Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) reported financial results for the fourth quarter and full year ended December 31, 2009.
Financial Results
As of December 31, 2009, cash, cash equivalents and investments totaled $40.2 million compared to $55.6 million at December 31, 2008. Additionally, in December 2009 the Company earned a milestone payment of €3.0 million from Merck KGaA and recognized this milestone payment as revenue in 2009. The Company received $4.1 million in payment of this milestone in the first quarter of 2010 which is not included in December 31, 2009 cash.
Fourth Quarter Results
Net income for the three months ended December 31, 2009 was $3.9 million, or $0.17 per diluted share, compared to net income of $0.4 million, or $0.01 per diluted share, for the same period in 2008.
Total revenues for the three months ended December 31, 2009 were $10.2 million compared to $6.3 million for the same period in 2008.
Research and development expenses for the three months ended December 31, 2009 totaled $4.4 million compared to $4.3 million for the same period in 2008.
General and administrative expenses for the three months ended December 31, 2009 totaled $2.1 million compared to $1.8 million for the same period in 2008.
Full Year Results
Net income for the year ended December 31, 2009, was $7.5 million, or $0.31 per diluted share, compared to net income of $1.5 million, or $0.06 per diluted share, for 2008.
Total revenues for the year ended December 31, 2009 were $34.5 million compared to $26.5 million for 2008.
Research and development expenses for the year ended December 31, 2009 totaled $18.6 million compared to $16.2 million for 2008.
General and administrative expenses for the year ended December 31, 2009 totaled $8.6 million compared to $9.8 million for 2008.
Clinical and Preclinical Programs
EMD 1201081 (IMO-2055), a TLR9 Agonist, in Cancer Treatment (Collaboration with Merck KGaA)
* Phase 2 Clinical Trial of EMD 1201081 in Squamous Cell Carcinoma of the Head and Neck
In December 2009, Merck KGaA initiated a Phase 2 clinical trial of EMD 1201081, also known as IMO-2055, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The Company achieved a milestone under its agreement with Merck KGaA related to this trial initiation and received a milestone payment of €3.0 million (approximately $4.1 million) from Merck KGaA in the first quarter of 2010.
* Phase 1b Clinical Trial of EMD 1201081 in Combination with Tarceva® and Avastin in Non-small Cell Lung Cancer (NSCLC)
In September 2009, the Company presented preliminary data from a Phase 1b clinical trial evaluating EMD 1201081 in combination with Tarceva and Avastin in patients with NSCLC that had progressed during previous therapy. EMD 1201081 was well tolerated at dosages up to 0.48 mg/kg/week in combination with Tarceva plus Avastin. Eight of 16 patients in the dose-escalation portion of the trial remained on treatment at least 18 weeks. Of the 13 patients evaluable for disease status, three had a partial response and eight experienced stable disease.
Subsequent to the preliminary data presented in September 2009, Merck KGaA recruited patients for an expanded cohort at the anticipated recommended phase 2 dose level for EMD 1201081 in combination with Tarceva and Avastin.
* Phase 1b Clinical Trial of EMD 1201081 in Combination with Erbitux and Chemotherapy in Colorectal Cancer (CRC)
In January 2009, dosing of patients was initiated in a Phase 1b clinical trial evaluating EMD 1201081 in combination with Erbitux and chemotherapy in patients with CRC that had progressed during previous therapy. EMD 1201081 is being evaluated at three escalating dose levels in combination with standard dose regimens of Erbitux and chemotherapy to evaluate the safety of the combination and to determine the recommended dosage of IMO-2055 for potential use in a subsequent Phase 2 clinical trial.
As of March 2010, Merck KGaA has assumed responsibility for all current and future clinical trials in the development of EMD 1201081 for the treatment of cancer, excluding vaccines.
IMO-2125, a TLR9 Agonist, in Chronic Hepatitis C Virus (HCV) Infection
* Phase 1 Clinical Trial with IMO-2125 Monotherapy in Null Responder Patients with Chronic HCV Infection
In December 2009, the Company announced interim results from a Phase 1 clinical trial of IMO-2125 in null responder HCV patients treated through the first four cohorts of the trial. The Company defines null responder HCV patients as patients who have failed to achieve a 2 log10 reduction in viral load during previous 12 to 24 weeks of treatment with pegylated recombinant interferon-alpha plus ribavirin. IMO-2125 was well tolerated by all patients in the four cohorts at dosages of 0.04, 0.08, 0.16, and 0.32 mg/kg/week. IMO-2125-treated patients showed dose-dependent increases in natural interferon-alpha and other antiviral proteins. In addition, an increasing percentage of patients, ranging from 40% at the 0.08 mg/kg/week dose level to 75% at the 0.32 mg/kg/week dose level, achieved a maximum reduction in viral load of 1 log10 or more at least once during the four-week treatment period. In contrast, none of the patients who received placebo treatment or IMO-2125 at the 0.04-mg/kg/week dose level achieved a maximum reduction in viral load of 1 log10 or greater at any time during the four-week treatment period. The Company plans to present detailed interim results of the trial at a scientific meeting in the second quarter of 2010.
