On November 9, 2026 Pliant Therapeutics, Inc. (Nasdaq: PLRX), reported the presentation of preclinical proof-of-concept data and new clinical biomarker analyses related to PLN-101095 at the 41st Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

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

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

                  Schedule Your 30 min Free Demo!

Poster Presentations

Title: Selective targeting of integrins αvβ8 and αvβ1 improves anti-tumor responses mediated by immune checkpoint inhibition

Nika Rajabian, Ph.D., Postdoctoral Fellow from the National Cancer Institute, presented data demonstrating that blocking of integrins αvβ8 and αvβ1 in combination with anti-PD-1 reduced TGF-β signaling leading to modulation of fibroblastic cell populations in the tumor microenvironment and increased infiltration and activation of cytotoxic CD8+ T cells. This resulted in improved anti-tumor activity and survival. Researchers concluded that these data provided rationale for an ongoing, first-in-human phase I clinical trial (NCT06270706) of PLN-101095 in combination with pembrolizumab in solid cancers.

The above reflects work done under a collaboration agreement between the National Cancer Institute and Pliant Therapeutics.

Title: Plasma biomarkers of immune activation predict sensitization to immune checkpoint inhibition (ICI) in patients with advanced solid tumors receiving dual αvβ8/αvβ1 integrin inhibitor PLN-101095

Martin L. Decaris, Ph.D., Vice President of Translational Sciences at Pliant Therapeutics presented new biomarker data from the Phase 1 trial of PLN-101095 showing that early induction of immune activation biomarkers during PLN-101095 monotherapy was associated with subsequent clinical response following pembrolizumab initiation. These findings support the hypothesis that TGF-β pathway inhibition promotes immune activation, T-cell recruitment into the tumor microenvironment, and enhanced cytotoxic effector function.

This poster is available in the Publications section of Pliant’s website www.PliantRx.com.

FORTIFY – PLN-101095 Phase 1b Indication Expansion Trial

PLN-101095 is currently being evaluated in a Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT06270706) to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095 when administered orally in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. The Phase 1b portion of FORTIFY is an indication expansion trial that is currently enrolling three cohorts of patients with non-small cell lung cancer (NSCLC), tumors with high tumor mutational burden or clear cell renal cell carcinoma. Patients will be treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab will be added as combination therapy.

(Press release, Pliant Therapeutics, NOV 9, 2026, View Source [SID1234674523])

On November 9, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQB: MDNAF), a clinical-stage immunotherapy company developing Superkines for cancer and autoimmune disease, reported new clinical data from the Phase 1/2 ABILITY-1 study of MDNA11 presented during an oral session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting.

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

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

                  Schedule Your 30 min Free Demo!

The presentation, titled "MDNA11 Demonstrates Clinical Activity as Monotherapy and in Combination with Pembrolizumab in Biomarker-Enriched Gastrointestinal Malignancies, Including ICI-Refractory Disease," was delivered by Professor Paolo Ascierto, MD, Director of Department of Skin Cancers, Cancer Immunotherapy and Development Therapeutics, National Cancer Institute IRCCS, Fondazione G. Pascale Naples, Italy.

As previously announced on November 4, 2026, the Company will host a KOL webinar on November 10, 2026 at 9:00 a.m. ET with Dr. Tawbi and Dr. Mansinho to discuss the results and their clinical implications. In addition, the webinar will include a presentation of new data from the ICI-resistant cutaneous melanoma and MSS endometrial cancer cohorts.

The SITC (Free SITC Whitepaper) presentation highlighted durable antitumor activity with MDNA11 alone and in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with MSI-H or MSS TMB-H gastrointestinal (GI) cancers, including patients whose disease had progressed following prior ICI therapy.

Among 20 efficacy-evaluable patients with protocol-defined MSI-H or MSS TMB-H GI cancers, MDNA11 ± pembrolizumab achieved a 40% ORR (8/20) and 80% DCR (16/20). Responses were observed across multiple GI tumor types, including colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma and anal squamous cell carcinoma. The cohort was heavily pretreated, with a median of three prior systemic treatment lines, including adjuvant therapy (range 1-10); 65% had received prior ICI therapy, 45% had received at least four prior systemic treatment lines and 35% had active liver metastases at baseline.

