Immunic, Inc. Reports Year End 2023 Financial Results and Provides Corporate Update
– Significantly Strengthened Balance Sheet in
– Evidence for Neuroprotective Activity of Vidofludimus Calcium from Phase 2 CALLIPER Interim Analysis,
Consistent Across the Entire Progressive Multiple Sclerosis Population and All Subtypes; Top-Line CALLIPER Data Expected in
– Phase 3 ENSURE Program in Relapsing Multiple Sclerosis Ongoing –
– Expanded Vidofludimus Calcium Patent Portfolio
with Additional New Patents Granted; Exclusivity Protection Expected Into 2041 in
– Webcast to be Held Today,
"
"During the fourth quarter, we reported an interim biomarker analysis from our phase 2 CALLIPER trial of our lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium. The highly encouraging results demonstrated clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with progressive multiple sclerosis (PMS). Notably, this effect was observed across all subpopulations, including advanced secondary progressive multiple sclerosis (SPMS), which we believe is a segment of very high unmet need in multiple sclerosis (MS). Further, if the top-line CALLIPER data, expected in
Fourth Quarter 2023 and Subsequent Highlights
-
January 2024 : Announced a three-tranche private placement of up to$240 million , with participation from select new and existing investors, including lead investorBVF Partners , as well asAvidity Partners ,Janus Henderson Investors ,Soleus Capital ,RTW Investments andAdage Capital Partners . A total of$80 million in gross proceeds was received byImmunic in the first tranche, which closed onJanuary 8, 2024 . -
November 2023 : Received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 17/992,162, covering the dosing regimens associated with vidofludimus calcium and other salt as well as free acid forms for the treatment of MS, including all regimens tested in the MS clinical program. -
November 2023 : Received a Notice of Allowance from the USPTO for patent application 17/391,442, covering a daily dose of about 10 mg to 45 mg of vidofludimus calcium and other salt as well as free acid forms, including the 30 mg dosage used in the ongoing twin phase 3 ENSURE trials, for the treatment of RMS. The claims are expected to provide protection into 2041, unless extended further. -
November 2023 : Presented data from the phase 1b clinical trial of IMU-856 in patients with celiac disease in a poster presentation at theAssociation of European Coeliac Societies (AOECS) 35thGeneral Assembly Conference 2023. -
October 2023 : Presented data from the phase 1b clinical trial of IMU-856 in patients with celiac disease in a moderated poster session; along with data from the phase 2 CALDOSE-1 trial of vidofludimus calcium in moderate-to-severe ulcerative colitis (UC) in an oral presentation, both at the United European Gastroenterology Week (UEGW) 2023. -
October 2023 : Presented data from the phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting MS in an ePoster at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting. -
October 2023 : Reported positive interim data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS. Serum NfL improvements were consistently observed for vidofludimus calcium across PMS and all disease subtypes, as well as in patients who showed or did not show disease and/or magnetic resonance imaging (MRI) activity.Immunic believes that this data illustrates biomarker evidence that vidofludimus calcium's activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential. Enrollment of the trial was completed in August. In total, 467 patients with primary PMS, or active or non-active SPMS, were randomized to either 45 mg of vidofludimus calcium or placebo.
Anticipated Clinical Milestones
-
Vidofludimus calcium in MS: Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in
April 2025 . An interim futility analysis of the ENSURE program is expected in late 2024. The read-out of the first of the ENSURE trials is currently anticipated in the second quarter of 2026; and the second ENSURE trial in the second half of 2026. - IMU-856 in celiac disease: Based on the positive data from the phase 1b clinical trial, the company is preparing for clinical phase 2 testing of IMU-856 in OACD patients despite gluten-free diet.
