MoonLake Immunotherapeutics Reports Third
Quarter 2024 Financial Results and Provides a Business
Update
- Ended the third
quarter with $493.9 million in cash, cash equivalents and
short-term marketable debt securities, expected to support a
roadmap rich in potential catalysts and a cash runway to the end of
2026
- Strong market
performance of other IL-17 inhibitors in hidradenitis suppurativa
(HS) and other inflammatory indications validating large market
opportunity for sonelokimab
- Phase 3 clinical
program in HS is progressing as per plan with primary endpoint
readout anticipated as of mid-2025
- Preparations for
Phase 3 clinical program in psoriatic arthritis (PsA) completed
with patient enrollment expected to commence imminently
- Additional Phase
2 programs, including trials in palmoplantar pustulosis (PPP) and
axial spondyloarthritis (axSpA), and Phase 3 trial in adolescent
HS, on track to commence around year-end
ZUG, Switzerland, November 7,
2024 – MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake” or the
“Company”), a clinical-stage biotechnology company focused on
creating next-level therapies for inflammatory diseases, today
announced its financial results for the third quarter of 2024.
During this period, MoonLake has made
significant progress with the clinical development of its Nanobody®
sonelokimab, which targets IL-17A and IL-17F dimers and are heavily
implicated in the pathology of several Type 3 dermatological and
rheumatological inflammatory conditions.
Dr. Jorge Santos da Silva, Chief
Executive Officer of MoonLake Immunotherapeutics, said:
“MoonLake continued to make good clinical progress with sonelokimab
in the third quarter across several large dermatology and
rheumatology indications, with multiple Phase 3 and Phase 2 trials
either underway or starting soon. The strong clinical data that we
continue to build on suggests that the ability to inhibit all
IL-17A and IL-17F containing dimers, together with the molecular
advantages of our Nanobody®, translate into higher clinical
responses for patients, and provide ample opportunity for
differentiation of sonelokimab versus all competitors. We look
forward to 2025 with multiple data catalysts, including the
expected primary readout of our Phase 3 VELA program in HS as of
mid-year.”
Q3 highlights:
- Phase 3 HS
program progressing well: clinical study sites across North America
and Europe are actively enrolling patients into the identical
VELA-1 and VELA-2 studies, to enable the anticipated primary
endpoint readout as of mid-2025
- Preparations for
the Phase 3 PsA program completed: imminent enrollment of first
patients into the IZAR-1 study for bio-naïve* patients and into the
IZAR-2 study for TNF-IR** patients, the first study including an
IL-23 inhibitor as an active reference arm
- Preparation for
first ever dedicated clinical trial in adolescent HS on track:
Phase 3 VELA TEEN clinical trial scheduled to commence around
year-end
- Preparations for
three additional Phase 2 trials advancing well: the LEDA trial in
PPP and the S-OLARIS trial in axSpA anticipated to start around
year-end, and the P-OLARIS trial in patients with seronegative
spondylarthritis scheduled to start in early 2025
- Strong
commercial performance of other IL-17 inhibitors in both HS and
other inflammatory indications continues to outperform “street”
expectations, leading to greater awareness and diagnosis, driving
market growth and further validating the significant commercial
opportunity for sonelokimab with its highly differentiated
molecular characteristics (small Nanobody® size and both IL17A and
IL-17F dimer binding) and potentially best in class clinical data
to date
* Patients without previous exposure to biologics
** Patients with an inadequate response to TNF
inhibitors
Third quarter 2024 financial
results
As of September 30, 2024, MoonLake held
cash, cash equivalents and short-term marketable debt securities of
$493.9 million. Research and development expenses for the quarter
ended September 30, 2024, were $35.7 million, compared to
$23.7 million in the previous quarter. The increase was primarily
due to expenses pertaining to the ramp-up of the Phase 3 VELA
program in HS and to prepare for the start of the new clinical
trials in PsA, PPP and axSpA. General and administrative expenses
for the quarter ended September 30, 2024 were $7.4 million,
compared to the $6.9 million incurred in the previous quarter. The
increase was primarily due to personnel-related costs to support
organizational growth.
