On November 14, 2022 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its consolidated financial and operational results for the third quarter ended September 30, 2022 (Press release, Idera Pharmaceuticals, NOV 14, 2022, View Source [SID1234624081]).
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"We are pleased to have completed the merger of Idera and Aceragen at the end of the third quarter, better enabling us to deliver important therapies for people living with rare diseases," stated John Taylor, Idera’s Chief Executive Officer. "Our resulting cash position is expected to provide runway into Q3 2023 and fund the advancement of our pipeline, including ACG-701 and ACG-801, through important anticipated 2023 clinical milestones. Our team continues to execute on the integration effort and diligently progress toward our near-term clinical milestones, which include initiation of our cystic fibrosis (CF) and Farber disease clinical trials and anticipated data from our melioidosis study."
Clinical Development Updates
REPRIEVE Study in Cystic Fibrosis: Randomized, double-blind, placebo-controlled Phase 2 study evaluating treatment with ACG-701, a proprietary oral formulation of sodium fusidate, in newly diagnosed pulmonary exacerbations in CF patients.
The REPRIEVE study is on track for initiation by the end of 2022, with data anticipated in Q3 2023
TERRA Study for Melioidosis: Randomized, double-blind, placebo-controlled Phase 2 study evaluating ACG-701 in hospitalized melioidosis patients.
The independent Data Monitoring Committee (DMC) for the TERRA Study is expected to meet by the end of 2022 to recommend whether the study should continue as planned or, if efficacy and safety data are compelling, to be immediately unblinded for full analysis. This DMC assessment is intended to be in lieu of the interim analysis originally anticipated in Q1 2023.
ADVANCE Study for Farber Disease: Randomized, double-blind, placebo-controlled, first-in-human, Phase 2 study of ACG-801 in patients with Farber disease.
The ADVANCE study is on track for initiation in the second half of 2023.
Corporate Updates
Since June 30, 2022, the following corporate updates were announced:
As previously disclosed, on September 28, 2022, the Company announced its acquisition, via a stock-for-stock transaction, of Aceragen, Inc., a private biotechnology company addressing severe, rare pulmonary and rheumatic diseases for which there is significant medical need and limited or no available treatments.
The combined cash of the two companies is expected to provide runway into Q3 2023, funding the advancement of ACG-701 and ACG-801 through important 2023 clinical milestones.
In connection with the acquisition, the Company announced several leadership and Board changes:
John Taylor, the former Chief Executive Officer of Aceragen, was named Chief Executive Officer of the Company. Additional management team members are Carl Kraus, Aceragen’s former Chief Medical Officer, who now serves in that role for Idera; Bryant Lim, who continues in his role as Idera’s Chief Business Officer and General Counsel; Daniel Salain, Aceragen’s former Chief Operating Officer, who serves in that role for Idera; Andy Jordan, Aceragen’s former Chief Financial Officer, who was appointed Chief Strategy Officer for Idera; and John Kirby, who continues in his role as Idera’s Chief Financial Officer.
Vincent Milano, Idera’s former Chief Executive Officer, was named Chair of the Board of Directors for the Company. Idera Board members Cristina Csimma, Pharm. D., M.H.P., James Geraghty, Maxine Gowen, Ph.D., and Michael Dougherty continue in their positions and are joined by John Taylor and Ron Wooten, Senior Founding Partner, NovaQuest Capital Management LLC. Mr. Taylor and Mr. Wooten previously served on Aceragen’s board.
Third Quarter Financial Results
The Company’s pro forma cash position as of September 30, 2022 was $26.8 million. Research and development expenses for the three months ended September 30, 2022 totaled $1.5 million, compared to $3.5 million for the same period in 2021. General and administrative expenses for the three months ended September 30, 2022 totaled $2.3 million, compared to $2.3 million for the same period in 2021. Restructuring costs for the three months ended September 30, 2022 totaled approximately $2.8 million, compared to $0.1 million for the same period in 2021, and relate to a reduction in force due to our acquisition of Aceragen. Merger related costs for the three months ended September 30, 2022 totaled $2.8 million. The Company recorded an income tax benefit of $6.0 million in the three months ended September 30, 2022.
As a result of the factors above, net loss applicable to common stockholders for the three months ended September 30, 2022 was $3.1 million or $0.06 per basic and diluted share compared to net loss applicable to common stockholders of $6.0 million or $0.11 per basic and diluted share for the same period in 2021.