On October 30, 2025 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported it will present new preclinical and translational data from multiple investigational programs at two scientific conferences in November – the World ADC Conference in San Diego, California, and PEGS Europe, in Lisbon, Portugal.

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At these global forums, SOTIO will highlight progress across its next-generation antibody-drug conjugates (ADCs) and immunocytokine pipeline, which is advancing toward new treatment options for patients with solid tumors in areas of unmet medical need. Topics of the presentations include:

SOT106, a novel ADC targeting LRRC15 for the treatment of mesenchymal tumors, with a particular focus on soft tissue sarcoma and osteosarcoma. Preclinical data demonstrate a high therapeutic index and strong anti-tumor activity, supporting its potential best-in-class profile.
SOT109, SOTIO’s lead CDH17-targeting ADC for gastrointestinal cancers, including colorectal and other GI malignancies. Preclinical findings show robust efficacy and a favorable safety profile, reinforcing best-in-class therapeutic potential.
SOT201, a cis-acting PD-1/IL-15 mutein-based immunocytokine designed to target and reinvigorate exhausted T cells in the tumor microenvironment while maintaining a systemic immune balance. SOT201 is currently under clinical evaluation in the Phase 1 VICTORIA-01 study in patients with advanced metastatic cancers.
"These data reflect the significant progress we are making across our pipeline and the strength of our scientific foundation," said Radek Špíšek, M.D., Ph.D., chief executive officer of SOTIO. "By integrating deep insights into cancer biology with next-generation therapeutic modalities, we aim to provide new therapies for diseases with high unmet medical need."

World ADC oral presentation details:

Title: "Exploring Novel Pharmacology & Translational Aspects of SOT106 Targeting LRRC15 in Solid Tumors"
Session: Pharmacology track
Presenter: Lenka Palova Jelinkova
Date & Time: November 3, 2025, 10:30am PT

Title: "Advancing a Preclinical Pipeline of ADCs Targeting Gastrointestinal Cancers"
Session: Preclinical track
Presenter: Amy Jensen-Smith
Date & Time: November 5, 2025, 3:00pm PT

PEGS Europe oral presentation details:

Keynote Presentation Title: "SOT109: A CDH17 Targeting ADC with Best-in-Class Potential Activity for the Treatment of CRC and Other GI Cancers"
Session: Engineering Antibody-Drug Conjugates
Presenter: Radek Špíšek
Date & Time: November 12, 2025, 1:50pm CET

Title: "Preclinical Pharmacology and Translational Aspects of a Cis-Acting PD-1/IL-15 Mutein-Based Immunocytokine SOT201"
Session: Next-Generation Immunotherapies
Presenter: Anna Jirovec
Date & Time: November 13, 2025, 5:10pm CET

Presentation materials will be available upon request following the live presentations.

(Press release, SOTIO, OCT 30, 2025, View Source [SID1234657189])

On October 30, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported financial results and updates for the third quarter ended September 30, 2025.

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"As we approach year-end, we remain focused on our two key PYRUKYND milestones – the potential U.S. approval in thalassemia and the topline results from the RISE UP Phase 3 trial in sickle cell disease. Our recent engagements with these communities have underscored the urgent need for innovation and PYRUKYND’s potential to address critical gaps in care for these serious and life-threatening diseases," said Brian Goff, Chief Executive Officer, Agios. "We continued strong execution across our rare disease portfolio in the third quarter, including the completion of enrollment in our Phase 2b tebapivat trial for lower-risk MDS. We look forward to building on this strong momentum and remain steadfast in our commitment to delivering meaningful progress for the patients we serve."

Third Quarter 2025 and Recent Corporate Highlights
Commercial Performance – PYRUKYND (mitapivat)

Generated $12.9 million in net revenue for the third quarter of 2025, representing an increase of 44 percent from $9.0 million in the third quarter of 2024 and a 3 percent increase from $12.5 million in the second quarter of 2025.
262 unique patients completed prescription enrollment forms, representing an increase of 6 percent over the second quarter of 2025.
149 patients are on therapy in the U.S., inclusive of new starts and continued therapy, representing an increase of 5 percent over the second quarter of 2025.
R&D Highlights
PYRUKYND (mitapivat)

Thalassemia –
United States –
U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia by three months, to December 7, 2025.
Extension was triggered by FDA request for a Risk Evaluation and Mitigation Strategy (REMS) to address the potential risk of hepatocellular injury described in the original application.
Extension was not the result of new or additional efficacy or safety data requested by the FDA or submitted by Agios.
U.S. commercial launch preparations remain underway, and the application remains under active FDA review.
Europe –
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of PYRUKYND in adults for the treatment of anemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia.
A final decision from the European Commission is expected by early 2026.
Gulf Cooperation Council (GCC) –
PYRUKYND received approval in Saudi Arabia for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.
Commercial launch activities are underway in Saudi Arabia in partnership with NewBridge Pharmaceuticals.
In the United Arab Emirates, PYRUKYND thalassemia regulatory application remains under active review.
Sickle Cell Disease –
Topline results from the RISE UP Phase 3 trial of mitapivat in sickle cell disease are expected by year-end, potentially supporting a U.S. commercial launch in 2026.
Tebapivat

Lower-risk Myelodysplastic Syndromes (LR-MDS) –
Completed patient enrollment in the Phase 2b trial of tebapivat in LR-MDS. Following findings from the Phase 2a trial, the Phase 2b trial is evaluating three higher daily doses (10 mg, 15 mg, and 20 mg) versus placebo over 24 weeks. Topline results from this trial are expected in early 2026.
Third Quarter 2025 Financial Results
For the quarter ended September 30, 2025, net loss was $103.4 million dollars, compared to net income of $947.9 million dollars for the quarter ended September 30, 2024. The net income in the third quarter of 2024 was due to the milestone payment from Servier and the sale of royalty rights to Royalty Pharma, both of which were recorded in that quarter.

