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Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: ERN, ERP

Immunic, Inc. Reports Second Quarter 2022 Financial Results and Provides Corporate Update


? Initial Clinical Activity Results of IMU-935 in Psoriasis Expected in the Fourth Quarter ?

? Unblinded Safety Data from the Single and Multiple Ascending Dose Parts of
Phase 1 Clinical Trial of IMU-856 in Healthy Human Subjects Expected in the Third Quarter ?

? $88.1 Million in Cash and Cash Equivalents Expected to Fund Immunic
Into the Fourth Quarter of 2023 ?

? Webcast to be Held Today, August 4, 2022, at 8:00 am ET ?

NEW YORK, Aug. 4, 2022 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced financial results for the second quarter ended June 30, 2022 and provided a corporate update.

"The second quarter was a period of continued progress in each of our key clinical programs, setting the stage for important data readouts during the second half of this year, including for IMU-935, a highly potent and selective oral IL-17 inhibitor, and IMU-856, an orally available and systemically acting small molecule shown preclinically to regulate intestinal barrier function and regenerate bowel epithelium," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Most notably, we look forward to reporting initial clinical activity data from part C of our phase 1 clinical trial of IMU-935 in moderate-to-severe psoriasis patients in the fourth quarter of this year. Additionally, during the third quarter, we expect to report unblinded safety data from both the single (SAD) and multiple ascending dose (MAD) parts of our phase 1 clinical trial of IMU-856 in healthy human subjects."

Dr. Vitt continued, "As we reported in June, the top-line data from our phase 2 CALDOSE-1 trial of our selective oral DHODH inhibitor, vidofludimus calcium (IMU-838), in patients with moderate-to-severe ulcerative colitis (UC), did not meet its primary endpoint due to a previously unknown interaction with chronic concurrent steroid use. Based on a post-hoc analysis of our phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) patients, we do not believe this will be an issue for our ongoing program in multiple sclerosis (MS) as chronic administration of corticosteroids is not generally used in this patient population or permitted in our ongoing MS trials. Based on the totality of data generated thus far, demonstrating an impressive suppression of MRI lesions, evidence for neuroprotective effects and an unrivaled safety and tolerability profile, we remain highly optimistic about the potential for vidofludimus calcium to become a highly differentiated and uniquely valuable treatment option in relapsing multiple sclerosis (RMS)."

Second Quarter 2022 and Subsequent Highlights
Clinical Updates
Anticipated Clinical Milestones
Financial and Operating Results
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_alOspcfoRBWZpGzVMIbfFg 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 clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products: its lead development program, vidofludimus calcium (IMU-838), a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect, is currently being developed as a treatment option for multiple sclerosis, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor ROR?/ROR?t, is targeted for development in psoriasis, and castration-resistant prostate cancer. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction. 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, expected 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, 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.

Contact Information

Immunic, Inc.
Jessica Breu
Head of Investor Relations and Communications
+49 89 2080 477 09
[email protected]

US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
[email protected]

US Media Contact
KOGS Communication
Edna Kaplan
+1 617 974 8659
[email protected]

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,



2022


2021


2022


2021

Operating expenses:









Research and development


$      16,538


$      15,738


$      33,983


$      27,257

General and administrative


4,072


3,432


8,062


7,050

4SC royalty settlement


?


?


?


17,250

Total operating expenses


20,610


19,170


42,045


51,557

Loss from operations


(20,610)


(19,170)


(42,045)


(51,557)

Other income (expense):









Interest income


106


13


113


41

Other income (expense), net


(1,397)


1,223


(777)


(952)

Total other income (expense)


(1,291)


1,236


(664)


(911)

Net loss


$     (21,901)


$     (17,934)


$     (42,709)


$     (52,468)










Net loss per share, basic and diluted


$         (0.72)


$         (0.82)


$         (1.49)


$         (2.44)










Weighted-average common shares outstanding, basic and diluted


30,248,767


21,749,439


28,686,910


21,463,656

 

 

Immunic, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)



June 30, 2022


December 31, 2021


(Unaudited)



Assets




Current assets:




Cash and cash equivalents

$        88,078


$           86,863

Other current assets and prepaid expenses

16,683


18,125

Total current assets

104,761


104,988

Property and equipment, net

139


152

Goodwill

32,970


32,970

Right-of-use assets, net

745


948

Other long-term assets

42


42

Total assets

$      138,657


$         139,100

Liabilities and Stockholders' Equity




Current liabilities:




Accounts payable

$          4,117


$              3,745

Accrued expenses

5,741


7,071

Other current liabilities

544


585

Total current liabilities

10,402


11,401

Long term liabilities




Operating lease liabilities

407


584

Total long-term liabilities

407


584

Total liabilities

10,809


11,985

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, 2022 and December 31, 2021

?


?

Common stock, $0.0001 par value; 130,000,000 shares authorized and 21,749,439 and 21,168,240 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

3


3

Additional paid-in capital

368,087


324,237

Accumulated other comprehensive loss

(660)


(252)

Accumulated deficit

(239,582)


(196,873)

Total stockholders' equity

127,848


127,115

Total liabilities and stockholders' equity

$      138,657


$         139,100

 

Immunic, Inc. Logo (PRNewsfoto/Immunic, Inc.)

 

SOURCE Immunic, Inc.


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