On November 9, 2026 ADC Therapeutics SA (NYSE: ADCT) reported full financial results for the third quarter ended September 30, 2026, and provided recent operational updates.

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"During the third quarter, we made meaningful progress toward strengthening ADC Therapeutics’ balance sheet and increasing strategic optionality while advancing clinical opportunities for ZYNLONTA," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "In addition, we continue to deliver on sales while focusing on opportunities to expand ZYNLONTA’s role in the treatment of B-cell malignancies to drive growth. With multiple abstracts accepted for presentation at ASH (Free ASH Whitepaper), including the full results from LOTIS-7, we look forward to highlighting the breadth of ZYNLONTA’s clinical potential at this meeting."

"As treatment options for patients with B-cell malignancies continue to evolve, we believe ZYNLONTA has an opportunity to play an important role in addressing significant unmet needs," said Mohamed Zaki, M.D., Ph.D., Chief Medical Officer of ADC Therapeutics. "The upcoming LOTIS-7 Phase 1b and marginal zone lymphoma IIT data at ASH (Free ASH Whitepaper) highlights the potential for ZYNLONTA to play an important role in the treatment of r/r DLBCL and indolent lymphomas. We plan to use these findings to guide our clinical development priorities and regulatory strategy."

Third Quarter 2026 Operational Updates and Recent Milestones

Strategic financial restructuring strengthens balance sheet and supports continued investment in ZYNLONTA. In October 2026, the Company announced a comprehensive strategic financial restructuring that included an $86.6 million private investment in public equity (PIPE) financing with participation from new investor Bain Capital Life Sciences and existing investors Redmile, TCGX, and Nantahala Capital. As part of the PIPE, approximately 12.9 million common shares were issued, as well as 48 million warrants with a strike price of CHF 0.08. The Company also amended its HealthCare Royalty financing agreement to eliminate a $150 million change-of-control payment, amended its senior secured loan agreement to reduce outstanding principal by $68.5 million to $50 million, eliminated scheduled principal amortization and removed the minimum liquidity covenant.

These transactions strengthened the Company’s capital structure, enhanced strategic optionality and extended the expected cash runway into 2029.

Multiple ZYNLONTA abstracts, including five oral presentations, to be presented at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Multiple abstracts highlighting ZYNLONTA’s potential across multiple B-cell malignancies have been accepted for presentation at ASH (Free ASH Whitepaper) in December. Oral presentations will feature updated results from the Phase 1b LOTIS-7 trial evaluating ZYNLONTA in combination with glofitamab in relapsed or refractory large B-cell lymphoma; full results from the Phase 3 LOTIS-5 trial evaluating ZYNLONTA in combination with rituximab in relapsed or refractory diffuse large B-cell lymphoma (DLBCL); and investigator-initiated studies (IITs) in marginal zone lymphoma, mantle cell lymphoma and Waldenström macroglobulinemia.

Continued progress toward potential commercialization of ZYNLONTA in Japan. ADC Therapeutics’ Japanese licensing partner, Tanabe Pharma Corporation (formerly Mitsubishi Tanabe Pharma Corporation), has submitted a marketing authorization application with Japan’s Ministry of Health, Labor and Welfare for ZYNLONTA to treat patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. Tanabe Pharma has also entered into an exclusive sublicensing agreement with Nippon Shinyaku Co., Ltd., for the commercialization of ZYNLONTA in Japan.

Third Quarter 2026 Financial Results

Product Revenues: Net product revenues were $21.0 million and $59.7 million for the third quarter and nine months ended September 30, 2026, as compared to $15.8 million and $51.2 million for the same periods in 2025. The increase period-over-period was primarily driven by volume increase.

License Revenues and Royalties: License revenue and royalties were $0.7 million and $2.1 million for the third quarter and nine months ended September 30, 2026, as compared to $0.7 million and $7.1 million for the same periods in 2025. The decrease for the nine-month period was primarily driven by a prior-year milestone received from our partner.

