Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven,
clinical-stage biotechnology company transforming the discovery and
development of novel antibody-based therapies, today reported
financial results for the six months ended June 30, 2022 and
provided corporate updates.
“We are prioritizing development of two
anti-CTLA-4 antibodies, which have best-in-class profiles and are
on track to deliver proof-of-concept clinical results in
combination therapy in 2023. Anti-CTLA-4 therapy is known for dose
dependent toxicity, making it extremely difficult to optimize
dosing levels, dosing frequency and dosing intervals for prevailing
anti-CTLA-4 therapy, especially in combination therapy with
anti-PD-1. We have solved this problem with differentiated
candidates suitable for the massive market opportunity for next
generation anti-CTLA-4 therapies, increasing market penetration
into known and new indications with enhanced safety and efficacy,
especially for tumor types not addressed with the currently
available therapy, and rapid entry into new markets such as China
with few approved indications for anti-CTLA-4 in combination with
widely accessible anti-PD-1 therapy,” said Peter Luo, Ph.D.,
Co-founder, Chief Executive Officer and Chairman of Adagene. “We
are also excited to advance our next generation anti-CD137
agonistic antibody, ADG206, into clinic given its first- and
best-in-class potential in both monotherapy and in combination with
multiple agents.”
Dr. Luo continued: “On the longer-term horizon,
we have developed a portfolio of masked, bispecific T cell engagers
(TCEs) for tumor directed T cell therapies, armed with proprietary,
tailor-made anti-CD3 and CD28 by leveraging our NEObody™ and
SAFEbody® technologies, that aim to push the boundaries of what is
possible with TCEs – to achieve safe, potent and durable responses
for patients by combining our novel modalities with the fundamental
pathways across the cancer immunity cycle.”
He concluded: “Building on success of existing
technology licensing deals, we are also pursuing additional
collaboration agreements that leverage our pipeline, our integrated
AI-powered antibody discovery platform, and our SAFEbody precision
masking technology, to bring potential non-dilutive funding to
Adagene. We believe that the combination of our proprietary
technology platforms and our highly differentiated clinical and
preclinical pipelines presents us with many value-creating levers
to navigate today’s turbulent financial markets.”
PIPELINE & BUSINESS
HIGHLIGHTS
ADG116 (anti-CTLA-4 NEObody™ targeting a
unique epitope)
- Encouraging efficacy
demonstrated as a single agent and in combination with
anti-PD-1:
- Observed one partial response with
ADG116 monotherapy in a tumor type where no anti-CTLA-4 therapy is
currently approved.
- Observed one confirmed rapid
complete response with repeat dosing for ADG116 in combination with
toripalimab in a tumor type where no anti-CTLA-4 therapy is
currently approved.
- Presentation of data from this
phase 1b/2 trial will take place at the Society
for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022)
in Boston, November 8-12, 2022.
- For competitive reasons, Adagene is
currently not disclosing the dose or tumor types of these objective
responses.
- Compelling safety
demonstrated as a single agent and in combination with
anti-PD-1:
- Completed monotherapy dose
escalation of ADG116 in 30 patients up to 15 mg/kg administered
every three weeks with repeat dosing, and continued to enroll
patients in dose expansion at 10 mg/kg.
- Only one dose-limiting toxicity
event reported at ESMO-IO 2021 for the 10 mg/kg dose. As of this
release, no additional or late-onset dose-limiting toxicities
reported with ADG116 monotherapy, including in patients who
received more than four cycles.
- A safety review committee cleared
advancement to dose expansion with 3 mg/kg of ADG116 for
combination cohorts with toripalimab.
- Continued advancement of
combinations with anti-PD-1 or anti-CD137:
- Completing dose escalation of
ADG116 in combination with the anti-PD-1 antibody, pembrolizumab
(ADG116-P001 / KEYNOTE-C97). Presentation of data from this phase
1b/2 trial will take place at SITC 2022.
