MoonLake Immunotherapeutics Reports First
Quarter 2023 Financial Results and Provides a Business
Update
- Capital Markets
Day held in April highlighted the differentiating features of
sonelokimab and strong competitive position following competitor
data in moderate-to-severe hidradenitis suppurativa (HS)
- Preparations are
well underway for the announcement of top-line results from a Phase
2 trial of sonelokimab in moderate-to-severe HS around the end of
June with final read-out of 24-week data by Q4 this year
- Patient
enrollment in a global Phase 2 trial in active psoriatic arthritis
(PsA) is on schedule with primary end-point readout expected in Q4
this year
- Expected cash
runway extended to the end of 2024
ZUG, Switzerland, May 12, 2023
– MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake”), a
clinical-stage biotechnology company focused on creating next-level
therapies for inflammatory diseases, today provided a business
update, following the filing of its first quarter financial results
on May 11.
MoonLake continues to make substantial progress
with the clinical development of sonelokimab, which is currently
being investigated in two Phase II clinical trials: the first,
‘MIRA’, in moderate-to-severe HS and the second, ‘ARGO’, in PsA.
Sonelokimab has already been successfully assessed in a randomized,
placebo-controlled, Phase 2b trial in 313 patients with
moderate-to-severe plaque-type psoriasis in which it demonstrated a
rapid and durable skin clearance (PASI100). Sonelokimab efficiently
inhibits IL-17F in addition to IL-17A and therefore could represent
a major improvement in treating inflammation in these
dermatological and rheumatological diseases. The Nanobody’s®
smaller size versus traditional antibodies and albumin-binding
domain provide an opportunity for further efficacy.
Dr. Jorge Santos da Silva, Chief
Executive Officer of MoonLake Immunotherapeutics, said:
“2023 has started off very strongly for MoonLake. Patient
enrollment and randomization were completed ahead of schedule in
our global Phase 2 trial of sonelokimab in moderate-to-severe HS
and we are now anticipating announcement of the top-line results
next month. We were delighted to reflect on the pivotal design of
the trial and the baseline characteristics of enrolled patients in
our Capital Markets Day in April together with Professor Kenneth B.
Gordon, Chair of Dermatology at the Medical College of Wisconsin,
and believe that our study is most comparable to the Phase 3 trials
of competitors. Based on sonelokimab’s mechanism of action and
unique characteristics, we are confident that we can ‘meet or beat’
the best results shown in such trials, which would translate into a
greater than 20 percentage point delta on HiSCR 75 compared to
placebo and represent a meaningful difference to the lives of
patients with HS, an estimated $10bn market opportunity in the
United States alone. Patient enrollment in our second global Phase
2 trial, in active PsA, is progressing well with primary end-point
readout expected in Q4 of this year.”
Q1 highlights (including post-period
end)
- Patient
enrollment and randomization completed ahead of schedule in a
global Phase 2 trial of sonelokimab in moderate-to-severe HS
(MIRA). This is the first global, randomized, double-blind,
placebo-controlled trial using Hidradenitis Suppurativa Clinical
Response (HiSCR) 75, a higher measure of clinical response, as its
primary endpoint with top-line results anticipated next month.
- Capital Markets
Day hosted in New York on April 19th featured a series of
presentations from MoonLake’s executive team who provided a
financial update and look to the year ahead at near-term catalysts
and the Company’s publication roadmap. The event program
highlighted key features of sonelokimab and included a clinical
trial progress update. The program also referenced the release of
important competitor data at the American Academy of Dermatology
(AAD) Annual Meeting in March. In addition, external speaker
Professor Kenneth B. Gordon, Chair of Dermatology at the Medical
College of Wisconsin, provided an update on the treatment landscape
and pipeline, reflecting on data and key takeaways from AAD.
- Collaboration
agreement signed with SHL Medical, a world-leading provider of
advanced drug delivery solutions, to develop an autoinjector for
clinical and potential subsequent commercial supply of MoonLake’s
Nanobody® sonelokimab.
First quarter 2023 financial
results
As of March 31, 2023, MoonLake held cash,
cash equivalents and short-term marketable debt securities of $63.1
million, compared to $72.1 million as of December 31, 2022,
corresponding to a cash burn of $9.1 million1 in the first
quarter.
Research and development expenses for the
quarter ended March 31, 2023, were $7.4 million, compared to
$11.4 million in the previous quarter. The decrease was primarily
due to a milestone expense under MoonLake’s in-license agreement of
sonelokimab that was recognized in the previous quarter. General
and administrative expenses for the quarter ended March 31,
2023 were $5.5 million, compared to $5.3 million in the previous
quarter.
