Trovagene Presents Outlook for Second Half of 2018

Trovagene Presents Outlook for Second Half of 2018

DIEGO, July 9, 2018 /PRNewswire/ Trovagene, Inc. (NASDAQ: TROV), a clinical-stage oncology therapeutics company, developing targeted therapeutics for the treatment of hematologic and solid tumor cancers, today

provided an update on key value-creating milestones for the second half of 2018 and a review of its year-to-date achievements.

We continue to focus on advancing our two active clinical trials with PCM-075; a Phase 1b/2 trial in

patients with Acute Myeloid Leukemia (AML) and a Phase 2 trial in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC), said Tom Adams, Chairman of the Board and Interim Chief Executive Officer of Trovagene. We

believe PCM-075 has the potential to address a critical need for new treatment options for patients across a variety of leukemias/lymphomas and solid tumor cancers.

As a team, we achieved a number of key milestones in the first half of 2018 and we continue to execute on our business plan and to advancing our

clinical development program in the second half of 2018. We are encouraged by the high level of interest from outside parties and we are evaluating strategic development partnerships for our drug asset outside the U.S.

Looking ahead to the second half of 2018, the Company s Board of Directors is undertaking a search for a new CEO, who has the relevant therapeutic and

drug development experience to lead Trovagene into its next stage.

Anticipated Second Half 2018 Milestones

Trovagene anticipates achieving the following milestones during the second half of 2018:

Clinical Milestones for PCM-075

Phase 1b/2 trial of PCM-075 in Combination with Either

Low-Dose Cytarabine (LDAC) or Decitabine for the Treatment of Acute Myeloid Leukemia (AML)

Phase 2 trial of PCM-075

in Combination with Abiraterone Acetate (Zytiga ) and Prednisone for the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC)

First Half 2018 Achievements and Highlights

Trovagene achieved important clinical milestones during the first half of 2018, highlighted by the following accomplishments:

underlying mechanism of synergy was further examined by performing gene-expression comparison across more than 30 different synergistic and non-synergistic cell lines across multiple tumor types. From this

analysis, multiple hypothesis-generating mechanisms were identified, one of which was the retinoic acid pathway, which when activated is predictive of synergy.

PCM-075 is a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple hematologic and solid tumor cancers.

Separate studies with other PLK inhibitors have shown that inhibition of polo-like-kinases can lead to tumor cell death, including a Phase 2 study in Acute Myeloid Leukemia (AML) where response rates up to 31% were observed when used in conjunction

with a standard therapy for AML (low-dose cytarabine-LDAC) versus treatment with LDAC alone with a 13.3% response rate. A Phase 1 open-label, dose escalation safety study of

PCM-075 has been completed in patients with advanced metastatic solid tumor cancers and published in Investigational New Drugs. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) in this

trial was 24 mg/m2. Trovagene has an ongoing Phase 1b/2 clinical trial with PCM-075 in AML that was accepted by the National Library of Medicine (NLM)

and is now publicly viewable on www.clinicaltrials.gov. The NCT number assigned by clinicaltrials.gov for this study is NCT03303339. PCM-075 has been granted Orphan Drug Designation by

the FDA for the treatment of patients with AML. Trovagene is enrolling a Phase 2 trial of PCM-075 in combination with Zytiga (abiraterone

acetate) and prednisone in metastatic Castration- Resistant Prostate Cancer that was accepted by the National Library of Medicine (NLM) and is now publicly viewable on www.clnincaltrials.gov. The NCT number assigned by clinicaltrials.gov

for this study is NCT03414034.

PCM-075 only targets the PLK1 isoform (not PLK2 or PLK3), is orally

available, has a 24-hour drug half-life with reversible on-target hematologic toxicities. Trovagene believes that targeting only PLK1 with reversible on-target activity and an improved dose/scheduling protocol can significantly improve on the long-term outcome observed in previous studies with a PLK inhibitor in AML.

PCM-075 has demonstrated synergy in preclinical studies with over 10 chemotherapeutic and target agents used in

hematologic and solid tumor cancers, including FLT3 and HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the combination of its targeted PLK1 inhibitor, PCM-075, with other compounds has the

potential for improved clinical efficacy in Acute Myeloid Leukemia (AML), metastatic Castration-Resistant Prostate Cancer (mCRPC), Non-Hodgkin Lymphoma (NHL), Triple Negative Breast Cancer (TNBC), as well as

other hematologic and solid tumor cancers.

About Trovagene, Inc.

Trovagene is a clinical-stage, oncology therapeutics company. The Company s primary focus is to develop oncology therapeutics for the treatment of

hematologic and solid tumor cancers for improved cancer care, utilizing its technology in tumor genomics. Trovagene has intellectual property and proprietary technology that enables the Company to analyze circulating tumor DNA (ctDNA) and clinically

actionable markers to identify patients most likely to respond to specific cancer therapies. Trovagene plans to continue to vertically integrate its tumor genomics technology with the development of targeted cancer therapeutics. For more

information, please visit https://www.trovagene.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may

be identified by the use of words such as anticipate, believe, forecast, estimated and intend or other similar terms or expressions that concern Trovagene s expectations, strategy,

plans or intentions. These forward-looking statements are based on Trovagene s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from

those indicated by such forward-looking statements. These factors include, but are not limited to, our need for additional financing; our ability to continue as a going concern; clinical trials

involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other

safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of

patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to

failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene s strategy to design

its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes. Additionally, there are no guarantees that future clinical trials will be completed or successful or

that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Trovagene s Form

10-K for the year ended December 31, 2017, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such

list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein

are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

VP, Corporate Communications