8-K

IMMUNIC, INC. (IMUX)

8-K 2021-11-04 For: 2021-11-04
View Original
Added on April 08, 2026

UNITED STATESSECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORTPursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):November 4, 2021

IMMUNIC, INC.

(Exact name of registrant as specified in itscharter)

Delaware 001-36201 56-2358443
(State or other jurisdictionof 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, includingarea 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 FinancialCondition

On November 4, 2021, Immunic, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2021 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

Corporate Presentation

On November 4, 2021, the Company posted an updated corporate 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 strategy, future operations, future financial position, future revenue, projected expenses, 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 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, 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 resources to meet business objectives and operational requirements, the fact that the results of earlier studies and 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, 2020, filed with the SEC on February 26, 2021, 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 Current Report on Form 8-K, the Press Release and the Presentation.

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 November 4, 2021
99.2 Presentation, dated November 4, 2021
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:  November 4, 2021 Immunic, Inc.
By: /s/ Daniel Vitt
Daniel Vitt
Chief Executive Officer

Immunic, Inc. Reports Third Quarter 2021 FinancialResults and Highlights Recent Activity

– Fully Enrolled Phase 2 CALDOSE-1 Trialof IMU-838 in Moderate-to-Severe Ulcerative Colitis –

– Initiated Phase 2 CALLIPER Trial inProgressive Multiple Sclerosis, Intended to Run Concurrently With and to Complement the Company’s Phase 3 ENSURE Program in RelapsingMultiple Sclerosis –

– $110.4 Million in Cash and Cash Equivalentsas of September 30, 2021 Expected to Fund Immunic Into 2023 –

– Webcast to be Held Today, November 4,2021, at 8:00 am ET –

**NEW YORK, November 4, 2021 – 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 third quarter ended September 30, 2021 and highlighted recent activity.

“During the quarter, we continued to make extraordinary progress advancing multiple programs through the clinic, including our selective oral DHODH inhibitor, IMU-838, as well as IMU-935, a highly potent and selective oral IL-17 inhibitor, setting the stage for an exciting year ahead with several upcoming value creating data readouts,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “Major milestones achieved in lead program, IMU-838, included enrollment of the final patient in our phase 2 CALDOSE-1 trial of IMU-838 in patients with moderate-to-severe ulcerative colitis (UC), for which we expect top-line data to be available in the first half of 2022, and enrollment of the first patients in our phase 2 CALLIPER trial in progressive multiple sclerosis (PMS).”

“We also made significant headway in the development of our second key asset, IMU-935, and expect unblinded safety, pharmacodynamic and pharmacokinetic data from the healthy volunteer portions of our ongoing phase 1 trial to be available in the fourth quarter of this year. We also initiated the patient part of the phase 1 trial in moderate-to-severe psoriasis and anticipate initial data from this patient population during the second quarter of 2022. Additionally, at our virtual R&D Day in July, we presented compelling new preclinical data highlighting the therapeutic potential of IMU-935 to affect metastatic castration resistant prostate cancer (mCRPC). We expect to initiate an open-label phase 1 dose escalation trial in mCRPC during the fourth quarter of this year, with Johann Sebastian de Bono, M.D., Ph.D., Regius Professor of Cancer Research and Professor in Experimental Cancer Medicine, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, United Kingdom, acting as the Principal Investigator.”

Dr. Vitt added, “Our rapid pace of growth has necessitated an expansion of our management team and we were pleased to welcome Patrick Walsh as Chief Business Officer. We look forward to leveraging his experience in business development and strategic partnering as we seek to realize the full potential of our clinical programs. On the financial front, in July, we bolstered our balance sheet with a $45.0 million financing, extending our runway through multiple clinical readouts and value inflection points into 2023.”