Matthias Bodenstedt, Chief Financial
Officer at MoonLake Immunotherapeutics, said: “MoonLake is
in a very solid financial position with a strong balance sheet. As
a result of careful financial management, planning and operating
efficiently, we have extended our expected cash runway to the end
of 2024 which is 18 months beyond our upcoming readout in HS. This
robust cash position also covers our other mid-stage PsA clinical
readout, as well as the ongoing preparations for our Phase 3
programs, and thereby gives us a lot of financial flexibility and
optionality. We have a unique asset in sonelokimab, which we expect
to soon be Phase 3 ready in three multi-billion dollar
indications.”
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 IL-17F/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
on www.moonlaketx.com.
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 the ability to design
multivalent therapeutic molecules with bespoke target
combinations.
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 has been assessed in a randomized,
placebo-controlled Phase 2b study in 313 patients with
moderate-to-severe plaque-type psoriasis. Sonelokimab demonstrated
a rapid and durable clinical response (Investigator’s Global
Assessment Score 0 or 1, Psoriasis Area and Severity Index 90/100)
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 Phase 1 study 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). Recently, a global phase 2
trial in psoriatic arthritis (NCT05640245, M1095-PSA-201, “ARGO”)
including multiple arms and over 200 patients has been initiated
(announced on Dec 14, 2022).
Sonelokimab is not yet approved for use in any
indication.
About the MIRA trial
The MIRA trial (M1095-HS-201) is a global,
randomized, double-blind, placebo-controlled trial to evaluate the
efficacy and safety of the Nanobody® sonelokimab, administered
subcutaneously, in the treatment of adult patients with active
moderate to severe hidradenitis suppurativa. The trial will
comprise over 200 patients, and will evaluate two different doses
of sonelokimab, with placebo control and adalimumab as an active
control reference arm. The primary endpoint of the trial 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 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 on:
https://www.clinicaltrials.gov/ct2/show/NCT05322473
About the ARGO trial
The ARGO trial (M1095-PSA-201) is a global,
randomized, double-blind, placebo-controlled trial to evaluate the
efficacy and safety of the sonelokimab, administered
subcutaneously, in the treatment of adult patients with active PsA.
The trial is expected to comprise of approximately 200 patients,
and is designed to evaluate different doses of sonelokimab, with
placebo control and adalimumab as an active reference arm. The
primary endpoint of the trial is the percentage of participants
achieving ≥50% improvement in signs and symptoms of disease from
baseline, compared to placebo, as measured by the American College
of Rheumatology (ACR) 50 response. The trial will also evaluate a
number of secondary endpoints, including improvement compared to
placebo in ACR70, complete skin clearance as measured by at least a
100% improvement in the Psoriasis Area and Severity Index, physical
function as measured by the Health Assessment
Questionnaire-Disability Index, enthesitis as measured by the Leeds
Enthesitis Index and pain as measured by the Patients Assessment of
Arthritis Pain. Further details are available on:
https://clinicaltrials.gov/ct2/show/NCT05640245
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
patient enrollment in the MIRA and ARGO trials, the efficacy and
safety of sonelokimab for the treatment of HS and PsA, 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, 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.
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
Matthias Bodenstedt, CFO
ir@moonlaketx.com
MoonLake Immunotherapeutics
Media
Patricia Sousa, Director Corporate Affairs
media@moonlaketx.com
Matthew Cole, Mary-Jane Elliott
Consilium Strategic Communications
Tel: +44 (0) 20 3709 5700
media@moonlaketx.com
MoonLake@consilium-comms.com
MOONLAKE
IMMUNOTHERAPEUTICSCONDENSED CONSOLIDATED BALANCE
SHEETS
(Amounts in USD, except share data)
|
|
March 31, 2023 (Unaudited) |
|
December 31, 2022 |
Current assets |
|
|
|
|
Cash and cash equivalents |
|
$ 50,129,197 |
|
$ 39,505,627 |
Short-term marketable debt securities |
