Immunic, Inc. Reports Third Quarter 2024 Financial Results and Provides Corporate Update
– Positive Interim Analysis of Phase 3 ENSURE Program, Unblinded Independent Data Monitoring Committee Confirmed that Predetermined Futility Criteria Have Not Been Met and Recommended Trials Should Continue as Planned –
– Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain on Track –
– Top-Line Data from Phase 2 CALLIPER Trial Expected in
– Webcast to be Held Today,
"During the third quarter, we have continued to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), for our potentially transformative, orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838)," stated
"In September, we had the opportunity to present four posters at the prestigious 40th
Third Quarter 2024 and Subsequent Highlights
-
October 2024 : Announced a positive outcome of the non-binding, interim futility analysis of the phase 3 ENSURE program of vidofludimus calcium for the treatment of RMS. An unblinded IDMC confirmed that the trials are not futile and recommended that they should continue without changes, including no need for a potential upsizing of the sample size. -
September 2024 : Presented key data at the 40thCongress of ECTRIMS, highlighting vidofludimus calcium's therapeutic potential in MS, in one oral poster presentation and three ePosters. -
September 2024 : Enrolled the first patient in an investigator-sponsored phase 2 clinical trial of vidofludimus calcium, entitled, "Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE)." -
September 2024 : Hosted an MS R&D Day inNew York , during which management was joined by two renowned experts in the field, Francesca Montarolo, Ph.D., Neuroscience InstituteCavalieri Ottolenghi (NICO) andUniversity of Turin, Italy , andAmit Bar-Or , M.D., FRCPC,Perelman School of Medicine ,University of Pennsylvania . The event focused on today's MS landscape and on vidofludimus calcium's potential to become the treatment of choice for both relapsing and progressive MS patients. -
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. -
July 2024 : Announced the appointment ofJason Tardio , MBA, as Chief Operating Officer and President, to lead internal efforts in positioning the company for the potential launch of vidofludimus calcium and to work closely withPatrick Walsh , Chief Business Officer, to prepare 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.
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 . - Completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026.
- Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in
- 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
-
Research and Development (R&D) Expenses were
$21.4 million for the three months endedSeptember 30, 2024 , as compared to$19.8 million for the three months endedSeptember 30, 2023 . The$1.6 million increase reflects (i) a$1.4 million increase in external development costs related to the vidofludimus calcium program, (ii) a$0.3 million increase in external development costs related to IMU-856, (iii) a$0.3 million increase in personnel costs due to an increase in headcount and (iv) a$0.3 million increase related costs across numerous categories. The increases were offset by a decrease of$0.7 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer.
For the nine months endedSeptember 30, 2024 , R&D expenses were$58.4 million , as compared to$63.9 million for the nine months endedSeptember 30, 2023 . The$5.5 million decrease reflects (i) a decrease of$4.1 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer, (ii) a$2.6 million decrease in external development costs related to IMU-856 due to the completion of the phase 1 clinical trial in celiac disease and (iii) a$0.5 million decrease related costs across numerous categories. The decreases were offset by (i) a$1.2 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 and (ii) a$0.5 million increase in external development costs related to the vidofludimus calcium program. -
General and Administrative (G&A) Expenses were
$4.4 million for the three months endedSeptember 30, 2024 , as compared to$3.8 million for the same period endedSeptember 30, 2023 . The$0.6 million increase was primarily due to a$0.6 million increase in personnel expense in G&A,$0.2 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount.
For the nine months endedSeptember 30, 2024 , G&A expenses were$14.0 million , as compared to$11.9 million for the same period endedSeptember 30, 2023 . The$2.1 million increase was primarily due to (i) a$1.7 million increase in personnel expense in G&A,$0.9 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount, (ii)$0.3 million in legal and consultancy expenses and (iii) a$0.1 million increase related to costs across numerous categories. -
Interest Income remained unchanged at
$0.8 million during the three months endedSeptember 30, 2024 , as compared to the three months endedSeptember 30, 2023 .
