On March 9, 2026 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, reported that it will participate in the following scientific conferences:

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Eurogin HPV Conference (Vienna, Austria)
Date: Thursday, March 19
Time: 8:00 AM CET
Presentation: DNA Immunotherapy INO-3107 Demonstrates Long-Term Surgical Intervention Reduction in HPV-6 & 11 RRP

World Vaccine Congress DC (Washington, DC)
Date: Monday, March 30
Time: 11:50 AM ET
Presentation: Novel DNA-Encoded Monoclonal Antibody Technology: Durable and Tolerable In Vivo Expression of mAbs Targeting COVID

Available abstracts will be shared on INOVIO’s website following presentations.

(Press release, Inovio, MAR 9, 2026, View Source [SID1234663365])

On March 9, 2026 Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/NYSE: AZN) reported that its supplemental Biologics License Application (sBLA) for ENHERTU (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant benefit over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in December 2025 for ENHERTU based on data from the DESTINY-Breast05 phase 3 trial presented at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. The Prescription Drug User Fee Act (PDUFA) date, the FDA target action date for their regulatory decision, is July 7, 2026.

Results from DESTINY-Breast05 showed ENHERTU significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% (hazard ratio [HR]=0.47; 95% confidence interval [CI]: 0.34-0.66; p<0.0001) compared to trastuzumab emtansine (T-DM1) as a post-neoadjuvant treatment for patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy. Trial results demonstrated a three-year IDFS rate of 92.4% (95% CI: 89.7-94.4) in the ENHERTU arm compared to 83.7% with T-DM1 (95% CI: 80.2-86.7). IDFS findings were consistent across all prespecified subgroups.

Data also showed that ENHERTU significantly reduced the risk of disease recurrence or death by 53% (HR=0.47; 95% CI: 0.34-0.66; p<0.0001) compared to T-DM1. Treatment with ENHERTU in DESTINY-Breast05 also reduced the risk of distant disease recurrence (distant recurrence-free interval [DRFI]) by 51% (HR=0.49; 95% CI: 0.34-0.71) and the risk of brain metastases (brain metastasis-free interval [BMFI]) by 36% (HR=0.64; 95% CI: 0.35-1.17) versus T-DM1.

The sBLA is being reviewed under Project Orbis, which provides a framework for the concurrent submission and review of oncology medicines among participating international partners. This initiative is designed to bring effective cancer treatments to patients as early as possible.

"For patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "This Priority Review reinforces the potential of ENHERTU to become a new standard of care for HER2 positive early breast cancer based on the results of DESTINY-Breast05."

"While there has been significant progress in treating HER2 positive early breast cancer, managing patients at a higher risk of recurrence remains challenging," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. "With this Priority Review, we move closer to bringing ENHERTU to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure."

The safety profile of ENHERTU observed in DESTINY-Breast05 was consistent with its known profile with no new safety concerns identified. Grade 3 or higher treatment emergent adverse event (TEAE) rates were comparable between ENHERTU (50.6%) and T-DM1 (51.9%). The most common grade 3 or higher TEAEs occurring in 5% or more of patients treated with ENHERTU were decreased neutrophil count (15.5%), decreased white blood cell count (10.1%), decreased platelet count (6.7%) and neutropenia (8.1%). Rates of interstitial lung disease (ILD) or pneumonitis were low in both arms with ILD events occurring in 9.6% of the ENHERTU arm and 1.6% of the T-DM1 arm. The majority of ILD or pneumonitis events were low grade (grade 1 [ENHERTU=16; 2.0%; T-DM1=8; 1.0%] or grade 2 [ENHERTU=52; 6.5%; T-DM1=5; 0.6%]). There were no grade 3 or higher ILD or pneumonitis events for T-DM1. In the ENHERTU arm, there were seven grade 3 events (0.9%) and two grade 5 events (0.2%) as determined by an independent adjudication committee.

