Immunic, Inc. Reports Second Quarter 2024 Financial Results and Provides Corporate Update
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– Strengthened Board of Directors with Appointment of
– Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain on Track –
– Webcast to be Held Today,
"During the second quarter and subsequent period, we continued to achieve clinical and operational progress, punctuated with the addition of
"We look forward to reporting the top-line data from our phase 2 CALLIPER trial of vidofludimus calcium in PMS patients in April of next year. The previously reported interim analysis showed a clear separation from placebo in neurofilament light chain (NfL) levels across the PMS patient population, including non-relapsing secondary progressive MS (SPMS), a subtype with the highest unmet medical need. If the top-line data continues to show a neuroprotective effect, and meets the trial's primary and key secondary endpoints, we may also be able to potentially position the drug as the first oral treatment option for non-relapsing SPMS. Notably, we also remain on track with our phase 3 ENSURE program in RMS and expect to complete the first ENSURE trial in the second quarter of 2026 and the second ENSURE trial in the second half of 2026."
Second Quarter 2024 and Subsequent Highlights
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July 2024 : Announced the appointment ofSimona Skerjanec ,M.Pharm , MBA, a thought leader in brain health with decades of experience in drug development and commercialization, to the Board of Directors, effective as ofJuly 22, 2024 . -
July 2024 : AppointedJason Tardio , MBA, as Chief Operating Officer and President, effective as ofJuly 12, 2024 , to lead internal efforts in positioning the company for its potential launch of vidofludimus calcium and to work closely withPatrick Walsh , Chief Business Officer, to prepare the company for a range of potential partnership outcomes for vidofludimus calcium andImmunic's other drug candidates. Additionally, reported that Werner Gladdines, former Vice President, Program Management & Clinical Development Operations, was promoted to Chief Development Officer. -
April 2024 : Announced publication of data from the phase 2 EMPhASIS trial of vidofludimus calcium in patients with relapsing-remitting MS in Neurology® Neuroimmunology & Neuroinflammation, an official journal of theAmerican Academy of Neurology . -
April 2024 : Hosted an MS R&D Day inSan Francisco , 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.
Anticipated Clinical Milestones
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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 the fourth quarter of 2024. Completion 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, contingent on financing, licensing or partnering.
Financial and Operating Results
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Research and Development (R&D) Expenses were
$18.3 million for the three months endedJune 30, 2024 , as compared to$21.2 million for the three months endedJune 30, 2023 . The$2.8 million decrease reflects (i) a$1.8 million decrease in external development costs related to IMU-856 due to the completion of the phase 1 trial in celiac disease, (ii) a decrease of$1.0 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer and (iii) a$0.5 million decrease in related costs across numerous categories. The decreases were offset by a$0.5 million increase in external development costs related to the vidofludimus calcium programs.
For the six months endedJune 30, 2024 , R&D expenses were$37.0 million , as compared to$44.1 million for the six months endedJune 30, 2023 . The$7.1 million decrease reflects (i) a decrease of$3.4 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer, (ii) a$2.9 million decrease in external development costs related to IMU-856 due to the completion of the phase 1 trial in celiac disease, (iii) a$0.9 million decrease in external development costs related to the vidofludimus calcium programs and (iv) a$0.8 million decrease in related costs across numerous categories. The decreases were offset by a$0.9 million increase in personnel costs,$0.2 million of which is related to non-cash stock compensation and the remainder of which is due to an increase in headcount.
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General and Administrative (G&A) Expenses were
$4.5 million for the three months endedJune 30, 2024 , as compared to$3.8 million for the same period endedJune 30, 2023 . The$0.6 million increase was primarily due to (i) a$0.3 million increase in personnel expense in G&A,$0.1 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount, (ii) a$0.1 million increase in legal and consultancy expenses and (iii) a$0.2 million increase related to costs across numerous categories.
For the six months endedJune 30, 2024 , G&A expenses were$9.6 million , as compared to$8.1 million for the same period endedJune 30, 2023 . The$1.5 million increase was primarily due to (i) a$1.1 million increase in personnel expense in G&A,$0.6 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount, (ii) a$0.2 million increase in legal and consultancy expenses and (iii) a$0.2 million increase related to costs across numerous categories.
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Interest Income remained unchanged at
$1.0 million during the three months endedJune 30, 2024 , as compared to the three months endedJune 30, 2023 .
For the six months endedJune 30, 2024 , interest income was$2.2 million , as compared to$1.8 million for the same period endedJune 30, 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 six months endedJune 30, 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
$0.4 million for the three months endedJune 30, 2024 , as compared to$0.1 million for the same period endedJune 30, 2023 . The$0.4 million increase was primarily attributable to a$0.7 million increase in foreign exchange gains. The increase was offset by (i) a$0.2 million decrease in other grants received in 2023 and (ii) a$0.1 million decrease in R&D tax incentives for clinical trials inAustralia as a result of decreased spending on clinical trials inAustralia .
For the six months endedJune 30, 2024 , other income (expense) was ($1.7 million ), as compared to$1.2 million for the same period endingJune 30, 2023 . The$2.9 million decrease was primarily attributable to (i) a$1.7 million expense related to the portion of deal costs from theJanuary 2024 PIPE financing related to the tranche rights that were established at the time of the deal closing, (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, (iii) a$0.5 million decrease in R&D tax incentives for clinical trials inAustralia as a result of decreased spending on clinical trials inAustralia and (iv) a$0.4 million decrease in other grants received in 2023. The decrease was offset by a$0.8 million increase in foreign exchange gains.
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Net Loss for the three months ended
June 30, 2024 , was approximately$21.4 million , or$0.21 per basic and diluted share, based on 101,272,580 weighted average common shares outstanding, compared to a net loss of approximately$24.0 million , or$0.54 per basic and diluted share, based on 44,432,955 weighted average common shares outstanding for the same period endedJune 30, 2023 .
Net loss for the six months endedJune 30, 2024 , was approximately$51.0 million , or$0.51 per basic and diluted share, based on 99,607,158 weighted average common shares outstanding, compared to a net loss of approximately$49.3 million or$1.12 per basic and diluted share, based on 44,036,352 weighted average common shares outstanding for the same period endedJune 30, 2023 .
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Cash and Cash Equivalents as of
June 30, 2024 were$79.7 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 new management hires and promotions, 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
+1 212 896 1241
ckasunich@kcsa.com
Financials
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Condensed Consolidated Statements of Operations |
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(In thousands, except share and per share amounts) |
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(Unaudited) |
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|
||||||||
|
|
Three Months
Ended |
|
Six Months
Ended |
||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ 18,323 |
|
$ 21,172 |
|
$ 37,059 |
|
$ 44,135 |
General and administrative |
|
4,491 |
|
3,849 |
|
9,636 |
|
8,137 |
Total operating expenses |
|
22,814 |
|
25,021 |
|
46,695 |
|
52,272 |
Loss from operations |
|
(22,814) |
|
(25,021) |
|
(46,695) |
|
(52,272) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
998 |
|
968 |
|
2,185 |
|
1,768 |
Change in fair value of the tranche rights |
|
— |
|
— |
|
(4,796) |
|
— |
Other income (expense), net |
|
436 |
|
54 |
|
(1,658) |
|
1,233 |
Total other income (expense) |
|
1,434 |
|
1,022 |
|
(4,269) |
|
3,001 |
Net loss |
|
$ (21,380) |
|
$ (23,999) |
|
$ (50,964) |
|
$ (49,271) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ (0.21) |
|
$ (0.54) |
|
$ (0.51) |
|
$ (1.12) |
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding, basic and diluted |
|
101,272,580 |
|
44,432,955 |
|
99,607,158 |
|
44,036,352 |
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Condensed Consolidated Balance Sheets |
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(In thousands, except share and per share amounts) |
|||
(Unaudited) |
|||
|
|||
|
|
|
|
|
(Unaudited) |
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ 79,698 |
|
$ 46,674 |
Other current assets and prepaid expenses |
5,280 |
|
5,860 |
Total current assets |
84,978 |
|
52,534 |
Property and equipment, net |
585 |
|
466 |
Right-of-use assets |
928 |
|
1,299 |
Total assets |
$ 86,491 |
|
$ 54,299 |
Liabilities and Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ 7,894 |
|
$ 5,099 |
Accrued expenses |
13,775 |
|
18,664 |
Other current liabilities |
1,008 |
|
966 |
Total current liabilities |
22,677 |
|
24,729 |
Long term liabilities |
|
|
|
Operating lease liabilities |
241 |
|
639 |
Total long-term liabilities |
241 |
|
639 |
Total liabilities |
22,918 |
|
25,368 |
Commitments and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, |
— |
|
— |
Common stock, |
8 |
|
4 |
Additional paid-in capital |
521,639 |
|
436,060 |
Accumulated other comprehensive income |
3,782 |
|
3,759 |
Accumulated deficit |
(461,856) |
|
(410,892) |
Total stockholders' equity |
63,573 |
|
28,931 |
Total liabilities and stockholders' equity |
$ 86,491 |
|
$ 54,299 |
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