- Evaluation ongoing of ADG116 in
combination with the anti-CD137 therapy, ADG106, to optimize the
dose and schedule for this novel, proprietary combination. Adagene
is a global leader in exploring the synergistic clinical effects
for the dual pathway targeting CTLA-4 and CD137 given the
compelling preclinical rationale for this powerful
combination.
- Paving the way for combination
trials in China, advanced dose escalation to 10 mg/kg in phase 1
monotherapy trial (ADG116-1002). A significant untapped clinical
and market opportunity exists for the proven combination of
anti-CTLA-4 and anti-PD-1 therapies as the combination is only
approved in one tumor type in China.
ADG126 (anti-CTLA-4 SAFEbody® targeting
a unique epitope with precision masking)
- Compelling clinical safety
demonstrated at unprecedented dosing levels with repeat
dosing:
- Completed monotherapy dose
escalation of ADG126 in 19 patients up to 20 mg/kg administered
every three weeks with repeat dosing, and continued to enroll
patients in dose expansion at 10 mg/kg.
- ADG126 monotherapy was well
tolerated with no dose-limiting toxicities or treatment-related
serious adverse events observed following repeat dosing across all
dose levels, as reported in an abstract at the 2022 American
Society of Clinical Oncology annual meeting.
- Clinical evaluation with anti-PD-1
therapies is ongoing to establish the dose and schedule for phase 2
combination cohorts. In combination cohorts with toripalimab, the
safety review committee has cleared the 6 mg/kg dose administered
every three weeks, approved dose expansion at 6 mg/kg, and
recommended further dose escalation to 10 mg/kg, the highest dose
level ever reported for the combination of anti-CTLA-4 and
anti-PD-1 therapies.
- Encouraging antitumor
activity observed as monotherapy in cold tumors:
- In a cohort of heavily pre-treated
patients, ADG126 monotherapy resulted in durable reductions in
target lesions over 20% in two patients with cold tumors:
- One ovarian cancer patient
who experienced significant, continued reduction of an
established ovarian cancer biomarker, CA125, dropping 90%
to within the normal range for full clinical benefit after
receiving up to 18 cycles of treatment at 1 mg/kg, as of this
release.
- One uveal melanoma patient who
received prior immuno-oncology treatment, having progressed after
the combination of nivolumab and ipilimumab.
- Updated interim results will be
presented in a poster on September 12 at the European Society for
Medical Oncology (ESMO) Congress 2022 in Paris, September
9 – 13, 2022
- Both monotherapy and combination
trials continue to enroll patients with advanced, metastatic tumors
in the US, China and APAC, evaluating optimized doses of ADG126 in
targeted tumors.
- Pharmacokinetics show
effectiveness of precision masking technology:
- In monotherapy evaluation, ADG126
plasma pharmacokinetics (PK) were approximately linear and
activated ADG126 accumulated steadily during repeat dosing across
different dose levels.
- This reflects prolonged exposures
of activated ADG126 in the tumor microenvironment (TME), with
cleaved ADG126 in plasma on average accumulating >2-fold during
repeat dosing.
ADG106 (agonistic anti-CD137
NEObody™)
- Given prioritization of
anti-CTLA-4 programs, combination trial with toripalimab in China
is winding down:
- Results from the phase 1b/2 trial
(ADG106-1008) in China evaluating ADG106 in combination with
toripalimab, showed one observed partial response in a
nasopharyngeal carcinoma (NPC) patient out of 20 patients enrolled.
Currently, four patients remain on therapy.
- Given prioritization of its two
anti-CTLA-4 clinical programs and potential of its next generation
anti-CD137 therapy, ADG206, Adagene is winding down the ADG106-1008
trial and does not intend to proceed with the previously planned
trial of ADG106 and pembrolizumab.
- Focusing clinical
development on investigator-initiated trials (IITs) in selected
indications:
- Reflecting its strategic presence
and collaborations in Singapore, Adagene continues to support the
ongoing IITs in Singapore and explore the anti-CD137 opportunity
with ADG106 in selected indications in a combination setting,
including:
- An ongoing phase 1b/2 clinical
trial (ADG106-T6001) evaluating ADG106 in combination with the
anti-PD-1 antibody, nivolumab, for patients with advanced non-small
cell lung cancer (NSCLC) who have progressed after prior treatment.
