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Immunocore announces 2026 strategic priorities at 44th Annual J.P. Morgan Healthcare Conference

On January 9, 2026 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported its strategic priorities for 2026 including its plans for reaching more patients with melanoma and other diseases with high unmet needs.

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The Company highlights the potential of its melanoma franchise building on KIMMTRAK’s performance including the completion of enrollment in TEBE-AM, the registrational late-line cutaneous melanoma trial, in the first half of this year. In addition to enrolling patients in three Phase 3 trials, the Company expects to present data from multiple Phase 1/2 trials in 2026.

"2026 will be an important year for Immunocore. We are building a leading melanoma franchise – first with KIMMTRAK, the standard of care for HLA-A*02:01-positive patients with metastatic uveal melanoma, and next in cutaneous melanoma through the TEBE-AM Phase 3 trial, which is our top priority for 2026," said Bahija Jallal, CEO of Immunocore. "We expect to complete enrollment in the first half, positioning us for data readout as early as the second half of the year. We also continue to advance our broad pipeline, with pivotal readouts in oncology and infectious diseases, and dosing of the first patient in our first autoimmune trial this year."

"We have a significant amount of data for our PRAME bispecific candidates, as monotherapy and combinations, and are enrolling patients in our first-line cutaneous melanoma Phase 3 trial," said David Berman, Head of Research & Development. "In the second half of 2026, we plan to share clinical data from both brenetafusp in ovarian and lung cancer and IMC-P115C, our PRAME half-life extended candidate, which will inform next development steps."

Key Strategic Priorities 2026

The Company has pioneered a leading scalable, off-the-shelf immunomodulating platform and will focus on the following three priorities in 2026, as it continues developing and delivering transformative treatment options to patients:

Grow KIMMTRAK (tebentafusp) and prepare for potential new melanoma indications: reaching more metastatic uveal melanoma (mUM) patients and delivering KIMMTRAK’s lifecycle management program through two ongoing registrational Phase 3 trials (TEBE-AM and ATOM). The Company is also enrolling a third registrational trial, PRISM-MEL-301, evaluating brenetafusp in first-line melanoma.
Expand beyond melanoma into other tumor types: in 2026, the Company anticipates having multiple Phase 1 readouts with its PRAME bispecific candidates – brenetafusp and IMC-P115C (PRAME-A02-HLE) – across multiple tumor types, including ovarian and non-small cell lung cancer (NSCLC), in combination with multiple therapies. This data will inform next steps. The Company is also enrolling patients in a Phase 1 dose escalation trial, including combinations, in colorectal cancer with IMC-R117C (PIWIL1-A02).
Realize growth opportunities beyond oncology: in 2025, the Company showed important proof of concept data for its infectious disease platform and continues to dose escalate and monitor the viral rebound kinetics in the Phase 1 trial in people living with HIV. The Company is also advancing its two autoimmune disease candidates towards the clinic: initiation of the Phase 1 trial for IMC-S118AI (PPI x PD1), and submission of a clinical trial application for IMC-U120AI (CD1a x PD1).

Upcoming Expected Catalysts

KIMMTRAK

2026: Entering its fifth year post-approval; expect moderating revenue growth driven by continued increase in US community centers and global penetration
First half of 2026: Long-term 5-year Overall Survival (OS) data from Phase 3 tebentafusp trial in mUM
Second half of 2026: Additional real-world evidence data from KIMMTRAK in mUM
Tebentafusp

First half of 2026: Complete enrollment of Phase 3 registrational trial in previously treated cutaneous melanoma (TEBE-AM), with topline readout as early as 2H 2026
Continue enrollment of Phase 3 registrational adjuvant uveal melanoma trial (ATOM); led by the EORTC
PRAME programs

Second half of 2026: Present data from Phase 1/2 brenetafusp combinations in ovarian, including platinum sensitive ovarian cancer
Second half of 2026: Present data from Phase 1/2 brenetafusp monotherapy and combinations in NSCLC
Second half of 2026: Present initial data from Phase 1 trial with IMC-P115C (PRAME-A02-HLE) in multiple solid tumors
Continue enrollment in Phase 3 brenetafusp combination trial in 1L cutaneous melanoma (PRISM-MEL-301)
PIWIL1

