What changed in this filing

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Item 2. Management’s Discussion and Analysis

2020-08-11 compared with 2020-05-07 · 217 added, 111 removed, 74 unchanged (82% of the section changed)

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Such discussion represents only the best present assessment of our management.

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, oncology therapeutics company, developing drugs that target mitosis (cell division) to treat various types of cancer, including colorectal, prostate and leukemia.

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

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

We licensed onvansertib, a first-in-class, third-generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, from Nerviano Medical Sciences (NMS) in March, 2017, 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 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;

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");

and a Phase 1b/2 open-label clinical trial of onvansertib in combination with standard-of-care chemotherapy, decitabine, 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.

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 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 [IC50] = 2nM), whereas low or no activity was observed on a panel of 63 kinases (IC50>500 nM), including the PLK members PLK2 and PLK3 (IC50>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 IC50 (a measure concentration for 50% target inhibition) below 100 nM in 75 cell lines and IC50 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 solid tumor cancers, leukemias and lymphomas including mCRPC, mCRC, triple negative breast cancer (“TNBC”), AML and non-Hodgkin lymphoma (“NHL”).

We continue to focus on advancing our three active clinical trials with onvansertib in 2020.

We have advanced our business and clinical studies through the following events to-date in 2020:

Trovagene Announces Corporate Name Change to Cardiff Oncology, Inc.

and Appointment of Mark Erlander, PhD to Chief Executive Officer

On May 6, 2020, we announced a change in our company name from Trovagene, Inc.

to Cardiff Oncology, Inc., and a change in leadership with Mark Erlander, PhS, assuming the role of Chief Executive Officer.

Thomas Adams, PhD, our current Chairman and CEO will transition his role to Executive Chairman.

Our new name reflects our mission and commitment to turning the tide on cancer by advancing the development of onvansertib, a first-in-class, third-generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, across multiple cancer types.

The change in company name and leadership will be effective as of Friday, May 8, 2020.

In connection with the new corporate name, the Company’s Nasdaq ticker symbol will change to ‘CRDF’ and will be effective at the open of the market on Friday, May 8, 2020.

The Company’s former ticker symbol ‘TROV’ will remain effective through market close as of May 7, 2020.

The website for Cardiff Oncology will be www.cardiffoncology.com.

Trovagene Announces Presentation of Data from Trial in KRAS-Mutated Metastatic Colorectal (mCRC) Cancer Demonstrating Consistent Tumor Regression Across KRAS Mutation Subtypes and Durable Response

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.

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 irinotecan, 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 solid tumor cancers, leukemias and lymphomas including mCRC, mCRPC, pancreatic cancer, triple negative breast cancer (“TNBC”), AML and other hematological malignancies.

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 Avastin® in patients with KRAS-mutated metastatic colorectal cancer (mCRC), which is being conducted at USC Norris Comprehensive Cancer Center and The Mayo Clinic;

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

• and TROV-052 is a Phase 2 open-label clinical trial of onvansertib in combination with standard-of-care chemotherapy, decitabine, in patients with acute myeloid leukemia (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.

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 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 or more 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 one of the genes.

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

Synergy occurs when the combination of two drugs results in activity greater than that of each individual drug.

Onvansertib in combination with irinotecan (the “IRI” in 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 May 29, 2020, at the American Society for Clinical Oncology (ASCO) conference, demonstrated the safety and efficacy on onvansertib has been demonstrated.

Of the 11 patients evaluable for efficacy, 91% (10 of 11) achieved clinical benefit;

5 patients (45%) having a partial response (PR) and 5 (45%) having stable disease (SD).

The response to

treatment appears to be durable, with progression-free survival to-date of >6 months with patients remaining on treatment.

Additionally, on May 26, 2020, the FDA granted Fast Track Designation to onvansertib for the second-line treatment of patients with KRAS-mutated mCRC and in June, 2020, we initiated an Expanded Access Program to afford more patients access to onvansertib, beyond the ongoing clinical trial.