Dose escalation is complete and dose expansion is ongoing.
- An ongoing Phase 1b/2 clinical
trial (ADG106-T6002) evaluating ADG106 in combination with
neoadjuvant chemotherapy (doxorubicin and cyclophosphamide followed
by paclitaxel) in patients with early-stage, HER2 negative breast
cancer.
ADG206 (masked, IgG1
FC engineered anti-CD137
POWERbody™)
- On track for clinical
development as a next generation anti-CD137
candidate that combines masking, Fc-engineering and novel epitope
to deliver balance between safety and efficacy:
- Adagene submitted a Human Research
Ethics Committee (HREC) regulatory filing in Australia to advance
this anti-CD137 POWERbody™, ADG206, into a phase 1 clinical trial
in patients with advanced metastatic solid tumors.
- Patient dosing is planned in early
2023.
- ADG206 is designed to solve the
safety and efficacy challenges of anti-CD137 therapy, leveraging
the same novel epitope as ADG106 and learnings from development of
urelumab (another company’s anti-CD137 targeting antibody), which
showed single agent clinical efficacy and dose-dependent liver
toxicity in clinic.
- Preclinical data demonstrated
that ADG206 was well tolerated and had robust anti-tumor activity
as a single agent in multiple tumor models, with approximately
4-fold stronger anti-CD137 agonistic activity of its activated form
than a urelumab analog; ADG206 also demonstrated enhanced
anti-tumor activity in combination with other agents, including
checkpoint inhibitors and anti-CTLA-4 therapy.
Preclinical Discovery
Programs
- ADG153: Given
updated program timelines and ongoing business development
activities, Adagene now plans the regulatory submission for its
masked, IgG1 anti-CD47 SAFEbody, ADG153, in the first half of 2023.
This candidate is differentiated by its strong antibody-dependent
cellular cytotoxicity (ADCC) and antibody-dependent cellular
phagocytosis (ADCP) activity designed to realize the full potential
of anti-CD47 therapy for both hematologic and solid tumor
indications. Preclinical data demonstrated that ADG153 IgG1 was
well tolerated, did not induce human hemagglutination and
significantly reduced anemia-related and antigen sink
liabilities; ADG153 IgG1 also demonstrated greater anti-tumor
activity than the benchmark (magrolimab analog).
- American Association for
Cancer Research (AACR) Annual Meeting 2022: Data
demonstrated the potential best-in-class profiles for three
differentiated preclinical product candidates in IND-enabling
studies (ADG206, ADG153, ADG138), which all apply SAFEbody
precision masking technology. The robust preclinical poster
presentations for these and other product candidates are available
on the Publications page of the company’s website.
- CD28 T-cell engagers
(TCEs): Data at AACR introduced a new capability for
Adagene’s proprietary bispecific TCEs with CD28. CD28 bispecific
POWERbody TCEs exhibit enormous potential to fulfill the promises
of safe and durable T cell-mediated synergistic immunotherapies
when combined with CD3 bispecific TCEs and/or checkpoint
inhibitors. Preclinical data demonstrated the potential to mitigate
the serious safety concerns of CD28 activation and make custom
designed antibodies targeting a highly conserved epitope with broad
species reactivity. Multiple tumor associated antigen (TAA) x
CD28 POWERbodies are in progress, such as B7-H3xCD28 and
TROP2xCD28, which can also be combined with the company’s CD3 TCEs
and/or checkpoint inhibitors to achieve safe, powerful and durable
immunotherapy for solid tumors. The full poster presentation
may be viewed here.