Based on the interim data, the Company extended the trial and is currently recruiting patients in a fifth cohort at 0.48 mg/kg/week.
* Phase 1 Clinical Trial with IMO-2125 in Combination with Ribavirin in Treatment-naïve Patients with Chronic HCV Infection
In October 2009, the Company announced initiation of a Phase 1 clinical trial to assess the safety of IMO-2125 in combination with ribavirin in treatment-naïve patients with chronic HCV infection. A total of 15 patients are planned for the first cohort, with 12 randomized to receive IMO-2125 and ribavirin and three randomized to receive placebo and ribavirin. Starting with the second cohort, 12 patients will be randomized to receive IMO-2125 and ribavirin and six patients will be randomized to receive pegylated recombinant alfa-2a interferon and ribavirin as the control. The primary objective of the trial is to assess the safety and tolerability of IMO-2125 in combination with ribavirin. In addition, the Company plans to monitor the effect of treatment on HCV RNA levels.
IMO-3100, a Dual Antagonist of TLR7 and TLR9, in Autoimmune and Inflammatory Diseases
* Phase 1 Clinical Trial with IMO-3100
In January 2010, the Company initiated a single-dose, dose-escalation Phase 1 clinical trial of IMO-3100 in healthy subjects. In this trial, IMO-3100 is being administered by subcutaneous injection to healthy subjects, with the primary objective being the evaluation of safety and tolerability. Secondary objectives are to characterize the pharmacokinetic profile of IMO-3100 and to assess the pharmacodynamic mechanism of action through measurement of the ex vivo response of peripheral blood mononuclear cells to TLR7 and TLR9 agonists. The trial is being conducted at a single U.S. site.
The Company plans to use the results from this rising single-dose trial to select dosages for an anticipated follow-up trial in healthy subjects, the purpose of which would be to characterize safety, pharmacokinetics, and ex vivo pharmacodynamic mechanism of action with weekly subcutaneous administration for four weeks. The Company intends to identify an initial autoimmune disease indication for further clinical development of IMO-3100 by the end of 2010.
IMO-2134, a TLR9 Agonist, for Respiratory Diseases
During our collaboration with Novartis, IMO-2134 was identified as a lead compound for development in asthma and allergy indications and Novartis initiated a Phase 1 clinical trial of IMO-2134, also known as QAX935. Upon the termination of the research collaboration and option agreement in February 2010, the Company regained all rights to IMO-2134. The Company is currently evaluating the next steps in developing IMO-2134 for respiratory diseases.
TLR7, 8 and 9 Agonists as Vaccine Adjuvants (Collaboration with Merck & Co., Inc.)
In December 2006, the Company and Merck & Co. Inc. entered into an exclusive license and research collaboration agreement to research, develop and commercialize vaccine products containing the Company’s TLR7, 8, and 9 agonists in the fields of oncology, infectious diseases and Alzheimer’s disease. As part of the agreement, the two companies engaged in a two-year research collaboration to generate novel agonists targeting TLR7 and TLR8 incorporating both Merck and Idera chemistry for use in the licensed fields. In November 2009, Merck extended the research collaboration with the Company for a fourth year to December 2010. Under the terms of the agreement, Merck is funding the research and development activities, including our research and development activities under the collaboration.
TLR7 and TLR8 Agonists
The Company has created synthetic stabilized immune modulatory RNA (SIMRA) compounds that mimic viral RNA and induce immune responses by functioning as agonists of TLR7 and TLR8. The Company is continuing to study selected dual TLR7 and TLR8 agonists in preclinical models of hematological cancers and has observed antitumor activity of a dual agonist of TLR7 and TLR8 as monotherapy and in combination with selected targeted drugs currently approved for cancer treatment.
TLR Antisense
The Company has identified antisense compounds targeted to human TLRs 2, 3, 4, 5, 6, 7, 8, and 9 and to the TLR-associated signaling protein MyD88. The Company is studying these compounds for potential applications in autoimmune and inflammatory diseases.
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