EX-99.1 2 a17-26164_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Trovagene Announces Third Quarter 2017 Company Highlights and Financial Results

 

SAN DIEGO, CA — November 9, 2017 — Trovagene, Inc. (NASDAQ: TROV), a clinical-stage precision medicine biotechnology company, today announced company highlights and financial results for the third quarter ended September 30, 2017. The company is issuing this press release in lieu of conducting a conference call.

 

“We are excited by our continued clinical research advancement of PCM-075, our oral and highly selective Polo-like Kinase 1 (PLK1) inhibitor,” said Bill Welch, Chief Executive Officer of Trovagene, “including the FDA’s authorization to proceed with our Phase 1b/2 clinical trial in acute myeloid leukemia (AML) as well as the granting of Orphan Drug Designation by the FDA for PCM-075 to treat patients with AML.”

 

Company Highlights

 

Trovagene made significant progress in the third quarter to advance the clinical research of PCM-075 for solid and hematologic tumor cancers, including the publication of a Phase 1 safety study of PCM-075 in patients with advanced metastatic solid tumors, the FDA’s authorization to proceed with a Phase 1b/2 trial in AML and the announcement of multiple combination preclinical studies demonstrating apparent synergy of PCM-075 in combination with ten different chemotherapeutics commonly used in solid and hematologic tumor cancers as well as targeted therapies, such as abiraterone acetate, and FLT3 inhibitors.

 

“We are increasingly encouraged by the synergy data observed with the combination of PCM-075 and abiraterone acetate,” said Dr. Mark Erlander, Chief Scientific Officer of Trovagene. Abiraterone acetate, marketed as Zytiga® by Centocor Ortho Biotech, Inc., a member of the Johnson & Johnson family of companies, is the leading global anti-androgen therapy for metastatic Castration-Resistant Prostate Cancer (mCRPC) with 2016 sales in excess of $2.0 billion. “Even with broad adoption of Zytiga®, we believe there continues to be a large medical need to extend its benefit of response in mCRPC. We are working closely with key investigators to develop a Phase 2 clinical trial protocol with oral dosing of PCM-075 and abiraterone with a planned submission to our existing solid tumor IND,” said Dr. Erlander.

 

Other Clinical Development Highlights of PCM-075

 

·                  Announced results of preclinical research on August 16, 2017, indicating potential synergy (interaction of discrete drugs such that the total effect is greater than the sum of the individual effects) of PCM-075 with Quizartinib, an investigational FLT3 Inhibitor, by Daiichi Sankyo, in FLT3 mutant xenograft mouse models. The FDA recently approved

 



 

Rydapt® (midostaurin) by Novartis for the treatment of newly diagnosed adult patients with AML that are FLT3 mutation-positive in combination with cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy. There are two additional FLT3 inhibitors in ongoing phase 3 trials, including Quizartinib. Trovagene believes that a combination of PCM-075 with a FLT3 inhibitor for AML patients with a FLT3 mutation could extend treatment response and possibly slow or reduce resistance to FLT3 activity.

 

·                  Announced results of preclinical research on August 21, 2017, indicating potential synergy of PCM-075 with a histone deacetylase, or HDAC, inhibitor in NHL cell lines. This synergy assessment study was conducted by Dr. Steven Grant, Associate Director for Translational Research and co-Leader, Developmental Therapeutics Program, Massey Cancer Center.

 

·                  Announced that the FDA granted Orphan Drug Designation to PCM-075 on September 28, 2017, for the treatment of patients with AML.

 

·                  Announced receiving FDA authorization to proceed with its Phase 1b/2 trial of PCM-075 in patients with AML on July 26, 2017. This trial is designed to determine the safety, tolerability, dosing and scheduling of PCM-075 for patients with AML, while providing a preliminary assessment of anti-leukemic activity, and exploring the use of correlative biomarker analysis to select patients most likely to respond.