"The 40% response rate observed in this 20-patient cohort of MSI-H or MSS/TMB-H gastrointestinal cancers is very promising, particularly because we are seeing responses in patients whose cancers have already progressed on immunotherapy and for whom effective treatment options are limited," stated Professor Paolo Ascierto, recipient of the 2026 SITC (Free SITC Whitepaper) Lifetime Achievement Award. "What stands out even more is the activity of MDNA11 monotherapy in patients with active liver metastases – a population that is difficult to treat and typically responds poorly to checkpoint inhibitors."

"The ABILITY-1 data presented at SITC (Free SITC Whitepaper) strengthens our conviction that MDNA11 can address a meaningful unmet need after checkpoint inhibitor failure in many different cancers," said Fahar Merchant, PhD, President and Chief Executive Officer of Medicenna. "We are particularly encouraged by the single-agent activity of MDNA11 in ICI-refractory GI cancers and the durability of these responses across multiple tumor types. Results from the melanoma and endometrial cancer cohorts, all refractory to immune checkpoint inhibitors, are similarly promising, positioning MDNA11 for potential registrational studies as we strengthen evidence to confirm durability of tumor control."

Key Findings in MSI-H/TMB-H Gastrointestinal Cancers

Combined cohort: 40% ORR (8/20) and 80% DCR (16/20); 5/8 responses were confirmed; ORR includes unconfirmed and ongoing responses.
Median duration of response was not reached with responses ongoing
MDNA11 monotherapy: 36% ORR (4/11) and 82% DCR (9/11).
MDNA11 + pembrolizumab: 44% ORR (4/9) and 78% DCR (7/9).ICI-refractory subset: 31% ORR (4/13), including 33% ORR (3/9 with MDNA11 monotherapy and 25% ORR (1/4) with MDNA11 + pembrolizumab.
Tumor regression was observed in 55% of evaluable patients (11/20).
Published post-ICI datasets in MSI-H/dMMR GI cancers have reported limited activity with available salvage approaches, including ORRs of approximately 11% with ICI rechallenge and approximately 12-13% with chemotherapy ± targeted therapy. Emerging salvage programs have reported ORRs in the approximately 7-22% range. These cross-trial comparisons are descriptive; patient populations, prior treatment exposure and response assessment differ across studies.

Single-Agent Activity in Patients with Liver Metastases

Liver metastases are associated with lower response rates and shorter progression-free survival following checkpoint inhibition in MSI-H/dMMR GI cancers. In ABILITY-1, MDNA11 showed single-agent activity in patients with active liver metastases:

All 4 evaluable MSI-H GI patients with measurable liver target lesions treated with MDNA11 monotherapy experienced regression of their liver lesions.
All 8 measurable hepatic target lesions (100%) regressed in patients with PDAC, CRC and cholangiocarcinoma
"The activity observed in patients whose cancers had already progressed on checkpoint therapy is clinically important, particularly the consistent regression of active liver lesions with MDNA11 monotherapy," said André Mansinho, MD, a principal investigator in the ABILITY-1 study and Director of Clinical Research at START Lisbon. "These patients often have limited effective treatment options, and liver metastases are associated with poorer outcomes even with checkpoint inhibition. The durability and breadth of activity suggests differential activity likely driven by the unique beta-enhanced design and albumin directed localization supporting the potential of MDNA11 to address unmet needs in cancer immunotherapy."

Clinical Activity in ICI-Resistant Cutaneous Melanoma and MSS Endometrial Cancer

ABILITY-1 also demonstrated durable activity with MDNA11 alone and in combination with pembrolizumab in heavily pretreated, Stage IV cutaneous melanoma. In the protocol defined expansion cohorts (N=18), 100% had Stage IV disease, 90% had prior exposure to both PD-1 and CTLA-4 therapy, and 30% had liver metastases.

In patients with secondary ICI resistance treated with MDNA11 monotherapy (n=10), ORR was 30% and DCR was 60%.
In patients with primary ICI resistance treated with MDNA11 + pembrolizumab (n=8), ORR was 38% and DCR was 38%.
MDNA11 plus pembrolizumab also showed efficacy signals in MSS endometrial cancer

In an expansion cohort comprising patients with secondary resistance to prior immune checkpoint inhibitor therapy (including multiple patients who had progressed following prior pembrolizumab plus lenvatinib), MDNA11 in combination with pembrolizumab achieved a confirmed objective response rate of 28.6% (2/7).
Additional data on melanoma and endometrial cancers will be shared during the KOL event.

Manageable Safety Profile

Across the pooled monotherapy and combination cohorts of the ABILITY-1 safety population (N=69 monotherapy; N=73 combination ), MDNA11 continued to demonstrate a manageable safety profile:

No dose-limiting toxicities were observed through 120 µg/kg.
More than 90% of treatment-related adverse events (TRAEs) were Grade 1 or Grade 2 and were predominantly transient, with a median duration of one to two days.
Approximately 65% of ≥ Grade 3 TRAEs were laboratory abnormalities, mostly asymptomatic.
Grade 4 TRAE were exceedingly rare, comprising 0.3% of all TRAE events in both treatment groups, and all but one were asymptomatic laboratory abnormalities.
One transient Grade 4 cytokine release syndrome event occurred in a patient with baseline low blood pressure and resolved within four days.
No Grade 5 treatment-related adverse events were reported.
No new safety signals were observed with the addition of pembrolizumab.
Treatment related dose reductions in monotherapy and combination were 2.9% and 5.5%, respectively. Treatment related permanent discontinuation were 0% and 4% in the monotherapy and combination arms, respectively.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

KOL Event

Medicenna will host a KOL event on November 10, 2026 from 9:00 to 10:00 a.m. ET featuring Hussein A. Tawbi, MD, PhD, Professor of Melanoma Medical Oncology and Director of Personalized Cancer Therapy at The University of Texas MD Anderson Cancer Center, and André Mansinho, MD, MSc, Director of Clinical Research at START Lisbon, to discuss the SITC (Free SITC Whitepaper) data, the new melanoma and endometrial cohort data, and the clinical development potential for MDNA11. To register, visit View Source

About MDNA11 and the ABILITY-1 Study

MDNA11 is an investigational, long-acting IL-2 Superkine engineered to preferentially activate and expand cancer-fighting CD8+ T cells and natural killer cells, with minimal stimulation of immunosuppressive regulatory T cells.

ABILITY-1 (NCT05086692) is an open-label, multicenter Phase 1/2 dose-escalation and expansion study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MDNA11 alone and in combination with pembrolizumab in patients with advanced solid tumors. The study is being conducted in collaboration with Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

(Press release, Medicenna Therapeutics, NOV 9, 2026, View Source [SID1234674522])

On Nvoember 9, 2026 BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported the outcome of its End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) regarding BH-30643 for the treatment of patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung cancer (NSCLC). BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR inhibitor designed to overcome the limitations of currently approved EGFR inhibitors for the treatment of EGFR-mutant NSCLC.

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

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

                  Schedule Your 30 min Free Demo!

BlossomHill plans to advance BH-30643 into SOLARA-2, the Phase 2 portion of the SOLARA trial, following alignment with FDA on a recommended Phase 2 dose of 50 mg twice daily. SOLARA-2 is the global, open-label, single-arm Phase 2 portion of the SOLARA trial, intended to generate data that could potentially support an accelerated approval application in patients with EGFR C797S-positive NSCLC, a population for which there are currently no approved oral targeted therapies. SOLARA-2 is designed to evaluate both chemotherapy-naive and chemotherapy-pretreated patients following treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). The trial will leverage the current global footprint of the SOLARA trial, with the first patient anticipated to be dosed in the first quarter of 2027. BH-30643 previously received FDA Fast Track designation for EGFR C797S-positive NSCLC.

"We are pleased with the outcome of our End-of-Phase 1 meeting with FDA and are confident in our development strategy for BH-30643 in EGFR C797S-positive NSCLC. Our planned Phase 2 trial, designed with registrational intent, builds on the encouraging clinical activity observed in SOLARA, where BH-30643 has demonstrated promising anti-tumor activity in NSCLC patients with EGFR C797S-positive resistance, including those with and without concurrent T790M mutation and brain metastasis, and those who have received multiple prior therapies," said J. Jean Cui, Ph.D., Founder and Chief Executive Officer of BlossomHill Therapeutics. "The selection of 50 mg twice daily as our recommended Phase 2 dose, together with the clinical experience we have observed to date, provides strong support for advancing the program. By evaluating BH-30643 in both chemotherapy-naive and chemotherapy-pretreated patients, we aim to further characterize its potential to address this important resistance mechanism and generate the evidence needed to support a potential accelerated approval."

Preliminary data from SOLARA were presented in 2026 at both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and World Conference on Lung Cancer (WCLC). The company expects to share additional updates from SOLARA at medical meetings in 2027, including updates on C797S durability and TKI-naive durability, as well as initial data from the chemotherapy-combination cohort.

SOLARA-2 Trial
SOLARA-2 is the pivotal single-arm Phase 2 portion of the SOLARA trial, designed with registrational intent to evaluate BH-30643 in approximately 150 patients with locally advanced or metastatic EGFR C797S-positive NSCLC who have previously received a third-generation EGFR TKI. The open-label study will include two sub-cohorts of approximately 75 patients each: chemotherapy-naive patients and chemotherapy-pretreated patients. All patients will receive BH-30643 at the recommended Phase 2 dose of 50 mg twice daily. The primary endpoint will be objective response rate (ORR), as assessed by blinded independent central review (BICR), with additional endpoints including duration of response (DOR), progression-free survival (PFS), overall survival (OS), intracranial ORR and safety. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).

About BH-30643
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR inhibitor for the treatment of EGFR-mutant NSCLC. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories — classical mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations and exon 20 insertions — while maintaining marked selectivity over wild-type EGFR. BH-30643 has received Fast Track designation and is being evaluated in SOLARA, a global Phase 1, first-in-human clinical trial with ongoing dose expansion cohorts enrolling in both TKI-pretreated and TKI-naive settings, including a C797S resistance cohort. SOLARA-2, a global Phase 2 pivotal study in C797S-Positive NSCLC is scheduled to dose the first patient in the first quarter of 2027. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).

(Press release, BlossomHill Therapeutics, NOV 9, 2026, View Source [SID1234674521])

On November 9, 2026 Oncovita, a French biotechnology company specialized in therapeutic and prophylactic vaccines, reported that the European Commission has granted orphan medicinal product designation to its lead investigational candidate, MVdeltaC, for the treatment of mesothelioma.
The decision, dated October 19, 2026, follows a positive opinion adopted on September 10, 2026, by the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP). It complements the U.S. Food and Drug Administration (FDA) orphan drug designation for MVdeltaC in pleural mesothelioma, announced in June 2025.

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

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

                  Schedule Your 30 min Free Demo!

A significant European regulatory milestone

European orphan designation involves an assessment of both the rare-disease criteria and the therapeutic context. Where satisfactory treatments are already authorised, sponsors must provide evidence supporting an assumption that their candidate could offer significant benefit to patients compared with existing methods.

"The European designation is an important milestone for MVdeltaC, particularly because the EU framework requires a substantiated rationale for potential significant benefit when treatments already exist," said Stéphane Altaba, CEO of Oncovita. "Together with the FDA designation obtained in 2025, it provides further encouragement for our development programme in mesothelioma. Our priority is now to advance our drug candidate into clinical development in late 2027 ".

A new immunotherapeutic approach for a challenging cancer

Mesothelioma is a rare and aggressive cancer. Its pleural form affects the membrane surrounding the lungs and is commonly associated with past asbestos exposure. Despite advances in treatment, substantial unmet needs remain, particularly for a majority of patients whose disease progresses with currently available therapies.
MVdeltaC is an investigational immuno-oncolytic therapy developed using Oncovita’s proprietary Measovir platform. It is based on the attenuated Schwarz strain of the measles vaccine virus, genetically modified to inactivate the viral C virulence factor.
The candidate is designed to combine direct lysis of tumour cells with activation of an anti-tumour immune response. Preclinical studies presented at the European Association for Cancer Research congress in June 2026 reported immunogenic tumour cell death, anti-tumour activity and immune memory in several experimental models of cancer, including mesothelioma models.

"Patients with pleural mesothelioma urgently need additional treatment options, particularly when their disease progresses despite existing therapies," said Professor Arnaud Scherpereel, a specialist in pneumology and thoracic oncology at Lille University Hospital. "MVdeltaC is a promising therapeutic approach, combining direct tumour cell killing with the potential to stimulate a broader anti-tumour immune response.The preclinical findings are encouraging and strengthen the rationale for bringing this innovative approach into clinical development. I believe MVdeltaC deserves to be investigated clinically for its potential to provide a meaningful new treatment option for patients with mesothelioma."

Clinical development planned for late 2027

Oncovita is preparing the transition of MVdeltaC into clinical development, including GMP/clinical-grade manufacturing. The company plans to initiate its first clinical trial in late 2027, subject to the required regulatory and ethics approvals.
The European and U.S. orphan designations provide access to incentives intended to support the development of treatments for rare diseases. In the EU, these include protocol assistance, potential reductions in regulatory fees and eligibility for ten years of market exclusivity following marketing authorisation, provided the applicable conditions are met.

(Press release, Oncovita, NOV 9, 2026, View Source [SID1234674520])

On November 9, 2026 Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, reported financial results for the third quarter ended September 30, 2026 and provided a summary of recent business highlights. The Company has elected not to host a third quarter earnings conference call after release of its financial results.

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

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

                  Schedule Your 30 min Free Demo!

"We are entering the next phase of Zymeworks growth with a fundamentally stronger and more diversified business. The transformation of Zymeworks is becoming increasingly visible in our financial profile and in the breadth of opportunities available to us," said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. "Over the course of 2026, Ziihera has expanded its label into first-line HER2-positive advanced gastroesophageal adenocarcinoma, we have completed the acquisition of Theravance Biopharma, adding a recurring commercial cash-flow stream through YUPELRI. We have also made progress on strategic transactions that can expand the opportunities for our R&D portfolio, while reducing risk, maintaining R&D discipline, and adding potential future milestones and royalties. We are pleased to report an increase in our financial guidance for 2026 as a result of this business development execution. These advancements demonstrate the strategy we set out a year ago – to build a durable financial foundation through partnered and commercial assets, while maintaining the ability to create additional value through R&D, acquisitions, partnerships and disciplined capital allocation."

Financial Highlights

Royalty revenue from Jazz Pharmaceuticals (Jazz) and BeOne Medicines (BeOne) was $2.3 million in the three months ended September 30, 2026, driven primarily by net product sales of Ziihera by Jazz in the United States.
YUPELRI collaboration revenue increased 4% year-over-year (YoY). Quarterly U.S. net sales of $71.5 million for YUPELRI, recognized by Viatris, in 3Q-2026, increasing 0.2% YoY (3Q-2026 vs 3Q-2025).
Increased doses of YUPELRI pulled through the hospital channel grew at a double-digit rate YoY, reflecting continued underlying momentum. Theravance Biopharma contributed approximately $1.5 million of revenue during the quarter, reflecting seven days of ownership following the September 23, 2026 acquisition date.
Under the terms of our collaboration with Jazz, Zymeworks received a $250 million milestone payment related to Ziihera’s U.S. FDA approval for first-line treatment of HER2-positive advanced GEA in October 2026. Zymeworks remains eligible for up to $190 million in potential additional global regulatory milestones related to ex-U.S. approvals for Ziihera in HER2-positive GEA from Jazz and BeOne.
During 2026, Zymeworks has accessed $600 million of non-dilutive financing through a non-recourse royalty-backed note, and a non-recourse note, with a weighted average cost of capital of less than 10%. The financing supported the Theravance Biopharma acquisition and the Company’s share repurchase program while minimizing equity dilution. The Company currently has no current plans for additional equity issuances.
Repurchased 534,381 shares for $14.0 million in the third quarter of 2026, with total share repurchases of 5,737,790 shares for $140.4 million in the first nine months of 2026 at an average price of $24.48 per share (exclusive of commission expense and estimated excise tax).
The Company has increased its 2026 financial guidance for total revenue to be between $337 million and $351 million (previously between $278 million and $292 million) and adjusted EBITDA to be between $176 million and $190 million (previously between $114 million and $128 million), excluding the impact of any future transactions. This financial guidance is subject to expiration or termination of the waiting period under HSR as it relates to the Roche collaboration, expected during the fourth quarter of 2026.

Business Highlights

Expanding Revenue Diversification Through Theravance Biopharma Acquisition

On September 23, 2026, Zymeworks completed the previously announced acquisition of Theravance Biopharma. With the completion of the transaction, Theravance Biopharma is now part of Zymeworks, further advancing Zymeworks’ strategy to build a diversified revenue-generating biotechnology company, combining innovative R&D with growing commercial and royalty-based cash flows. Post-closing, we expect $13 million to $15 million of annualized overhead and corporate costs to be eliminated, reducing future operating expenses.
On September 28, 2026, Zymeworks announced the appointment of Stuart Knight as Executive Vice President, Chief Information Officer, as well as Jesse Fecker as Vice President of Intellectual Property, both of whom join Zymeworks from Theravance Biopharma.
On October 19, 2026, Zymeworks announced the appointment of Suzanne Monahan as Senior Vice President and General Manager, Theravance Biopharma.

Recent Developments

Recent key developments related to our portfolio are discussed below:

Ziihera (zanidatamab-hrii)

On August 25, 2026, our partner Jazz received U.S. FDA approval for two Ziihera-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive GEA. Jazz subsequently launched U.S. commercialization, and secured a recommendation in the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Clinical Practice Guidelines, as well as a Category 2A recommendation from the National Comprehensive Cancer Network (NCCN), positioning Ziihera as a preferred treatment for first-line GEA patients.
On October 23, 2026, results from the second interim, and final formal, analysis of HERIZON-GEA-01 were presented as a late-breaking rapid oral presentation at the ESMO (Free ESMO Whitepaper) Annual Congress 2026. Key findings include:
Nearly 40% of patients alive at three years with Ziihera plus tislelizumab and chemotherapy, irrespective of PD-L1 status, achieving a median overall survival (OS) of 27 months.
Mature HERIZON-GEA-01 results show Ziihera plus chemotherapy delivered statistically significant and clinically meaningful OS benefit, reducing the rate of death by 24% versus trastuzumab plus chemotherapy.
The Ziihera plus tislelizumab and chemotherapy regimen reduced the risk of death by 35% (hazard ratio [HR] 0.65; 95% CI: 0.52–0.80), improving from an HR of 0.72 at the first interim analysis.

Other Partnered Programs

ZW209

On October 23, 2026, Zymeworks announced an exclusive global collaboration and license agreement with Roche for the development of ZW209. Under the agreement, Zymeworks is eligible to receive an upfront payment of $55 million, a $40 million payment upon initiation of the Phase 1b trial, additional development, commercial and sales-based milestone payments of up to $718 million, and tiered high single digit to mid-teens royalties on future net sales of any approved medicines resulting from the collaboration. This transaction is subject to the expiration or termination of the waiting period under HSR.
ZW209 has received Investigational New Drug clearance from the U.S. FDA. We anticipate initiating a Phase 1, open-label, multicenter, global study in 2026 investigating ZW209 in collaboration with Roche to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Roche will fund the Phase 1a trial and be responsible for subsequent global development and commercialization of ZW209.

"Importantly, this collaboration with Roche demonstrates how the components of our business model work together in practice. By combining recurring commercial cash flows with a disciplined approach to R&D and partnerships, we are building a business model that can generate value through multiple pathways," said Kenneth Galbraith. "Recurring cash flows provide greater flexibility to invest selectively in programs and opportunities with meaningful value-creation potential, while our R&D engine and business development activities create additional opportunities to generate milestones, royalties, licensing proceeds and other sources of long-term value. Just as importantly, we can increasingly match the capital and ownership structure to each opportunity, whether acquiring and operating a business, partnering an asset, licensing a program or bringing in external venture capital, without assuming that every opportunity must be funded entirely from our balance sheet."

Pasritamig

On November 7, 2026, our partner Johnson & Johnson presented new data on the Phase 1 study of pasritamig (KLK2×CD3) in combination with JNJ-9401 (PSMA×CD28) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Results demonstrated encouraging anti-tumor activity in heavily pretreated patients with metastatic castration-resistant prostate cancer:

At the recommended Phase 2 regimen, the combination achieved a 73% PSA50 response rate, 47% PSA90 response rate, and undetectable PSA in 27% of patients, with responses ongoing beyond six months in all four patients achieving undetectable PSA.
The combination maintained a favorable safety profile, with no Grade ≥3 treatment-related adverse events, no Grade ≥2 CRS and no treatment discontinuations at the recommended regimen.

Wholly-Owned R&D Pipeline

On October 24, 2026, Zymeworks presented new Phase 1 data for folate receptor alpha-targeting antibody-drug conjugate, ZW191, at the ESMO (Free ESMO Whitepaper) Annual Congress. Updated data presented for ZW191 demonstrates compelling anti-tumor activity in heavily pretreated patients with platinum-resistant ovarian cancer across folate receptor alpha expression levels:
Confirmed objective response rates of 64.5% at the 6.4 mg/kg dose in patients with high-grade serous platinum-resistant ovarian cancer.
Median duration of response not yet reached at either dose level at median 7 months follow-up, with six-month progression-free survival rate of 61% in both groups.
Favorable tolerability profile, particularly at 6.4 mg/kg, supports continued clinical development in partnership or through a strategic collaboration.
On November 7, 2026, Zymeworks presented preclinical data at SITC (Free SITC Whitepaper) on a novel PD-1xVEGFxIL-7 multispecific antibody with optimized geometry that achieves targeting of IL-7 to PD-1+ T cells. The poster presentation titled "Engineering targeted IL-7 delivery to enhance anti-tumor T cell fitness and persistence" shows that combining checkpoint and angiogenesis blockade with a T cell cytokine signal, PD-1xVEGFxIL-7 represents a mechanistically distinct strategy to improve the durability of anti-tumor responses.
On December 13, 2026, Zymeworks will present new preclinical data for a penta-specific antibody at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exhibition via a poster presentation titled "ZW1953: A multispecific T cell engager targeting FLT3, CLEC12A, and CD33 with conditional CD28 co-stimulation designed to overcome resistance mechanisms and improve treatment responses in AML", representing the first scientific disclosure for Zymeworks in a hematological cancer indication.

The Company plans to host a R&D Day on February 11th, 2027 in New York, NY. A live webcast of the event will be accessible through Zymeworks’ Investor Relations website at ir.zymeworks.com. A detailed agenda, including registration and dial-in information, will be provided closer to the event.

Financial Results for the Quarter Ended September 30, 2026

The key financial highlights for our 2026 third quarter results are as follows:

Theravance Biopharma Acquisition – The acquisition of Theravance Biopharma closed on September 23, 2026 and had a limited impact on third quarter operating results given the timing of the transaction. Theravance Biopharma contributed approximately $1.5 million of revenue during the quarter, reflecting seven days of ownership following the acquisition date. The primary earnings impact related to integration and transaction-related costs associated with the acquisition.

Revenue – Total revenue was $256.5 million in 3Q-2026, compared to $27.6 million for the same period in 2025. The increase was primarily due to the $250.0 million milestone earned from Jazz following the U.S. approval of Ziihera for first-line HER2-positive GEA in August 2026. The increase was partially offset by the absence of a $25.0 million development milestone from Johnson & Johnson Innovative Medicine recognized during the third quarter of 2025.

Research and Development (R&D) Expenses – R&D expenses were $36.1 million in 3Q-2026, compared to $35.6 million for the same period in 2025. R&D expenses were generally consistent with the prior year period, as lower spending on ZW171 following discontinuation of the program in 2025 and reduced spending on certain preclinical programs after completion of IND-enabling activities were largely offset by employee-related costs associated with the Theravance Biopharma acquisition.

Selling, General and Administrative (SG&A) Expenses – SG&A expenses were $42.7 million in 3Q-2026, compared to $14.1 million for the same period in 2025. The increase was primarily driven by costs associated with the Theravance Biopharma acquisition, including severance and transaction-related professional fees, together with higher stock-based compensation expense associated with 2026 equity awards, including leadership transition awards and the settlement of certain Theravance Biopharma equity awards.

Other Income, net – Net other expense was $4.4 million in 3Q-2026, compared to net other income of $3.8 million for the same period in 2025. The change was driven primarily by interest expense related to the royalty-backed note financing arrangement with Royalty Pharma executed in March 2026 and lower interest income resulting from reduced investment balances.

Net Loss – Net income was $173.7 million in 3Q-2026, compared to a net loss of $19.6 million for the same period in 2025. The increase was driven primarily by the $250.0 million milestone earned from Jazz following U.S. approval of Ziihera for first-line HER2-positive GEA in August 2026, partially offset by nonrecurring acquisition related costs and interest expense associated with the Company’s royalty-based note financing arrangement with Royalty Pharma in March 2026.

Since initiating its share repurchase program in August 2024, the Company has cumulatively utilized $279.8 million to reacquire 12,940,827 shares at an average price of $21.63 per share (exclusive of commission expense and estimated excise tax). As of November 6, 2026, the Company had approximately 69.0 million common shares outstanding.

(Press release, Zymeworks, NOV 9, 2026, View Source [SID1234674519])