Full Press Release Details
Immunic, Inc. Reports Second Quarter
2019 Financial Results and Highlights Recent Activity
DIEGO, August 8, 2019 - Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused
on developing potentially best-in-class oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today
announced financial results for the second quarter ended June 30, 2019 and highlights recent activity.
"The April closing of our transaction
with Vital Therapies, listing on The Nasdaq Capital Market and capital infusion of $30 million from a key investor syndicate, have
strengthened the company, increased our visibility and allowed the team to meaningfully progress and soon expand our product pipeline,"
stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "The pace of our recent activity and anticipated
milestones testifies to these efforts. As previously reported, we expect to announce the findings from our interim dosing analysis
of IMU-838 as part of the CALDOSE-1 phase 2 study in patients with moderate-to-severe ulcerative colitis during the third quarter
of 2019. We expect that this data will inform dose selection for the CALDOSE-2 phase 2 trial of IMU-838 in Crohn's disease
patients, expected to begin during the second half of the year. Further, we plan to dose the first healthy volunteer as part of
our phase 1 single and multiple ascending dose trials of IMU-935, directed by our Australian subsidiary, during September. Additional
key inflection points are expected to follow next year."
Second Quarter 2019 and Subsequent Highlights:
Upcoming Anticipated Clinical Milestones
Financial and Operating Results
For the six months ended
June 30, 2019, R&D expenses were $9.4 million, compared to $3.9 million for the same period ended June 30, 2018. The
increase is primarily due to i) higher external development costs for the IMU-838 program of $3.0 million, and ii) a
contingent payment under the asset purchase agreement with 4SC AG,
triggered by the exchange agreement with Immunic AG, settled in stock valued at $1.5 million.
For the six months ended June
30, 2019, G&A expenses were $10.3 million, compared to $1.0 million for the period ended June 30, 2018. The increase is primarily
due to i) one-time costs related to the exchange agreement transaction including $6.4 million of stock-based compensation for the
company's executives, key employees and members of the board of directors and $1.7 million of direct transaction costs, and
ii) $0.6 million of public company expenses.
Other income for the six months
ended June 30, 2019 was $0.6 million compared to $24,000 in the same period of 2018. The increase is primarily due to $0.5 million
in reimbursement of research and development expenses in connection with the aforementioned option and license agreement with Daiichi
Net loss for the six months ended
June 30, 2019 was approximately $19.0 million, or $3.60 per basic and diluted share, based on 5,282,412 weighted average common
shares outstanding, compared to a net loss of approximately $4.9 million, or $5.83 per basic and diluted share, based on 846,953
weighted average common shares outstanding for the six months ended June 30, 2018. Substantially all of the company's operating
losses have resulted from expenses incurred in connection with its research and development programs and from general and administrative
costs associated with operations.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical
company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases,
including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn's disease, and psoriasis. The
company is developing three small molecule products: IMU-838 is a selective immune modulator that inhibits the intracellular metabolism
of activated immune cells by blocking the enzyme DHODH; IMU-935 is an inverse agonist of ROR t; and IMU-856 targets the restoration
of the intestinal barrier function. Immunic's lead development program, IMU-838, is in phase 2 clinical development for relapsing-remitting
multiple sclerosis and ulcerative colitis, with an additional phase 2 trial in Crohn's disease planned for the
second half of 2019. An investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis
is planned to start at the Mayo Clinic. For further information, please visit: www.immunic-therapeutics.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 IMU-838, IMU-935 and IMU-856 to safely
and effectively target diseases; the timing of future clinical trials and expected results of such trials; the nature, strategy
and focus of the company; and the development and commercial potential of any product candidates of the company. 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, 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. 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.
Manager IR and Communications
Rx Communications Group
Condensed Consolidated Statements of
(In thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 6,029 | $ | 2,157 | $ | 9,384 | $ | 3,940 | ||||||||
| General and administrative | 8,978 | 513 | 10,285 | 1,017 | ||||||||||||
| Total operating expenses | 15,007 | 2,670 | 19,669 | 4,957 | ||||||||||||
| Loss from operations | (15,007 | ) | (2,670 | ) | (19,669 | ) | (4,957 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense) | 34 | - | 34 | (1 | ) | |||||||||||
| Other income (expense), net | 259 | - | 608 | 25 | ||||||||||||
| Total other income | 293 | - | 642 | 24 | ||||||||||||
| Net loss | $ | (14,714 | ) | $ | (2,670 | ) | $ | (19,027 | ) | $ | (4,933 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.52 | ) | $ | (3.15 | ) | $ | (3.60 | ) | $ | (5.82 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 9,669,129 | 846,953 | 5,282,412 | 846,953 |
Condensed Consolidated Balance Sheets
(In thousands, except share and per share
| June 30, 2019 | December 31, 2018 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 36,121 | $ | 13,072 | ||||
| Note receivable | 920 | - | ||||||
| Other current assets and prepaid expenses | 2,452 | 259 | ||||||
| Total current assets | 39,493 | 13,331 | ||||||
| Property and equipment, net | 43 | 40 | ||||||
| Goodwill | 32,970 | - | ||||||
| Right of use assets, net | 68 | - | ||||||
| Total assets | $ | 72,574 | $ | 13,371 | ||||
| Liabilities, Preferred Stock and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,462 | $ | 1,400 | ||||
| Accrued expenses | 1,586 | 416 | ||||||
| Other current liabilities | 74 | 104 | ||||||
| Total current liabilities | 3,122 | 1,920 | ||||||
| Long-term liabilities: | ||||||||
| Other long-term liabilities | 41 | - | ||||||
| Total long-term liabilities | 41 | - | ||||||
| Total liabilities | 3,163 | 1,920 | ||||||
| Commitments and contingencies | ||||||||
| Series A-2 Convertible preferred stock, 1.00 par value, 299,456 shares authorized, issued and outstanding at December 31, 2018 | - | 34,313 | ||||||
| Series A-1 Convertible preferred stock, 1.00 par value,13,541 authorized, issued and outstanding at December 31, 2018 | - | 2,879 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding at June 30, 2019 and December 31, 2018 | - | - | ||||||
| Common stock, $0.0001 par value; 130,000,000 and 846,953 shares authorized and 9,986,399 and 846,953 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 1 | - | ||||||
| Additional paid-in capital | 114,137 | 56 | ||||||
| Accumulated other comprehensive (loss) | (722 | ) | (819 | ) | ||||
| Accumulated deficit | (44,005 | ) | (24,978 | ) | ||||
| Total stockholders' equity (deficit) | 69,411 | (25,741 | ) | |||||
| Total liabilities, preferred stock and stockholders' equity (deficit) | $ | 72,574 | $ | 13,371 |