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EpicentRx presents new clinical data at CTOS 2026

On November 12, 2026 EpicentRx reported its CEO Dr. Tony Reid will be at The Connective Tissue Oncology Society 2026 Annual Meeting taking place November 18–21, 2026, in Seoul, South Korea. New clinical data from the Phase 1/2 BETAPRIME trial will be presented in the abstract entitled: ADAPT-001 with a checkpoint inhibitor in angiosarcoma refractory to checkpoint inhibition: activity and durability of response.

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(Press release, EpicentRx, NOV 12, 2026, View Source [SID1234674672])

CytoDyn Announces $5 Million Private Investment to Advance Leronlimab in Colorectal Cancer and Other Solid Tumors

On November 12, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including colorectal cancer (CRC) and triple-negative breast cancer (TNBC), reported that a private investor has made an additional $5 million investment into the Company in support of its clinical development of leronlimab.

The investor, who wishes to remain anonymous at this time, has previously invested in the Company and has a longstanding interest in advancing innovative cancer therapies and improving patient access to promising treatment approaches. The investment was completed at a purchase price of $0.24 per common share, with no accompanying warrants, resulting in total proceeds of $5 million. The proceeds will support further development of the Company’s colorectal cancer program, building on emerging findings from its CLOVER study, while also furthering the exploration of leronlimab in earlier lines of treatment and other oncology indications, including TNBC, pancreatic cancer and glioblastoma.

"We are grateful for this investor’s continued confidence in leronlimab and commitment to supporting the development of new treatment options for patients with cancer," said Robert E. Hoffman, Chief Executive Officer of CytoDyn. "We believe this investment reflects support for CytoDyn’s recent data, as well as the emerging scientific and clinical evidence supporting leronlimab’s therapeutic potential across multiple solid-tumor indications. The investment comes at an important time as we continue to build on emerging clinical findings and advance the development of leronlimab across multiple solid tumors. This support will help us advance our clinical and translational research efforts as we continue to generate the evidence needed to inform future regulatory pathways."

(Press release, CytoDyn, NOV 12, 2026, View Source [SID1234674671])

Curis Provides Third Quarter 2026 Business Update

On November 12, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported its financial and operating results for the third quarter ended September 30, 2026.

"We are encouraged by our progress in both the TakeAim CLL study and the TakeAim Lymphoma study," said James Dentzer, Chief Executive Officer of Curis. "The excitement among clinicians and patients reflects the clear unmet need in both CLL and PCNSL, where emavusertib has the potential to change the treatment landscape when combined with approved BTK inhibitors."

Operational Highlights

Curis is currently enrolling patients in 2 ongoing studies, the TakeAim CLL study (CA-4948-203, NCT07271667) and the TakeAim Lymphoma study in PCNSL (CA-4948-101, NCT03328078).

TakeAim CLL

The TakeAim CLL Study is an open label phase 2 study of emavusertib in combination with zanubrutinib in patients with CLL. To be eligible for enrollment, participants must have received zanubrutinib for at least 12 months, achieved a partial response (PR) or partial response with lymphocytosis (PR-L), and have measurable residual disease (MRD+) as determined by the clonoSEQ assay.

To date, 12 patients have been enrolled in the study with initial data expected in December 2026.

TakeAim Lymphoma

The TakeAim Lymphoma Study is a registrational study of emavusertib in combination with ibrutinib in patients with Relapsed/Refractory (R/R) PCNSL (CA-4948-101, NCT03328078). In 2025, Curis presented initial clinical data to the U.S. Food and Drug Administration (FDA) and European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA) and received guidance that the ongoing registrational study could support regulatory applications for accelerated approval in R/R PCNSL.

In July 2026, the Company reported updated data for 7 BTK-naïve and 39 BTKi-experienced patients:

(as of July 1, 2026)

Evaluable*

All

Patients

BTKi-naïve

100% ORR

86% ORR

(5 of 5)

(6 of 7)

BTKi-experienced

33% ORR

26% ORR

(10 of 30)

(10 of 39)

* evaluable excludes patients who did not complete at least 1 cycle (~1 month) of treatment

About PCNSL and CLL

In PCNSL and CLL, disease is driven by NF-kB dysregulation, which is in turn driven by two biologic pathways: BCR and TLR1. The goal of combining emavusertib with a BTK inhibitor (BTKi) in the TakeAim Lymphoma and TakeAim CLL Studies is to enable a dual blockade of NF-kB, by inhibiting both the BCR and TLR pathways. BTKi blocks the BCR pathway; emavusertib blocks the TLR pathway.

