On August 12, 2025 Adagene Inc. ("Adagene" or the "Company") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, reported financial results for the six months ended June 30, 2025 and provided corporate updates (Press release, Adagene, AUG 12, 2025, View Source [SID1234655122]).

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"The first half of 2025 was tremendously important for Adagene, as we shared the early overall survival benefit with ADG126 in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) that exceeds standard of care and is highly competitive with data from other products in development. The safety and tolerability data from ADG126 in combination with pembrolizumab in our Phase 1b/2 study in microsatellite stable colorectal cancer contributes to a large body of growing evidence that the power of CTLA-4 inhibition can be harnessed more safely with our approach utilizing conditional activation in the tumor microenvironment. Grade 3 treatment-related adverse events were less than 20%, which is an outstanding achievement given that ADG126 was dosed 10 to 20 times higher than the approved CTLA-4 inhibitors, in order to drive dose-dependent depletion of regulatory T-cells at the desired level inside tumors," said Peter Luo, Ph.D., Chairman, CEO and President of R&D at Adagene. "Now that we have aligned with the FDA on Phase 2 and Phase 3 design elements, which do not require an ADG126 monotherapy arm, we have a clear line of sight into what will be required for regulatory approval. We look forward to initiating the Phase 2 study later this year."

PIPELINE HIGHLIGHTS

ADG126 – Phase 1b/2 data and regulatory update:

As presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Poster #248), mOS for the 10 mg/kg cohorts was 19.4 months in microsatellite stable colorectal cancer (MSS CRC) patients free of liver metastasis (NLM), comparing favorably with historical fruquintinib benchmarks of 10.8 months from the FRESCOi study and 12.1 months from the FRESCO-2ii study for the same NLM patient population. Only 1 out of 41 patients in the 10 mg/kg cohorts was censored due to early withdrawal within the first 12 months. Median OS for the 20 mg/kg cohorts has not yet been reached. ADG126 showed a 29% confirmed overall response rate (ORR) in MSS CRC. ADG126 can be dosed at 20 mg/kg Q6W in combination with KEYTRUDA (200 mg, Q3W) with less than 20% Grade 3 adverse events having been observed. All six responders in the 20 mg/kg cohorts remain on treatment, with four patients on study for over one year.

As recently reported, Adagene has now gained alignment with the FDA on Phase 2 and Phase 3 trial design elements for ADG126, and the Company plans to begin enrollment in 2H 2025. In addition, Adagene has initiated evaluation of ADG126 plus pembrolizumab in combination with standard of care in MSS CRC patients, as approved by the Merck/Adagene joint development committee and supported by the 2021 supply agreement between the two partners.

MAJOR COLLABORATIONS

Sanofi: In July, Sanofi agreed to make a strategic investment of up to US$25 million in Adagene. The Company plans to use the proceeds to fund its research and development activities, including clinical development of ADG126, through a randomized Phase 2 trial in MSS CRC. To further explore the clinical potential of ADG126, Adagene will supply Sanofi with ADG126 to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with other anticancer therapies in over 100 patients in a Phase 1b/2 clinical trial in advanced solid tumors. Adagene continues to own worldwide commercial rights to ADG126.

Sanofi has also exercised its option to select a third SAFEbody discovery program, utilizing Adagene’s proprietary masking technology and antibody engineering expertise. The bispecific therapeutic, with undisclosed targets, will be engineered by Adagene and induces an option exercise fee, as well as milestones and royalties as per the 2022 partnership agreement with Adagene.

Exelixis: Including upfront and other milestone payments, Adagene has received over US$18 million in total from Exelixis to date, under a technology license agreement to develop novel masked antibody-drug conjugate candidates.

ConjugateBio: In July 2025, Adagene entered into a partnering agreement with ConjugateBio to develop novel antibody drug conjugates. Adagene will provide ConjugateBio with a proprietary antibody for use in partner companies’ bispecific ADC development programs.