2027: Present initial data from Phase 1 dose escalation in colorectal cancer

Infectious Diseases

Second half of 2026: Present additional data from Phase 1 HIV trial

Autoimmune Diseases

First half of 2026: Dose first patient in Phase 1 trial in type 1 diabetes with IMC-S118AI
Second half of 2026: File clinical trial application/Investigational New Drug application for a Phase 1 trial in atopic dermatitis with IMC-U120AI
Preliminary Year-End 2025 cash position

Preliminary unaudited cash, cash equivalents and marketable securities were approximately $864 million as of December 31, 2025. In the fourth quarter of 2025, the Company paid sales-related rebate accruals. Immunocore will report its final and complete fourth-quarter and full-year 2025 financial results in late February 2026, and the actual results could be different from these preliminary unaudited financial results.

44th Annual J.P. Morgan Healthcare Conference

The Company has updated its corporate presentation to reflect its business and strategic updates. The Immunocore management team will discuss these updates during a live and webcast presentation at the 44th Annual J.P. Morgan Healthcare Conference, on Wednesday, January 14, 2026, at 8:15 a.m. Pacific Standard Time (PST). The presentation and webcast will be available in the ‘Investors’ section of Immunocore’s website at www.immunocore.com. A replay of the presentation will be made available for a limited time.

(Press release, Immunocore, JAN 9, 2026, View Source [SID1234661895])

iBio Announces $26 Million Private Placement

On January 9, 2026 iBio, Inc. (NASDAQ:IBIO), an AI-driven innovator of precision antibody therapies, reported that it has entered into a securities purchase agreement with existing healthcare-focused, high-quality institutional investors for a private placement ("PIPE") financing that is expected to result in gross proceeds of approximately $26 million to the Company before placement agent fees and offering expenses. The offering is expected to close on or about January 13, 2026, subject to customary closing conditions.

The financing was led by Frazier Life Sciences and included participation from other existing investors.

iBio intends to use the net proceeds received from the offering to advance its preclinical cardiometabolic programs, including IBIO-610, IBIO-600, and the myostatin and activin A bispecific programs, through key development milestones, as well as to continue to progress its other preclinical pipeline assets, and the balance, if any, to fund iBio’s working capital requirements and for other general corporate purposes. This financing extends iBio’s cash runway into calendar 2028.

Pursuant to the terms of the securities purchase agreement, the Company is selling an aggregate of 11,061,738 shares of common stock (or pre-funded warrant in lieu thereof) at a purchase price of $2.35 per share (or $2.349 per pre-funded warrant), subject to certain beneficial ownership limitations set by each holder.

Leerink Partners acted as the lead placement agent for the offering. LifeSci Capital and Oppenheimer & Co. acted as co-placement agents.

The unregistered shares of common stock and pre-funded warrants sold in the PIPE financing described above were offered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and, along with the shares of common stock underlying the pre-funded warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the shares of common stock, the pre-funded warrants and the shares of common stock underlying the pre-funded warrants may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to the terms of the securities purchase agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered shares of common stock and the shares issuable upon exercise of the unregistered pre-funded warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, iBioPharma, JAN 9, 2026, View Source [SID1234661894])

Heron Therapeutics Announces Preliminary, Unaudited Q4 and Full-Year 2025 Net Revenue; ZYNRELEF® Largest Contributor to Q4 Growth

On January 9, 2026 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported preliminary, unaudited fourth quarter and full-year 2025 net revenue.

"We are encouraged by the growth in Q4 2025, driven in particular by the momentum in our Acute Care franchise with ZYNRELEF and APONVIE," said Craig Collard, Chief Executive Officer of Heron. "In addition to our revenue growth, we are extremely pleased with the continued progress made across all aspects of our business throughout the past year."

