Idera Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2019 Financial Results
“The third quarter of this year marked another consecutive period of focused execution for our company as we continue advancing tilsotolimod for patients and their families,” stated
Milano continued, “Overall, our team is executing on a high level and we are well positioned to continue to accelerate our activity through the end of this year and, importantly, into 2020.”
ILLUMINATE (tilsotolimod) Clinical Development
ILLUMINATE 301 – Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory metastatic melanoma:
- Approximately 90 sites active in 11 countries;
- Planned enrollment target of 454 patients;
- As of
October 23, 2019 , 342 patients enrolled representing 75% enrollment; - Targeting completion of enrollment during first half of 2020; and
- Clinical trial collaboration and supply agreement in place with BMS for supply of ipilimumab for the trial.
ILLUMINATE 204 – Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:
- Completed enrollment with 52 patients (49 evaluable) at tilsotolimod 8 mg with ipilimumab in
February 2019 ; - Of the four unconfirmed responders of the 13 responders reported on
Aug. 8, 2019 :- Two were confirmed per RECIST v1.1 criteria, one remains unconfirmed, and one experienced disease progression, leading to a total of 11 of 12 confirmed responses, as of
Oct. 23, 2019 ;- 3 confirmed complete responses (CR);
- 71% (35) achieving disease control (best response of CR, PR or Stable Disease (SD)); and
- Durable responses (greater than six months) were observed in five of 10 confirmed responses per RECIST v1.1.
- Two were confirmed per RECIST v1.1 criteria, one remains unconfirmed, and one experienced disease progression, leading to a total of 11 of 12 confirmed responses, as of
- Safety profile observed consistent with previously reported results; and
- Final results from the ILLUMINATE 204 trial are expected to be submitted for an abstract at a medical conference during the first half of 2020.
ILLUMINATE 206 – Phase 2, multi-center trial to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab in treating patients with anti-PD-1 Refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Relapsed/Refractory Immunotherapy-Naïve Microsatellite Stable Colorectal Cancer (MSS-CRC).
·Trial initiated on
ILLUMINATE 101 – Phase 1b trial of tilsotolimod monotherapy in patients with refractory solid tumors:
- Completed enrollment in all dose cohorts of the trial;
- Data presented at the
European Society for Medical Oncology (ESMO ) 2019 Conference inBarcelona Spain ;- Of 45 evaluable patients, 15 (33.3%) had best response of stable disease (SD);
- One patient with uterine leiomyosarcoma has been on tilsotolimod treatment for more than a year with durable stable disease and is continuing under a treatment investigational new drug;
- One patient in the melanoma cohort achieved an unconfirmed partial response (uPR). This patient discontinued from the study prior to the confirmation of response.
AbbVie Collaboration – On
Intellectual Property – On
Financial Results
Third Quarter Results
Net loss applicable to common stockholders for the three months ended
As of
About
Harnessing the approach of the earliest researchers in immunotherapy and the company’s vast experience in developing proprietary immunomodulatory platforms, Idera’s TLR agonist development program is focused on priming the immune system to play a more powerful role in fighting cancer, ultimately increasing the number of people who can benefit from immunotherapy.
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, 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.
Condensed Statements of Operations
(In thousands, except per share data)
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Alliance revenue | $ | - | $ | 145 | $ | 1,448 | $ | 563 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 8,359 | 8,860 | 26,485 | 32,912 | ||||||||||||
General and administrative | 3,023 | 3,984 | 9,061 | 11,849 | ||||||||||||
Merger-related costs, net | - | (3,836 | ) | - | 1,245 | |||||||||||
Restructuring costs | 5 | 3,017 | 181 | 3,017 | ||||||||||||
Total operating expenses | 11,387 | 12,025 | 35,727 | 49,023 | ||||||||||||
Loss from operations | (11,387 | ) | (11,880 | ) | (34,279 | ) | (48,460 | ) | ||||||||
Other income (expense), net | 254 | 275 | 996 | 729 | ||||||||||||
Net loss | $ | (11,133 | ) | $ | (11,605 | ) | $ | (33,283 | ) | $ | (47,731 | ) | ||||
Net loss per common share applicable to common stockholders — basic and diluted | $ | (0.39 | ) | $ | (0.43 | ) | $ | (1.17 | ) | $ | (1.81 | ) | ||||
Weighted-average number of common shares used in computing net loss per share applicable to common stockholders — basic and diluted | 28,847 | 27,175 | 28,332 | 26,404 | ||||||||||||
Condensed Balance Sheet Data
(In thousands)
September 30, | December 31, | ||||||
2019 | 2018 | ||||||
Cash, cash equivalents and short-term investments | $ | 41,586 | $ | 71,431 | |||
Other assets | 3,806 | 1,592 | |||||
Total assets | $ | 45,392 | $ | 73,023 | |||
Total liabilities | $ | 7,766 | $ | 9,029 | |||
Total stockholders' equity | 37,626 | 63,994 | |||||
Total liabilities and stockholders' equity | $ | 45,392 | $ | 73,023 | |||
Source:
Contact:
SVP, Investor Relations
Phone (484) 348-1677
rdoody@iderapharma.com
Source: Idera Pharmaceuticals, Inc.