On April 29, 2026 Spherix reported breadth of physician-driven research underscores emerging trends in oncology as three abstracts are accepted at ASCO (Free ASCO Whitepaper) 2026:

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Operational and clinical drivers of subcutaneous PD-1/PD-L1 inhibitor adoption: A mixed-methods analysis of U.S. oncology practice patterns.
Tumor-specific drivers of PD-1/PD-L1 inhibitor brand preference in NSCLC, melanoma, and renal cell carcinoma: A U.S. oncologist perspective.
Treatment decision-making after CAR-T and bispecific antibody therapy in relapsed/refractory multiple myeloma: Real-world perspectives from U.S. hematologist/oncologists.
Spherix Global Insights continues to expand its presence in oncology market intelligence with the release of new findings from its RealTime Dynamix service focused on PD-1 inhibition in solid tumors, alongside the company’s acceptance of three abstracts at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including one poster presentation, coauthored with Dr. Kimberly Ku of Illinois CancerCare. Together, these milestones underscore both the breadth of Spherix’s oncology research portfolio and the growing impact of its physician-derived insights on the broader oncology community.

The latest RealTime Dynamix research, based on a survey of more than 100 U.S. oncologists, highlights a rapidly evolving PD-1 landscape marked by increasing overall utilization, meaningful shifts in route of administration, and emerging complexities in real-world treatment decision-making.

Across tumor types, oncologists report that use of PD-1 inhibitor regimens is expected to grow over the next six months, reinforcing the class’s continued central role in solid tumor management. At the same time, the data reveal a notable transition from traditional intravenous administration toward subcutaneous options. While intravenous regimens remain foundational – often serving as the preferred starting point – physicians increasingly signal a willingness to adopt subcutaneous alternatives, particularly in maintenance settings where convenience and efficiency are more highly valued.

Importantly, this shift is not without friction. Spherix findings suggest that while uptake of subcutaneous PD-1 inhibitors is accelerating, particularly in monotherapy settings, utilization may be more limited in combination regimens due to logistical challenges and access considerations encountered in real-world practice. These dynamics highlight a nuanced adoption curve, where clinical enthusiasm is tempered by operational realities.

The competitive landscape remains highly differentiated by tumor type. Pembrolizumab (Keytruda, Merck) continues to lead across multiple non-small cell lung cancer (NSCLC) segments and renal cell carcinoma (RCC), while nivolumab (Opdivo, Bristol Myers Squibb) maintains a strong position in melanoma. However, the introduction of subcutaneous formulations is reshaping share dynamics within brands, with meaningful internal shifts from intravenous to subcutaneous use projected across key indications in the coming months.

Beyond branded therapies, Spherix research points to a growing awareness of PD-1 biosimilars in development, though physician visibility into actual product selection remains limited. Oncologists largely recognize the value of biosimilars – particularly in high-volume settings such as NSCLC – yet report that treatment decisions are often dictated at the institutional or payer level, reducing direct physician control over brand choice.

Collectively, these findings illustrate a market in transition, where innovation in formulation, evolving treatment strategies, and cost considerations are converging to shape the next phase of PD-1 utilization.

Spherix’s upcoming presence at ASCO (Free ASCO Whitepaper) 2026 builds on this momentum. The company’s three accepted abstracts, including a poster presentation, reflect the depth and rigor of its oncology research and mark a significant milestone as Spherix brings its real-world evidence and physician insights to one of the field’s most prominent global stages for the first time.

The accepted research spans key areas of oncology, further reinforcing Spherix’s commitment to delivering timely, actionable insights that inform strategic decision-making across the healthcare ecosystem. By pairing robust primary research with deep therapeutic expertise, Spherix continues to provide a uniquely comprehensive view of rapidly evolving markets.

As the oncology landscape grows increasingly complex, Spherix remains focused on illuminating the intersection of clinical innovation and real-world practice – equipping stakeholders with the clarity needed to navigate change and anticipate what comes next.

About RealTime Dynamix

RealTime Dynamix is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.

