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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):
November 7, 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 November 7, 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 ended September 30, 2024 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 November 7, 2024, the Company
posted an updated presentation (the “Presentation”) on its website. A copy of the Presentation is filed herewith as Exhibit
99.2 and is incorporated herein by reference.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this Current Report on Form
8-K, the Press Release and the Presentation are “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 Current Report on Form 8-K, the Press Release and the Presentation regarding new management hires
and promotions, 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; announcements regarding the positive outcomes of the interim analysis of the phase 3 ENSURE trials; 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;
expectations regarding the capitalization, resources and ownership structure of the Company; the executive and board structure 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 minimum average price and trading volume 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 SEC. Copies of these filings are available online at www.sec.gov
or ir.imux.com/sec-filings.
The statements made in this Current Report on
Form 8-K, the Press Release and the Presentation speak only as of the date stated herein, and subsequent events and developments may cause
the Company’s expectations and beliefs to change. While the Company may elect to update these forward-looking statements publicly
at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future
events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s
views as of any date after the date stated herein.
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: November 7, 2024 |
Immunic, Inc. |
| |
|
|
| |
By: |
/s/ Daniel Vitt |
| |
|
Daniel Vitt |
| |
|
Chief Executive Officer |
Immunic, Inc. Reports Third Quarter 2024
Financial Results and Provides Corporate Update
–
Positive Interim Analysis of Phase 3 ENSURE Program, Unblinded Independent Data Monitoring Committee Confirmed that Predetermined Futility
Criteria Have Not Been Met and Recommended Trials Should
Continue
as Planned –
–
Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis
Remain on Track –
–
Top-Line Data from Phase 2 CALLIPER Trial Expected in April 2025 –
–
Webcast to be Held Today, November 7, at 8:00 am ET –
NEW YORK,
November 7, 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 third quarter and nine months ended September 30, 2024,
and provided a corporate update.
“During the third quarter, we have continued
to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in
relapsing multiple sclerosis (RMS), for our potentially transformative, orally available lead asset, nuclear receptor related 1 (Nurr1)
activator, vidofludimus calcium (IMU-838),” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “As recently reported,
we are progressing, as planned, with our phase 3 ENSURE program in RMS, after an interim, non-binding futility analysis, conducted by
an unblinded Independent Data Monitoring Committee (IDMC), recommended that the trials are not futile and should continue as planned,
without any sample size increase, marking a key milestone for the program. We continue to expect to complete the ENSURE-1 trial in the
second quarter of 2026 and the ENSURE-2 trial in the second half of 2026. Our next important clinical readout for this program is the
CALLIPER top-line data in PMS, which we expect to release in April of next year. As previously reported, the CALLIPER interim data supported
the potential effectiveness of vidofludimus calcium in slowing disease progression in PMS and further substantiated its neuroprotective
capabilities through the activation of Nurr1. Should the top-line data continue to demonstrate this neuroprotective effect, and the phase
2 trial meets its primary and key secondary endpoints, we may be able to position vidofludimus calcium as the first oral treatment option
for non-relapsing secondary progressive MS (SPMS).”
“In September, we had the opportunity to
present four posters at the prestigious 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS),
showcasing data on key aspects of vidofludimus calcium’s profile. This included the neurofilament light chain (NfL) interim data
from our phase 2 CALLIPER trial, which showed a clear separation from placebo in NfL levels across the PMS patient population, including
non-relapsing SPMS, a subtype with the highest unmet medical need. We also presented antiviral data suggesting an effect on reducing fatigue,
Nurr1 target data supporting the neuroprotective potential, and pathogenic T cell data further supporting the drug’s anti-inflammatory
effects. The presentations at ECTRIMS followed closely on the heels of our MS R&D Day, which featured two world renowned industry
experts alongside Immunic’s management team to discuss vidofludimus calcium’s unique profile, including its safety and tolerability,
and its potential to significantly elevate today’s standard of care. We continue to believe that, if approved, vidofludimus calcium,
with its combined neuroprotective, anti-inflammatory and anti-viral effects, would represent a unique new treatment option targeted to
the complex pathophysiology of MS.”
| |
 |
Dr. Vitt
continued, “During the quarter, we continued phase 2 clinical preparations for IMU-856, our orally available, systemically acting
small molecule modulator targeting Sirtuin 6 (SIRT6), a protein which serves as a transcriptional regulator of intestinal barrier function
and physiological regeneration of bowel epithelium, including exploring potential financing, licensing or partnering opportunities to
fund this clinical program. 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. Data from our phase 1b clinical trial showed that, in patients with celiac disease during periods of gluten-free diet and gluten
challenge, IMU-856 demonstrated positive effects 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. Based on this
encouraging data, we are considering additional possible clinical applications in other gastrointestinal disorders.”