Key News Releases

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 metastatic colorectal cancer (mCRC).

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

On May 29, 2020, we announced positive efficacy and favorable safety data from our ongoing Phase 1b/2 clinical trial in KRAS-mutated mCRC in a virtual oral poster presentation at the American Society of Clinical Oncology (ASCO) conference.

The data continues to demonstrate that the primary efficacy endpoint of overall objective response (ORR), as measured by tumor regression, is ten-fold greater than current standard-of-care of 4%.

As of the date of the ASCO presentation, 89% of evaluable patients in the trial have achieved a clinical response and the response appears durable with patients having progression-free survival (PFS) of at least 6 months.

Onvansertib has also shown its effectiveness in targeting the most prevalent KRAS mutation subtypes associated with colorectal cancer, which until recently have been considered to be undruggable.

On May 28, 2020, we announced that the U.S.

Food and Drug Administration (FDA) granted Fast Track Designation to onvansertib, for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC).

Being granted Fast Track designation for onvansertib in KRAS-mutated metastatic colorectal cancer underscores the urgent need for new treatment options for these patients and makes onvansertib eligible for accelerated approval and priority review.

On May 13, 2020, we announced an agreement with PoC Capital, LLC, to fund the completion of our ongoing Phase 1b/2 clinical trial in patients with KRAS-mutated metastatic Colorectal Cancer (mCRC).

Our agreement with PoC Capital follows the Company's announcement of positive safety and efficacy data from our Phase 1b trial, presented at the American Association for Cancer Research (AACR) conference.

On April 28, 2020, we announced new positive results from our ongoing Phase 1b/2 clinical trial of onvansertib in combination with FOLFIRI and Avastin® (bevacizumab) for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC).

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Afsaneh Barzi, at the American Association for Cancer Research (AACR) conference on Monday, April 27th, 2020.

The ongoing Phase 1b/2 trial has enrolled 12 patients with 88% response in 7 of 8 evaluable patients;

to-date 3 patients with a partial response (PR);

At the time of this presentation the Phase 1b/2 trial had enrolled 12 patients, with 88% response in 7 of 8 evaluable patients;

3 patients with a partial response (PR);

4 patients with stable disease (SD).

Data show median progression-free survival (PFS) of at least 6.5 months with 6 patients continuing on treatment to-date;

one patient has gone on to have successful curative surgery.

Changes in KRAS mutation blood levels is the biomarker used in this trial;

decreases to non-detectable in cycle one of treatment is predictive of future tumor regression and response.

Trovagene Announces Expansion of Board of Directors with the Addition of Three Industry Leaders

Data showed median progression-free survival (PFS) of at least 6.5 months with 6 patients continuing on treatment;

one patient went on to have successful curative surgery.

The biomarker used in this trial is changes in KRAS mutation blood levels;

decreases to non-detectable levels in cycle one of treatment is predictive of future tumor regression and response.

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.

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 13, 2020, at the American Society for Clinical Oncology Genitourinary Cancers (ASCO GU) conference, demonstrated the safety and efficacy of onvansertib have been demonstrated in patients.

Overall, 63% (12 of

19) of evaluable patients achieved partial response (PR) or stable disease (SD) following 12 weeks of treatment with onvansertib and Zytiga.

Response to treatment is evaluated based on prostate specific antigen (PSA) values (primary endpoint) and radiographic scans.

Additionally, onvansertib-induced circulating tumor cell (CTC) decrease has been shown to be associated with progression-free survival.

TROV-052 is a Phase 2 Study of onvansertib in combination with standard-of-care chemotherapy 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.

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.

The rationale for this trial is based on the need for new and better therapeutic options for patients in the relapsed or refractory AML setting.

Current treatment options are often limited by the patient’s age and health status.

Combination treatment with onvansertib and standard-of-care chemotherapy may provide a new safe and effective therapeutic option.

Data presented on June 12, 2020 at the European Hematology Association (EHA) conference, demonstrated the safety and efficacy of onvansertib has been demonstrated in patients.