Collaborations
-
Sanofi: Established a technology licensing
agreement with Sanofi in March 2022 to generate masked versions of
antibodies provided by Sanofi, including monoclonal and bispecific
candidate antibodies, with a potential transaction value of US$2.5
billion. The collaboration includes an upfront payment of US$17.5
million received in April 2022 for the initial two programs
(US$8.75 million per program), an option fee for two additional
programs, potential milestone payments of up to US$2.5 billion
(US$625 million per program), and tiered royalties.
-
Exelixis: Received a US$3.0 million milestone
payment from Exelixis in January 2022 for the successful nomination
of lead SAFEbody candidates for one of the collaboration programs
and an additional $1.1 million upfront payment in June 2022, based
on a technology licensing agreement to develop novel masked
antibody-drug conjugate candidates. Terms of the agreement, which
was executed in February 2021, include an upfront payment of US$11
million for two programs, potential milestones and tiered
royalties.
- China: Advanced
global partnerships and collaboration with Sanjin and Dragon Boat
Biopharmaceutical for two antibodies out-licensed in Greater China,
including an anti-PD-L1 (ADG104) in phase 2 development, and a
novel anti-CSF-1R (ADG125/BC006) in phase 1.
Corporate
- Adagene is making progress
to evaluate business processes that meet the requirements of the
Holding Foreign Companies Accountable Act (HFCAA) and the
Accelerating Holding Foreign Companies Accountable Act (AHFCAA) in
the event that AHFCAA becomes enacted prior to the filing of annual
report for the year of 2023 on Form 20-F. The company is closely
monitoring the status and implications of HFCAA and AHFCAA in order
to take decisive action to minimize its impact on the company.
- Adagene continues to
streamline its operations while focusing on its most
advanced and promising clinical and preclinical programs to reduce
its cash burn.
UPDATED MILESTONES & OUTLOOK
Adagene is updating its business outlook to reflect
prioritization of its anti-CTLA-4 clinical development programs and
achievement of meaningful milestones with its current cash
resources. Based on current plans, Adagene expects its cash balance
to sufficiently fund operations into late 2024, with the following
upcoming milestones:
2022
- Present ADG126 monotherapy dose
escalation data at ESMO 2022
- Present additional ADG116 data at
SITC 2022
- ADG116 results of dose escalation
in combination with anti-PD-1 therapy to establish the dose(s) and
schedule(s) for dose expansion; advance phase 2a dose expansion
cohorts in targeted tumors
- ADG126 results of dose escalation
in combination with anti-PD-1 therapy to establish the dose(s) and
schedule(s) for dose expansion; advance phase 2a dose expansion
cohorts in targeted tumors
2023
- ADG116 phase 2a proof-of-concept
data from combination dose expansion cohorts
- ADG126 phase 2a proof-of-concept
data from combination dose expansion cohorts
- Establish registration path and
strategy (e.g., recommended phase 2 dose, indication and design)
for phase 2/3 pivotal trial of anti-CTLA-4 in combination with
anti-PD-1 therapy in targeted tumors
- Initiate patient dosing in ADG206
phase 1 trial
- Submit IND or equivalent for
ADG153, and initiate phase 1 trial
- Results from IIT combination
studies of ADG106
- Additional collaborations and/or
technology licensing agreements
FINANCIAL HIGHLIGHTS
Cash and Cash Equivalents:Cash
and cash equivalents were US$168.0 million as of June 30, 2022,
compared to US$174.4 million as of December 31, 2021. The 2022 cash
balance includes an upfront payment of US$17.5 million from Sanofi,
and a milestone payment of US$3.0 million and upfront payment of
US$1.1 million from Exelixis, related to Adagene’s respective
collaboration and technology licensing agreements with those
companies.
Net Revenue:Net revenue was
US$3.9 million for the six months ended June 30, 2022, compared to
US$1.4 million for the same period in 2021. The increase was
related to revenue recognized due to fulfillment of performance
obligations over time associated with the collaboration and
technology licensing agreement with Sanofi to develop
antibody-based therapies. Due to the Sanofi and Exelixis
collaborations, contract liabilities also increased to US$20.2
million as of June 30, 2022, compared to US$5.5 million as of
December 31, 2021.