BTKi is an established standard of care in Relapsed/Refractory (R/R) PCNSL. For BTKi-naïve patients, response rates can be 39%-67%. For salvage-line patients, patients who have been treated with BTKi and progressed, outcomes are generally poor, with many patients proceeding directly to hospice or best supportive care. Initial clinical data have shown that adding emavusertib to a BTKi regimen, directly after a patient progresses on BTKi monotherapy, can enable patients to reverse their disease progression and achieve an objective response.

BTKi is also standard of care in CLL, where outcomes are more favorable than in PCNSL. In the registrational study for the BTKi zanubrutinib in CLL, 93% of patients were able to achieve an objective response, though only 7% achieved complete response2. More recent clinical studies have shown that adding emavusertib to a BTKi regimen, blocking both the TLR and BCR pathways, can enable patients with NHL to achieve deeper responses, including complete responses or undetectable minimal residual disease (MRD).

Corporate

Completed a public offering in August 2026 and a private placement in October 2026 extending cash runway into 2027.

Third Quarter 2026 Financial Results

For the third quarter of 2026, Curis reported a net loss of $8.1 million or $1.94 per share on both a basic and diluted basis as compared to $7.7 million or $9.86 per share on both a basic and diluted basis, for the same period in 2025. Curis reported a net loss of $40.9 million or $16.77 per share on both a basic and diluted basis, for the nine months ended September 30, 2026, as compared to a net loss of $26.9 million or $43.82 per share on both a basic and diluted basis for the same period in 2025.

There was no revenue reported for the quarter or the year ended September 30, 2026 due to the sale of Erivedge royalties to Oberland in the fourth quarter of 2025. Revenues were $3.2 million and $8.3 million for the quarter and year ended September 30, 2025, respectively.

Research and development expenses were $5.6 million for the third quarter of 2026, as compared to $6.4 million for the same period in 2025. The decrease was primarily attributable to lower employee-related costs, partially offset by an increase in clinical costs. Research and development expenses were $18.8 million for the nine months ended September 30, 2026, as compared to $22.4 million for the same period in 2025.

General and administrative expenses were $3.2 million for the third quarter of 2026, as compared to $3.7 million for the same period in 2025. The decrease was primarily attributable to lower employee-related costs, partially offset by an increase in legal costs. General and administrative expenses were $11.4 million for the nine months ended September 30, 2026, as compared to $11.2 million for the same period in 2025.

Other income was $0.6 million for the third quarter of 2026, as compared to other expense of $0.8 million for the same period in 2025. The increase was primarily attributable to the change in fair value of the warrant liability associated with the January 2026 Private Placement, partially offset by a decrease in the expense related to the sale of future royalties. Other expense was $10.7 million for the nine months ended September 30, 2026, as compared to other expense of $1.6 million for the same period in 2025.

Curis’s cash and cash equivalents totaled $5.0 million as of September 30, 2026, and the Company had approximately 4.1 million shares of common stock outstanding. The Company believes that the $5.0 million of existing cash and cash equivalents as of September 30, 2026, together with the net proceeds of approximately $7.5 million from the October 2026 Private Placement, should enable it to fund our existing operations into the first quarter of 2027.

Conference Call and Webcast Information

Curis management will host a conference call today, November 12, 2026, at 4:30 p.m. ET, to discuss the business update and these financial results.

Participants may join by dialing (800)-836-8184 from the United States or (646)-357-8785 from other locations or a live audio webcast can be accessed here or from the investor section of the Curis website. A replay of the conference call will be available at www.curis.com.

(Press release, Curis, NOV 12, 2026, View Source [SID1234674670])

Crescent Biopharma Reports Third Quarter 2026 Financial Results and Recent Business Highlights

On November 12, 2026 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported financial results for the third quarter ended September 30, 2026 and recent business highlights.

"This has been a defining year for Crescent. We advanced three programs into the clinic and established a leading position in developing next generation IO and ADC combinations which we believe have the potential to redefine cancer care. Together with our partner Kelun-Biotech, we have achieved a remarkable nine IND clearances, and anticipate that more than 2,000 patients will be dosed across our portfolio by mid-2027. We plan to aggressively pursue additional combination opportunities that can further our efforts to develop CR-001 as a best-in-class IO backbone therapy. Building on the pipeline progress we outlined last month, we are pleased to have now commenced patient dosing in the global APOLLO trial of CR-002, our PD-L1-targeted ADC," said Joshua Brumm, chief executive officer of Crescent. "The team’s strong execution has positioned us for several meaningful clinical data readouts in 2027, beginning in the first quarter with monotherapy results from our global ASCEND trial of CR-001, including first-line NSCLC patients, followed by initial standard of care chemotherapy combination data from multiple tumor types. We are poised for an exciting year ahead as we work to deliver the next wave of therapies for people living with cancer."