Third Quarter 2024 and Subsequent Highlights
| · | October 2024: Announced a positive outcome of the non-binding, interim
futility analysis of the phase 3 ENSURE program of vidofludimus calcium for the treatment of RMS. An unblinded IDMC confirmed that the
trials are not futile and recommended that they should continue without changes, including no need for a potential upsizing of the sample
size. |
| · | September 2024: Presented key data at the 40th Congress
of ECTRIMS, highlighting vidofludimus calcium’s therapeutic potential in MS, in one oral poster presentation and three ePosters. |
| · | September 2024: Enrolled the first patient in an investigator-sponsored
phase 2 clinical trial of vidofludimus calcium, entitled, “Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing
Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE).” |
| · | September 2024: Hosted an MS R&D Day in New York, during which
management was joined by two renowned experts in the field, Francesca Montarolo, Ph.D., Neuroscience Institute Cavalieri Ottolenghi (NICO)
and University of Turin, Italy, and Amit Bar-Or, M.D., FRCPC, Perelman School of Medicine, University of Pennsylvania. The event focused
on today's MS landscape and on vidofludimus calcium’s potential to become the treatment of choice for both relapsing and progressive
MS patients. |
| · | July 2024: Announced the appointment of Simona Skerjanec, M.Pharm,
MBA, a thought leader in brain health with decades of experience in drug development and commercialization, to the Board of Directors. |
| · | July 2024: Announced the appointment of Jason Tardio, MBA, as Chief
Operating Officer and President, to lead internal efforts in positioning the company for the potential launch of vidofludimus calcium
and to work closely with Patrick Walsh, Chief Business Officer, to prepare for a range of potential partnership outcomes for vidofludimus
calcium and Immunic’s other drug candidates. Additionally, reported that Werner Gladdines, former Vice President, Program Management
& Clinical Development Operations, was promoted to Chief Development Officer. |
Anticipated Clinical Milestones
| · | Vidofludimus calcium in MS: |
| o | Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April 2025. |
| o | Completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected
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, contingent on financing, licensing or partnering. |
Financial and Operating Results
| · | Research and Development (R&D) Expenses were $21.4 million for the three months ended September
30, 2024, as compared to $19.8 million for the three months ended September 30, 2023. The $1.6 million increase reflects (i) a $1.4 million
increase in external development costs related to the vidofludimus calcium program, (ii) a $0.3 million increase in external development
costs related to IMU-856, (iii) a $0.3 million increase in personnel costs due to an increase in headcount and (iv) a $0.3 million increase
related costs across numerous categories. The increases were offset by a decrease of $0.7 million from deprioritizing the izumerogant
program in psoriasis and castration-resistant prostate cancer. |
For the nine months ended September
30, 2024, R&D expenses were $58.4 million, as compared to $63.9 million for the nine months ended September 30, 2023. The $5.5 million
decrease reflects (i) a decrease of $4.1 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate
cancer, (ii) a $2.6 million decrease in external development costs related to IMU-856 due to the completion of the phase 1 clinical trial
in celiac disease and (iii) a $0.5 million decrease related costs across numerous categories. The decreases were offset by (i) a $1.2
million increase in personnel costs, $0.2 million of which is related to non-cash stock compensation and the remainder of which is due
to an increase in headcount and (ii) a $0.5 million increase in external development costs related to the vidofludimus calcium program.
| · | General and Administrative (G&A) Expenses were $4.4 million for the three months ended September
30, 2024, as compared to $3.8 million for the same period ended September 30, 2023. The $0.6 million increase was primarily due to a $0.6
million increase in personnel expense in G&A, $0.2 million of which is related to non-cash stock compensation expense and the remainder
of which is related to an increase in headcount. |
For the nine months ended September
30, 2024, G&A expenses were $14.0 million, as compared to $11.9 million for the same period ended September 30, 2023. The $2.1 million
increase was primarily due to (i) a $1.7 million increase in personnel expense in G&A, $0.9 million of which is related to non-cash
stock compensation expense and the remainder of which is related to an increase in headcount, (ii) $0.3 million in legal and consultancy
expenses and (iii) a $0.1 million increase related to costs across numerous categories.