Interest income for the nine months endedSeptember 30, 2024 was$2.9 million , as compared to$2.5 million for the nine months endedSeptember 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 nine months endedSeptember 30, 2024 was a non-cash charge related to theJanuary 2024 Financing fromJanuary 8, 2024 untilMarch 4, 2024 . These tranches were initially classified as a liability, but were reclassified to equity onMarch 4, 2024 , when stockholders approved the increase in authorized shares from 130 million to 500 million shares of common stock and therefore the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclass to equity. -
Other Income (Expense) was
$0.6 million for the three months endedSeptember 30, 2024 , as compared to$35 thousand for the same period endedSeptember 30, 2023 . The$0.5 million increase was primarily attributable to a$0.6 million increase in R&D tax incentives for clinical trials inAustralia .
For the nine months endedSeptember 30, 2024 , other income (expense) was ($1.1 million ), as compared to$1.3 million for the same period endingSeptember 30, 2023 . The$2.4 million decrease was primarily attributable to (i) a$1.7 million expense related to the portion of deal costs from theJanuary 2024 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 and (iii) a$0.4 million decrease in other grants which were received in 2023. The decrease was offset by a$0.9 million increase in foreign exchange gains. -
Net Loss for the three months ended
September 30, 2024 , was approximately$24.4 million , or$0.24 per basic and diluted share, based on 101,272,580 weighted average common shares outstanding, compared to a net loss of approximately$22.8 million , or$0.51 per basic and diluted share, based on 44,574,377 weighted average common shares outstanding for the same period endedSeptember 30, 2023 .
Net loss for the nine months endedSeptember 30, 2024 , was approximately$75.3 million , or$0.75 per basic and diluted share, based on 99,998,245 weighted average common shares outstanding, compared to a net loss of approximately$72.0 million or$1.63 per basic and diluted share, based on 44,227,264 weighted average common shares outstanding for the same period endedSeptember 30, 2023 . -
Cash and Cash Equivalents as of
September 30, 2024 were$59.1 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, new management hires and promotions, 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
Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (Unaudited) |
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|
Three Months
Ended |
|
Nine Months
Ended |
||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ 21,370 |
|
$ 19,796 |
|
$ 58,429 |
|
$ 63,931 |
General and administrative |
|
4,356 |
|
3,774 |
|
13,992 |
|
11,911 |
Total operating expenses |
|
25,726 |
|
23,570 |
|
72,421 |
|
75,842 |
Loss from operations |
|
(25,726) |
|
(23,570) |
|
(72,421) |
|
(75,842) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
776 |
|
766 |
|
2,961 |
|
2,534 |
Change in fair value of the tranche rights |
|
— |
|
— |
|
(4,796) |
|
— |
Other income (expense), net |
|
582 |
|
35 |
|
(1,076) |
|
1,268 |
Total other income (expense) |
|
1,358 |
|
801 |
|
(2,911) |
|
3,802 |
Net loss |
|
$ (24,368) |
|
$ (22,769) |
|
$ (75,332) |
|
$ (72,040) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ (0.24) |
|
$ (0.51) |
|
$ (0.75) |
|
$ (1.63) |
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding, basic and diluted |
|
101,272,580 |
|
44,574,377 |
|
99,998,245 |
|
44,227,264 |
Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) |
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|
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|
|
|
|
(Unaudited) |
|
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Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ 59,071 |
|
$ 46,674 |
Other current assets and prepaid expenses |
4,195 |
|
5,860 |
Total current assets |
63,266 |
|
52,534 |
Property and equipment, net |
618 |
|
466 |
Right-of-use assets, net |
878 |
|
1,299 |
Total assets |
$ 64,762 |
|
$ 54,299 |
Liabilities and Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ 6,042 |
|
$ 5,099 |
Accrued expenses |
16,245 |
|
18,664 |
Other current liabilities |
1,070 |
|
966 |
Total current liabilities |
23,357 |
|
24,729 |
Long term liabilities |
|
|
|
Operating lease liabilities |
186 |
|
639 |
Total long-term liabilities |
186 |
|
639 |
Total liabilities |
23,543 |
|
25,368 |
Commitments and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, |
— |
|
— |
Common stock, |
8 |
|
4 |
Additional paid-in capital |
523,549 |
|
436,060 |
Accumulated other comprehensive income |
3,886 |
|
3,759 |
Accumulated deficit |
(486,224) |
|
(410,892) |
Total stockholders' equity |
41,219 |
|
28,931 |
Total liabilities and stockholders' equity |
$ 64,762 |
|
$ 54,299 |
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