"We are pleased with the promising data we are seeing in all three of our ongoing clinical programs and the continued support from our clinical trial sites and investigators," said Dr. Thomas Adams, Executive Chairman of Trovagene. "We began the year with an update from our trial in KRAS-mutated metastatic colorectal cancer (mCRC) at the ASCO-GI conference, and most recently presented new data from this trial in an oral presentation at the American Association for Clinical Research (AACR) annual meeting, demonstrating consistent tumor shrinkage, across KRAS mutations, and progression-free survival exceeding that of current standard-of-care. Treatment with onvansertib has been so successful in KRAS-mutated mCRC, an indication which until now had a response rate of only 4% and a very poor prognosis, that one of the patients in our trial went on to have successful curative surgery, an unlikely event in this patient population. We also continue to see the safety and efficacy of onvansertib in our two Phase 2 trials; Zytiga-resistant castration-resistant prostate cancer (mCRPC) and relapsed/refractory acute myeloid leukemia (AML), with additional data readouts from all three trials anticipated throughout 2020."
The Company has advanced its business to-date in 2020, with the following activities and milestone achievements:
Announced company name change from Trovagene, Inc. to Cardiff Oncology, Inc. and appointment of Mark Erlander, PhD, as Chief Executive Officer, with an effective date of Friday, May 8, 2020
On May 6, 2020, we announced a change in our Company name change from Trovagene, Inc. to Cardiff Oncology, Inc., and a change in leadership with Mark Erlander, PhD, 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 the Company's mission and commitment to turning the tide on cancer by advancing the development of onvansertib, our first-in-class, third-generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, across multiple cancer types. Our company name and leadership changes 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.
Announced presentation of data from clinical trial in KRAS-mutated metastatic colorectal cancer demonstrating consistent tumor regression across KRAS mutation subtypes and durable response
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). The data were featured in a virtual oral presentation, delivered by Dr. Afsaneh Barzi, at the American Association for Cancer Research (AACR) conference on Monday, April 27, 2020. The ongoing Phase 1b/2 trial has enrolled 12 patients with 88% response in 7 of 8 evaluable patients to-date: 3 patients exhibiting a partial response (PR), and 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, and one patient having gone on to successful curative surgery. The level of KRAS mutations in blood during treatment is the biomarker used in this trial, with a decrease to non-detectable level in cycle one of treatment being predictive of future tumor regression and response.
Announced expansion of Board of Directors with the addition of three industry leaders
On April 22, 2020, we announced the election of three new independent Directors to our Board of Directors; Dr. James Armitage, Ms. Lâle White and Dr. Gary Pace. 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.
Announced presentation of Phase 2 data demonstrating the ability of onvansertib to overcome Zytiga-resistance and provide clinical benefit for mCRPC patients
On February 13, 2020, we announced the presentation of positive data from our ongoing Phase 2 trial of onvansertib in combination with Zytiga for the treatment of patients with Zytiga-resistant mCRPC. The data demonstrated the efficacy of onvansertib in Zytiga-resistant mCRPC across known androgen receptor resistance mechanisms. Additionally, the appearance of an onvansertib-induced decrease in circulating tumor cells (CTCs) was established as a surrogate for efficacy, and was associated with greater progression-free survival in mCRPC patients.
Announced that Trovagene received approximately $1.45 million from exercise of warrants
On January 29, 2020, we announced that the Company 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. 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.
First Quarter 2020 Financial Results
Total operating expenses were approximately $4.2 million for the three months ended March 31, 2020, an increase of $0.2 million from $4.0 million for the same period in 2019. The increase in operating expenses is attributed to advancing the onvansertib clinical development programs.
Net cash used in operating activities in the first quarter of 2020 and the first quarter of 2019 was $3.4 million.
Research and development expenses increased by approximately $0.1 million to $2.7 million for the three months ended March 31, 2020 from $2.6 million for the same period in 2019. The increase in research and development expenses was primarily due to costs associated with advancing clinical studies related to the development of our drug candidate, onvansertib. We expect increases in research and development costs to continue as we advance our onvansertib clinical development programs in mCRC, mCRPC and AML.
Selling, general and administrative expenses increased by approximately $0.1 million to $1.5 million for the three months ended March 31, 2020 from $1.4 million for the same period in 2019. The increase is primarily due to an increase in facilities and other costs, and outside services.
The weighted average basic and diluted shares of common stock outstanding used to calculate per share results for the three months ended March 31, 2020 was 9.9 million.
As of March 31, 2020, Trovagene had approximately $9.3 million of cash and cash equivalents.
About Trovagene, Inc.
Trovagene is a clinical-stage biotechnology company with the singular mission of developing new treatment options for cancer patients in indications with the greatest medical need. Our goal is to overcome resistance, improve response to treatment 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 have three ongoing clinical programs that are demonstrating the safety and efficacy of onvansertib: a Phase 1b/2 study of onvansertib in combination with FOLFIRI/Avastin in KRAS-mutated metastatic colorectal cancer (mCRC); a Phase 2 study of onvansertib in combination with Zytiga (abiraterone)/prednisone in Zytiga-resistant metastatic castration-resistant prostate cancer (mCRPC); and a Phase 2 study of onvansertib in combination with decitabine in relapsed or refractory acute myeloid leukemia (AML). For more information, please visit https://www.trovageneoncology.com.
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