(Press release, Spherix, APR 29, 2026, View Source [SID1234664921])

On April 29, 2026 Biogen Inc. (Nasdaq: BIIB) reported first quarter 2026 financial results. Commenting on the quarter, President and Chief Executive Officer Christopher A. Viehbacher said:

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"We significantly advanced our transformation into the New Biogen through strong commercial and pipeline execution and the announcement of our intent to acquire Apellis. We believe the planned acquisition of Apellis will bolster our revenue and earnings growth, adding two differentiated commercial medicines and deepening the foundation for felzartamab, our key Phase 3 asset in kidney disease. This acquisition and the acquired rights to felzartamab in China come while we also expanded sales of our growth products, demonstrated continued resilience in our MS portfolio and reported important positive new data that reinforce our confidence in the late‑stage pipeline."
Financial Highlights
Q1 ’26 Q1 ’25 △
r (CC*)
Total Revenue (in millions) $2,478 $2,431 2% (2)%
GAAP diluted EPS $2.15 $1.64 31% N/A
Non-GAAP diluted EPS $3.57 $3.02 18% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q1 ’26 Q1 ’25 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$958 $953 —% (3)%
Rare disease revenue(2)
$557 $563 (1)% (5)%
Biosimilars revenue $182 $181 1% (7)%
Other product revenue(3)
$55 $29 88% 87%
Total product revenue $1,752 $1,727 1% (3)%
Revenue from anti-CD20 therapeutic programs $419 $378 11% 11%
Alzheimer’s collaboration revenue(4)
$60 $33 80% 80%
Contract manufacturing, royalty and other revenue $247 $293 (16)% (20)%
Total revenue $2,478 $2,431 2% (2)%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
(1) Multiple sclerosis includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY and TYSABRI.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE.
(4) Includes Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.

•Within MS product revenue TYSABRI benefitted from approximately $40 million from a favorable adjustment to discounts and allowances and inventory timing in the U.S. and $19 million of favorable inventory timing outside the U.S.

•Contract manufacturing, royalty and other revenue benefitted from the acceleration of manufacturing activity in the first quarter.

Expense Summary
(in millions) Q1 ’26 Q1 ’25 △
GAAP cost of sales*
$661 $629 (5)%
% of Total Revenue 27% 26%
Non-GAAP cost of sales*
$610 $580 (5)%
% of Total Revenue 25% 24%
GAAP R&D expense $539 $434 (24)%
Non-GAAP R&D expense $480 $427 (13)%
GAAP SG&A expense $607 $573 (6)%
Non-GAAP SG&A expense $600 $572 (5)%
GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense $34 $201 NMF

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
IPR&D = in-process R&D; NMF = no meaningful figure.
* Excluding amortization and impairment of acquired intangible assets

•The increase in first quarter 2026 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by product mix.

•The increase in first quarter 2026 GAAP R&D expense was primarily driven by approximately $57 million of step-up amortization related to SKYCLARYS inventory as well as increased investment in late-stage programs including litifilimab and felzartamab. The increase in first quarter 2026 Non-GAAP R&D expense was primarily driven by increased investment in late-stage programs including litifilimab and felzartamab.

•The increase in first quarter 2026 GAAP and Non-GAAP SG&A was primarily driven by investments to support product launches.

•First quarter 2026 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was $34 million.
Other Financial Highlights

•First quarter 2026 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $74 million, which includes approximately $57 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $17 million related to Biogen’s collaboration with Supernus Pharmaceuticals, Inc. for the commercialization of ZURZUVAE in the U.S.

•First quarter 2026 GAAP other expense was approximately $20 million driven by net interest expense partially offset by net unrealized gains on equity securities. First quarter 2026 Non-GAAP other expense was approximately $42 million primarily driven by net interest expense.

•First quarter 2026 GAAP and Non-GAAP effective tax rates were 15.4% and 15.3%, respectively. First quarter 2025 GAAP and Non-GAAP effective tax rates were 22.7% and 19.4%, respectively. The year over year decrease in the Non-GAAP effective tax rate was due to favorable impacts from a foreign tax settlement and vesting of certain share-based awards partly offset by the increase in U.S. taxation on foreign earnings in 2026 under the One Big Beautiful Bill Act.

Financial Position

•First quarter 2026 net cash flow from operations was approximately $646 million. Capital expenditures were approximately $51 million, and free cash flow, a Non-GAAP financial measure defined as net cash flow from operations less capital expenditures, was approximately $594 million.

•As of March 31, 2026, Biogen had cash and cash equivalents totaling approximately $4.7 billion and approximately $6.3 billion in total debt, resulting in net debt of approximately $1.5 billion.

