-- Highly aggressive KRAS-mutated tumors account for ~50% of metastatic colorectal cancer (mCRC); no targeted treatments available and response to standard-of-care is only 5%

- Significant tumor regression observed with onvansertib in combination with standard-of-care paclitaxel in models of p53-mutated TNBC

- Trial assessing safety and efficacy of onvansertib in combination with FOLFIRI and Avastin® (bevacizumab) in KRAS-mutated mCRC

- Administration of onvansertib in combination with standard-of-care chemotherapy is safe and well-tolerated and resulted in anti-leukemic activity that appears to be sustainable over time

- Phase 1b dose escalation clinical trial confirmed safety, preliminary efficacy and identified the recommended phase 2 dose of onvansertib

- Trial leads to discovery that onvansertib stops rise in PSA in patients with treatment-resistant, highly-aggressive and difficult-to-treat androgen-receptor variant 7 (AR-V7) tumors

- Acute Myeloid Leukemia (AML) clinical trial data to be presented in an oral presentation

Management team to meet with investment institutions, analysts and shareholders in NYC to provide an overview of the Company and its advancing clinical development of onvansertib

Trial will evaluate safety and efficacy of onvansertib plus FOLFIRI and Avastin® (bevacizumab) for treatment of patients with KRAS-mutated metastatic Colorectal Cancer (mCRC)

Conference Call Begins at 11:00 am EDT

ONZEALD is currently being evaluated in a Phase 3 trial in patients with metastatic breast cancer and brain metastases

Additional funding further extends runway for Trovagene to accelerate clinical development of onvansertib for the treatment of cancers where new therapeutic options are most needed

Data provides support for clinical evaluation of onvansertib in combination with venetoclax in patients with difficult-to-treat relapsed or refractory acute myeloid leukemia (AML)

Complete response achieved in 3 of 6 (50%) evaluable patients at the highest doses (27mg/m2 and 40mg/m2) of onvansertib in combination with standard-of-care decitabine

Investment follows recent receipt of ~$3.2 million from exercise of previously issued warrants

Early PSA response observed when onvansertib is added to abiraterone (Zytiga®) in 2 of 6 patients to-date; first patient achieves primary efficacy endpoint

Greatest anti-leukemic activity has been observed in the onvansertib + decitabine arm, with complete response in 2 of 4 (50%) of evaluable patients from the two highest dose levels

Reverse stock split intended to bring company into compliance with minimum bid price requirement for maintaining listing on Nasdaq Capital Market

Safety lead-in completed, no overlapping toxicities, combination is safe and well tolerated

Trovagene receives "may proceed" notification from FDA for Phase 1b/2 trial of Onvansertib in combination with standard-of-care in patients with mCRC harboring KRAS mutations

Broad patent covers anti-androgen or androgen antagonist drugs, including combination treatment with Zytiga®, Xtandi® and Erleada® in multibillion-dollar market

- Preliminary Anti-Leukemic Activity Demonstrates >80% Response to Treatment with Onvansertib in Combination with Low-Dose Cytarabine (LDAC) or Decitabine in Dose Escalation Phase 1b of Trial

New website offers visitors greater insight into the Company's focus in oncology drug development, predictive clinical biomarkers and advances in Onvansertib clinical program

Targeted treatment with highly-selective, oral Polo-like Kinase 1 (PLK1) inhibitor, onvansertib, in combination with standard-of-care chemotherapy may represent a new treatment option in AML

New patent claims strengthen patent estate revenue Aligns with Onvansertib Clinical Development and Biomarker Strategy in AML

-Webcast and Conference Call for Investors and Analysts on Wednesday, October 24th at 8:30 am EDT

Patent agreement covers rights to develop combination therapies and identified predictive clinical biomarker across cancer types, expanding indications for Onvansertib

Safety Review Committee (SRC) recommends proceeding to the next dose level cohort of Onvansertib in combination with decitabine in dose-escalation phase of trial

