“Despite the disappointing objective response rate (ORR) results from ILLUMINATE-301, our Phase 3 trial in anti-PD-1 refractory advanced melanoma, we continue to explore the potential for tilsotolimod to enhance patients’ immune systems,” stated
ILLUMINATE (tilsotolimod) Clinical Development
ILLUMINATE-301: The Company reported in
ILLUMINATE-206: Enrollment continues in the Company’s Phase 2, open-label, multicohort, multicenter study to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab for the treatment of solid tumors, beginning with MSS-CRC.
- Initial safety run-in of 10 patients, which included ipilimumab at 1 mg/kg every 8 weeks and nivolumab at 3 mg/kg every 2 weeks, showed that the regimen was generally well tolerated.
- Changes in the study design intended to improve potential outcomes in this patient population include increasing ipilimumab dosing frequency to every 3 weeks and limiting the number of allowed prior lines of treatment to 2.
- Data from the next 10 patients under the modified study design is anticipated in the fourth quarter of 2021.
Corporate Update Since
February 2021, the Company entered into a collaboration and option agreement with Scriptr Global, Inc.to research, develop, and potentially commercialize gene therapy candidates for myotonic dystrophy 1 (DM1) and Friedrich’s Ataxia (FA).
- The Company received
$16.3 millionin net proceeds from its equity distribution agreement and equity line of credit.
- Considering the data related to ILLUMINATE-301’s ORR endpoint, in
April 2021the Company initiated a reduction in force that will impact approximately 50% of our workforce by May 31, 2021. The decision was made to better align our workforce to our needs in ongoing tilsotolimod and business development activities.
- The Company’s Board of Directors (the “Board”) has elected current Board member
Michael Doughertyas the Chair of the Board, effective April 28, 2021. He succeeds James Geraghty, who initiated this transition in the interest of Board leadership refreshment after serving as our Board Chair since 2013. Mr. Geraghtyis planning to continue to serve as a non-executive director on our Board.
“I want to thank Jim for his tireless leadership over the last 8 years and am looking forward to his continued contributions to our Board,” stated
First Quarter Financial Results
Research and development expenses for the three months ended
As a result of the factors above, net income for the three months ended
Harnessing the approach of the earliest researchers in immunotherapy and the Company’s vast experience in developing proprietary immunology platforms, Idera’s lead 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. Idera also continues to focus on the acquisition, development, and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs. To learn more about Idera, visit IderaPharma.com.
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, financial position, funding for continued operations, cash reserves, projected costs, prospects clinical trials and related endpoints, 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," “schedule,” and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company’s current expectations and projections about future events and various assumptions. 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. These forward-looking statements involve known and unknown risks, uncertainties, and other factors, which may be beyond Idera’s control, and which may cause the actual results, performance, or achievements of the Company to be materially different from future results, performance, or achievements expressed or implied by such 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 including, without limitation: 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; whether topline results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials 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
Statements of Operations
(In thousands, except per share data)
|Three Months Ended|
|Research and development||$||6,871||$||9,510|
|General and administrative||3,156||3,642|
|Total operating expenses||10,027||13,152|
|Loss from operations||(10,027||)||(13,152||)|
|Other income (expense)|
|Warrant revaluation gain||6,983||1,101|
|Future tranche right revaluation gain||118,803||20,711|
|Other income (expense), net||(21||)||157|
|Net income (loss) applicable to common stockholders|
|Net income (loss) per common share applicable to common stockholders|
|Weighted-average number of common shares used in computing net income (loss) per share applicable to common stockholders|
Balance Sheet Data
|Cash, cash equivalents, and short-term investments||$||44,541||$||37,728|
|Total stockholders' equity (deficit)||42,304||(91,172||)|
|Total liabilities and stockholders' equity (deficit)||$||48,008||$||42,399|
Investor Relations &
Phone (484) 348-1675
Chief Financial Officer
Phone (484) 348-1627
Source: Idera Pharmaceuticals, Inc.