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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
February 22, 2024
IMMUNIC, INC.
(Exact name of registrant as specified in its
charter)
Delaware |
001-36201 |
56-2358443 |
(State or other jurisdiction
of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
1200 Avenue of the Americas, Suite 200
New York, NY 10036
USA
(Address of principal executive offices)
Registrant’s telephone number, including
area code: (332) 255-9818
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of exchange on which registered |
Common Stock, par value $0.0001 |
IMUX |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§ 240.12b2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. Yes ☐ No ☐
Item 2.02. Results of Operations and Financial Condition
On February 22, 2024, Immunic, Inc. (the “Company”) issued
a press release, a copy of which is furnished herewith as Exhibit 99.1, announcing the Company’s financial results for the quarter
and year ended December 31, 2023 and providing a corporate update (the “Press Release”).
The information contained in Item 2.02 of this Current Report on Form
8-K, including the Press Release, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act
of 1934, as amended, or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933,
as amended. In addition, this information shall not be deemed incorporated by reference into any of the Company’s filings with the
Securities and Exchange Commission, except as shall be expressly set forth by specific reference in any such filing.
Item 8.01. Other Events
On February 22, 2024, the Company posted an updated presentation on
its website. A copy of the presentation is filed herewith as Exhibit 99.2 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
Dated: February 22, 2024 |
Immunic, Inc. |
|
|
|
|
By: |
/s/ Daniel Vitt |
|
|
Daniel Vitt |
|
|
Chief Executive Officer |
Immunic, Inc. Reports Year
End 2023 Financial Results and Provides Corporate Update
–
Significantly Strengthened Balance Sheet in January 2024 with Execution of Three-Tranche Private Placement of up to $240 Million, Extending
Cash Runway Into the Third Quarter of 2025 Based on Initial $80 Million Tranche –
–
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 the United States, Unless Extended Further –
–
Webcast to be Held Today, February 22, 2024, at 8:00 am ET –
NEW YORK,
February 22, 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 fourth quarter and year ended December 31, 2023, and provided
a corporate update.
“Immunic made remarkable progress throughout
2023, and these achievements were punctuated by the successful three-tranche private placement of up to $240 million, which we announced
last month. Our ability to execute this transaction, with a group of top-tier, existing and new investors, we believe affirms the enormous
value inherent in our two advanced clinical programs” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.
“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 $80 million tranche of our recent financing, which extended our cash runway
into the third quarter of 2025. An interim futility analysis for our phase 3 ENSURE program is expected late this year, and the read-out
of the first of the ENSURE trials is anticipated in the second quarter of 2026. If approved, we believe that vidofludimus calcium has
the potential to be a unique treatment option targeted to the complex pathophysiology of MS, based on its combined neuroprotective, anti-inflammatory,
and antiviral effects. It is important to note that we continue to build on the multiple layers of patent protection around vidofludimus
and its salt and free acid forms. In November, we were granted two fundamental new patents in the United States covering the specific
dose strength used in clinical trials for the treatment of relapsing multiple sclerosis (RMS), as well as the dosing regimens associated
with the treatment of MS. As a result, our extensive patent portfolio now provides protection into 2041 in the United States, unless extended
further.”
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, with participation from select new and existing investors, including lead investor BVF Partners, as well as Avidity Partners,
Janus Henderson Investors, Soleus Capital, RTW Investments and Adage Capital Partners. A total of $80 million in gross proceeds was received
by Immunic in the first tranche, which closed on January 8, 2024. |
| · | 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 for the twelve months ended December
31, 2023, as compared to $71.2 million for the twelve months ended December 31, 2022. The $12.0 million increase reflects (i) a $19.1
million increase in external development costs related to the ongoing clinical programs of vidofludimus calcium in RMS and PMS, the ongoing
IMU-856 clinical program as well as increased drug supply costs for vidofludimus calcium to support ongoing trials and (ii) a $2.2 million
increase in personnel expense in research and development related to an increase in headcount, $0.2 million of which was due to non-cash
stock based compensation. The increases were partially offset by (i) a decrease of $6.5 million from deprioritizing the izumerogant program
in psoriasis and castration-resistant prostate cancer, (ii) a decrease of $2.5 million in external development costs related to the phase
2 clinical trial of vidofludimus calcium in ulcerative colitis and (iii) a $0.3 million increase in related costs across numerous categories. |
| · | General and Administrative (G&A) Expenses were $16.0 million for the twelve months ended December
31, 2023, as compared to $15.3 million for the same period ended December 31, 2022. The $0.7 million increase was primarily due to (i)
a $0.9 million increase in legal and consultancy expense, travel expense and facility expenses and (ii) a $0.3 million increase across
numerous categories. The increases were partially offset by a decrease of $0.5 million in personnel expense in general and administrative
which was primarily due to non-cash stock based compensation decrease. |
| · | Other Income (Expense) was $5.6 million for the twelve months ended December 31, 2023, as compared
to ($0.9 million) for the same period ended December 31, 2022. The $6.5 million increase was primarily attributable to (i) a $3.9 million
decrease in foreign exchange losses, (ii) a $2.3 million research allowance attributable to tax year 2021 and 2022 from the German Federal
Ministry of Finance and (iii) a $2.0 million increase in interest income as a result of higher interest rates. The increase was partially
offset by (i) a $1.6 million decrease in research and development tax incentives for clinical trials in Australia as a result of decreased
spending on clinical trials in Australia and (ii) a $0.1 million decrease across numerous categories. |
| · | Net Loss for the twelve months ended December 31, 2023, was approximately $93.6 million, or
$2.11 per basic and diluted share, based on 44,320,050 weighted average common shares outstanding, compared to a net loss of approximately
$120.4 million, or $3.78 per basic and diluted share, based on 31,819,006 weighted average common shares outstanding for the same period
ended December 31, 2022. |
| · | Cash, Cash Equivalents and Investments as of December 31, 2023 were $46.7 million. With these funds
and the approximately $75.0 million in net proceeds raised in the first tranche of the January 2024 private placement, Immunic expects
to be able to fund its operations into the third quarter of 2025. |
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 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, 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.
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.
Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
| |
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.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
| |
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, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding at December 31, 2023 and 2022 | |
| — | | |
| — | |
Common stock, $0.0001 par value; 130,000,000 shares authorized and 45,177,730 and 39,307,286 shares issued and outstanding at December 31, 2023 and 2022, respectively | |
| 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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