SAN DIEGO--(BUSINESS WIRE)--Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, today announced company highlights and financial results for the full year ended December 31, 2014.
“Since the beginning of 2014, we have made significant progress toward our goal of becoming a leading precision oncology biotechnology company,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “We made substantial strides with our lead product candidate entrectinib on both the clinical and regulatory fronts, we achieved CLIA registration of our in-house diagnostics laboratory, we acquired rights to a number of additional promising development programs and we have bolstered our balance sheet and strengthened our team. We look forward to continuing our efforts to develop first-in-class and best-in-class precision medicines to help cancer patients with unmet needs.”
Company Highlights
Teva Asset Acquisition and Concurrent Financing
Ignyta and Teva Pharmaceutical Industries Ltd. jointly announced in a separate press release today that Ignyta has acquired worldwide rights and assets relating to four targeted oncology development programs from Teva. Concurrently, Ignyta entered into purchase agreements with Teva and selected healthcare investors to sell to such investors a total of approximately 4.2 million shares of its common stock in a registered direct offering, which resulted in gross aggregate proceeds to Ignyta of approximately $42 million. The news release detailing these transactions can be found on Ignyta’s website at www.ignyta.com.
Regulatory Developments for Entrectinib
In February 2015 and December 2014, the company announced that the U.S. Food and Drug Administration (FDA) granted the company orphan drug designation for entrectinib, Ignyta’s proprietary oral tyrosine kinase inhibitor targeting solid tumor indications, for the treatment of neuroblastoma and for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive non-small cell lung cancer and colorectal cancer, as well as rare pediatric disease designation for entrectinib for the treatment of neuroblastoma.
Under the FDA's Orphan Drug Designation program, orphan drug designation is granted by the FDA to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation allows the drug developer to be eligible for a seven-year period of U.S. marketing exclusivity upon approval of the drug, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical trial design assistance and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
Under the FDA's Pediatric Disease Priority Review Voucher program, upon the approval of a qualifying new drug application (NDA) or biologics license application (BLA) for the treatment of a rare pediatric disease, the sponsor of such application would be eligible for a Pediatric Disease Priority Review Voucher that can be used to obtain priority review for a subsequent NDA or BLA. The FDA defines a "rare pediatric disease" as a disease that affects fewer than 200,000 individuals in the U.S. primarily aged from birth to 18 years. The Priority Review Voucher may be sold or transferred an unlimited number of times.
Clinical Developments for Entrectinib
In July 2014, Ignyta announced the commencement of its global Phase I/II clinical trial of entrectinib. This clinical trial is called STARTRK-1, which is the first of the “Studies Targeting Alterations Responsive to Targeted Receptor Kinase” inhibition, and is a Phase I/IIa, multicenter, single-arm, open-label clinical trial of continuous daily dosing of oral entrectinib in adult patients with locally advanced or metastatic cancer confirmed to be positive for relevant molecular alterations. The trial will involve multiple clinical sites in the U.S., Europe, and Asia.
Ignyta has also continued the ALKA-372-001 dose escalation clinical trial of entrectinib, which is designed to determine the maximum tolerated dose (MTD), recommended Phase II dose and preliminary anti-cancer activity of single agent entrectinib in patients with solid tumors with activating alterations in the TrkA, ROS1 or ALK tyrosine kinase receptors.
In September 2014, Ignyta announced interim results from the ALKA-372-001 clinical trial at the 2014 Congress of the European Society for Medical Oncology (ESMO) in Madrid, Spain. The interim findings as of such date showed:
- No dose-limiting toxicities were observed, and only one Grade 3 or higher possibly drug-related adverse event was observed (Grade 3 fatigue, which subsided with dose reduction);
- Eight patients remained on active treatment across the three dosing schedules, with four patients having received 9 to 21 cycles of treatment;
- Entrectinib demonstrated a complete response in a patient with ROS1-positive non-small cell lung cancer (NSCLC);
- Entrectinib demonstrated five partial responses, in patients with three different cancer histologies (colorectal cancer, NSCLC and neuroblastoma) and in patients with each of TrkA, ROS1 and ALK alterations; and
- Entrectinib demonstrated prolonged stable disease in two patients: one with ALK-positive NSCLC and one with ROS1-positive pancreatic cancer.
