On October 29, 2020 Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (Nasdaq: IDRA) reported its financial and operational results for the third quarter ended September 30, 2020 (Press release, Idera Pharmaceuticals, OCT 29, 2020, View Source [SID1234569368]).
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"Tilsotolimod is the most advanced TLR-9 agonist therapy in development, and we have made tremendous strides against our objectives for 2020," stated Vincent Milano, Idera’s Chief Executive Officer. "We continue to work diligently against our timelines for ILLUMINATE-301, which currently remain on track for data in the first quarter of 2021. In addition, our recent patent and allowed application for tilsotolimod method-of-use in colorectal and head and neck cancers as well as the continuation of ILLUMINATE-206 reinforce our ‘beyond melanoma’ strategy. We also have the financing to help our outstanding team continue to execute these key objectives."
Corporate Update
Since June 30, 2020, the following corporate updates were announced:
·The Company entered into a private placement of up to $20.0 million, with $5.1 million received in July 2020. The Company anticipates that its current cash, cash equivalents, and short-term investments will fund our operations through the second quarter of 2021. With this private placement, the Company has now entered into three financing vehicles since December 2019, which it believes could provide proceeds of up to $118.2 million to fund the potential NDA filing and commercial launch of tilsotolimod.
·The Company received a new U.S. Patent and allowed application for tilsotolimod, providing exclusivity through September 2037 when intratumoral tilsotolimod is used with certain immune checkpoint inhibitors in treating colorectal cancer (CRC) and head and neck squamous cell carcinoma (HNSCC).
ILLUMINATE (tilsotolimod) Clinical Development Updates
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) by blinded independent central review using 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 of 10 patients, which included Yervoy at 1 mg/kg every 8 weeks and Opdivo 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 Yervoy dosing frequency to every 3 weeks and limiting the number of allowed prior lines of treatment to 2; and
·The Company has opened enrollment for the next 10 patients under the modified study design, with data anticipated in the second quarter of 2021.
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 results 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, ILLUMINATE-301, were shared in a Mini Oral presentation at the ESMO (Free ESMO Whitepaper) Virtual Congress in September 2020.
Third Quarter Financial Results
Research and development expenses for the three months ended September 30, 2020, totaled $4.8 million compared to $8.4 million for the same period in 2019. General and administrative expense for the three months ended September 30, 2020, totaled $2.7 million compared to $3.0 million for the same period in 2019. Additionally, during the three months ended September 30, 2020, we recorded $0.7 million and $12.4 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to securities issued in connection with our December 2019 private placement transaction.
As a result of the factors above, net loss applicable to common stockholders for the three months ended September 30, 2020, was $20.6 million, or $0.59 per basic and diluted share, compared to net loss applicable to common stockholders of $11.1 million, or $0.39 per basic and diluted share, for the same period in 2019. Excluding the non-cash loss of approximately $13.1 million for the three months ended September 30, 2020, related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $7.5 million, or $0.21 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 September 30, 2020, our cash, cash equivalents, and short-term investments totaled $29.0 million. Based on our current operating plan, we anticipate that our current cash, cash equivalents, and short-term investments, will fund our operations through the second quarter of 2021.