In the completed Phase 1b portion of this trial, the recommended Phase 2 dose (RP2D) was established at onvansertib 60 mg/m 2 .

Onvansertib adverse events were primarily on-target hematological events, in accordance with the mechanism of action, and were reversible and manageable.

Anti-leukemic activity was observed at a wide range of onvansertib dose levels (27 to 90 mg/m 2 ) and the complete response rate achieved in patients was 24% through all dose levels, and 31% at the 4 higher dose levels (27 to 90 mg/m 2 ).

Decreases in mutant ctDNA after 1 cycle of treatment were highly predictive of clinical response and target engagement (biomarker positivity) in circulating blast cells was associated with a greater decrease in bone marrow blast cells.

Phase 2 is enrolling patients and is ongoing.

Key News Release

On June 15, 2020, we announced the presentation of final results of our Phase 1b study, and preliminary positive data from our Phase 2 study.

The data was presented as a virtual poster presentation at the European Hematology Association (EHA) annual conference and highlighted the efficacy, durability of response, favorable safety and tolerability, as well as correlative biomarker data.

Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m 2 ), indicating a large therapeutic window.

Financial and Company Updates

On June 16, 2020, we announced we entered into a securities purchase agreement, jointly led by biotech-focused institutional investors, Acorn Bioventures, LP, and CAM Capital, for aggregate gross proceeds of $13.5 million.

On May 27, 2020, we announced we entered into a definitive securities purchase agreement with biotech-focused institutional investor, Acorn Bioventures, LP, for gross proceeds of $2.5 million.

On May 19, 2020, we announced we entered into a securities purchase agreement with our Board of Directors and Executives for aggregate gross proceeds of $810,000.

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, Ms.

Lâle White and Dr.

Each new Director brings extensive and relevant experience to the Company and will provide valuable perspective and meaningful impact as we enhance value to our shareholders.

Trovagene Announces Acceptance of Phase 1b/2 KRAS-Mutated Metastatic Colorectal Cancer (mCRC) Trial Abstract for Presentation at the 2020 ASCO Annual Meeting

On April 1, 2020, we announced that its Phase 1b/2 clinical trial of onvansertib in combination with standard-of-care FOLFIRI/Avastin® (bevacizumab) for second-line treatment of patients with KRAS-mutated mCRC, will be featured in a presentation at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting to be held from May 29 - June 2, 2020.

Trovagene Presents Phase 2 Data Demonstrating the Ability of Onvansertib to Overcome Zytiga ® -Resistance and Provide Clinical Benefit for mCRPC Patients

On February 13, 2020 Trovagene announced positive data from our ongoing Phase 2 trial of onvansertib in combination with Zytiga® (abiraterone - Johnson & Johnson)/prednisone, all administered orally, for the treatment of patients with Zytiga ® -resistant metastatic castration-resistant prostate cancer (mCRPC).

Data demonstrates efficacy of onvansertib across known androgen receptor resistance mechanisms.

Additionally, onvansertib-induced decreases in circulating tumor cells (CTCs) is a surrogate for efficacy and has been associated with greater progression-free survival in mCRPC patients.

Trovagene Receives Approximately $1.45 Million from Exercise of Warrants

On January 29, 2020, Trovagene announced that it received approximately $1.45 million in proceeds from holders exercising common stock purchase warrants at an exercise price of $1.56 per share.

The warrants were issued as part of the units sold to certain institutional investors in October, 2019.

The Company intends to use the proceeds to continue funding its clinical development activities and for working capital and general corporate purposes.

Additionally, we received two separate individual investments of approximately $1.0 million each in March and April, respectively, for a total of approximately $3.45 million to-date in 2020.

Our accumulated deficit through March 31, 2020 is $212,992,505 .

James Armitage, Dr.

Gary Pace and Ms.

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

Our accumulated deficit through June 30, 2020 is $220,389,581.

To date, we have generated minimal revenues and expect to incur additional losses to perform further research and development activities.