Third Quarter 2021 and Subsequent Highlights

· October 2021: Enrolled and randomized the last patient in the phase 2 CALDOSE-1<br>trial in patients with moderate-to-severe UC. At completion of patient recruitment, the trial has randomized a total of 263 patients into<br>four arms: three active dosing arms of 10 mg, 30 mg and 45 mg, as well as placebo.
· October 2021: Dosed the first patient with moderate-to-severe psoriasis in<br>part C of the ongoing phase 1 trial of IMU-935, representing the first-time patients have been treated with the company’s potentially<br>best-in-class ROR³t inverse agonist.
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· October 2021: Appointed Patrick Walsh to the newly created role of Chief<br>Business Officer.
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· September 2021: Enrolled the first patient in the phase 2 CALLIPER trial<br>of IMU-838 in patients with PMS.
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· September 2021: Signed an in-license agreement with the University Medical<br>Center Göttingen, Germany, covering the combination of DHODH inhibitors and nucleoside analogues to treat viral infections (COVID-19<br>and Influenza). Additionally, announced remarkable preclinical data showing that certain DHODH inhibitors, including IMU-838, strongly<br>synergize with selected nucleoside analogues to inhibit SARS-CoV-2 replication in vitro.
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· July 2021: Completed a $45.0 million underwritten public offering of common<br>stock.
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· July 2021: Hosted a virtual R&D Day to provide an update on the preclinical<br>and clinical development of IMU-935.
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Anticipated Clinical Milestones

· IMU-838 in relapsing multiple sclerosis: The twin, multicenter, randomized,<br>double-blind, phase 3 ENSURE-1 and ENSURE-2 trials of 30 mg daily IMU-838 or placebo will run concurrently. Dosing of the first patient<br>is expected in the fourth quarter of 2021.
· IMU-838 in UC: Top-line data of the induction phase of the phase 2<br>CALDOSE-1 trial of IMU-838 in patients with moderate-to-severe UC is expected to be available in the second quarter of 2022.
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· **IMU-935 phase 1 program in healthy volunteers and psoriasis patients:**The experimental phase of the multiple ascending dose (MAD) part of the phase 1 trial of IMU-935 has recently been completed. Unblinded<br>safety, pharmacodynamic and pharmacokinetic (PK) data from the single ascending dose (SAD) and MAD parts in healthy volunteers is expected<br>to be available in the fourth quarter of 2021. Initial human data from the third portion of the phase 1 trial in patients with moderate-to-severe<br>psoriasis is expected to be available in the second quarter of 2022.
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· IMU-935 phase 1 trial in CRPC: An open-label phase 1 dose escalation<br>trial designed to establish a potential recommended phase 2 dose and to assess safety, tolerability, anti-tumor activity, biomarkers and<br>PK of IMU-935 in patients with progressive mCRPC, is expected to commence in the fourth quarter of 2021. The trial was recently approved<br>by the Medicines and Healthcare products Regulatory Agency (MHRA), the Research Ethics Committee (REC) and the Health Research Authority<br>(HRA) in the United Kingdom.
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· IMU-856 phase 1 program: The SAD part of the ongoing phase 1 trial<br>of IMU-856 has been completed. Based on the favorable data available so far, the Ethics Committee in Australia has agreed to proceed to<br>the MAD part and the first cohort is currently being dosed. Unblinded safety data from the SAD and MAD parts in healthy volunteers is<br>expected to be available in the third quarter of 2022. Initiation of the third portion of the phase 1 trial in patients with intestinal<br>barrier function associated diseases is expected in the first half of 2022.
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Financial and Operating Results