Financing Transactions
In September 2014, Ignyta announced that it had secured a $31 million term loan facility from Silicon Valley Bank (SVB). Under the loan facility, the company received initial funding of $21 million, approximately $11 million of which was used to repay the company’s existing loan with SVB, and it has a conditional option to receive an additional $10 million.
The loan agreement provides that the second tranche of $10 million may be drawn down at Ignyta’s discretion at any time prior to September 30, 2015, provided that Ignyta has initiated the Phase IIa portion of the ongoing STARTRK-1 Phase I/IIa clinical study of entrectinib and other customary funding conditions are met.
In March 2014, the company announced that it had issued an aggregate of 6,031,750 shares of its common stock in an underwritten public offering at a purchase price per share of $9.15, which resulted in aggregate net proceeds of approximately $51.6 million and enabled the company to up-list to the Nasdaq Capital Market.
License of Additional Product Candidate
In August 2014, Ignyta announced that it entered into a license agreement with Nerviano Medical Sciences S.r.l. that grants Ignyta exclusive global development and commercialization rights to its RXDX-103 drug development program. RXDX-103 targets the cell division cycle 7-related (Cdc7) protein kinase and is in development for the potential treatment of multiple cancers.
Financial Results
For the 2014 fiscal year, net loss was $40.0 million, or $2.18 per share, compared with $14.2 million, or $3.83 per share, for the 2013 fiscal year.
Ignyta had no material revenues during 2014 or 2013.
Research and development expenses for 2014 were $30.5 million, compared with $10.2 million for 2013. The increase was primarily attributable to a $10 million milestone payment the company made to Nerviano relating to the entrectinib program and the payment of an upfront license fee of $3.5 million to Nerviano for rights to the RXDX-103 program, as well as an increase in activities relating to development of entrectinib. The company also incurred an increase between periods for personnel expenses related to additional employees and consultants to help advance its product candidates and facilities related expenses as a result of the expansion of its leased facilities space.
General and administrative expenses were $9.5 million for 2014, compared with $3.7 million for 2013. The increase was primarily caused by increases in personnel, audit, legal and intellectual property costs, some of which resulted from activities relating to operating as a public company, and facilities related expenses as a result of the expansion of the company’s leased facilities space.
At December 31, 2014, the company had cash, cash equivalents and available-for-sale securities totaling $76.6 million and current and long-term debt of $21.0 million. At December 31, 2013, the company had cash and cash equivalents totaling $51.8 million and current and long-term debt of $10.0 million.
Ignyta Slide Deck and Conference Call
Ignyta has posted a slide presentation relating to the Teva transaction, its new development programs and the concurrent equity financing on the Investors page of the company’s website at http://investor.ignyta.com. On Tuesday, March 17, 2015, Ignyta will host a conference call with interested parties beginning at 5:00 p.m. ET (2:00 p.m. PT) to discuss the transactions and related matters. A live webcast of the conference call will be available online on the Investors page of the company's website at http://investor.ignyta.com. The call will also be archived and accessible at that site for one year. Alternatively, callers may participate in the conference call by dialing (888) 734-0328 (domestic) or (678) 894-3054 (international), and entering passcode 5138138.
Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, Ignyta’s development plans for its new product candidates, its other product candidates and discovery programs, the company’s financial results and status, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.
About Ignyta, Inc.
Ignyta, Inc., located in San Diego, California, is a precision oncology biotechnology company pursuing an integrated therapeutic (Rx) and companion diagnostic (Dx) strategy for treating cancer patients. The company’s goal with this Rx/Dx approach is to discover, develop and commercialize new drugs that target activated cancer genes and pathways for the customized treatment of cancer. It aims to achieve this goal by pairing each of its product candidates with biomarker-based companion diagnostics that are designed to identify, at the molecular level, the patients who are most likely to benefit from the precisely targeted drugs the company develops. For more information, please visit: www.ignyta.com.