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Off-Balance Sheet Arrangements

We had no off-balance sheet arrangements as of March 31, 2020 .

We had no off-balance sheet arrangements as of June 30, 2020.

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 ITEM 7.

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RESULTS OF OPERATIONS

Three Months Ended March 31, 2020 and 2019

Our total revenues were $67,704 and $62,021 for the three months ended March 31, 2020 and 2019 , respectively.

The components of our revenues were as follows:

Three Months Ended March 31,

Three Months Ended June 30, 2020 and 2019

Our total revenues consisted of the following:

Three Months Ended June 30,

2020 2019 Increase (Decrease)

Royalties $ 42,633 $ 36,852 $ 5,781

Services and other — 1,496 (1,496)

Total revenues $ 42,633 $ 38,348 $ 4,285

The increase in royalty income for the three months ended March 31, 2020 as compared to the prior period is primarily from fluctuations of our sales-based or usage-based royalties on our intellectual property licenses.

The increase in royalty income for the three months ended June 30, 2020 as compared to the prior period is primarily from fluctuations of our sales-based or usage-based royalties on our intellectual property licenses.

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

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Research and development expenses consisted of the following:

Three Months Ended March 31,

Three Months Ended June 30,

2020 2019 Increase (Decrease)

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Total research and development $ 2,475,722 $ 2,830,340 $ (354,618)

Research and development expenses increase d by $57,092 to $2,705,691 for the three months ended March 31, 2020 from $2,648,599 for the same period in 2019 .

The overall increase in research and development expenses was primarily due to costs associated with clinical programs and outside service costs for three ongoing clinical trials related to the development of our lead drug candidate, onvansertib, facilities and other increased primarily due to increased travel and conferences to present data related to our lead drug candidate, onvansertib.

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

Research and development expenses decreased by $354,618 to $2,475,722 for the three months ended June 30, 2020 from $2,830,340 for the same period in 2019.

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

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

Selling, General and Administrative Expenses

Selling, general and administrative expenses consisted of the following:

Three Months Ended March 31,

Three Months Ended June 30,

2020 2019 Increase (Decrease)

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Total selling, general and administrative $ 1,669,227 $ 1,427,967 $ 241,260

Selling, general and administrative expenses increase d by $110,834 to $1,486,019 for the three months ended March 31, 2020 from $1,375,185 for the same period in 2019 .

The significant components of the increase were primarily due to the increase in facilities and other costs, and outside services.

The increase in facilities and other cost was due to an increase in insurance costs for the three months ended March 31, 2020 as compared to the same period of 2019.

Selling, general and administrative expenses increased by $241,260 to $1,669,227 for the three months ended June 30, 2020 from $1,427,967 for the same period in 2019.

The significant components of the increase were primarily due to the increase in stock-based compensation, salaries and staff costs, facilities and other costs, partially offset by a reduction in outside services.

The increase in Stock-based compensation is primarily due to stock options granted in June 2019.

The increase in salaries and staff costs is primarily due to annual increases in salary and promotions.

The increase in facilities and other cost was due to an increase in insurance costs for the three months ended June 30, 2020 as compared to the same period of 2019.

Interest Income

Interest income was $35,823 for the three months ended March 31, 2020 as compared to $64,743 for the same period of 2019 .

The decrease of interest income is primarily due to lower interest rates for three months ended March 31, 2020 as compared to the same period of 2019 .

Interest income was $15,671 for the three months ended June 30, 2020 as compared to $69,761 for the same period of 2019.

The decrease of interest income is primarily due to lower interest rates for three months ended June 30, 2020 as compared to the same period of 2019.

Change in Fair Value of Derivative Financial Instruments — Warrants

We have issued warrants that are accounted for as derivative liabilities.

As of March 31, 2020 , the derivative financial instruments — warrants liabilities were revalued to $2,020 , resulting in a decrease in value of $2,107 from December 31, 2019 , based primarily upon the fluctuation in our stock price as well as the changes in the expected term, volatility, and risk-free interest rates for the expected term.

