Full Press Release Details
Adagene Reports Six Month Financial Results
for 2023 and Provides Corporate Update
- Best-in-class anti-CTLA-4 candidates designed
for more than 30-fold increase in therapeutic index, addressing patient populations where CTLA-4-mediated Treg depletion is essential
Strong efficacy signal observed in MSS CRC phase 2 single arm study for SAFEbody ADG126 in combination
with pembrolizumab at the 10 mg/kg every three weeks dosing regimen -
- Advancing MSS CRC cohort with ten more patients
at the active every three weeks dosing regimen for SAFEbody ADG126 plus pembrolizumab following Simon's two-stage statistical design
Roche initiates randomized phase 1b/2 trial with SAFEbody ADG126 in novel triple combination for first-line
hepatocellular carcinoma -
Cash balance of US$128.8 million supports operations to
DIEGO, Calif. and SUZHOU, China, August 31, 2023 - 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, 2023 and provided corporate updates.
anti-CTLA-4 clinical programs demonstrate that an enhanced therapeutic index is capable of unleashing the clinical potential of CTLA-4
treatment, with the right dosing regimens, as a cornerstone in combination with PD-1 and beyond," said Peter Luo, Ph.D.,
Chairman, CEO and President of R&D at Adagene. "We have observed impressive clinical responses in the initial basket trial for
ADG126 plus PD-1 therapy in patients where CTLA-4-mediated Treg depletion is essential for efficacy, including cold tumors such as MSS
CRC, PD-L1 low expressing and PD-1 resistant warm tumors, enabled by our safety profile for higher, more frequent and repeat dosing."
He continued, "This safety and efficacy
profile allows us to evaluate ADG126 plus pembrolizumab in a homogenous patient group for the first time in advanced/metastatic MSS CRC
patients, following Simon's two-stage statistical design for a single arm phase 2 trial. We are very excited to observe a strong
efficacy signal in the first stage and we are now enrolling patients in the second stage with the active dose of ADG126 10 mg/kg every
three weeks. We are optimistic about our ability to push the boundaries of CTLA-4 therapy to improve cancer care."
| ADG116 monotherapy has demonstrated a favorable safety profile at doses up to 15 mg/kg (N=59). | ||
| In heavily pre-treated patients across tumors, ADG116 monotherapy resulted in an overall response rate (ORR) of 13% (3/23 evaluable), including confirmed partial responses (PR) in renal cell carcinoma (RCC) and MSI-H endometrial cancer, as well as an initial PR in Kaposi's sarcoma. | ||
| ADG116 (3 mg/kg Q6W) in combination with anti-PD-1 therapy (N=22) showed a manageable safety profile and an encouraging efficacy profile in dose escalation. Clinical responses from the ongoing combination cohorts include a sustained complete response (CR) for greater than one year in a head and neck squamous cell carcinoma ( HNSCC) patient dosed with repeat cycles of ADG116 3 mg/kg (initially every three weeks, then every six weeks) plus toripalimab (ORR = 20%; 1/5 evaluable). |
| Additionally, an initial PR was observed in a patient with MSS CRC dosed with repeat cycles of ADG116 3 mg/kg every six weeks plus toripalimab (ORR = 14%; 1/7 evaluable). | ||
| ADG116 is clinically active and ready to advance into randomized phase 2 studies as resources allow, while combination dose expansion is evaluating ADG116 with anti-PD-1 therapy. |
| Data presented at the American Association for Cancer Research (AACR) annual meeting 2023 showed ADG126 monotherapy was well tolerated in dose escalation with no dose-limiting toxicities or Grade 3 or higher TRAEs observed (N=30) in patients with advanced/metastatic solid tumors. ADG126 was administered up to 20 mg/kg every three weeks with repeat dosing. | ||
| The safety profile of ADG126 in combination with anti-PD-1 therapy (N=31) also showed best-in-class potential, including repeat dosing beyond four cycles at 10 mg/kg every three or six weeks, potentially enabling triple combination with other agents on top of ADG126 plus anti-PD-1 backbone therapy . | ||
| Data presented at AACR showed a strong efficacy profile for ADG126 10 mg/kg in combination with the anti-PD-1 therapy toripalimab, including two confirmed PRs in patients with anal SCC and penile SCC, as well as significant tumor shrinkage ( 20% reduction in target lesion) and prolonged stable disease observed in patients with cold tumors, including MSS CRC with liver metastases. | ||
| At the 2023 AACR annual meeting, an additional confirmed PR was reported in a patient with MSI-H endometrial cancer who received ADG126 10 mg/kg in combination with the anti-PD-1 inhibitor pembrolizumab. | ||
| Following the AACR annual meeting, two additional confirmed responses were observed in patients treated with ADG126 10 mg/kg plus pembrolizumab outside of the MSS CRC dose expansion cohort: |
| In dose escalation, among the evaluable patients dosed at 10 mg/kg every three weeks in combination with anti-PD-1 therapy, a 40% overall response rate (4/10) was observed, with 10% Grade 3 TRAEs reported, no TRAEs greater than Grade 3 reported, and no dose limiting toxicities. Activity has also been observed at 10 mg/kg every six weeks and at 6 mg/kg every three weeks. | ||