Company overview, update on Onvansertib clinical development program and anticipated near-term value-creation milestones

Target engagement and inhibition of PLK1 by Onvansertib predictive of treatment response

Safety Review Committee (SRC) recommends proceeding to the next dose level cohort of Onvansertib in combination with low-dose cytarabine (LDAC) in dose-escalation phase of trial

Onvansertib's product profile and attributes may offer the potential to provide significant clinical benefit with regard to efficacy and safety in patients with various types of cancer

Additional pharmacodynamic data supports inhibition of PLK1 in leukemic cells as measured by pTCTP in its Phase 1b/2 trial in Acute Myeloid Leukemia (AML)

William Welch has resigned as CEO and Director

Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute and Massachusetts General Hospital officially activated and recruiting patients for Phase 2 open-label trial of PCM-075 and abiraterone acetate (Zytiga®) in metastatic Castration-Resistant Prostate Cancer (mCRPC)

Safety Review Committee (SRC) recommends proceeding to the second dosing cohort of PCM-075 in combination with decitabine in dose-escalation phase of trial

Safety Review Committee (SRC) recommends proceeding to the second dosing cohort of PCM-075 in combination with low-dose cytarabine (LDAC) in dose-escalation phase of trial

Methodology to assess changes in leukemic cells, genomic alterations and pTCTP status for Phase 1b/2 Clinical Trial of PCM-075. Update on clinical trial recruitment.

Combination of PCM-075, a highly-selective Polo-like Kinase 1 (PLK1) inhibitor, and Quizartinib resulted in 97% tumor growth inhibition and regression in FLT3 AML model

Yale Cancer Center and Kansas University Cancer Center now actively screening and enrolling patients in Phase 1b/2 Study of PCM-075 in Acute Myeloid Leukemia (AML)

Targeted treatment with highly-selective Polo-like Kinase 1 inhibitor PCM-075 in combination with Zytiga® (abiraterone acetate) may represent a new treatment option in CRPC

PCM-075, Trovagene's highly-selective Polo-like Kinase 1 (PLK1) inhibitor may extend patient response to therapy when used in combination with Zytiga® (abiraterone) in mCRPC

Activation of second trial site for Phase 1b/2 clinical trial of PCM-075, in combination with standard-of care, to evaluate dose and scheduling, and preliminary anti-leukemic activity

PCM-075, Trovagene's Polo-like Kinase 1 (PLK1) inhibitor enhances activity of abiraterone in mCRPC tumor cells and may represent a novel combination treatment option in mCRPC

Targeted treatment with highly selective Polo-like Kinase 1 inhibitor, PCM-075, may represent a new option in TNBC, particularly in combination with other abiraterone acetate

Activation of first trial site for Phase 1b/2 clinical trial of PCM-075, in combination with standard-of care, to evaluate dose and scheduling, and preliminary anti-leukemic activity

PCM-075 enhances activity of abiraterone in mCRPC tumors cells and may represent a novel treatment option to extend the benefit of anti-androgen therapy

Dr. Athena Countouriotis joins Trovagene's Board of Directors, bringing significant experience in oncology clinical development and orphan indications

Additionally, Trovagene announces PCM-075 synergy in combination with more than ten chemo and targeted therapeutics across a broad range of solid tumor and hematologic malignancies

Human AML xenograft with FLT3 mutation shows PCM-075 in combination with Quizartinib resulted in 96% tumor growth inhibition with tumor regression

PCM-075, in combination with decitabine, in patients with Acute Myeloid Leukemia (AML) for exploration of the safety, tolerability, dose and scheduling, and antitumor activity

Greater selectivity for PLK1, potency, oral bioavailability and short half-life underscore PCM-075's potential as safe and effective treatment for solid tumor and hematological malignancies

Study evaluated safety, dose limiting toxicities, related maximum tolerated dose and indication of anti-tumor activity in patients with advanced or metastatic solid tumors