CORPORATE UPDATES

In April, Adagene appointed John Maraganore, Ph.D. as Executive Advisor to provide strategic guidance, and to contribute to Adagene’s growth, value creation and benefit for patients.

In May, Mickael Chane-Du joined Adagene as Chief Strategy Officer to promote and advance Adagene’s financing, internal strategic planning and external business development efforts.

FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents:

Cash and cash equivalents were US$62.8 million as of June 30, 2025, compared to US$85.2 million as of December 31, 2024. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$6.6 million as of June 30, 2025 from US$18.2 million as of December 31, 2024. Further, the cash balance as of June 30, 2025 does not include any equity proceed received from Sanofi in July 2025.

Research and Development (R&D) Expenses:

R&D expenses were US$12.0 million for the six months ended June 30, 2025, compared to US$14.7 million for the same period in 2024. The decrease of approximately 18% in R&D expenses reflects clinical focus on and prioritization of the company’s masked, anti-CTLA-4 SAFEbody ADG126.

Administrative Expenses:

Administrative expenses were US$3.7 million for the six months ended June 30, 2025, compared to US$3.6 million for the same period in 2024.

Net Loss:

Net loss attributable to Adagene Inc.’s shareholders was US$13.5 million for the six months ended June 30, 2025, compared to US$17.0 million for the same period in 2024.

Ordinary Shares Outstanding:

As of June 30, 2025, there were 58,914,087 ordinary shares issued and outstanding. 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 share-based compensation expenses, was US$11.4 million for the six months ended June 30, 2025, compared to US$14.5 million for the same period in 2024. Please refer to the section in this press release titled "Reconciliation of GAAP and Non-GAAP Results" for details.

On August 12, 2025 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported positive topline results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy (Press release, Merck & Co, AUG 12, 2025, View Source [SID1234655107]). In this study, KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv), given before and after surgery (radical cystectomy), demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint, as well as overall survival (OS) and pathologic complete response (pCR) rate, key secondary endpoints, compared to surgery (radical cystectomy) alone.

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"Patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy have not seen any treatment advance beyond surgery and face high rates of disease recurrence and a poor prognosis, even after having their bladder removed," said Dr. Christof Vulsteke, MD, PhD, head of Integrated Cancer Center Ghent (IKG) and Clinical Trial Unit Oncology Ghent and KEYNOTE-905 principal investigator. "The KEYNOTE-905 study results mark the first time a systemic treatment approach, used before and after surgery, significantly extended survival over standard-of-care surgery in this population, demonstrating the potential of this combination to address a critical unmet need."

The trial, evaluating Merck’s KEYTRUDA, an anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate (ADC), was conducted in collaboration with Pfizer (previously Seagen) and Astellas and builds on the clinical success of this combination in locally advanced or metastatic urothelial cancer. The trial is continuing to evaluate the secondary EFS, OS, and pCR rate endpoints for neoadjuvant and adjuvant KEYTRUDA versus surgery alone as they continue to mature.

"There is a real and pressing need for more effective options for patients with bladder cancer who are ineligible for cisplatin-based treatment," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "The compelling survival results observed in this study reinforce the potential of combining KEYTRUDA with an antibody-drug conjugate to help address a significant unmet need in this vulnerable population."

The safety profile of KEYTRUDA plus Padcev in this study was consistent with the known safety profiles of each agent. No new safety signals were identified with the combination. The companies plan to share these results with regulatory authorities worldwide and will present the data at an upcoming medical meeting.

KEYTRUDA plus Padcev is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the U.S., the European Union (EU), Japan and several other countries around the world. KEYTRUDA as monotherapy is also approved in the U.S., EU, Japan and other countries for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC).

Five additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic. Three of these studies are in MIBC including KEYNOTE-866 (NCT03924856), KEYNOTE-992 (NCT04241185) and KEYNOTE-B15 (NCT04700124), which is also known as EV-304 and is being conducted in collaboration with Pfizer and Astellas. KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in the Phase 3 KEYNOTE-676 (NCT03711032) trial, and as adjuvant treatment in patients with localized muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma KEYNOTE-123 (NCT03244384).