Cost of Product Sales: Cost of product sales was $2.0 million and $7.9 million for the third quarter and nine months ended September 30, 2026, as compared to $1.2 million and $4.1 million for the same periods in 2025. The increase in cost of product sales was primarily attributable to a change in focus of certain personnel costs from research and development clinical supply activities to commercial manufacturing activities.

Research and Development (R&D) Expense: R&D expense was $14.7 million and $52.0 million for the third quarter and nine months ended September 30, 2026, as compared to $26.8 million and $85.8 million for the same periods in 2025. The decrease in R&D costs was primarily driven by a reduction in spending on discontinued programs, completion of the IND-enabling activities for our PSMA-targeting ADC and lower ZYNLONTA spend. The decrease was also driven by a shift of certain personnel costs reflecting a change in focus from research and development activities toward commercial manufacturing and fulfillment activities. A total of $1.7 million for the quarter and $5.5 million for the nine-month periodwas allocated to cost of product sales ($1.0 million QoQ/$3.3 million YoY), inventory capitalization and selling and marketing expense.

Selling and Marketing (S&M) Expense: S&M expense was $8.7 million and $34.0 million for the third quarter and nine months ended September 30, 2026, as compared to $10.7 million and $31.4 million for the same periods in 2025. The decrease quarter-over-quarter was primarily due to lower marketing and advertising expenses. The increase for the nine-month period was primarily driven by higher cash-based retention and incentive awards.

General & Administrative (G&A) Expense: G&A expense was $10.7 million and $30.3 million for the third quarter and nine months ended September 30, 2026, as compared to $8.3 million and $27.1 million for the same periods in 2025. The increase period-over-period was primarily due to increased professional expenses, cash-based retention awards and share-based compensation expense, partially offset by lower wages and benefits.

Restructuring, impairment and other related costs: In connection with the strategic reorganization and workforce reduction announced in June 2026, we recognized $0.1 million in expense reversal for the third quarter and $2.6 million in employee severance and related benefit costs for the nine months ended September 30, 2026. In connection with the strategic reprioritization and restructuring plan announced in June 2025, we incurred $0.4 million and $13.5 million in restructuring, impairment and other related costs for the third quarter and nine months ended September 30, 2025, which consisted of $6.2 million in employee severance and related benefit costs, $6.4 million in non-cash impairment of assets and $0.8 million in retirement costs in connection with the close down of the UK facility.

Total Operating Expenses and Adjusted Total Operating Expenses: Total operating expenses were $36.1 million and $126.8 million for the third quarter and nine months ended September 30, 2026, as compared to $47.4 million and $161.9 million for the same periods in 2025, a reduction of 24% and 22%, respectively. On a non-GAAP basis, total adjusted operating expenses were $32.1 million and $112.1 million for the third quarter and nine months ended September 30, 2026, as compared to $45.0 million and $141.9 million for the same periods in 2025, a reduction of 29% and 21%, respectively. The reduction in total adjusted operating expenses was primarily driven by lower R&D expenses.

Net Loss and Adjusted Net Loss: Net loss for the third quarter and nine months ended September 30, 2026, was $25.3 million or $74.8 million, or a net loss of $0.16 and $0.48 per basic and diluted share, as compared to a net loss of $41.0 million and $136.2 million, or a net loss of $0.30 and $1.14 per basic and diluted share, for the same periods in 2025. On a non-GAAP basis, adjusted net loss for the third quarter and nine months ended September 30, 2026, was $8.8 million and $44.8 million, or a net loss of $0.06 and $0.29 per basic and diluted share, as compared to a net loss of $25.5 million and $78.2 million, or a net loss of $0.19 and $0.66 per basic and diluted share, for the same periods in 2025. The lower net loss and adjusted net loss were primarily due to lower operating expenses and, on a per basic and diluted share basis, by a higher number of weighted average shares outstanding. Net loss was also favorably impacted by the change in fair value of warrants and the cumulative catch-up adjustment of the Company’s deferred royalty obligation.

