Full Press Release Details
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 -
August 4, 2022 - 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
Anticipated Clinical Milestones
Financial and Operating Results
For the six months ended June 30,
2022, R&D expenses were $34.0 million, as compared to $27.3 million for the same period ended June 30, 2021. The $6.7 million increase
reflects (i) a $12.1 million increase in external development costs related to the ongoing clinical trials of vidofludimus calcium for
the phase 3 program in RMS and the phase 2 trial in PMS, IMU-935 and IMU-856, and (ii) a $1.8 million increase in personnel expense in
research and development, $0.7 million of which is related to non-cash stock compensation expense and the remainder of which is related
to an increase in headcount. The increases were partially offset by (i) a $6.3 million decrease in external development costs related
to clinical trials of vidofludimus calcium related to COVID-19 and UC, and (ii) a decrease of $0.9 million in external development costs
across numerous categories.
For the six months ended June 30 ,2022,
G&A expenses were $8.1 million, as compared to $7.1 million for the same period ended June 30, 2021. The $1.0 million increase was
primarily due to personnel expenses, $0.3 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 six months ended June 30,
2022, other expense was ($0.7 million), as compared to ($0.9 million) for the same period ended June 30, 2021. The $0.2 million decrease
was primarily attributable to an increase in research and development tax incentives for clinical trials in Australia as a result of increased
spending on clinical trials in Australia as well as the impact of foreign exchange rates on loans between Immunic AG and Immunic Australia
Pty Ltd, partially offset by an increase in the loss on an intercompany loan between Immunic, Inc. and Immunic AG.
Net loss for the six months ended
June 30, 2022, was approximately $42.7 million, or $1.49 per basic and diluted share, based on 28,686,910 weighted average common shares
outstanding, compared to a net loss of approximately $52.5 million, or $2.44 per basic and diluted share, based on 21,463,656 weighted
average common shares outstanding for the same period ended June 30, 2021.
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.
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.
Statement Regarding Forward-Looking Statements
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.
Head of Investor Relations and Communications
Rx Communications Group
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| 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 |
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| 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 |