| · | Interest Income remained unchanged at $0.8 million during the three months ended September 30,
2024, as compared to the three months ended September 30, 2023. |
Interest income for the nine months
ended September 30, 2024 was $2.9 million, as compared to $2.5 million for the nine months ended September 30, 2023. The $0.4 million
increase was due to higher interest rates.
| · | The Change in Fair Value of the Tranche Rights of $4.8 million for the nine months ended September
30, 2024 was a non-cash charge related to the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially
classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in authorized shares
from 130 million to 500 million shares of common stock and therefore the tranche 2 and tranche 3 rights needed to be revalued to fair
value upon the reclass to equity. |
| · | Other Income (Expense) was $0.6 million for the three months ended September 30, 2024, as compared
to $35 thousand for the same period ended September 30, 2023. The $0.5 million increase was primarily attributable to a $0.6 million increase
in R&D tax incentives for clinical trials in Australia. |
For the nine months ended September
30, 2024, other income (expense) was ($1.1 million), as compared to $1.3 million for the same period ending September 30, 2023. The $2.4
million decrease was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing
related to the tranche rights that were established at the time of the deal closing, (ii) the German Federal Ministry of Finance grant
of $1.1 million being recognized in the fourth quarter of 2023 and (iii) a $0.4 million decrease in other grants which were received in
2023. The decrease was offset by a $0.9 million increase in foreign exchange gains.
| · | Net Loss for the three months ended September 30, 2024, was approximately $24.4 million, or $0.24
per basic and diluted share, based on 101,272,580 weighted average common shares outstanding, compared to a net loss of approximately
$22.8 million, or $0.51 per basic and diluted share, based on 44,574,377 weighted average common shares outstanding for the same period
ended September 30, 2023. |
Net loss for the nine months ended
September 30, 2024, was approximately $75.3 million, or $0.75 per basic and diluted share, based on 99,998,245 weighted average common
shares outstanding, compared to a net loss of approximately $72.0 million or $1.63 per basic and diluted share, based on 44,227,264 weighted
average common shares outstanding for the same period ended September 30, 2023.
| · | Cash and Cash Equivalents as of September 30, 2024 were $59.1 million. With these funds, 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_v2_K1Ze-QKS34X6c9W9ywg 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, new
management hires and promotions, 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; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure
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 minimum average price and trading volume
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.
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
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com
Financials
Immunic, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
| | |
Three Months Ended September 30, | |
Nine Months Ended September 30, |
| | |
2024 | |
2023 | |
2024 | |
2023 |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
$ | 21,370 | | |
$ | 19,796 | | |
$ | 58,429 | | |
$ | 63,931 | |
| General and administrative | |
| 4,356 | | |
| 3,774 | | |
| 13,992 | | |
| 11,911 | |
| Total operating expenses | |
| 25,726 | | |
| 23,570 | | |
| 72,421 | | |
| 75,842 | |
| Loss from operations | |
| (25,726 | ) | |
| (23,570 | ) | |
| (72,421 | ) | |
| (75,842 | ) |
| Other income (expense): | |
| | | |
| | | |
| | | |
| | |
| Interest income | |
| 776 | | |
| 766 | | |
| 2,961 | | |
| 2,534 | |
| Change in fair value of the tranche rights | |
| — | | |
| — | | |
| (4,796 | ) | |
| — | |
| Other income (expense), net | |
| 582 | | |
| 35 | | |
| (1,076 | ) | |
| 1,268 | |
| Total other income (expense) | |
| 1,358 | | |
| 801 | | |
| (2,911 | ) | |
| 3,802 | |
| Net loss | |
$ | (24,368 | ) | |
$ | (22,769 | ) | |
$ | (75,332 | ) | |
$ | (72,040 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss per share, basic and diluted | |
$ | (0.24 | ) | |
$ | (0.51 | ) | |
$ | (0.75 | ) | |
$ | (1.63 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted-average common shares outstanding, basic and diluted | |
| 101,272,580 | | |
| 44,574,377 | | |
| 99,998,245 | | |
| 44,227,264 | |
Immunic, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
| | |
September 30, 2024 | |
December 31, 2023 |
| | |
(Unaudited) | |
|
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 59,071 | | |
$ | 46,674 | |
| Other current assets and prepaid expenses | |
| 4,195 | | |
| 5,860 | |
| Total current assets | |
| 63,266 | | |
| 52,534 | |
| Property and equipment, net | |
| 618 | | |
| 466 | |
| Right-of-use assets, net | |
| 878 | | |
| 1,299 | |
| Total assets | |
$ | 64,762 | | |
$ | 54,299 | |
| Liabilities and Stockholders’ Equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 6,042 | | |
$ | 5,099 | |
| Accrued expenses | |
| 16,245 | | |
| 18,664 | |
| Other current liabilities | |
| 1,070 | | |
| 966 | |
| Total current liabilities | |
| 23,357 | | |
| 24,729 | |
| Long term liabilities | |
| | | |
| | |
| Operating lease liabilities | |
| 186 | | |