The decrease in value upon remeasurement at March 31, 2020 was recorded as a gain from the change in fair value of derivative financial instruments — warrants in the condensed statement of operations.

As of June 30, 2020, the derivative financial instruments — warrants liabilities were revalued to $46,164, resulting in an increase in value of $44,144 from March 31, 2020, based primarily upon the fluctuation in our stock price as well as the changes in the expected term, volatility, and risk-free interest rates for the expected term.

The increase in value upon remeasurement at June 30, 2020 was recorded as a loss from the change in fair value of derivative financial instruments — warrants in the condensed statement of operations.

Net loss and per share amounts were as follows:

Three Months Ended March 31,

Three Months Ended June 30,

2020 2019 Increase (Decrease)

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Weighted average shares outstanding — basic and diluted 14,492,159 5,408,124 9,084,035

The $84,478 decrease in net loss attributable to common shareholders was primarily the result of the decrease of $0.3 million attributable to the d eemed dividend recognized on beneficial conversion features of Series C Convertible Preferred Stock issuance occurring during the three months ended March 31, 2019, offset by an increase in operating expenses of $0.2 million for three months ended March 31, 2020 compared to the same period in the prior year.

The $0.61 decrease in basic net loss per share was impacted by the increase in basic weighted average shares outstanding resulting primarily from the issuance of approximately 6.6 million shares of common stock and common stock equivalents from April 1, 2019 through March 31, 2020.

The $3,265,713 increase in net loss attributable to common shareholders was primarily the result of an increase of $3.3 million attributable to the d eemed dividends recognized on beneficial conversion features of convertible preferred stock issuances occurring during the three months ended June 30, 2020, compared to the same period in the prior year.

The $0.25 decrease in basic net loss per share was impacted by the increase in basic weighted average shares outstanding resulting

primarily from the issuance of approximately 15.9 million shares of common stock and common stock equivalents from July 1, 2019 through June 30, 2020.

Six Months Ended June 30, 2020 and 2019

Our total revenues consisted of the following:

Six Months Ended June 30,

2020 2019 Increase (Decrease)

Royalties $ 110,337 $ 98,873 $ 11,464

Services and other — 1,496 (1,496)

Total revenues $ 110,337 $ 100,369 $ 9,968

The increase in revenues for the six months ended June 30, 2020 as compared to the prior period is primarily from fluctuations of our sales-based or usage-based royalties on our intellectual property licenses.

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:

Six Months Ended June 30,

2020 2019 Increase (Decrease)

Salaries and staff costs $ 849,126 $ 783,939 $ 65,187

Stock-based compensation 146,953 196,138 (49,185)

Clinical trials, outside services, and lab supplies 3,782,184 4,062,903 (280,719)

Facilities and other 403,150 435,959 (32,809)

Total research and development $ 5,181,413 $ 5,478,939 $ (297,526)

Research and development expenses decreased by $297,526 to $5,181,413 for the six months ended June 30, 2020 from $5,478,939 for the same period in 2019.

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

Selling, General and Administrative Expenses

Selling, general and administrative expenses consisted of the following:

Six Months Ended June 30,

2020 2019 Increase (Decrease)

Salaries and staff costs $ 1,045,138 $ 981,158 $ 63,980

Stock-based compensation 312,132 152,763 159,369

Outside services and professional fees 979,603 1,034,045 (54,442)

Facilities and other 818,373 635,186 183,187

Total selling, general and administrative $ 3,155,246 $ 2,803,152 $ 352,094

Selling, general and administrative expenses increased by $352,094 to $3,155,246 for the six months ended June 30, 2020 from $2,803,152 for the same period in 2019.

The increase in stock-based compensation is primarily due to stock options granted in June 2019.

The increase in

salaries and staff costs is primarily due to annual salary increases and promotions.

The increase in facilities and other cost was due to an increase in insurance costs for the six months ended June 30, 2020 as compared to the same period of 2019.

Interest Income and Expense

Interest income was $51,494 for the six months ended June 30, 2020 as compared to $134,504 for the same period of 2019.

