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Adagene Reports Financial Results for the Six Months Ended

Key Takeaway: Adagene Reports Financial Results for the Six Months Ended June 30, 2021 and Provides Corporate Updates - Established three clinical collaborations with Merck to conduct global combination trials with pembrolizumab for three clinical-stage oncology candidates - - Evidence o

Full Press Release Details

Adagene Reports Financial Results for the Six
Months Ended June 30, 2021
and Provides Corporate Updates
- Established three clinical collaborations
with Merck to conduct global combination trials
with pembrolizumab for three clinical-stage oncology candidates -
- Evidence of ADG106 efficacy with favorable
safety profile shown in monotherapy trials; combination trials
ramping up to target biomarker-enriched indications and PD-1 resistant
- Strong potential for differentiated profile
NEObody anti-CTLA-4 candidate, ADG116, demonstrated in ongoing phase 1 trial -
- First SAFEbody program, ADG126, advancing
in phase 1 dose-escalation -
- Continued execution of multiple preclinical
programs towards IND, leveraging the company's powerful
antibody-based technology platforms -
- Further strengthened leadership team and
expanded network of scientific
and strategic advisors to develop best-in-class pipeline -
SAN FRANCISCO, Calif. and SUZHOU, China, August
26, 2021 - Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company
committed to transforming the discovery and development of novel antibody-based immunotherapies, today reported financial results for
the six months ended June 30, 2021, and provided corporate updates.
"During the first half of 2021, we advanced
our clinical pipeline of three highly differentiated immuno-oncology candidates, while building a robust pipeline of novel preclinical
programs that leverage our unique computational biology and artificial intelligence (AI) powered technology platforms," said Peter
Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "With three Merck collaborations now in place, we've
refined our global clinical development strategies to enhance efficiency and optimize our plans moving forward, while we anticipate key
upcoming data from ongoing trials. Our pipeline aims to transform cancer therapy with the first of a new class of agonist antibodies targeting
CD137, as well as new modalities and novel combinations to unlock the value of CTLA-4 as a proven target and the backbone of future immunotherapies.
Applying our unique technology platforms and translational expertise, our goal is to strike a balance between safety and efficacy, addressing
the core challenge of oncology drug development."
Recent Highlights and Upcoming Milestones
ADG106: This NEObody program is
a fully human ligand-blocking, agonistic anti-CD137 IgG4 monoclonal antibody (mAb) that is being evaluated in patients with advanced
solid tumors and/or non-Hodgkin's lymphoma.
ADG116: This NEObody program,
targeting a unique epitope of CTLA-4, is being evaluated in patients with advanced/metastatic solid tumors. ADG116 is designed to
enhance efficacy by potent Treg depletion in the tumor microenvironment (TME) and to maintain its physiological function by soft
ligand blocking in order to address safety concerns associated with existing CTLA-4 therapeutics.
- Obtained approval of Investigational New Drug application (IND) from China's National Medical Products Administration (NMPA) for a phase 1 monotherapy trial in China (ADG116-1002).
- On track to advance a phase 1 trial of ADG116 in combination with pembrolizumab (ADG116-P001; KEYNOTE C97) in the U.S. and APAC in 2022.
ADG126: The SAFEbody
program targets CTLA-4 with a compelling preclinical profile and is designed to provide enhanced safety. ADG126 is designed for
conditional activation in the TME, as well as to enhance efficacy by potent Treg depletion and to maintain its physiological
function by soft ligand blocking in order to expand the therapeutic index and further address safety concerns with existing CTLA-4
Preclinical Discovery Programs: The company
continues to expand and advance a pipeline of innovative preclinical programs leveraging its NEObody, SAFEbody and/or POWERbody
technologies to support the goal of submitting more than ten INDs or equivalent applications in the next three to five years.
Financial Highlights
Cash and Cash Equivalents
Cash and cash equivalents were US$208.3 million
as of June 30, 2021, compared to US$75.2 million as of December 31, 2020. The increase was mainly due to net proceeds of US$145.9 million