· Research and Development (R&D) Expenses were $15.5 million<br>for the three months ended September 30, 2021, as compared to $11.0 million for the same period ended September 30, 2020. The $4.4 million<br>increase reflects (i) a $3.8 million increase in preparation costs related to the phase 3 program of IMU-838 in RMS, (ii) a $2.3 million<br>increase in costs related to the phase 2 trial of IMU-838 in PMS, (iii) a $0.8 million increase in external development costs related<br>to the phase 2 clinical trial of IMU-838 in UC, (iv) a $1.1 million increase in external development costs related to the phase 1 clinical<br>trial of IMU-935, (v) a $0.6 million increase in personnel expenses in research and development due to an increase in headcount, and (vi)<br>$0.2 million related to increased costs across numerous categories. The increases were partially offset by (i) a $3.5 million decrease<br>in external development costs related to the phase 2 clinical trial in COVID-19 as trials were finished in the first quarter of 2021,<br>and (ii) a decrease of $0.9 million in drug supply costs for IMU-856.
For the nine months ended September 30, 2021, R&D expenses were $42.7 million, as compared to $27.5 million for the same period<br>ended September 30, 2020. The $15.3 million increase was primarily attributable to (i) a $6.9 million increase in preparation costs related<br>to the phase 3 program of IMU-838 in RMS, (ii) a $4.7 million increase in preparation costs related to the phase 2 trial of IMU-838 in<br>PMS, (iii) a $3.0 million increase in external development costs related to the phase 2 clinical trial of IMU-838 in UC, (iv) a $1.7 million<br>increase in personnel expenses in research and development related to an increase in headcount, (v) a $1.2 million increase in external<br>development costs related to the phase 1 clinical trial of IMU-935, (vi) a $1.3 million increase in external costs for IMU-856, and (vii)<br>$0.7 million related to increased costs across numerous categories. The increases were partially offset by (i) a decrease of $2.1 million<br>in drug supply costs for IMU-856, and (ii) a $2.1 million decrease in external development costs related to the phase 2 clinical trial<br>in COVID-19.
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· General and Administrative (G&A) Expenses were $2.9 million<br>for the three months ended September 30, 2021, as compared to $2.5 million for the same period ended September 30, 2020. The $0.4 million<br>increase was primarily due to a $0.5 million increase related to non-cash stock compensation expense offset by a $0.1 million decrease<br>in costs across numerous categories.
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For the nine months ended September 30, 2021, G&A expenses were $10.0 million, as compared to $7.3 million for the same period<br>ended September 30, 2020. The $2.6 million increase was primarily due to (i) a $2.2 million increase related to non-cash stock compensation<br>expense, and (ii) a $0.4 million increase across numerous categories.
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· 4SC Royalty Settlement: On March 31, 2021, Immunic AG and 4SC<br>AG entered into a Settlement Agreement, pursuant to which Immunic AG settled its remaining obligation of a 4.4% royalty on net sales of<br>IMU-838, for $17.25 million. The payment was made 50% in cash and 50% in shares of Immunic’s common stock. No further payment obligations<br>remain between Immunic and 4SC AG.
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· Other Income (Expense) was $(0.9) million for the three months<br>ended September 30, 2021, as compared to $0.6 million for the same period ended September 30, 2020. The $1.5 million decrease was primarily<br>attributable to (i) a $1.2 million foreign exchange loss on a $52.0 million intercompany loan between Immunic, Inc. and Immunic AG, (ii)<br>a $0.2 million decrease related to lower research and development tax incentives for clinical trials in Australia as a result of decreased<br>spending on clinical trials in Australia year over year, and (iii) $0.1 million related to a decrease in recognized deferred income attributable<br>to reimbursements of R&D expenses in connection with the option agreement with Daiichi Sankyo Co., Ltd. realized in the third quarter<br>of 2020.
For the nine months ended September 30, 2021, Other Income was $(1.8) million, as compared to $1.9 million for the same period ended<br>September 30, 2020. The $3.7 million decrease was primarily attributable to (i) a $3.2 million foreign exchange loss on a $52.0 million<br>intercompany loan between Immunic, Inc. and Immunic AG, and (ii) a $1.0 million decrease in recognized deferred income attributable to<br>reimbursements of R&D expenses in connection with the option agreement with Daiichi Sankyo Co., Ltd. realized in the first nine months<br>of 2020. The decrease was partially offset by a $0.5 million increase in research and development tax incentives for clinical trials in<br>Australia as a result of increased spending on clinical trials in Australia.
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· Net Loss for the three months ended September 30, 2021, was approximately<br>$19.3 million, or $0.76 per basic and diluted share, based on 25,320,091 weighted average common shares outstanding, compared to a net<br>loss of approximately $12.9 million, or $0.70 per basic and diluted share, based on 18,405,840 weighted average common shares outstanding<br>for the same period ended September 30, 2020.<br><br>Net loss for the nine months ended September 30, 2021, was approximately $71.8 million, or $3.33 per basic and diluted share, based on<br>21,559,964 weighted average common shares outstanding, compared to a net loss of approximately $32.9 million, or $2.35 per basic and diluted<br>share, based on 13,966,690 weighted average common shares outstanding for the same period ended September 30, 2020.
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· Cash and Cash Equivalents as of September 30, 2021, were $110.4 million,<br>which management expects to be sufficient to fund operations into 2023.
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Webcast Information

