- Onvansertib demonstrates efficacy in Zytiga®-resistant metastatic castration-resistant prostate cancer (mCRPC) across known androgen receptor resistance mechanisms

- All patients showed tumor regression by radiographic scan at 8 weeks and confirmation by further tumor shrinkage at 16 weeks; clinical benefit achieved in 100% (n=5) of patients

- Efficacy observed 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% (5/16)

- Patients develop resistance to venetoclax in about 11 months with no viable therapeutic options; median survival of only 1.7 to 2.3 months and poor prognosis

- 72% of patients had decreases in PSA levels with the addition of onvansertib to Zytiga® following 1 cycle of treatment; 60% of patients completing 3 months of treatment and evaluable for efficacy achieved primary endpoint of disease control

- Results from completed Phase 1b and ongoing Phase 2 trial of onvansertib in relapsed/refractory AML to be presented in oral session

-- 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