Cash and Cash Equivalents: As of September 30, 2026, cash and cash equivalents were $189.2 million, compared to $261.3 million as of December 31, 2025, a change primarily driven by cash used in operations. The Company has an expected cash runway into 2029.

(Press release, ADC Therapeutics, NOV 9, 2026, View Source [SID1234674460])

On November 9, 2026 Adagene Inc. (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, reported completion of enrollment in its randomized Phase 2 dose-optimization trial of muzastotug (ADG126), a masked, anti-CTLA-4 SAFEbody, in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with late-line microsatellite stable colorectal cancer (MSS CRC) without liver metastases.

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"Completing enrollment in this randomized trial is an important step toward identifying the dose regimen of muzastotug for the Phase 3 registration trial," said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. "We acknowledge Sanofi’s additional equity investment associated with this trial, which supports continued development of muzastotug in solid tumors, including MSS CRC, where dose-limiting challenges have restricted the use of anti-CTLA-4 therapies. As we look ahead to initial results in the first half of 2027, we hope new data will validate muzastotug’s broad applicability and combinability, further enhanced by its induction and maintenance dosing regimens. This could position muzastotug as a transformative next-generation backbone for combination therapies across multiple indications, in both early- and late-line treatment settings. It could also unlock value in indications where legacy CTLA-4/PD-1 based combinations are already FDA-approved, as well as in historically refractory tumors like MSS CRC."

About the Phase 2 Trial

The randomized Phase 2 trial (NCT05405595) was incorporated into the existing protocol for the Phase 1b/2 study following a 2025 meeting with the U.S. Food and Drug Administration (FDA). The primary endpoint of the Phase 2 trial is overall response rate (ORR), and secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

The study enrolled 60 patients, randomized 1:1 into one of two treatment arms evaluating different dose regimens of muzastotug in combination with pembrolizumab. Both arms use induction to rapidly establish activated muzastotug exposure in tumors, followed by maintenance to sustain exposure and potentially improve ORR and OS:

· Arm A: Muzastotug 10 mg/kg every three weeks (Q3W) for four doses, followed by 10 mg/kg every six weeks (Q6W) maintenance

· Arm B: Muzastotug 20 mg/kg Q6W for two doses, followed by 15 mg/kg Q6W maintenance

As previously announced in July 2025, the following elements of the Phase 3 trial design were also confirmed following a meeting with the FDA:

· Patient Population: Trials will enroll late-line patients with MSS CRC without liver metastases, including those with peritoneal metastasis/involvement.

· Phase 3 Trial Design: The FDA agreed with Adagene’s proposed standard-of-care (SOC) control arm for the Phase 3 clinical trial and confirmed that a muzastotug monotherapy arm was not required.

· Phase 3 Endpoints: The primary endpoint of the Phase 3 trial will be OS. Secondary endpoints will include PFS, DOR and ORR.

(Press release, Adagene, NOV 9, 2026, View Source [SID1234674459])

On November 9, 2026 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported third-quarter 2026 financial results and provided an update on the commercial launch of ZEVASKYN.

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"Maximizing the opportunity for ZEVASKYN remains our number one priority. During the third quarter, we continued to build the commercial foundation for ZEVASKYN, with expansion of our QTC network and more centers gaining firsthand treatment experience," said Vish Seshadri, Ph.D., Chief Executive Officer of Abeona Therapeutics. "The acquisition of APT-1011 represents an important step in building Abeona into a diversified commercial-stage company, adding a uniquely differentiated late-stage orphan-drug asset with substantial commercial potential in a rapidly growing disease with high unmet need."

ZEVASKYN Commercial Update

ZEVASKYN treatment activity increased in the third quarter. Since launch, 15 patient treatments have been completed with ZEVASKYN, including six during the third quarter of 2026.

