TrovaGene Inc. (NASDAQ:TROV) PCM-075 Demonstrates Synergy

TrovaGene Inc. (NASDAQ:TROV) PCM-075 Demonstrates Synergy

TrovaGene Inc. (NASDAQ:TROV) shares gained 9.9% after the biotechnology company reported positive preclinical research, demonstrating synergy of PCM-075 in combination with Johnson & Johnson (NYSE:JNJ) drug Zytiga. Trial results indicate that when combined, the two appear to signal a previously unknown pathway.

TrovaGene Inc. (NASDAQ:TROV)

According To Trovagene Chief Scientific Officer, Mark Erlander, the unique combination could enhance the PCM-075 mechanism in arresting cells during mitosis with subsequent tumor cell death. The biotechnology company is investigating the adenosine triphosphate (ATP) competitive inhibitor for the treatment of metastatic castration-resistant prostate cancer.

“We previously completed a Phase 1 trial in metastatic solid tumor cancers, which provided a recommended Phase 2 dose and dosing schedule for PCM-075 in a combination regimen. We are working closely with key investigators to develop a Phase 2 clinical trial protocol with oral dosing of PCM-075 and abiraterone utilizing our existing solid tumor IND,” said CEO, Bill Welch.

Orphan Drug Designation

The U.S. Food and Drug Administration (FDA) has already granted an Orphan Drug Designation to PCM-075 for the treatment of acute myeloid leukemia. According to TrovaGene Inc. (NASDAQ:TROV) CEO, the designation underscores the agency desire to accelerate the development of the therapy given that AML affects nearly 20,000 people every year in the U.S.

The Orphan Drug Designation will allow TrovaGene to accelerate the development of PCM-075. The designation also allows the company up to seven years of market exclusivity upon regulatory approval. The company plans to initiate a Phase 1b/2 open-label trial to evaluate the safety and anti-leukemic activity of the candidate drug in combination with standard care.

TROV Stock Performance

TrovaGene Inc. (NASDAQ:TROV) has been a shadow of itself in the market this year as the stock is down by more than 50% as it continues to trade in a strong downtrend. Investor confidence on the tock appears to have hit all-time lows, seen by the stock struggling to rise above the $1 a share mark.

The company reported a net loss of (-$36.81) million in its most recent quarter as it continues to waver on its path to profitability. Arousing further investors’ concerns is the rate at which the company is burning cash. TrovaGene Inc. (NASDAQ:TROV) reportedly has $7.78 million in the bank compared to negative cash flows of $29.40 million.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Is this a Turn-Around for TrovaGene Inc (NASDAQ:TROV)

TrovaGene Inc (NASDAQ:TROV)

Shares of TrovaGene Inc (NASDAQ:TROV) are trading with exceptionally heavy volume after the biotechnology company’s drug candidate PCM-075 was granted an Orphan Drug designation by the U.S. Food and Drug Administration (FDA). PCM-075 is being developed for the treatment of patients with Acute Myeloid Leukemia (AM).

TROV Stock Movement

TrovaGene Inc (NASDAQ:TROV) shares have a listed 30-day, daily average volume of less than 650,000. However less than 30 minutes into trading over 3.5 million shares have traded hands. On Friday, TROV stock closed at $0.85 but gapped up to open at $1.02 before hitting an inter-day high, as of 10AM, of $1.03. TROV shares have since come off those levels and are trading near $0.90.

TROV investors have not had a good 2017. Year-to-date shares are down over 50% and down over 30% for the quarter. TROV stock has done well more recently though. In mid-July investors sent shares tanking from $1.60 and, until last Friday, the shares languished below $1 for all of September and October. Earlier this year, TROV shares hit their 52-week of $4.75.

TrovaGene Inc (NASDAQ:TROV)

TrovaGene Developments

The granting of the Orphan Drug designation allows the drug, once ap[proved, to be eligible for a seven-year period of U.S. marketing exclusivity, as well as other development assistance and financial incentives.

Acute myeloid leukemia (AML) is a hematologic malignancy in which myeloid lineage cells of the bone marrow cease to differentiate appropriately, resulting in a marked increase in the number of circulating immature blast cells. As a consequence, the counts of mature red blood cells, platelets, and normal white blood cells decline, causing fatigue, shortness of breath, bleeding, and increased susceptibility to infection.