Regulatory submissions for ENHERTU based on DESTINY-Breast05 are under review in the EU and Japan. In addition, an sBLA for ENHERTU followed by paclitaxel, trastuzumab and pertuzumab (THP) currently is under review in the U.S. for the neoadjuvant treatment of adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on results from the DESTINY-Breast11 trial with a PDUFA date of May 18, 2026.

About DESTINY-Breast05

DESTINY-Breast05 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus T-DM1 in patients with HER2 positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomization until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed DFS. Other secondary endpoints include overall survival, DRFI, BMFI, interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

About Post-Neoadjuvant Treatment for HER2 Positive Early Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1 In the U.S., more than 320,000 cases of breast cancer are diagnosed annually with more than 42,000 deaths.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.3 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.3 Approximately one in five cases of breast cancer is considered HER2 positive.4

For patients with HER2 positive early breast cancer, achieving pathologic complete response (pCR) with neoadjuvant treatment is the earliest indicator of improved long-term survival.5 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence.6,7,8,9,10

Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death and current treatment options have shown limited impact on central nervous system recurrence.11 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.12

Post-neoadjuvant therapy represents a key opportunity to minimize the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients.13,14

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, MAR 9, 2026, View Source [SID1234663383])

On March 9, 2026 Ipsen (Euronext: IPN; ADR: IPSEY) reported that it is voluntarily withdrawing Tazverik (tazemetostat) in all indications from all Ipsen markets. Ipsen’s decision to withdraw is based on emerging data from the ongoing Phase Ib/III SYMPHONY-1 trial (evaluating tazemetostat in combination with lenalidomide plus rituximab (R2) vs R2 in follicular lymphoma). The Independent Data Monitoring Committee (IDMC) advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of these data, Ipsen is withdrawing Tazverik effective immediately, including both for follicular lymphoma (FL) and epithelioid sarcoma (ES).

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In addition to withdrawing Tazverik from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrolment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active tazemetostat clinical trials and expanded access programs.

"While this is an extremely disappointing outcome, the safety of patients remains our priority", said Christelle Huguet, PhD & EVP Head of R&D at Ipsen. "Emerging data from this confirmatory study have highlighted a safety profile that is unfavorable compared to that previously observed in clinical evaluation. We will now work closely with investigators and clinical teams to support patients through the respective next steps and transition plans."

Ipsen is working with the United States (U.S.) Food and Drug Administration (FDA) on the next steps to execute the withdrawal of Tazverik and provide all necessary information to complete this process. Tazverik is marketed in the U.S. by Ipsen in FL and ES. Tazverik received accelerated approval from the U.S. FDA in 2020 for adults with relapsed or refractory FL whose tumors are positive for an EZH2 mutation and who have received at least two prior therapies as well as relapsed or refractory FL adult patients who have no satisfactory alternative treatment options. Tazverik also received U.S. FDA accelerated approval in 2020 for the treatment of adults and adolescents aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

The withdrawal is not expected to impact the Company’s financial guidance.

About Tazverik
Tazverik is an EZH2 inhibitor indicated in the U.S. for the treatment of:
Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval regulatory pathways based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
View the U.S. Full Prescribing Information here
Tazverik is available in Japan, Macau, Hong Kong & China via Ipsen partners.

About SYMPHONY-1
SYMPHONY‑1 (EZH‑302; NCT04224493) is an Ipsen‑led global Phase Ib/III study evaluating Tazverik in combination with lenalidomide and rituximab (R²) as a second‑line therapy for relapsed/refractory follicular lymphoma. This study also serves as the confirmatory trial required under the accelerated approval pathway for Tazverik in follicular lymphoma.

The trial spans 229 sites across 15 countries, including the U.S., EU, China, and others, and includes independently powered analyses for EZH2‑wild‑type and EZH2‑mutant patient populations.

(Press release, Ipsen, MAR 9, 2026, View Source [SID1234663366])

On March 9, 2026 enGene Holdings Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported its financial results for the first quarter ended January 31, 2026, and provided a business update.

