On March 7, 2018 Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel nucleic acid-based therapeutics for oncology and rare diseases, reported its financial and operational results for the fourth quarter and year ended December 31, 2017 (Press release, Idera Pharmaceuticals, MAR 7, 2018, View Source [SID1234524648]).
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"Our company made tremendous progress throughout 2017 advancing our development programs and we expect the first half of 2018 to be marked by a number of key inflection points for each of these programs," stated Vincent Milano, Idera’s chief executive officer. "In 2018, we are continuing to enroll patients in the ILLUMINATE 204 Phase 2 trial of IMO-2125, with the next planned data update at ASCO (Free ASCO Whitepaper) and completion of enrollment expected by year end. We also recently initiated the Phase 3 ILLUMINATE 301 trial. For IMO-8400, we plan to report top-line data from our Phase 2 trial in dermatomyositis by the end of the 2nd quarter. We also intend to finalize our development plans for our lead nucleic acid chemistry research candidate, IDRA-008 shortly," continued Milano.
"In January, we announced our proposed merger with BioCryst Pharmaceuticals, Inc. that we believe will build greater and more sustainable value for the benefit of stockholders as well as patients with rare diseases beyond what we could achieve alone. The Idera Board determined this combination was compelling from both a strategic and financial perspective following a careful evaluation of a range of strategies to enhance long-term stockholder value. The transaction will create a leading rare disease company with a robust pipeline including two promising Phase 3 rare disease programs and combines synergistic discovery engines that will not only expand the number of rare diseases we can target but create meaningful opportunities for differentiation in the market through joint small molecule and oligo treatments. Importantly, joining with BioCryst will also enable us to achieve cost synergies and increase our financial strength and flexibility," Milano expressed.
Clinical Development Program Updates:
ILLUMINATE (IMO-2125) Clinical Development
ILLUMINATE 204 – Phase 1/2 trial of IMO-2125 in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:
As of March 7, 2018, enrolled 26 patients at 8 mg (RP2D) dose with ipilimumab, enrollment completion expected by year end 2018;
5 of the first 10 evaluable patients at the 8 mg dose of IMO-2125 were responders (50% Overall Response Rate [ORR]);
7 trial sites currently enrolling patients with goal of expansion to 10 sites during first half of 2018;
In pembrolizumab combination arm of the trial, phase 1 dose escalation continues into the last dosing cohort (32 mg); and
Next clinical data update expected at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2018.
ILLUMINATE 101 – Phase 1b trial of intratumoral IMO-2125 monotherapy in patients with refractory solid tumors:
Completed enrollment in first two cohorts (11 patients treated with 8 mg dose of IMO-2125, 8 patients treated with 16 mg dose of IMO-2125);
Two subjects in cohort 1 (8 mg) continue IMO-2125 monotherapy on the 101 study as of March 7, 2018; and
Enrollment of third cohort has commenced (8 patients to be treated with 23 mg dose of IMO-2125).
ILLUMINATE 301 – Randomized phase 3 trial of IMO-2125 in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory metastatic melanoma:
Trial initiated in Q1 2018;
Approximately 80 sites planned for trial participation across 12 countries;
Planned enrollment of approximately 300 patients with Overall Response Rate (ORR) and Overall Survival (OS) as primary endpoints; and
U.S. Food and Drug Administration granted Fast Track Designation for IMO-2125 in combination with ipilimumab for treatment of PD-1 refractory metastatic melanoma in fourth quarter of 2017.
Pioneer (IMO-8400) Development Activities
PIONEER – Phase 2 trial of IMO-8400 in adult patients with dermatomyositis:
Enrollment concluded during Q3 2017 (30 patients); and
Topline phase 2 trial data expected in Q2 2018.
Nucleic Acid Chemistry Research Group
IDRA-008 Development Activities:
Selected apolipoprotein C-III (APOC-III) as first gene target for development for treatment of familial chylomicronemia syndrome (FCS) and familial partial lipodystrophy (FPL);
Completion of pre-clinical toxicology and IND-enabling studies in Q1 2018;
Pre-clinical pharmacology study in cyno-model comparing IDRA-008 to competitive clinical development asset, volanesorsen expected to readout towards the latter part of Q1 2018;
Development decision for IDRA-008 expected during Q2 2018; and
The Company is continuing to evaluate rare-disease opportunities for application of its core nucleic acid chemistry research capability and expertise to yield innovative oligonucleotide therapeutic concepts that address significant unmet medical needs.
Financial Results
Fourth Quarter Results
Net loss applicable to common stockholders for the three months ended December 31, 2017 was $14.9 million, or $0.08 per basic and diluted share, compared to net income applicable to common stockholders of $0.8 million, or $0.01 per basic and diluted share, for the same period in 2016. Revenue in the fourth quarter of 2017 was nominal and primarily related to our collaboration with GSK. Revenue in the fourth quarter of 2016 was $15.3 million, primarily related to the agreement we entered into with Vivelix in November 2016 in which we received an upfront, non-refundable fee of $15 million. Research and development expenses for the three months ended December 31, 2017 totaled $10.4 million compared to $11.0 million for the same period in 2016. General and administrative expense for the three months ended December 31, 2017 totaled $4.8 million compared to $3.5 million for the same period in 2016.
Full Year Results
Net loss applicable to common stockholders for the year ended December 31, 2017 was $66.0 million or $0.42 per basic and diluted share, compared to net loss applicable to common stockholders of $38.4 million, or $0.30 per basic and diluted share, for the same period in 2016. Revenue for the year ended December 31, 2017 was $0.9 million compared to revenue of $16.2 million for the same period in 2016. Revenue in the 2017 period primarily related to our collaboration with GSK. Revenue in the 2016 period primarily related to collaborations with both GSK and Vivelix, including an upfront, non-refundable fee of $15 million received in connection with the Vivelix Agreement. Research and development expenses for the year ended December 31, 2017 totaled $50.7 million compared to $39.8 million for the same period in 2016. General and administrative expenses for the year ended December 31, 2017 totaled $16.7 million compared to $15.1 million for the same period in 2016.
As of December 31, 2017, our cash, cash equivalents and investments totaled $112.6 million compared to $109.0 million as of December 31, 2016. We currently anticipate that, based on our current operating plan and without taking into account the transaction with BioCryst, our existing cash, cash equivalents and investments will fund our operations into the second quarter of 2019.
Corporate Updates:
On January 22, 2018, BioCryst Pharmaceuticals, Inc. ("BioCryst") and Idera jointly announced the signing of a definitive merger agreement to create a company focused on the development and commercialization of medicines to serve patients suffering from rare diseases. The combined company will be renamed upon closing, and will be led by Vincent Milano, the current chief executive officer of Idera. Jon Stonehouse, the current chief executive officer of BioCryst, will serve as a member of the Board of Directors. The transaction is subject to approval by the stockholders of both companies, as well as the satisfaction of customary closing conditions. The transaction is expected to be completed by the end of the second quarter of 2018.