On April 30, 2020 Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (Nasdaq: IDRA) reported its financial and operational results for the first quarter ended March 31, 2020 (Press release, Idera Pharmaceuticals, APR 30, 2020, View Source [SID1234556900]).
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"I’m proud of what Idera has accomplished since the beginning of the year, despite the worldwide impact of the COVID-19 pandemic. We have completed and reported encouraging data from ILLUMINATE-204, secured additional financing to help execute our key objectives, and, to date, are on track with timelines for both ILLUMINATE-301 and ILLUMINATE-206," stated Vincent Milano, Idera’s Chief Executive Officer. "The level of dedication and determination from our employees, our partners, and our investigators is incredibly inspiring."
Since December 31, 2019, the Company entered into a private placement financing of up to $20.7 million, with $5 million received in April 2020. The Company anticipates that its current cash, cash equivalents, and short-term investments will fund our operations into the second quarter of 2021.
ILLUMINATE (tilsotolimod) Clinical Development Updates
ILLUMINATE-204: Phase 1/2 trial of tilsotolimod in combination with Yervoy* or Keytruda± (pembrolizumab) in patients with anti-PD-1 refractory advanced melanoma:
·Final topline results released in April 2020 from the recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy, which is the treatment regimen being evaluated in the Company’s registrational trial, ILLUINATE-301.
oMedian overall survival (OS) was 21.0 months (95% confidence interval (CI): 9.8 months-not reached (NR));
oThe overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) was 22.4%, including 2 complete responses (95% CI: 11.8-36.6%);
oThe disease control rate (stable disease or better) was 71.4% (95% CI: 56.7%-83.4%);
oMedian duration of response was 11.4 months (95% CI: 3.3 months-NR); and
oThe combination regimen was generally well tolerated.
·Final data from the trial to be submitted for presentation at a medical conference in the second half of 2020.
ILLUMINATE-301: Randomized phase 3 trial of tilsotolimod in combination with Yervoy (ipilimumab) versus Yervoy alone in patients with anti-PD-1 refractory advanced melanoma:
·Primary endpoint family of overall response rate (ORR) per RECIST v1.1 and overall survival (OS);
·Trial initiated in March 2018;
·Enrollment completed in March 2020; and
·ORR and other preliminary data expected in the first quarter of 2021.
ILLUMINATE-206: Phase 2, open-label, multicohort, multicenter study to test the safety and effectiveness of tilsotolimod in combination with Yervoy and Opdivo* (nivolumab) for the treatment of solid tumors:
·Trial initiated in September 2019 with 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 the second quarter of 2020.
First Quarter Financial Results
Research and development expenses for the three months ended March 31, 2020 totaled $9.5 million compared to $8.1 million for the same period in 2019. General and administrative expense for the three months ended March 31, 2020 totaled $3.6 million compared to $3.1 million for the same period in 2019. Additionally, during the three months ended March 31, 2020 we recorded $1.1 million and $20.7 million of non-cash warrant revaluation income and non-cash future tranche right revaluation income, respectively, related to securities issued in connection with our December 2019 private placement transaction.
As a result of the factors above, net income applicable to common stockholders for the three months ended March 31, 2020 was $8.8 million, or $0.27 per basic share and $0.22 per diluted share, compared to net loss applicable to common stockholders of $11.0 million, or $0.40 per basic and diluted share, for the same period in 2019. Excluding the non-cash income of approximately $21.8 million for the three months ended March 31, 2020 related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $13.0 million, or $0.43 per basic and diluted share (calculated based upon the basic weighted-average number of common shares, due to the antidilutive effect of net loss).
As of March 31, 2020, our cash, cash equivalents, and short-term investments totaled $33.5 million, which includes a $6.2 million contingently refundable option fee received in connection with the December 2019 private placement transaction. Based on our current operating plan, we anticipate that our current cash, cash equivalents, and short-term investments, including the $6.2 million contingently refundable option fee and the $5.0 million gross proceeds in cash received in April 2020 pursuant to the April 2020 Securities Purchase Agreement, will fund our operations into the second quarter of 2021.