On August 3, 2018 Trovagene, Inc. (NASDAQ: TROV), a clinical-stage oncology therapeutics company, developing targeted therapeutics for the treatment of leukemias, lymphomas and solid tumor cancers, reported company highlights and financial results for the second quarter ended June 30, 2018 (Press release, Trovagene,AUG 3, 2018, View Source [SID1234528423]). The company is issuing this press release in lieu of conducting a conference call.

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Trovagene is a clinical-stage oncology therapeutics company, developing targeted therapeutics for the treatment of solid tumor cancers and leukemias/lymphomas.

"We are continuing to advance our clinical development of PCM-075 in Acute Myeloid Leukemia (AML) and metastatic Castration-Resistant Prostate Cancer (mCRPC), achieving several key milestones during the second quarter," said Tom Adams, Executive Chairman of Trovagene. "In our AML trial, we have successfully completed treatment of 10 patients with PCM-075, 6 at the first dose level of 12 mg/m2 and 4 at the second dose level of 18 mg/m2, in combination with either low-dose cytarabine (LDAC) or decitabine. I’m also pleased to report that we received Investigational Review Board (IRB) approval for our Phase 2 trial of PCM-075 in combination with abiraterone acetate (Zytiga) in patients with mCRPC from the Harvard Medical Cancer Centers and patient recruitment is underway."

During the second quarter of 2018 the Company has advanced its business with the following activities:

Announced Preliminary Clinical Data from First Dosing Cohort Demonstrating Durable Treatment Effect of PCM-075 in Combination with Cytarabine or Decitabine in Patients with Relapsed or Refractory AML
On June 27, 2018, Trovagene announced preliminary clinical data from the first dosing cohort showing a treatment effect with PCM-075 in combination with low-dose cytarabine (LDAC) or decitabine, as measured by decreases in leukemic cells in both peripheral blood and bone marrow in patients in its ongoing Phase 1b/2 trial in relapsed or refractory Acute Myeloid Leukemia (AML). Both blood and bone marrow samples were obtained from patients with relapsed or refractory AML enrolled in the Phase 1b/2 trial prior to, and at timepoints following administration of PCM-075, in combination with cytarabine or decitabine. Among the 6 patients evaluated, no dose-limiting toxicities (DLTs) were observed that would prohibit further escalation of the PCM-075 dosing. Three patients exhibited substantial reductions in the percentage of both circulating leukemic cells within the blood and leukemic cells within the bone marrow. Two of these three patients continued on treatment in the second cycle and further decreases in circulating leukemic cells in the blood and within the bone marrow were observed. One patient had a decrease in his bone marrow blasts from 96% to 40% at the end of cycle 2 and has continued on treatment in cycle 3.
Announced the Start of Recruitment and Enrollment for Phase 2 Clinical Trial of PCM-075 in Combination with Zytiga in Patients with mCRPC
On June 21, 2018, Trovagene announced it has received Institutional Review Board (IRB) approval from Dana-Farber/Harvard Cancer Center and its Phase 2 clinical trial of PCM-075 in combination with Zytiga (abiraterone acetate) and prednisone in mCRPC is officially activated and recruiting patients. The trial is being conducted by Beth Israel Deaconess Medical Center (BIDMC), Dana-Farber Cancer Institute (Dana-Farber), and Massachusetts General Hospital Cancer Center (MGH). David Einstein, MD, Genitourinary Oncology Program at BIDMC, is the principal investigator for the trial.
Announced Completion of First Dosing Cohort of Patients Treated with PCM-075 in Combination with Decitabine in Ongoing Phase 1b/2 AML trial
On June 15, 2018, Trovagene announced completion of the first dose cohort of PCM-075 in combination with decitabine, in its Phase 1b/2 clinical trial in patients with AML. Three patients were treated with PCM-075 at 12 mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with decitabine. The combination of PCM-075 and decitabine was well tolerated in all patients. The independent Safety Review Committee (SRC) has recommended escalating to the second dose cohort of three patients at 18 mg/m2 of PCM-075 (approximately a 50% increase) in combination with decitabine.
Announced Completion of First Dosing Cohort of Patients in Ongoing Phase 1b/2 AML trial of PCM-075 in Acute Myeloid Leukemia
On May 17, 2018, Trovagene announced the completion of the first dose cohort in its Phase 1b/2 clinical trial of PCM-075 in combination with LDAC, in AML. Three patients were treated with PCM-075 at 12 mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with LDAC. Patients eligible for Phase 1b have relapsed or refractory disease and may have received as many as three prior regimens for treatment of their AML. The combination of PCM-075 and LDAC was well tolerated in all patients. The independent Safety Review Committee (SRC) has recommended escalating to the second dose cohort of three patients at PCM-075 at 18 mg/m2 (approximately a 50% increase) in combination with LDAC.
Announced Presentation of Data at AACR (Free AACR Whitepaper) Meeting 2018 on Pharmacodynamic and Tumor Biomarkers During Treatment with PCM-075 and Low-Dose Cytarabine
On April 17, 2018, Trovagene announced the presentation of pharmacodynamic and biomarker data from the first patient to complete a safety treatment cycle in its Phase 1b/2 clinical trial of PCM-075 in AML at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL. The poster entitled Pharmacodynamic and Tumor Biomarker Analysis of a PLK1 Inhibitor, PCM-075, in a Phase 1b/2 Trial for Acute Myeloid Leukemia presents the methodology developed to track dynamic changes in blood leukemic cells, genomic alterations and PLK1 inhibition in AML patients treated with PCM-075 in combination with LDAC.
Announced Presentation of data at AACR (Free AACR Whitepaper) Meeting 2018 Showing Synergy of PCM-075 in Combination with FLT3 Inhibitors in Acute Myeloid Leukemia (AML)
On April 16, 2018, Trovagene announced the presentation of data showing that PCM-075 exhibits synergistic activity when combined with FLT3 inhibitors in a human xenograft AML model, at the AACR (Free AACR Whitepaper) Annual Meeting in Chicago, IL. The poster entitled Selective Polo-like Kinase 1 (PLK1) Inhibitor PCM-075 is Highly Active Alone and Shows Synergy When Combined with FLT3 Inhibitors in Models of Acute Myeloid Leukemia (AML) presents data demonstrating that PCM-075 in combination with quizartinib (Daiichi-Sankyo) resulted in 97.3% tumor growth inhibition (TGI), compared to 77.9% with quizartinib and 80.2% with PCM-075 as monotherapy.
Second Quarter 2018 Financial Results

