On May 7, 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 first quarter March 31, 2026 and provided a summary of recent business highlights.

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"Having a U.S. PDUFA date established under priority review by the FDA for zanidatamab for the treatment of first-line HER2-positive advanced GEA, represents a significant regulatory and strategic milestone for Zymeworks. Zanidatamab’s progress across additional clinical indications continues to highlight the value of our strategy to accumulate long-term cash flows from differentiated assets, whether generated internally or externally, with meaningful clinical and commercial potential. Pending global approvals in GEA, we expect zanidatamab to contribute significant milestone payments and to generate long-term, high-quality royalty revenues," said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. "Over the past quarter, we have further strengthened our leadership team with the addition of individuals bringing extensive experience in strategic capital allocation, investment execution, and deal-making, enhancing our ability to identify and maximize value for our emerging royalty and R&D portfolios. We look forward to the potential of bringing an important new therapy to patients."

Recent Developments

Wholly-Owned Programs

In April 2026, we shared new preclinical and clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Presentations included new preclinical combination insights from ZW191, as well as additional clinical data from Part 1 of our Phase 1 trial of ZW191:

In Part 1 of our Phase 1 trial of ZW191 in platinum resistant ovarian cancer (PROC) patients, ZW191 demonstrated a confirmed objective response rate of 56% across all dose levels, with tumor regression observed in 68% of patients and disease control achieved in 94%. Notably, ZW191 demonstrated compelling efficacy in the 6.4-9.6 mg/kg dose range regardless of FRα expression, with confirmed objective response rates of 61% observed in both ovarian and 57% in endometrial cancers, with disease control observed in 100% of patients, and no new safety signals. These findings highlight the potential for ZW191 to benefit a broad patient population, including those with low or heterogeneous target expression. In March 2026, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW191, for the treatment of patients with advanced or metastatic PROC.
Part 2 of our Phase 1 study evaluating both 6.4 mg/kg and 9.6 mg/kg dose regimens in PROC is fully-enrolled with 60 total patients and remains ongoing.
ZW191’s differentiated clinical profile in nonclinical studies, including favorable tolerability, bodes well for combination strategies including chemotherapy, targeted therapies, and immunotherapies that are mechanistically supported by preclinical studies.
At AACR (Free AACR Whitepaper), we also presented preclinical data from our emerging RAS inhibitor antibody-drug conjugate (ADC) platform and three novel candidates designed to target treatment of RAS mutated cancers:

A pan-RASi ADC platform with high anti-tumor activity against RAS-driven cancers
ZW418, a biparatopic PTK7-targeting ADC incorporating a novel pan-RAS inhibitor payload for the treatment of non-small cell lung cancer (NSCLC)
ZW427, a Ly6E-targeting ADC bearing a novel pan-RAS inhibitor payload for the treatment of RAS mutated cancers including colorectal, pancreatic, and NSCLC
ZW439, a novel CLDN18.2-targeting pan-RAS inhibitor ADC for the treatment of RAS mutated pancreatic cancer
"At AACR (Free AACR Whitepaper), our team presented three posters highlighting novel preclinical RAS-targeting ADC candidates, demonstrating the breadth of our capabilities in antibody engineering, linker chemistry, and the development of new proprietary payloads. These programs reflect a modular, highly tunable platform designed to address historically challenging targets. In parallel, updated Phase 1 data for ZW191 continue to reinforce the differentiated profile we have seen to date, with breadth and durability of responses, along with activity across varying levels of FRα expression, that we believe position ZW191 as a potential best-in-class therapy," stated Adam Schayowitz, Ph.D., MBA., Head of R&D at Zymeworks. "Taken together, these data reflect the strength and scalability of our ADC platform and open up a range of future opportunities for both our ADC platforms and product candidates."

Partnered Programs

Zanidatamab

In April 2026, the U.S. FDA accepted our partner Jazz’s sBLA filing for Ziihera (zanidatamab-hrii) combinations for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or GEA for priority review with a PDUFA date of August 25, 2026. Pending approval, Jazz expects to commercially launch zanidatamab in the U.S. in this indication. Zymeworks is entitled to receive a $250.0 million milestone payment from Jazz related to approval of Ziihera in GEA in the United States.

