On August 8, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage Precision Cancer Medicine company, developing drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, reported company highlights and financial results for the second quarter ended June 30, 2019 (Press release, Trovagene, AUG 8, 2019, View Source [SID1234538549]). The company is issuing this press release in lieu of conducting a conference call.
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"We continue to make great progress with our clinical development of onvansertib with three clinical trials actively enrolling patients and advancing as planned," said Dr. Thomas Adams, Chief Executive Officer and Chairman of Trovagene. "We initiated enrollment in our third study, a Phase 1b/2 clinical trial in metastatic Colorectal Cancer (mCRC) at USC Morris Comprehensive Cancer Center and the Mayo Clinic, and look forward to providing preliminary safety and efficacy readouts later this year. Additionally, we recently announced the acceptance of three abstracts for presentation at ESMO (Free ESMO Whitepaper) in September, including our AML clinical trial for an oral presentation. We believe this is an indication of the level of interest in, and potential value of onvansertib in the evolving cancer treatment landscape across a number of different cancer types."
Dr. Adams added, "We achieved a number of key milestones in the second quarter of 2019, including: preclinical data demonstrating significant synergy of onvansertib in combination with venetoclax (Venclexta – AbbVie), the emerging first-line standard of care in AML; updates to our Phase1b/2 AML trial showing patients achieving a complete response (CR and CRi) to treatment with onvansertib in combination with decitabine; early data from our Phase 2 study of onvansertib in combination with Zytiga in patients with mCRPC demonstrating response to treatment and the first patient to achieve the primary efficacy endpoint of disease stabilization; and our research collaboration with Nektar Therapeutics to evaluate the combination of onvansertib and Nektar’s pegylated irinotecan, Onzeald, in models of CRC."
The Company has advanced its business, with the following recent activities and milestone achievements:
Clinical Development:
Announced ESMO (Free ESMO Whitepaper) Accepts Trovagene AML Clinical Trial Abstract for Oral Presentation
On July 22, 2019, Trovagene announced the acceptance of three abstracts for presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference in Barcelona on September 27 to October 1, 2019. The abstract accepted for an oral presentation (Abstract #2411), "Polo-like Kinase Inhibitor, Onvansertib, in Combination with Low-Dose Cytarabine or Decitabine in Patients with Relapsed/Refractory Acute Myeloid Leukemia in Phase 1b," will be presented by Amer Zeidan, MBBS, MHS, Yale University, and will feature safety and preliminary efficacy data, including patients who achieved a complete response, as well as biomarker data and correlation with treatment response.
Announced Initiation of Enrollment for Phase 1b/2 Clinical Trial in KRAS-Mutated Colorectal Cancer at Leading Cancer Centers
On July 9, 2019, Trovagene announced the initiation of patient enrollment of its Phase 1b/2 study of onvansertib in combination with FOLFIRI and Avastin (bevacizumab) for second-line treatment of patients with metastatic colorectal cancer (mCRC) with a KRAS mutation (NCT03829410). The trial is being conducted at USC Norris Comprehensive Cancer Center, Hoag Cancer Center and The Mayo Clinic, under the leadership of recognized colorectal cancer key opinion leaders, Heinz-Josef Lenz, MD, FACP, Section Head of GI Oncology and Co-Director of the Colorectal Center at USC Norris, and Afsaneh Barzi, MD, PhD, oncologist at USC Norris and principal investigator of the trial.
Announced Research Collaboration with Nektar Therapeutics to Evaluate Efficacy of the Combination of Onvansertib and ONZEALD in Models of Colorectal Cancer
On May 23, 2019, Trovagene announced that it had entered into a research collaboration to explore the combination of Trovagene’s PLK1 inhibitor, onvansertib, and Nektar’s topoisomerase I inhibitor, ONZEALD, for the treatment of metastatic colorectal cancer (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, Trovagene announced preclinical data that provides support for clinical evaluation of onvansertib in combination with venetoclax (Venclexta – AbbVie) in patients with difficult-to-treat relapsed or refractory acute myeloid leukemia (AML). Preclinical data showed that the 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.