| Adagene has dosed two different arms in its dose expansion cohort of patients with MSS CRC without liver metastases treated with ADG126 in combination with pembrolizumab: ADG126 10 mg/kg every six weeks plus pembrolizumab (10 patients) and ADG126 10 mg/kg every three weeks plus pembrolizumab (13 patients). Based on the strong efficacy signal observed in the ADG126 10 mg/kg three-week cohort, the company is enrolling an additional 10 patients treated with this active dosing regimen, following Simon's two-stage statistical design for a single-arm phase 2 trial. | ||
| Preliminary evaluation and analysis of efficacy data from this tumor type-specific cohort in MSS CRC is expected later this year or early 2024. |
Fangyong (Felix) Du, Ph.D, Chief Technology Officer at Adagene since 2020, is stepping down from the
board for personal reasons. The company also appointed Yan Li, one of the founding members and Senior
Vice President of Bioinformatics and Information Technology at Adagene, as director.
this year, Adagene also announced the following updates to its board: Mervyn Turner, Ph.D., former
head of worldwide licensing and external research at Merck Research Laboratories appointed director; Yumeng Wang replaced Lefei Sun as
a director designated by General Atlantic Singapore AI Pte. Ltd; and Yuwen Liu resigned
from the Board and audit committee due to expiration of her initial appointment.
Financial Highlights
Cash and Cash Equivalents:
Cash and cash equivalents were US$128.8 million
as of June 30, 2023, compared to US$143.8 million as of December 31, 2022.
borrowings from commercial banks in China (denominated in RMB) decreased
to US$24.9 million as of June 30, 2023 from US$27.8 million as of December 31, 2022. The
associated loan proceeds were primarily used to pay for the company's R&D activities in China,
including CMC costs of clinical and preclinical programs.
US$17.3 million for the six months ended June 30, 2023, compared to US$3.9 million for the same period in 2022. The increase of approximately
341% reflects net revenue recognized upon fulfillment of certain performance obligations associated with the collaboration and technology
licensing agreements with Sanofi and Exelixis, respectively. Net revenue also included a milestone payment of US$3.0 million from
Exelixis received in June 2023.
Research and Development (R&D) Expenses:
R&D expenses were US$21.3 million for the
six months ended June 30, 2023, compared to US$45.1 million for the same period in 2022. The decrease of approximately 53% in R&D
expenses reflects a reduction in preclinical spending and winding down of the ADG106 clinical program, offset by investment in the anti-CTLA-4
franchise. The Company prioritized its high value clinical projects and implemented a series of cost control measures, including a reduction
Administrative Expenses:
Administrative expenses were US$4.5 million for
the six months ended June 30, 2023, compared to US$6.8 million for the same period in 2022. The decrease was due to reduction in
both personnel and office related expenses as a result of cost-control measures.
Other Operating income, Net:
Other operating income, net was US$3.4 million
for the six months ended June 30, 2023. Other operating income, net included a one-time compensation payment from a contract manufacturer
in relation to company losses for a preclinical-related outsourcing arrangement.
Net loss attributable to Adagene Inc.'s
shareholders was US$4.1 million for the six months ended June 30, 2023, compared to US$47.6 million for the same period in 2022.
Ordinary Shares Outstanding:
As of June 30, 2023, there were 54,793,339
ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares
Non-GAAP net loss, which is defined as net loss
attributable to ordinary shareholders for the period after excluding share-based compensation expenses, was US$0.1 million for the six
months ended June 30, 2023, compared to US$41.9 million for the same period in 2022. 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 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 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 period. The company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the 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
period should not be considered in isolation or construed as an alternative to operating profit, loss for the 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 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 period 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
Non-GAAP net loss and non-GAAP net loss per ordinary shares for the
period represent net loss attributable to ordinary shareholders for the period excluding share-based compensation expenses. 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 period to net loss attributable to ordinary shareholders for the period.
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