Idera Pharmaceuticals Reports Fourth Quarter and Year End 2016 Financial Results and Provides Corporate Update
- IMO-2125 Confirmed Responses in PD-1 Refractory Melanoma Appear Durable -
- First Third Generation Antisense (3GA) Target Selected; Poised to
During 2016, the Company:
- Completed enrollment in the dose escalation cohorts of the ipilimumab combination arm of the ongoing Phase 1/2 clinical trial of intratumoral IMO-2125 in PD-1 refractory metastatic melanoma;
- No dose-limiting toxicity reported in studied dose levels; MTD not reached;
- Patients with confirmed clinical responses have been on study past one year; and
- Supplementary patients being added to inform recommended phase 2 dose selection.
- Commenced enrollment into the dose escalation cohorts of the pembrolizumab combination arm of the Phase 1/2 clinical trial of intratumoral IMO-2125 in PD-1 refractory metastatic melanoma;
- Created 22 specific 3GA compounds targeting 22 genes for potential internal clinical development or partnering opportunities;
- Selected the first clinical target for human development from the 3GA technology platform for an undisclosed liver target with expected initiation of clinical development targeted for 2018; IND-enabling activities underway;
- Initiated enrollment into the IMO-8400 Phase 2 clinical trial in dermatomyositis which is being conducted at 22 sites both in the U.S. and abroad and is expected to complete enrollment in 2017 with data planned for the first half of 2018;
- Planned additional IMO-2125 clinical trials to further understand drug activity as a monotherapy in additional solid tumors as well as exploration of additional combinations and tumor types with both trials anticipated to commence in 2017;
- Executed an out-licensing agreement for Idera’s Toll-like Receptor 7, 8 and 9 antagonist IMO-9200 granting
Vivelix Pharmaceuticals, Ltd.worldwide rights to develop and market the compound for non-malignant gastrointestinal disorders. Idera received $15 millionin upfront payment and is eligible for future development, regulatory and sales milestone payments up to $140 millionalong with royalties from global net sales;
- Generated estimated net proceeds of
$49M, after deducting underwriters’ discounts and commissions and estimated offering expenses, from a public offering of common stock;
- Presented positive clinical, translational and safety data from the initial cohorts of the phase 1 dose escalation portion of the Company’s ongoing Phase 1/2 clinical trial of intratumoral IMO-2125 in combination with ipilimumab in patients with PD-1 refractory metastatic melanoma at the
Society for Immunotherapy of Cancer( SITC) Annual Meeting in November;
- Presented pre-clinical data updates on both novel mechanism of action and selective targeting of single point mutations with 3rd Generation Antisense (3GA) at the
Cold Springs Harbor Laboratory Conference on Regulatory & Non-Coding RNAsconference and the Annual Meeting of the Oligonucleotide Therapeutic Society, respectively; and,
- Completed registrational development plan for IMO-2125 for PD-1 refractory metastatic melanoma.
“2016 was an incredibly important period for driving Idera’s future direction and opportunities for success,” stated
Continued Milano, “As we begin 2017, we are now in position to gain further insight into the potential for IMO-2125 with additional data, clarify the path to registration for IMO-2125 for PD-1 refractory melanoma, commence understanding of IMO-2125’s opportunity beyond melanoma, complete enrollment of the IMO-8400 trial in dermatomyositis and continue to advance the 3GA platform technology towards its first clinical evaluation in 2018. We also along the way, will opportunistically explore collaborations for both IMO-2125 and the 3GA platform technology to maximize the potential value and importantly patient reach for these exciting therapeutic solutions.”
Research and Development Program Updates
IMO-2125 and IMO-8400 are the Company’s lead clinical development drug candidates. IMO-2125 is an oligonucleotide-based agonist of Toll-like receptor (TLR) 9. IMO-8400 is an oligonucleotide-based antagonist of TLRs 7, 8, and 9. The Company also announced, in late 2015, the first two potential development targets from its proprietary 3GA technology platform: NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4). The Company continues to evaluate these and other potential targets. The Company plans to take the first 3GA candidate into human proof of concept studies in 2017.
Toll-like Receptor (TLR) Agonism
Idera’s development program in immuno-oncology is based on the rationale that intra-tumoral injections of IMO-2125, a TLR9 agonist, will activate dendritic cells and modulate the tumor microenvironment to potentiate the anti-tumor activity of checkpoint inhibitors and other immunotherapies. This rationale is supported by pre-clinical data in multiple tumor types.