In April 2026, BeOne announced that the U.S. FDA has granted Priority Review to a sBLA for TEVIMBRA (tislelizumab) in combination with Ziihera and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma. In April 2026, BeOne also received acceptance for the filing of the sBLA for zanidatamab by the Center for Drug Evaluation of the China National Medical Products Administration (NMPA) to seek approval for zanidatamab for the first-line treatment for HER2+ locally advanced or metastatic GEA, including cancers of the stomach, gastroesophageal junction, and esophagus. BeOne has also received filing acceptance for an sBLA for tislelizumab by the CDE in China based on the HERIZON-GEA-01 data. Zymeworks is entitled to receive a $15.0 million milestone payment from BeOne related to approval of Ziihera in GEA in China.

In April 2026, Jazz presented three posters and an oral presentation at AACR (Free AACR Whitepaper) exploring zanidatamab’s utility across HER2-expressing solid tumors beyond biliary tract cancer and GEA. Jazz also announced that they will present multiple presentations on zanidatamab at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including a rapid oral presentation of PD-L1 subgroup data from HERIZON-GEA-01 evaluating zanidatamab combinations, and additional analyses of tolerability, biomarker response and real-world treatment patterns in first-line HER2+ GEA. The second interim overall survival analysis for the HERIZON-GEA-01 trial is expected in mid-2026.

Our royalty revenue from Jazz and BeOne was $1.6 million in the three months ended March 31, 2026, driven primarily by net product sales of Ziihera by Jazz.

Business Updates

We recently announced leadership appointments and transitions to align with the evolution of our corporate strategy, including the following changes:

Ms. Kristin Stafford appointed as Executive Vice President, Chief Financial Officer, effective April 1, 2026.
Dr. Adam Schayowitz, Ph.D., MBA appointed as Executive Vice President, Head of R&D, effective April 9, 2026.
Mr. Scott Platshon appointed as Executive Vice President, Chief Business Officer, effective April 9, 2026.
Mr. Paul R. Schneider appointed as Executive Vice President, General Counsel, effective May 13, 2026.
Share Repurchase Program

In November 2025, the Board of Directors authorized a share repurchase program providing the ability to repurchase up to $125.0 million in common stock. As of May 6, 2026, the Company has utilized approximately $95.8 million of this approved repurchase program to acquire 3,930,734 shares at an average price of $24.37 per share (exclusive of commission expense and estimated excise tax). As of May 6, 2026, the Company had approximately 73.0 million common shares outstanding.

Financial Outlook

Operating Expense Discipline: The Company today is reiterating its previously provided guidance on adjusted gross operating expense (non-GAAP), which combines adjusted research and development (R&D) expense (non-GAAP) and adjusted general and administrative (G&A) expense (non-GAAP) (excluding stock compensation expense), reflecting a disciplined framework of approximately $300.0 million in aggregate adjusted gross operating expenditures (non-GAAP) over a three-year period ending December 31, 2028. The Company is also reiterating that it expects a greater proportion of adjusted gross operating expense (non-GAAP) to be incurred in 2026 and decline in 2027 and 2028, reflecting a deliberate and measured investment across R&D and G&A aligned with clearly defined strategic priorities. This outlook reflects current expectations, underscores the Company’s continued focus on cost discipline and capital allocation rigor, and does not include any potential acquisition-related expenses or new partnerships and collaborations. The Company’s GAAP gross operating expenses in 2025 were $198.5 million and the Company currently expects adjusted gross operating expenses (non-GAAP) in 2026 to be approximately 20% lower than adjusted gross operating expenses (non-GAAP) in 2025 of $170.5 million, excluding the impact of any acquisition-related expenses or new partnerships and collaborations.

Financial Results for the Quarter Ended March 31, 2026

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

Revenue – Total revenue was $2.4 million in 1Q-2026, compared to $27.1 million for the same period in 2025. The decrease was driven mainly by the achievement of non-recurring clinical milestone payments in 2025, as well as continued declines in development support and drug supply revenue from Jazz . Revenue in the current‑year period reflects ongoing collaboration activity and increased royalty revenue, which is expected to grow over time as commercial sales of Ziihera increase.

Research and Development (R&D) Expenses – R&D expenses were $34.5 million in 1Q-2026, compared to $35.7 million for the same period in 2025, primarily reflecting a shift in program mix, as reduced spending on later‑stage and discontinued programs exceeded increased investment in early‑stage clinical studies and preclinical pipeline activities.

