On April 29, 2021 Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (Nasdaq: IDRA) reported its financial and operational results for the first quarter ended March 31, 2021 (Press release, Idera Pharmaceuticals, APR 29, 2021, View Source [SID1234578763]).
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"Despite the disappointing objective response rate (ORR) results from ILLUMINATE-301, our Phase 3 trial in anti-PD-1 refractory advanced melanoma, we continue to explore the potential for tilsotolimod to enhance patients’ immune systems," stated Vincent Milano, Idera’s Chief Executive Officer. "We are evaluating our next steps regarding continuation of ILLUMINATE-301 toward its overall survival (OS) endpoint. We also continue to enroll and treat patients in ILLUMINATE-206, our Phase 2 study in microsatellite-stable colorectal cancer (MSS-CRC)."
Continued Mr. Milano, "In addition, we are very active in our business development efforts to identify and secure new development- or commercial-stage assets to enhance our portfolio, and we believe that our current cash position is strong."
ILLUMINATE (tilsotolimod) Clinical Development
ILLUMINATE-301: The Company reported in March 2021 that it did not meet its primary endpoint of ORR from its randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma. Patient status continues to be monitored in follow-up stages of the trial.
ILLUMINATE-206: Enrollment continues in the Company’s 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, beginning with MSS-CRC.
Initial safety run-in of 10 patients, which included ipilimumab at 1 mg/kg every 8 weeks and nivolumab at 3 mg/kg every 2 weeks, showed that the regimen was generally well tolerated.
Changes in the study design intended to improve potential outcomes in this patient population include increasing ipilimumab dosing frequency to every 3 weeks and limiting the number of allowed prior lines of treatment to 2.
Data from the next 10 patients under the modified study design is anticipated in the fourth quarter of 2021.
Corporate Update Since December 2020
In February 2021, the Company entered into a collaboration and option agreement with Scriptr Global, Inc. to research, develop, and potentially commercialize gene therapy candidates for myotonic dystrophy 1 (DM1) and Friedrich’s Ataxia (FA).
The Company received $16.3 million in net proceeds from its equity distribution agreement and equity line of credit.
Considering the data related to ILLUMINATE-301’s ORR endpoint, in April 2021 the Company initiated a reduction in force that will impact approximately 50% of our workforce by May 31, 2021. The decision was made to better align our workforce to our needs in ongoing tilsotolimod and business development activities.
The Company’s Board of Directors (the "Board") has elected current Board member Michael Dougherty as the Chair of the Board, effective April 28, 2021. He succeeds James Geraghty, who initiated this transition in the interest of Board leadership refreshment after serving as our Board Chair since 2013. Mr. Geraghty is planning to continue to serve as a non-executive director on our Board.
"I want to thank Jim for his tireless leadership over the last 8 years and am looking forward to his continued contributions to our Board," stated Mr. Milano. "I’m also grateful to have Mike step into this broader leadership role on our Board as we take Idera forward."
First Quarter Financial Results
Research and development expenses for the three months ended March 31, 2021 totaled $6.9 million, compared to $9.5 million for the same period in 2020. General and administrative expense for the three months ended March 31, 2021 totaled $3.2 million compared to $3.6 million for the same period in 2020. Additionally, during the three months ended March 31, 2021 and 2020, we recorded a $7.0 million and $1.1 million non-cash warrant revaluation gain, respectively, and a $118.8 million and $20.7 million non-cash future tranche right revaluation gain, respectively, related to securities issued in connection with our December 2019 private placement transaction.
As a result of the factors above, net income for the three months ended March 31, 2021 was $115.7 million, compared to net income of $8.8 million for the same period in 2020. Net income applicable to common stockholders for the three months ended March 31, 2021 was $109.6 million, or $2.66 per basic share, compared to net income applicable to common stockholders of $8.2 million, or $0.27 per basic share, for the same period in 2020. On a diluted basis, net loss applicable to common stockholders for the three months ended March 31, 2021 was $10.0 million, or $0.14 per diluted share, compared to net income applicable to common stockholders of $8.0 million, or $0.22 per diluted share, for the same period in 2020. Excluding the non-cash gain of approximately $125.8 million and $21.8 million for the three months ended March 31, 2021 and 2020, respectively, related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $10.0 million, or $0.24 per basic and diluted share, and $13.0 million, or $0.43 per basic and diluted share, respectively (calculated based upon the basic weighted-average number of common shares, due to the antidilutive effect of net loss).