Sandoz announces collaboration with mAbxience to expand patient access to life-enhancing biosimilar medicines

On September 17, 2026 Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announces a licensing, development, manufacturing and commercialisation agreement with mAbxience, marking another significant step to broaden patient access to high-quality biosimilar medicines worldwide.

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The agreement paves the way for the two companies to collaborate on a proposed emicizumab biosimilar, currently in early-stage development. The reference medicine, Hemlibra* (emicizumab), is used to treat patients with haemophilia A1,2, making emicizumab the first haemophilia medicine in the Sandoz biosimilar pipeline. The reference medicine market is worth an estimated USD 5.7 billion in global sales.3

Richard Saynor, Chief Executive Officer, Sandoz, says: "This agreement with mAbxience reflects our continued commitment to our Purpose of pioneering access for patients. The addition of emicizumab strengthens our pipeline and expands our presence in rare diseases, an area where we believe biosimilars can play an important role in addressing unmet patient needs while supporting the long-term sustainability of healthcare systems in the face of rising treatment costs."

Haemophilia A is a rare genetic disorder caused by inadequate or defective factor VIII (FVIII), a blood-clotting protein, which causes prolonged bleeding in patients4. It is the most common form of haemophilia, accounting for approximately 80% of all cases5, with more than half of patients having a severe form of the disease6.

Under the terms of the agreement, Sandoz will have exclusive global commercialisation rights for the proposed emicizumab biosimilar, excluding Argentina, Uruguay and Paraguay, while mAbxience will be responsible for development and manufacturing. Both parties have agreed to keep the financial terms of the agreement confidential. The agreement also provides a basis for the two companies to evaluate potential future collaboration opportunities based on their shared commitment to expanding patient access to biosimilar medicines around the world.

Overall, the collaboration expands the industry-leading Sandoz biosimilar pipeline to 40 assets and builds on the earlier agreements with Henlius for up to 10 assets and Samsung Bioepis for up to five assets. It also represents another milestone in the Company’s strategy to capture a significant share of the unprecedented upcoming biosimilar loss-of-exclusivity market. Sandoz continues to build on its experience as the pioneer and global leader with a portfolio of 13 molecules available in nearly 100 countries.

*Hemlibra is a registered trademark of Chugai Seiyaku Kabushiki Kaisha.

(Press release, Sandoz, SEP 17, 2026, View Source [SID1234670928])

AbbVie to Present Phase 3 Etentamig Results and Data from Broad Multiple Myeloma Portfolio at the 2026 International Myeloma Society (IMS) Meeting

On September 17, 2026 AbbVie (NYSE: ABBV) reported that new data from its broad multiple myeloma research portfolio will be featured at the 23rd International Myeloma Society (IMS) Annual Meeting, taking place September 23-26, 2026, in Glasgow, Scotland. A plenary presentation will feature full results from the Phase 3 CERVINO study evaluating investigational drug etentamig, a second-generation BCMA x CD3 bispecific T-cell engager. Topline results demonstrated statistically significant and clinically meaningful improvements in objective response rate (ORR) and progression-free survival (PFS), with etentamig meeting the dual primary endpoints versus standard available therapies in adults with triple-class exposed relapsed/refractory multiple myeloma (RRMM).

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Beyond the full CERVINO data, AbbVie will present research demonstrating the breadth of its myeloma pipeline across T-cell engagers, targeted therapies, rational combinations and real-world evidence. Presentations will feature investigational assets including ABBV-2001 (ISB 2001), a CD38 x BCMA x CD3 trispecific T-cell engager, and surzetoclax, a BCL-2 small-molecule inhibitor, alongside studies evaluating etentamig across multiple treatment settings.

Additional presentations from these investigational assets will explore treatment sequencing, infection-related healthcare utilization and costs, and real-world outcomes, reinforcing AbbVie’s strategy to advance understanding of disease heterogeneity, mechanisms of resistance and the evolving needs of patients living with multiple myeloma.