•For the first quarter of 2026 the Company’s weighted average diluted shares were approximately 148 million.
Full Year 2026 Financial Guidance

Biogen is updating its guidance for full year 2026 to reflect an approximately $1.00 impact from acquired IPR&D charges resulting from ongoing business development activities to support Biogen’s growth strategy. This comprises approximately $0.20 recorded in the first quarter and approximately $0.80 expected in the second quarter. This updated guidance excludes the anticipated Apellis transaction. Full year 2026 Non-GAAP diluted EPS range is expected as follows:
Full Year 2026 Non-GAAP Diluted EPS
Prior Guidance (February 2026) $15.25 to $16.25
Approx. impact from acquired IPR&D charges recorded in Q1 and expected in Q2 2026*
(Excluding the Apellis transaction)
($1.00)
Updated Guidance $14.25 to $15.25

*Includes an expected approximately $0.55 Non-GAAP diluted EPS impact from the deal with TJ Biopharma for felzartamab Greater China region rights and an additional $0.25 Non-GAAP diluted EPS impact from a milestone expected to occur in the second quarter of 2026.

Total revenue is expected to decline by a mid-single digit percentage for 2026 as compared to 2025 as further declines in multiple sclerosis product revenue, excluding VUMERITY, are expected to be partially offset by increases in revenue from growth products.

For full year 2026 as compared to full year 2025, Biogen expects the gross margin percentage, and combined Non-GAAP R&D expense and Non-GAAP SG&A expense to be roughly consistent year-over-year. Biogen expects full year 2026 Non-GAAP effective tax rate to be between approximately 17% and 18%.

This guidance also assumes that foreign exchange rates as of April 24, 2026, will remain in effect for the remainder of the year, net of hedging activities.

Other than the acquired IPR&D impact expressly stated above, this financial guidance does not include any other potential future acquired IPR&D charges, impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential healthcare reform, as all are difficult to predict. Other important financial considerations will be provided on the conference call and webcast.

Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2026 that could cause any of these assumptions and expectations to change and/or actual results to vary from this financial guidance.

Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable without unreasonable effort to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from equity security investments; and the ultimate outcome of pending or future litigation. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Conference Call and Webcast

The Company’s earnings conference call for the first quarter will be broadcast via the internet at 8:00 a.m. ET on April 29, 2026 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

(Press release, Biogen, APR 29, 2026, View Source [SID1234664903])

On April 29, 2026 Laguna Biotherapeutics, Inc. (Laguna), a clinical-stage biotechnology company focused on novel live bacterial therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, granting a "safe to proceed" for its lead clinical candidate from the QUAIL platform, LGNA-100.

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LGNA-100 is a first-in-class, attenuated live bacterial immunotherapy designed to safely harness our immune system’s evolved response to Listeria; robustly and durably expanding and activating endogenous γδ T cells that can directly kill cancer cells while also improving existing immunotherapies. The Phase 1 first-in-human study will validate the QUAIL platform and evaluate LGNA-100 in patients with high-risk leukemia following hematopoietic stem cell transplantation (HSCT) to prevent leukemic relapse.

"The IND clearance of our first clinical study is a defining moment and transformative milestone for Laguna as we transition into a clinical-stage company," said Jonathan Kotula, Ph.D., CEO of Laguna. "Our goal is to create systems-level therapies for complex diseases. With LGNA-100, and the QUAIL platform we are taking a fundamentally new approach to selectively stimulate innate T cells to improve long-term outcomes for pediatric patients with high-risk leukemia."

The clinical rationale for the QUAIL platform builds directly upon decades of research into the human γδ T cell response to Listeria, and the protective role of γδ T cells against leukemia recurrence following HSCT. A presentation covering our clinical rationale will be presented at the ISCT 2026 Annual Meeting on May 6 in Dublin, Ireland.

"In the setting of αβ-depleted HSCT, γδ T cells are critical effectors that provide potent graft-versus-leukemia activity without driving graft-versus-host disease," said Dr. Alice Bertaina, MD, PhD, Co-Director of the Bass Center for Childhood Cancer and Blood Diseases, Lucile Packard Children’s Hospital at Stanford University and lead Clinical Advisor for Laguna. "While early pharmacologic activators like zoledronic acid (ZOL) showed the clinical potential of this approach, intense ZOL stimulation pushes these cells into a more mature, terminally differentiated and exhausted state. Our comprehensive preclinical evaluations demonstrate that LGNA-100 drives a distinct, multifunctional γδ T cell response with improved kinetic, phenotypic, and functional features compared to ZOL, supporting more durable activation without hyperactivation or early exhaustion. I am very excited to see this translated into the clinic for these high-risk leukemia patients."

