Immunic, Inc. Reports First Quarter 2024 Financial Results and Provides Corporate Update
– Substantially Bolstered Balance Sheet Through a Three-Tranche Private Placement Totaling Up to
– Received Fourth
– Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain Underway –
– Webcast to be Held Today,
"During the first quarter and subsequent period, we have continued to advance both the phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and the twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), for our potentially groundbreaking, orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838)," stated
"We are well capitalized to execute on our upcoming MS milestones, following our successful
First Quarter 2024 and Subsequent Highlights
-
April 2024 : Hosted an MS R&D Day, during which management discussed the latest developments in the MS landscape, along with recent preclinical and clinical data supporting the neuroprotective potential of vidofludimus calcium. -
March 2024 : Received Notice of Allowance from the USPTO for patent application 16/981,122 entitled, "Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents," covering the composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material. -
February 2024 : Presented data from the company's phase 2 CALLIPER and CALVID-1 clinical trials of vidofludimus calcium, in two poster presentations at theAmericas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024. -
January 2024 : Announced a three-tranche private placement totaling up to$240 million , with participation from select new and existing investors. These included lead investorBVF Partners , alongsideAvidity Partners ,Janus Henderson Investors ,Soleus Capital ,RTW Investments andAdage Capital Partners . The initial tranche successfully closed onJanuary 8, 2024 , withImmunic securing$80 million in gross proceeds.
Clinical Development Programs
-
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
$18.7 million for the three months endedMarch 31, 2024 , as compared to$22.9 million for the three months endedMarch 31, 2023 . The$4.2 million decrease reflects (i) a decrease of$2.4 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer and (ii) a$2.5 million decrease in external development costs related to the vidofludimus calcium and IMU-856 programs. The decreases were partially offset by a$0.7 million increase in personnel costs,$0.3 million of which is related to non-cash stock compensation and the remainder of which is due to an increase in headcount. -
General and Administrative (G&A) Expenses were
$5.1 million for the three months endedMarch 31, 2024 , as compared to$4.2 million for the same period endedMarch 31, 2023 . The$0.9 million increase was primarily due to (i) a$0.8 million increase in personnel expense in general and administrative,$0.5 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount and (ii)$0.1 million in legal and consultancy expenses. -
Interest Income was
$1.2 million for the three months endedMarch 31, 2024 , as compared to$0.8 million for the same period endedMarch 31, 2023 . The$0.4 million increase was due to higher interest rates. - The Change in Fair Value of the Tranche Rights of
$4.8 million for the three months endedMarch 31, 2024 was a non-cash charge related to the change in value of the tranche rights associated with the future tranches 2 and 3 of theJanuary 2024 private placement. -
Other Income (Expense) was (
$2.1 million ) for the three months endedMarch 31, 2024 , as compared to$1.2 million for the same period endedMarch 31, 2023 . The$3.3 million decrease was primarily attributable to (i) a$1.7 million expense related to the portion of deal costs from theJanuary 2024 private placement related to the tranche rights that were established at the time of the closing of tranche 1, (ii) theGerman Federal Ministry of Finance grant of$1.1 million being recognized in the fourth quarter of 2023 which was one quarter earlier than in the prior year when the grant was recognized in the first quarter of 2023 and (iii) a$0.5 million decrease in research and development tax incentives for clinical trials inAustralia as a result of decreased spending on clinical trials inAustralia . -
Net Loss for the three months ended
March 31, 2024 , was approximately$29.6 million , or$0.30 per basic and diluted share, based on 97,299,955 weighted average common shares outstanding, compared to a net loss of approximately$25.3 million , or$0.58 per basic and diluted share, based on 43,664,783 weighted average common shares outstanding for the same period endedMarch 31, 2023 . -
Cash and Cash Equivalents as of
March 31, 2024 were$97.3 million . With these funds,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
Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (Unaudited) |
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Three Months
Ended |
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|
|
2024 |
|
2023 |
Operating expenses: |
|
|
|
|
Research and development |
|
$ 18,736 |
|
$ 22,963 |
General and administrative |
|
5,145 |
|
4,288 |
Total operating expenses |
|
23,881 |
|
27,251 |
Loss from operations |
|
(23,881) |
|
(27,251) |
Other income (expense): |
|
|
|
|
Interest income |
|
1,187 |
|
800 |
Change in fair value of the tranche rights |
|
(4,796) |
|
— |
Other income (expense), net |
|
(2,094) |
|
1,179 |
Total other income (expense) |
|
(5,703) |
|
1,979 |
Net loss |
|
$ (29,584) |
|
$ (25,272) |
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ (0.30) |
|
$ (0.58) |
|
|
|
|
|
Weighted-average common shares outstanding, basic and diluted |
|
97,299,955 |
|
43,664,783 |
Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) |
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|
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|
|
|
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(Unaudited) |
|
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Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ 97,312 |
|
$ 46,674 |
Other current assets and prepaid expenses |
5,303 |
|
5,860 |
Total current assets |
102,615 |
|
52,534 |
Property and equipment, net |
442 |
|
466 |
Right-of-use assets, net |
1,098 |
|
1,299 |
Total assets |
$ 104,155 |
|
$ 54,299 |
Liabilities and Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ 6,767 |
|
$ 5,099 |
Accrued expenses |
12,419 |
|
18,664 |
Other current liabilities |
960 |
|
966 |
Total current liabilities |
20,146 |
|
24,729 |
Long-term liabilities |
|
|
|
Operating lease liabilities |
433 |
|
639 |
Total long-term liabilities |
433 |
|
639 |
Total liabilities |
20,579 |
|
25,368 |
Commitments and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, |
— |
|
— |
Common stock, |
8 |
|
4 |
Additional paid-in capital |
519,757 |
|
436,060 |
Accumulated other comprehensive income |
4,287 |
|
3,759 |
Accumulated deficit |
(440,476) |
|
(410,892) |
Total stockholders' equity |
83,576 |
|
28,931 |
Total liabilities and stockholders' equity |
$ 104,155 |
|
$ 54,299 |
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