On December 23, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported that Kim Kelderman, President and Chief Executive Officer, will present at the 2026 J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 9:00 a.m. PST. A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Press release, Bio-Techne, DEC 23, 2025, View Source [SID1234661606])

On December 23, 2025 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products reported business and financial results for the fiscal year ended September 30, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2025 was a pivotal year for Citius as we successfully launched LYMPHIR following its FDA approval, marking the first new systemic therapy for cutaneous T-cell lymphoma (CTCL) patients since 2018. This milestone reflects our ability to execute and our commitment to delivering impactful treatments for patients with limited options," said Leonard Mazur, Chairman and CEO of Citius Pharma. "With LYMPHIR commercially available as of December 2025, we are focused on its successful launch and adoption in 2026, with even greater opportunities ahead to drive value for patients and shareholders. We are actively engaging with the FDA to advance Mino-Lok, exploring additional indications and markets for LYMPHIR, and working diligently to strengthen our financial and operational foundation to support sustained growth. We look forward to reporting on our continued progress in the coming months."

Fiscal Year 2025 Business Highlights and Subsequent Developments

● Citius Pharma subsidiary, Citius Oncology (Nasdaq: CTOR), launched LYMPHIR (denileukin diftitox-cxdl), a novel IL-2 receptor-directed immunotherapy, in the U.S. in December 2025 for the treatment of adult patients with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy;

● Citius Pharma drove commercial preparations for LYMPHIR’s launch through its shared management services agreement with Citius Oncology:

- Executed service agreements with the three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR throughout the U.S.;

- Secured access to LYMPHIR in 19 international markets through regional distribution partners via named patient programs (NPPs), which allows access to LYMPHIR where permitted by local law without constituting commercial approval outside the U.S.;

- Ensured production and sufficient supply of LYMPHIR for up to 18 months of estimated commercial demand;

- Secured inclusion of LYMPHIR in the National Comprehensive Cancer Network (NCCN) guidelines and compendia with a Category 2A recommendation, and a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) to aid in obtaining coverage and reimbursement;

- Partnered to deploy an AI-powered sales and marketing platform to enhance commercial targeting, real-time field execution, and provider engagement; and,

- Contracted with a leading provider of global commercialization services to supply medical information, pharmacovigilance, revenue cycle management, program management, data and analytics, and channel management services;

● Raised approximately $61 million in gross proceeds from capital raises:

- Citius Pharma closed $25 million in gross proceeds from strategic financings during and after the fiscal year end; and,

- Citius Oncology closed $36 million in gross proceeds from strategic financings during and after the fiscal year end; and,

● Continued to engage with the FDA on the paths forward for Mino-Lok and Halo-Lido.

Fiscal Year 2025 Financial Highlights

● Cash and cash equivalents of $4.3 million as of September 30, 2025;

● Citius Pharma did not report revenues for the year;

● R&D expenses were $9.2 million for the full year ended September 30, 2025, compared to $11.9 million for the full year ended September 30, 2024;

● G&A expenses were $18.5 million for the full year ended September 30, 2025, compared to $18.2 million for the full year ended September 30, 2024;

● Stock-based compensation expense was $10.8 million for the full year ended September 30, 2025, compared to $11.8 million for the full year ended September 30, 2024; and,

● Net loss was $39.7 million, or ($3.38) per share for the fiscal year ended September 30, 2025 compared to a net loss of $40.2 million, or ($5.97) per share for the full year ended September 30, 2024.

(Press release, Citius Pharmaceuticals, DEC 23, 2025, View Source [SID1234661607])

On December 23, 2025 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that it will host a conference call and live webcast at 4:00 p.m. ET on Wednesday, January 7, 2026 to provide an update on 12-month overall survival (OS) from its ongoing Phase 2a clinical trial of atebimetinib + modified Gemcitabine / nab-paclitaxel (mGnP) in first-line pancreatic cancer patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to share updated overall survival data from our ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "We are increasingly confident in atebimetinib’s ability to extend and improve the lives of patients with pancreatic cancer."

The conference call will be webcast live and archived in the Investor Relations section of Immuneering’s website at Events & Presentations | Immuneering Corporation.

(Press release, Immuneering, DEC 23, 2025, View Source [SID1234661609])

On December 23, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported the publication of clinical results from the ovarian cancer cohort of its Phase 1b C-800-01 trial evaluating botensilimab plus balstilimab (BOT+BAL) in The Journal for ImmunoTherapy of Cancer (JITC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The peer-reviewed manuscript titled, "Botensilimab (Fc-enhanced anti–CTLA-4 antibody) plus balstilimab (anti–PD-1 antibody) in patients with treatment-refractory ovarian cancer," is available online here.i

In this heavily pretreated population, BOT+BAL demonstrated clinically meaningful activity and durable benefit in women with treatment-refractory ovarian cancer, a population with few remaining options. The combination achieved a 23% overall response rate and 31% clinical benefit rate, including durable responses with a median duration of 9.7 months. Median overall survival reached 14.8 months, with an estimated of 75% of patients alive at 12 months.