"Despite meaningful progress in multiple myeloma, the disease remains incurable and patients continue to face challenges related to treatment resistance, disease heterogeneity, tolerability and durable disease control," said Daejin Abidoye, M.D., vice president and therapeutic area head, oncology, solid tumor and hematology at AbbVie. "Our presence at IMS reflects the depth and momentum of our multiple myeloma strategy as we advance our scientifically differentiated portfolio, spanning T-cell engagers, targeted therapies and rational combinations designed to address distinct disease mechanisms and evolving patient needs, with the goal of delivering more precise, durable and accessible treatment options."

The full list of AbbVie presentations at IMS includes:

Note: All presentation times are listed in local Glasgow time.

Abstract Title

Date/Time

Session

Abstract Number

Real-World (RW)
Characteristics, Treatment

Patterns, and Outcomes
in Triple-Class Exposed

(TCE)
Relapsed/Refractory
Multiple Myeloma

(RRMM) in Europe:
Results from the
HARMONY Big

Data Platform

Wednesday,
September 23, 2026

12:00–1:00 PM

Poster Presentation

PA-386

Etentamig in Patients with
Relapsed/Refractory

Multiple Myeloma (RRMM)
with Prior Exposure to B-
Cell Maturation Antigen
(BCMA)-Targeted
Therapy

Thursday, September
24, 2026

12:00–1:00 PM

Poster Presentation

PA-181

A Phase 1/2, Open-Label,
Platform Study to

Evaluate the Safety and
Efficacy of Etentamig

Monotherapy or
Combination Therapy in
Patients with Multiple
Myeloma

Friday, September 25,
2026

12:00–1:00 PM

Poster Presentation

PA-008

Phase 1/2, Open-Label,
Platform Study of
Surzetoclax with
Etentamig in Biomarker-

Selected Patients with
Relapsed/Refractory

Multiple Myeloma (RRMM)

Friday, September 25,
2026

12:00–1:00 PM

Poster Presentation

PA-346

Real-World (RW)
Infection-Related
Healthcare Resource
Utilization (HCRU) and
Costs in Patients (pts)
with Multiple Myeloma
(MM) Receiving

T-cell Redirecting
Therapies (TCRTs)

Friday, September 25,
2026

12:00–1:00 PM

Poster Presentation

PA-387

CERVINO: Phase (Ph) 3
Results of Etentamig vs

Investigator’s Choice of
Standard Available

Therapies (SAT) in
Patients (Pts) With Triple-
Class

Exposed Relapsed or
Refractory Multiple
Myeloma

(RRMM)

Friday, September 25,
2026

3:00–5:00 PM

Plenary Session

Hall 5

LBA-01

Etentamig Combined With
Pomalidomide Plus

Dexamethasone
(Pom+Dex) in Relapsed/

Refractory Multiple
Myeloma (RRMM) After
1–3

Prior Lines of Therapy: A
Phase 1b Dose-
Escalation and Safety
Expansion Study

Saturday, September
26, 2026

8:30–9:30 AM

Oral Presentation

Abstract Session 9

Hall 5

OA-24

AbbVie Advances ABBV-
2001/ISB 2001: A Unique,
Single-Molecule
Trispecific T-cell Engager
(TCE) Approach Toward
Robust Anti-Myeloma
Activity with Superior
Tumor Cytotoxicity

Saturday, September
26, 2026

9:30–10:20 AM

Oral Presentation

Future Targets and
New Modalities of
Therapy

Hall 5

N/A

Surzetoclax: A Potentially
Best-in-Class BCL-2

Inhibitor for the Treatment
of Multiple Myeloma

with t(11;14) Translocation
or High BCL-2

Expression

N/A

Poster Presentation

PA-468

More information about the IMS 2026 meeting, including AbbVie’s presence, will be available here.

Additional information around AbbVie’s ongoing clinical trials in multiple myeloma can be found at clinicaltrials.gov.

