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Exicure, Inc. Announces Agreement to Sell GPC-100 Program Assets to GPCRT Inc. for KRW 6.5 Billion

On November 10, 2026 Exicure, Inc. (Nasdaq: XCUR) ("Exicure" or the "Company") reported that on November 4, 2026, the Company and its wholly owned subsidiary, GPCR Therapeutics USA Inc. ("GPCR USA"), entered into an Intellectual Property, Asset and License Assignment Agreement (the "Agreement") with GPCRT Inc. ("GPCRT"), a company organized under the laws of the Republic of Korea, under which GPCRT has agreed to acquire the Company’s GPC-100 (burixafor) program assets for an aggregate cash purchase price of KRW 6.5 billion (approximately US$4.8 million).

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The assets to be sold consist of the Company’s rights under its License and Collaboration Agreement with GPCR Therapeutics, Inc. dated January 19, 2025, together with the related contracts, intellectual property, clinical and regulatory data, materials and equipment of the Company and GPCR USA used in the GPC-100 program. GPC-100 is being evaluated in combination with propranolol for stem cell mobilization in patients with multiple myeloma, and GPCR USA completed its Phase 2 clinical trial of GPC-100 in January 2026. GPCR USA will remain a wholly owned subsidiary of Exicure following the closing.

Of the purchase price, KRW 500 million has previously been paid by GPCRT and will be credited against the purchase price, KRW 2.0 billion is payable on or before November 16, 2026 and the remaining KRW 4.0 billion is payable at the closing, in each case subject to any other payment date agreed by the parties in writing. From and after the closing, GPCRT will assume the obligations under the License and Collaboration Agreement, including future milestone and royalty payments, and under the assigned program contracts, and GPCRT will bear the costs of the GPC-100 program incurred on or after September 1, 2026, as provided in the Agreement. Exicure and GPCR USA will retain all other liabilities, including GPC-100 program liabilities incurred before September 1, 2026.

The closing is subject to customary closing conditions, including required approvals and third-party consents, a waiver and release from GPCR Therapeutics, Inc. and any approval of the Company’s stockholders that may be required. There can be no assurance that the transaction will be completed on the anticipated timetable or at all.

The sale of the GPC-100 program assets is part of the Company’s ongoing evaluation of strategic alternatives intended to maximize stockholder value and is expected to strengthen the Company’s financial position.

Additional information regarding the Agreement is included in the Current Report on Form 8-K filed by the Company with the U.S. Securities and Exchange Commission (the "SEC").

(Press release, Exicure, NOV 10, 2026, View Source [SID1234674557])

Corbus Pharmaceuticals Reports Q3 2026 Financial Results and Provides a Corporate Update

On November 10, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical-stage company focused on developing new therapies in oncology and obesity, reported a corporate update and reported financial results for the 2026 third quarter ended September 30, 2026.

"During the third quarter, we achieved key milestones with both clinical programs: initiating dosing in our TEMPO-1 Phase 3 study of sutantatug envedotin in oropharyngeal cancer and announcing positive topline data from our CANYON-1 Phase 1b study of CRB-913 in obesity," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "The commencement of the TEMPO-1 trial marks our transition to late-stage clinical development, bringing us meaningfully closer to delivering sutantatug envedotin as a potentially novel, targeted therapeutic for those impacted by OPSCC who were previously treated with platinum-based and anti-PD1 therapy. Based on our Phase 1/2 data, we believe that sutantatug envedotin has the potential to address the critical unmet need of patients with this difficult-to-treat, primarily HPV-driven disease. For CRB-913, our topline CANYON-1 data demonstrated, for the first time, that a highly peripherally restricted CB1 inverse agonist can deliver a safe and tolerable therapeutic alternative with competitive weight loss to oral GLP-1s. We look forward to presenting additional data at ObesityWeek."

Key Corporate and Program Updates

Sutantatug envedotin (CRB-701) is a next-generation, highly stable Nectin-4-targeting antibody drug conjugate (ADC) being developed to treat oropharyngeal squamous cell carcinoma (OPSCC), a subtype of head and neck squamous cell carcinoma (HNSCC), as well as cervical cancer. The U.S. Food and Drug Administration (FDA) has granted Fast Track designations to sutantatug envedotin for the treatment of both cancer types. Sutantatug envedotin is licensed from CSPC Megalith Biopharmaceutical Co. Ltd (CSPC).