"Pediatric AML remains one of the most challenging frontiers in oncology, demanding novel modalities that can detect and kill the disease without compounding toxicities," said Bill Newell, former CEO of Sutro Biopharma and Strategic Advisor to Laguna. "Having spent years evaluating platforms to tackle these exact malignancies, I believe Laguna’s approach using γδ T cells to potentially solve the problems associated with high-risk leukemia is a massive leap forward. Securing this IND is a testament to the rigor of their science and positions LGNA-100 as a highly differentiated asset in the cancer immunotherapy space."

The Phase 1 clinical study is a company-sponsored open-label, first-in-human, single ascending dose study designed to assess safety and tolerability, and support the proof of LGNA-100’s mechanism of action. The study will evaluate LGNA-100 administered via intravenous (IV) infusion in pediatric and young adult participants with high-risk acute leukemias and MDS who have received an αβ-depleted HSCT.

About LGNA-100

LGNA-100 also known as QUAIL-100 is an investigational cancer immunotherapeutic agent derived from Listeria monocytogenes (Lm), developed from the QUAIL platform, designed to activate and expand a patient’s endogenous γδ T cells.

(Press release, Laguna Bio, APR 29, 2026, View Source [SID1234664922])

On April 29, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for TEVIMBRA (tislelizumab) in combination with ZIIHERA (zanidatamab) and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2-positive (HER2) gastric, gastroesophageal junction, or esophageal adenocarcinoma. The FDA has also granted Breakthrough Therapy Designation to the regimen of ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy, with and without TEVIMBRA, in this indication.

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Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said:

"HERIZON‑GEA‑01 has the potential to shift the treatment paradigm in this historically difficult-to-treat disease, with the TEVIMBRA-containing arm demonstrating an unprecedented 26-month survival benefit. The FDA’s Priority Review designation is a major milestone in our effort to bring better first‑line options to patients with HER2‑positive gastroesophageal adenocarcinoma. We will work in partnership with regulators to support the review process, with the aim of rapidly bringing this new treatment option to patients."

Data supporting sBLA filing

The sBLA submission is based on the first interim analysis (IA1) of HERIZON-GEA-01, a global Phase 3 clinical trial designed to evaluate ZIIHERA plus chemotherapy, with and without TEVIMBRA, compared with the control arm of trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ GEA. Key findings of the trial include:

Overall survival (OS): The arm in which TEVIMBRA was added to ZIIHERA and chemotherapy resulted in a statistically significant improvement in OS (median OS of 26.4 months) at IA1. The ZIIHERA plus chemotherapy arm achieved a median OS of 24.4 months and the control arm resulted in a median OS of 19.2 months.
Progression-free survival (PFS): Both ZIIHERA-containing arms delivered a statistically significant and clinically meaningful improvement in median PFS of 12.4 months compared with 8.1 months in the control arm.
Improvement in OS and PFS was observed regardless of PD-L1 status.
The safety findings for the ZIIHERA plus TEVIMBRA and chemotherapy arm were generally consistent with the known effects of the components of the combination regimen, and no new safety signals were identified.
Project Orbis pathway

BeOne plans to participate in the FDA’s Project Orbis, an initiative that provides a framework for collaborative review of oncology products among international partners, for the submission of the HERIZON-GEA-01 data in territories in which BeOne holds the ZIIHERA license. With this pathway, BeOne aims to accelerate approval and patient access to this treatment, recognizing the global significance of the HERIZON‑GEA‑01 results, which demonstrated meaningful survival improvements in a disease where outcomes have remained largely unchanged for more than a decade.

About the HERIZON-GEA-01 Phase 3 Trial

HERIZON-GEA-01 (NCT05152147) is a global, randomized, open-label Phase 3 trial, conducted jointly with Jazz Pharmaceuticals, to evaluate and compare the efficacy and safety of ZIIHERA plus chemotherapy, with and without TEVIMBRA, to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for adult patients with advanced/metastatic HER2+ GEA. The trial randomized 914 patients from approximately 300 trial sites in more than 30 countries. Patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Patients were randomized to the three trial arms: ZIIHERA in combination with chemotherapy and TEVIMBRA; ZIIHERA in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial is evaluating dual primary endpoints, PFS per blinded independent central review (BICR) and OS.

