On May 6, 2021 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, reported financial results for the first quarter ended March 31, 2021 and highlighted recent activity (Press release, Immunic, MAY 6, 2021, View Source [SID1234579417]).
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"Our clinical program activities have continued unabated, with significant progress having recently been achieved for our lead asset, selective oral DHODH inhibitor, IMU-838," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Last month, we announced key interim data from our phase 2 EMPhASIS Cohort 2 sub-trial of IMU-838 in patients with relapsing-remitting multiple sclerosis (RRMS), confirming 30 mg as the most appropriate dose for our envisaged phase 3 program. We will now move directly to the filing of an Investigational New Drug (IND) application in the United States and are currently working to complete the package, with the expectation of initiating the phase 3 program in the second half of this year."
"Beyond RRMS, during the first quarter, we reported positive top-line data from the investigator-sponsored, open-label phase 2 proof-of-concept trial of IMU-838 in primary sclerosing cholangitis (PSC), conducted in collaboration with the Mayo Clinic. Results confirmed safety and tolerability and provided encouraging activity signals. In order to find the optimized dose for future clinical activities in PSC, we plan to initiate a phase 1 trial in hepatic impaired patients. Backed by the promising results from our phase 2 CALVID-1 trial of IMU-838 which underlined its broad antiviral activity, our phase 2 trial in ulcerative colitis (UC) has seen recent strong recruitment which we expect to be completed in the second half of this year."
Dr. Vitt added, "With the ongoing accumulation of robust data for IMU-838, including repeated confirmation of safety and efficacy across multiple indications, we made a strategic decision during the first quarter to settle our remaining royalty obligation to 4SC AG, giving us full rights to our most advanced asset and securing our ability to unlock its future potential."
First Quarter 2021 and Subsequent Highlights
April 2021: Announced EMPhASIS interim analysis of 10 mg Cohort 2 confirming IMU-838’s dose response in RRMS and supporting phase 3 dose selection. Previously published data from Cohort 1, together with Cohort 2 data from 59 randomized patients who completed week 12 magnetic resonance imaging assessments, confirmed that 30 mg once daily IMU-838 is the most appropriate dose for the company’s planned phase 3 program in RRMS.
March 2021: Announced the signing of an agreement with 4SC AG to settle the remaining obligation of a 4.4% royalty on net sales of IMU-838, for $17.25 million. The payment was made 50% in cash and 50% in shares of Immunic’s common stock. No further payment obligations remain between Immunic and 4SC AG.
February 2021: Reported positive top-line data from the investigator-sponsored phase 2 proof-of-concept clinical trial of IMU-838 in PSC, conducted in collaboration with investigators at Mayo Clinic. Data showed a statistically significant decrease in serum alkaline phosphatase (ALP) levels (p=0.041) in the 11-patient per-protocol (PP) population after 24-weeks of treatment, as compared to baseline. Additionally, IMU-838’s favorable safety and tolerability profile was confirmed in the patient population.
February 2021: Announced top-line clinical efficacy, safety, disease marker and virology data from the main analysis of the phase 2 CALVID-1 trial of IMU-838 in hospitalized patients with moderate COVID-19. The data showed clinical activity based on multiple secondary endpoints and confirmed IMU-838 to be safe and well-tolerated in this patient population.
Meanwhile, additional available data from the full analysis of all 223 randomized patients support the conclusions made in the main analysis and have provided data on a few additional endpoints. Notably, the rate and timing of anti-SARS-CoV-2 antibodies patients are developing in response to the infection was found to be identical between the IMU-838 and placebo treatment arms. The full analysis was also able to detect a relationship between drug trough levels in blood plasma and the clinical recovery endpoint.
With the progressing rollout of vaccines in many countries, however, the company believes that the opportunity to execute a phase 3 program as a monotherapy and to benefit from any potential commercialization in this indication within a reasonable time frame is no longer viable.