Etentamig, ABBV-2001 (ISB 2001) and surzetoclax are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies.

(Press release, AbbVie, SEP 17, 2026, View Source [SID1234670927])

Lantern Pharma to Present Open-Medicine AI — a Multi-Agentic Platform for End-to-End Therapeutic Development — Business Model, Roadmap, and Value Proposition on September 23

On September 17, 2026 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage, AI-native biopharma company using artificial intelligence and genomic data to develop precision oncology therapies, reported that it will host a live webinar on Wednesday, September 23, 2026 at 12:30 PM Eastern to present the business model, development roadmap, and value proposition of Open-Medicine AI (OMAI), the company’s wholly owned subsidiary building a multi-agentic AI platform for end-to-end therapeutic development.

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Panna Sharma, Founder and CEO of Open-Medicine AI, will lead the session, which is intended for investors, biopharma and academic collaborators, and prospective partners. The webinar will explain how OMAI is extending the AI co-scientist approach first commercialized in withZeta.ai — launched in April 2026 and focused on rare and aggressive cancers — into additional disease categories, new therapeutic modalities, and the downstream development challenges that consume most of the time and cost between a validated target and a treated patient. A question-and-answer period will follow the presentation.

Built Where the Problems Are

Most AI for drug discovery is built at a distance from drug development. Open-Medicine AI was built inside it. Its co-scientists were developed within Lantern’s own clinical programs — with the same data, constraints, regulatory requirements, and decision points that determine whether a molecule reaches patients — and were first put to work in withZeta.ai, which launched in April 2026 and is in use across rare and aggressive cancers.

The drug discovery and development markets are already moving in this direction. Independent analysts estimate the AI in drug discovery market at approximately $2.9 billion in 2026, growing to $13.8 billion by 2033.1 Additionally, analysts have noted that AI deployments in pharma are moving from pilots to enterprise-scale, agentic systems.2, 3

The result is a platform that does more than propose candidates. It reasons across the full development pathway — target and biomarker selection, compound and modality design, translational analysis, trial design, and regulatory strategy — in which the agents carry the operating knowledge of the scientists and clinicians who built them. The webinar will present:

The platform: the multi-agentic architecture behind Open-Medicine AI, how its co-scientists coordinate across the development pathway, and what distinguishes an agent trained inside active clinical programs from a general-purpose model
The roadmap: the next generation of co-scientists beyond rare cancers, the disease categories and therapeutic modalities being prioritized, and the downstream development challenges — trial design, patient selection, regulatory and translational work — that the platform is being extended to address
The business model: how Open-Medicine AI intends to generate revenue through subscription access and enterprise licensing, and how it works with biopharma companies, research institutions, service providers, and drug developers
The value proposition: where the platform is designed to remove time, cost, and failure from the path between a validated target and a treated patient, and how that is measured
Why now: why an AI platform for therapeutic development is best built by a company that develops therapeutics, and what that means for Lantern Pharma shareholders and for the researchers, developers, and technology partners who will use it
"We did not set out to build an AI company. We set out to get cancer drugs to patients faster and with less capital, and we built the tools we needed to do that because they did not exist. withZeta.ai is what came out of that work, and it is now running inside real programs with real regulatory and clinical consequences. Open-Medicine AI takes that architecture beyond rare cancers and beyond Lantern — into new disease categories, new modalities, and the downstream parts of development where most of the time, cost, and failure live. On September 23 we will show what we have built, how it will be adopted by industry professionals and service providers, and what the development roadmap for the platform and business could look like. We believe that the most useful AI for therapeutic development will come from the people who have actually developed therapeutics and taken them into meaningful trials for the benefit of patients, and done so with a data-driven, time- and cost-conscious mentality."

