Full Press Release Details
Immunic, Inc. Reports Year
End 2022 Financial Results
and Provides Corporate Update
- Initial Results From
Ongoing Part C of Phase 1 Clinical Trial of IMU-856 in Celiac Disease Expected Mid-2023 -
- Interim Results From
Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in the Second Half of 2023 -
- $116.4 Million in Cash,
Cash Equivalents and Investments Expected to Fund Immunic Into the Fourth Quarter of 2024 -
- Webcast to be Held
Today, February 23, 2023, at 8:00 am ET -
NEW YORK, February 23, 2023 - 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 year ended December 31, 2022, and provided
"We made significant progress throughout
the year in advancing our lead asset, vidofludimus calcium, for the treatment of multiple sclerosis (MS). Our next MS-related data inflection
point, expected in the second half of 2023, is an interim analysis of our phase 2 CALLIPER trial in progressive MS, which will provide
selected biomarker data to guide study progress," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "As
previously announced, the CALLIPER trial is designed to corroborate the neuroprotective potential of vidofludimus calcium, which, if confirmed,
would provide an additional key differentiator for the drug in the MS market. Furthermore, we look forward to reporting data from the
interim analysis of the phase 3 ENSURE program late next year and to read-out the first of our identical, twin phase 3 ENSURE trials in
relapsing MS at the end of 2025. Considering the promising clinical activity observed, thus far, along with vidofludimus calcium's established
safety and tolerability profile, we believe that the design of the ENSURE program gives us a straightforward path toward potential regulatory
approval in relapsing MS. Vidofludimus calcium has the potential to be a unique treatment option targeted to the biology of MS, differentiated
by its combined anti-inflammatory, antiviral and neuroprotective effects."
"Our second clinical asset, IMU-935, recently
received the proposed International Nonproprietary Name (INN), izumerogant, from the World Health Organization. We plan to provide further
updates and guidance on potential next steps for our phase 1b clinical trial in patients with moderate-to-severe psoriasis towards the
end of the first quarter of 2023."
Dr. Vitt continued, "During our recently
held celiac disease R&D webcast, we shared that IMU-856 appears to influence the tightly regulated network of genes and proteins associated
with intestinal epithelial cell interaction and adhesion, restoring intestinal barrier function while maintaining immunocompetency. These
characteristics indicate that IMU-856 could possibly present an entirely new and innovative approach for the treatment of a number of
gastrointestinal diseases, including celiac disease, without the serious consequences associated with immunosuppressive therapies. We
believe IMU-856 has the potential to be a first-in-class oral celiac disease therapy. We expect to report data from the ongoing Part C
of our phase 1 clinical trial in celiac disease patients mid this year."
Fourth Quarter 2022 and Subsequent Highlights
Anticipated Clinical Milestones
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_Gfg-b_qaSWugtw_SM5Gt-A
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), currently in phase 3 clinical trials for the treatment of
multiple sclerosis, selectively inhibits activated immune cells and shows combined anti-inflammatory, anti-viral and neuroprotective effects.
Izumerogant (IMU-935) is a selective inverse agonist of ROR /ROR t, which inhibits the IL-17 pathway, and is currently being
studied in clinical proof-of-concept trials in psoriasis and castration-resistant prostate cancer. IMU-856 is targeted to restore intestinal
barrier function and regenerate bowel epithelium, which would be applicable in numerous gastrointestinal diseases, such as celiac disease,
where it is currently being evaluated in a clinical proof-of-concept trial. For further information, please visit: www.imux.com.
Cautionary Statement Regarding Forward-Looking
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, expected development, timing 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 three 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 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,
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, 2021, filed with the SEC on February 24, 2022, 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.
Head of Investor Relations and Communications
Rx Communications Group
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| Years Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 71,255 | $ | 61,115 | ||||
| General and administrative | 15,263 | 13,300 | ||||||
| Goodwill impairment | 32,970 | - | ||||||
| 4SC Royalty Settlement | - | 17,250 | ||||||
| Total operating expenses | 119,488 | 91,665 | ||||||
| Loss from operations | (119,488 | ) | (91,665 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 1,041 | 66 | ||||||
| Other expense, net | (1,960 | ) | (1,346 | ) | ||||
| Total other expense, net | (919 | ) | (1,280 | ) | ||||
| Net loss | $ | (120,407 | ) | $ | (92,945 | ) | ||
| Net loss per share, basic and diluted | $ | (3.78 | ) | $ | (3.93 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 31,819,006 | 23,652,779 |
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 106,745 | $ | 86,863 | ||||
| Investments - other | 9,629 | - | ||||||
| Other current assets and prepaid expenses | 9,490 | 18,125 | ||||||
| Total current assets | 125,864 | 104,988 | ||||||
| Property and equipment, net | 294 | 152 | ||||||
| Goodwill | - | 32,970 | ||||||
| Right of use asset, net | 1,552 | 948 | ||||||
| Other long-term assets | 43 | 42 | ||||||
| Total assets | $ | 127,753 | $ | 139,100 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,281 | $ | 3,745 | ||||
| Accrued expenses | 7,986 | 7,071 | ||||||
| Other current liabilities | 810 | 585 | ||||||
| Total current liabilities | 13,077 | 11,401 | ||||||
| Long-term liabilities: | ||||||||
| Operating lease liabilities | 992 | 584 | ||||||
| Total long-term liabilities | 992 | 584 | ||||||
| Total liabilities | 14,069 | 11,985 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding at December 31, 2022 and 2021 | - | - | ||||||
| Common stock, $0.0001 par value; 130,000,000 shares authorized and 39,307,286 and 26,335,418 shares issued and outstanding at December 31, 2022 and 2021, respectively | 4 | 3 | ||||||
| Additional paid-in capital | 427,925 | 324,237 | ||||||
| Accumulated other comprehensive income (loss) | 3,035 | (252 | ) | |||||
| Accumulated deficit | (317,280 | ) | (196,873 | ) | ||||
| Total stockholders' equity | 113,684 | 127,115 | ||||||
| Total liabilities and stockholders' equity | $ | 127,753 | $ | 139,100 |