Anticipated Clinical Milestones
IMU-838 in RRMS: As previously announced, Immunic remains in discussions with regulatory authorities, including the FDA and the European Medicines Agency, regarding the planned phase 3 program in RRMS. At the FDA’s request, the company is proceeding directly to submission of an IND application, instead of holding an end-of-phase 2 meeting. Feasibility and other preparatory activities for the phase 3 program are ongoing and initiation is expected in the second half of 2021.
IMU-838 in UC: Recruitment of the phase 2 CALDOSE-1 trial of IMU-838 in patients with UC is expected to be completed in the second half of 2021 and top-line data of the induction phase is expected to be available in the first half of 2022, as previously announced.
IMU-838 in PSC: Immunic plans to perform a phase 1 trial in hepatic impaired patients which will allow for dose optimization of IMU-838 for potential future clinical activities in PSC.
IMU-935 phase 1 program: Based on a positive outcome of the single ascending dose (SAD) cohort of the phase 1 trial of IMU-935, the company received approval from the Ethics Committee in Australia, during first quarter of 2021, to proceed with the multiple ascending dose (MAD) portion of the trial and subjects in the first cohort are currently being dosed. Unblinded safety, pharmacodynamics and pharmacokinetics data from the SAD and MAD parts in healthy volunteers is expected to be available in the second half of 2021. Initiation of a third portion of the phase 1 trial in patients with mild-to-moderate psoriasis is expected in the third quarter of 2021 and is anticipated to last approximately 12 months.
IMU-856 phase 1 program: The SAD part of the ongoing phase 1 trial of IMU-856 has been completed. Based on the favorable data available, the company expects to receive clearance from the Ethics Committee in Australia to proceed to the MAD part in healthy volunteers, in the near future. Unblinded safety data from the SAD and MAD parts in healthy volunteers is expected to be available in the second half of 2021. Initiation of the third portion of the phase 1 trial in patients with several diseases involving bowel barrier dysfunction is expected in the second half of 2021.
Financial and Operating Results
Research and Development (R&D) Expenses were $11.5 million for the three months ended March 31, 2021, as compared to $6.4 million for the same period ended March 31, 2020. The $5.1 million increase was primarily due to (i) a $1.7 million increase in external development costs related to the phase 2 clinical trial in patients with COVID-19 as trials did not start until the second quarter of 2020, (ii) a $1.4 million increase in drug supply costs related to IMU-838 to support the company’s ongoing and future clinical trials, (iii) a $0.9 million increase in preparation costs related to the phase 3 program of IMU-838 in multiple sclerosis, (iv) $0.4 million related to increased cost for the ulcerative colitis trial, and (v) $0.7 million related to increased costs across numerous categories.
General and Administrative (G&A) Expenses were $20.9 million for the three months ended March 31, 2021, as compared to $2.6 million for the same period ended March 31, 2020. The $18.3 million increase was primarily due to (i) a $17.3 million settlement of royalty obligations to 4SC AG, and (ii) a $1.3 million increase in personnel expenses of which $1.2 million is related to non-cash stock compensation expense, partially offset by a $0.3 million decrease in travel related costs.
Other Income (Expense) was $(2.1) million for the three months ended March 31, 2021, as compared to $0.5 million for the same period ended March 31, 2020. The $2.6 million decrease was primarily attributable to (i) a $2.5 million foreign exchange loss on a $52.0 million intercompany loan between Immunic, Inc. and Immunic AG, and (ii) a $0.4 million decrease in recognized deferred income attributable to reimbursements of R&D expenses in connection with the option agreement with Daiichi Sankyo Co., Ltd. realized in the first quarter of 2020. The decrease was partially offset by a $0.2 million increase in R&D tax incentives for clinical trials in Australia as a result of increased spending on clinical trials in Australia.
Net Loss for the three months ended March 31, 2021 was approximately $34.5 million, or $1.63 per basic and diluted share, based on 21,174,698 weighted average common shares outstanding, compared to a net loss of approximately $8.5 million, or $0.79 per basic and diluted share, based on 10,749,460 weighted average common shares outstanding for the same period ended March 31, 2020.
Cash and Cash Equivalents as of March 31, 2021 were $114.8 million, which management expects to be sufficient to fund operations into the second half of 2022.