General and Administrative (G&A) Expenses – G&A expenses were $15.1 million in 1Q-2026, compared to $17.0 million for the same period in 2025. The decrease was primarily driven by lower professional fees, consulting, and information technology‑related costs reflecting the absence of prior-year non-recurring initiatives and post-implementation cost reductions, partially offset by higher salaries and benefits reflecting previously disclosed leadership transitions.

Other Income, net – Other income was $0.8 million in 1Q-2026, compared to $3.5 million for the same period in 2025. The change was driven primarily by $2.1 million of interest expense related to the royalty-backed note financing arrangement with Royalty Pharma executed in March 2026 and lower interest income.

Net Loss – Net loss was $44.2 million in 1Q-2026, compared to a net loss of $22.6 million for the same period in 2025. The change in 2026 was primarily due to a decrease in revenue, driven by the non-recurring clinical milestones earned in 1Q-2025.

Liquidity – As of March 31, 2026, we had $403.8 million of cash resources consisting of cash, cash equivalents and marketable securities, comprised of $244.3 million in cash and cash equivalents and $159.6 million in marketable securities. Based on current operating plans, and assuming full execution of the $125.0 million share repurchase plan, we expect our existing cash resources as of March 31, 2026, when combined with anticipated regulatory milestone payments of $440.0 million related to the potential approvals of Ziihera in GEA in the U.S., Europe, Japan, and China, to fund our planned operations beyond 2028. This anticipated cash runway does not take into account any contribution from additional future milestone payments or royalties related to Ziihera, other current licensed product candidates or contributions from future partnerships and collaborations.

(Press release, Zymeworks, MAY 7, 2026, View Source [SID1234665363])

On May 7, 2026 ParcelBio, a biotechnology company developing a new class of potent and durable mRNA medicines, reported it has raised $13 million in seed financing led by Breyer Capital, with participation from General Catalyst, Y Combinator, Metaplanet, SurgePoint Capital, ZAKA VC, and other investors.

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The financing will support development of ParcelBio’s proprietary APEXm (Amplified and Prolonged EXpression mRNA) platform and advance its pipeline, including its lead in vivo CAR-T program for autoimmune disease, as well as additional programs in oncology and encoded protein therapeutics.

Current mRNA technologies are limited in their ability to achieve both high protein expression and sustained durability, often requiring tradeoffs between potency, duration, and manufacturability. These constraints have restricted the broader application of mRNA beyond vaccines and short-acting therapeutics.

ParcelBio is developing a new category of mRNA medicines designed to overcome these limitations. Its proprietary APEXm platform engineers RNA molecules to actively recruit the cell’s native RNA-stabilizing machinery, enabling significantly higher and more durable protein expression. This approach leads to a step-change in biological performance, reaching therapeutic thresholds that have historically been out of reach for mRNA.

"mRNA has transformed medicine, but today’s technologies are fundamentally limited in how much protein they can produce and for how long," said David Weinberg, Ph.D., Chief Executive Officer and Co-Founder of ParcelBio. "We engineered RNA to work with the cell’s machinery rather than against it, enabling meaningful improvements in both expression and durability that we believe are essential for true disease modification."

Unlike circular RNA and other next-generation approaches that often introduce manufacturing complexity or reduce peak output, ParcelBio’s platform maintains a simple, linear mRNA architecture while delivering both high peak expression and sustained activity. The platform is modular and broadly applicable across proteins and cell types, enabling diverse therapeutic applications ranging from immune reprogramming to protein replacement.

ParcelBio’s lead program focuses on in vivo CAR-T therapies targeting pathogenic B cells across autoimmune diseases, with the goal of achieving deep B-cell depletion for durable, drug-free remission. By enabling sustained CAR expression without viral delivery or ex vivo manufacturing, the company aims to develop scalable, off-the-shelf therapies with curative potential. Additional programs are in development in oncology and encoded protein therapeutics.

Preclinical data demonstrate that ParcelBio’s APEXm RNA drives significantly higher and more durable protein expression compared to a leading clinical mRNA design, translating into deeper biological responses, including more complete target cell depletion in in vivo CAR-T models. The company will be debuting the APEXm platform and preclinical data in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting on May 14, 2026.