Research and Development (R&D)
Expenses: R&D expenses were US$45.1 million for the
six months ended June 30, 2022, compared to US$31.5 million for the
same period in 2021. The rise in R&D expenses was primarily due
to increased R&D activities for the company’s clinical
programs, as well as preclinical testing for candidates in the
IND-enabling phase.
Administrative
Expenses:Administrative expenses were US$6.8 million for
the six months ended June 30, 2022, compared to US$7.4 million for
the same period in 2021. The decrease was primarily due to
reduction in share-based compensation expenses.
Net Loss:The net loss
attributable to Adagene Inc.’s shareholders was US$47.6 million for
the six months ended June 30, 2022, compared to US$37.2 million for
the six months ended June 30, 2021.
Ordinary Shares Outstanding:As
of June 30, 2022, there were 54,278,981 ordinary shares issued and
outstanding. Please note that each American depository share, or
ADS, represents one and one quarter (1.25) ordinary shares of the
company.
Non-GAAP Net Loss: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, as appliable, was US$41.9
million for the six months ended June 30, 2022, compared to US$27.0
million for the six months ended June 30, 2021. 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, 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 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. The Company believes that non-GAAP net loss and non-GAAP net
loss per ordinary shares for the year 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 should not be considered in isolation
or construed as an alternative to operating profit, loss for the
year 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 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 here may not be comparable to similarly titled measures
presented by other companies. Other companies may calculate
similarly titled measures differently, limiting their usefulness as
comparative measures to the Company’s data. The Company encourages
investors and others to review its financial information in its
entirety and not rely on a single financial measure.
Non-GAAP net loss and non-GAAP net loss per
ordinary shares for the year represent net loss attributable to
ordinary shareholders for the year excluding (i) share-based
compensation expenses, and (ii) accretion of convertible redeemable
preferred shares to redemption value. Share-based compensation
expense is a non-cash expense arising from the grant of stock-based
awards to employees. The Company believes that the exclusion of
share-based compensation expenses from the net loss in the
Reconciliation of GAAP and Non-GAAP Results assists management and
investors in making meaningful period-to-period comparisons in the
Company's operating performance or peer group comparisons because
(i) the amount of share-based compensation expenses in any specific
period may not directly correlate to the Company’s underlying
performance, (ii) such expenses can vary significantly between
periods as a result of the timing of grants of new stock-based
awards, and (iii) other companies may use different forms of
employee compensation or different valuation methodologies for
their share-based compensation.
Please see the “Reconciliation of GAAP and
Non-GAAP Results” included in this press release for a full
reconciliation of non-GAAP net loss and non-GAAP net loss per
ordinary shares for the year to net loss attributable to ordinary
shareholders for the year/period.
About AdageneAdagene
Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage
biotechnology company committed to transforming the discovery and
development of novel antibody-based cancer
immunotherapies. Adagene combines computational biology
and artificial intelligence to design novel antibodies that address
unmet patient needs. Powered by its proprietary Dynamic
Precision Library (DPL) platform, composed of NEObody™,
SAFEbody®, and POWERbody™ technologies, Adagene’s highly
differentiated pipeline features novel immunotherapy
programs. Adagene has forged strategic collaborations
with reputable global partners that leverage its technology in
multiple approaches at the vanguard of science.
For more information, please
visit: https://investor.adagene.com.
Follow Adagene on WeChat, LinkedIn and Twitter.
SAFEbody® is a registered trademark
in the United
States, China, Australia, Japan, Singapore, and
the European Union.