Received FDA clearance in July 2026 to proceed with the TEMPO-1 study, the first registrational trial launched that is specifically designed to evaluate a targeted treatment in patients with 2L+ OPSCC, and initiated dosing in September 2026.
TEMPO-1 is a randomized controlled study (n=250) comparing sutantatug envedotin with investigators’ choice of capecitabine, cetuximab or docetaxel in 2L+ OPSCC. The primary endpoint to support potential accelerated approval is objective response rate, while overall survival serves as the primary endpoint to support a potential conversion to full approval.
Anticipate reporting sutantatug envedotin plus Keytruda combination data in first-line (1L) OPSCC in Q1 2027 to support potential further registration-enabling trials in the 1L setting.
CRB-913 is a highly peripherally restricted oral CB1 inverse agonist for the treatment of obesity.

Reported topline data in the CANYON-1 Phase 1b trial, a 16-week, double-blind, placebo-controlled, dose-ranging study that enrolled 254 obese, non-diabetic adults at multiple U.S. sites. Participants received CRB-913 at 20 mg, 40 mg or 60 mg once daily, or placebo, for 12 weeks, followed by 4 weeks of safety follow-up.
The data demonstrated statistically significant and clinically meaningful weight loss at all three doses with the 60 mg dose achieving a mean weight loss of 5% at 12 weeks (<0.0001). No plateau was observed at any dose.
CRB-913 was associated with a favorable safety profile and notably fewer and milder gastrointestinal (GI) adverse events based on cross-trial comparison with published data of currently marketed oral GLP-1 drugs.
Taken together, these data support CRB-913’s potential to establish a new class of oral, non-incretin obesity medicines.
Topline data press release available here.
Data to be presented in a late-breaking poster at ObesityWeek 2026 on November 15, 2026.
The Company plans to engage with the FDA on the development plan and is also evaluating the potential to combine CRB-913 with GLP-1 therapy.

Chief Medical Officer Appointment

Announced appointment of Leonardo Viana Nicacio, M.D., as Chief Medical Officer, in August 2026. Dr. Nicacio has more than 20 years of pharmaceutical industry experience, with leadership roles in clinical development and global medical affairs at Protara Therapeutics, Stemline Therapeutics, Seagen (now part of Pfizer), AstraZeneca, Flatiron Health, Sanofi and YM Biosciences. His experience spans oncology drug development across multiple tumor types, including significant contributions to the development and approval of the ADCs PADCEV for urothelial carcinoma and TIVDAK for metastatic cervical cancer.
Financial Results for the Quarter Ended September 30, 2026

The Company reported a net loss of approximately $37.8 million, or a net loss per basic and diluted share of $1.81, for the three months ended September 30, 2026, compared to a net loss of approximately $23.3 million, or a net loss per basic and diluted share of $1.90, for the three months ended September 30, 2025.

Operating expenses increased by $14.4 million to approximately $38.8 million for the three months ended September 30, 2026, compared to approximately $24.4 million for the three months ended September 30, 2025. The increase was primarily attributable to a $15.0 million development milestone incurred in Q3 2026 pursuant to the CSPC licensing agreement for sutantatug envedotin.

The Company had $115.3 million of cash, cash equivalents, and investments on hand as of September 30, 2026, which is expected to fund operations into 2028 based on current operating plans and planned expenditures.

(Press release, Corbus Pharmaceuticals, NOV 10, 2026, View Source [SID1234674556])

Cellectar Biosciences Reports Third Quarter 2026 Financial Results and Provides Corporate Updates

On November 10, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of cancer therapies, reported financial results for the quarter ended September 30, 2026, and provided a corporate update.

"We remain focused on executing the clinical, regulatory and operational activities necessary to position iopofosine I 131 for potential registration and commercialization in Waldenström macroglobulinemia, and we believe our third quarter progress represents a significant step toward that goal," said James Caruso, president and chief executive officer of Cellectar Biosciences. "The new sub-analysis efficacy data presented at the International Workshop for Waldenström Macroglobulinemia (IWWM) further strengthen our confidence in the clinical profile of iopofosine I 131, demonstrating high response rates, durable outcomes and a favorable safety profile in a difficult-to-treat post-BTK inhibitor patient population, which is the same patient population being evaluated in our Phase 3 confirmatory clinical trial."

"To further maximize the long-term value of the program, we have initiated our Phase 1b dosimetry trial, which we believe offers an important opportunity to further characterize iopofosine I 131 across WM treatment settings, including first and second line. With these trials underway, a planned NDA submission in the first half of 2027, and continued advancement of our broader PDC pipeline, we believe Cellectar is entering a period of significant value creation with multiple meaningful milestones in 2027," continued Mr. Caruso.