— Panna Sharma, President and Chief Executive Officer, Lantern Pharma

Webinar Details

Title

Open-Medicine AI: A Multi-Agentic Platform for End-to-End Therapeutic Development — Business Model, Roadmap, and Value Proposition

Date

Wednesday, September 23, 2026

Time

12:30 PM Eastern / 9:30 AM Pacific

Presenter

Panna Sharma, President and CEO, Lantern Pharma; Founder and CEO, Open-Medicine AI

Format

45 minutes — a 30–35 minute presentation followed by live Q&A; questions may be submitted in advance to [email protected]

Registration

View Source

Replay

A recording will be available on the Investors section of www.lanternpharma.com following the event

(Press release, Lantern Pharma, SEP 17, 2026, View Source;a-Multi-Agentic-Platform-for-End-to-End-Therapeutic-Development–Business-Model-Roadmap-and-Value-Proposition-on-September-23/default.aspx [SID1234670926])

INNATE PHARMA REPORTS FIRST HALF 2026 BUSINESS UPDATE AND FINANCIAL RESULTS

On September 17, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the six months ended June 30, 2026. The consolidated financial statements are attached to this press release.

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"2026 continues to be an important year of execution for Innate, marked by our strategic partnership with Sobi and the strengthening of our financial position," said Jonathan Dickinson, CEO of Innate Pharma. "With the TELLOMAK-3 Phase 3 study initiated, we are targeting the first patient in the study in Q1 2027 as we work toward a filing for accelerated approval in Sézary syndrome. Looking ahead, we will present Phase 1 data from IPH4502 at ENA 2026 and expect the PACIFIC-9 Phase 3 readout for monalizumab by year-end, as we remain focused on delivering value for patients and shareholders."

Pipeline highlights:
Lacutamab (anti-KIR3DL2 antibody), partnered with Sobi:

Cutaneous T-Cell Lymphoma

•In August 2026, Innate Pharma entered into a strategic partnership with Sobi to license lacutamab in T-cell lymphoma (Link PR). The partnership is intended to enable initiation of the TELLOMAK-3 confirmatory Phase 3 study in cutaneous T-cell lymphoma (CTCL), a key step toward filing for accelerated approval of lacutamab in Sézary syndrome, a subtype of CTCL.

•On September 16, Innate Pharma announced closing of the transaction under the partnership agreement, following expiration of the anti-trust waiting periods and completion of other conditions (Link PR). This triggers a USD 75 million upfront payment and marks the initiation of the TELLOMAK-3 confirmatory Phase 3 study, with first patient expected in Q1 2027.

•Under the agreement, Innate is conducting the TELLOMAK-3 Phase 3 confirmatory trial in cutaneous T-cell lymphoma. The TELLOMAK-3 study will subsequently support applications for full approvals in key jurisdictions in Sézary syndrome and mycosis fungoides, the most common subtype. Sobi will receive exclusive global rights to commercialize lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following positive Phase 3 results.

•Under the terms of the agreement, Sobi will pay Innate Pharma USD 75 million, payable on closing. Innate will be eligible to receive up to a further USD 40 million in respect of near-term development milestones connected to Sézary syndrome. Additionally, Innate will be eligible to receive up to USD 465 million related to the option for Sobi to get full development rights and to future regulatory and commercial milestones. Innate will be eligible to receive tiered double-digit royalties on net sales.

•In February 2025, the FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary syndrome based on TELLOMAK Phase 2 results demonstrating encouraging efficacy and a favorable safety profile in patients with Sézary syndrome, heavily pretreated, post-mogamulizumab. Breakthrough Therapy Designation is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically significant endpoint over available medicines. Lacutamab has also received Fast Track designation from the FDA, PRIME designation from the EMA and orphan drug status in both the United States and Europe.

Peripheral T-Cell Lymphoma (PTCL)

•The investigator-sponsored Phase 2 KILT (anti-KIR in T-Cell Lymphoma) trial, led by the Lymphoma Study Association (LYSA), evaluating lacutamab in combination with GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL has ended recruitment.