Safe Harbor Statement
This press release contains forward-looking
statements, including statements regarding the potential
implications of clinical data for patients, and Adagene’s
advancement of, and anticipated preclinical activities, clinical
development, regulatory milestones, and commercialization of its
product candidates. Actual results may differ materially from those
indicated in the forward-looking statements as a result of various
important factors, including but not limited to Adagene’s ability
to demonstrate the safety and efficacy of its drug candidates; the
clinical results for its drug candidates, which may not support
further development or regulatory approval; the content and timing
of decisions made by the relevant regulatory authorities regarding
regulatory approval of Adagene’s drug candidates; Adagene’s ability
to achieve commercial success for its drug candidates, if approved;
Adagene’s ability to obtain and maintain protection of intellectual
property for its technology and drugs; Adagene’s reliance on third
parties to conduct drug development, manufacturing and other
services; Adagene’s limited operating history and Adagene’s ability
to obtain additional funding for operations and to complete the
development and commercialization of its drug candidates; Adagene’s
ability to enter into additional collaboration agreements beyond
its existing strategic partnerships or collaborations, and the
impact of the COVID-19 pandemic on Adagene’s clinical development,
commercial and other operations, as well as those risks more fully
discussed in the “Risk Factors” section in Adagene’s annual report
for the year of 2021 on Form 20-F filed with the U.S. Securities
and Exchange Commission. All forward-looking statements are based
on information currently available to Adagene, and Adagene
undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as may be required by law.
Investor & Media
Contact:Ami KnoeflerAdagene650-739-9952ir@adagene.com
FINANCIAL TABLES FOLLOW
Unaudited Consolidated Balance
Sheets
|
|
December 31,2021 |
|
June 30,2022 |
|
|
US$ |
|
US$ |
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
|
174,391,243 |
|
|
168,035,499 |
|
Accounts receivable, net |
|
3,000,000 |
|
|
— |
|
Amounts due from related parties |
|
4,506,670 |
|
|
1,870,082 |
|
Prepayments and other current assets |
|
4,055,921 |
|
|
5,107,271 |
|
Total current
assets |
|
185,953,834 |
|
|
175,012,852 |
|
Property, equipment and software, net |
|
3,487,617 |
|
|
3,072,032 |
|
Operating lease right-of-use assets |
|
— |
|
|
399,789 |
|
Other non-current assets |
|
69,275 |
|
|
72,799 |
|
TOTAL
ASSETS |
|
189,510,726 |
|
|
178,557,472 |
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
|
3,321,615 |
|
|
4,665,872 |
|
Contract liabilities |
|
5,500,000 |
|
|
20,176,826 |
|
Amounts due to related parties |
|
10,466,061 |
|
|
17,508,933 |
|
Accruals and other current liabilities |
|
4,379,243 |
|
|
4,237,621 |
|
Income tax payable |
|
1,657,450 |
|
|
2,256,601 |
|
Short-term borrowings |
|
3,121,226 |
|
|
5,960,008 |
|
Current portion of long-term borrowings |
|
1,376,319 |
|
|
1,352,177 |
|
Current portion of operating lease liabilities |
|
— |
|
|
297,066 |
|
Total current
liabilities |
|
29,821,914 |
|
|
56,455,104 |
|
Long-term borrowings |
|
2,991,829 |
|
|
9,260,363 |
|
Operating lease liabilities |
|
— |
|
|
128,083 |
|
Deferred tax liabilities |
|
44,163 |
|
|
— |
|
Other non-current liabilities |
|
94,107 |
|
|
29,800 |
|
TOTAL
