital is primarily due to the decrease in cash and cash equivalents and an increase in accrued liabilities.

Net cash (used)/provided by investing activities was $(67,622) and $22,842 for the years ended December 31, 2019 and 2018 , respectively.

Investing activities during the year ended December 31, 2019 consisted primarily of the purchase of capital equipment of $67,622 , while investing activities during the year ended December 31, 2018 consisted primarily of cash provided by disposal of capital equipment of $27,942 .

Our use of cash was primarily a result of the net loss of $19,306,672 for the year ended December 31, 2020, adjusted for items mainly related to stock-based compensation of $1,764,804, release of clinical trial funding commitment of $1,100,415, and depreciation of $466,009.

The net change in our operating assets and liabilities was $654,531 increasing cash used in operations.

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 used by investing activities was $211,880 and $67,622 for the years ended December 31, 2020 and 2019, respectively.

Investing activities during the year ended December 31, 2020 and 2019 consisted of the purchase of capital equipment.

Net cash provided by financing activities was $137,312,231 during the year ended December 31, 2020, compared to $12,077,281 provided in financing activities during the year ended December 31, 2019.

Financing activities during the year ended December 31, 2019 related primarily to sales of Common Stock, Warrants and proceeds from exercise of warrants.

Financing activities during the year ended December 31, 2018 related primarily to sales of Common Stock and Series B Convertible Preferred Stock and proceeds from exercise of warrants, offset by the pay-off of our Equipment Line of Credit.

Based on our current business plan and assumptions, we expect to continue to incur significant losses and require significant additional capital to further advance our clinical trial programs and support our other operations.

Considering our current cash resources, we believe our existing resources will be sufficient to fund our planned operations into third quarter of 2020.

In addition, we have based our cash sufficiency estimates on our current business plan and assumptions that may prove to be wrong.

We could utilize our available capital resources sooner than we currently expect, and we could need additional funding to sustain our operations even sooner than currently anticipated.

These circumstances raise substantial doubt about our ability to continue as a going concern.

Financing activities during the year ended December 31, 2020 and 2019 related primarily to sales of Common Stock, Preferred Stock, Warrants and proceeds from exercise of warrants.

As of December 31, 2020 and 2019, we had working capital of $127,237,483 and $6,571,985, respectively.

The increase in working capital is primarily due to the increase in cash and cash equivalents from financing activities during the year ended December 31, 2020.

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

As of December 31, 2020, we had $130,980,681 in cash and cash equivalents and we believe we have sufficient cash to meet our funding requirements for at least the next 12 months following the issuance date of these financial statements.

For the foreseeable future, we expect to continue to incur losses and require additional capital to further advance our clinical trial programs and support our other operations.

We cannot be certain that additional funding will be available on acceptable terms, or at all.

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

The economic effects of COVID-19 could also have an adverse effect on our ability to raise additional capital.

Our working capital requirements will depend upon numerous factors including but not limited to the nature, cost and timing of our research and development programs.

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We continually assess our spending plans to effectively and efficiently address our liquidity needs.

Controlled Equity Offering and Public Offerings

On May 27, 2016 we filed a Form S-3 Registration Statement to offer and sell in one or more offerings, any combination of common stock, preferred stock, debt securities, warrants, or units having an aggregate initial offering price not exceeding $250,000,000.

The preferred stock, debt securities, warrants, and units may be convertible or exercisable or exchangeable for common stock or preferred stock or other securities.

This Registration Statement was declared effective on June 13, 2016.

Gross proceeds of $2.4 million from the sale of 5,859 shares of our common stock at a weighted-average price of $403.92 under a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co.

as sales agent (the “Agent”) have been raised since the date of effectiveness of the Form S-3 on June 13, 2016.

On March 15, 2017, we filed a supplement to our Form S-3 registration statement to offer and sell additional shares of our common stock having an aggregate offering price up to $20,698,357 through the Agent.

Gross proceeds of approximately $0.1 million were raised in 2017 through the Controlled Equity Offering Agreement with the Agent.

On June 12, 2018, we closed an underwritten public offering (“June 2018 underwritten public offering”) consisting of (i) 1,523,333 shares of common stock, (ii) warrants to purchase an aggregate of 3,450,000 shares of common stock, including the over-allotment option for 450,000 option warrants, at an exercise price of $6.60 per share, expiring on June 12, 2023, and (iii) 8,860 shares of Series B Convertible Preferred Stock with a stated value of $1,000.

The net proceeds to us were approximately $16.2 million.

In March 2019 we received approximately $3.3 million in proceeds from the exercise of approximately 497,000 warrants under the June 2018 underwritten public offering.

On January 25, 2019, we entered into a Master Services Agreement and a Stock and Warrant Subscription Agreement with PoC Capital, LLC (“PoC”), whereby PoC has agreed to finance $1.7 million in clinical studies, including the development costs associated with Phase 1b/2 trial of onvansertib in combination with FOLFIRI and Avastin ® in patients with mCRC harboring KRAS mutation in exchange for (i) 183,334 shares of common stock, (ii) 200,000 shares of Series C Convertible Preferred Stock, each share of which is convertible into 1.67 shares of common stock, and (iii) warrants to purchase 150,000 shares of common stock with an exercise price of $3.762 per share, expiring on January 25, 2024.