About KEYNOTE-905/EV-303

KEYNOTE-905, also known as EV-303, is an open-label, randomized, multi-arm, controlled, Phase 3 trial (ClinicalTrials.gov, NCT03924895) evaluating perioperative KEYTRUDA, with or without Padcev, versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. The trial enrolled 595 patients who were randomized to receive either:

Arm A: Three cycles of preoperative KEYTRUDA, followed by surgery to remove the bladder (radical cystectomy), followed by 14 cycles of postoperative KEYTRUDA;
Arm B: Surgery alone;
Arm C: Three cycles of preoperative KEYTRUDA plus enfortumab vedotin, followed by surgery to remove the bladder (radical cystectomy), followed postoperatively by six cycles of KEYTRUDA plus enfortumab vedotin and then eight cycles of KEYTRUDA alone.
The primary objective of this trial was to compare EFS between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy or death due to any cause. The key secondary objectives were to compare OS and difference in pCR rate between arm C and arm B, as well as EFS, OS and the difference in pCR rate between arm A and arm B. The study remains ongoing to test hypotheses between arm A and arm B.

About bladder cancer

Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally. Muscle-invasive bladder cancer represents approximately 30% of all bladder cancer cases. The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong survival. However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone.

On August 11, 2025 Assertio Holdings, Inc. ("Assertio" or the "Company") (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs, reported financial results for the second quarter ended June 30, 2025.

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Said Brendan O’Grady, Chief Executive Officer, "The second quarter business and financial results demonstrate continued progress executing our 2025 transformation priorities intended to create sustainable near-term growth and increased long-term value. As part of our transformation process, we are taking steps to streamline our operations to secure additional operating expense savings. We started this process with the divestment of Assertio Therapeutics as communicated last quarter. Pursuant to this effort, we are also consolidating products from previously acquired subsidiaries to further optimize our cost structure.

"Based on strong commercial execution in our core growth assets, Rolvedon achieved the highest level of customer demand since we acquired the product and Sympazan continues to see growth in both prescribers and prescription demand. The remainder of our portfolio is tracking to our expectations. In addition, balance sheet cash and investments increased to more than $98 million as a result of our focus and continued business performance."

(Press release, Assertio Holdings, AUG 11, 2025, View Source [SID1234661832])

On August 11, 2025 Tahoe Therapeutics reported $30 million in new funding to build the definitive foundational dataset for training Virtual Cell Models (Press release, Tahoe Therapeutics, AUG 11, 2025, View Source [SID1234655088]). With this, the team will generate one billion single-cell datapoints, mapping one million drug-patient interactions, a scale previously impossible. The dataset will support the discovery of new precision medicines for cancer and beyond. Tahoe will also select a single partner to share the data and accelerate translation to clinical outcomes.

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The round was led by Amplify Partners, joined by a distinguished group of investors including Databricks Ventures, Wing Venture Capital, General Catalyst, Civilization Ventures, Conviction, Mubadala Capital Ventures, and AIX Ventures.

The raise follows the release of Tahoe‑100M, the world’s first gigascale perturbative single-cell dataset, which has become foundational for teams building virtual cell models, ranging from major AI labs to focused research institutions. Open-sourced just a few months ago, Tahoe-100M has been downloaded nearly 100,000 times. The dataset and the models trained on it have already led to the discovery of promising new therapeutic candidates for major cancer subtypes as well as novel targets across multiple modalities.

Tahoe is now expanding on that foundation: the company plans to generate one billion single-cell datapoints, mapping how tens of thousands of drug molecules interact with human biology. This new dataset will expand the boundaries of biological foundation models, aiming to reduce clinical trial failure rates and accelerate the development of precision medicines.

"Building Tahoe-100M required us to invent new ways to generate single-cell data," said Nima Alidoust, co-founder and CEO of Tahoe Therapeutics. "Now, we’re applying that superpower to go 10x further. This next phase is about using these massive datasets to bring about the GPT moment for AI models of human cells, translating insights to clinical readouts, and developing new medicines with much lower clinical failure rates."