Bill Welch, Chief Executive Officer of TrovaGene Inc (NASDAQ:TROV) stated in a press release,”AML is an aggressive cancer of the blood and bone marrow with approximately 20,000 new cases in the U.S each year. We see the FDA’s granting of orphan drug designation for PCM-075 as underscoring the medical need for new therapies for patients with AML and an important step forward in our clinical development program.”

Analysts have a consensus price target of $6 on shares of TrovaGene Inc (NASDAQ:TROV). Three analysts cover TROV stock. Two rte it as a “Strong Buy” while one rates it as a “Hold”.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

TrovaGene Inc (NASDAQ:TROV) Gaps Lower On $7.1 Million Direct Offering

TrovaGene Inc (NASDAQ:TROV)

The impressive rise of TrovaGene Inc (NASDAQ:TROV) came to an abrupt end in Friday’s trading session after the stock gapped lower on the announcement of a new $7.1 million registered direct offering. The stock had spiked earlier in the week after the company announced an agreement with Novogene for the Chinese launch of NextCollect.

Shareholder Dilution Concerns

TrovaGene Inc (NASDAQ:TROV) is a leading developer of molecular genetic diagnostics for use in clinical research and medical testing. The company boasts of a proprietary technology designed to detect and monitor specific types of tumors using urine and blood samples. The company also offers a Precision Cancer Monitoring (PCM) platform that tracks and quantifies levels of ctDNA in samples under study.

Shares of TrovaGene Inc (NASDAQ:TROV) shed 20.57% in market value in Friday trading session to end the week at $1.12 a share. Friday’s sell-off threatens to push the stock lower as it continues to trade in a $1.10 to $1.17 trading range. 13% of the share’s float are held by short-sellers.

Last week’s sell-off came on growing concerns about the stock’s potential dilution. The company has entered into a securities purchase agreement that will reportedly raise $7.1 million through the sale of 6,191,000 shares of its common stock in the public offering.

The company has also issued warrants for the purchase of up to 4,643,626 shares of common stock in a private placement. The combined purchase price for one registered share of common stock and one unregistered warrant of purchase will be $1.15. TrovaGene Inc (NASDAQ:TROV) expects the offering to close on July 19, 2017 subject to satisfaction of customary closing conditions.

China Expansion

The public and private offering comes on the heels of the company inking a deal with Novogene for the validation of its urine collection and nucleic acid preservation device in the Chinese market. Under the terms of the agreement, the company is to sell to the Chinese company the device in addition to reagents and methods for the extraction of cfDNA.

“We are delighted to work with Trovagene. We look forward to validating their proprietary urine collection, stabilization and cfDNA extraction technology in our laboratories, and to developing innovative urine-based tests for the Chinese market,” said David Jiang, Novogene Senior Vice President.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $TROV and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

TrovaGene Inc (NASDAQ:TROV) Rallies on NextCollect China Deal and NASDAQ Compliance Confirmation

TrovaGene Inc (NASDAQ:TROV)

Shares of TrovaGene Inc (NASDAQ:TROV) rallied by 10.69% after the company announced the signing of an agreement with Novogene Co Ltd for the purchase of its proprietary NextCollect device. Fuelling investor’s sentiments on the stock is also confirmation that the stock has regained NASDAQ compliance after being hit with a delisting notice.

TrovaGene Inc (NASDAQ:TROV) has registered an impressive run ever since it bounced from its lows of $0.60 a share in June. The stock’s upward momentum, however, appears to have found resistance at the $1.65 a share mark as it continues to trade in a tight $1.45 to $1.63 a share range.

TrovaGene Inc (NASDAQ:TROV)
Daily Candle Bar Graph for TrovaGene Inc (NASDAQ:TROV)

The NASDAQ Capital Market had on May 30, 2017 warned that the company faced delisting from the exchange on the stock’s price remaining below the $1 a share minimum bid requirement. The stock came into compliance with the requirement on July 6, 2017, thanks to a strong bullish momentum.

TrovaGene Inc (NASDAQ:TROV) bills itself as a precision medicine biotechnology company focused on the development of therapies for improving cancer care. The company boasts of a proprietary Precision Cancer Monitoring technology currently in use for tumor genomics. The biotechnology company also owns a proprietary technology for measuring circulating tumor DNA in urine and blood.

China Expansion

The company’s proprietary urine collection and nucleic preservation device is set to premiere in the Chinese market thanks to the agreement with Novogene. In addition to selling the NextCollect device to the Chinese company, TrovaGene Inc (NASDAQ:TROV) will offer reagents and methods for the extraction of cell-free DNA from urine.