The decrease of interest income is primarily due to lower interest rates for six months ended June 30, 2020 as compared to the same period of 2019.

Change in Fair Value of Derivative Financial Instruments — Warrants

We have issued warrants that are accounted for as derivative liabilities.

As of June 30, 2020, the derivative financial instruments — warrants liabilities were revalued to $46,164, resulting in an increase in value of $42,037 from December 31, 2019, based primarily upon the fluctuation in our stock price as well as the changes in the expected term, volatility, and risk-free interest rates for the expected term.

Net loss and per share amounts were as follows:

Six Months Ended June 30,

2020 2019 Increase (Decrease)

Net loss attributable to common shareholders $ (11,491,698) $ (8,310,463) $ 3,181,235

Net loss per common share — basic and diluted $ (0.94) $ (1.75) $ (0.81)

Weighted average shares outstanding — basic and diluted 12,201,232 4,750,993 7,450,239

The $3,181,235 increase in net loss attributable to common shareholders was primarily the result of an increase of $3.0 million attributable to the d eemed dividends recognized on beneficial conversion features of convertible preferred stock issuances, an increase in the loss recorded from the change in fair value of derivative financial instruments and a decrease in interest income, for the six months ended June 30, 2020 compared to the same period in the prior year.

The $0.81 decrease in basic net loss per share was impacted by the increase in basic weighted average shares outstanding resulting primarily from the issuance of approximately 15.9 million shares of common stock and common stock equivalents from July 1, 2019 through June 30, 2020.

LIQUIDITY AND CAPITAL RESOURCES

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

The extent of the impact of COVID-19 on the 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 the Company's ability to raise additional capital.

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 financial condition or results of operations is uncertain.

As of March 31, 2020 , we had $9,277,025 in cash and cash equivalents.

Net cash used in operating activities for the three months ended March 31, 2020 was $3,374,637 , compared to $3,360,046 for the three months ended March 31, 2019 .

Our use of cash was primarily a result of the net loss of $4,088,562 for the three months ended March 31, 2020 , adjusted for non-cash items related to release of clinical trial funding commitment of $293,017 stock-based compensation of $177,309 , and depreciation and amortization of $119,320 .

The net change in our operating assets and liabilities was $126,386 offsetting cash used in operations.

As of June 30, 2020, we had $27,754,813 in cash and cash equivalents.

Net cash used in operating activities for the six months ended June 30, 2020 was $7,665,787, compared to $6,803,159 for the six months ended June 30, 2019.

Our use of cash was primarily a result of the net loss of $8,213,094 for the six months ended June 30, 2020, adjusted for non-cash items related to release of clinical trial funding commitment of $506,509, stock-based compensation of $459,085, and depreciation and amortization of $233,909.

The net change in our operating assets and liabilities was $728,402 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 in investing activities was $0 during the three months ended March 31, 2020 , compared to $5,274 for the same period in 2019 , which were for capital expenditures in the prior period.

Net cash provided in financing activities was $2,456,370 during the three months ended March 31, 2020 , compared to $3,242,266 for the same period in 2019 .

Net cash provided in financing activities during the three months ended March 31, 2020 was primarily from $1.5 million of proceeds from the exercise of warrants and $1.0 million from the sale of common stock and warrants.

Net cash provided in financing activities during the three months ended March 31, 2019 was primarily from $3.3 million of proceeds from the exercise of warrants.

As of March 31, 2020 , and December 31, 2019 , we had working capital of $5,401,608 and $6,571,985 , respectively.

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 the fourth 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.

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.

To date, our sources of cash have been primarily limited to the sale of equity securities.

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

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

If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of one or more product candidates, all of which may have a material adverse impact on our operations.

We may also be required to (i) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available;

or (ii) relinquish or otherwise dispose of rights to technologies, product candidates or products that we would otherwise seek to develop or commercialize ourselves on unfavorable terms.

