Ad hoc announcement pursuant to Art. 53
LR Molecular Partners AG (SIX: MOLN;
NASDAQ: MOLN), a clinical-stage biotech company pioneering the
design and development of DARPin therapeutics for medical
challenges that other drug modalities cannot readily address
("Molecular Partners" or the "Company"), today announced corporate
highlights and unaudited financial results for the first quarter of
2024.
“This quarter we demonstrated continued progress across our
clinical and preclinical pipeline with preparations underway for
two new clinical candidates and first-in-human data for our Radio
DARPin platform in 2025,” said Patrick Amstutz, Ph.D., Molecular
Partners’ Chief Executive Officer. “Building on encouraging initial
data and clinical activity, MP0533 dose escalation will expand and
now explore higher potential doses, to see what the true clinical
impact can be and which patient subpopulations can benefit most. We
plan to share data from these higher dose clinical cohorts starting
in the second half of this year. For our emerging pipeline, we plan
to announce preclinical data from our Switch-DARPin Platform at EHA
and anticipate translational efficacy data in the second half of
2024. Our lead Radio-DARPin candidate is advancing into
IND-enabling studies in collaboration with our partner Orano Med,
with initiation of clinical studies planned for 2025 and
pre-clinical data to be presented at SNMMI in June 2024.”
Financial and Business Outlook
For the full year 2024, at constant exchange rates, the Company
expects total operating expenses of CHF 70-80 million, remaining
consistent with the prior year. Of this figure, approximately CHF 8
million will be non-cash effective costs for share-based payments,
IFRS pension accounting and depreciation.
With CHF 174.1 million in cash and short-term time
deposits and no debt as of March 31, 2024, the Company expects to
be funded well into 2026. This guidance does not include any
potential receipts from R&D partnerships.
Research & Development Highlights
MP0533: Clinical update and planned dose escalation
expansion MP0533 (CD33 x CD123 x CD70 x CD3), a novel
tetra-specific T cell-engaging DARPin, is currently being evaluated
in a Phase 1/2a clinical trial for patients with
relapsed/refractory acute myeloid leukemia (r/r AML) and
myelodysplastic syndrome/AML (MDS/AML) (NCT05673057).
Results presented at the American Society of Hematology (ASH)
Annual Meeting 2023 from the first 11 patients treated with MP0533
indicated a favorable safety profile across the first four dosing
regimens (DRs), with no dose-limiting toxicities observed. The
study is on track with DR 7 enrollment complete and dosing
currently ongoing. Based on the current MP0533 safety data and
discussion with treating physicians and key opinion leaders, a
protocol amendment was filed on April 25, 2024 to expand enrollment
to higher dose cohorts (DRs 8-11) for further characterization of
the MP0533 dose-response. The company expects to enroll patients in
higher cohorts seamlessly in the second half of 2024.
The mechanism of action of MP0533 is designed to preferentially
kill AML cells (blasts and leukemic progenitor and stem cells) that
express any combination of the cell surface antigens CD33, CD123,
and CD70, while sparing healthy cells which tend to express only
one or none of these targets. Updated data, with cut-off as of
March 12, 2024, show that MP0533 continues to demonstrate clinical
activity similar to what has been reported in earlier dose cohorts.
In DRs 5 and 6, an additional 17 patients were treated with MP0533,
and of these, 2 patients reached ELN criteria of Morphological
Leukemia Free State (MLFS), with additional patients showing early
blast reductions in the bone marrow. The drug safety profile
remains acceptable with the majority of adverse events reported as
infusion-related reactions and cytokine release syndrome. The
current data supports expansion to higher dose cohorts to explore
the activity of MP0533 in a highly heterogeneous r/r AML patient
population. Diverse parameters (e.g., leukemic stem cells, clonal
evolution, immune activation) are being examined to inform the next
development steps including the potential of earlier lines of
treatment, and combination settings. The Company anticipates
providing a next clinical update from the study in the second half
of 2024 at a scientific congress.
Radio-DARPin Therapy PlatformMolecular Partners
continues to advance its RDT platform and programs. At the J.P.
Morgan Healthcare Conference in January 2024, the company presented
data demonstrating successful increase of tumor uptake and
reduction of kidney absorption by applying novel engineering
approaches to modify the DARPin backbone (Stealth-DARPins) and its
half-life. This enabled further internal progress of the RDT
platform and pipeline expansion.