|
12,920,960 |
|
32,609,108 |
Other receivables |
|
378,445 |
|
217,129 |
Prepaid expenses |
|
3,075,862 |
|
4,179,468 |
Total current assets |
|
66,504,464 |
|
76,511,332 |
|
|
|
|
|
Non-current assets |
|
|
|
|
Operating lease right-of-use assets |
|
246,256 |
|
282,580 |
Property and equipment, net |
|
46,099 |
|
49,389 |
Total non-current assets |
|
292,355 |
|
331,969 |
Total assets |
|
$ 66,796,819 |
|
$ 76,843,301 |
|
|
|
|
|
Current liabilities |
|
|
|
|
Trade and other payables |
|
$ 3,827,403 |
|
$ 254,972 |
Short-term portion of operating lease liabilities |
|
155,173 |
|
153,629 |
Accrued expenses and other current liabilities |
|
3,296,839 |
|
7,256,845 |
Total current liabilities |
|
7,279,415 |
|
7,665,446 |
|
|
|
|
|
Non-current liabilities |
|
|
|
|
Long-term portion of operating lease liabilities |
|
91,081 |
|
128,951 |
Pension liability |
|
314,174 |
|
282,206 |
Total non-current liabilities |
|
405,255 |
|
411,157 |
Total liabilities |
|
7,684,670 |
|
8,076,603 |
Commitments and contingencies (Note 15) |
|
|
|
|
|
|
|
|
|
Equity (deficit) |
|
|
|
|
Class A Ordinary Shares: $0.0001 par value; 500,000,000 shares
authorized; 39,154,203 shares issued and outstanding as of
March 31, 2023; 38,977,600 shares issued and outstanding as of
December 31, 2022 |
|
3,916 |
|
3,898 |
Class C Ordinary Shares: $0.0001 par value; 100,000,000 shares
authorized; 13,546,908 shares issued and outstanding as of
March 31, 2023; 13,723,511 shares issued and outstanding as of
December 31, 2022 |
|
1,355 |
|
1,373 |
Additional paid-in capital |
|
131,308,849 |
|
129,192,291 |
Accumulated deficit |
|
(89,655,068) |
|
(80,650,212) |
Accumulated other comprehensive income (loss) |
|
340,108 |
|
350,946 |
Total shareholders’ equity (deficit) |
|
41,999,160 |
|
48,898,296 |
Noncontrolling interests |
|
17,112,989 |
|
19,868,402 |
Total equity (deficit) |
|
59,112,149 |
|
68,766,698 |
Total liabilities and equity (deficit) |
|
$ 66,796,819 |
|
$ 76,843,301 |
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 |
|
|
March 31, |
|
December 31, |
|
March 31, |
|
|
2023 |
|
2022 |
|
2022 |
Operating expenses |
|
|
|
|
|
|
Research and development |
|
$ (7,415,097) |
|
$ (11,369,112) |
|
$ (10,454,948) |
General and administrative |
|
(5,516,469) |
|
(5,327,311) |
|
(5,487,368) |
Total operating expenses |
|
(12,931,566) |
|
(16,696,423) |
|
(15,942,316) |
Operating loss |
|
(12,931,566) |
|
(16,696,423) |
|
(15,942,316) |
|
|
|
|
|
|
|
Other income (expense), net |
|
723,589 |
|
239,505 |
|
69,506 |
Loss before income tax |
|
(12,207,977) |
|
(16,456,918) |
|
(15,872,810) |
|
|
|
|
|
|
|
Income tax expense |
|
(11,010) |
|
(11,012) |
|
(7,332) |
Net loss |
|
$ (12,218,987) |
|
$ (16,467,930) |
|
$ (15,880,142) |
Of which: net loss attributable to controlling interests
shareholders |
|
(9,004,856) |
|
(11,861,934) |
|
(15,880,142) |
Of which: net loss attributable to noncontrolling interests
shareholders |
|
(3,214,131) |
|
(4,605,996) |
|
— |
|
|
|
|
|
|
|
Net unrealized gain on marketable securities and short term
investments |
|
24,472 |
|
313,747 |
|
— |
Actuarial gain (loss) on employee benefit plans |
|
(42,144) |
|
(187,557) |
|
266,269 |
Other comprehensive income (loss) |
|
(17,672) |
|
126,190 |
|
266,269 |
Comprehensive loss |
|
$ (12,236,659) |
|
$ (16,341,740) |
|
$ (15,613,873) |
Comprehensive loss attributable to controlling interests
shareholders |
|
(9,017,481) |
|
(11,772,007) |
|
(15,613,873) |
Comprehensive loss attributable to noncontrolling interests |
|
(3,219,178) |
|
(4,569,733) |
|
— |
|
|
|
|
|
|
|
Weighted-average number of Class A Ordinary Shares, basic and
diluted |
|
39,061,977 |
|
38,843,776 |
|
— |
Basic and diluted net loss per share attributable to
controlling interests shareholders |
|
$ (0.23) |
|
$ (0.31) |
|
$ — |
|
|
|
|
|
|
|
Weighted-average number of Common Shares2 |
|
— |
|
— |
|
5,013,646 |
Basic and diluted net loss per Common Share |
|
$ — |
|
$ — |
|
$ (3.17) |
|
|
|
|
|
|
|
2 As a result of the Business Combination, the Company has
retroactively restated the weighted average number of shares
outstanding prior to April 5, 2022 to give effect to the Exchange
Ratio. For definitions of capitalized terms, refer to the unaudited
condensed consolidated financial statements filed on Form 10-Q for
the quarter ended March 31, 2023. |
1 Values may not add up due to rounding.
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