We are evaluating all options to raise additional capital, increase revenue, as well as reduce costs, in an effort to strengthen our liquidity position, which may include the following:

(1) Raising capital through public and private equity offerings;

(2) Introducing operation and business development initiatives to bring in new revenue streams;

(3) Reducing operating costs by identifying internal synergies;

or (4) Engaging in strategic partnerships.

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

Net cash used in investing activities was $0 during the six months ended June 30, 2020, compared to $5,274 for the same period in 2019, which were for capital expenditures in the prior period.

Net cash provided in financing activities was $25,225,308 during the six months ended June 30, 2020, compared to $6,146,570 for the same period in 2019.

Net cash provided in financing activities during the six months ended June 30, 2020 was primarily from $18.8 million of proceeds from the sale of common stock, preferred stock and warrants and from $6.1

million of proceeds from the exercise of warrants.

Net cash provided in financing activities during the six months ended June 30, 2019 was primarily from $3.3 million of proceeds from the exercise of warrants and $2.9 million from the sale of common stock and warrants.

As of June 30, 2020, and December 31, 2019, we had working capital of $23,857,104 and $6,571,985, respectively.

The Company has incurred net losses since its inception and has negative operating cash flows.

As of June 30, 2020, the Company had $27.8 million in cash and cash equivalents and believes it has sufficient cash to meet its funding requirements for at least the next 12 months following the issuance date of these financial statements.

For the foreseeable future, the Company expects to continue to incur losses and require additional capital to further advance its clinical trial programs and support its other operations.

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

To the extent that the Company can raise additional funds by issuing equity securities, the Company’s stockholders may experience additional dilution.

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

Controlled Equity Offerings and Public Offerings

On March 30, 2020, we entered into a Securities Purchase Agreement with Lincoln Park Capital Fund, LLC (“LPC”), pursuant to which we agreed to offer, issue and sell to LPC, (i) in a registered direct offering, an aggregate of (a) 800,000 shares of common stock and (b) Series I warrants to purchase up to 131,967 shares (the “Series I Warrant Shares”) of our common stock.

In a concurrent private placement, we also sold to LPC Series J warrants (the “Series J Warrants”) to purchase one share of our common stock for each Share and for each Series I Warrant purchased for cash in the registered direct offering.

The Series J Warrants are exercisable six months following the date of issuance at an exercise price of $0.948 per share and will expire 5.5 years following the date of issuance.

On April 9, 2020, we entered into a Securities Purchase Agreement with LPC, pursuant to which we agreed to offer, issue and sell to LPC, (i) in a registered direct offering, an aggregate of (a) 904,970 shares of common stock and (b) Series K warrants to purchase up to 255,000 shares (the “Series K Warrant Shares”) of our common stock.

In a concurrent private placement, we also sold to LPC Series L warrants (the “Series L Warrants”) to purchase one share of our Common Stock for each Share and for each Series K Warrant purchased for cash in the registered direct offering.

The Series L Warrants are exercisable six months following the date of issuance at an exercise price of $0.81 per share and will expire 5.5 years following the date of issuance.

On May 8, 2020, we entered into a Stock and Warrant Subscription Agreement (the “SPA”) with PoC Capital, LLC (“PoC”) pursuant to which we issued to PoC at an aggregate issue price of $2,300,000, (i) 602,833 shares of our common stock, (ii) 154,670 shares of our Series D Preferred Stock and (iii) warrants (the “Warrants”) exercisable for 859,813 shares of our common stock, in exchange for PoC funding clinical development of onvansertib, our first-in-class, 3rd generation oral and highly selective PLK1 inhibitor in a Phase 1b/2 clinical trial in patients with metastatic colorectal cancer pursuant to a Master Services Agreement dated as of January 25, 2019 by and among us, Integrium, LLC and PoC, as amended.

The Warrants are exercisable six months following the date of issuance at an exercise price of $1.50 per share and will expire 5.5 years following the date of issuance.

On May 11, 2020 and May 14, 2020, we entered into Securities Purchase Agreements with certain of our directors and executives pursuant to which we sold 447,761 shares of common stock at a purchase price of $1.34 per share and 146,854 shares of common stock at a purchase price of $1.43 per share.