IPH4502 (Nectin-4 exatecan ADC):

•In July 2026, Innate announced completion of dose-escalation and backfill enrollment in the ongoing Phase 1 study of IPH4502, with 76 patients enrolled across multiple tumor types known to express Nectin-4.

Preliminary anti-tumor activity has been observed in heavily pre-treated patients, including objective responses in urothelial cancer following prior enfortumab vedotin, as well as in NSCLC and HNSCC. A favorable safety profile has been observed to date, with limited hematological toxicity.

Initial Phase 1 dose-escalation data will be presented at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026) on November 18, 2026.

Monalizumab (anti-NKG2A antibody), developed in collaboration with AstraZeneca:

PACIFIC-9 is an AstraZeneca-sponsored Phase 3 study evaluating durvalumab in combination with monalizumab or oleclumab in patients with unresectable Stage III NSCLC who have not progressed following platinum-based chemoradiation therapy (CRT). Enrollment in the trial is complete, and data readout is expected in H2 2026.

The Phase 3 program is supported by clinical findings from the Phase 2 COAST study, in which the combination of durvalumab and monalizumab suggested prolonged progression-free survival compared with durvalumab alone.

IPH5201 (anti-CD39 antibody, developed in collaboration with AstraZeneca):

The Phase 2 MATISSE study evaluating IPH5201 in combination with durvalumab and platinum-based chemotherapy in resectable NSCLC is ongoing. Encouraging results from a pre-planned interim analysis presented at AACR (Free AACR Whitepaper) 2026 showed an overall pathological complete response rate of 27.5%, with higher response rates observed in patients with PD-L1-positive tumors.

▪Following the interim analysis, MATISSE continues enrollment in the PD-L1 ≥1% patient population.

Preclinical ADC pipeline

•For its preclinical ADC portfolio, Innate is leveraging its proprietary linker technology, in clinical development through IPH4502. Innate’s next-generation ADC approaches include bispecific ADCs designed to address tumor antigen heterogeneity, approaches aimed at enhancing internalization to unlock activity in tumors with low target expression, and dual-payload approaches intended to overcome payload resistance.

Post period events and Corporate Update:
•In August 2026, Innate Pharma announced the appointment of Markus Jensen, 57, as Chief Medical Officer and member of the Executive Leadership Team, effective September 1, 2026. He succeeds Sonia Quaratino and oversees the Company’s clinical development activities as Innate prepares to advance lacutamab into Phase 3 and continues development of IPH4502. Markus Jensen joined Innate Pharma in 2024 as head of clinical pharmacology and has served as global clinical lead for Company key programs, including IPH4502. He brings more than 25 years of experience spanning clinical medicine, academic research and the pharmaceutical industry. Prior to joining Innate, he held leadership positions at Bayer for more than 16 years, with a particular focus on oncology and clinical development. He holds a medical degree from the University of Cologne and is double board certified by Ärztekammer Nordrhein in Internal Medicine and Clinical Pharmacology.

•On August 18, 2026, Innate completed a capital increase without preferential subscription consisting of a private placement of 17,647,059 new ordinary shares of the Company for aggregate gross proceeds to the Company of an approximately €30 million. Together with the $75 million upfront payment, the proceeds of the private placement are expected to extend the Company’s projected cash runway through end of Q1 2028.

•As of June 30, 2026, the balance available under our April 2023 sales agreement under the At-The-Market program remains at $75 million.

Financials highlights for the first half of 2026:
The key elements of Innate’s financial position and financial results as of and for the six-month period ended June 30, 2026 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €21.4 million (€m) as of June 30, 2026 (€44.8m as of December 31, 2025).

