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Idera Pharmaceuticals (Nasdaq: IDRA) has announced the termination of its ILLUMINATE-301 trial, which tested tilsotolimod with ipilimumab for advanced melanoma, due to failure to meet its primary endpoint of overall survival. The decision follows disappointing results reported in March 2021, indicating no significant improvement in patient outcomes. Idera's CEO, Vincent Milano, expressed gratitude for the involvement of patients and investigators, while the company continues to focus on other trials, including ILLUMINATE-206 for colorectal cancer. Additionally, Chief Medical Officer Elizabeth Tarka will depart the company on May 28, 2021.
Idera Pharmaceuticals (Nasdaq: IDRA) reported Q1 2021 results, revealing a net income of $115.7 million, significantly up from $8.8 million in Q1 2020. This was primarily driven by non-cash gains from the revaluation of warrants and securities. Despite these gains, the company faced setbacks, notably not meeting the primary endpoint in its ILLUMINATE-301 trial for advanced melanoma. A reduction in workforce of 50% is planned to align resources with ongoing projects, including ILLUMINATE-206 in colorectal cancer. Idera aims to strengthen its portfolio through strategic collaborations.
Idera Pharmaceuticals announced that its pivotal trial, ILLUMINATE-301, did not meet its primary endpoint of objective response rate (ORR) for the treatment of advanced melanoma. The trial compared tilsotolimod plus ipilimumab to ipilimumab alone but showed an ORR of only 8.8% for the combination versus 8.6% for ipilimumab. Despite this setback, the company plans to evaluate overall survival data and continue its ILLUMINATE-206 study for colorectal cancer. The trial had a disease control rate of 34.5% for the combination.
Idera Pharmaceuticals (Nasdaq: IDRA) reported its Q4 and full-year results, revealing a net loss of $76.7 million in Q4 2020, up from $51.3 million in Q4 2019. The full-year net loss was $112.7 million, compared to $84.6 million in 2019. Research and development expenses decreased to $5.1 million in Q4 2020 from $8.4 million in Q4 2019. Idera is focused on its pivotal trial, ILLUMINATE-301, for tilsotolimod in advanced melanoma, with data expected soon. The company has $37.7 million in cash, which will sustain operations into Q2 2022.
Idera Pharmaceuticals (NASDAQ: IDRA) announced a pivotal outlook for 2021, highlighting the anticipated data from its ILLUMINATE program. CEO Vincent Milano stated that topline response data from ILLUMINATE-301 is expected late this quarter, with further updates from ILLUMINATE-206 in Q3. The company's cash reserves are projected to support operations into Q1 2022. Idera aims to leverage its innovative science to bring therapeutic advancements for patients suffering from advanced melanoma and colorectal cancer. Upcoming presentations will take place at notable conferences in January 2021.
Idera Pharmaceuticals (Nasdaq: IDRA) has closed a second tranche of a securities purchase agreement, raising up to $20.7 million through the sale of 2,747,252 shares and warrants. This tranche secured $5 million in gross proceeds, with intentions to fund the ILLUMINATE-301 clinical trial for its lead product, tilsotolimod. The company aims to address unmet medical needs in anti-PD-1 refractory advanced melanoma. Idera's therapies have received Fast Track and Orphan Drug designations from the FDA, enhancing their potential market appeal.
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) announced the appointment of Daniel Soland as Senior VP and COO, starting January 4, 2021. Soland, a seasoned biotech leader, will oversee Idera's commercial strategy as the company prepares for its pivotal trial results and the commercial launch of tilsotolimod in 2021. Clayton Fletcher, current SVP of Business Development, will retire but continue as a consultant. Tilsotolimod is under investigation for treating advanced refractory melanoma and has received Fast Track and Orphan Drug designations from the FDA.
Idera Pharmaceuticals (Nasdaq: IDRA) reported its Q3 2020 financial results, showing a net loss of $20.6 million or $0.59 per share, compared to $11.1 million or $0.39 per share in Q3 2019. Research and development expenses fell to $4.8 million, down from $8.4 million year-over-year. The company remains on track for ILLUMINATE-301 trial data expected in Q1 2021 and has secured $20 million in a private placement. A new patent for tilsotolimod ensures exclusivity in treating colorectal and head and neck cancers through September 2037.
Idera Pharmaceuticals (IDRA) announced the presentation of final data from two key trials at the upcoming ESMO Virtual Congress 2020. The ILLUMINATE-204 trial focuses on intratumoral tilsotolimod in advanced melanoma patients, combining it with Yervoy (ipilimumab). Additionally, final results from the ILLUMINATE-101 trial, evaluating tilsotolimod monotherapy for refractory solid tumors, will be shared. Idera will also present at the H.C. Wainwright 22nd Annual Global Investment Conference. The investigational agent has received Fast Track and Orphan Drug designations from the FDA.
Idera Pharmaceuticals (Nasdaq: IDRA) reported Q2 2020 financial results and clinical updates. The company advanced its clinical pipeline, particularly with tilsotolimod, maintaining timelines for the ILLUMINATE-301 trial despite COVID-19 disruptions. Financially, Idera secured $40.7 million through private placements, ensuring funding into Q2 2021. R&D expenses reduced to $5.4 million from $10.0 million YOY, but net loss increased to $24.2 million, or $0.72 per share. As of June 30, 2020, cash and equivalents totaled $31.0 million, supporting operations moving forward.
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