Full Press Release Details
Immunic, Inc. Reports First Quarter
2022 Financial Results
and Provides Corporate Update
Top-Line Data from Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Moderate-to-Severe Ulcerative Colitis Expected Next Month -
Part C Portion of Phase 1 Trial of IMU-935 in Psoriasis Patients Ongoing; Data Expected in the Second Half of 2022 -
Current Cash and Cash Equivalents Expected to Fund Immunic Into the Third Quarter of 2023 -
Webcast to be Held Today, May 10, 2022, at 8:00 am ET -
May 10, 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 first quarter ended March 31, 2022 and provides a corporate update.
"The first quarter of 2022 was marked by
continued momentum, both financially and within our clinical pipeline programs," stated Daniel Vitt, Ph.D., Chief Executive Officer
and President of Immunic. "Notably, we extended our cash runway into the third quarter of 2023. The increased funds further solidify
our ability to advance our programs and achieve key value inflection points, including next month's highly-anticipated read-out
of top-line data from our phase 2 CALDOSE-1 trial of lead asset, selective oral DHODH inhibitor, vidofludimus calcium (IMU-838), in patients
with moderate-to-severe ulcerative colitis (UC)."
"During the most recent period, patient
enrollment in both our phase 3 ENSURE program of vidofludimus calcium in patients with relapsing multiple sclerosis (RMS) and our phase
2 CALLIPER trial of vidofludimus calcium in patients with progressive multiple sclerosis (PMS) also progressed, and we remain highly enthusiastic
about the potential for this novel therapeutic to become a best-in-class DHODH inhibitor in RMS, given its demonstrated activity in preventing
lesion formation, as shown in our phase 2 EMPhASIS trial in RRMS, and its exceptional safety and tolerability profile, to date. Additionally,
in February, we significantly bolstered our intellectual property portfolio, having received Notice of Allowances for composition-of-matter
patents for IMU-935, a highly potent and selective oral IL-17 inhibitor. We expect to report initial clinical efficacy data from Part
C of our phase 1 clinical trial of IMU-935 in psoriasis patients during the second half and initial clinical safety data from the phase
1 dose escalation trial in metastatic castration-resistant prostate cancer (mCRPC) in the third quarter of this year."
First Quarter 2022 and Subsequent Highlights
Anticipated Clinical Milestones
Financial and Operating Results
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_vB3ACf6TTA2JW2sL084vbQ
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.
(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, ulcerative
colitis, Crohn's disease, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor ROR /ROR t,
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.
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 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, 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 March 31, | ||||||||
| 2022 | 2021 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 17,445 | $ | 11,519 | ||||
| General and administrative | 3,990 | 3,618 | ||||||
| 4SC Royalty Settlement | - | 17,250 | ||||||
| Total operating expenses | 21,435 | 32,387 | ||||||
| Loss from operations | (21,435 | ) | (32,387 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 7 | 28 | ||||||
| Other income (expense), net | 620 | (2,175 | ) | |||||
| Total other income (expense) | 627 | (2,147 | ) | |||||
| Net loss | $ | (20,808 | ) | $ | (34,534 | ) | ||
| Net loss per share, basic and diluted | $ | (0.74 | ) | $ | (1.63 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 28,127,288 | 21,174,698 |
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| March 31, 2022 (Unaudited) | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 95,710 | $ | 86,863 | ||||
| Other current assets and prepaid expenses | 20,169 | 18,125 | ||||||
| Total current assets | 115,879 | 104,988 | ||||||
| Property and equipment, net | 155 | 152 | ||||||
| Goodwill | 32,970 | 32,970 | ||||||
| Right-of-use assets, net | 874 | 948 | ||||||
| Other long-term assets | 42 | 42 | ||||||
| Total assets | $ | 149,920 | $ | 139,100 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,288 | $ | 3,745 | ||||
| Accrued expenses | 7,520 | 7,071 | ||||||
| Other current liabilities | 649 | 585 | ||||||
| Total current liabilities | 11,457 | 11,401 | ||||||
| Long-term liabilities | ||||||||
| Operating lease liabilities | 502 | 584 | ||||||
| Total long-term liabilities | 502 | 584 | ||||||
| Total liabilities | 11,959 | 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 March 31, 2022 and December 31, 2021 | - | - | ||||||
| Common stock, $0.0001 par value; 130,000,000 shares authorized and 29,240,383 and 26,335,418 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively | 3 | 3 | ||||||
| Additional paid-in capital | 355,949 | 324,237 | ||||||
| Accumulated other comprehensive loss | (310 | ) | (252 | ) | ||||
| Accumulated deficit | (217,681 | ) | (196,873 | ) | ||||
| Total stockholders' equity | 137,961 | 127,115 | ||||||
| Total liabilities and stockholders' equity | $ | 149,920 | $ | 139,100 |