EXTON, PA — Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) reported its financial and operational results for the second quarter ended June 30, 2020.
“Idera meaningfully advanced its clinical pipeline and strengthened its financial resources in the first part of 2020. Further encouraged by data from ILLUMINATE-204, which we reported in the second quarter, we continue to work diligently against our timelines for ILLUMINATE-301. Those timelines currently remain on track for data in the first quarter of 2021, despite disruptions from the global impact of COVID-19,” stated Vincent Milano, Idera’s Chief Executive Officer.
“In addition, as part of our ‘beyond melanoma’ strategy, early data from ILLUMINATE-206 reinforces our optimism in the potential of tilsotolimod in patients with micro-satellite stable colorectal cancer. Lastly, our team’s outstanding perseverance and dedication to our patients combined with the further financing we recently secured will help us continue to execute these key objectives and potentially beyond.”
Since March 31, 2020, the Company entered into two private placement financings of up to $40.7 million, with $5.0 million received in April 2020 and $5.1 million received in July 2020.
The Company anticipates that its current cash, cash equivalents, and short-term investments will fund their operations into the second quarter of 2021.
With the Company’s current financing vehicles, there exists the possibility to extend that runway through subsequent proceeds to fund the potential NDA filing and commercial launch of tilsotolimod.
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 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;
- Planned 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
- Enrollment of the next 10 patients is targeted to begin in the fourth quarter of 2020, 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 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, ILLUMINATE-301; and
- Final data from the trial will be shared in a Mini Oral presentation at the ESMO Virtual Congress 2020, to be held September 19-21, 2020.
Second Quarter Financial Results
Research and development expenses for the three months ended June 30, 2020 totaled $5.4 million compared to $10.0 million for the same period in 2019.
General and administrative expense for the three months ended June 30, 2020 totaled $2.6 million compared to $2.9 million for the same period in 2019.
Additionally, during the three months ended June 30, 2020, the Company recorded $0.9 million and $15.3 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to securities issued in connection with their December 2019 private placement transaction.
As a result of the factors above, net loss applicable to common stockholders for the three months ended June 30, 2020 was $24.2 million, or $0.72 per basic and diluted share, compared to net loss applicable to common stockholders of $11.2 million, or $0.39 per basic and diluted share, for the same period in 2019.
Excluding the non-cash loss of approximately $16.3 million for the three months ended June 30, 2020 related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $8.0 million, or $0.24 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 June 30, 2020, the Company’s cash, cash equivalents, and short-term investments totaled $31.0 million. Based on their current operating plan, the Company anticipates that their current cash, cash equivalents, and short-term investments, including $5.1 million gross proceeds in cash received in July 2020 pursuant to the July 2020 Securities Purchase Agreement, will fund the Company’s operations into the second quarter of 2021.
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