With the new capital, Tahoe is advancing its own therapeutic programs toward the clinic, while also launching a new model of strategic collaboration. The company will select a single partner, a pharmaceutical or AI company with complementary strengths, to access the forthcoming dataset. Together, the goal is to develop the first medicines powered by virtual cell models, combining Tahoe’s data with the partner’s clinical or modeling expertise.

"While structural models have accelerated molecular design, they rarely translate to clinical success — a problem that remains one of the biggest challenges in drug development," said Sunil Dhaliwal, General Partner at Amplify Partners. "Tahoe Therapeutics is uniquely positioned to move the industry past this bottleneck by generating massive drug-patient datasets and training high-dimensional, cell-based AI models. We’re proud to back this exceptional team as they combine biology and computation to accelerate clinical impact."

Tahoe founders, Nima Alidoust, Johnny Yu, Hani Goodzari, and Kevan Shokat hold deep experience in single-cell genomics, ML, and drug discovery. The company’s platform makes large-scale, single-cell drug screening across diverse patient contexts not only possible, but scalable. Built on scientific breakthroughs at UCSF, Tahoe is creating the raw materials needed to train disease-relevant foundation models of human cells and chart a new course for precision medicine.

On August 11, 2025 Thermo Fisher Scientific, the world leader in serving science, reported it has received approval from the U.S. Food and Drug Administration (FDA) for its Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients who may be candidates for HERNEXEOS (zongertinib tablets), a tyrosine kinase inhibitor (TKI), developed by Boehringer Ingelheim (Press release, Thermo Fisher Scientific, AUG 11, 2025, View Source [SID1234655087]). The test allows clinicians and pathologists to assess if non-small cell lung cancer (NSCLC) tumors harbor human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations.

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Lung cancer is the second most common cancer in both men and women in the United States, with NSCLC accounting for about 85–90% of all lung cancer cases.1 Among those diagnosed with NSCLC, approximately 2 to 4 percent of patients present with a HER2 mutation.2 The FDA approved HERNEXEOS on August 8, 2025 as the first and only orally administered targeted therapy for adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication was approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. More information and full Prescribing Information can be found at HERNEXEOS.com.

"This rare form of non-small cell lung cancer is linked to a poor prognosis and limited treatment options, making HERNEXEOS an important advancement in addressing the unmet needs of patients," said Vicky Brown, Senior Vice President and Head of Immunology, Oncology, and Eye Health, Boehringer Ingelheim. "Through our collaboration with Thermo Fisher and leveraging the company’s proven track record with companion diagnostics, we’re pleased that patients have another tool that can be used to identify those with HER2 (ERBB2) tyrosine kinase activating mutations in non-small cell lung cancer."

The Oncomine Dx Target Test received its first approval by the FDA as an NGS CDx in 2017, followed by regulatory approvals in 20 countries for 11 biomarkers and over 20 targeted therapies (availability of these approvals vary per region). The test is reimbursed by government and commercial insurers in the U.S., Europe, Japan, South Korea, and Israel, covering more than 550 million lives globally. In the US alone, it is approved for targeted therapies in NSCLC, cholangiocarcinoma (CC), astrocytoma (AC) and oligodendroglioma (OG), anaplastic thyroid cancer (ATC), medullary thyroid cancer (MTC), and thyroid cancer (TC).

"The FDA’s approval of HERNEXEOS for previously treated patients living with HER2 (ERBB2)-mutant advanced non-small cell lung cancer signifies continued success in our efforts to develop timely and accessible companion diagnostics," said Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher Scientific. "We’re continuing to expand our solutions for our pharma partners, as this approval quickly follows the recent FDA approval of our latest rapid NGS solution that can deliver results in as little as 24 hours."

For more information on the Oncomine Dx Target Test and Thermo Fisher’s leadership in companion diagnostics, please visit thermofisher.com/cdx.