Net product revenue from sales of PYRUKYND for the third quarter of 2025 was $12.9 million, compared to $9.0 million for the third quarter of 2024.

Cost of sales for the third quarter of 2025 was $1.7 million.

Research and Development (R&D) Expenses were $86.8 million for the third quarter of 2025, an increase of $14.3 million compared to the third quarter of 2024. The year-over-year increase was primarily driven by increased clinical trial costs associated with the PK activation franchise.

Selling, General and Administrative (SG&A) Expenses were $41.3 million for the third quarter of 2025, representing an increase of $2.7 million compared to the third quarter of 2024, primarily driven by disciplined investment in preparation for the potential U.S. commercial launch of PYRUKYND in thalassemia.

Cash, cash equivalents and marketable securities as of September 30, 2025, were $1.3 billion compared to $1.5 billion as of December 31, 2024. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to prepare for potential PYRUKYND commercial launches in thalassemia and sickle cell disease, advance existing clinical programs, and opportunistically expand its pipeline through both internally and externally discovered assets.
Conference Call Information
Agios will host a conference call and live webcast today at 8:00 a.m. ET to discuss the company’s third quarter 2025 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

(Press release, Agios Pharmaceuticals, OCT 30, 2025, View Source [SID1234657125])

On October 30, 2025 Boehringer Ingelheim and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and COO: Abdul Mullick) reported that Boehringer Ingelheim has licensed a pre-clinical program from Kyowa Kirin to develop a potential first-in-class, small molecule for the treatment of autoimmune diseases.

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Autoimmune diseases represent a substantial and growing global health challenge, affecting approximately one in ten people and imposing a significant burden on patients and healthcare systems. Despite progress in therapeutic innovation, there remains a high need for more effective and long-lasting treatment options. As a recognized leader in autoimmune disease research and development, Boehringer Ingelheim advances new approaches that target the root causes of autoimmune conditions, with the goal of delivering highly targeted new therapies.

"Our commitment to delivering life changing therapies for patients with autoimmune diseases is unwavering. We are pleased to add a potential first in class program to our growing pipeline," said Carine Boustany, US Innovation Unit Site Head and Global Head of Immunology and Respiratory Diseases at Boehringer Ingelheim. "This agreement constitutes an important step toward delivering breakthrough treatments for patients ."

Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin, commented, "This compound, discovered through Kyowa Kirin’s deep expertise in innovative technology and disease biology, holds tremendous potential. Leveraging Boehringer Ingelheim’s renowned expertise in inflammatory diseases, we are confident that this innovation will be developed efficiently and delivered to the patients who need it most."

Under the terms of the agreement Boehringer Ingelheim will receive exclusive worldwide rights from Kyowa Kirin to develop this small molecule program. Kyowa Kirin is eligible to receive up to € 640 million, including an upfront payment, success-based development, regulatory, and commercial milestone payments, in addition to royalties on possible sales.

(Press release, Kyowa Hakko Kirin, OCT 30, 2025, View Source [SID1234657155])

On October 30, 2025 Nektar Therapeutics (Nasdaq: NKTR) reported that company management will be webcasting its participation in the Jefferies Global Healthcare Conference being held November 17-20, 2025 in London.

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Jefferies Global Healthcare Conference in London on Thursday, November 20, 2025 – webcast to be available at 11:00 a.m. Greenwich Mean Time / 3:00 a.m. Pacific Time – link here
The fireside chat will be accessible via the webcast link above as well as on the Investor Events section of the Nektar website: View Source A replay of the presentation will be available for 30 days.

If you would like to request a one-on-one meeting with company management during the conference, please reach out to your Jefferies representative.

(Press release, Nektar Therapeutics, OCT 30, 2025, View Source [SID1234657173])

On October 30, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported plans to report its third quarter 2025 financial results and provide a business update on Friday, November 7th, 2025, before market open. The company will be hosting a teleconference in conjunction with this press release which will include review of the upcoming data presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting highlighting the full data set demonstrating CD47 overexpression as a key potential predictive biomarker for response with evorpacept in HER2+ gastric cancer.

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Third Quarter 2025 Webcast Information:
Date & Time: Friday, November 7, 2025 at 5:30 a.m. PT / 8:30 a.m. ET
Webcast Access: View Source;tp_key=b49359356f
Participant Listening Options by Phone: To access the conference call, please dial 1-877- 407-0752 or +1-201-389-0912 and ask to be joined into the ALX Oncology Third Quarter 2025 Financial Results Conference Call. Another option for instant telephone access to the event is to use the Call me link: View Source;passcode=13755276&h=true&info=company&r=true&B=6

A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, www.alxoncology.com. An archived webcast will be available on the Company’s website after the event.

The poster presentation titled, CD47 expression as a predictive biomarker for evorpacept in HER2-positive gastric/gastroesophageal cancer from the Phase 2 randomized ASPEN-06 trial, abstract number 496, will be presented at SITC (Free SITC Whitepaper) on Saturday, November 8th and available to SITC (Free SITC Whitepaper) attendees as an eposter on November 7th. The poster will be presented by Dr. Zev A. Wainberg, Professor of Medicine and Co-Director of GI Oncology Program, University of California, Los Angeles.

(Press release, ALX Oncology, OCT 30, 2025, View Source [SID1234657126])