Broader qualified treatment center (QTC) participation supported increased ZEVASKYN treatment activity. Abeona expanded its national ZEVASKYN QTC network to eight sites during the third quarter, increasing geographic access for eligible patients:

Children’s Hospital of Philadelphia and the University of Texas Medical Branch completed their first ZEVASKYN patient treatments during the third quarter, increasing the number of QTCs with treatment experience from two to four.
University of Florida (UF) Health in Gainesville, Florida, was activated in September 2026 as the eighth ZEVASKYN QTC, expanding access for eligible pediatric and adult RDEB patients in Florida and the Southeastern U.S.
Cincinnati Children’s, one of the largest epidermolysis bullosa treatment centers in the U.S., was activated as a ZEVASKYN QTC in July 2026.

New Technology Add-On Payment (NTAP) status for ZEVASKYN became effective October 1, 2026. Under the Centers for Medicare & Medicaid Services (CMS) fiscal year 2027 Hospital Inpatient Prospective Payment System Final Rule. Under the standard NTAP pathway, qualifying technologies must be new and meaningfully differentiated from existing technologies, meet CMS cost criteria, and demonstrate substantial clinical improvement relative to existing treatments. NTAP provides a pathway for eligible hospitals to receive supplemental reimbursement, in addition to the diagnosis-related group base payment, when treating eligible Medicare beneficiaries with ZEVASKYN. This designation is expected to help support patient access and hospital adoption among eligible Medicare beneficiaries, who represent approximately 10 percent of RDEB patients.

Corporate and Pipeline Developments

Abeona acquired APT-1011, now ABO-801, from Ellodi Pharmaceuticals and announced a $30 million PIPE financing. In a separate press release issued today, Abeona announced the acquisition of ABO-801, a Phase 3-ready, once-daily oral disintegrating tablet formulation of fluticasone propionate in development for EoE. Under the terms of the asset purchase agreement, Abeona has issued to Ellodi $20 million of Abeona common stock at closing, with no upfront cash consideration. Ellodi is also eligible to receive payments of $30 million upon FDA approval of ABO-801 and up to an additional $30 million upon achievement of specified sales milestones. In addition, Ellodi is eligible to receive tiered royalties on net sales of ABO-801 ranging from low to mid teen percentages.

Also announced in a separate press release issued today, Abeona entered into a securities purchase agreement for a private placement of $30 million in gross proceeds before fees and expenses. The Company intends to use the net proceeds from the private placement for general corporate purposes, including funding the development of the Company’s product candidate pipeline and supporting commercialization efforts for ZEVASKYN.

Ultragenyx secures U.S. FDA approval of FAYUVI. In September, Ultragenyx Pharmaceutical Inc. received FDA approval of FAYUVI (rebisufligene etisparvovec-hopf) gene therapy for Sanfilippo Syndrome Type A (MPS IIIA). Abeona previously advanced the program before licensing it to Ultragenyx in May 2022. Pursuant to its licensing agreement with Ultragenyx, Abeona is eligible to receive certain commercial milestone payments and tiered royalties of up to 8 percent on future product sales.

Third Quarter 2026 Financial Results

Net ZEVASKYN revenue for the quarter ended September 30, 2026 was $13.5 million, an 18% increase compared with $11.4 million for the second quarter of 2026. As previously disclosed in August 2026, revenue was not recognized for one treatment in the third quarter because the associated batch did not meet the release criterion for the identity assay.

Cost of sales was $5.7 million for the third quarter of 2026, compared with $4.2 million for the second quarter of 2026.

Research and development expenses were $3.7 million for the third quarter of 2026, compared with $5.0 million for the second quarter of 2026.

Selling, general and administrative expenses were $17.1 million for the third quarter of 2026, compared with $15.8 million for the second quarter of 2026.