Immunic will host a webcast today at 8:00 am ET. To participate, please register in advance at: https://imux.zoom.us/webinar/register/WN_VcZaYTP9RFqHZj7N5qMNJg 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, 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, ulcerative colitis, Crohn’s disease, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor ROR³t, is targeted for development in psoriasis, castration-resistant prostate cancer and Guillain-Barré syndrome. 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, 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 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, 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 resources to meet business objectives and operational requirements, the fact that the results of earlier studies and 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, 2020, filed with the SEC on February 26, 2021, 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

jessica.breu@imux.com

US IR Contact

Rx Communications Group

Paula Schwartz

+1-917-322-2216

immunic@rxir.com

US Media Contact

KOGS Communication

Edna Kaplan

+1 781 639 1910

kaplan@kogspr.com

Financials
Immunic, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Nine Months
Ended September 30, Ended September 30,
2021 2020 2021 2020
Operating expenses:
Research and development $ 15,480 $ 11,040 $ 42,737 $ 27,461
General and administrative 2,907 2,505 9,957 7,320
4SC Royalty Settlement 17,250
Total operating expenses 18,387 13,545 69,944 34,781
Loss from operations (18,387 ) (13,545 ) (69,944 ) (34,781 )
Other income (expense):
Interest income 10 20 51 48
Other income (expense), net (915 ) 612 (1,867 ) 1,875
Total other income (expense) (905 ) 632 (1,816 ) 1,923
Net loss $ (19,292 ) $ (12,913 ) $ (71,760 ) $ (32,858 )
Net loss per share, basic and diluted $ (0.76 ) $ (0.70 ) $ (3.33 ) $ (2.35 )
Weighted-average common shares outstanding, basicand diluted 25,320,091 18,405,840 21,559,964 13,966,690

Immunic, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
December 31,
2020
Assets
Current assets:
Cash and cash equivalents 110,444 $ 127,452
Other current assets and prepaid expenses 12,051 6,293
Total current assets 122,495 133,745
Property and equipment, net 196 203
Goodwill 32,970 32,970
Right-of-use assets, net 1,054 901
Other long-term assets 42 42
Total assets 156,757 $ 167,861
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable 3,241 $ 3,700
Accrued expenses 6,771 4,318
Other current liabilities 579 379
Total current liabilities 10,591 8,397
Long term liabilities
Operating lease liabilities 701 679
Total long-term liabilities 701 679
Total liabilities 11,292 9,076
Commitments and contingencies (Note 4)
Stockholders’ equity:
Preferred stock, 0.0001 par value; 20,000,000 authorized and no shares
issued or outstanding at September 30, 2021 and December 31, 2020
Common stock, 0.0001 par value; 130,000,000 shares authorized and
26,249,439 and 21,168,240 shares issued and outstanding as of September
30, 2021 and December 31, 2020, respectively 3 2
Additional paid-in capital 321,950 266,823
Accumulated other comprehensive loss (800 ) (4,112 )
Accumulated deficit (175,688 ) (103,928 )
Total stockholders’ equity 145,465 158,785
Total liabilities and stockholders’ equity 156,757 $ 167,861

All values are in US Dollars.