Immunic, Inc. Reports Year End 2023 Financial Results and Provides Corporate Update
- Immunic successfully executed a three-tranche private placement of up to $240 million in January 2024, extending its cash runway into the third quarter of 2025.
- Positive interim analysis results from the phase 2 CALLIPER trial demonstrated the neuroprotective activity of vidofludimus calcium in progressive multiple sclerosis patients, setting the stage for potential oral treatment options.
- The expanded patent portfolio ensures exclusivity protection for vidofludimus calcium into 2041 in the United States, with the potential for further extensions.
- Promising results from the phase 1b clinical trial of IMU-856 in celiac disease patients suggest a new therapeutic approach for gastrointestinal disorders.
- The company continues to advance its clinical pipeline with ongoing phase 3 ENSURE program in relapsing multiple sclerosis, positioning itself for future growth and innovation.
- None.
Insights
The private placement of up to $240 million by Immunic, Inc. is a significant financial event that underscores investor confidence and provides the company with a robust cash runway into Q3 2025. This strategic move, particularly the initial $80 million tranche, secures funding for ongoing clinical trials and may alleviate immediate dilution concerns for existing shareholders. The company's ability to attract top-tier investors, such as BVF Partners and Janus Henderson Investors, is indicative of a strong investment thesis surrounding Immunic's pipeline.
The financial implications of the expanded patent portfolio, with protection extending into 2041, are substantial. This fortifies Immunic's competitive position, potentially delaying generic competition and sustaining long-term revenue streams from vidofludimus calcium if approved. However, it's crucial to monitor the company's burn rate and subsequent tranches to ensure that the capital raised is efficiently utilized to advance clinical programs without unnecessary dilution.
The interim analysis of the Phase 2 CALLIPER trial is a pivotal milestone in Immunic's clinical development pathway. The neuroprotective activity of vidofludimus calcium, particularly across all subtypes of Progressive Multiple Sclerosis (PMS), suggests a broad therapeutic potential. The ability to demonstrate efficacy in advanced Secondary Progressive Multiple Sclerosis (SPMS) addresses a critical unmet need, which could expedite regulatory approval and market adoption.
However, while interim results are promising, the definitive value of vidofludimus calcium hinges on the outcome of the top-line CALLIPER data expected in April 2025 and subsequent Phase 3 ENSURE program results. It's essential to consider the risk of clinical trial failure, which could significantly impact Immunic's valuation and future prospects. Moreover, the therapeutic landscape for MS is competitive and the efficacy and safety profile of vidofludimus calcium must be compelling to displace existing treatments.
The granting of new patents covering specific dose strengths and dosing regimens is a strategic win for Immunic, bolstering its intellectual property portfolio. This level of exclusivity is a key driver for pharmaceutical innovation, as it provides a period of market exclusivity that can justify the high costs of drug development. The extension of patent protection into 2041 is particularly noteworthy, as it may provide a longer period of market exclusivity than the standard 20-year patent term.
However, it's important to note that patent challenges and litigation are common in the pharmaceutical industry and the actual duration of market exclusivity can be unpredictable. Furthermore, the potential for patent extensions through regulatory mechanisms such as the Orphan Drug Act or Pediatric Research Equity Act could further extend market exclusivity, contingent upon regulatory approval and the specifics of the drug's indication and patient population.
– Significantly Strengthened Balance Sheet in January 2024 with Execution of Three-Tranche Private Placement of up to
– 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 April 2025 –
– 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, February 22, 2024, at 8:00 am ET –
"Immunic made remarkable progress throughout 2023, and these achievements were punctuated by the successful three-tranche private placement of up to
"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 April 2025, continues to show a neuroprotective effect, we may be able to position vidofludimus calcium as the first oral treatment option for advanced SPMS. This eagerly anticipated data is fully funded by the first
Dr. Vitt continued, "During the fourth quarter, we presented the previously reported positive results from our phase 1b clinical trial of our second key clinical program, IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), in patients with celiac disease, at two prestigious medical conferences. The results demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. We believe this data provides initial clinical proof-of-concept for a potentially new, oral therapeutic approach to a multitude of gastrointestinal disorders through the regeneration of bowel architecture, rather than the traditional immunomodulatory approaches used in many gastrointestinal indications, today. We are currently preparing for phase 2 testing in ongoing active celiac disease (OACD) and are considering additional clinical applications in other gastrointestinal disorders."
Fourth Quarter 2023 and Subsequent Highlights
- January 2024: Announced a three-tranche private placement of up to
$240 million $80 million - 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 the Association of European Coeliac Societies (AOECS) 35th General 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 $71.2 million $12.0 million $19.1 million $2.2 million $0.2 million $6.5 million $2.5 million $0.3 million - General and Administrative (G&A) Expenses were
$16.0 million $15.3 million $0.7 million $0.9 million $0.3 million $0.5 million - Other Income (Expense) was
$5.6 million $0.9 million $6.5 million $3.9 million $2.3 million $2.0 million $1.6 million Australia as a result of decreased spending on clinical trials inAustralia and (ii) a$0.1 million - Net Loss for the twelve months ended December 31, 2023, was approximately
$93 $2.11 $120.4 million $3.78 - Cash, Cash Equivalents and Investments as of December 31, 2023 were
$46.7 million $75.0 million
Webcast Information
Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_NCQiFCMpTJ2WEqAc2FnB3A or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.
An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at: ir.imux.com/events-and-presentations.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.
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 Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; and the company's expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the
Contact Information
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com
Financials
Immunic, Inc. | |||
Years Ended December 31, | |||
2023 | 2022 | ||
Operating expenses: | |||
Research and development | $ 83,215 | $ 71,255 | |
General and administrative | 16,008 | 15,263 | |
Goodwill impairment | — | 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) | |
Weighted-average common shares outstanding, basic and diluted | 44,320,050 | 31,819,006 | |
Immunic, Inc. | |||
December 31, | |||
2023 | 2022 | ||
Assets | |||
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 | |||
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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SOURCE Immunic, Inc.
FAQ
What was the amount raised in the private placement in January 2024?
When is the top-line CALLIPER data expected?
What is the focus of the phase 3 ENSURE program?
What does the expanded patent portfolio provide?
What were the positive results from the phase 1b clinical trial of IMU-856?
Who is the Chief Executive Officer and President of Immunic?