from the company's Initial Public Offering in February 2021. In addition, in March 2021, Adagene received US$11.0 million from Exelixis,
Inc., as per the terms of the collaboration and license agreement.
Prepayments and Other Current Assets
Prepayments and other current assets were US$5.4
million as of June 30, 2021, compared to US$3.8 million as of December 31, 2020. The increase was driven by expanded R&D activities
and associated advanced payments made.
Contract Liabilities
Contract liabilities were US$11.1 million as of
June 30, 2021, compared to US$0.7 million as of December 31, 2020. The increase was due to the collaboration and license agreement signed
with Exelixis as the related performance obligations have not been fulfilled.
Net revenue was US$1.4 million for the six months
ended June 30, 2021, compared to US$0.3 million for the same period in 2020. The increase was due to a payment of US$1.2 million from
Dragon Boat Pharmaceuticals, a subsidiary of Sanjin, related to fulfillment of performance obligations associated with the companies'
collaboration to develop antibody-based therapies.
Research and Development Expenses
Research and development expenses were US$31.5
million for the six months ended June 30, 2021, compared to US$14.9 million for the same period in 2020. The increase was primarily attributable
to an (i) increase in payroll and other related personnel costs by US$4.3 million due to headcount growth and average payroll increase
in research and development, (ii) increase in non-cash share-based compensation expenses by US$3.1 million, and (iii) increase in costs
related to preclinical testing and clinical trials due to progression of the programs and increased contract manufacturing costs by US$8.0
million. Adagene incurred US$16.6 million for project ADG106, ADG116 and ADG126 for the six months ended June 30, 2021, compared to US$13.0
million for the same period in 2020. Besides, Adagene incurred US$14.8 million for preclinical product candidates, research pipeline and
others for the six months ended June 30, 2021, compared to US$1.9 million for the same period in 2020.
General and Administrative (G&A) Expenses
G&A expenses were US$7.4 million for the six
months ended June 30, 2021, compared to US$4.7 million for the same period in 2020. The increase was primarily due to an (i) increase
in headcount and average payroll and (ii) increase in professional fees and office expenses.
The net loss attributable to Adagene Inc.'s
shareholders was US$37.2 million for the six months ended June 30, 2021, compared to US$18.2 million for the six months ended June 30,
Non-GAAP net loss, which is defined as net loss
attributable to ordinary shareholders for the period after excluding (i) share-based compensation expenses and (ii) accretion of convertible
redeemable preferred shares to redemption value was US$27.0 million for the six months ended June 30, 2021, compared to US$11.1 million
for the six months ended June 30, 2020. Please refer to the section in this press release titled "Reconciliation of GAAP and Non-GAAP
Results" for details.
Non-GAAP Financial Measures
The Company uses non-GAAP net loss and non-GAAP
net loss per ordinary shares for the year/period, which are non-GAAP financial measures, in evaluating its operating results and for financial
and operational decision-making purposes. The Company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the
year/period help identify underlying trends in the Company's business that could otherwise be distorted by the effect of certain
expenses that the Company includes in its loss for the year/period. The Company believes that non-GAAP net loss and non-GAAP net loss
per ordinary shares for the year/period provide useful information about its results of operations, enhances the overall understanding
of its past performance and future prospects and allows for greater visibility with respect to key metrics used by its management in its
financial and operational decision-making.
Non-GAAP net loss and non-GAAP net loss per ordinary
shares for the year/period should not be considered in isolation or construed as an alternative to operating profit, loss for the year/period
or any other measure of performance or as an indicator of its operating performance. Investors are encouraged to review non-GAAP net loss
and non-GAAP net loss per ordinary shares for the year/period and the reconciliation to their most directly comparable GAAP measures.
Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period here may not be comparable to similarly titled measures
Last updated: Aug 26, 2021