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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): August 8, 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 August 8, 2024, Immunic, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 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 August 8, 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; 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

 

Exhibit Description
   
99.1 Press Release, dated August 8, 2024.
99.2 Presentation, dated August 8, 2024.
104 Cover Page to this Current Report on Form 8-K in Inline XBRL

 

 

 

 

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: August 8, 2024 Immunic, Inc.
     
  By: /s/ Daniel Vitt
    Daniel Vitt
    Chief Executive Officer

 

   

 

Immunic, Inc. Reports Second Quarter 2024 Financial Results
and Provides Corporate Update

 

– Jason Tardio, Experienced Multiple Sclerosis Drug Commercialization Executive, Formerly with Novartis and Biogen, Appointed Chief Operating Officer and President –

 

– Strengthened Board of Directors with Appointment of Simona Skerjanec, Senior Pharmaceutical Executive and Thought Leader in Brain Health –

 

Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain on Track

 

– Webcast to be Held Today, August 8, at 8:00 am ET –

 

NEW YORK, August 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 second quarter and six months ended June 30, 2024, and provided a corporate update.

 

“During the second quarter and subsequent period, we continued to achieve clinical and operational progress, punctuated with the addition of Jason Tardio to our team, in the newly-created position of Chief Operating Officer and President. Jason’s proven experience in launching and commercializing multiple sclerosis (MS) drugs for major biotechnology and pharmaceutical companies, including Novartis and Biogen, as well as his extensive partnering experience, will be invaluable, especially as we move closer to the potential commercialization of our late-stage clinical asset, vidofludimus calcium (IMU-838), an orally available nuclear receptor related 1 (Nurr1) activator. We also welcomed Simona Skerjanec to our Board of Directors, who most recently served as the Senior Vice President, Global Head Neuroscience and Rare Diseases at Roche, where she had a successful track record achieving double-digit sales growth, including with Ocrevus® (ocrelizumab), one of the most successful medicines for MS,” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “We plan to provide detail on our MS development program at our next MS R&D Day in New York City in September. The event will feature two renowned industry experts alongside Immunic’s management team to discuss the unique profile of vidofludimus calcium and its potential to become a groundbreaking treatment of choice for both relapsing MS (RMS) and progressive MS (PMS) patients. We believe that vidofludimus calcium could elevate today’s standard of care by providing a holistic solution for the full range of MS patients, given that it is designed to selectively manage all components of smoldering MS with its neuroprotective, anti-inflammatory and antiviral effects.”

 

“We look forward to reporting the top-line data from our phase 2 CALLIPER trial of vidofludimus calcium in PMS patients in April of next year. The previously reported interim analysis showed a clear separation from placebo in neurofilament light chain (NfL) levels across the PMS patient population, including non-relapsing secondary progressive MS (SPMS), a subtype with the highest unmet medical need. If the top-line data continues to show a neuroprotective effect, and meets the trial’s primary and key secondary endpoints, we may also be able to potentially position the drug as the first oral treatment option for non-relapsing SPMS. Notably, we also remain on track with our phase 3 ENSURE program in RMS and expect to complete the first ENSURE trial in the second quarter of 2026 and the second ENSURE trial in the second half of 2026.”

 

 

 

 

   

 

Dr. Vitt continued, “During the second quarter, we also continued preparations for phase 2 clinical testing of our second clinical program, IMU-856, an 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. We are exploring potential financing, licensing or partnering opportunities to fund the next clinical development steps for this program. We believe that IMU-856 represents a potentially groundbreaking therapeutic approach for treating gastrointestinal disorders by restoring a healthy gut through the renewal of the bowel wall. Data from our phase 1b clinical trial in celiac disease patients showed that IMU-856 had 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 data, we are also considering additional possible clinical applications in other gastrointestinal disorders.”

 

Second Quarter 2024 and Subsequent Highlights

 

·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, effective as of July 22, 2024.
·July 2024: Appointed Jason Tardio, MBA, as Chief Operating Officer and President, effective as of July 12, 2024, to lead internal efforts in positioning the company for its potential launch of vidofludimus calcium and to work closely with Patrick Walsh, Chief Business Officer, to prepare the company 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.
·April 2024: Announced publication of data from the phase 2 EMPhASIS trial of vidofludimus calcium in patients with relapsing-remitting MS in Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology.
·April 2024: Hosted an MS R&D Day in San Francisco, 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.

 

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 the fourth quarter of 2024. Completion 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, contingent on financing, licensing or partnering.

 

Financial and Operating Results

 

·Research and Development (R&D) Expenses were $18.3 million for the three months ended June 30, 2024, as compared to $21.2 million for the three months ended June 30, 2023. The $2.8 million decrease reflects (i) a $1.8 million decrease in external development costs related to IMU-856 due to the completion of the phase 1 trial in celiac disease, (ii) a decrease of $1.0 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer and (iii) a $0.5 million decrease in related costs across numerous categories. The decreases were offset by a $0.5 million increase in external development costs related to the vidofludimus calcium programs.

 

 

 

 

   

 

For the six months ended June 30, 2024, R&D expenses were $37.0 million, as compared to $44.1 million for the six months ended June 30, 2023. The $7.1 million decrease reflects (i) a decrease of $3.4 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer, (ii) a $2.9 million decrease in external development costs related to IMU-856 due to the completion of the phase 1 trial in celiac disease, (iii) a $0.9 million decrease in external development costs related to the vidofludimus calcium programs and (iv) a $0.8 million decrease in related costs across numerous categories. The decreases were offset by a $0.9 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.