On May 26, 2020, we entered into a Securities Purchase Agreement with Acorn Bioventures, LP (“Acorn”), pursuant to which we agreed to offer, issue and sell to Acorn, (i) in a registered direct offering, an aggregate of 1,205,400 shares of common stock, par value $0.0001 per share and (ii) in a concurrent private placement, Series M warrants to purchase up to 482,160 shares of common stock.

The Series M Warrants are exercisable six months following the date of issuance at an exercise price of $2.024 per share and will expire 5.5 years following the date of issuance.

On June 15, 2020 we entered into a Securities Purchase Agreement with Acorn, CDK Associates, L.L.C.

(“CDK”) and Third Street Holdings LLC (“Third Street”), pursuant to which we agreed to offer, issue and sell to Acorn, CDK and Third Street, (i) in a registered direct offering, an aggregate of 1,984,328 shares of common stock and (ii) in a concurrent private placement, (a) an aggregate of 865,824 shares of Series E Preferred Stock (“Series E Preferred Stock”) and (b) Series N warrants to purchase up to 2,213,115 shares of common stock.

The Series E Preferred Stock is convertible at any time determined by dividing the $10 stated value per share of the Series E Preferred Stock by a conversion price of $2.44 per share,

subject to adjustment in accordance with the Certificate of Designation.

The Series N Warrants are exercisable six months following the date of issuance at an exercise price of $2.39 per share and will expire 5.5 years following the date of issuance.

In conjunction with the June 15, 2020 offering, we issued 184,426 warrants as an advisory fee.

These warrants are exercisable six months following the date of issuance at an exercise price of $3.05 per share and will expire 5.5 years following the date of issuance.

CONTRACTUAL OBLIGATIONS

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Commitments and Contingencies , and (ii) Item 7 Management Discussion and Analysis of Financial Condition and Results of Operations — Contractual Obligations and Commitments , included in our Annual Report on Form 10-K as of December 31, 2019.

There have been no material changes to our contractual oblications in our Form 10-K for the year ended December 31, 2019 , except for the following.

There have been no material changes to our contractual obligations in our Form 10-K for the year ended December 31, 2019, except for the following.

Small Business Administration Payroll Protection Program Loan

On April 15, 2020, the Company was granted a loan (the “Loan”) from JPMorgan Chase Bank, N.A.

On April 15, 2020, we were granted a loan (the “Loan”) from JPMorgan Chase Bank, N.A.

in the aggregate amount of $305,000, pursuant to the Paycheck Protection Program (the “PPP”) under Division A, Title I of the CARES Act, which was enacted March 27, 2020.

The Loan, which was in the form of a Note dated April 15, 2020 issued by the Company, matures on April 15, 2022 and bears interest at a rate of 0.98% per annum, payable monthly commencing on November 15, 2020.

The Loan, which was in the form of a Note dated April 15, 2020 issued by us, matures on April 15, 2022 and bears interest at a rate of 0.98% per annum, payable monthly commencing on April 15, 2021.

The Note may be prepaid by the Company at any time prior to maturity with no prepayment penalties.

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Under the terms of the PPP, certain amounts of the Loan may be forgiven if they are used for qualifying expenses as described in the CARES Act.

The application for these funds required the Company to, in good faith, certify that the current economic uncertainty made the loan request necessary to support the ongoing operations of the Company.

This certification further required the Company to take into account our current business activity and our ability to access other sources of liquidity sufficient to support ongoing operations in a manner that is not significantly detrimental to the business.

The certification made by the Company did not contain any objective criteria and is subject to interpretation.

If, despite the good-faith belief that given the Company’s circumstances all eligibility requirements for the PPP were satisfied, it is later determined that the Company had violated any applicable laws or regulations or it is otherwise determined the Company was ineligible to receive the PPP, it may be required to repay the PPP in its entirety and/or be subject to additional penalties.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

1 unchanged sentence

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