Financial and Operating Results
-
Research and Development (R&D) Expenses were
$83.2 million for the twelve months endedDecember 31, 2023 , as compared to$71.2 million for the twelve months endedDecember 31, 2022 . The$12.0 million increase reflects (i) a$19.1 million increase in external development costs related to the ongoing clinical programs of vidofludimus calcium in RMS and PMS, the ongoing IMU-856 clinical program as well as increased drug supply costs for vidofludimus calcium to support ongoing trials and (ii) a$2.2 million increase in personnel expense in research and development related to an increase in headcount,$0.2 million of which was due to non-cash stock based compensation. The increases were partially offset by (i) a decrease of$6.5 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer, (ii) a decrease of$2.5 million in external development costs related to the phase 2 clinical trial of vidofludimus calcium in ulcerative colitis and (iii) a$0.3 million increase in related costs across numerous categories. -
General and Administrative (G&A) Expenses were
$16.0 million for the twelve months endedDecember 31, 2023 , as compared to$15.3 million for the same period endedDecember 31, 2022 . The$0.7 million increase was primarily due to (i) a$0.9 million increase in legal and consultancy expense, travel expense and facility expenses and (ii) a$0.3 million increase across numerous categories. The increases were partially offset by a decrease of$0.5 million in personnel expense in general and administrative which was primarily due to non-cash stock based compensation decrease. -
Other Income (Expense) was
$5.6 million for the twelve months endedDecember 31, 2023 , as compared to ($0.9 million ) for the same period endedDecember 31, 2022 . The$6.5 million increase was primarily attributable to (i) a$3.9 million decrease in foreign exchange losses, (ii) a$2.3 million research allowance attributable to tax year 2021 and 2022 from theGerman Federal Ministry of Finance and (iii) a$2.0 million increase in interest income as a result of higher interest rates. The increase was partially offset by (i) a$1.6 million decrease in research and development tax incentives for clinical trials inAustralia as a result of decreased spending on clinical trials inAustralia and (ii) a$0.1 million decrease across numerous categories. -
Net Loss for the twelve months ended
December 31, 2023 , was approximately$93 .6 million, or$2.11 per basic and diluted share, based on 44,320,050 weighted average common shares outstanding, compared to a net loss of approximately$120.4 million , or$3.78 per basic and diluted share, based on 31,819,006 weighted average common shares outstanding for the same period endedDecember 31, 2022 . -
Cash, Cash Equivalents and Investments as of
December 31, 2023 were$46.7 million . With these funds and the approximately$75.0 million in net proceeds raised in the first tranche of theJanuary 2024 private placement,Immunic expects to be able to fund its operations into the third quarter of 2025.
Webcast Information
An archived replay of the webcast will be available approximately one hour after completion on
About
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to
Contact Information
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
+1 917 633 7790
immunic@rxir.com
US Media Contact
KOGS Communication
+1 617 974 8659
kaplan@kogspr.com
Financials
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Years Ended |
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2023 |
|
2022 |
Operating expenses: |
|
|
|
Research and development |
$ 83,215 |
|
$ 71,255 |
General and administrative |
16,008 |
|
15,263 |
|
— |
|
32,970 |
Total operating expenses |
99,223 |
|
119,488 |
Loss from operations |
(99,223) |
|
(119,488) |
Other income (expense): |
|
|
|
Interest income |
3,075 |
|
1,041 |
Other income (expense), net |
2,536 |
|
(1,960) |
Total other income (expense), net |
5,611 |
|
(919) |
Net loss |
$ (93,612) |
|
$ (120,407) |
|
|
|
|
Net loss per share, basic and diluted |
$ (2.11) |
|
$ (3.78) |
|
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|
|
Weighted-average common shares outstanding, basic and diluted |
44,320,050 |
|
31,819,006 |
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2023 |
|
2022 |
Assets |
|
|
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Current assets: |
|
|
|
Cash and cash equivalents |
$ 46,674 |
|
$ 106,745 |
Investments - other |
— |
|
9,629 |
Prepaid expenses and other current assets |
5,860 |
|
9,490 |
Total current assets |
52,534 |
|
125,864 |
Property and equipment, net |
466 |
|
294 |
Right of use asset, net |
1,299 |
|
1,552 |
Other long-term assets |
— |
|
43 |
Total assets |
$ 54,299 |
|
$ 127,753 |
Liabilities and Stockholders' Equity |
|
|
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Current liabilities: |
|
|
|
Accounts payable |
$ 5,099 |
|
$ 4,281 |
Accrued expenses |
18,664 |
|
7,986 |
Other current liabilities |
966 |
|
810 |
Total current liabilities |
24,729 |
|
13,077 |
Long-term liabilities: |
|
|
|
Operating lease liabilities |
639 |
|
992 |
Total long-term liabilities |
639 |
|
992 |
Total liabilities |
25,368 |
|
14,069 |
Commitments and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, |
— |
|
— |
Common stock, |
4 |
|
4 |
Additional paid-in capital |
436,060 |
|
427,925 |
Accumulated other comprehensive income |
3,759 |
|
3,035 |
Accumulated deficit |
(410,892) |
|
(317,280) |
Total stockholders' equity |
28,931 |
|
113,684 |
Total liabilities and stockholders' equity |
$ 54,299 |
|
$ 127,753 |
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