NovoGene plans to validate the urine DNA extraction methods at its facilities as part of the agreement. Shipments for the device to China are set to begin this month.

“We are delighted to work with Trovagene. We look forward to validating their proprietary urine collection, stabilization and cfDNA extraction technology in our laboratories, and to developing innovative urine-based tests for the Chinese market, said Trovagene CEO, Bill Welch.

PCM-075 Supply Agreement

Separately, NovoGene has executed a supplier agreement with NerPharMa S.r.l for the manufacture of drug product PCM-075. The agreement covers clinical and commercial supply of the product. The agreement according to the chief executive marks a step forward in the development of the competitive inhibitor which is usually overexpressed in different hematologic malignancies.

“We are pleased to be working with Trovagene to manufacture and provide finished product for their investigational and commercial needs,” said NerPharMa CEO, Angelo Colombo.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

TrovaGene Inc (NASDAQ:TROV) Signs Agreement with AstraZeneca (AZN)

TrovaGene Inc (NASDAQ:TROV)

TrovaGene Inc (NASDAQ:TROV) has announced entering into an agreement with AstraZeneca plc (ADR) (NYSE:AZN) that will see the latter supply Trovera® urine ctDNA biomarker tests and services. TrovaGene Inc is a precision medicine biotechnology company.

Initially, the Trovera® EGFR urine liquid biopsy test will be applied in an open label prospective biomarker trial to evaluate whether the collective use of noninvasive testing i.e. blood and urine testing are as effective and reliable as tissue testing in identifying the mutation status of the epidermal growth factor receptor (EGFR) T790M.

In a statement, TrovaGene Inc (NASDAQ:TROV) Chief Executive Officer, Bill Welch, said they are pleased to work AstraZeneca and to have their urine liquid biopsy test incorporated in a trial intended to explore new and non-invasive means of detecting the EGFR mutation.

TrovaGene Inc (NASDAQ:TROV) offers CLIA laboratory testing services for several clinical research third parties and biopharmaceutical companies. It is this expertise that has supported the development of biomarkers for PCM-075, a polo-like kinase 1 (PLK1) inhibitor. The company intends to use an acute myeloid leukemia (AML) genetic panel to evaluate the response to PCM-075 in its phase 1/2 trial.

Recently AstraZeneca got the US Food and Drug Administration for its Tagrisso (osimertinib) used in the treatment of metastatic EGFR T790M mutation-positive non-small cell lung cancer.

Additionally, AstraZeneca recently announced getting marketing approval from the Drug Controller General of India (DCGI) for asthma drug Symbicort. According to the company, Symbicort is a non-variable dose drug combination made of formoterol fumarate and budesonide dehydrate which are administered through a special device. The drug is meant for treatment of severe asthma as well as patients with severe chronic obstructive pulmonary disease (COPD) and who have a history of exacerbations.

Symbicort has been approved for use in asthma and COPD treatment in 910 countries. According to two major studies, the addition of budesonide to formoterol led to improvement in asthma symptoms and lung function in addition to reducing exacerbation.

Additionally, in two one-year clinical studies in patients suffering from COPD, Symbicort exhibited superior to placebo, formoterol, and budesonide in regards to lung function in addition to registering reduction in the rate of exacerbation as compared to formoterol and placebo.

TrovaGene Inc (NASDAQ:TROV) surged 37.36% and closed at $1.30 in Thursday’s trading session.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $TROV and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

TrovaGene Inc. (NASDAQ:TROV) Trades Higher On AstraZeneca plc. (ADR)(NYSE:AZN) Partnership

TrovaGene Inc. (NASDAQ:TROV)

TrovaGene Inc. (NASDAQ:TROV) was a big mover after announcing plans to lend AstraZeneca plc. (ADR)(NYSE:AZN) its Trovera urine-based ctDNA biomarker test and related services. Under terms of the agreement, the giant pharmaceutical company is allowed to use the urine liquid biopsy test in its biomarker study.

AstraZeneca- TrovaGene Deal

The study seeks to evaluate whether blood and urine testing, in combination, can be used to identify epidermal growth factor receptor T790M.

“We’re pleased to partner with AstraZeneca and to have our urine liquid biopsy test included in a trial designed to explore new and non-invasive ways to detect if patients have this EGFR mutation and may be appropriate for specific treatment options,” said Bill Welch, Chief Executive Officer of Trovagene. “This agreement marks a major milestone for Trovagene,” said TrovaGene Inc. (NASDAQ:TROV) CEO, Bill Welch.