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"As data from LEGEND’s pivotal cohort in high-risk, BCG-unresponsive NMIBC continues to mature, we look forward to providing an update at a spring medical conference," said Ron Cooper, President and Chief Executive Officer, enGene. "On the heels of our successful November follow-on offering, we entered 2026 in a position of financial strength and ready to execute. With RMAT and CDRP designations for detalimogene, we are in active dialogue with the FDA to ensure regulatory and manufacturing readiness as we plan for a BLA submission in the second half of this year and potential launch in 2027."

Recent Corporate Updates

Expanded debt facility: In January 2026, the Company expanded its existing loan and security agreement with Hercules Capital, Inc. (NYSE: HTGC) ("Hercules"), for up to $125 million. Access to the additional non-dilutive capital strengthens enGene’s balance sheet in preparation for its planned Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for detalimogene voraplasmid as a treatment for high-risk, Bacillus Calmette-Guérin ("BCG")-unresponsive non-muscle invasive bladder cancer ("NMIBC") with carcinoma in situ ("CIS") in the second half of 2026, and the potential commercial launch of detalimogene should it receive FDA approval.

Successful completion of public offering: In November 2025, the Company successfully closed an underwritten public offering of its common shares and pre-funded warrants at an offering price of $8.50 per share and $8.4999 per pre-funded warrant. The offering totaled $140.1 million in net proceeds, following the full exercise of the underwriters’ option to purchase additional shares.

LEGEND pivotal cohort update: In November 2025, enGene reported preliminary data from LEGEND’s pivotal cohort for patients enrolled following a protocol amendment implemented in the fourth quarter of 2024. The preliminary analysis of the post-amendment patients with at least one post-baseline disease assessment included 62 patients at 3 months and 37 patients at 6 months and demonstrated:

63% complete response (CR) rate at any time (n=62);
56% CR rate at 3 months (n=62);
62% CR rate at 6 months (n=37), including 4 patients who successfully converted to CR post reinduction; and
All 5 patients who completed the 9-month assessment had a CR.
The Company completed enrollment of 125 patients in total. Data from these patients demonstrated a generally favorable tolerability profile:

42% of patients experienced a treatment-related adverse event (TRAE);
1.6% of patients experienced dose interruptions due to TRAEs; and
0.8% of patients experienced dose discontinuations due to TRAEs.
enGene continues to believe that detalimogene’s emerging profile supports its potential first-line use in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer with CIS.

CMC Development and Readiness Pilot (CDRP) Program: In November 2025, the Company was selected as one of nine companies to participate in the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy. Acceptance into the program further supports enGene’s confidence in detalimogene’s potential and aligns with enGene’s commitment to strong manufacturing practices as clinical development advances.

Anticipated Milestones

Update from LEGEND pivotal cohort planned for a spring 2026 medical conference.
12-month complete response data from LEGEND pivotal cohort expected in 2H 2026.
Planned BLA filing for LEGEND’s pivotal cohort in the second half of 2026.
First Quarter 2026 Financial Results

As of January 31, 2026, cash, cash equivalents and marketable securities were $312.5 million. The Company expects that its cash, cash equivalents and marketable securities will fund operating expenses, debt obligations and capital expenditures into the second half of 2028.

Total operating expenses were $31.2 million for the three months ended January 31, 2026, compared to $26.6 million for 2025. Research and development expenses increased by $2.3 million, primarily driven by increased personnel and clinical costs related to our LEGEND trial and in preparation for our planned Biologics License Application submission in the second half of 2026. General and administrative expenses increased by $2.3 million, primarily driven by personnel and facilities costs as the Company scales its general and administrative function to support the operation of a public company.

For the three months ended January 31, 2026, net loss attributable to common shareholders was approximately $29.8 million, or $0.44 per share, compared to approximately $24.6 million, or $0.48 per share, for the three months ended January 31, 2025. The increase in net loss is mainly attributed to the increase in operating expenses, partially offset by net interest income earned during the period.

