Trovagene, Inc. (NASDAQ: TROV) is a clinical-stage, oncology therapeutics company, using a precision medicine approach to develop drugs that target mitosis (cell division) to treat various types of cancer, including leukemias, lymphomas, and solid tumors. 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.
The company is continuing to advance its clinical development of PCM-075 in Acute Myeloid Leukemia (AML) and Metastatic Castration-Resistant Prostate Cancer (mCRPC), achieving several key milestones in the recent past.
PCM-075 expanding pipeline and current stage:
Key & unique differentiating factor:
► Precision Cancer Medicine, predictive biomarker approach
► Leveraging a proven cancer target, PLK1
► Onvansertib – first-in-class, 3rd generation, oral PLK1 inhibitor
► Synergy strategy – Onvansertib in combination with approved drugs
- Exclusive License Agreement with MIT for Combination Therapy of Anti-Androgens and Polo-like Kinase Inhibitors in Prostate Cancer: On Oct. 3, 2018, the company announced that it has entered into an exclusive patent license agreement with the Massachusetts Institute of Technology (MIT). Under the agreement, Trovagene has exclusive rights to develop combination therapies that include anti-androgen or androgen antagonist and a Polo-like Kinase (PLK) inhibitor for the treatment of cancer. The exclusive license agreement is part of the Company’s strategy to explore the efficacy of Onvansertib, its first-in-class, 3rd generation, highly-selective, oral PLK1 inhibitor, in combination with anti-androgen drugs in cancers including prostate, breast, pancreatic, lung and gastrointestinal.
- Completion of Dosing Cohort of Patients Treated with Onvansertib in Combination with Decitabine in Ongoing Phase 1b/2 AML Trial: On Sep 27th, the company announced completion of the second dosing cohort of Onvansertib, its first-in-class, 3rd generation, highly-selective oral Polo-like Kinase 1 (PLK1) Inhibitor, in combination with standard-of-care decitabine, in its Phase 1b/2 clinical trial in patients with Acute Myeloid Leukemia (AML). All three patients in the cohort successfully completed treatment with Onvansertib at 18mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with decitabine and the combination was well tolerated.
- Predictive Clinical Biomarker Approach to Identify Acute Myeloid Leukemia (AML) Patients Most Likely to Respond to Onvansertib: On September 5th, the company announced that it had developed a method for predicting response to treatment by measuring the ability of Onvansertib, a 3rd generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, to inhibit PLK1 in patients with Acute Myeloid Leukemia (AML). Trovagene has filed a U.S. patent application with the USPTO to protect its method for evaluating the responsiveness of cancer to a Polo-like Kinase 1 (PLK1) inhibitor by determining the ability of the PLK1 inhibitor to inhibit phosphorylation of a unique target of PLK1 in cells of the cancer.
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Looking ahead to 2019, the company is well poised for rapid growth. Trovagene is Integrating Technology in Tumor Genomics with the Development of Precision Cancer Therapeutics and the Analyst tracking the stock believes that the company’ deep understanding of tumor genomics may allow for effective targeting of appropriate cancer patients, which, in turn, may improve patient care and outcomes.
TROV has significant experience and expertise with biomarkers and technology in cancer, including AML. The company is the patent holder of NPM1 for diagnosis and monitoring of patient response. NPM1-mutated AML is a genetic marker in leukemia and accounts for approximately one-third of all AML patients.
Per www.marketbeat.com, Their average twelve-month price target is $27.50, suggesting that the stock has a possible upside of 3,060.92%. The high price target for TROV is $48.00, and the low-price target for TROV is $7.00. Considering all this, the company is in an extremely favorable risk-reward position, and value investors should consider exposure in this sector as the backdrop remains favorable.
Below are the excerpts of recent analyst rating on the script:
Description & about the Company: Trovagene is a clinical-stage, precision medicine oncology therapeutics company. Trovagene’s lead drug candidate, PCM-075, is a Polo-like Kinase 1 (PLK1) selective adenosine triphosphate (ATP) competitive inhibitor.
PCM-075 was developed to have high selectivity to PLK1, to be administered orally, and to have a relatively short drug half-life of approximately 24 hours compared to other PLK inhibitors. PCM-075 has completed a safety study in patients with advanced metastatic solid tumors with a phase 1b/2 clinical trial in patients with AML underway.
PCM-075 has shown preclinical antitumor activity as a single agent and in synergy combinations with more than ten different chemotherapeutics and targeted therapies, such as Zytiga® (abiraterone acetate), Beleodaq® (belinostat), Quizartinib (AC220), a development stage FLT3 inhibitor, and Velcade® (bortezomib) in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC) and other liquid and solid tumor cancers.
2018 Milestones – Significant value-creation throughout 2018
Other recent announcements:
- 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
- Announced the Start of Recruitment and Enrollment for Phase 2 Clinical Trial of PCM-075 in Combination with Zytiga® in Patients with mCRPC
- Announced Completion of First Dosing Cohort of Patients Treated with PCM-075 in Combination with Decitabine in Ongoing Phase 1b/2 AML trial
- Announced Completion of First Dosing Cohort of Patients in Ongoing Phase 1b/2 AML trial of PCM-075 in Acute Myeloid Leukemia
- Announced Presentation of Data at AACR Meeting 2018 on Pharmacodynamic and Tumor Biomarkers During Treatment with PCM-075 and Low-Dose Cytarabine
- Announced Presentation of data at AACR Meeting 2018 Showing Synergy of PCM-075 in Combination with FLT3 Inhibitors in Acute Myeloid Leukemia (AML
Quarterly Financial Results (in, thousands):
- Revenue – TROV’ total revenues were $111,813 and $102,011 for the three months ended June 30, 2018, and 2017, The increase in royalty income related primarily to higher receipts of payments in excess of minimum royalties in comparison to the same period of the prior year. Revenue from diagnostic services is recognized when payment is received for the test results. The amount of payments received was lower in 2018 as compared to the same period in the prior year.
- Profitability – 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.
- Liquidity and financial flexibility – As of June 30, 2018, Trovagene had approximately $18.5 million of cash and cash equivalents. 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.
Key risk factors and potential stock drivers:
- Successful completion of the upcoming milestones would lead future direction for the company. Any adversities might adversely impact the overall investor sentiments.
- TROV has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.
- Notwithstanding the expected improvement in the business and financial risk profile of the company, TROV is still a loss-making entity. Therefore, the company’s ability to achieve successful commercialization will continue to remain a long-term stock sensitivity factor.
- On Friday, Oct 12th, 2018, TROV closed at $0.8656, with a volume of 1.3 million shares exchanging hands. Market capitalization is $15.311 million. The current RSI is 54.63
- In the past 52 weeks, shares of TROV have traded as low as $0.65 and as high as $12.00
- At $0.8656, shares of TROV are trading above its 50-day moving average (MA) at $0.82 and below its 200-day moving average (MA) at $2.47
- The present support and resistance levels for the stock are at $0.81 & $0.91 respectively.
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