Full Press Release Details
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 $240 Million, Extending Cash Runway Into
the Third Quarter of 2025, Based on Initial $80 Million Tranche -
Received Fourth U.S. Patent Directed to Use of Vidofludimus Calcium in Multiple Sclerosis; Multilayered Intellectual Property Strategy
Provides Protection Into 2041 in the United States -
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 -
May 8, 2024 - Immunic, Inc. (Nasdaq:
IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic
inflammatory and autoimmune diseases, today announced financial results for the first quarter ended March 31, 2024, and provided a corporate
"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 $240 million, with a group of
top-tier new and existing investors, which we believe reflects the enormous potential of our clinical programs. In addition to strengthening
our capital position, we also continued to build on the several layers of patents, currently protecting vidofludimus calcium into 2041
in the United States, with the United States Patent and Trademark Office's (USPTO) Notice of Allowance last month for our fourth patent
application covering a key composition-of-matter of a specific polymorph of vidofludimus calcium and related production of the material."
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
First Quarter 2024 and Subsequent Highlights
Clinical Development Programs
Financial and Operating Results
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.
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.
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 Ukraine - Russia conflict and the conflict in the Middle East on planned and ongoing clinical
trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future
liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational
requirements including the ability to satisfy the conditions required to receive funding in tranche 2 and 3 of the January 2024 private
placement, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial
results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and
the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these
risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report
on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company's subsequent filings
with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any
forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation
to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic
expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.
Vice President Investor Relations and Communications
Rx Communications Group
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| 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 |
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| 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, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding as of March 31, 2024 and December 31, 2023 | - | - | ||||||
| Common stock, $0.0001 par value; 500,000,000 and 130,000,000 shares authorized as of March 31, 2024 and December 31, 2023, respectively, and 90,079,016 and 45,177,730 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 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 |