Announced Update to Phase 1b/2 AML Trial Data Presented at AACR (Free AACR Whitepaper) – Additional Patients Achieve Complete Response at Two Highest Dose Levels of Onvansertib
On April 5, 2019, Trovagene announced updates to the Phase1b/2 AML trial data presented at the AACR (Free AACR Whitepaper) conference on April 1, 2019. Complete response (2 CRs and 1 CRi) to treatment with onvansertib in combination with decitabine was achieved in 3 of 6 (50%) evaluable patients at the highest doses (27mg/m2 and 40mg/m2). The first complete response was achieved at the highest dose of onvansertib (40mg/m2) in combination with low-dose cytarabine (LDAC). Overall, approximately a 90% clinical benefit rate has been achieved to-date in the trial and there have been no dose limiting toxicities observed. Dose escalation is continuing with enrollment in the onvansertib 60mg/m2 cohort.
Announced Early Data from Phase 2 Trial Indicates Activity of Onvansertib in Prostate Cancer Patients Showing Initial Resistance to Anti-Androgen Therapy
On April 2, 2019, Trovagene announced early data from its ongoing Phase 2 study evaluating onvansertib in combination with Zytiga in patients with mCRPC. Early prostate specific antigen ("PSA") response was observed when onvansertib is added to abiraterone (Zytiga) in 2 of 6 patients to-date; the first patient achieved the primary efficacy endpoint of disease stabilization. The PSA trajectory in the patient achieving the primary efficacy endpoint indicates alteration of the natural history of early signs of resistance to Zytiga. Patients with observed responses to-date harbor the highly aggressive androgen receptor variant (AR-V7) which is known to be resistant to treatment with Zytiga.
Announced Phase 1b/2 Dose Escalation Trial of Onvansertib in Relapsed/Refractory AML Demonstrates Safety, Tolerability and Relative Durability with Complete Responses at Highest Dose Levels
On April 1, 2019, Trovagene announced the presentation of new data from its ongoing Phase 1b/2 study evaluating onvansertib in combination with standard-of-care chemotherapy in AML. The greatest anti-leukemic activity has been observed in the onvansertib + decitabine arm, with complete response in 2 (1 CR and 1 CRi) of 4 (50%) evaluable patients from the two highest dose levels. There have been no dose-limiting toxicities observed to-date and two-thirds of patients have completed ≥2 cycles of treatment, with 2 patients currently on treatment for more than 11 and 5 months, respectively. There has been a significant association observed between biomarker-positive patients and response to onvansertib treatment.
Financial:
Announced Equity Investments of $3.0 Million at Premium to Market Price from Institutional Investor, Lincoln Park Capital
On April 5 and May 13, 2019, respectively, Trovagene announced that it has entered into definitive purchase agreements with Lincoln Park Capital Fund, LLC ("Lincoln Park") an existing institutional investor, in which Lincoln Park agreed to purchase in a registered direct offering shares of common stock and pre-funded warrants at a premium to the closing sale price on April 5 and May 10, 2019, respectively, on the Nasdaq Capital Market. In a concurrent private placement, Lincoln Park agreed to purchase warrants to purchase shares of common stock.
Second Quarter 2019 Financial Results
Total operating expenses were approximately $4.4 million for the three months ended June 30, 2019, a decrease of $0.2 million from $4.6 million for the same period in 2018. The decrease in operating expenses is attributed to a reduction of $0.6 million in SG&A, $0.2 million for cost of revenues related to the disposition of the CLIA lab and $0.2 million restructuring, and partially offset by an increase of $0.9 million in R&D costs.
Net cash used in operating activities in the second quarter of 2019 was approximately $3.4 million, compared to $3.3 million in the same period in 2018. The year-over-year increase of $0.1 million can be attributed primarily to the development of onvansertib as we advance our clinical trials, and partially offset by lower salaries and staff costs.
Research and development expenses increased by approximately $0.9 million to $2.8 million for the three months ended June 30, 2019 from $1.9 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 clinical studies related to the development of our drug candidate, onvansertib. We expect increases in research and development costs as we advance the onvansertib clinical development programs in AML, mCRPC and mCRC.
Selling, general and administrative expenses decreased by approximately $0.6 million to $1.5 million for the three months ended June 30, 2019 from $2.1 million for the same period in 2018. The significant components of the decrease were primarily due to the reduction in salaries and staff costs and stock-based compensation.
The weighted average diluted shares of common stock outstanding used to calculate per share results for the three months ended June 30, 2019 was 5.2 million shares.
As of June 30, 2019, Trovagene had approximately $10.8 million of cash and cash equivalents.