| 639 | |
| Total long-term liabilities | |
| 186 | | |
| 639 | |
| Total liabilities | |
| 23,543 | | |
| 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 September 30, 2024 and December 31, 2023 | |
| — | | |
| — | |
| Common stock, $0.0001 par value; 500,000,000 and 130,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively, and 90,079,016 and 45,177,730 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively. | |
| 8 | | |
| 4 | |
| Additional paid-in capital | |
| 523,549 | | |
| 436,060 | |
| Accumulated other comprehensive income | |
| 3,886 | | |
| 3,759 | |
| Accumulated deficit | |
| (486,224 | ) | |
| (410,892 | ) |
| Total stockholders’ equity | |
| 41,219 | | |
| 28,931 | |
| Total liabilities and stockholders’ equity | |
$ | 64,762 | | |
$ | 54,299 | |
v3.24.3
Cover
|
Nov. 07, 2024 |
| Cover [Abstract] |
|
| Document Type |
8-K
|
| Amendment Flag |
false
|
| Document Period End Date |
Nov. 07, 2024
|
| Entity File Number |
001-36201
|
| Entity Registrant Name |
IMMUNIC, INC.
|
| Entity Central Index Key |
0001280776
|
| Entity Tax Identification Number |
56-2358443
|
| Entity Incorporation, State or Country Code |
DE
|
| Entity Address, Address Line One |
1200 Avenue of the Americas
|
| Entity Address, Address Line Two |
Suite 200
|
| Entity Address, City or Town |
New York
|
| Entity Address, State or Province |
NY
|
| Entity Address, Country |
US
|
| Entity Address, Postal Zip Code |
10036
|
| City Area Code |
(332)
|
| Local Phone Number |
255-9818
|
| Written Communications |
false
|
| Soliciting Material |
false
|
| Pre-commencement Tender Offer |
false
|
| Pre-commencement Issuer Tender Offer |
false
|
| Title of 12(b) Security |
Common Stock, par value $0.0001
|
| Trading Symbol |
IMUX
|
| Security Exchange Name |
NASDAQ
|
| Entity Emerging Growth Company |
false
|
| X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
| Name: |
dei_AmendmentFlag |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
| Name: |
dei_DocumentPeriodEndDate |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:dateItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
| Name: |
dei_DocumentType |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:submissionTypeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
| Name: |
dei_EntityAddressAddressLine1 |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionAddress Line 2 such as Street or Suite number
| Name: |
dei_EntityAddressAddressLine2 |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- Definition
+ References
+ Details
| Name: |
dei_EntityAddressCityOrTown |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionISO 3166-1 alpha-2 country code.
| Name: |
dei_EntityAddressCountry |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:countryCodeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionCode for the postal or zip code
| Name: |
dei_EntityAddressPostalZipCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionName of the state or province.
| Name: |
dei_EntityAddressStateOrProvince |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:stateOrProvinceItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityCentralIndexKey |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:centralIndexKeyItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionIndicate if registrant meets the emerging growth company criteria. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityEmergingGrowthCompany |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
| Name: |
dei_EntityFileNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:fileNumberItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
| Name: |
dei_EntityIncorporationStateCountryCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarStateCountryItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityRegistrantName |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
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dei_EntityTaxIdentificationNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:employerIdItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionLocal phone number for entity.
| Name: |
dei_LocalPhoneNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
| Name: |
dei_PreCommencementIssuerTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
| Name: |
dei_PreCommencementTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
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| Balance Type: |
na |
| Period Type: |
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|
| X |
- DefinitionTitle of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
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dei_Security12bTitle |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:securityTitleItemType |
| Balance Type: |
na |
| Period Type: |
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|
| X |
- DefinitionName of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
| Name: |
dei_SecurityExchangeName |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarExchangeCodeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
| Name: |
dei_SolicitingMaterial |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
| Name: |
dei_TradingSymbol |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:tradingSymbolItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
| Name: |
dei_WrittenCommunications |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
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