Net loss was $(4.8) million, or $(0.08) per basic and diluted common share, for the quarter ended September 30, 2026, compared with a net loss of $(20.2) million, or $(0.35) per basic and diluted common share, for the second quarter of 2026.

Cash, cash equivalents and short-term investments totaled $134.9 million as of September 30, 2026, compared with $146.8 million as of June 30, 2026. The September 30, 2026 balance excludes the $30 million in gross proceeds from the private placement financing completed after quarter end.

Conference Call Details

The Company will host a conference call and webcast on November 9, 2026, at 8:30 a.m. ET to discuss the third-quarter financial results, ZEVASKYN commercial progress and the acquisition of ABO-801 and PIPE financing. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 208009 five minutes prior to the start of the call. A live, listen-only webcast can be accessed on the Investors & Media section of Abeona’s website at View Source An archived webcast replay will be available for 30 days following the call.

(Press release, Abeona Therapeutics, NOV 9, 2026, View Source [SID1234674458])

On November 8, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the first patient has been dosed in registrational Phase III study of the Company’s novel BCL2 inhibitor mesutoclax (ICP-248) in combination with azacitidine versus venetoclax with azacitidine in elderly or unfit patients with treatment naive (TN) acute myeloid leukemia (AML).

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Mesutoclax is a novel, oral BCL2 inhibitor developed by InnoCare that can exert anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Mesutoclax has been granted two Breakthrough Therapy Designations (BTD) in China.

Mesutoclax is accelerating multiple clinical trials in B-cell lymphomas and myeloid malignancies, with five registrational clinical trials currently underway. The Phase III trial of mesutoclax with orelabrutinib in 1L CLL/SLL has completed patient enrollment. The registrational Phase II clinical trial of mesutoclax in BTK inhibitor-treated mantle cell lymphoma (MCL) has completed patient enrollment. The registrational Phase III Trial of Mesutoclax in Combination with Orelabrutinib in Relapsed / Refractory MZL was initiated in China. The registrational Phase III clinical trial of mesutoclax in combination with orelabrutinib in r/r MCL is ongoing in China. In addition, global clinical development of mesutoclax in AML and myelodysplastic syndrome (MDS) is accelerating in China, the U.S., and Australia. The study of mesutoclax in MDS has been selected for an oral presentation at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held on December 12–15 in New Orleans, U.S. The study of mesutoclax in AML and B-cell malignancies have been selected as posters at the upcoming ASH (Free ASH Whitepaper) respectively.

Data presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrated that mesutoclax in combination with azacitidine in patients with AML achieved outstanding efficacy and safety. As of April 13, 2026, among the evaluable TN AML patients, 81.8% achieved composite CR (cCR, CR+CRi). Among cCR responders, 83% achieved cCR in the first treatment cycle, demonstrating that the mesutoclax regimen enables rapid and deep remission. Among patients who achieved overall response, 86.5% were MRD (Minimal Residual Disease) negative. In terms of safety, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. Notably, both 30-day mortality and 60-day mortality were 0% among TN AML patients. At the recommended dose, the 6-month overall survival (OS) rate was 90.5%. Updated data will be presented at the 68th ASH (Free ASH Whitepaper) Annual Meeting.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "As the first BCL2 inhibitor granted Breakthrough Therapy Designation (BTD) in China, mesutoclax has rapidly advanced across multiple clinical programs throughout China and globally, positioning it to become a globally competitive innovative therapy, further consolidating the Company’s leading position in hemato-oncology. We will continue to accelerate our clinical trials to provide better treatment options for more patients as soon as possible."

AML is a malignant hematological disease originating from hematopoietic stem/progenitor cells. The risk of developing AML increases with age and is more common among older adults.

(Press release, InnoCare Pharma, NOV 8, 2026, View Source [SID1234674442])

On November 8, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies, reported that it has presented the latest preclinical results of its novel costimulatory T cell engager (Cos-TCE) platform AnTenGager‑D2 in a Rapid Oral Abstract Presentation at the 2026 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (SITC 2026). The study was selected as TOP150 abstracts by the conference.