Recent Business Highlights & Anticipated Milestones

CR-001, PD-1 x VEGF Bispecific Antibody
Clinical Execution Progress in ASCEND, a Global Phase 1/2 Trial of CR-001
•In October 2026, Crescent announced completion of dose escalation in ASCEND, a global Phase 1/2 trial of CR-001, its investigational PD-1 x VEGF bispecific, with patients enrolled across several tumor types at clinical sites in the United States, Europe and South Korea.
•Crescent is on track to report initial monotherapy data from ASCEND in the first quarter of 2027, including:
◦Preliminary antitumor response as measured by overall response rate (ORR) from a first-line NSCLC cohort of up to 12 patients.

◦Safety, tolerability, pharmacokinetic and pharmacodynamic data from more than 125 treatment-naïve and previously treated patients across multiple solid tumor types.
•Patient dosing has commenced in ASCEND expansion cohorts which are evaluating CR-001 with various standard of care chemotherapy combinations across several solid tumor types in treatment-naive and previously treated patients, including first-line NSCLC, colorectal, biliary tract, gastric and endometrial cancers. Crescent is on track to report initial data from hundreds of patients in mid-2027 (Q2/Q3).
•Data from the expansion cohorts, along with monotherapy data from ASCEND, will inform future clinical development for CR-001. Pending results and further interactions with regulators, Crescent plans to initiate the first of multiple Phase 3 trials of CR-001 in early 2028.
•Trial in progress posters of the ASCEND study design were featured during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2026 Congress held October 23-27, 2026 in Madrid, Spain and at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting held November 4-8, 2026 in Phoenix, Arizona.
Multiple Studies Evaluating CR-001 in Combination with Novel ADCs
•Under a collaboration agreement, Crescent granted Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., ("Kelun-Biotech") exclusive rights to research, develop, and commercialize CR-001 (also known as SKB118) in Greater China. Both Kelun-Biotech and Crescent have rights to independently develop CR-001 in combinations, including with their respective antibody-drug conjugate (ADC) pipelines.
•Kelun-Biotech is conducting multiple Phase 2 trials in China evaluating CR-001 (SKB118) in combination with sacituzumab tirumotecan (sac-TMT), its TROP2-directed ADC. Initial data from a study in patients with locally advanced or metastatic NSCLC are expected in mid-2027 (Q2/Q3). Additional studies are underway in participants with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-squamous NSCLC who have failed EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy, as well as in patients with advanced solid tumors.
•A Phase 1/2 trial of CR-001(SKB118) in combination with CR-003 (also known as SKB105), an integrin-beta 6 (ITGB6)-directed ADC, is expected to commence in the first half of 2027.
CR-002, Topoisomerase Inhibitor ADC Targeting PD-L1
•Earlier this month, the first patient was dosed in the global Phase 1/2 APOLLO trial of CR-002, a topoisomerase inhibitor ADC targeting programmed cell death ligand 1 (PD-L1). APOLLO is designed to enroll patients in the United States, Europe and Asia Pacific with advanced solid tumors, including NSCLC, head and neck squamous cell carcinoma (HNSCC), and various gastrointestinal and gynecological tumors. The study’s dose escalation and tumor-specific backfill cohorts are expected to enroll approximately 200 participants with the opportunity for additional participants in expansion cohorts.
•Crescent anticipates reporting initial data from APOLLO in the second half of 2027, including safety, tolerability, pharmacokinetics and preliminary antitumor activity.
•Preclinical data for CR-002 will be featured in a poster presentation at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics being held November 18-20, 2026 in Barcelona, Spain.

CR-003, Topoisomerase Inhibitor ADC Targeting ITGB6

•Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (SKB105), an ITGB6-targeted ADC, in the United States, Europe and all markets outside of Greater China.

•A Phase 1/2 trial of CR-003 (SKB105) in participants with advanced solid tumors conducted by Kelun-Biotech in China is ongoing and proof-of-concept data are expected in the first quarter of 2027. Crescent plans to leverage data generated in China to support the global clinical development of CR-003 (SKB105).

Third Quarter 2026 Financial Results

Cash position: Cash and cash equivalents were $289.4 million as of September 30, 2026 which includes the $133.4 million in net proceeds from the July 2026 public offering. Crescent expects that its existing cash and cash equivalents will fund operations into the second half of 2028.

Research and development (R&D) expenses: R&D expenses were $34.3 million and $20.3 million for the three months ended September 30, 2026 and 2025, respectively. R&D expenses increased to support the increased clinical development on the global Phase 1/2 ASCEND trial and the costs incurred in preparation for the initiation on the global Phase 1/2 APOLLO trial.

General and administrative (G&A) expenses: G&A expenses were $8.7 million and $5.5 million for the three months ended September 30, 2026 and 2025, respectively. The increase in G&A expenses was primarily driven by increased personnel costs, including increased share-based compensation and professional service costs in continued support of the Company’s pipeline.