"ParcelBio’s durable, tunable expression is designed to collapse the tradeoffs that have constrained mRNA in chronic, deep-tissue disease, bringing durable, controllable immune reset within reach in refractory autoimmunity and beyond," said Dr. Morgan Cheatham, Partner and Head of Healthcare and Life Sciences at Breyer Capital. "Breyer Capital’s life sciences thesis is organized around the technologies that redefine what medicine can reach: programmable biology, controllable expression, and durable therapeutic impact. ParcelBio is built to advance all three."

"Most RNA platforms force a tradeoff between potency, durability, and manufacturability," said Chris Carlson, Ph.D., Chief Scientific Officer and Co-Founder of ParcelBio. "Our approach eliminates that tradeoff, enabling both higher peak expression and longer duration within a manufacturable system, and opening the door to entirely new classes of medicines."

(Press release, ParcelBio, MAY 7, 2026, View Source [SID1234665362])

On May 7, 2026 enGene Therapeutics Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported additional interim results from the pivotal cohort of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid (also known as detalimogene) in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS) with or without concomitant papillary disease, which enrolled 125 patients. These data, as of April 21, 2026, demonstrated that patients treated with detalimogene achieved a 54% complete response (CR) at any time and a 43% CR rate at six months. The progression rate to muscle-invasive or advanced disease was low, at 3.2%. Detalimogene was generally well tolerated with 55% of patients having experienced a treatment-related adverse event, mostly mild (Grade 1 and 2).

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"These updated data continue to reinforce the favorable safety and tolerability profile of detalimogene and its clinical activity in a heavily pretreated, high-risk NMIBC patient population with limited therapeutic options. Importantly, the low rate of progression to muscle-invasive disease leaves patients eligible for other bladder-sparing therapies," said Ron Cooper, President and Chief Executive Officer, enGene. "While durability outcomes to date are not what we hoped, these data are preliminary. We are focused on evaluating the totality of the data as it evolves and plan to continue to engage with the FDA and the medical community."

LEGEND Pivotal Cohort Data Update

The interim analysis is based on the 125 patients enrolled in Cohort 1. Patients who discontinued without any disease evaluation or who discontinued after a CR were considered not evaluable for subsequent landmark CR analysis.

Efficacy overview:

54% (95% CI: 45%, 63%) CR at any time (67/124)
91% of responses occurred at first disease assessment
43% (95% CI: 34%, 52%) CR rate at 6 months (52/121) with 14% (6/43) of patients having successfully converted from non-CR to CR post re-induction
Two re-induced patients have not yet had a 6-month assessment
Of the 52 responders at 6 months:
37/44 patients who had a 9-month assessment were in CR; an additional 8 patients are pending evaluation
13/22 patients who had a 12-month assessment were in CR; an additional 11 patients are pending evaluation
A maximum of 21 patients, including the 2 currently undergoing re-induction, still have the potential to achieve a CR at 12 months
The Kaplan-Meier (KM) estimate of the 12-month duration of response (DoR) is 25% (95% CI: 11%, 41%)
The KM estimate for median DoR is 37.3 weeks (range: 31.6-43.9 weeks)
Low rate of progression to muscle invasive or more advanced disease (3.2%)
Safety overview:

55% of patients experienced a treatment-related adverse event (TRAE)
Among patients with any TRAE, 91% experienced Grade 1-2 TRAEs
Grade ≥3 TRAEs were reported in 6 patients (4.8%)
Low percentage of patients experienced TRAEs leading to treatment interruption (2.4%) and treatment discontinuation (2.4%)
Among the 32 patients who had their first disease assessment after the last data analysis (October 24, 2025, reported November 11, 2025), CR rates were lower than previously reported results. The CR rate at any time was 39% and at 6 months was 32% for these patients. A preliminary subgroup analysis has not revealed any material differences in demographics or key disease characteristics. A more comprehensive analysis of these patients, including potential contributing factors, is ongoing.

As a beneficiary of FDA’s RMAT designation and a participant in the FDA’s CDRP program, enGene has completed the required FDA manufacturing validation batches and submitted a Statistical Analysis Plan (SAP) to the agency. The Company plans further engagement with the FDA as it approaches a potential Biologics License Application (BLA) filing and plans to provide an update in the second half of 2026.