Third Quarter 2026 and Recent Corporate Highlights

Iopofosine I 131, the company’s Phospholipid Drug Conjugate (PDC) designed to provide targeted delivery of iodine-131 (radioisotope)
Presented additional Phase 2b CLOVER-WaM data supporting the clinical profile of iopofosine I 131 in patients with relapsed/refractory Waldenström macroglobulinemia (r/r WM) following Bruton Tyrosine Kinase inhibitor (BTKi) therapy at the International Workshop for Waldenström Macroglobulinemia (IWWM). The poster presentation highlighted efficacy results from a subset of patients treated with iopofosine I 131 immediately following BTKi therapy. Patients in the analysis received a median of three prior lines of therapy (range: 2-7), including patients with TP53 mutations (17%) and MYD88 wild-type disease (29%), both of which have demonstrated lower response rates and shorter duration of response when it occurs.
Key findings from the immediately post-BTKi evaluable patients (n=24) include:
Overall Response Rate (ORR): 87.5%
Major Response Rate (MRR): 79.2%
Median Duration of Response (DoR): 16.0 months
Treatment Free Survival (TFS): 19.1 months
Clinical Benefit Rate (CBR): 100%
Safety: Treatment emergent adverse events (TEAE) occurred in less than 10% of patients, with the only Grade 3 or higher TEAE being cytopenias.
Reported plans to present three posters highlighting the durable clinical activity of iopofosine I 131 in WM at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2026).
The presentations will feature updated 12-month follow-up data from the Phase 2b CLOVER WaM clinical trial, including a new analysis demonstrating significantly longer duration of response among patients treated after only two prior lines of therapy compared with more heavily pretreated patients.
These findings further support the potential of iopofosine I 131 to address a substantial unmet need in relapsed or refractory WM and may support future evaluation in earlier treatment settings.
The Company will also present, for the first time, the detailed design of its confirmatory Phase 3 trial in WM patients previously treated with BTKi.
Advanced preparations for the planned Phase 3 confirmatory trial of iopofosine I 131, including activation of initial clinical trial sites.
The Phase 3 confirmatory clinical trial will be a comparator, randomized controlled trial in post-first line, post-BTKi patients (100 WM patients per arm) evaluating progression-free survival as the primary endpoint.
Remains on track to dose the first patient in the first quarter of 2027 and to submit in 1H27 a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking accelerated approval.
Initiated preparations for Phase 1b dosimetry clinical trial of iopofosine I 131 in all treatment lines in WM patients as requested by the FDA.
Supports uptake of iopofosine I 131 into cancer cells while sparing healthy tissue and organs.
The Phase 1b trial will also measure clinical activity, which is expected to provide data from 20-30 newly diagnosed and relapsed WM patients, potentially validating its potential to treat earlier lines of disease.
Reported a case study highlighting a complete response lasting more than eight years following treatment with iopofosine I 131 in a heavily pretreated patient with diffuse large B-cell lymphoma (DLBCL).
The case study described a 53-year-old patient with high-grade, double-hit DLBCL who had received four prior lines of therapy. Treatment with iopofosine I 131 resulted in a complete response by Day 85 that has been maintained for more than eight years without disease progression or additional anticancer therapy.
The Company plans to submit these findings for journal publication or presentation at a future medical meeting.
CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumor
The dose-finding Phase 1b trial evaluating CLR 125 in refractory triple-negative breast cancer (TNBC) continues to enroll. Initial dosimetry, and safety data from the dose-escalation Phase 1b trial are expected to be shared in the fourth quarter of 2026 at a medical meeting.
Phospholipid Drug Conjugate (PDC) Platform
Hosted a virtual educational webinar highlighting Cellectar’s validated PDC platform. The webinar, titled "The Platform Behind the Pipeline: Unlocking the Full Potential of Cellectar’s Phospholipid Drug Conjugate Technology" focused on the broader potential of the phospholipid ether (PLE) platform and its combinability with a wide variety of therapeutic molecules, including small-molecule chemotherapeutics, radiotherapeutics, and other molecules that utilize alternative therapeutic approaches.
A replay of the webinar can be accessed in the "News & Events" section of Cellectar’s website or accessible here.