 

·General and Administrative (G&A) Expenses were $4.5 million for the three months ended June 30, 2024, as compared to $3.8 million for the same period ended June 30, 2023. The $0.6 million increase was primarily due to (i) a $0.3 million increase in personnel expense in G&A, $0.1 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount, (ii) a $0.1 million increase in legal and consultancy expenses and (iii) a $0.2 million increase related to costs across numerous categories.

 

For the six months ended June 30, 2024, G&A expenses were $9.6 million, as compared to $8.1 million for the same period ended June 30, 2023. The $1.5 million increase was primarily due to (i) a $1.1 million increase in personnel expense in G&A, $0.6 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount, (ii) a $0.2 million increase in legal and consultancy expenses and (iii) a $0.2 million increase related to costs across numerous categories.

 

·Interest Income remained unchanged at $1.0 million during the three months ended June 30, 2024, as compared to the three months ended June 30, 2023.

 

For the six months ended June 30, 2024, interest income was $2.2 million, as compared to $1.8 million for the same period ended June 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 six months ended June 30, 2024 was a non-cash charge related to the change in value of the tranche rights associated with the future tranches 2 and 3 of the January 2024 private placement.

 

·Other Income (Expense) was $0.4 million for the three months ended June 30, 2024, as compared to $0.1 million for the same period ended June 30, 2023. The $0.4 million increase was primarily attributable to a $0.7 million increase in foreign exchange gains. The increase was offset by (i) a $0.2 million decrease in other grants received in 2023 and (ii) a $0.1 million decrease in R&D tax incentives for clinical trials in Australia as a result of decreased spending on clinical trials in Australia.

 

 

 

 

   

 

For the six months ended June 30, 2024, other income (expense) was ($1.7 million), as compared to $1.2 million for the same period ending June 30, 2023. The $2.9 million decrease was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 PIPE 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 which was one quarter earlier than in the prior year, when the grant was recognized in the first quarter of 2023, (iii) a $0.5 million decrease in R&D tax incentives for clinical trials in Australia as a result of decreased spending on clinical trials in Australia and (iv) a $0.4 million decrease in other grants received in 2023. The decrease was offset by a $0.8 million increase in foreign exchange gains.

 

·Net Loss for the three months ended June 30, 2024, was approximately $21.4 million, or $0.21 per basic and diluted share, based on 101,272,580 weighted average common shares outstanding, compared to a net loss of approximately $24.0 million, or $0.54 per basic and diluted share, based on 44,432,955 weighted average common shares outstanding for the same period ended June 30, 2023.

 

Net loss for the six months ended June 30, 2024, was approximately $51.0 million, or $0.51 per basic and diluted share, based on 99,607,158 weighted average common shares outstanding, compared to a net loss of approximately $49.3 million or $1.12 per basic and diluted share, based on 44,036,352 weighted average common shares outstanding for the same period ended June 30, 2023.

 

·Cash and Cash Equivalents as of June 30, 2024 were $79.7 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_ae1TwcxTQ9GTkRUmQSOgTA 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 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; 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 June 30,

 

Six Months

Ended June 30,

   2024  2023  2024  2023
Operating expenses:                    
Research and development  $18,323   $21,172   $37,059   $44,135 
General and administrative   4,491    3,849    9,636    8,137 
Total operating expenses   22,814    25,021    46,695    52,272 
Loss from operations   (22,814)   (25,021)   (46,695)   (52,272)
Other income (expense):                    
Interest income   998    968    2,185    1,768 
Change in fair value of the tranche rights           (4,796)    
Other income (expense), net   436    54    (1,658)   1,233 
Total other income (expense)   1,434    1,022    (4,269)   3,001 
Net loss  $(21,380)  $(23,999)  $(50,964)  $(49,271)
                     
Net loss per share, basic and diluted  $(0.21)  $(0.54)  $(0.51)  $(1.12)
                     
Weighted-average common shares outstanding, basic and diluted   101,272,580    44,432,955    99,607,158    44,036,352 

 

 

 

 

   

 

Immunic, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

   June 30, 2024  December 31, 2023
   (Unaudited)   
Assets          
Current assets:          
Cash and cash equivalents  $79,698   $46,674 
Other current assets and prepaid expenses   5,280    5,860 
Total current assets   84,978    52,534 
Property and equipment, net   585    466 
Right-of-use assets   928    1,299 
Total assets  $86,491   $54,299 
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable  $7,894   $5,099 
Accrued expenses   13,775    18,664 
Other current liabilities   1,008    966 
Total current liabilities   22,677    24,729 
Long term liabilities          
Operating lease liabilities   241    639 
Total long-term liabilities   241    639 
Total liabilities   22,918    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 June 30, 2024 and December 31, 2023        
Common stock, $0.0001 par value; 500,000,000 and 130,000,000 shares authorized as of June 30, 2024 and December 31, 2023, respectively, and 90,079,016 and 45,177,730 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively   8    4 
Additional paid-in capital   521,639    436,060 
Accumulated other comprehensive income   3,782    3,759 
Accumulated deficit   (461,856)   (410,892)
Total stockholders’ equity   63,573    28,931 
Total liabilities and stockholders’ equity  $86,491   $54,299 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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