Net loss: Net loss was $37.7 million and $24.6 million, or $0.90 and $1.27 per basic and diluted share, for the three months ended September 30, 2026 and 2025, respectively.

Shares outstanding: As of September 30, 2026, Crescent had approximately 44.1 million ordinary shares and ordinary share equivalents issued and outstanding, including ordinary shares underlying pre-funded warrants and non-voting convertible preferred stock.

(Press release, Crescent Biopharma, NOV 12, 2026, View Source [SID1234674669])

Cardiff Oncology Reports Third Quarter 2026 Results and Provides Business Update

On November 12, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company targeting RAS-mutated cancer by leveraging PLK1 inhibition, reported financial results for the third quarter ended September 30, 2026, and provided a business update.

"We’re greatly encouraged by the performance of onvansertib in first-line RAS-mutated mCRC. As the data mature, the benefit of onvansertib in combination with FOLFIRI/bev is becoming more evident, with growing separation between the onvansertib and control arms," said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. "Building on the strength of these data, we are actively preparing for our upcoming registrational trial. There are currently no treatment options specifically approved for patients with pan RAS-mutated mCRC in the first-line setting and we believe onvansertib has the potential to become an important new treatment for these patients."

Clinical Highlights

Randomized Phase 2 Trial in First-Line RAS-Mutated Metastatic Colorectal Cancer ("mCRC") Ongoing

Cardiff’s randomized Phase 2 trial evaluating onvansertib in combination with FOLFIRI/ bevacizumab ("bev") or FOLFOX/bev as first-line therapy in patients with RAS-mutated mCRC remains ongoing. Median progression-free survival ("PFS") has not been reached in the 30 mg onvansertib + FOLFIRI/bev arm, the Company’s proposed Phase 3 regimen.

As of September 28, 2026, 6 patients remain on the FOLFIRI/bev regimen, with 5 patients in the onvansertib (20 or 30 mg) + FOLFIRI/bev arms and 1 patient on standard-of-care ("SoC") FOLFIRI/bev. Patients who remain in the 30 mg onvansertib + FOLFIRI/bev arm have been on treatment for at least 21 months, with the longest duration of treatment being over 29 months.

For comparison, the median PFS in the combined SoC arms has been reached at approximately 11 months, consistent with what has been historically reported.

Corporate Updates

·
In July, Cardiff completed a $10 million registered direct offering of common stock and warrants to support working capital and general corporate purposes. The full press release is available here.
·
In September, Cardiff and its licensor, Nerviano Medical Sciences S.r.l. ("NMS"), resolved all outstanding disputes regarding global rights to onvansertib and amended their 2017 exclusive license agreement. The full press release is available here.
·
In October, Cardiff appointed Leila Alland, MD, as interim Chief Medical Officer. Dr. Alland is a seasoned oncology executive who has served as Chief Medical Officer at several clinical-stage biotechnology companies and previously held leadership positions at AstraZeneca, Bristol Myers Squibb, Novartis and Schering-Plough, where she contributed to the development and approval of multiple oncology therapies. The full press release is available here.

Upcoming Events

·
Cardiff management will present at the UBS Global Biopharma Conference and participate in one-on-one investor meetings on November 16–17, 2026. Dr. Mohindru’s presentation is scheduled for November 16 at 2:40 p.m. GMT. A live webcast and replay will be available in the "Events" section of the Cardiff Oncology website.
·
Updated data from an investigator-sponsored clinical trial in CMML will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting on December 13, 2026.

Third Quarter 2026 Financial Results

Liquidity, cash burn, and cash runway

As of September 30, 2026, Cardiff Oncology had approximately $33.8 million in cash, cash equivalents, and short-term investments. Net cash used in operating activities for the nine months ended September 30, 2026 was approximately $33.9 million, an increase of $2.0 million from $31.9 million for the same period in 2025. In July 2026, the Company raised net proceeds of approximately $9.1 million in a registered direct offering. Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations to the end of the third quarter of 2027.

Operating results

Total operating expenses were approximately $32.0 million for the nine months ended September 30, 2026, a decrease of $9.5 million from $41.5 million for the same period in 2025. R&D expenses decreased by $12.5 million, reflecting the completion of clinical trials, fewer patients on treatment in the Phase 2 mCRC trial, a reduction in preclinical activities, and completion of chemistry, manufacturing and controls ("CMC") activities as the Company prepares for its planned Phase 3 mCRC trial. SG&A expenses increased by $3.1 million, driven by legal and professional fees related to the Company’s dispute with NMS, which was resolved on September 14, 2026, and also by employee severance costs. Net loss was $30.4 million, compared with $38.6 million for the prior year period.

(Press release, Cardiff Oncology, NOV 12, 2026, View Source [SID1234674668])