Immunic, Inc. Reports First Quarter 2024 Financial Results and Provides Corporate Update
Immunic, Inc. reported Q1 2024 financial results, highlighting a three-tranche private placement of up to $240 million to extend cash runway, received a fourth US patent for MS treatment, and is progressing with phase 3 ENSURE trials in RMS and phase 2 CALLIPER trial in PMS. The company aims to position vidofludimus calcium as the first oral treatment for MS, while also advancing IMU-856 for gastrointestinal disorders.
Successfully secured a three-tranche private placement of up to $240 million, bolstering the balance sheet and extending cash runway into Q3 2025.
Received a fourth US patent for the use of vidofludimus calcium in MS, providing protection until 2041 in the United States.
Progressing with twin phase 3 ENSURE trials in RMS and phase 2 CALLIPER trial in PMS, showcasing commitment to advancing potentially groundbreaking therapies.
Positioning vidofludimus calcium as a holistic treatment option for MS patients by selectively managing all components of smoldering MS with neuroprotective, anti-inflammatory, and antiviral effects.
Preparing for clinical phase 2 testing of IMU-856 for gastrointestinal disorders based on positive phase 1b trial data in celiac disease patients.
Reported a net loss of approximately $29.6 million for Q1 2024, with a loss of $0.30 per basic and diluted share, compared to a net loss of $25.3 million for the same period in 2023.
Research and Development (R&D) expenses decreased by $4.2 million, driven by deprioritizing the izumerogant program and lower external development costs, partially offset by increased personnel costs.
General and Administrative (G&A) expenses increased by $0.9 million, primarily due to higher personnel expenses and legal/consultancy expenses.
Insights
The recent private placement by Immunic, Inc. which raised
Immunic's development of vidofludimus calcium (IMU-838) as a potential MS treatment is noteworthy, especially with the mention of a 'clear separation from placebo' during interim analysis of the phase 2 CALLIPER trial. This could signify substantial progress in treating non-relapsing SPMS. Additionally, the patent portfolio strength, with protection extending into 2041 in the U.S., suggests a robust intellectual property position that could shield the company from immediate generic competition, if the drug is approved.
Moreover, the company's second program, IMU-856, shows potential in the treatment of gastrointestinal disorders and positive data from its phase 1b clinical trial could signal a new therapeutic approach. Investors might find promise in this diversification of the development pipeline, highlighting the company's capability to innovate across different domains of chronic inflammatory and autoimmune diseases.
The grant of the fourth U.S. patent covering vidofludimus calcium strengthens Immunic's multilayered intellectual property strategy. This development is particularly important as it reflects the company's ability to secure long-term monopoly rights for its flagship product, which is an attractive aspect for investors. The extension of protection into 2041 provides a significant competitive edge and could potentially lead to licensing opportunities or strategic partnerships, influencing the company's market position and shareholder value positively.
– 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, May 8, 2024, at 8:00 am ET –
"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 Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Just last month, we hosted a Multiple Sclerosis (MS) R&D Day, highlighting the latest developments in the MS landscape as well as our highly encouraging preclinical and clinical data supporting the neuroprotective potential and reduced disability-worsening associated with vidofludimus calcium, which represent important distinctions compared to currently available MS therapies. We also shared our strong belief that vidofludimus calcium could elevate today's standard of care by providing a holistic solution for the full spectrum of MS patients, given that it is designed to selectively manage all three components of smoldering MS with its neuroprotective, anti-inflammatory and antiviral effects. Importantly, the clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with PMS and non-relapsing secondary progressive multiple sclerosis (SPMS), which was observed in the recent interim analysis from our phase 2 CALLIPER trial, is significant, and, if this separation is also evident in the top-line CALLIPER data expected in April of next year, we may also be able to position vidofludimus calcium as the first oral treatment option for non-relapsing SPMS. Additionally, as it relates to our phase 3 ENSURE program, we expect to read-out the first of the ENSURE trials in the second quarter of 2026 and anticipate reading out the second ENSURE trial in the second half of 2026."
"We are well capitalized to execute on our upcoming MS milestones, following our successful January 2024, three-tranche private placement of up to
Dr. Vitt concluded, "Our second program, IMU-856, an orally available, systemically acting small molecule modulator that targets Sirtuin 6 ("SIRT6"), a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, also shows great promise. As we have noted previously, based on initial clinical proof-of-concept data, we believe that IMU-856 could be an entirely new therapeutic approach to treating gastrointestinal disorders by restoring a healthy gut through renewal of the bowel wall. In particular, the data from our phase 1b clinical trial in celiac disease patients during periods of gluten-free diet and gluten challenge demonstrated positive effects for IMU-856 over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients' symptoms, biomarker response, and enhancement of nutrient absorption. We are currently preparing clinical phase 2 testing of IMU-856 in patients with ongoing active celiac disease (OACD) despite gluten-free diet, while also exploring the possibility of additional clinical uses in other gastrointestinal conditions."
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 the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024.
- January 2024: Announced a three-tranche private placement totaling up to
$240 million $80 million
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 $22.9 million $4.2 million $2.4 million $2.5 million $0.7 million $0.3 million - General and Administrative (G&A) Expenses were
$5.1 million $4.2 million $0.9 million $0.8 million $0.5 million $0.1 million - Interest Income was
$1.2 million $0.8 million $0.4 million - The Change in Fair Value of the Tranche Rights of
$4.8 million - Other Income (Expense) was (
$2.1 million $1.2 million $3.3 million $1.7 million $1.1 million $0.5 million Australia 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 $0.30 $25.3 million $0.58 - Cash and Cash Equivalents as of March 31, 2024 were
$97.3 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_K6jgjaMURFiJjgA5i9-M8g 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. Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (Unaudited) | ||||
Three Months Ended March 31, | ||||
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 | ||
Immunic, Inc. Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) | |||
March 31, 2024 | December 31, 2023 | ||
(Unaudited) | |||
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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SOURCE Immunic, Inc.
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