Also in January 2024, Molecular Partners entered a strategic
collaboration with Orano Med to co-develop 212Pb-based RDTs for
patients with solid tumors. The collaboration combines the power of
DARPins, as a highly differentiated modality for tumor-targeted
delivery of radioisotopes, with Orano Med’s leading capabilities in
Targeted Alpha Therapy and supply, to further advance the RDT
platform and expand Molecular Partners’ RDT portfolio.
The tumor-associated protein Delta-like ligand 3 (DLL3) was
selected as the target of the Company’s lead RDT program to be
advanced into IND-enabling studies in the first half of 2024. The
initiation of clinical studies and first-in-human data for our RDT
platform are expected in 2025 through co-development with Orano
Med.
Molecular Partners will provide an update in an oral
presentation at the Society of Nuclear Medicine and Molecular
Imaging (SNMMI) Annual Meeting 2024 in Toronto on June 11.
Abstract Title: Lead-212 Radio-DARPin Therapeutic (RDT)
targeting delta-like ligand 3 (DLL3) shows promising preclinical
antitumor efficacy and tolerability in small cell lung cancer
(SCLC)
Session Title: Integrated Session: Radionuclides
(CMIIT/RPSC)Presentation Timing: June 11, 2024; 8:00-9:15 am local
time
Molecular Partners also expects to nominate additional targets
and RDT candidates in 2024.
In addition, Molecular Partners continued to progress its RDT
portfolio of projects in partnership with Novartis.
Switch-DARPin Platform
The Switch-DARPin platform provides a logic-gated “on/off”
function (the “Switch”) to multispecific DARPin candidates leading
to target activation only in the presence of defined antigens. The
objective is conditional activation of a targeted immune response.
The first Switch-DARPin program (cKIT x CD16a x CD47) was
introduced at the annual J.P. Morgan Healthcare Conference in
January 2024. This approach is designed to induce exhaustive
killing of hematopoietic stem cells as next-generation conditioning
regimen to increase long-term disease control post hematopoietic
stem cell transplant (HSCT) for AML patients, including those with
a poor cytogenetic risk profile, and those currently not eligible
for standard high-intensity conditioning. Our intent is to extend
the access to potentially curative HSCT for more patients with AML
as well as additional hematologic malignancies, and genetic
diseases requiring HSC transplant.
The company will present initial preclinical data at the
European Hematology Association (EHA) Congress 2024 in Madrid on
June 14 and has planned preclinical proof-of-concept studies for
the second half of 2024.
EHA 2024 Abstract Title: C-KIT X CD16a X CD47 Switch-DARPin with
conditional blockade of CD47: a next-generation targeted
conditioning for hematopoietic stem cell transplantation
Session Title: Stem Cell Transplantation – ExperimentalAbstract
Number for Publication: P1294Poster Session Timing: June 14, 2024;
6-7 pm CET
MP0317: Final Phase 1 data at ASCO
MP0317 simultaneously targets CD40 and fibroblast activation
protein (FAP) to enable tumor-localized immune activation. The
phase 1 dose-escalation study of MP0317 in patients with advanced
solid tumors (NCT05098405) was completed in January 2024. The final
outcomes of the 46 treated patients will be presented at the
American Society of Clinical Oncology (ASCO) Annual Meeting 2024 in
Chicago, IL on June 1.
Abstract Title: Effect of MP0317, a FAP x CD40 DARPin, on safety
profile and tumor-localized CD40 activation in a phase 1 study in
patients with advanced solid tumors.
Session Title: Developmental Therapeutics - Immunotherapy
Abstract Number: 2573Poster Session Timing: June 1, 2024 from 9:00
am CDT (Hall A)
Corporate and Management HighlightsOn February
5, 2024 a putative class action complaint against the Company, its
directors, and certain of its executive officers was dismissed
without prejudice in the Company’s favor, and the plaintiff filed a
stipulation of dismissal with prejudice on February 23, 2024. The
case was ordered closed on February 29, 2024. The original case was
filed on July 12, 2022 in the U.S. District Court for the Southern
District of New York.
At the Company’s Annual General Meeting on April 17 2024, all
motions proposed by the Board of Directors at the Annual General
Meeting were approved by the shareholders of the Company.