Matthias Bodenstedt, Chief Financial
Officer at MoonLake Immunotherapeutics, said: “MoonLake
delivered a solid financial performance in Q3, with a strong cash
position to at least the end of 2026. We continue to maintain a
tight control of costs with a laser focus on value and delivery of
our core company goals. We are incredibly fortunate to be
custodians of sonelokimab which, as a pipeline-in-a-product across
multiple large indications, could be worth over $8bn in sales by
2035 across the indications we are currently targeting. To
optimally capture this opportunity, we continue to invest into our
large clinical development programs (enrolling over 2,500 patients
globally) whilst ramping up preparations for regulatory filings,
and other pre-commercial activities.”
Upcoming investor and medical
conferences:
- American College
of Rheumatology (ACR) Conference, November 14-19 Washington DC,
US
- Jefferies London
Healthcare Conference, November 19-21, 2024, London, UK
- Citi’s 19th
Annual BioPharma Conference, December 3-5, Miami, US
- JP Morgan Annual
Healthcare Conference, January 13-16, San Francisco, US
- 14th Conference
of the European Hidradenitis Suppurativa Foundation e.V., Vilnius,
Lithuania, February 12-14
- American Academy
of Dermatology 2025 Annual Meeting, 7-11 March, Orlando,
Florida
-Ends-
About MoonLake
Immunotherapeutics
MoonLake Immunotherapeutics is a clinical-stage
biopharmaceutical company unlocking the potential of sonelokimab, a
novel investigational Nanobody® for the treatment of inflammatory
disease, to revolutionize outcomes for patients. Sonelokimab
inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F,
and IL17F/F dimers that drive inflammation. The company’s focus is
on inflammatory diseases with a major unmet need, including
hidradenitis suppurativa and psoriatic arthritis – conditions
affecting millions of people worldwide with a large need for
improved treatment options. MoonLake was founded in 2021 and is
headquartered in Zug, Switzerland. Further information is available
at www.moonlaketx.com.
About Sonelokimab
Sonelokimab (M1095) is an investigational ~40
kDa humanized Nanobody® consisting of three VHH domains covalently
linked by flexible glycine-serine spacers. With two domains,
sonelokimab selectively binds with high affinity to IL-17A and
IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F
dimers. A third central domain binds to human albumin, facilitating
further enrichment of sonelokimab at sites of inflammatory
edema.
Sonelokimab is being assessed in two lead
indications, HS and PSA, and MoonLake is pursuing other indications
in dermatology and rheumatology.
For HS, sonelokimab is being assessed in the
Phase 3 trials, VELA-1 and VELA-2, following the successful outcome
of MoonLake’s end-of-Phase 2 interactions with the FDA and as well
as positive feedback from its interactions with the EMA announced
in February 2024. In June 2023, topline results of the MIRA trial
(NCT05322473) at 12 weeks showed that the trial met its primary
endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR)75,
which is a higher measure of clinical response versus the HiSCR50
measure used in other clinical trials, setting a landmark
milestone. In October 2023, the full dataset from the MIRA trial at
24 weeks showed that maintenance treatment with sonelokimab led to
further improvements in HiSCR75 response rates and other high
threshold clinical and patient relevant outcomes. The safety
profile of sonelokimab in the MIRA trial was consistent with
previous trials with no new safety signals detected.
For PsA, sonelokimab is being assessed in the
Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in
March 2024 of the full dataset from the global Phase 2 ARGO trial
(M1095-PSA-201) evaluating the efficacy and safety of the Nanobody®
sonelokimab over 24 weeks in patients with active PsA. Significant
improvements were observed across all key outcomes, including up to
61% of patients treated with sonelokimab achieving an American
College of Rheumatology (ACR) 50 response and Minimal Disease
Activity (MDA) at week 24. This followed the positive top-line
results in November 2023, where the trial met its primary endpoint
with a statistically significant greater proportion of patients
treated with either sonelokimab 60mg or 120mg (with induction)
achieving ACR50 response compared to those on placebo at week 12.
All key secondary endpoints in the trial were met for the 60mg and
120mg doses with induction. The safety profile of sonelokimab in
the ARGO trial was consistent with previous trials with no new
safety signals detected.
A Phase 2 trial is expected to be initiated in
2024 for palmo-plantar pustulosis (PPP), a debilitating
inflammatory skin condition affecting a significant number of
patients. In addition, in 2024, a Phase 3 trial is expected to be
initiated in adolescent HS, a condition that typically manifests at
this early stage of a patient’s life, and the period in which
irreversible damage and inflammatory remission is most
critical.
Sonelokimab also is also planned to be assessed
for seronegative spondyloarthritis with a Phase 2 trial in
radiographic and non-radiographic axial spondyloarthritis (axSpA)
expected to start by end of 2024, and a Phase 2 trial in axSpA with
PsA in 2025. The trials are expected to feature an innovative
design complementing traditional clinical outcomes with modern
imaging techniques.
