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EXTON, Pa., May 02, 2019 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (“Idera”) (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development, and ultimately the commercialization, of therapeutic drug candidates for both oncology and rare disease indications, today reported its financial and operational results for the first quarter ended March 31, 2019.
“The first quarter of this year represented another period of solid execution from everyone on our team,” stated Vincent Milano, Idera’s Chief Executive Officer. “During this quarter, we completed enrollment of ILLUMINATE-204, positioning ourselves to provide a full analysis from this trial in the fourth quarter of this year. We’ve also made significant progress with the enrollment of Idera’s first pivotal trial, ILLUMINATE-301, for which we expect to complete accrual during the fourth quarter. And, we recently presented the data from the ILLUMINATE-101 monotherapy trial at AACR, strengthening the body of translational and clinical evidence that tilsotolimod stimulates an immune response within the tumor microenvironment. We believe that this may be a key to enhancing the outcomes of existing immunotherapy regimens.”
Milano continued, “Lastly, we’ve made great strides in preparing to initiate the expansion of activities for tilsotolimod through the ILLUMINATE-206 multi-cohort trial, which we anticipate will launch this quarter. We appreciate the financial commitment and teamwork from our collaboration partner, Bristol-Myers Squibb, which assisted us in taking on this endeavor. Overall, this has been a highly productive quarter for our team and the momentum continues to swell as we advance towards these critical catalysts for our company.”
ILLUMINATE (tilsotolimod) Clinical Development
ILLUMINATE 301 – Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory metastatic melanoma:
ILLUMINATE 206 – Phase 2, multi-center trial to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab in treating patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Microsatellite Stable Colorectal Cancer (MSS-CRC).
ILLUMINATE 204 – Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:
ILLUMINATE 101 – Phase 1b trial of tilsotolimod monotherapy in patients with refractory solid tumors:
First Quarter Results
Net loss applicable to common stockholders for the three months ended March 31, 2019 was $11.0 million, or $0.40 per basic and diluted share, compared to net loss applicable to common stockholders of $20.1 million, or $0.81 per basic and diluted share, for the same period in 2018. Revenue for each of the three months ended March 31, 2019 and 2018 was nominal. Research and development expenses for the three months ended March 31, 2019 totaled $8.1 million compared to $13.6 million for the same period in 2018. General and administrative expense for the three months ended March 31, 2019 totaled $3.1 million compared to $3.5 million for the same period in 2018. Merger-related costs, net for the three months ended March 31, 2018 totaled $3.4 million and related to our contemplated merger transaction. No such costs were incurred for the same period in 2019. Restructuring costs for the three months ended March 31, 2019 was nominal and related to our decision in July 2018 to wind-down our discovery operations. No such costs were incurred for the same period in 2018.
As of March 31, 2019, our cash, cash equivalents and investments totaled $59.9 million compared to $71.4 million as of December 31, 2018. We currently anticipate that, based on our current operating plan, our existing cash, cash equivalents and investments will fund our operations into the second quarter of 2020.
About Idera Pharmaceuticals
Harnessing the approach of the earliest researchers in immunotherapy and the company’s vast experience in developing proprietary immunomodulatory platforms, Idera’s TLR agonist 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 Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the company’s strategy, future operations, collaborations, cash resources, financial position, future revenues, projected costs, prospects, clinical trials, plans and objectives of management, are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. 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. 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 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 for the period anticipated; 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; whether products based on the company’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 U.S. Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the company's products receive approval, they will be successfully distributed and marketed; whether the Company's collaborations will be successful; and such other important factors set forth under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the period ended December 31, 2018. Although Idera may elect to do so at some point in the future, the company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Idera Pharmaceuticals, Inc.
Condensed Statements of Operations
(In thousands, except per share data)
|Three Months Ended|
|Research and development||8,102||13,556|
|General and administrative||3,143||3,481|
|Merger-related costs, net||-||3,498|
|Total operating expenses||11,376||20,535|
|Loss from operations||(11,376||)||(20,280||)|
|Other income (expense), net||402||185|
|Net loss per common share applicable |
to common stockholders — basic and diluted
|Weighted-average number of common shares used in computing net|
loss per share applicable to common stockholders — basic and diluted
Idera Pharmaceuticals, Inc.
Condensed Balance Sheet Data
|March 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||59,864||$||71,431|
|Total stockholders' equity||55,672||63,994|
|Total liabilities and stockholders' equity||$||62,001||$||73,023|
Source: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals Contact:
Robert A. Doody, Jr.
VP, Investor Relations & Communications
Phone (484) 348-1677
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