About Gastroesophageal Adenocarcinoma

Gastroesophageal adenocarcinoma (GEA), which includes cancers of the stomach, gastroesophageal junction, and esophagus, is the fifth most common cancer worldwide. Approximately 20% of GEA patients have HER2-positive disease1,2,3, which has high morbidity and mortality, and patients are urgently in need of new treatment options. The overall prognosis for patients with GEA remains poor, with a global five-year survival rate of less than 30% for gastric cancer and about 19% for GEA.4

About ZIIHERA (zanidatamab)

ZIIHERA (zanidatamab) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.5

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions.

ZIIHERA is a registered trademark of Zymeworks BC Inc.

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes more than 15,000 patients enrolled to date in 30+ countries and regions across 72 trials, including 22 registration-enabling studies. TEVIMBRA is approved in 50 countries, and more than 1.9 million patients have been treated globally.

Select Important Safety Information

Serious and sometimes fatal adverse reactions occurred with TEVIMBRA treatment. Warnings and precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

Please see full U.S. Prescribing Information including the U.S. Medication Guide.

The information in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, APR 29, 2026, View Source [SID1234664906])

On April 29, 2026 Tacalyx, a leader in the discovery and development of cancer therapies directed at Tumour Associated Carbohydrate Antigens (TACAs), reported the selection of its first clinical candidate, TCX-201, which is being advanced toward clinical development with the goal of filing a clinical trial application (CTA) in 2027. In support of this progress, the company has secured €11 million in a first closing of its seed extension round from its existing international investor syndicate, including Boehringer Ingelheim Venture Fund (BIVF), Kurma Partners, High-Tech Gründerfonds (HTGF), Eurazeo, Creathor Ventures, and Thuja Capital. The company intends to expand the round with additional investors in a subsequent closing. The proceeds will be used to see TCX-201 through preclinical development while advancing the company’s broader pipeline.

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TCX-201 is an antibody drug conjugate (ADC) against an undisclosed TACA, developed using the company’s proprietary platform for the treatment of gastrointestinal malignancies and other solid tumours. TACAs represent a largely untapped class of targets found on tumour cell surface structures that may enable the development of highly selective therapies for patients with hard-to-treat tumours. In parallel, the newly secured capital will allow Tacalyx to continue to progress and expand its rich portfolio of first-in-class and best-in-class programmes designed to address multiple solid tumour indications with a high unmet medical need. The selection of the next clinical candidate is planned for the end of 2026.

"We are deeply grateful to our investors for their unwavering commitment in our mission to develop novel and effective treatments against solid tumours", said Jean Engela, CEO of Tacalyx. "Over the past years, we have built a powerful platform capable of reliably discovering and developing high-affinity antibodies against TACAs, sugar structures specifically found on tumour cells. Heralding a new stage for the company, Tacalyx has selected a clinical candidate for its TCX-201 programme and is now progressing preclinical activities to prepare for the CTA submission. With that, we are now redoubling our laser focus on translating the cutting-edge science on which the company was founded into transformative cancer therapies. Cancer patients cannot wait."

Klaus Schollmeier, Chairman of the Board of Tacalyx, said: "Tacalyx has delivered on its promise to unlock the therapeutic potential of TACAs, a frontier in oncology that has long been considered undruggable. With the selection of its first clinical candidate and significant advances with its earlier pipeline, the company is now rapidly transitioning from discovery research to a clinical-stage biotech. I am proud of the team’s achievements."

TACAs are distinctive glycan structures that are uniquely expressed or overexpressed on tumour cells and often play critical roles in tumour progression, including cell adhesion, immune evasion and metastasis. Because TACAs are found across a range of diverse cancer types, they represent promising targets for the development of pan-cancer therapeutics. Importantly, TACAs remain consistently expressed even in tumours lacking actionable genomic alterations or after standard therapies fail, positioning them as a differentiated and largely untapped class of cancer-specific targets with the potential to address treatment resistance. However, these novel targets have historically been difficult to address with antibodies, leaving much of this therapeutic space largely unexplored. Tacalyx is a pioneer in the discovery and development of therapies targeting TACAs. The company has built a proprietary discovery platform capable of reliably identifying and generating high-affinity antibodies against TACAs, enabling these previously inaccessible targets to become druggable. These antibodies can be further developed into novel antibody-based therapeutics tailored to specific clinical needs, including ADCs, TCEs and multi-specifics.

(Press release, Tacalyx, APR 29, 2026, View Source [SID1234664923])