On August 3, 2017 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported financial results for the second quarter ended June 30, 2017 and provided a business update (Press release, Insmed, AUG 3, 2017, View Source [SID1234520035]). Schedule your 30 min Free 1stOncology Demo! Business Update
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On track to report top-line results from phase 3 CONVERT study in September plus or minus one month. The CONVERT study, or INS-212, is evaluating amikacin liposome inhalation suspension (ALIS) in treatment refractory NTM lung disease caused by MAC. The primary efficacy endpoint is the proportion of subjects who achieve culture conversion at Month 6 in the ALIS plus multi-drug regimen arm compared to the multi-drug regimen without ALIS arm. The Company reported that the last patient in the study has progressed beyond the Month 6 measure. Additionally, Insmed reported that the dropout rate observed in the study was lower than the initially assumed dropout rate.
Plan to initiate enrollment of phase 2 dose-ranging study of INS1007 in non-cystic fibrosis (non-CF) bronchiectasis in the second half of 2017. INS1007 is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase I (DPP1), an enzyme responsible for activating neutrophil serine proteases in neutrophils when they are formed in the bone marrow. Pending dialogue with the FDA, Insmed plans to evaluate two doses of INS1007 (10mg and 25mg) vs. placebo over 24 weeks. The primary endpoint is expected to evaluate time to first exacerbation while secondary endpoints are expected to evaluate mechanistic, clinical and outcomes-based measures. Insmed is also evaluating the potential of INS1007 in other indications.
The FDA provides established name for lead development program. The FDA recently advised Insmed that the established name for its phase 3 product candidate in development for the treatment of refractory nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC) will be amikacin liposome inhalation suspension, or ALIS.
Enhanced management team with appointment of chief financial officer, chief medical officer and chief product strategy officer. During the second quarter the company announced changes to its senior leadership team with the appointment of Paolo Tombesi as chief financial officer and Paul Streck, M.D., as chief medical officer. Additionally, Eugene Sullivan, M.D., assumed the newly created role of chief product strategy officer.
"Throughout 2017 we have remained committed to our mission of transforming the lives of patients with rare diseases. We continue to focus on the execution and evaluation of our phase 3 CONVERT study for which we continue to anticipate top-line results in September plus or minus one month. If the study meets the primary endpoint, we intend to complete preparation for a U.S. regulatory filing with the FDA, under Subpart H, for the treatment of patients with refractory NTM," said Will Lewis, president and chief executive officer of Insmed. "Our pre-commercialization activities are also accelerating, as is our assessment of the regulatory pathway beyond the U.S. with a particular focus on Japan. We are also moving ahead with our planning for life cycle management for ALIS and advancing our pipeline."
Second Quarter Financial Results
For the second quarter of 2017, Insmed reported a net loss of $44.7 million, or $0.72 per share, compared with a net loss of $36.6 million, or $0.59 per share, for the second quarter of 2016.
Research and development expenses were $26.9 million for the second quarter of 2017, compared with $23.9 million for the second quarter of 2016. The increase was primarily due to an increase in expenses related to INS1007 and higher compensation and related expenses due to an increase in headcount partially offset by decreases in ALIS manufacturing expenses.
General and administrative expenses for the second quarter of 2017 were $16.6 million, compared with $12.3 million for the second quarter of 2016. The increase was primarily due to higher expenses related to our pre-commercial planning activities for ALIS and higher compensation and related expenses due to an increase in headcount, as compared to the prior year period.
Balance Sheet and Other Financial Highlights
As of June 30, 2017, Insmed had cash and cash equivalents of approximately $91 million. The Company’s operating expenses for the second quarter of 2017 were approximately $44 million, and its cash-based operating expenses (as defined below) for the second quarter of 2017 were approximately $38 million. Insmed ended the second quarter of 2017 with approximately $55 million in debt.