Idera is currently conducting a Phase 1/2 clinical trial of intratumoral IMO-2125 in combination with ipilimumab, a CTLA4 antibody, and in a separate arm exploration of the combination of intratumoral IMO-2125 with pembrolizumab, an anti-PD1 antibody. The Phase 1 dose exploration portion of the trial is being conducted at the
Additionally, in 2017 the company plans to initiate trials exploring IMO-2125 as a monotherapy agent in multiple solid tumor types and exploration of intratumoral IMO-2125 in combination with other checkpoint inhibitors in various solid tumor types.
At the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium held
At the upcoming
Additionally, on the same day,
Third Generation Antisense Platform (3GA)
Idera’s proprietary third-generation antisense (3GA) platform technology is focused on silencing the mRNA associated with disease causing genes. Idera has designed 3GA oligonucleotides to overcome specific challenges associated with earlier generation antisense technologies and RNAi technologies such as immunotoxicities and less than optimal therapeutic index.
Over the past two years, Idera has generated 22 unique compounds developed to target specific genes across a wide variety of therapeutic areas such as rare diseases, oncology, autoimmune disorders, metabolic conditions and single point mutations. The company is currently conducting activities ranging from cell culture through IND-enabling toxicology. The current portfolio is designed to create both internal development candidates as well as partnering opportunities for disease areas outside of Idera’s stated focus.
The first partnering endeavor is demonstrated through Idera’s collaboration with GSK developing an undisclosed 3GA gene target for renal conditions. Idera and GSK entered into the collaboration in late 2015 and GSK’s stated goal is to achieve selection of clinical development candidate in the first quarter of 2018.
Additionally, in January of 2017, Idera announced selection of its first internal candidate to enter clinical development. For strategic and competitive purposes, Idera is withholding naming the specific target until the second half of 2017. Idera has selected a well-established liver target, with available, validated pre-clinical animal models, well-understood clinical endpoints, which has the potential for both rare and broader disease applications. Idera is currently conducting the IND-enabling toxicology for this program and expects to file and IND and enter the clinic in 2018.
Toll-like Receptor (TLR) Antagonism
Dermatomyositis Clinical Development Program
In late 2015, Idera announced the initiation of a Phase 2 clinical trial of IMO-8400 in patients with dermatomyositis, a rare auto-immune condition, which negatively affects skin and may result in debilitating muscle weakness. TLRs have been reported to play an important role in the pathogenesis of the disease. This randomized, double-blind, placebo controlled Phase 2 trial is expected to enroll 36 patients and will be conducted at approximately 22 clinical sites worldwide. The Company plans to complete enrollment of this trial by the end of 2017 and have clinical data available in 2018.
Fourth Quarter Results
Net income applicable to common stockholders for the three months ended
Full Year Results
Net loss applicable to common stockholders for the year ended
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, clinical trials, plans, and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether the Company’s cash resources will be sufficient to fund the Company’s continuing operations and the further development of the Company’s programs for the period anticipated; whether interim results from a clinical trial, such as the preliminary results reported in this release, will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials such as the results described in this release will be indicative of the results that will be generated in future clinical trials, including in clinical trials in different disease indications; whether products based on Idera's technology will advance into or through the clinical trial process when anticipated or at all or warrant submission for regulatory approval; whether such products will receive approval from the
|Idera Pharmaceuticals, Inc.
Condensed Statements of Operations
(In thousands, except per share data)
|Three Months Ended||Years Ended|
|December 31,||December 31,|
|Research & Development||11,007||8,565||39,824||33,699|
|General & Administrative||3,531||3,708||15,132||15,396|
|Total Operating Expenses||14,538||12,273||54,956||49,095|
|Income (loss) from Operations||743||(12,083||)||(38,757||)||(48,846||)|
|Other Income (Expense), Net||79||93||368||291|
|Net Income (Loss)||$||822||$||(11,990||)||$||(38,389||)||$||(48,555||)|
|Basic net income (loss) per common share applicable to common stockholders||$||0.01||$||(0.10||)||$||(0.30||)||$||(0.42||)|
|Shares used in computing basic net income (loss) per common share applicable to common stockholders||146,255||118,865||127,597||115,092|
|Diluted net income (loss) per common share applicable to common stockholders||$||0.01||$||(0.10||)||$||(0.30||)||$||(0.42||)|
|Shares used in computing diluted net income (loss) per common share applicable to common stockholders||151,930||118,865||127,597||115,092|
|Idera Pharmaceuticals, Inc.
Condensed Balance Sheet Data
|At December 31,|
|Cash, Cash Equivalents & Investments||$||109,014||$||87,157|
|Total Stockholders' Equity||103,349||83,582|
|Total Liabilities & Stockholders' Equity||$||113,231||$||92,276|
IDERA PHARMACEUTICALS Contact:
Robert A. Doody, Jr.VP, Investor Relations & CommunicationsPhone (617) 679-5515 RDOODY@IDERAPHARMA.COM