On February 27, 2020 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company developing drugs that target cell division (mitosis) for the treatment of various cancers including prostate, colorectal and leukemia, reported company highlights and financial results for the fourth quarter and full-year ended December 31, 2019 (Press release, Trovagene, FEB 27, 2020, View Source [SID1234554905]). The company is issuing this press release in lieu of conducting a conference calll.
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"We continue to advance the clinical development of onvansertib, our first-in-class, third-generation, oral and highly selective Polo-like Kinase 1 (PLK1) inhibitor, including very encouraging to-date results from our Phase 1b/2 trial in KRAS-mutated metastatic colorectal cancer (mCRC)," said Dr. Thomas Adams, Chief Executive Officer and Chairman of Trovagene. "Regardless of the specific KRAS mutation, we are seeing quantitative decreases in the mutational burden of this once considered ‘undruggable’ mutation and confirmation of the activity of onvansertib by radiographic scans showing tumor regression in all treated patients. Additionally, in our Phase 2 study in metastatic castration-resistant prostate cancer (mCRPC), onvansertib is demonstrating its ability to overcome resistance in patients treated first-line with androgen-receptor signaling inhibitor, Zytiga. Data presented earlier this month at ASCO (Free ASCO Whitepaper)-GU show both efficacy and durability of response to treatment when onvansertib is added to daily Zytiga therapy. Notably, several patients currently on treatment have had progression-free survival of greater than seven months. Enrollment is also on track in our Phase 2 study of onvansertib in patients with acute myeloid leukemia (AML). We continue to see efficacy in this difficult-to-treat, relapsed/refractory patient population, including in patients who have relapsed following initial treatment with venetoclax, a scenario with limited treatment options and a great need for new targeted therapeutics."
The Company has advanced its business in the fourth quarter of 2019, and to-date in 2020, with the following activities and milestone achievements:
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 demonstrates the efficacy of onvansertib in Zytiga-resistant mCRPC across known androgen receptor resistance mechanisms. Additionally, onvansertib-induced decreases in circulating tumor cells (CTCs) is a surrogate for efficacy and associated with greater progression-free survival in mCRPC patients.
Announced data demonstrating the effectiveness of onvansertib as a pan-KRAS inhibitor with confirmed tumor regression and clinical benefit achieved in KRAS-mutated mCRC patients
On January 27, 2020, we announced the presentation of data from our ongoing Phase 1b/2 trial of onvansertib in combination with FOLFIRI/Avastin in patients with KRAS-muted mCRC. All patients treated showed tumor regression by radiographic scan at 8 weeks and confirmation by further tumor shrinkage at 16 weeks, with clinical benefit achieved in 100% of patients. Tumor regression occurred across all major KRAS mutations associated with mCRC, an indication of onvansertib’s pan-KRAS inhibitory effect; three patients had greater than 25% tumor shrinkage. One patient is proceeding to curative surgery, which is considered to be unprecedented in this patient population, in which there has been only a 5% response rate to standard-of-care therapy.
Announced positive data presented in an oral session at the American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") conference demonstrating efficacy, durability of response and safety of onvansertib in completed Phase 1b trial in AML
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 AML, in an oral session at ASH (Free ASH Whitepaper). Efficacy was observed in patients treated at onvansertib doses ranging from 27 to 90 mg/m2, with a complete response (CR) and CR with incomplete count recovery (Cri) rate of 31% (5 out of 16) of 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) of 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 AML
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 mCRPC
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 data presented at ESMO (Free ESMO Whitepaper) 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 (Free ESMO Whitepaper) demonstrating significant tumor regression observed with onvansertib in combination with standard-of-care paclitaxel in models of p53-mutated TNBC. Onvansertib’s 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 needs to provide targeted treatment options to overcome resistance to paclitaxel as a single agent therapy in TNBC.
Fourth Quarter 2019 Financial Results
Total operating expenses were approximately $4.4 million for the three months ended December 31, 2019, an increase of $0.2 million from $4.2 million for the same period in 2018. The increase in operating expenses is attributed to advancing the onvansertib clinical development programs.
Net cash used in operating activities in the fourth quarter of 2019 was $3.3 million, compared to $3.6 million in the fourth quarter of 2018. The quarter-over-quarter decrease of $0.3 million can be attributed primarily to a favorable change in assets and liabilities offset by increased expenses pertaining to the clinical development of onvansertib.
Research and development expenses increased by approximately $0.4 million to $2.9 million for the three months ended December 31, 2019 from $2.5 million for the same period in 2018. The overall increase in research and development expenses was primarily due to the increased outside service costs for 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 the onvansertib clinical development programs in mCRC, mCRPC and AML.
Selling, general and administrative expenses decreased by approximately $0.2 million to $1.5 million for the three months ended December 31, 2019 from $1.7 million for the same period in 2018. The reduction is primarily due to a decrease in outside services and professional fees.
The weighted average basic and diluted shares of common stock outstanding used to calculate per share results for the three months ended December 31, 2019 was 8.3 million.
As of December 31, 2019, Trovagene had approximately $10.2 million of cash and cash equivalents.