These findings build on results from the broader C-800-01 dataset presented at ESMO (Free ESMO Whitepaper) 2025, where BOT+BAL showed activity across multiple refractory solid tumors. Collectively, these data reinforce the potential of BOT+BAL to generate meaningful immune responses in cancers historically considered unresponsive to immunotherapy.

High Unmet Need in Treatment-Refractory Ovarian Cancer

Ovarian cancer causes approximately 13,000 deaths annually in the U.S. and 200,000 globallyii,iii, and outcomes are particularly poor once tumors become platinum-resistant or platinum-refractory. Therapy with first-generation checkpoint inhibitors has yielded modest responses, with objective response rates between 8–10% and median progression-free survival of roughly 2 monthsiv,v, leaving many women with rapidly diminishing options and no approved immunotherapy combinations.

Publication Highlights

The study enrolled 44 women with treatment-refractory ovarian cancer who had received multiple prior lines of therapy. Nearly three-quarters were platinum-resistant or platinum-refractory, and most had high-grade serous tumors.
Activity was demonstrated in primary platinum-refractory patients—a rare and high-risk group often excluded from clinical studies.
Responses occurred in multiple ovarian cancer subtypes including high-grade serous, clear cell, and endometrioid tumors.
The BOT+BAL combination demonstrated a manageable and reversible safety profile, consistent with CTLA-4 and PD-1 therapy. Most common treatment-related adverse events such as diarrhea/colitis (43%; 16% grade 3), fatigue and nausea (36%) were effectively managed using established treatment guidelines. No treatment-related deaths were reported.
Steven O’Day, MD, Chief Medical Officer, Agenus, commented, "These results offer a meaningful signal of clinical activity for women with platinum-refractory ovarian cancer, a group that has seen little therapeutic progress. Botensilimab’s unique immune activation profile translated into clinically significant responses in a population long considered resistant to immunotherapy. These findings strengthen our confidence in BOT+BAL’s potential and support moving this combination into larger, randomized studies."

Rebecca Porter, M.D., Ph.D., Dana-Farber Cancer Institute and Lead Author added, "These women faced some of the most treatment-resistant forms of ovarian cancer, yet several achieved meaningful and durable benefit. Seeing this level of activity in such a heavily pretreated population is encouraging and provides important insights to the field regarding therapy approaches for patients with very limited remaining options."

Patient Access and Ongoing Development

BOT+BAL continues to advance through global clinical development across multiple tumor types. In parallel, eligible patients may be able to access BOT+BAL through regulatory-authorized early access mechanisms, including France’s AAC program, where treatment is reimbursed, as well as paid named-patient programs in select countries where permitted by local regulations. These programs are intended to provide access for patients with serious or life-threatening diseases who lack satisfactory therapeutic alternatives.

(Press release, Agenus, DEC 23, 2025, View Source;Balstilimab-in-Highly-Refractory-Ovarian-Cancer-Published-in-JITC/default.aspx [SID1234661612])

On December 23, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer. Phio reported that it has taken a major step forward in its drug development program for PH-762. The company will begin a toxicology study, which is required by the FDA prior to commencing a human pivotal trial. Concurrently, initiatives are continuing to advance the delivery of commercially viable drug product in 2026 that meets FDA’s current Good Manufacturing Practices. A portion of the net proceeds from Phio’s recent financing is being directed to these two major initiatives.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recently, positive interim safety and efficacy results were reported in the on-going Phase 1b dose escalation clinical trial with the INTASYL compound PH-762 for the treatment of skin cancer. To date, a total of 18 patients with cutaneous carcinomas have completed treatment across five dose escalating cohorts in the Phase 1b trial. The cumulative pathologic response in 16 patients with cSCC include six with a complete response (100% clearance), two with a near complete response (> 90% clearance) and two with a partial response (> 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response (> 50% clearance). Six patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance). No patients in the study, however, exhibited clinical progression of disease. To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort.

"The conduct of this nonclinical study is a very significant step in progressing the drug development pathway of PH-762 toward an NDA approval. Phio’s communication with FDA is essential in advancing our development strategy for PH-762," stated Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals. "In addition, the initiative to deliver commercially viable drug product from our US supplier is on target for later in 2026. This is another critical advancement in the drug development program of PH-762."

(Press release, Phio Pharmaceuticals, DEC 23, 2025, View Source [SID1234661613])