Sonelokimab has also been assessed in a
randomized, placebo-controlled third party Phase 2b trial
(NCT03384745) in 313 patients with moderate-to-severe plaque-type
psoriasis. High threshold clinical responses (Investigator’s Global
Assessment Score 0 or 1, and Psoriasis Area and Severity Index
90/100) were observed in patients with moderate-to-severe
plaque-type psoriasis. Sonelokimab was generally well tolerated,
with a safety profile similar to the active control, secukinumab
(Papp KA, et al. Lancet. 2021; 397:1564-1575).
In an earlier third party Phase 1 trial in
patients with moderate-to-severe plaque-type psoriasis, sonelokimab
has been shown to decrease (to normal skin levels) the cutaneous
gene expression of pro-inflammatory cytokines and chemokines
(Svecova D. J Am Acad Dermatol. 2019;81:196–203).
About
Nanobodies®
Nanobodies® represent a new generation of
antibody-derived targeted therapies. They consist of one or more
domains based on the small antigen-binding variable regions of
heavy-chain-only antibodies (VHH). Nanobodies® have a number of
potential advantages over traditional antibodies, including their
small size, enhanced tissue penetration, resistance to temperature
changes, ease of manufacturing, and their ability to be designed
into multivalent therapeutic molecules with bespoke target
combinations.
The terms Nanobody® and Nanobodies® are
trademarks of Ablynx, a Sanofi company.
About the VELA program
The VELA program is expected to enroll 800
patients across two similarly designed Phase 3 trials (VELA-1 and
VELA-2) with the aim to evaluate the efficacy and safety of the
Nanobody® sonelokimab, administered subcutaneously, in adult
patients with active moderate-to-severe hidradenitis suppurativa.
Similar to the design of the landmark Phase 2 MIRA trial, the
primary endpoint of the program is the percentage of participants
achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75),
defined as a ≥75% reduction in total abscess and inflammatory
nodule (AN) count with no increase in abscess or draining tunnel
count relative to baseline. The trial will also evaluate a number
of secondary endpoints, including the proportion of patients
achieving Hidradenitis Suppurative Clinical Response (HiSCR50), the
change from baseline in International Hidradenitis Suppurativa
Severity Score System (IHS4), the proportion of patients achieving
a Dermatology Life Quality Index (DLQI) total score of ≤5, and the
proportion of patients achieving at least 30% reduction from
baseline in Numerical Rating Scale (NRS30) in the Patient’s Global
Assessment of Skin Pain (PGA Skin Pain). Further details are
available under NCT06411379 and NCT06411899 at
www.clinicaltrials.gov.
About IZAR
IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089)
are global, randomized, double-blind, placebo-controlled Phase 3
trials designed to evaluate the efficacy and safety of sonelokimab
compared with placebo in a total of approximately 1,500 adults with
active PsA, with a primary endpoint of superiority to placebo in
ACR 50 response at Week 16. IZAR-1 will enroll biologic-naïve
patients and include an evaluation of radiographic progression,
while IZAR-2 will enroll patients with an inadequate response to
tumor necrosis factor-α inhibitors (TNF-IR) — reflecting patients
commonly seen in clinical practice — and will be the first PsA
trial to include a risankizumab active reference arm. Both trials
will also assess a range of secondary endpoints reflecting the
multiple disease manifestations characteristic of PsA. These
include skin and nail outcomes, multidomain outcomes, and
patient-reported outcome measures such as pain and quality of life
assessments.
About Hidradenitis Suppurativa
Hidradenitis suppurativa is a severely
debilitating chronic skin condition resulting in irreversible
tissue destruction. HS manifests as painful inflammatory skin
lesions, typically around the armpits, groin, and buttocks. Over
time, uncontrolled and inadequately treated inflammation can result
in irreversible tissue destruction and scarring. The disease
affects 0.05–4.1% of the global population, with three times more
females affected than males. Real-world data in the US indicates
that at least 2 million unique patients have been diagnosed with
and treated for HS between 2016 and 2023 alone, highlighting a
significant unmet need and impact on healthcare systems, and a
market opportunity exceeding $10bn by 2035. Onset typically occurs
in early adulthood and HS has a profound negative impact on quality
of life, with a higher morbidity than other dermatologic
conditions. There is increasing scientific evidence to support
IL-17A- and IL-17-mediated inflammation as a key driver of the
pathogenesis of HS, with other identified risk factors including
genetics, cigarette smoking, and obesity.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic,
progressive and complex inflammatory disease that manifests across
multiple domains, leading to substantial functional impairment and
decreased quality of life. The clinical features of PsA are
diverse, comprising both musculoskeletal (peripheral arthritis,
spondylitis, dactylitis, and enthesitis) and non-musculoskeletal
(skin and nail disease) domains. PsA occurs in up to 30% of
patients with psoriasis, most commonly those aged between 30 and 60
years. Although the exact mechanism of disease is not fully
understood, evidence suggests that activation of the IL-17 pathway
plays an important role in the disease pathophysiology.
