Idera Pharmaceuticals Reports First Quarter 2015 Financial Results and Provides Corporate Update
"During the first quarter of this year, we continued to build momentum as we executed on our numerous clinical development programs focused on oncology and rare diseases," stated
"We also are pleased to report that we recently enrolled our first patient harboring the MYD88 L265P oncogenic mutation into our Phase 1/2 clinical trial for diffuse large B-cell lymphoma (DLBCL)," continued Milano. "We are closing in on finalizing clinical arrangements for our intratumoral TLR9 agonist development program and look forward to providing details of the first trial which we plan to initiate in the second half of this year. Our rare disease development programs are on track as we plan to initiate clinical studies in dermatomyositis (DM) and Duchenne muscular dystrophy (DMD) in late 2015 and early 2016, respectively. Finally, our team is continuing the momentum with our gene silencing oligonucleotides (GSO) technology platform as we plan to announce our first disease indications in the second half of this year."
Program Updates
Oncology Programs
Genetically Defined Forms of B-cell Lymphoma
Our program in genetically defined forms of B-cell lymphoma is based on independent research and our pre-clinical studies offering evidence that, in certain B-cell lymphomas, the presence of the MYD88 L265P oncogenic mutation led to over-activation of TLR7 and TLR9 signaling and that blocking these TLRs promoted tumor cell death.
We have enrolled the targeted number of patients at each of the three dose levels to fulfill the requirements for dose escalation, pending successful completion of treatments through the next scheduled data review by the independent safety data monitoring committee, of our Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström's macroglobulinemia, a form of non-Hodgkin lymphoma.
The trial is designed to evaluate IMO-8400's safety, tolerability and potential clinical activity in patients who have a history of relapse or failure to respond to one or more prior therapies. We anticipate efficacy and safety data from this trial will be available in the fourth quarter of 2015.
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Immuno-Oncology Program
We are currently finalizing our first clinical arrangement for our planned clinical trials to determine the safety and efficacy of intratumorally delivered TLR9 agonist in combination with check-point inhibitors. The company intends to initiate the first of multiple clinical trials in the second half of 2015 with anticipated data availability in 2016.
Rare Disease Programs
We are planning to initiate clinical development of IMO-8400 for the treatment of rare diseases. We have selected dermatomyositis and DMD as the first rare diseases for which we plan to develop IMO-8400. We selected these indications for development based on the reported increase in TLR expression in these disease states, expression of cytokines indicative of key TLR-mediated pathways, the identification of prospective biomarkers for evaluation in early clinical trials and with respect to dermatomyositis, the presence of auto-antibodies that can induce TLR-mediated immune responses. We anticipate commencing clinical development in these two indications by initiating a Phase 2 clinical trial in dermatomyositis by the end of 2015 and a Phase 1/2 clinical trial in DMD in early 2016.
Gene Silencing Oligonucleotides
We are currently undertaking an analysis of priority oncology and rare disease indications for development of drug candidates from our GSO technology. Our key considerations in identifying disease indications in our GSO program include: strong evidence that the disease is caused by a specific protein; clear criteria to identify a target patient population; biomarkers for early assessment of clinical proof-of-concept; a targeted therapeutic mechanism for action; and unmet medical need to allow for a rapid development path to approval. We are planning to conduct disease model studies and begin IND-enabling development programs in each of the first two disease indications selected for further development in our GSO program in the second half of 2015.
Recent Corporate Highlights
Financing
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Financial Results
First Quarter 2015 Results
Net loss applicable to common stockholders for the three months ended
As of
About
Forward Looking Statements
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, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, 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. Factors that may cause such a difference include: whether results obtained in preclinical studies and clinical trials such as the results described in this release will be indicative of the results that will be generated in future clinical trials; 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
Idera Pharmaceuticals, Inc. | ||
Condensed Statements of Operations | ||
(In thousands, except per share data) | ||
Three Months Ended | ||
March 31, | ||
2015 | 2014 | |
Alliance Revenue | $ 34 | $ 3 |
Operating Expenses | ||
Research & Development | 8,720 | 6,933 |
General & Administrative | 3,837 | 2,043 |
Total Operating Expenses | 12,557 | 8,976 |
Loss from Operations | (12,523) | (8,973) |
Other Income (Expense), Net | 42 | 12 |
Net Loss | (12,481) | (8,961) |
Preferred stock dividends | -- | 185 |
Net loss applicable to common stockholders | $ (12,481) | $ (9,146) |
Basic and diluted net loss per common share applicable to common stockholders | $ (0.12) | $ (0.12) |
Shares used in computing basic and diluted net loss per common share applicable to common stockholders | 105,067 | 76,018 |
Idera Pharmaceuticals, Inc. | ||
Condensed Balance Sheet Data | ||
(In thousands) | ||
At March 31, | At December 31, | |
2015 | 2014 | |
Cash, Cash Equivalents & Investments | $ 116,877 | $ 48,571 |
Other Assets | 3,433 | 2,855 |
Total Assets | $ 120,310 | $ 51,426 |
Total Liabilities | $ 7,045 | $ 8,024 |
Total Stockholders' Equity | 113,265 | 43,402 |
Total Liabilities & Stockholders' Equity | $ 120,310 | $ 51,426 |
CONTACT: Investor Contact:Robert Doody Vice President, Investor Relations & Corporate Communications. 484-639-7235 rdoody@iderapharma.com