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Ignyta, Inc. (1557421) SEC Filing 10-Q Quarterly report for the period ending Thursday, June 30, 2016

Ignyta, Inc.

CIK: 1557421

Exhibit 99.1

Ignyta Announces First Quarter 2016

Company Highlights and Financial Results

May 10, 2016 4:00 PM Eastern Time

SAN DIEGO—(BUSINESS WIRE)—Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, today announced company highlights and financial results for the first quarter ended March 31, 2016.

“During 2016, we have continued to make significant progress towards becoming a leading precision medicine company focused on the development of first-in-class and best-in-class therapies for the benefit of cancer patients, and we have steadily advanced each of our three clinical stage assets,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “For our lead program, entrectinib, we have continued to successfully execute our potentially registration-enabling Phase 2 clinical trial, STARTRK-2. We also announced at the AACR Annual Meeting compelling results from our two Phase 1 clinical trials, highlighting entrectinib’s emerging safety and efficacy profile. For the RXDX-105 program, we selected a recommended Phase 2 dose and initiated the Phase 1b portion of our ongoing clinical trial. For the taladegib program, we reported a complete response in a patient with medulloblastoma – providing the first clinical proof of concept for taladegib in a solid tumor type outside of advanced basal cell carcinoma. Finally, we strengthened our balance sheet, enabling us to continue to move rapidly to develop meaningful new therapies for the benefit of cancer patients.”

Company Highlights

Updated Entrectinib Data Presented at AACR Annual Meeting

In April 2016, updated results of the two Phase 1 clinical trials of entrectinib, the company’s proprietary oral tyrosine kinase inhibitor targeting solid tumors harboring activating alterations to NTRK1, NTRK2, NTRK3, ROS1 or ALK, were presented in an oral plenary session at the 2016 Annual Meeting of the American Association for Cancer Research (AACR) in New Orleans, Louisiana.

The data cut-off for the AACR presentation was March 7, 2016. Highlights of the data included:

Safety

A total of 119 patients with a range of solid tumors had been dosed across the two Phase 1 clinical trials, with 45 patients treated at the recommended Phase 2 dose (RP2D) of 600 mg, taken orally once per day (QD).

 

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The following information was filed by Ignyta, Inc. on Tuesday, May 10, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Definitive Proxy Statement (Form DEF 14A)
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Ignyta, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2016 10-K Annual Report includes:

  • Voting Procedures
  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors

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Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Balance Sheets
Condensed Balance Sheets (parenthetical)
Condensed Statements Of Cash Flows
Condensed Statements Of Operations And Comprehensive Loss
Asset Acquisition
Asset Acquisition - Additional Information (detail)
Balance Sheet Details
Balance Sheet Details (tables)
Balance Sheet Details - Additional Information (detail)
Balance Sheet Details - Schedule Of Accrued Expenses And Other Liabilities (detail)
Balance Sheet Details - Schedule Of Other Long-term Liabilities (detail)
Balance Sheet Details - Schedule Of Property And Equipment (detail)
Commitments And Contingencies
Commitments And Contingencies - Additional Information (detail)
Equity Awards
Equity Awards (tables)
Equity Awards - Additional Information (detail)
Equity Awards - Assumptions Used To Estimate Fair Value Of Option Granted (detail)
Equity Awards - Summary Of Option Activity And Other Related Information (detail)
Equity Awards - Summary Of Stock-based Compensation Expense For Equity Awards Including Rsus To Employees And Non-employees (detail)
Fair Value Measurements
Fair Value Measurements (tables)
Fair Value Measurements - Schedule Of Fair Value Of Cash, Cash Equivalents And Available-for-sale Investment Securities (detail)
Investment Securities
Investment Securities (tables)
Investment Securities - Summary Of Available For Sale Investment Securities Held By The Company (detail)
License Agreements
License Agreements - Additional Information (detail)
Organization And Basis Of Presentation
Organization And Basis Of Presentation (policies)
Organization And Basis Of Presentation - Additional Information (detail)
Stockholders' Equity
Stockholders' Equity - Additional Information (detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies - Additional Information (detail)
Term Loan Facility
Term Loan Facility (tables)
Term Loan Facility - Additional Information (detail)
Term Loan Facility - Future Minimum Principal Payments (detail)

Material Contracts, Statements, Certifications & more

Ignyta, Inc. provided additional information to their SEC Filing as exhibits

CIK: 1557421
Form Type: 10-Q Quarterly Report
Accession Number: 0001193125-16-676749
Submitted to the SEC: Tue Aug 09 2016 4:08:52 PM EST
Accepted by the SEC: Tue Aug 09 2016
Period: Thursday, June 30, 2016
Industry: Pharmaceutical Preparations

External Resources:
SEC.gov

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