Full Press Release Details
Immunic, Inc. Reports Third Quarter 2021 Financial
Results and Highlights Recent Activity
- Fully Enrolled Phase 2 CALDOSE-1 Trial
of IMU-838 in Moderate-to-Severe Ulcerative Colitis -
- Initiated Phase 2 CALLIPER Trial in
Progressive Multiple Sclerosis, Intended to Run Concurrently With and to Complement the Company's Phase 3 ENSURE Program in Relapsing
Multiple Sclerosis -
- $110.4 Million in Cash and Cash Equivalents
as 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
"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
Anticipated Clinical Milestones
Financial and Operating Results
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.
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-Barr 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.
Head of Investor Relations and Communications
Rx Communications Group
| 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) | ||||||||
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| 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 |