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 our 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. The RMAT program is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening conditions, where preliminary clinical evidence suggests potential to address unmet medical needs. Similarly, Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Detalimogene has also been selected to participate in the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program 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). The LEGEND trial is actively enrolling patients with sites participating in the USA, Canada, Europe, and the Asia-Pacific region.

(Press release, enGene, MAR 9, 2026, View Source [SID1234663384])

On March 9, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported it has closed the sale of an additional $50 million of shares of its common stock to investors from its July 2025 equity private placement of up to $100 million, following achievement of a clinical milestone within its PiNACLE pivotal trial evaluating rondecabtagene autoleucel (ronde-cel) in patients with relapsed/refractory large B-cell lymphoma (LBCL) in the third- or later-line setting. The Company also announced the appointment of Smital Shah as its Chief Financial and Business Officer, effective March 9, 2026.

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"Smital’s deep expertise in navigating complex financial landscapes and her proven track record of strategic leadership in the biotechnology industry make her the ideal partner to guide Lyell’s financial strategy as we enter a transformative year of execution," said Lynn Seely, M.D., President and CEO of Lyell. "The attainment of the second $50 million tranche of the private placement is evidence of Lyell’s continued advancement toward significant value inflection points. Smital’s insights will be invaluable in ensuring we remain well-capitalized and operationally disciplined to deliver on our mission of bringing next-generation cell therapies to patients with cancer."

Closing of Additional $50 Million Equity Private Placement Following Achievement of Clinical Milestone for Ronde-cel
Under the terms of the securities purchase agreement for the July 2025 equity private placement of up to $100 million, and following the initial closing of $50 million, Lyell held the right to require investors to purchase an additional $50 million of common stock upon the achievement of a clinical milestone for ronde-cel, a dual-targeting CD19/CD20 CAR T-cell therapy in pivotal clinical development for patients with LBCL. Following the successful achievement of this clinical milestone, Lyell exercised this right and the investors purchased these shares from Lyell at a purchase price per share of $25.61, resulting in gross proceeds of approximately $50 million, bringing the total equity private placement proceeds to approximately $100 million. With the closing of this additional tranche, Lyell expects its cash, cash equivalents and marketable securities to be sufficient to meet working capital and capital expenditure needs into the second quarter of 2027.

The offer and sale of the foregoing securities were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The investors have been granted customary resale Form S-3 registration rights for the shares of common stock issued to them in the financing.

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

Smital Shah Appointed Chief Financial and Business Officer
Ms. Shah joins Lyell with over two decades of extensive leadership experience spanning corporate finance, capital markets and strategic operations within the biopharmaceutical industry. Most recently, she operated as an independent Chief Financial Officer and Chief Business Officer consultant, providing strategic guidance to multiple life sciences organizations. From 2014 to 2022, Ms. Shah served as the Chief Business and Financial Officer at ProQR Therapeutics (Nasdaq: PRQR) where she was responsible for directing all business functions, including finance, communications, commercial strategy, business development and legal.

Prior to her tenure at ProQR, Ms. Shah managed multi-billion-dollar debt, cash and investment portfolios at Gilead Sciences, Inc. She developed financial expertise through her tenure as an investment banker at Leerink Partners and J.P. Morgan, where she focused on capital raising and complex strategic transactions across the biotechnology sector. She began her career in various research and development roles at Johnson & Johnson.

Ms. Shah served on the Board of Directors of Pliant Therapeutics until June 2025 and as a Board Member and Chair of the Audit Committee at Graphite Bio until its merger with LENZ Therapeutics in 2024. She holds a B.S. in Chemical Engineering from the University of Mumbai, an M.S. in Chemical Engineering from Virginia Tech, as well as an M.B.A. in Finance from the University of California, Berkeley, Haas School of Business.

(Press release, Lyell Immunopharma, MAR 9, 2026, View Source [SID1234663367])