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Details of the Presentation

Title: A CD2-based costimulatory T cell engager platform integrating a novel CD3γε/δε-targeting antibody and steric-hindrance-based CD3 masking

Poster: #896

Study Overview:

CD3-based T cell engagers (TCEs) have shown promising therapeutic efficacy in the treatment of hematological malignancies. However, clinical progress in solid tumors has been slow, largely owing to tumor microenvironmental factors such as the induction of T cell exhaustion and the potential of CD3-bispecifics mediated T cell anergy and dysfunction in the absence of adequate co-stimulation.
The CD2/CD58 axis serves as a pivotal bifunctional regulator, mediating both adhesion and co-stimulation during human T cell activation. In this study, we developed a novel costimulatory T cell engager (AnTenGager-D2) platform integrating a novel CD3γε/δε-targeting antibody, steric-hindrance-based CD3 masking, and an engineered CD2-binder, which enables conditional T cell activation via CD3 (signal 1) and CD2 (signal 2) stimulation upon TAA crosslinking, providing enhanced anti-tumor activity and a wider therapeutic index.
ATG-109 (KLK2×CD2×CD3 AnTenGager-D2 TCE) is a candidate molecule developed based on the AnTenGager-D2 platform. In this study, we evaluated its in vitro anti-tumor activity, thermostability, pharmacokinetic profile, and in vivo anti-tumor efficacy in a prostate cancer cell derived xenograft model.
Results:

Characterization of the parental anti-CD3 mAbs of AnTenGager-D2. By screening 6108 full-length human proteins and further 403 human heterodimers using Retrogenix’s Cell Microarray Technology, AnTenGager parental anti-CD3 mAb showed high specificity of CD3δ+CD3ε, CD3γ+CD3ε heterodimer. AnTenGager-D2 parental anti-CD3 mAbs (ATG-CD3) demonstrated "fast-on-fast-off" binding kinetics in SPR assay. ATG-CD3 mAbs induced substantially lower cytokine release than benchmark CD3 clones.
Engineered CD58 IgV proteins exhibit superior thermostability and enhanced TDCC activity. CD58 integrated DLL3 AnTenGagers showed enhanced T cell dependent cytotoxicity against DLL3 positive tumor cell (NCI-H524), with an IC50 value of single-digit picomoles.
AnTenGager-D2 platform expands the safety window of co-stimulatory TCEs via appropriate structural integration of engineered CD58v protein. The platform displays limited antigen-independent T cell activation and no T cell-T cell crosslinking. Among DLL3-targeting AnTenGager-D2 TCEs, Format F2 demonstrated the largest safety window.
ATG-109 demonstrates enhanced efficacy and low cytokine release. ATG-109 showed lower binding affinity to CD3+ Jurkat cells in the absence of KLK2 crosslinking. ATG-109 demonstrated enhanced TDCC against KLK2 positive tumor cell (VCaP) compared to benchmark and showed no non-specific cytotoxicity against KLK2-negative cells (Du145).
ATG-109 demonstrates potent in vivo efficacy in human PBMC re-established prostate cancer cell derived xenograft model.
ATG-109 demonstrates good thermostability and exhibits good PK profile in hFcRn mice with T1/2 of ~ 183.5h. ATG-109 demonstrated a melting temperature (Tm) of > 68 ℃ and showed good stability at 10 mg/ml evaluated by SEC-HPLC (40 ℃ for 4 weeks).
Conclusion:

AnTenGager-D2 is a proprietary platform developed by Antengene for developing next-generation co-stimulatory TCEs with enhanced efficacy and safety. ATG-109, a KLK2-targeting AnTenGager-D2 TCE, showed superior preclinical efficacy compared to a clinical benchmark. The Company will further advance these preclinical studies.

(Press release, Antengene, NOV 8, 2026, View Source [SID1234674441])