It does not come as a surprise that TrovaGene Inc. (NASDAQ:TROV) stock traded higher in the market if what AstraZeneca brings to the table is anything to go by. The giant pharmaceutical choosing the company’s liquid biopsy test for its own study validates the technology in the industry – something that could lead to bigger things in the near future. The company currently conducts testing services for other biopharmaceutical companies and third parties as part of renewed focus on liquid biopsy tests and systems.

PCM-075 Clinical Study

In addition to pursuing growth on the development of biopsy kits and systems, TrovaGene Inc. (NASDAQ:TROV) is also ramping up efforts regarding its drug pipeline. The company recently reported data from a phase 1 study of PCM-075 kinase 1 inhibitor.

According to the company, data results are positive for the Phase1/2 clinical trial in patients with acute myeloid leukemia. TrovaGene also investigated the drug on its anti-tumor activity as well as its ability to modulate intracellular targets.

“We believe the phase 1 data indicates broad applications for PCM-075 in hematologic malignancies and solid tumors and we plan to continue to assess, and explore, additional precision cancer therapeutic opportunities going forward,” said Chief Scientific Officer, Dr. Mark Erlanger

Separately, the San Diego-based precision medicine biotechnology company reported a net loss of (-$10) million for the first three months of the year, compared to a net loss of (-$10.3) million reported the previous year. Revenue in the quarter totaled $95,000.

TrovaGene Inc. (NASDAQ:TROV) stock was up by 19.93% in Monday’s trading session ending the day at $0.968 a share.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $TROV and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.

Why TrovaGene Inc (NASDAQ:TROV) Reported Restructuring Plan?

TrovaGene Inc (NASDAQ:TROV)

TrovaGene Inc (NASDAQ:TROV), a molecular diagnostic firm, released its financial report for the fourth quarter and year closed December 31, 2016. The company also reported a restructuring plan that will support the firm’s expansion into segment of precision cancer therapeutics.

The update

Trovagene reported a license deal with Nerviano Medical Sciences that allows company’s exclusive international commercialization and development rights to PCM-075, which is an oral, investigative medicine and a highly-selective ATP competitive inhibitor of the PLK 1.  A phase I safety trial of PCM-075 was completed in people suffering with advanced metastatic disease. The company intends to advance PCM-075 initially in subjects with acute myeloid leukemia and appears to be initiating a clinical advancement plan this year.

Bill Welch, CEO of TrovaGene Inc (NASDAQ:TROV), reported that they are thrilled to report the implementation of their plan to vertically integrate ctDNA PCM know-how with precision cancer therapeutics by advancing medicines where their deep knowledge of tumor genomics may permit for effective targeting of cancer patients.

TrovaGene Inc (NASDAQ:TROV) projects the restructuring plan will reduce yearly pre-tax costs by almost $8 million per year excluding one-time separation expenses via the decline of almost 30 personnel and costs mainly linked to research, operations and clinical studies.  The company will sustain its CLIA/CAP-accredited lab for clinical services to pharma firms and for internal programs.

A corporate restructuring was required to support Trovagene’s precision cancer therapeutic prospects. They consider the changes to be in the best interest of all investors as they look to establish an industry pioneering precision medicine firm.

TrovaGene Inc (NASDAQ:TROV) recorded a net loss of $8.5 million as against a net loss of $10.2 million for Q3 2016, and a net loss of $7.4 million for Q4 2015.

Total operating expenses came at almost $9.9 million in Q4 2016, slightly down from $10 million in Q3 2016, and a jump from $7.5 million in Q4 2015. Net cash deployed in operating activities in 4Q2016 was $9 million, compared to $7 million in Q3 2016. This quarter-over-quarter jump can be attributed mainly to greater research and development expenses linked with advancement of a multigene panel, a record payment to Boreal Genomics and specific non-recurring administration costs.

As of December 2016, the company had short-term investments and cash/cash equivalents of almost $37.9 million. In the last trading session, the stock price of Trovagene gained more than 6% to close the day at $1.75.

3/16/2017
Ticker Symbol TROV
Last Price a/o 3:21 PM EST  $1.75
Average Volume  245.21K
Market Cap (mlns)  $53.10M
Shares Outstanding (mlns) 30.34M
Share Float (mlns) 27.66M
Inside Ownership 0.80%
Short Float 8.07%
Short Interest Ratio 9.11
Quarterly Return -23.91%
YTD Return -16.67%
Year Return -65.95%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.