Any clinical costs in excess of the financed amount will be our responsibility.

PoC will not make payments to us, but directly to the contract research organization based on their invoices.

On April 4, 2019, we entered into a Securities Purchase Agreement with Lincoln Park Capital Fund, LLC (“LPC”), gross proceeds were approximately $1.5 million.

The April 2019 Securities Purchase Agreement consisted of (i) 382,166 shares of common stock (including pre-funded warrants) at a purchase price of $3.925 per share and (ii) 382,166 Series B Warrants with an exercise price of $3.80 per share, expiring on October 5, 2024.

None of the Series B Warrants have been exercised as of February 20, 2020.

On May 10, 2019, we entered into a Securities Purchase Agreement with LPC, gross proceeds were approximately $1.5 million.

The May 2019 Securities Purchase Agreement consisted of (i) 458,015 shares of common stock (including pre-funded warrants) at a purchase price of $3.275 per share and (ii) 458,015 Series D Warrants with an exercise price of $3.15 per share, expiring on November 12, 2024.

None of the Series D Warrants have been exercised as of February 20, 2020.

On August 20, 2019, we entered into a Securities Purchase Agreement with LPC, gross proceeds were approximately $1.5 million.

The August 2019 Securities Purchase Agreement consisted of (i) 727,802 shares of common stock (including pre-funded warrants) at a purchase price of $2.061 per share and (ii) 727,802 Series F Warrants with an exercise price of $1.936 per share, expiring on February 24, 2025.

None of the Series F Warrants have been exercised as of February 20, 2020.

On October 30, 2019, we closed a private placement with certain institutional investors for gross proceeds of approximately $5.0 million.

We sold an aggregate of (i) 2,756,340 shares of common stock (including pre-funded warrants) at a purchase price of $1.814 per share, (ii) 2,756,340 Series G Warrants with an exercise price of $1.56 per share, expiring on April 30, 2025, (iii) 2,756,340 Series H Warrants with an exercise price of $1.56 per share, expiring on April 30, 2021, and (iv) 206,726 Placement Agent Warrants at an exercise price of $2.2675 per share, expiring on April 30, 2025.

None of the Series G or Placement Agent Warrants have been exercised as of February 20, 2020.

We received net proceeds of approximately $1.5 million from the exercise of 1,005,072 Series H Warrants on January 27, 2020.

Nasdaq Notice

Controlled Equity Offerings and Public Offerings

See Note 5 to the financial statements.

Nasdaq Compliance

On September 5, 2017, we received a written notice from Nasdaq notifying us that we were not in compliance with Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market, as the minimum bid price of our common stock had been below $1.00 per share for 30 consecutive business days.

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In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had until March 5, 2018, to regain compliance with the minimum bid price requirement.

On March 6, 2018, Nasdaq informed us that we were eligible for an additional 180 calendar day period until September 4, 2018 to regain compliance with the minimum $1.00 bid price per share requirement.

To regain compliance, the closing bid price of our common stock must meet or exceed $1.00 per share for at least ten consecutive business days during this 180 calendar day period.

On September 7, 2018, we received a letter from Nasdaq indicating that, based upon our continued non-compliance with the Minimum Bid Price Rule, our common stock would be subject to delisting unless we requested a hearing before a Nasdaq Hearings Panel.

We timely requested a hearing before the Panel which was held on November 8, 2018.

On November 15, 2018, we announced that the Panel granted our request for continued listing on The Nasdaq Capital Market,

subject to effecting a reverse stock split of our common stock and evidencing a closing bid price of over $1.00 for at least 10 consecutive trading days.

On February 12, 2019, we announced that our stockholders approved a reverse stock split of our issued and outstanding shares of common stock and on February 19, 2019, we effected a six for one reverse stock split of our issued and outstanding shares of common stock.

We were eligible for extensions and hearings and ultimately announced on February 12, 2019 that our stockholders approved a reverse stock split of our issued and outstanding shares of common stock and on February 19, 2019, we effected a six for one reverse stock split of our issued and outstanding shares of common stock.

On March 11, 2019 we received a letter from Nasdaq, informing us that we had regained compliance with the minimum bid price requirement.

We remain subject to a Nasdaq Panel Monitor until March 10, 2020.

If we do not maintain compliance with Nasdaq requirements for continued listing or fail to comply with other requirements for continued listing, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.

A delisting of our common stock from The Nasdaq Capital Market could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock.

In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and fewer business development opportunities.

Contractual Obligations and Commitments

The following table is a summary of contractual obligations that existed as of December 31, 2019 , and is based on information appearing in the notes to Financial Statements included elsewhere in this Annual Report on Form 10-K.

Payments Due by period

Operating leases

Total obligations

We were subject to a Nasdaq Panel Monitor until March 10, 2020.

We received a letter from Nasdaq on May 29, 2020 informing us that we are in compliance with applicable Nasdaq Listing Rules.

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