As of June 30, 2026, financial liabilities amount to €20.2m (€22.6m as of December 31, 2025). This change is mainly due to loan repayments.
Revenue and other income amounted to €5.7m in the first half of 2026 (€4.9m in the first half of 2025) and mainly comprised of:
◦Revenue from collaboration and licensing agreements, which mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi. They are recognized when the entity’s performance obligation is met. They are recognized at a point in time or spread over time according to the percentage of completion of the work that the Company is committed to carry out under these agreements:
▪(i) Since December 31, 2025, the revenue from collaboration and licensing agreements for monalizumab has been fully recognized. Therefore, no revenue is recognized for the six months ended June 30, 2026, as compared to €0.1 million for the six months ended June 30, 2025.

(ii) No revenue related to IPH5201 were generated during the six months ended June 30, 2026 as during the six months ended June 30, 2025. As a reminder, the revenue is related to the milestone payment received from AstraZeneca following the signature on June 1, 2022 of an amendment to the initial contract signed in October 2018. This amendment sets the terms of the collaboration following AstraZeneca’s decision to advance IPH5201 to a Phase 2 study.
The Company will conduct the study. Both parties will share the external cost related to the study and incurred by the Company and AstraZeneca will provide products necessary to conduct the clinical trial. Revenue from invoicing of research and development costs for the six months ended June 30, 2026 was 0.4 million compared to 0.9 million for the six months ended June 30, 2025, or a decrease of (0.5) million.

(iii) No revenue were generated for the license and collaboration agreement signed with Sanofi in 2016 for the six months ended June 30, 2026, as well as for the six months ended June 30, 2025. On April 23, 2025, the Company announced that, in alignment with both company’s current strategic priorities, Sanofi and Innate agreed to terminate the 2016 Agreement as it relates to SAR’579/IPH6101 (CD123 ANKET). Innate regained the rights to SAR’579/IPH6101 in July 2025. Data from the Sanofi-led Phase 1/2 study and Phase 2 preliminary dose expansion of the trial have been transferred to Innate. In a recent corporate update, Sanofi announced deprioritization of SAR’514, a trifunctional anti-BCMA NK-cell engager. Sanofi retains exclusive development and commercialization rights, and the license terms remain unchanged. It has not triggered any milestone payments as of June 30, 2026.

(iiii) Revenue related to the research collaboration and licensing agreement signed with Sanofi in 2022 remained constant over the period, with revenue amounting to €0.2 million for the first half of 2026, as for the first half of 2025. As previously disclosed, in December 2022, the Company entered into a research collaboration and license agreement with Genzyme Corporation, a wholly owned subsidiary of Sanofi ("Sanofi"), under which the Company granted Sanofi an exclusive license to Innate’s B7-H3 ANKET program and options for two additional targets. In March 2023, Innate Pharma received an upfront payment of €25 million under its research, collaboration and license agreement with Sanofi. This amount consisted of €18.5 million relating to the exclusive license to the B7-H3 technology, which was recognized in profit or loss in June 2023; €1.5 million relating to research activities to be performed over a three-year period, recognized as revenue on a straight-line basis through November 2026; and €5 million relating to the two additional license options, recognized as contract liabilities until their expiration or until the options are exercised.
In December 2023, Sanofi exercised one of its license options for an ANKET program, resulting in the recognition of €2.5 million in revenue and the payment of a €15 million milestone, of which €13.3 million related to the license was recognized immediately in revenue and €1.7 million related to research activities. These research activities were discontinued following the termination of the agreement in October 2024, which led to the full recognition of the €1.7 million in revenue in 2024. As a result, Innate regained the rights to the IPH67 program, while Sanofi retains a right to compensation on any potential future revenues.
On January 24, 2026, following the expiration of the deadline to exercise the license option on an identified target, the revenue of €2.5 million has been fully recognized. Sanofi still has a right on a non-exclusive license option for an additional target, exercisable up to January 24, 2028. This option is not linked with any other revenue.