Cautionary Statement Regarding Forward
Looking Statements
This press release contains certain
“forward-looking statements” within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements include, but are not limited to, statements regarding
MoonLake’s expectations, hopes, beliefs, intentions or strategies
regarding the future including, without limitation, statements
regarding: plans for and timing of clinical trials, including
initiation of Phase 3 VELA TEEN trial of sonelokimab in adolescents
with HS, commencement of clinical trials of sonelokimab in PPP,
axSpA and seronegative spondylarthritis, topline results of the
Phase 3 VELA program of sonelokimab in HS and enrollment of first
patents into Phase 3 IZAR-1 and IZAR-2 trials, the efficacy and
safety of sonelokimab for the treatment of HS, PsA, PPP, axSpA and
seronegative spondylarthritis, including in comparison to existing
standards or care or other competing therapies, clinical trials and
research and development programs and the anticipated timing of the
results from those studies and trials, potential market
opportunities for sonelokimab and our anticipated cash usage and
the period of time we anticipate such cash to be available. In
addition, any statements that refer to projections, forecasts, or
other characterizations of future events or circumstances,
including any underlying assumptions, are forward- looking
statements. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,”
“potential,” “predict,” “project,” “should,” “would” and similar
expressions may identify forward-looking statements, but the
absence of these words does not mean that statement is not forward
looking.
Forward-looking statements are based on current
expectations and assumptions that, while considered reasonable by
MoonLake and its management, as the case may be, are inherently
uncertain. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. Actual results could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
risks and uncertainties associated with MoonLake’s business in
general and limited operating history, difficulty enrolling
patients in clinical trials, state and federal healthcare reform
measures that could result in reduced demand for MoonLake’s product
candidates and reliance on third parties to conduct and support its
preclinical studies and clinical trials and the other risks
described in or incorporated by reference into MoonLake’s Annual
Report on Form 10-K for the year ended December 31, 2023 and
subsequent filings with the Securities and Exchange Commission.
Nothing in this press release should be regarded
as a representation by any person that the forward-looking
statements set forth herein will be achieved or that any of the
contemplated results of such forward-looking statements will be
achieved. You should not place undue reliance on forward-looking
statements in this press release, which speak only as of the date
they are made and are qualified in their entirety by reference to
the cautionary statements herein. MoonLake does not undertake or
accept any duty to release publicly any updates or revisions to any
forward-looking statements to reflect any change in its
expectations or in the events, conditions or circumstances on which
any such statement is based.