 

·                  Announced expansion and strengthening of its Board of Directors with the appointment of Athena Countouriotis, M.D.  Dr. Countouriotis brings significant experience in oncology clinical development and orphan indications.

 

·                  Entered into an agreement with Novogene Co. Ltd., a leading global provider of genomic services and solutions and one of the largest sequencing capacities in the world, whereby Novogene will purchase NextCollect™, reagents and methods to extract cell-free DNA (cfDNA) for validation of urine DNA extraction methods in the Chinese market.

 

Third Quarter 2017 Financial Results

 

·                  Trovagene received gross proceeds of approximately $7.1 million from the sale of 6,191,500 shares of its common stock and 4,643,626 share of warrants through a registered direct offering and private placement in July 2017.

 

·                  Trovagene reported a net loss of $4.3 million, or $0.12 per diluted share in the third quarter of 2017, as compared to a net loss of $10.2 million, or $0.34 per diluted share, for the same quarter of 2016.

 

·                  Total operating expenses were approximately $5.9 million for the three months ended September 30, 2017, a reduction of $4.1 million from $10.0 million for the same period in 2016.

 



 

·                  Research and development expenses decreased by $2.5 million to $1.4 million for the three months ended September 30, 2017, from $3.9 million for the same period in 2016.

 

·                  Selling and Marketing expenses decreased by $2.5 million to $0.4 million for the three months ended September 30, 2017, from $2.9 for the same period in 2016.

 

·                  General and administrative expenses increased by $1.0 million to $3.7 million for the three months ended September 30, 2017, from $2.7 million for the same period in 2016. The increase was primarily due to the expenses related to the immediately vested restricted stock awards granted to the CEO.

 

·                  Net cash used in operating activities in the third quarter of 2017 was $6.6 million, compared to $7.0 million in the third quarter of 2016.  The quarter-over-quarter reduction can be attributed primarily to a decrease in research and development expenses as a result of a shift in business focus and lower selling and marketing expenses as a result of reduction in force.

 

·                  Net cash provided by financing activities in the third quarter of 2017 was $6.4 million, compared to $3.7 million in the second quarter of 2016.  The increase is primarily due to the sale of our securities during July fundraising activity.

 

·                  The weighted average diluted shares of common stock outstanding used to calculate per share results was 36.5 million.

 

·                  As of September 30, 2017, Trovagene had approximately $7.4 million of cash and cash equivalents.

 

About Trovagene, Inc.

 

Trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics.  Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies.  Trovagene offers its PCM technology at its CLIA/CAP — accredited laboratory and plans to continue to vertically integrate its PCM technology with precision 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, 2016, 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.

 

Trovagene Contact:

 

Vicki Kelemen

VP, Corporate Communications

858-952-7652

vkelemen@trovagene.com

 



 

Trovagene, Inc.

Condensed Consolidated Statements of Operations

(in thousands, except for per share amounts)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2017

 

2016

 

2017

 

2016

 

Revenues:

 

 

 

 

 

 

 

 

 

Royalties

 

$

59

 

$

47

 

$

170

 

$

208

 

Diagnostic services

 

58

 

38

 

142

 

69

 

Clinical research services

 

6

 

4

 

8

 

36

 

Total revenues

 

123

 

89

 

320

 

313

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of revenues

 

474

 

424

 

1,428

 

1,143

 

Research and development

 

1,414

 

3,937

 

6,676

 

11,222

 

Selling and marketing

 

420

 

2,941

 

2,443

 

9,127

 

General and administrative

 

3,659

 

2,711

 

9,915

 

9,184

 

Restructuring charges

 

(46

)

 

1,670

 

 

Total operating expenses

 

5,921

 

10,013

 

22,132

 

30,676

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(5,798

)

(9,924

)

(21,812

)

(30,363

)

 

 

 

 

 

 

 

 

 

 

Net interest expense

 

(16

)

(355

)

(877

)

(968

)

Gain on change in fair value of derivative financial instruments- warrants

 