Government funding for research expenditures of €2.5m in the first half of 2026 (€3.2m in the first half of 2025), decreasing by €0.6 million, or 20.1% in connection with decrease in personnel expenses following the restructuring of the organization to concentrate preclinical and clinical research and development efforts on higher value assets.
Operating expenses are €24.7m in the first half of 2026 (€30.3m in the first half of 2025), of which 68.4% (€16.9m) are related to R&D.
R&D expenses decreased by €3.6m to €16.9m in the first half of 2026 (€20.5m in the first half of 2025). This change is explained by direct R&D expenses, which slightly decreased by €1.5 million or 15% to reach €8.2 million for the first half of 2026. This decrease is related to the phasing of studies (maturity of clinical studies on lacutamab, and IPH5201, discontinuation of preclinical studies, partially offset by the ramp-up of IPH4502, our antibody-drug conjugate (ADC). In addition, Personnel and other R&D expenses decreased by €2.2 million, or 20.0%, to €8.6 million for the six months ended June 30, 2026, compared to €10.8 million for the six months ended June 30, 2025. This decrease is primarily due to a reduction in personnel expenses of €2.7 million, resulting from a reduction in the R&D workforce (from 133 to 92 employees), partially offset by a €0.7 million increase in other expenses, corresponding to a provision for risks and charges.
General and administrative (G&A) expenses decreased by €2.0m to €7.8m in the first half of 2026 (€9.8m in the first half of 2025) mainly resulting from an decrease in personnel expenses for €1.5 million due to employees reduction (29 employees for the six months ended June 30, 2026 vs. 42 for the six months ended June 30, 2025), a decrease in non-scientific and consulting fees for €0.2 million due to the suspension of the "At the Market" program on the Nasdaq , a decrease in Other expense for €0.2 million in connection with the Director & Officer (D&O) insurance policy.

•A net financial loss of €0.6m in the first half of 2026 (profit for €4.1m in the first half of 2025). This change is mainly due to an unfavorable variation in net foreign exchange gain with its unfavorable impact on the collaboration liabilities recorded during the first half of 2026 in connection with the change in the dollar exchange rate and an unfavorable variation in income resulting from financial assets and fair value revaluation due to an unfavorable effect of investment rates recorded on the financial markets.
A net loss of €19.6m for the first half of 2026 (net loss of €21.3m for the first half of 2025).
The table below summarizes the IFRS consolidated financial statements as of and for the six months ended June 30, 2026, including 2025 comparative information.

In thousands of euros, except for data per share
June 30, 2026
June 30, 2025
Revenue and other income
5,663
4,860
Research and development expenses
(16,877)
(20,520)
General and administrative expenses
(7,797)
(9,767)
Operating expenses
(24,674)
(30,287)
Operating income (loss)
(19,011)
(25,427)
Net financial income (loss)
(612)
4,083
Income tax expense


Net income (loss)
(19,623)
(21,344)
Weighted average number of shares ( in thousands) :
93,827
86,937
– Basic income (loss) per share
(0.21)
(0.25)
– Diluted income (loss) per share
(0.21)
(0.25)

June 30, 2026
December 31, 2025
Cash, cash equivalents and financial assets
21,376
44,765
Total assets
34,726
62,719
Total shareholders’ equity
-40,508
-21,704
Total financial debt
20,206
22,571

(Press release, Innate Pharma, SEP 17, 2026, View Source [SID1234670924])

Fennec Pharmaceuticals Announces ORAL PRESENTATION OF DETAILED Results From Investigator-Initiated Phase 2 STS-J01 Clinical Study of PEDMARK® in Japan AT SIOP 2026

On September 17, 2026 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported the oral presentation of detailed results from the investigator-initiated Phase 2 STS-J01 clinical trial evaluating PEDMARK (sodium thiosulfate injection) for the reduction of cisplatin-induced ototoxicity in pediatric and adolescent and young adult (AYA) patients with non-metastatic solid tumors in Japan. The data will be presented today during the 58th Annual International Society of Pediatric Oncology (SIOP) Annual Meeting in San Antonio, TX.

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PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors, and is also recognized by the National Comprehensive Cancer Network with a 2A endorsement for use in AYA patients.