Preliminary Fourth Quarter and Full Year 2025 Updates

Net revenue of approximately $40.5 million for the three months ended December 31, 2025.
ZYNRELEF net revenue of approximately $12.5 million for the three months ended December 31, 2025.
APONVIE net revenue of approximately $3.8 million for the three months ended December 31, 2025.
CINVANTI net revenue of approximately $22.9 million for the three months ended December 31, 2025.
SUSTOL net revenue of approximately $1.3 million for the three months ended December 31, 2025.
Net revenue of approximately $154.9 million for full-year 2025.
ZYNRELEF delivered the largest quarter-over-quarter revenue increase within the portfolio in Q4 (up ~35% vs Q3 2025).

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

About APONVIE for Prevention of Postoperative Nausea and Vomiting ("PONV") Prevention

APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of post operative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for the prevention of PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023. Please see full prescribing information at www.APONVIE.com.

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy). Please see full prescribing information at www.SUSTOL.com.

(Press release, Heron Therapeutics, JAN 9, 2026, View Source [SID1234661893])

Delcath Systems Announces Preliminary Fourth Quarter and Full Year 2025 Financial Results

On January 9, 2026 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported preliminary financial results and business updates for the fourth quarter and year-ended December 31, 2025.

Preliminary Fourth Quarter and Full-Year 2025 Financial Results (unaudited)

Total fourth quarter and full year revenue expected to be approximately $20.7 million and $85.2 million, respectively
HEPZATO KIT fourth quarter and full year revenue expected to be approximately $19.0 million and $78.8 million, respectively
CHEMOSAT fourth quarter and full year revenue expected to be approximately $1.7 million and $6.4 million, respectively
628,572 common shares repurchased for $6.0 million through December 31, 2025 under the approved $25.0 million Share Buyback Program
As of December 31, 2025, the Company had approximately $91.0 million of cash and short-term investments and no debt compared to cash and short-term investments of $88.9 million as of September 30, 2025
Final financial results for the fourth quarter and full year 2025 and a detailed business update will be provided during Delcath’s annual financial results release and business update call.

Recent Business Highlights

Currently 25 active centers
Approximately 140% growth in HEPZATO procedure volume in 2025 versus 2024
Independent investigators presented results from the Phase 2 CHOPIN trial sponsored by Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab in metastatic uveal melanoma at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone
Recent publications have highlighted the application, enhanced outcomes, and associated efficacy of percutaneous hepatic perfusion (PHP) in the management of metastatic uveal melanoma (mUM):
"Characterization of long-term survivors with liver metastases from uveal melanoma diagnosed between 2005 and 2021" in International Journal of Cancer
"Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience" in Cancers
"Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma" in Journal of Cancer Research and Clinical Oncology
"In 2026 we will continue to drive increased adoption and utilization of HEPZATO by raising awareness among treating physicians of the CHOPIN study findings," said Gerard Michel, Chief Executive Officer of Delcath. "Our strong financial position enables us to invest in both commercial expansion and the initiation of additional clinical programs in 2026."

Preliminary and Unaudited Nature of Reported Results

The Company has not yet completed its financial close process for the fourth quarter and full year 2025 and, as a result, actual results may vary from the estimated preliminary results set forth in this press release due to a number of factors, including audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended December 31, 2025, are finalized. The estimated preliminary financial results have not been audited or reviewed by the Company’s independent registered public accounting firm. These estimates should not be viewed as a substitute for the Company’s full, interim or annual audited financial statements.

(Press release, Delcath Systems, JAN 9, 2026, View Source [SID1234661892])

Curis Announces Closing of Private Placement Totaling up to $80.8 Million in Gross Proceeds

On January 9, 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 the closing of its previously announced private placement (the "PIPE financing") for gross proceeds of up to $80.8 million to the Company, including initial gross proceeds to the Company of approximately $20.2 million, in each case before placement agent fees and offering expenses.

In addition to the healthcare-focused institutional investors listed above, the private placement included participation from other new and existing institutional investors, as well as members of the Company’s management team and board of directors.

Laidlaw & Company (UK) Ltd. acted as sole placement agent for the PIPE financing.

(Press release, Curis, JAN 9, 2026, View Source [SID1234661891])