2026 Financial Highlights

Cash and Cash Equivalents: As of September 30, 2026, the company had cash and cash equivalents of $24.6 million, compared to $13.2 million as of December 31, 2025, which reflects net proceeds of approximately $31.7 million from the May 2026 offering. The company believes its cash balance as of September 30, 2026, is adequate to fund its budgeted operations into the second quarter of 2027.
Research and Development Expenses: R&D expenses for the three months ended September 30, 2026, were approximately $5.4 million, compared to approximately $2.5 million for the three months ended September 30, 2025. The initiation of our Phase 3 confirmatory trial of iopofosine I 131 in WM and increased activity in our ongoing Phase 1b trial of CLR 125 in TNBC were the primary drivers of the increase.
General and Administrative Expenses: G&A expenses for the three months ended September 30, 2026, were approximately $2.7 million, compared to approximately $2.3 million for the same period in 2025. The modest increase was primarily a result of increased professional fees and personnel costs.
Net Loss: The net loss attributable to common stockholders for the three months ended September 30, 2026, was $8.0 million, or $0.46 per share, compared to $4.4 million, or $1.41 per share, in the three months ended September 30, 2025.

Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, November 10, 2026, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days.

(Press release, Cellectar Biosciences, NOV 10, 2026, View Source [SID1234674555])

Black Diamond Therapeutics Announces Positive Updated Silevertinib Phase 2 Results, FDA Feedback Supporting a Clear Path to Potential Registration in 1L EGFR-NCM NSCLC, and Provides Corporate Update

On November 10, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, reported updated data from its Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients with EGFR non-classical mutations (NCMs), the outcome from its End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and associated Phase 3 plans, and financial results for the third quarter ended September 30, 2026.

"There remains significant unmet medical need in NSCLC patients with non-classical EGFR mutations, particularly in patients with brain metastases ," said Alex Spira M.D., Ph.D., Director of the Thoracic and Phase I Program at Virginia Cancer Specialists and Chief Scientific Officer of NEXT Oncology, and clinical investigator on the silevertinib Phase 2 trial. "Along with the exciting CNS response rate and progression free survival data from this Phase 2 trial, it is remarkable that not a single frontline patient treated with silevertinib has developed de novo brain metastases."

"Brain is the most common site of distant metastasis for patients with EGFR-mutant NSCLC", added Sergey Yurasov, M.D., Ph.D., Chief Medical Officer of Black Diamond Therapeutics. "We believe that silevertinib’s ability to significantly delay CNS progression is the key driver of the durable clinical benefit we are seeing in patients both with and without baseline brain metastases and is the foundation of the pivotal program design in 1L NSCLC."

"Our recent end of Phase 2 meeting with the FDA was highly collaborative, and we believe the feedback we received supports a clear path to potential accelerated and full approval for silevertinib in frontline NSCLC patients with EGFR non-classical mutations," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "This trial design offers a differentiated path to potential accelerated approval in EGFR-NCM patients, who represent about 25% of the frontline EGFR mutant patient population."

Silevertinib Recent Developments and Upcoming Milestones:
•Silevertinib 1L NSCLC Phase 2 Results Update: As of an October 7, 2026 data cutoff date, with a median patient follow-up of 15.9 months, updated results from the Phase 2 trial (conducted in the U.S. and Canada) of silevertinib dosed at 200 mg once daily (QD) in 43 frontline NSCLC patients harboring a broad spectrum of EGFR NCMs, were as follows:
◦Intention to Treat (ITT) Population: n=43
▪60% ORR (RECIST 1.1), 93% DCR, 15.0 month mPFS (95% confidence interval (CI): 11.0, 23.5)
▪18 patients remained on therapy, with the longest at 26.2 months
▪No new safety signals were observed
◦Patients with untreated brain metastases: n=16 (7 evaluable by RANO-BM)
▪86% CNS-ORR (RANO-BM)
▪12.2 months systemic mPFS (95% CI: 8.1, not estimable (NE)) by RECIST 1.1
◦Patients without brain metastases: n= 24
▪23.5 months mPFS (95% CI:11.0, NE)
▪No patients with progression in the brain
•Cohort 4 (n=20) of the Phase 2 trial is enrolling frontline patients with non-classical EGFRm NSCLC at the planned pivotal dose of 150 mg administered once daily; the first patient was dosed in the third quarter of 2026
•Summary from End of Phase 2 FDA Meeting on October 1, 2026:

◦Based on the FDA’s feedback, the Company intends to pursue a Phase 3 development program for silevertinib that will encompass all treatment-naïve patients with locally advanced or metastatic NSCLC whose tumors harbor an oncogenic EGFR mutation other than a classical mutation (ex19del, L858R) or exon 20 insertion.