1,529

 

88

 

2,013

 

675

 

Loss on extinguishment of debt

 

 

 

(1,656

)

 

Other loss, net

 

(7

)

 

(5

)

 

Net loss

 

$

(4,292

)

$

(10,191

)

$

(22,337

)

$

(30,656

)

Preferred stock dividend

 

(6

)

(6

)

(18

)

(18

)

Net loss attributable to common stockholders

 

$

(4,298

)

$

(10,197

)

$

(22,355

)

$

(30,674

)

Net loss per common share - basic

 

$

(0.12

)

$

(0.34

)

$

(0.68

)

$

(1.02

)

Net loss per common share - diluted

 

$

(0.12

)

$

(0.34

)

$

(0.68

)

$

(1.04

)

Weighted average shares outstanding - basic

 

36,466

 

30,340

 

32,826

 

30,019

 

Weighted average shares outstanding - diluted

 

36,466

 

30,340

 

32,826

 

30,137

 

 



 

Trovagene, Inc.

 

Condensed Consolidated Balance Sheets

 

(in thousands)

 

 

 

September 30,
2017

 

December 31,
2016

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash, cash equivalents and short-term investments

 

$

7,435

 

$

37,893

 

Accounts receivable

 

178

 

100

 

Prepaid expense and other current assets

 

939

 

957

 

Total current assets

 

8,552

 

38,950

 

Property and equipment, net

 

3,127

 

3,827

 

Other assets

 

539

 

1,173

 

Total Assets

 

$

12,218

 

$

43,950

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

676

 

1,131

 

Accrued expenses

 

2,620

 

4,021

 

Deferred rent

 

298

 

285

 

Current portion of long-term debt

 

1,488

 

2,360

 

Total current liabilities

 

5,082

 

7,797

 

 

 

 

 

 

 

Long-term debt, less current portion

 

 

14,176

 

Derivative financial instruments - warrants

 

2,038

 

835

 

Deferred rent, net of current portion

 

1,153

 

1,374

 

Total Liabilities

 

8,273

 

24,182

 

 

 

 

 

 

 

Stockholders’ equity

 

3,945

 

19,768

 

Total liabilities and stockholders’ equity

 

$

12,218

 

$

43,950

 

 



 

Trovagene, Inc.

 

Condensed Consolidated Statements of Cash Flows

 

(in thousands)

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2017

 

2016

 

 

 

 

 

 

 

Operating activities

 

 

 

 

 

Net loss

 

$

(22,337

)

$

(30,656

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Depreciation and amortization

 

957

 

694

 

Stock based compensation expense

 

3,117

 

5,942

 

Change in fair value of derivative financial instruments - warrants

 

(2,013

)

(675

)

Loss on extinguishment of debt

 

1,656

 

 

Other non-cash items

 

638

 

311

 

Changes in operating assets and liabilities

 

(1,968

)

2,349

 

Net cash used in operating activities

 

(19,950

)

(22,035

)

 

 

 

 

 

 

Investing activities:

 

 

 

 

 

Capital expenditures, net

 

(136

)

(798

)

Net sales and maturities (purchase) of short-term investments

 

24,062

 

(24,451

)

Net cash provided by (used in) investing activities

 

23,926

 

(25,249

)

 

 

 

 

 

 

Financing activities:

 

 

 

 

 

Proceeds from sales of common stock, net of expenses

 

6,635

 

2,294

 

Proceeds from exercise of options

 

 

367

 

Net repayment of debt

 

(17,083

)

(299

)

Net cash (used in) provided by financing activities

 

(10,448

)

2,362

 

Effect of exchange rate changes on cash and cash equivalents

 

(9

)

(2

)

Net change in cash and equivalents

 

(6,481

)

(44,924

)

Cash and cash equivalents—Beginning of period

 

13,915

 

67,493

 

Cash and cash equivalents—End of period

 

$

7,434

 

$

22,569