- Achieved
landmark milestone with positive results from Phase 2 MIRA trial in
hidradenitis suppurativa (HS), suggesting that, as early as week
12, the Nanobody® sonelokimab, relative to placebo, reaches the
highest clinical activity among all other therapies tested in
similarly stringent pivotal-like trials; top-line 24-week data
readout is expected in mid-October 2023
- Successfully
completed randomization of the target 200 patients several weeks
ahead of schedule in its global Phase 2 ARGO trial in active
psoriatic arthritis (PsA); top-line 12-week data readout is
expected in the first half of November 2023
- Raised gross
proceeds of approximately $460 million in an upsized public
follow-on offering, providing significant new funds to advance the
development of sonelokimab and for general corporate purposes
ZUG, Switzerland, August 10,
2023 – 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 second quarter of 2023.
MoonLake continues to make significant progress
with the clinical development of sonelokimab, which is currently
being investigated in two Phase 2 clinical trials: the first,
“MIRA”, in moderate-to-severe hidradenitis suppurativa (HS) and the
second, “ARGO”, in active psoriatic arthritis (PsA). Sonelokimab
has already been successfully assessed in a randomized,
placebo-controlled, Phase 2b trial in patients with
moderate-to-severe plaque-type psoriasis, in which it demonstrated
a rapid and durable skin clearance (Psoriasis Area Severity Index
(PASI) 100 response). Sonelokimab is an investigational Nanobody®
designed to inhibit 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 its albumin-binding
domain provide an opportunity for further efficacy. The MIRA and
the ARGO trials both achieved their target patient enrollment and
randomization faster than anticipated, reflecting the Company’s
strong execution and interest from physicians and patients in
MoonLake’s clinical development programs.
Dr. Jorge Santos da Silva, Chief
Executive Officer of MoonLake Immunotherapeutics, said:
“This quarter has been transformational for MoonLake. The positive
Phase 2 results from our MIRA trial were a landmark milestone. We
look ahead with confidence to a number of key catalysts for
sonelokimab this year, including the final 24-week data in HS,
expected in mid-October, and the topline 12-week data in active
PsA, expected in the first half of November, and to creating
long-term value for both patients and shareholders.”
Second Quarter 2023 Business Highlights
(including Post-Quarter End):
- On April 19,
MoonLake held a Capital Markets Day, which featured a series of
presentations from its executive team, who provided a look to the
year ahead at near-term catalysts and a financial update. External
speaker, Professor Kenneth B. Gordon, Chair of Dermatology at the
Medical College of Wisconsin, provided an update on the treatment
landscape for HS, reflecting on data and key takeaways from the
American Academy of Dermatology Annual Meeting.
- On May 3,
MoonLake announced a collaboration agreement with SHL Medical to
develop an autoinjector for clinical and potential subsequent
commercial supply of MoonLake’s Nanobody® sonelokimab.
- On June 25,
MoonLake announced it achieved a landmark milestone with positive
top-line 12-week data readout from its global Phase 2 MIRA trial
evaluating the efficacy and safety of the Nanobody® sonelokimab in
patients with moderate-to-severe HS. The trial met its primary
endpoint with a significantly greater proportion of patients
treated with both sonelokimab 120mg and 240mg achieving
Hidradenitis Suppurativa Clinical Response (HiSCR) 75 compared to
those on placebo at week 12. The results suggest that, as early as
week 12, the Nanobody® sonelokimab, relative to placebo, reaches
the highest clinical activity among all other therapies tested in
similarly stringent pivotal-like trials.
- On July 25 (post
period-end), MoonLake announced that:
- it successfully
completed randomization of the target 200 patients ahead of
schedule in its global Phase 2 ARGO trial in active PsA; and
- a Capital
Markets Day will be held on September 11, 2023 to discuss the PsA
market and to share expectations on the ARGO 12-week data readout
in PsA (results expected in the first half of November 2023) and
the MIRA 24-week data readout in HS (results expected in
mid-October 2023).
Second Quarter 2023 Financial
Highlights:
- On June 30,
2023, MoonLake closed a public offering of 8,000,000 Class A
Ordinary Shares at a public offering price of $50.00 per Share.
MoonLake also granted the underwriters of this offering the option
to purchase up to an additional 1,200,000 Class A Ordinary Shares
at the public offering price less the underwriting discounts and
commissions, and this option was exercised in full, bringing total
gross proceeds of this offering to $460 million.
- In addition,
during the three months ended June 30, 2023, MoonLake sold
544,894 Class A Ordinary Shares through an At-the-Market facility,
yielding gross proceeds of $15.2 million.
- As of
June 30, 2023, MoonLake held cash and cash equivalents and
short-term marketable debt securities of $501.8 million, compared
to $63.1 million as of March 31, 2023.
- Research and
development expenses for the quarter ended June 30, 2023, were
$8.7 million, compared to $7.4 million in the previous quarter. The
increase was primarily driven by expenses for the conduct of the
MIRA and ARGO studies.
- General and
administrative expenses for the quarter ended June 30, 2023,
were $4.5 million, compared to $5.5 million in the previous
quarter. The decrease was primarily driven by lower expenses for
professional services and share-based compensation.
Matthias Bodenstedt, Chief Financial
Officer of MoonLake Immunotherapeutics, said: “The past
quarter has seen MoonLake raise significant new funds, enabling us
to fund the advancement of sonelokimab into multiple Phase 3
programs and putting us in a very strong position for the next
phase of growth. We welcome our new shareholders who recognize the
value of our Nanobody® and are as excited as we are by our
continued advancement of sonelokimab’s clinical development to
address some of the fastest growing markets in inflammatory
diseases.”
Important upcoming anticipated events and
next expected data readouts for MoonLake:
September:
- Capital Markets Day to discuss PsA
market and provide guidance for upcoming 12-week ARGO PsA and
24-week MIRA HS readouts
October:
- MIRA trial top-line 12-week data to
be presented at a scientific meeting
- R&D Day virtual webcast to
share top-line 24-week MIRA HS trial data and Phase 3 plans in
HS
November:
- R&D Day virtual webcast to
share top-line 12-week ARGO PsA trial data
December:
- End of Phase 2 meeting with the FDA
to discuss Phase 2 HS data and Phase 3 development plan
Early 2024:
- R&D Day to share the final
Phase 3 plans and other clinical and business catalysts in 2024 and
beyond
Calendar of upcoming investor
conferences in the second half of 2023:
- Wedbush 2023 PacGrow Healthcare
Conference: August 8-9
- Wells Fargo Healthcare Conference
2023: September 6-8
- Stifel 2023 Immunology &
Inflammation Virtual Summit: September 19
- Cantor Fitzgerald Global Healthcare
Conference 2023: September 26-28
- Guggenheim Securities 5th Annual
Inflammation & Immunology Conference: November 6-7
- UBS Biopharma Conference 2023:
November 8-9
Jefferies London Healthcare Conference 2023:
November 14-16
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
at 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 is currently being assessed in two
ongoing trials, the Phase 2 MIRA trial in HS and the Phase 2 ARGO
trial in PsA. The MIRA 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. A significantly greater proportion of
patients treated with both sonelokimab 120mg and 240mg achieved
HiSCR75 compared to those on placebo at week 12. The positive
results suggest that, as early as week 12, sonelokimab, relative to
placebo, reaches the highest clinical activity among all other
therapies tested in similarly stringent pivotal-like trials. The
trial proceeds to week 24, with a 4-week safety follow-up.
Sonelokimab has also been assessed in a
randomized, placebo-controlled Phase 2b trial 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 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). Recently, a global phase 2
trial in psoriatic arthritis (NCT05640245, M1095-PSA-201, “ARGO”)
including multiple arms and over 200 patients has been
initiated.
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 HS. The trial recruited 234 patients, with the
aim to evaluate two 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
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 also evaluates 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 Nanobody® sonelokimab, administered
subcutaneously, in the treatment of adult patients with active PsA.