Financial Calendar
August 26, 2024 – Publication of Half-year Results 2024
(unaudited)
October 31, 2024 – Interim Management Statement Q3 2024
About Molecular Partners AG
Molecular Partners AG (SIX: MOLN, NASDAQ: MOLN) is a
clinical-stage biotech company pioneering the design and
development of DARPin therapeutics for medical challenges other
drug modalities cannot readily address. The Company has programs in
various stages of pre-clinical and clinical development, with
oncology as its main focus. Molecular Partners leverages the
advantages of DARPins to provide unique solutions to patients
through its proprietary programs as well as through partnerships
with leading pharmaceutical companies. Molecular Partners was
founded in 2004 and has offices in both Zurich, Switzerland and
Concord, MA, USA. For more information, visit
www.molecularpartners.com and find us on LinkedIn and Twitter/X
@MolecularPrtnrs.
For further details, please contact:
Seth Lewis, SVP Investor Relations & Strategy
Concord, Massachusetts, U.S.
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361
Laura Jeanbart, PhD, Head of Portfolio Management &
Communications
Zurich-Schlieren, Switzerland
laura.jeanbart@molecularpartners.com
Tel: +41 44 575 19 35
Cautionary Note Regarding Forward-Looking
StatementsAny statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995, as amended, including,
without limitation: implied and express statements regarding the
clinical development of Molecular Partners’ current or future
product candidates; expectations regarding timing for reporting
data from ongoing clinical trials or the initiation of future
clinical trials; the potential therapeutic and clinical benefits of
Molecular Partners’ product candidates and its RDT and
Switch-DARPin platforms; the selection and development of future
programs; Molecular Partners’ collaboration with Orano Med
including the benefits and results that may be achieved through the
collaboration; and Molecular Partners’ expected business and
financial outlook, including anticipated expenses and cash
utilization for 2024 and its expectation of its current cash
runway. These statements may be identified by words such as
“anticipate”, “believe”, “expect”, “guidance”, “intend”, “may”,
“plan”, “potential”, “will”, “would” and similar expressions, and
are based on Molecular Partners’ current beliefs and expectations.
These statements involve risks and uncertainties that could cause
actual results to differ materially from those reflected in such
statements. Some of the key factors that could cause actual results
to differ from Molecular Partners’ expectations include its plans
to develop and potentially commercialize its product candidates;
Molecular Partners’ reliance on third party partners and
collaborators over which it may not always have full control;
Molecular Partners’ ongoing and planned clinical trials and
preclinical studies for its product candidates, including the
timing of such trials and studies; the risk that the results of
preclinical studies and clinical trials may not be predictive of
future results in connection with future clinical trials; the
timing of and Molecular Partners’ ability to obtain and maintain
regulatory approvals for its product candidates; the extent of
clinical trials potentially required for Molecular Partners’
product candidates; the clinical utility and ability to achieve
market acceptance of Molecular Partners’ product candidates; the
potential that Molecular Partners’ product candidates may exhibit
serious adverse, undesirable or unacceptable side effects; the
impact of any health pandemic, macroeconomic factors and other
global events on Molecular Partners’ preclinical studies, clinical
trials or operations, or the operations of third parties on which
it relies; Molecular Partners’ plans and development of any new
indications for its product candidates; Molecular Partners’
commercialization, marketing and manufacturing capabilities and
strategy; Molecular Partners’ intellectual property position;
Molecular Partners’ ability to identify and in-license additional
product candidates; unanticipated factors in addition to the
foregoing that may impact Molecular Partners’ financial and
business projections and guidance; and other risks and
uncertainties that are described in the Risk Factors section of
Molecular Partners’ Annual Report on Form 20-F for the fiscal year
ended December 31, 2023, filed with Securities and Exchange
Commission (SEC) on March 14, 2024 and other filings Molecular
Partners makes with the SEC. These documents are available on the
Investors page of Molecular Partners’ website at
www.molecularpartners.com. Any forward-looking statements speak
only as of the date of this press release and are based on
information available to Molecular Partners as of the date of this
release, and Molecular Partners assumes no obligation to, and does
not intend to, update any forward-looking statements, whether as a
result of new information, future events or otherwise.
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