CONTACT
MoonLake Immunotherapeutics
Investors
Carla Bretes, Director IR & BD
ir@moonlaketx.com
MoonLake Immunotherapeutics
Media
Patricia Sousa, Director Corporate Affairs
media@moonlaketx.com
ICR Healthcare
Mary-Jane Elliott, Ashley Tapp, Namrata Taak
Tel: +44 (0) 20 3709 5700
MoonLake@ICRHealthcare.com
MOONLAKE
IMMUNOTHERAPEUTICSCONDENSED CONSOLIDATED BALANCE
SHEETS
(Amounts in USD, except share data)
|
|
September 30, 2024 (Unaudited) |
|
December 31.2023 |
Current
assets |
|
|
|
|
Cash and cash equivalents |
|
$ 375,656,291 |
|
$ 451,169,337 |
Short-term marketable debt securities |
|
118,268,400 |
|
59,838,900 |
Other receivables |
|
2,407,062 |
|
1,056,862 |
Prepaid expenses - current |
|
15,984,425 |
|
2,102,203 |
Total
current assets |
|
512,316,178 |
|
514,167,302 |
|
|
|
|
|
Non-current assets |
|
|
|
|
Operating lease right-of-use assets |
|
3,251,197 |
|
3,628,480 |
Property and equipment, net |
|
581,378 |
|
320,865 |
Prepaid expenses - non-current |
|
2,064,575 |
|
8,423,468 |
Total
non-current assets |
|
5,897,150 |
|
12,372,813 |
Total
assets |
|
$ 518,213,328 |
|
$ 526,540,115 |
|
|
|
|
|
Current
liabilities |
|
|
|
|
Trade and other payables |
|
$ 10,710,603 |
|
$ 1,837,684 |
Short-term portion of operating lease liabilities |
|
1,444,893 |
|
1,197,876 |
Accrued expenses and other current liabilities |
|
7,925,524 |
|
6,930,120 |
Total
current liabilities |
|
20,081,020 |
|
9,965,680 |
|
|
|
|
|
Non-current liabilities |
|
|
|
|
Long-term portion of operating lease liabilities |
|
1,935,709 |
|
2,499,990 |
Pension liability |
|
694,959 |
|
583,426 |
Total
non-current liabilities |
|
2,630,668 |
|
3,083,416 |
Total
liabilities |
|
22,711,688 |
|
13,049,096 |
Commitments and
contingencies (Note 15) |
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
Class A Ordinary Shares: $0.0001 par value; 500,000,000 shares
authorized; 63,046,025 shares issued and outstanding as of
September 30, 2024; 60,466,453 shares issued and outstanding
as of December 31, 2023 |
|
6,305 |
|
6,047 |
Class C Ordinary Shares: $0.0001 par value; 100,000,000 shares
authorized; 841,269 shares issued and outstanding as of
September 30, 2024; 2,505,476 shares issued and outstanding as
of December 31, 2023 |
|
84 |
|
251 |
Additional paid-in capital |
|
675,343,443 |
|
609,969,236 |
Accumulated deficit |
|
(189,988,477) |
|
(116,657,472) |
Accumulated other comprehensive income |
|
2,833,970 |
|
2,357,621 |
Total
shareholders’ equity |
|
488,195,325 |
|
495,675,683 |
Noncontrolling interests |
|
7,306,315 |
|
17,815,336 |
Total
equity |
|
495,501,640 |
|
513,491,019 |
Total
liabilities and equity |
|
$ 518,213,328 |
|
$ 526,540,115 |
|
|
|
|
|
|
|
|
|
|
MOONLAKE
IMMUNOTHERAPEUTICSCONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited)
(Amounts in USD, except share and per share
data)
|
|
For the Three Months Period Ended |
|
|
September 30, |
|
June 30, |
|
|
2024 |
|
2024 |
Operating
expenses |
|
|
|
|
Research and development |
|
$ (35,735,514) |
|
$ (23,662,147) |
General and administrative |
|
(7,376,495) |
|
(6,916,054) |
Total
operating expenses |
|
(43,112,009) |
|
(30,578,201) |
Operating
loss |
|
(43,112,009) |
|
(30,578,201) |
|
|
|
|
|
Other income, net |
|
7,089,691 |
|
5,898,148 |
Loss
before income tax |
|
(36,022,318) |
|
(24,680,053) |
|
|
|
|
|
Income tax expense |
|
(92,106) |
|
(78,701) |
Net
loss |
|
$ (36,114,424) |
|
$ (24,758,754) |
Of which: net loss attributable to controlling interests
shareholders |
|
(35,390,337) |
|
(24,267,012) |
Of which: net loss attributable to noncontrolling interests
shareholders |
|
(724,087) |
|
(491,742) |
|
|
|
|
|
Net unrealized gain (loss) on marketable securities and short term
investments |
|
(325,510) |
|
652,097 |
Actuarial gain (loss) on employee benefit plans |
|
(115,629) |
|
(76,479) |
Other
comprehensive income (loss) |
|
(441,139) |
|
575,618 |
Comprehensive loss |
|
$ (36,555,563) |
|
$ (24,183,136) |
Comprehensive loss attributable to controlling interests
shareholders |
|
(35,822,526) |
|
(23,703,201 |
Comprehensive loss attributable to noncontrolling interests |
|
(733,037) |
|
(479,935) |
|
|
|
|
|
Weighted-average
number of Class A Ordinary Shares, basic and diluted |
|
62,896,782 |
|
62,874,637 |
Basic and
diluted net loss per share attributable to controlling interests
shareholders |
|
$ (0.56) |
|
$ (0.39) |
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