Full Press Release Details
Immunic, Inc. Reports Second
Quarter 2024 Financial Results
and Provides Corporate Update
Jason Tardio, Experienced Multiple Sclerosis Drug Commercialization Executive, Formerly with Novartis and Biogen, Appointed Chief Operating
Officer and President -
Strengthened Board of Directors with Appointment of Simona Skerjanec, Senior Pharmaceutical Executive and Thought Leader in Brain Health
Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis
Webcast to be Held Today, August 8, at 8:00 am ET -
YORK, August 8, 2024 - Immunic, Inc. (Nasdaq:
IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic
inflammatory and autoimmune diseases, today announced financial results for the second quarter and six months ended June 30, 2024, and
provided a corporate update.
"During the second quarter and subsequent
period, we continued to achieve clinical and operational progress, punctuated with the addition of Jason Tardio to our team, in the newly-created
position of Chief Operating Officer and President. Jason's proven experience in launching and commercializing multiple sclerosis
(MS) drugs for major biotechnology and pharmaceutical companies, including Novartis and Biogen, as well as his extensive partnering experience,
will be invaluable, especially as we move closer to the potential commercialization of our late-stage clinical asset, vidofludimus calcium
(IMU-838), an orally available nuclear receptor related 1 (Nurr1) activator. We also welcomed Simona Skerjanec to our Board of Directors,
who most recently served as the Senior Vice President, Global Head Neuroscience and Rare Diseases at Roche, where she had a successful
track record achieving double-digit sales growth, including with Ocrevus (ocrelizumab), one of the most successful medicines for
MS," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We plan to provide detail on our MS development program
at our next MS R&D Day in New York City in September. The event will feature two renowned industry experts alongside Immunic's
management team to discuss the unique profile of vidofludimus calcium and its potential to become a groundbreaking treatment of choice
for both relapsing MS (RMS) and progressive MS (PMS) patients. We believe that vidofludimus calcium could elevate today's standard
of care by providing a holistic solution for the full range of MS patients, given that it is designed to selectively manage all components
of smoldering MS with its neuroprotective, anti-inflammatory and antiviral effects."
"We look forward to reporting the top-line
data from our phase 2 CALLIPER trial of vidofludimus calcium in PMS patients in April of next year. The previously reported interim analysis
showed a clear separation from placebo in neurofilament light chain (NfL) levels across the PMS patient population, including non-relapsing
secondary progressive MS (SPMS), a subtype with the highest unmet medical need. If the top-line data continues to show a neuroprotective
effect, and meets the trial's primary and key secondary endpoints, we may also be able to potentially position the drug as the first
oral treatment option for non-relapsing SPMS. Notably, we also remain on track with our phase 3 ENSURE program in RMS and expect to complete
the first ENSURE trial in the second quarter of 2026 and the second ENSURE trial in the second half of 2026."
continued, "During the second quarter, we also continued preparations for phase 2 clinical testing of our second clinical program,
IMU-856, an orally available, systemically acting small molecule modulator targeting Sirtuin 6 ("SIRT6"), a protein which serves
as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium. We are exploring potential
financing, licensing or partnering opportunities to fund the next clinical development steps for this program. We believe that IMU-856
represents a potentially groundbreaking therapeutic approach for treating gastrointestinal disorders by restoring a healthy gut through
the renewal of the bowel wall. Data from our phase 1b clinical trial in celiac disease patients showed that IMU-856 had positive effects
over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients' symptoms,
biomarker response, and enhancement of nutrient absorption. Based on this data, we are also considering additional possible clinical applications
in other gastrointestinal disorders."
Second Quarter 2024 and Subsequent Highlights
Anticipated Clinical Milestones
Financial and Operating Results
For the six months ended June 30, 2024,
R&D expenses were $37.0 million, as compared to $44.1 million for the six months ended June 30, 2023. The $7.1 million decrease reflects
(i) a decrease of $3.4 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer, (ii)
a $2.9 million decrease in external development costs related to IMU-856 due to the completion of the phase 1 trial in celiac disease,
(iii) a $0.9 million decrease in external development costs related to the vidofludimus calcium programs and (iv) a $0.8 million decrease
in related costs across numerous categories. The decreases were offset by a $0.9 million increase in personnel costs, $0.2 million of
which is related to non-cash stock compensation and the remainder of which is due to an increase in headcount.
For the six months ended June 30, 2024,
G&A expenses were $9.6 million, as compared to $8.1 million for the same period ended June 30, 2023. The $1.5 million increase was
primarily due to (i) a $1.1 million increase in personnel expense in G&A, $0.6 million of which is related to non-cash stock compensation
expense and the remainder of which is related to an increase in headcount, (ii) a $0.2 million increase in legal and consultancy expenses
and (iii) a $0.2 million increase related to costs across numerous categories.
For the six months ended June 30, 2024,
interest income was $2.2 million, as compared to $1.8 million for the same period ended June 30, 2023. The $0.4 million increase was due
to higher interest rates.
For the six months ended June 30, 2024,
other income (expense) was ($1.7 million), as compared to $1.2 million for the same period ending June 30, 2023. The $2.9 million decrease
was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 PIPE financing related
to the tranche rights that were established at the time of the deal closing, (ii) the German Federal Ministry of Finance grant of $1.1
million being recognized in the fourth quarter of 2023 which was one quarter earlier than in the prior year, when the grant was recognized
in the first quarter of 2023, (iii) a $0.5 million decrease in R&D tax incentives for clinical trials in Australia as a result of
decreased spending on clinical trials in Australia and (iv) a $0.4 million decrease in other grants received in 2023. The decrease was
offset by a $0.8 million increase in foreign exchange gains.
Net loss for the six months ended June
30, 2024, was approximately $51.0 million, or $0.51 per basic and diluted share, based on 99,607,158 weighted average common shares outstanding,
compared to a net loss of approximately $49.3 million or $1.12 per basic and diluted share, based on 44,036,352 weighted average common
shares outstanding for the same period ended June 30, 2023.
Immunic 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_ae1TwcxTQ9GTkRUmQSOgTA
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 biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory
and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical
trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2
clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe
ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor
related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate
dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate
bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is
currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule
being developed to specifically address the needs of gastrointestinal diseases. 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 new management
hires and promotions, strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash
and cash runway, expected timing, development 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 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; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure