Full Press Release Details
Adlai Nortye Reports Unaudited
First Half 2024 Financial Results and Highlights Recent Operational Progress
Company Announces Appointment of Roger Sawhney, M.D. as a New Member of the Board of Directors
SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU,
China, August 8, 2024 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the "Company" or "Adlai Nortye"), a
global clinical-stage biotechnology company focused on the development of innovative targeted and immune-modulating cancer therapies,
today announced its business highlights, the appointment of Roger Sawhney, M.D. to its Board of Directors and its first half financial
results for the period ended June 30, 2024.
am pleased with our team's important progress and operational execution across our innovative pipeline of targeted and immune -modulating
therapies," said Carsten Lu, CEO and Chairman of Adlai Nortye. "We strengthened our team, by having welcominged Archie Tse,
M.D., Ph.D., as the Head of Research and Development who brings critical expertise in oncology drug development, and Roger Sawhney, M.D.,
our newest member of our board of directors. We also shared encouraging safety and efficacy data, including one complete response for
AN4005, our first-in-class oral PD-L1 inhibitor from Phase 1 study, and successfully nominated the development candidate for AN8025, a
multifunctional fusion protein that serves as a T cell and APC modulator.
As we look to the second half of 2024 and beyond, we plan
to present a clinical update from AN4005 which has the potential to provide a more convenient treatment option for patients as an IV-administered
anti-PD-L1 therapy. Importantly, we remain highly focused on the advancement of our lead candidate, buparlisib, for the potential treatment
of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed after prior anti-PD(L)1 treatment
and remain on track to report the Phase 3 OS data in the first quarter of 2025."
Development and Business Highlights
Tse, M.D., Ph.D. appointed as Head of Research and Development. On March 29, the Company announced the appointment of Dr. Archie
Tse as Head of Research and Development. Dr. Tse brings a wealth of knowledge and industry expertise in oncology drug development. Prior
to joining the Company, Dr. Tse served as the Chief Scientific Officer, Senior Vice President, Head of Research and Early Clinical Development,
and Head of CMC at CStone Pharmaceuticals, where he provided strategic leadership and oversight to the research, early clinical development,
and CMC aspects of the entire CStone's pipeline. Before joining CStone, Dr. Tse held leadership positions in multinational companies,
including Merck (known as MSD outside of US and Canada) and Daiichi-Sankyo where he managed the advancement of innovative oncology drugs
across all stages of development, encompassing various modalities, including small molecule targeted therapies, mono- and multi-specific
antibodies, ADCs, and cancer vaccines. Prior to his career in the industry, Dr. Tse served as a faculty member at the Memorial Sloan Kettering
Cancer Center in New York. Dr. Tse holds Doctor of Medicine and Doctor of Biochemistry and Molecular Biology degrees from the University
of Southern California.
Company appointed Roger Sawhney, M. D. as a Director, effective August 8, 2024. Dr. Sawhney has nearly thirty years
of financial and strategic expertise across the life sciences industry. Dr. Sawhney currently serves as the Chief Financial Officer of
LB Pharmaceuticals, a neuro-psych focused Company, based in New York City. From September 2022 to December 2023, Dr. Sawhney served as
the Chief Financial Officer of Garuda Therapeutics, Inc. From March 2020 to May 2022, Dr. Sawhney served as the Chief Financial Officer
of Omega Therapeutics, Inc., a pioneer in mRNA-based therapeutics for precision gene modulation, and he served as the Chief Business Officer
of Omega from May 2022 to September 2022. From September 2018 to August 2020, Dr. Sawhney served at KKR & Co. Inc., a global investment
firm, as Director of its healthcare investment platform in the Americas where his work focused on investments across private and growth
equity in the healthcare sector. From July 2009 to August 2012, Dr. Sawhney served as Senior Vice President and Head of Global Corporate
Strategy for Novartis AG, as well as Senior Vice President of Corporate Strategy and Business Development for Outcome Health from February
2017 to February 2018. Dr. Sawhney has also served as Partner with Bain & Company from August 2012 to February 2017 and the Boston
Consulting Group from 1996 to 2009, where he managed numerous client engagements across the life sciences, med-tech and digital health
sectors. Dr. Sawhney holds an M.D. from Harvard Medical School and a B.A. in Economics from Stanford University.
The Company is conducting BURAN (NCT04338399),
a randomized, open-label phase 3 trial to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared
to weekly paclitaxel alone in patients with recurrent or metastatic HNSCC that has progressed after prior anti-PD(L)1 treatment.
The Company remains on track to present overall
survival (OS) data in the first quarter of 2025.
In an ongoing Phase 1 study (NCT04999384),
the Company is investigating the safety of AN4005, its oral small-molecule PD-L1 inhibitor.
The Company plans to provide a clinical update
in the second half of 2024.
The expansion cohort portion of the trial for
IO treatment-na ve patients was initiated in July 2024.
AN8025 is an in-house developed multifunctional
fusion protein, which serves as a T cell and APC modulator. The Company anticipates submitting the investigational drug application (IND)
AN9025 is an in-house developed oral small molecule
pan-RAS inhibitor. The Company anticipates submitting the IND in the second half of 2025.
Highlights for the Six Month Period Ended June 30, 2024
The consolidated financial statements of the Company
are prepared in accordance with IFRS as issued by the International Accounting Standard Board (IASB). The consolidated financial statements
are presented in US dollars, the Company's functional and presentation currency.
As of June 30, 2024, cash and cash equivalents
totaled US$98.0 million compared to US$91.5 million on December 31, 2023. Based on our current operating plan, we believe that our current
cash and cash equivalents will be sufficient to meet our current and anticipated working capital requirements and capital expenditures
for at least the next 12 months.
Net cash used in operating activities for the
six months ended June 30, 2024 was US$28.4 million, compared to US$18.3 million for the six months ended June 30, 2023.
Research and development expenses decreased by
4.5% from US$27.2 million for the six months ended June 30, 2023 to US$26.0 million for the six months ended June 30, 2024. The decrease
was primarily due to lower expenses associated with the development of the clinical stage programs, a result of a decrease in CRO service fees.
General and administrative expenses decreased
by 9.8% from US$5.2 million for the six months ended June 30, 2023 to US$4.7 million for the six months ended June 30, 2024, primarily
attributable to a decrease in share-based compensation expenses resulting from the vesting schedule of certain stock options in 2024.
Other income and gains increased by 852.4% from
US$0.3 million for the six months ended June 30, 2023 to US$2.6 million for the six months ended June 30, 2024, primarily attributable
to additional government grants received in 2024.
Fair value loss on financial liabilities at FVTPL
was US$45.9 million for the six months ended June 30, 2023, compared to nil for the six months ended June 30, 2024. Financial liabilities
at FVTPL recorded for the six months ended June 30, 2023 were caused by the repurchase rights of shareholders' investments before
the company went public. The fair value loss on financial liabilities recorded for the six months ended June 30, 2023 was due to valuation
changes before the company's initial public offering ("IPO"). There will no longer be any fair value loss on financial
liabilities at FVTPL after the company's IPO, as a result of all financial liabilities at FVTPL have been converted to ordinary
For the reasons described above, the Company's
net loss for the period ended June 30, 2024 decreased significantly by 64.8% from US$78.6 million for the six months ended June 30, 2023
to US$27.7 million for the six months ended June 30, 2024.
Buparlisib (AN2025) is an oral
pan-PI3K inhibitor that targets all class I PI3K isoforms and is active in both hematologic malignancies and solid tumors. In the global
phase II clinical trial for the treatment of head and neck squamous cell carcinoma (HNSCC), the median overall survival was as high as
10.4 months. It has received Fast-Track designation and an approval for initiating the phase III clinical study from FDA. The BURAN study
investigating Buparlisib is also the first global phase III clinical trial conducted by Adlai Nortye.
The BURAN study (NCT04338399)
is a randomized, open-label, multicenter phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly
paclitaxel compared to weekly paclitaxel alone in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
that have progressed after prior anti-PD(L)1 monotherapy; prior anti-PD(L)1 therapy in combination with platinum-based therapy;
or after sequential treatment of anti-PD(L)1 therapy, either prior to or post, platinum-based therapy.
AN4005 is an orally available,
small-molecule PD-L1 inhibitor that demonstrates antitumor activity by the blockade of PD-1/PD-L1 interaction. In nonclinical studies,
AN4005 has demonstrated significant pharmacological activity, target engagement and acceptable safety profiles, which support the clinical
development as a potential therapy for advanced malignancies. In pharmacology studies, AN4005 was shown to functionally overcome the inhibition
derived from PD-1/L1 interaction in reporter- and human PBMC (hPBMC)-based cellular assays. Small molecule PD-L1 inhibitors are expected