IMMUNIC, INC. annual report, FY2022

Immunic, Inc. — FY2022 Form 10-K

Reporting period: Fiscal year ended December 31, 2022; comparative figures are for the year ended December 31, 2021. Immunic is a clinical-stage biopharmaceutical company with no approved products or product-sales revenue. Its principal programs are vidofludimus calcium (IMU-838), izumerogant (IMU-935) and IMU-856.

Financial performance and position

Metric	FY2022	FY2021
Product-sales revenue	None	None
Research and development expense	$71.3 million	$61.1 million
General and administrative expense	$15.3 million	$13.3 million
Total operating expenses	$119.5 million	$91.7 million
Net loss	$120.4 million	$92.9 million
Net loss per share, basic and diluted	$3.78	$3.93
Cash used in operating activities	$65.1 million	$83.2 million
Cash and cash equivalents at year-end	$106.7 million	$86.9 million

Operating expenses rose 30%, including a $33.0 million non-cash goodwill impairment in Q4 2022. The impairment followed a sharp share-price decline after interim psoriasis data for izumerogant did not separate from placebo. FY2021 included a $17.25 million 4SC royalty-settlement expense, versus none in FY2022.
R&D expense increased 17%, principally reflecting higher development costs for the MS trials and izumerogant; lower spending on ulcerative colitis and COVID-19 trials partly offset the increase. G&A expense rose 15%.
At December 31, 2022, cash and cash equivalents were $106.7 million and other investments were $9.6 million. Current assets totaled $125.9 million versus current liabilities of $13.1 million. Total liabilities were $14.1 million, including operating lease liabilities; the filing reports no conventional borrowings on the balance sheet.
Stockholders’ equity was $113.7 million, down from $127.1 million, and accumulated deficit was $317.3 million. Financing activities provided $95.8 million, including net proceeds from a $60.0 million private placement and the at-the-market offering. Shares outstanding were 39.3 million at year-end; pre-funded warrants were exercised in January 2023, and 44.4 million shares were outstanding on February 17, 2023.

The company has no meaningful product-sales margin to report and expects continued losses as it advances its pipeline. Management states that year-end cash and investments are expected to fund operations beyond 12 months from issuance of the financial statements; elsewhere, the filing estimates cash runway into the fourth quarter of 2024.

Material operating and development updates

Vidofludimus calcium — multiple sclerosis: The twin Phase 3 ENSURE trials in relapsing MS and the Phase 2 CALLIPER trial in progressive MS were ongoing. Management expected an ENSURE interim analysis in late 2024 and the first trial’s topline results at the end of 2025; CALLIPER interim data were expected in the second half of 2023 and topline data at the end of 2024. These are forward-looking expectations, not results.
Vidofludimus calcium — ulcerative colitis: Phase 2 CALDOSE-1 did not meet its primary endpoint, and the overall population showed no meaningful efficacy differences from placebo. The filing describes a possible interaction with concurrent corticosteroid use; further IBD development was not planned without a partner.
Izumerogant: In the psoriasis Phase 1b interim analysis, active-dose groups did not separate from placebo on PASI reductions at four weeks; the trial continued, with no new safety signal reported. In the mCRPC Phase 1 trial, dose escalation up to 900 mg daily was completed, with no dose-limiting toxicities reported in initial safety data.
IMU-856: Single- and multiple-dose testing in healthy volunteers was reported as safe and well tolerated, with no maximum tolerated dose reached. A Phase 1 celiac-disease patient study was ongoing; initial results were expected in mid-2023.
Other notable changes: the investigator-sponsored COVID-19 IONIC trial was closed; the company discontinued its own PSC development program. The company was also exploring options, including potential licensing or a spin-off, for antiviral research activities.

Outlook, risks and unusual items

Management expects significant expenses and increasing operating losses for the foreseeable future and does not anticipate product revenue in the near term. Additional financing may be needed; equity financing could dilute shareholders, while debt or collaborations could impose restrictions or require rights to be relinquished. No external funding source is committed.
Clinical outcomes and timelines are uncertain. Key risks include failure of trials or regulatory approval, enrollment and execution delays, dependence on contract research and manufacturing providers, and competition.
Russia’s invasion of Ukraine disrupted planned trial sites, increased costs and delayed development; the company reported 19 active sites in western Ukraine and anticipated Ukraine would account for approximately 15%–20% of ENSURE enrollment. Inflation and global economic uncertainty may also raise costs or make financing harder.
The audited financial statements received an unmodified opinion. Management concluded disclosure controls and internal control over financial reporting were effective as of year-end. The auditor identified accrued clinical-trial expense estimation as a critical audit matter, not a qualification of its opinion. The company reported no material litigation.

Key facts for investors to verify

Whether the stated runway—described both as beyond 12 months and into Q4 2024—remains valid under current trial spending and financing assumptions.
Progress, enrollment and updated readout timing for ENSURE and CALLIPER, including the impact of Ukraine-related disruptions.
Further izumerogant psoriasis results and management’s development decision, given the interim lack of separation from placebo and associated goodwill write-off.
IMU-856 celiac-disease patient data and whether they support advancement beyond Phase 1.
Actual cash burn, financing capacity and dilution following the 2022 private placement, ATM sales and January 2023 warrant exercises.