The study enrolled 33 patients across 11 institutions in Japan, including 27 patients in the primary cohort and six in exploratory cohorts. Key study findings include:

● Among the 25 patients comprising the primary efficacy population, ASH (Free ASH Whitepaper)A-defined hearing loss occurred in 24.0% (6/25), significantly lower than the prespecified historical benchmark of 56.4% (P=0.001).
● Nineteen of 25 patients (76.0%) remained free of ASH (Free ASH Whitepaper)A-defined hearing loss. By Brock criteria, 84.0% of patients had Grade 0 hearing loss, and no patient experienced Grade 3 or Grade 4 hearing loss.
● Objective tumor responses were observed in 23 of 24 evaluable patients (95.8%), providing reassuring clinical context for delayed PEDMARK administration six hours following cisplatin.
● Prospective pharmacokinetic analyses further characterized the interaction between PEDMARK and cisplatin-derived platinum and provide mechanistic support for the six-hour administration strategy for pediatric and adolescent and young adult (AYA) patients.

"The clinical and pharmacologic findings of STS-J01 are compelling. We observed a significant reduction in hearing loss, with no Grade 3 or Grade 4 hearing loss by Brock criteria, alongside a 95.8% objective response rate in evaluable patients. The prospective pharmacokinetic analyses further provide important mechanistic insight into why the six-hour interval matters, supporting a model in which PEDMARK acts on residual circulating and exchangeable platinum after cisplatin has had time to distribute and initiate its antitumor activity. Together, these findings add an important independent body of evidence supporting the clinical rationale for delayed PEDMARK administration," said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals.

The safety profile was consistent with the known tolerability profile of PEDMARK and the expected toxicities of cisplatin-containing chemotherapy. No serious adverse event was attributed to PEDMARK, and no Grade 4 PEDMARK-related toxicity was observed.

"For patients navigating cancer in Japan, the ability to successfully treat their tumors while preserving hearing can have a profound impact on their lives long after treatment ends. Cisplatin remains an important and effective treatment, but the risk of permanent hearing loss represents a significant unmet need, particularly for children and young people who may live with its consequences for the rest of their lives," said Eiso Hiyama, M.D., PhD, lead investigator and professor in the Department of Pediatric Surgery at Hiroshima University Hospital in Hiroshima, Japan. "The results from STS-J01 are encouraging because they demonstrate significant hearing protection and provide reassuring clinical context regarding antitumor activity with delayed PEDMARK administration. We believe that these results provide further support and confidence in PEDMARK for healthcare professionals."

Fennec is pursuing registration in Japan and is currently exploring partnering or licensing opportunities for PEDMARK.

About the STS-J01 Study

STS-J01 is a Phase 2, investigator-initiated, open-label, single-arm clinical trial designed to evaluate PEDMARK for the prevention of cisplatin-induced ototoxicity. The study enrolled 33 patients in two cohorts: 27 children ages 3-18 years (primary cohort), and 6 patients in exploratory cohorts, all with localized-stage solid tumors, including neuroblastoma, hepatoblastoma, germ cell tumors, bone and soft tissue sarcomas, medulloblastoma, and atypical teratoid rhabdoid tumors. Patients received PEDMARK intravenously six hours after cisplatin infusion, with dosing adjusted by body weight. The primary endpoint was the incidence of hearing impairment at the end of treatment in the 3- to 18-year-old cohort, assessed according to American Speech-Language-Hearing Association (ASHA) criteria. Secondary endpoints included safety, antitumor efficacy, pharmacokinetics, and incidence of hearing loss as measured by Brock grading. Exploratory measures included longitudinal audiometric follow-up and validation of surrogate hearing tests.

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.i

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapy.ii Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.iii Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.iv,v While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

PEDMARK (sodium thiosulfate injection)

PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.vi,vii The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.viii,ix

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage
PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use
The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information
PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

(Press release, Fennec Pharmaceuticals, SEP 17, 2026, View Source [SID1234670923])