Forward-Looking Statements
This press release contains forward-looking statements about Ignyta as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the development of Ignyta’s new or other product candidates, the potential advantages and first-in-class or best-in-class nature of these drug programs and the potential for Ignyta to establish a leadership position in oncology personalized medicine and provide benefit to cancer patients. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; regulatory developments in the United States and foreign countries; Ignyta’s ability to develop, complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Ignyta’s plans to develop and commercialize its product candidates; the potential for final results of the ongoing Phase I/II clinical trials of entrectinib, or any future clinical trials of entrectinib or other product candidates, to differ from preliminary or expected results; Ignyta’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; Ignyta’s ability to obtain and maintain intellectual property protection for its product candidates; the potential for the company to fail to maintain the CLIA registration of its diagnostic laboratory or to fail to achieve full CLIA accreditation of such laboratory; the loss of key scientific or management personnel; competition in the industry in which Ignyta operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Ignyta assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at www.sec.gov, including without limitation Ignyta’s Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent Quarterly Reports on Form 10-Q.
| IGNYTA, INC. | ||||||||||
| SUMMARY STATEMENTS OF OPERATIONS | ||||||||||
| (Audited) | ||||||||||
| Year ended December 31, | ||||||||||
| 2014 | 2013 | |||||||||
| (in thousands, except per share data) | ||||||||||
|
Revenue |
$ | 150 | -- | |||||||
| Operating costs and expenses | ||||||||||
| Research and development | 30,505 | 10,171 | ||||||||
| General and administrative | 9,494 | 3,731 | ||||||||
| Total operating costs and expenses | 39,999 | 13,902 | ||||||||
| Loss from operations | (39,849 | ) | (13,902 | ) | ||||||
| Other income (expense) | 13 | (106 | ) | |||||||
| Interest income (expense) | (142 | ) | (204 | ) | ||||||
| Loss before income tax | (39,978 | ) | (14,212 | ) | ||||||
| Income tax provision | 12 | 2 | ||||||||
| Net loss | $ | (39,990 | ) | $ | (14,214 | ) | ||||
| Basic and diluted net loss per share | $ | (2.18 | ) | $ | (3.83 | ) | ||||
| Shares used to calculate net loss per share | 18,328 | 3,712 | ||||||||
| IGNYTA, INC. | ||||||||
| SUMMARY BALANCE SHEETS | ||||||||
| (Audited) | ||||||||
| December 31, | December 31, | |||||||
| 2014 | 2013 | |||||||
| (in thousands) | ||||||||
| ASSETS | ||||||||
| Cash and cash equivalents | $ | 6,346 | $ | 51,804 | ||||
| Short term investments | 63,201 | -- | ||||||
| Prepaid expenses and other current assets | 1,731 | 671 | ||||||
| Total current assets | 71,278 | 52,475 | ||||||
| Fixed assets, net | 6,281 | 831 | ||||||
| Long term investments | 7,086 | -- | ||||||
| Other assets | 659 | 13 | ||||||
| Total assets | $ | 85,304 | $ | 53,319 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Accounts payable | $ | 975 | $ | 812 | ||||
| Accrued expenses and other liabilities | 4,930 | 590 | ||||||
| Notes payable, current portion | 1,400 | -- | ||||||
| Lease payable, current portion | 172 | -- | ||||||
| Warrant liability | -- | 129 | ||||||
| Total current liabilities | 7,477 | 1,531 | ||||||
| Notes payable, net of current portion and discount | 18,830 | 8,950 | ||||||
| Lease payable, net of current portion | 344 | -- | ||||||
| Other liabilities | 2,705 | 1,050 | ||||||
| Total liabilities | 29,356 | 11,531 | ||||||
| Total stockholders’ equity | 55,948 | 41,788 | ||||||
| Total liabilities and stockholders' equity | $ | 85,304 | $ | 53,319 | ||||