The trial 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 also evaluates 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
expectations regarding the timing and outcome of 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, the timing for meeting with regulatory
authorities 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; expectations regarding the
timing and outcome of the MIRA and ARGO trials; positive results
from a clinical trial may not necessarily be predictive of the
results of future or ongoing clinical studies; MoonLake's
substantial dependence on the success of its Nanobody® sonelokimab;
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
Consilium Strategic
Communications
Mary-Jane Elliott, Ashley Tapp,
Namrata Taak
Tel: +44 (0) 20 3709 5700
media@moonlaketx.com
MOONLAKE
IMMUNOTHERAPEUTICSCONDENSED CONSOLIDATED BALANCE
SHEETS
(Amounts in USD, except share data)
|
|
June 30, 2023 (Unaudited) |
|
March 31, 2023 (Unaudited) |
Current assets |
|
|
|
|
Cash and cash equivalents |
|
$ 501,786,997 |
|
$ 50,129,197 |
Short-term marketable debt securities |
|
— |
|
12,920,960 |
Other receivables |
|
619,767 |
|
378,445 |
Prepaid expenses |
|
3,960,383 |
|
3,075,862 |
Total current assets |
|
506,367,147 |
|
66,504,464 |
|
|
|
|
|
Non-current assets |
|
|
|
|
Operating lease right-of-use assets |
|
211,238 |
|
246,256 |
Property and equipment, net |
|
42,810 |
|
46,099 |
Total non-current assets |
|
254,048 |
|
292,355 |
Total assets |
|
$ 506,621,195 |
|
$ 66,796,819 |
|
|
|
|
|
Current liabilities |
|
|
|
|
Trade and other payables |
|
$ 4,359,923 |
|
$ 3,827,403 |
Short-term portion of operating lease liabilities |
|
158,221 |
|
155,173 |
Accrued expenses and other current liabilities |
|
2,616,482 |
|
3,296,839 |
Total current liabilities |
|
7,134,626 |
|
7,279,415 |
|
|
|
|
|
Non-current liabilities |
|
|
|
|
Long-term portion of operating lease liabilities |
|
53,017 |
|
91,081 |
Pension liability |
|
323,597 |
|
314,174 |
Total non-current liabilities |
|
376,614 |
|
405,255 |
Total liabilities |
|
7,511,240 |
|
7,684,670 |
Commitments and contingencies (Note 15) |
|
|
|
|
|
|
|
|
|
Equity (deficit) |
|
|
|
|
Class A Ordinary Shares: $0.0001 par value; 500,000,000 shares
authorized; 53,486,810 shares issued and outstanding as of
June 30, 2023; 39,154,203 shares issued and outstanding as of
March 31, 2023 |
|
5,349 |
|
3,916 |
Class C Ordinary Shares: $0.0001 par value; 100,000,000 shares
authorized; 8,959,195 shares issued and outstanding as of
June 30, 2023; 13,546,908 shares issued and outstanding as of
March 31, 2023 |
|
896 |
|
1,355 |
Additional paid-in capital |
|
589,549,979 |
|
131,308,849 |
Accumulated deficit |
|
(99,794,347) |
|
(89,655,068) |
Accumulated other comprehensive income |
|
35,124 |
|
340,108 |
Total shareholders’ equity (deficit) |
|
489,797,001 |
|
41,999,160 |
Noncontrolling interests |
|
9,312,954 |
|
17,112,989 |
Total equity |
|
499,109,955 |
|
59,112,149 |
Total liabilities and equity |
|
$ 506,621,195 |
|
$ 66,796,819 |
|
|
|
|
|
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 |
|
For the Six Months Period Ended |
|
|
June 30, |
|
March 31, |
|
June 30, |
|
|
2023 |
|
2023 |
|
2023 |
Operating expenses |
|
|
|
|
|
|
Research and development |
|
$ (8,703,849) |
|
$ (7,415,097) |
|
$ (16,118,949) |
General and administrative |
|
(4,482,041) |
|
(5,516,469) |
|
(9,998,510) |
Total operating expenses |
|
(13,185,890) |
|
(12,931,566) |
|
(26,117,459) |
Operating loss |
|
(13,185,890) |
|
(12,931,566) |
|
(26,117,459) |
|
|
|
|
|
|
|
Other income, net |
|
842,652 |
|
723,589 |
|
1,566,242 |
Loss before income tax |
|
(12,343,238) |
|
(12,207,977) |
|
(24,551,217) |
|
|
|
|
|
|
|
Income tax expense |
|
(10,149) |
|
(11,010) |
|
(21,157) |
Net loss |
|
$ (12,353,387) |
|
$ (12,218,987) |
|
$ (24,572,374) |
Of which: net loss attributable to controlling interests
shareholders |
|
(10,139,279) |
|
(9,004,856) |
|
(19,144,135) |
Of which: net loss attributable to noncontrolling interests
shareholders |
|
(2,214,108) |
|
(3,214,131) |
|
(5,428,239) |
|
|
|
|
|
|
|
Net unrealized loss on marketable securities and short term
investments |
|
(415,225) |
|
24,472 |
|
(390,753) |
Actuarial gain (loss) on employee benefit plans |
|
(16,336) |
|
(42,144) |
|
(58,481) |
Other comprehensive income (loss) |
|
(431,561) |
|
(17,672) |
|
(449,234) |
Comprehensive loss |
|
$ (12,784,948) |
|
$ (12,236,659) |
|
$ (25,021,608) |
Comprehensive loss attributable to controlling interests
shareholders |
|
(10,488,185) |
|
(9,017,481) |
|
(19,505,667) |
Comprehensive loss attributable to noncontrolling interests |
|
(2,296,763) |
|
(3,219,178) |
|
(5,515,941) |
|
|
|
|
|
|
|
Weighted-average number of Class A Ordinary Shares, basic and
diluted |
|
43,718,464 |
|
39,061,977 |
|
41,403,084 |
Basic and diluted net loss per share attributable to
controlling interests
shareholders |
|
$ (0.23) |
|
$ (0.23) |
|
$ (0.46) |
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