LIABILITIES |
|
32,952,013 |
|
|
65,873,350 |
|
Commitments and
contingencies |
|
|
|
Shareholders’
equity: |
|
|
|
Ordinary shares (par value of US$0.0001 per share; 640,000,000
shares authorized, and 54,595,667 shares issued and outstanding as
of December 31, 2021; and 640,000,000 shares authorized, and
54,278,981 shares issued and outstanding as of June 30, 2022) |
|
5,627 |
|
|
5,657 |
|
Treasury shares (94,074 shares as of December 31, 2021 and
1,234,834 shares as of June 30, 2022) |
|
(619,605 |
) |
|
(3,666,957 |
) |
Additional paid-in capital |
|
336,099,931 |
|
|
342,631,313 |
|
Accumulated other comprehensive income (loss) |
|
(93,981 |
) |
|
190,167 |
|
Accumulated deficit |
|
(178,833,259 |
) |
|
(226,476,058 |
) |
Total shareholders’
equity |
|
156,558,713 |
|
|
112,684,122 |
|
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
189,510,726 |
|
|
178,557,472 |
|
Unaudited Consolidated Statements of
Comprehensive Loss
|
|
For the Six MonthsEnded June 30, 2021 |
|
For the Six MonthsEnded June 30, 2022 |
|
|
US$ |
|
US$ |
Revenues |
|
|
|
Licensing and collaboration revenue |
|
1,358,836 |
|
|
3,923,174 |
|
Expenses |
|
|
|
Research and development expenses |
|
(31,462,546 |
) |
|
(45,148,357 |
) |
Administrative expenses |
|
(7,400,123 |
) |
|
(6,848,925 |
) |
Loss from
operations |
|
(37,503,833 |
) |
|
(48,074,108 |
) |
Interest income |
|
69,332 |
|
|
14,931 |
|
Interest expense |
|
(192,866 |
) |
|
(211,434 |
) |
Other income, net |
|
822,837 |
|
|
430,671 |
|
Foreign exchange gain (loss), net |
|
(386,153 |
) |
|
756,085 |
|
Loss before income
tax |
|
(37,190,683 |
) |
|
(47,083,855 |
) |
Income tax expense |
|
— |
|
|
(558,944 |
) |
Net loss attributable
to Adagene Inc.’s shareholders |
|
(37,190,683 |
) |
|
(47,642,799 |
) |
Other comprehensive
income (loss) |
|
|
|
Foreign currency translation adjustments, net of nil tax |
|
197,483 |
|
|
284,148 |
|
Total comprehensive
loss attributable to Adagene Inc.’s shareholders |
|
(36,993,200 |
) |
|
(47,358,651 |
) |
Net loss attributable
to Adagene Inc.’s shareholders |
|
(37,190,683 |
) |
|
(47,642,799 |
) |
Accretion of convertible redeemable preferred shares to redemption
value |
|
(28,553 |
) |
|
— |
|
Net loss attributable
to ordinary shareholders |
|
(37,219,236 |
) |
|
(47,642,799 |
) |
Weighted average
number of ordinary shares used in per share
calculation: |
|
|
|
—Basic |
|
45,514,701 |
|
|
54,533,161 |
|
—Diluted |
|
45,514,701 |
|
|
54,533,161 |
|
Net loss per ordinary
share |
|
|
|
—Basic |
|
(0.82 |
) |
|
(0.87 |
) |
—Diluted |
|
(0.82 |
) |
|
(0.87 |
) |
Reconciliation of GAAP and Non-GAAP
Results
|
|
For the Six MonthsEnded June 30, 2021 |
|
For the Six MonthsEnded June 30, 2022 |
|
|
US$ |
|
US$ |
GAAP net loss attributable to ordinary
shareholders |
|
(37,219,236 |
) |
|
(47,642,799 |
) |
Add back: |
|
|
|
Share-based compensation expenses |
|
10,152,791 |
|
|
5,725,868 |
|
Accretion of convertible redeemable preferred shares to redemption
value |
|
28,553 |
|
|
— |
|
Non-GAAP net
loss |
|
(27,037,892 |
) |
|
(41,916,931 |
) |
Weighted average number of
ordinary shares used in per share calculation: |
|
|
|
—Basic |
|
45,514,701 |
|
|
54,533,161 |
|
—Diluted |
|
45,514,701 |
|
|
54,533,161 |
|
Non-GAAP net loss per
ordinary share |
|
|
|
—Basic |
|
(0.59 |
) |
|
(0.77 |
) |
—Diluted |
|
(0.59 |
) |
|
(0.77 |
) |
Adagene (NASDAQ:ADAG)
Historical Stock Chart
From Feb 2023 to Mar 2023
Adagene (NASDAQ:ADAG)
Historical Stock Chart
From Mar 2022 to Mar 2023