◦The FDA also provided feedback on a potential accelerated approval based on CNS-ORR per RANO-BM by blinded independent central review (BICR) and a potential full approval based on PFS per RECIST v1.1 by BICR.
◦The FDA indicated that systemic ORR and overall survival (OS) will need to be evaluated to show systemic ORR similarity to, and no evidence of an OS detriment compared to, the control arm.

◦The FDA acknowledged the Company’s justification for 150 mg QD as the pivotal dose. Safety data from a sufficient number of patients treated at 150 mg QD in the ongoing Cohort 4 are required to be submitted to the FDA prior to opening the Phase 3 trial.

•Phase 3 Trial Plan: The Company is planning a global Phase 3 registrational trial of silevertinib in frontline NSCLC patients with EGFR-NCMs with the potential to initiate in the second quarter of 2027. This trial would enroll 300 patients with EGFR-NCMs and untreated brain metastases randomized 1:1 to receive silevertinib 150 mg once daily or physician’s choice of osimertinib or afatinib. The primary endpoints are CNS-ORR (RANO-BM by BICR) for potential accelerated approval and systemic PFS (RECIST 1.1 by BICR) for potential full approval. The Phase 3 trial would also include an additional 80 patient single-arm cohort in frontline NSCLC patients with EGFR-NCMs without brain metastases, and a 20 patient single arm cohort in patients with leptomeningeal disease. Assuming a second quarter of 2027 initiation, preliminary data anticipated in 2028.

•Phase 2 Trial in Newly Diagnosed GBM: The randomized portion of the Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII+ glioblastoma (GBM) is enrolling patients at 150 mg QD, with the first patient dosed in the fourth quarter of 2026. The primary endpoint is PFS (RANO-BM by BICR), with OS as a secondary endpoint. The 150 mg QD dose of silevertinib for the randomized portion of the study was selected based on 6 patients dosed at 150 mg QD in combination with temozolomide (TMZ) in the completed safety run-in portion of the trial, in which no dose-limiting toxicities were observed. Interim PFS data are expected in the first half of 2028 (NCT07326566).

Third Quarter Ended September 30, 2026 Financial Highlights

•Cash Position: Black Diamond ended the third quarter of 2026 with approximately $102.0 million in cash, cash equivalents, and investments compared to $128.7 million as of December 31, 2025. Net cash used in operations was $8.3 million for the third quarter of 2026 compared to net cash used in operations of $7.9 million for the third quarter of 2025.

•Research and Development Expenses: Research and development (R&D) expenses were $7.0 million for the third quarter of 2026, compared to $7.4 million for the same period in 2025. The decrease in R&D expenses was primarily due to the progression of our Phase 2 trial for silevertinib in NSCLC, partially offset by increased spend related to the start-up and conduct for the Phase 2 trial for silevertinib in GBM.
•General and Administrative Expenses: General and administrative (G&A) expenses were $5.1 million for the third quarter of 2026, compared to $3.5 million for the same period in 2025. The increase in G&A expenses was primarily due to an increase in IP-related costs and higher non-income tax expense.
•Net Loss: Net loss for the third quarter of 2026 was $10.0 million, as compared to a net loss of $8.5 million for the same period in 2025.
Financial Guidance
•Black Diamond ended the third quarter of 2026 with approximately $102.0 million in cash, cash equivalents, and investments. The Company believes that its existing cash, cash equivalents and investments, will be sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.
About Silevertinib
Silevertinib is an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It is also designed to potently inhibit key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFRm NSCLC or EGFR-altered GBM have been treated with silevertinib.
In addition to the ongoing Phase 2 trial of silevertinib in patients with non-classical EGFRm NSCLC, the Company is also conducting a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (NCT07326566).

(Press release, Black Diamond Therapeutics, NOV 10, 2026, View Source [SID1234674554])

BioNTech to Acquire US FDA Priority Review Voucher

On November 10, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech") reported that it has entered into an agreement to acquire a US Food and Drug Administration ("FDA") Priority Review Voucher ("PRV") from Scholar Rock, Inc. (Nasdaq: SRRK, "Scholar Rock") for a total cash consideration of $205 million.

A PRV grants FDA priority review for a single application, which reduces the target FDA review timeline and could lead to expedited approval. BioNTech intends to use the PRV to support a future filing of an asset in its late-stage oncology pipeline. The transaction is subject to customary closing conditions, including clearance under the Hart-Scott Rodino ("HSR") Antitrust Improvements Act.

(Press release, BioNTech, NOV 10, 2026, View Source [SID1234674553])