Trovagene received gross proceeds of approximately $18.0 million from the sale of 9,140,000 shares of its common stock, 20,700,000 shares of warrants, and 8,600 shares of Series B Convertible Preferred Stock through an underwritten public offering that closed on June 12, 2018.
Trovagene reported a net loss of $3.7 million and a net loss of $6.5 million attributable to common shareholders, or $0.88 per diluted share in the second quarter of 2018, as compared to a net loss of $8.0 million and a net loss of $8.1 million attributable to common shareholders, or $3.12 per diluted share for the same quarter of 2017. The Company recorded a $2.8 million one-time, non-cash deemed dividend related to the beneficial conversion feature arising from the issuance of Series B Convertible Preferred Stock. Adjusted net loss per common share (non-GAAP) was $0.44 in the second quarter of 2018, as compared to adjusted net loss per common share (non-GAAP) of $3.12 for the same quarter of 2017. There will be no need to account for any subsequent, similar one-time, non-cash deemed dividends for Series B Convertible Preferred Stock issued in the June public offering.
Total operating expenses were approximately $4.6 million for the three months ended June 30, 2018, a reduction of $1.4 million from $6.0 million for the same period in 2017. The decrease in cash used in operating activities is attributed to having completed the transition from diagnostics to therapeutics and primary focus on advancing development of PCM-075.
Net cash used in operating activities in the second quarter of 2018 was $3.3 million, compared to $4.6 million in the second quarter of 2017. The year-over-year reduction of $1.3 million can be attributed primarily to the elimination of expenses associated with diagnostic programs and focus on therapeutics and the clinical development of its lead drug candidate, PCM-075.
Net cash provided by financing activities in the second quarter of 2018 was $15.1 million as compared to $16.7 million used in financing activities in the same period of 2017. Financing activities during the three months ended June 30, 2018 related primarily to the proceeds from sales of common stock and warrants.
Research and development expenses increased by approximately $1.0 million to $2.0 million for the three months ended June 30, 2018 from $1.0 million for the same period in 2017. 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, PCM-075. We expect increases in research and development costs as we continue to advance the development of PCM-075.
Selling, general and administrative expenses decreased by approximately $2.5 million to $2.2 million for the three months ended June 30, 2018 from $4.7 million for the same period in 2017. The significant components of the decrease were primarily due to the decrease in legal fees of approximately $2.1 million related to former CEO and CFO litigation settlement.
The weighted average diluted shares of common stock outstanding used to calculate per share results for the three months ended June 30, 2018 was 7.4 million.
As of June 30, 2018, Trovagene had approximately $18.5 million of cash and cash equivalents.