“In 2019, we made great progress with ILLUMINATE-301, our registrational trial of tilsotolimod in combination with ipilimumab in anti-PD-1 refractory patients with advanced melanoma. This was the result of outstanding focus and dedication across our organization and enabled us to finish enrollment in the first quarter of 2020, earlier than anticipated. It also positions us to have initial data from the trial early next year,” stated
ILLUMINATE (tilsotolimod) Clinical Development Update
ILLUMINATE-301: Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma:
- Primary endpoint family of ORR per RECIST v1.1 and overall survival (OS);
- Trial initiated in
- Enrollment completed in
March 2020; and
- ORR and other preliminary data expected in Q1 2021.
ILLUMINATE-206: Phase 2, open-label, multicohort, multicenter study to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab for the treatment of solid tumors:
- Trial initiated in
September 2019with the microsatellite stable colorectal cancer (MSS-CRC) cohort;
- Initial safety run-in cohort of 10 patients with MSS-CRC fully enrolled; and
- Preliminary data from this cohort expected in Q2 2020.
ILLUMINATE-204: Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with anti-PD-1 refractory advanced melanoma:
- Enrollment completed in
February 2019at tilsotolimod 8 mg with ipilimumab; and
- Final top-line results from the ILLUMINATE-204 trial, to include ORR, median OS, duration of response (DOR), and safety, are expected to be released in Q2 2020.
- Received new
U.S.Patent for tilsotolimod, providing exclusivity through September 2037when tilsotolimod is used with certain checkpoint inhibitors.
- Entered into private placement financing of up to
$97.7 million, with $10.1 millionreceived in December 2019from initial proceeds and option fees.
Jonathan Yinglingdeparted Idera as its Chief Scientific Officer effective January 31, 2020.
Fourth Quarter Results
Revenue in the fourth quarter of 2019 and 2018 was nominal. Research and development expenses for the three months ended
Additionally, during the fourth quarter of 2019 the Company recorded
As a result of the factors above, net loss applicable to common stockholders for the three months ended
Full Year Results
Revenue for the year ended
The 2019 period also included
As a result of the factors above, net loss applicable to common stockholders for the year ended
Harnessing the approach of the earliest researchers in immunotherapy and the company’s vast experience in developing proprietary immunology platforms, Idera’s lead development program is focused on priming the immune system to play a more powerful role in fighting cancer, ultimately increasing the number of people who can benefit from immunotherapy. Idera also continues to focus on the acquisition, development and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs. To learn more about Idera, visit www.iderapharma.com.
This press release contains forward-looking statements within the meaning of the safe harbor of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, financial position and clinical trial plans, including enrollment and timing of results, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," “schedule,” and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company’s current expectations and projections about future events and various assumptions. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties, and other factors, which may be beyond Idera’s control, and which may cause the actual results, performance, or achievements of the Company to be materially different from future results, performance, or achievements expressed or implied by such forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated or implied by its forward-looking statements including, without limitation: whether the Company’s cash resources will be sufficient to fund the Company’s continuing operations and the further development of the Company’s programs; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials will be indicative of the results that will be generated in future clinical trials, including in clinical trials in different disease indications; whether products based on Idera's technology will advance into or through the clinical trial process when anticipated or at all or warrant submission for regulatory approval; whether such products will receive approval from the FDA or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; and whether the Company's collaborations will be successful. All forward-looking statements included in this release are made as of the date hereof, and are expressly qualified in their entirety by this cautionary notice, including, without limitation, those risks and uncertainties described in the Company’s Annual Report on Form 10-K for the year ended
|Statements of Operations|
|(In thousands, except per share data)|
|Three Months Ended||Twelve Months Ended|
|Research and development||8,368||8,929||34,853||41,841|
|General and administrative||3,420||3,571||12,481||15,420|
|Merger-related costs, net||-||-||-||1,245|
|Total operating expenses||11,788||12,595||47,515||61,618|
|Loss from operations||(11,788||)||(12,496||)||(46,067||)||(60,956||)|
|Other income (expense)|
|Warrant revaluation expense||(598||)||-||(598||)||-|
|Future tranche right revaluation expense||(10,964||)||-||(10,964||)||-|
|Other income (expense), net||118||346||1,114||1,075|
|Deemed dividend related to
|Net loss attributable to common stockholders||$||(51,275||)||$||(12,150||)||$||(84,558||)||$||(59,881||)|
|Net loss per common share applicable to common stockholders — basic and diluted||$||(1.76||)||$||(0.45||)||$||(2.96||)||$||(2.25||)|
|Weighted-average number of common shares used in computing net loss per share applicable to common stockholders — basic and diluted||29,177||27,183||28,545||26,601|
|Balance Sheet Data|
|Cash, cash equivalents and short-term investments||$||42,793||$||71,431|
|Total stockholders' equity (deficit)||(11,168||)||63,994|
|Total liabilities and stockholders' equity (deficit)||$||47,489||$||73,023|
IDERA PHARMACEUTICALS Contacts:
Jill ConwellInvestor Relations & Corporate Communications Phone (484) 348-1675 JCONWELL@IDERAPHARMA.COM John J. Kirby Chief Financial Officer Phone (484) 348-1627 JKIRBY@IDERAPHARMA.COM
Source: Idera Pharmaceuticals, Inc.