The Company plans to share these data with the broader medical community at a Plenary Presentation at the upcoming American Urological Association meeting on May 15, 2026.

Safety Information

The overall tolerability profile associated with detalimogene is favorable. Of the 125 patients assessed for safety in Cohort 1, 69 patients (55%) experienced at least one TRAE, which were mainly Grade 1/2 in severity. The most common TRAEs were fatigue (22%), dysuria (14%), micturition urgency (12%), pollakiuria (12%), and bladder spasm (11%). Six patients experienced Grade ≥3 TRAEs, including one Grade 4 TRAE, which has resolved. There were no Grade 5 TRAEs reported. TRAEs leading to dose discontinuations (2.4%) and dose interruptions (2.4%) were rare.

Conference Call

enGene will host a conference call and live webcast at 8:00 a.m. ET today, May 7, 2026. Individuals interested in listening to the conference call may do so by clicking the following link, which is also available at the "Investors" section of the Company’s website at www.engene.com/investors. Following the live webcast, an archived version of the call will also be available on the Company’s website for 90 days.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on the healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75%-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50%-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. These designations are intended to expedite the development and review of drugs to serious or life-threatening conditions and fill an unmet medical need. Detalimogene has also been selected for the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, designed to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3).

(Press release, enGene, MAY 7, 2026, View Source [SID1234665361])

On May 7, 2026 AbCellera (Nasdaq: ABCL) reported that the Company will present at the following investor conferences:

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Bank of America Health Care Conference, May 13, 2026
Jefferies Global Healthcare Conference in New York, June 4, 2026

A live audio webcast of each presentation may be accessed through a link that will be posted on AbCellera’s Investor Relations website closer to date. A replay will be available through the same link following the presentation.

(Press release, AbCellera, MAY 7, 2026, View Source [SID1234665360])

On May 7, 2026 Repertoire Immune Medicines, a biotechnology company pioneering the discovery and development of programmable T cell-targeted immune medicines, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to RPTR-1-201 for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) after progression on, or intolerance to, available standard therapies. RPTR-1-201 is a novel T cell receptor (TCR) bispecific immune medicine that is currently in a Phase 1/2 trial for the treatment of multiple advanced solid tumors.

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"Patients with advanced TNBC often face limited options after progression on standard therapies," said Robert Andtbacka, MD, CM, Chief Medical Officer of Repertoire Immune Medicines. "Fast Track Designation underscores the seriousness of this disease and the unmet needs for new treatment options. RPTR-1-201 is designed to redirect T cells by targeting a tumor-selective epitope on tumor cells in selected patients, and we appreciate the FDA’s engagement as we evaluate its potential in this population."

"RPTR-1-201 reflects our ability to discover tumor-selective epitopes and intentionally engineer TCR bispecifics designed to engage them with high affinity and specificity," said Anthony Coyle, PhD, President and Head of Research and Development at Repertoire Immune Medicines. "Derived from our DECODE platform, RPTR-1-201 couples an epitope-specific TCR with an anti-CD3 domain to engage and redirect T cells. Fast Track Designation supports closer dialogue with the FDA as we advance the program and continue its clinical evaluation."

The FDA’s Fast Track program is intended to facilitate the development and expedite the review of investigational therapies that treat serious conditions and address unmet medical needs. The designation may enable more frequent interactions with the FDA and may allow rolling review of a future marketing application if relevant criteria are met.

RPTR-1-201 is a TCR bispecific molecule comprised of an engineered TCR that binds with high affinity and precision to a tumor-selective epitope and an anti-CD3 moiety that engages and redirects T cells to kill tumor cells. RPTR-1-201 is derived from Repertoire’s DECODE platform, which maps the immune synapse to identify TCR-epitope pairs and translate these insights into T cell-targeted immune medicines.

RPTR-1-201 is currently being evaluated in a Phase 1/2 clinical trial as monotherapy and in combination with an anti-PD-1 therapy in participants with advanced solid tumors (ClinicalTrials.gov Identifier: NCT07293754). Repertoire plans to discuss development options in the Fast Track indication with the FDA as the program advances.

(Press release, Repertoire, MAY 7, 2026, View Source [SID1234665359])