On March 9, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).

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The Phase 2 trial of NDV-01 demonstrated a 12-month complete response (CR) rate of 76% with a favorable safety profile. Notably, a 12-month CR rate of 80% was achieved in the BCG-unresponsive population, one of the most difficult-to-treat segments of NMIBC. Taken together, these findings support the potential best-in-class profile of NDV-01 and support advancement into the Phase 3 RESCUE registrational program evaluating NDV-01 in both 2L BCG-unresponsive and adjuvant intermediate-risk NMIBC.

"These 12-month data show the potential durability of NDV-01’s clinical response profile while continuing to demonstrate a clean safety profile," said Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics. "Importantly, we continue to observe strong responses in patients with BCG-unresponsive disease, with no progression to muscle-invasive disease and no patients requiring radical cystectomy. We believe these interim results provide meaningful clinical validation of the program and support advancing NDV-01 into the registrational Phase 3 RESCUE program with two separate registrational pathways: 2L BCG-unresponsive and adjuvant intermediate-risk, which we expect to initiate in mid-2026."

"I am highly encouraged by NDV-01’s high response rates, 12-month durability and favorable tolerability profile. Building on the clinical community’s familiarity with conventional Gem/Doce, these Phase 2 results provide robust validation of NDV-01’s novel sustained release formulation. In addition, NDV-01’s less than 5-minute administration simplifies dosing for clinical staff, supporting broad adoption in community urology practices where ~80% of NMIBC patients are treated – and potentially offering a significantly more streamlined user experience than currently approved therapies," said Max Kates, MD, Director of Urologic Oncology at Johns Hopkins and Relmada Clinical Advisor.

Highlights of the 12-month follow-up data from the Ongoing Phase 2 study of NDV-01:

Clinical Results (Response Data)
Complete Response
Anytime 95% (36/38)
3 month 87% (33/38)
6 month 86% (25/29)
9 month 85% (22/26)
12 month 76% (19/25)
12-month KM analysis 83%
N=48 patients dosed in overall population; KM: Kaplan-Meier analysis

Efficacy in BCG-Unresponsive Subpopulation**:

Clinical Results (Response Data)
Complete Response
Anytime 94% (16/17)
3 month 82% (14/17)
6 month 86% (12/14)
9 month 91% (10/11)
12 month 80% (8/10)
12-month KM analysis 84%
N=20 patients dosed in BCG-UR subpopulation; ** BCG-UR defined by FDA definition; BCG-UR: Bacillus Calmette-Guérin (BCG) – Unresponsive; KM: Kaplan-Meier analysis
No patient had progression to muscle-invasive disease
No patient underwent a radical cystectomy
No patients had a ≥ Grade 3 treatment related adverse event (TRAE)
No patients discontinued treatment due to AEs
Of the 48 patients who received ≥ 1 dose, 30 (63%) experienced a treatment-related adverse event (AE).
Among treatment-related AEs,
54% were transient uncomfortable urination (dysuria, <24 hours, Grade 1)
8% had an asymptomatic positive urine culture
8% had hematuria
Phase 3 RESCUE Registrational Pathways:

Registrational Pathway 1 – An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (NDV-01 vs. observation). There are no approved treatments for adjuvant intermediate risk NMIBC, which we estimate affects ~75,000 patients/year in the US.

Primary endpoint: Disease Free Survival (DFS)
Key secondary endpoints: High-grade recurrence free survival (HG-RFS), progression free survival (PFS), quality of life (QOL) metrics
Registration Pathway 2 – A single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) patients who are currently refractory to approved or developmental therapies. Patients with BCG-unresponsive NMIBC with CIS who fail first line (1L) therapies, which we estimate to affect ~5,000 patients/year in the US, have few, if any, effective treatment alternatives to radical cystectomy.

Primary endpoint: Complete response (CR) rate at any time
Key secondary endpoint: Duration of response (DOR), progression free survival (PFS), recurrence free survival (RFS) amongst responders
Expected Upcoming NDV-01 Milestones:

NDV-01 United States IND clearance – Mid-2026
Phase 3 RESCUE Program Initiation – Mid-2026
Initial 3-month results from Phase 3 2L BCG-unresponsive study expected by YE 2026
About NDV-01

NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is ready to use, convenient to administer in-office in approximately 5 minutes and does not require anesthesia or specialized equipment. It is protected by patents through 2038.

About the Phase 2 Study

The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with HG-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).

About NMIBC

NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 – 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

(Press release, Relmada Therapeutics, MAR 9, 2026, View Source [SID1234663371])

On March 9, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported that Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer, will participate in the Leerink Partners Global Healthcare Conference being held in Miami, Florida, from March 8-11, 2026.

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Leerink Partners Global Healthcare Conference Details
Format: Fireside Chat
Date Tuesday, March 10, 2026
Time: 8:40 AM ET
Webcast: Click Here

Management will also be available for one-one-one investor meetings during the conference. Please contact your Leerink Partners representative to schedule a meeting.

The webcast can also be accessed on the Events page the Investors section of the Relmada website at View Source An archived replay will be available for 90 days following the conclusion of the event.

(Press release, Relmada Therapeutics, MAR 9, 2026, View Source [SID1234663370])

On March 9, 2026 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress, reported financial results for the year ended December 31, 2025, and highlighted anticipated data disclosure timelines for its product pipeline.

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"I am excited about MacroGenics’ future prospects, and am inspired by the commitment of our employees over the past few quarters to sharpen our focus and advance our strategic priorities," said Eric Risser, President and CEO of MacroGenics. "Looking ahead, we anticipate several important milestones in 2026, including initial clinical data from the Phase 1 studies of MGC026 and MGC028, and from the LINNET study of lorigerlimab. Additionally, we plan to submit an IND for MGC030, a first-in-class topoisomerase I inhibitor-based ADC. Finally, with cash runway into late 2027, we believe we are well positioned to execute on our plan and drive meaningful value for our shareholders."

Corporate Progress and Anticipated Milestones

Innovative ADC Pipeline

MacroGenics is developing potential best-in-class or first-in-class antibody-drug conjugates (ADCs) that leverage its protein engineering expertise and incorporate potent glycan-linked exatecan payloads designed to enable an expanded therapeutic window. The proprietary drug-linker platform is licensed from Synaffix B.V., a Lonza company.

MacroGenics’ two clinical-stage ADC programs, MGC026 and MGC028, have demonstrated acceptable safety profiles to date, with no observations of interstitial lung disease, as well as encouraging early evidence of anti-tumor activity by Response Evaluation Criteria in Solid Tumors (RECIST).

MGC026 targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. The Company completed enrollment of a Phase 1 dose escalation study in 2025 and is currently enrolling patients in a dose expansion study in selected solid tumor indications. The Company anticipates reporting initial MGC026 clinical data in mid-2026.

MGC028 is a first-in-class ADC that targets ADAM9, a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple solid tumors. MGC028 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors. The Company anticipates reporting initial MGC028 clinical data in the second half of 2026.

MGC030 is a first-in-class preclinical ADC that targets an undisclosed antigen expressed across several solid tumors. An Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for the third quarter of 2026.
Lorigerlimab

The LINNET study is a Phase 2 monotherapy trial evaluating lorigerlimab, a PD-1 × CTLA-4 bispecific DART molecule, in patients with either platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). As previously announced, the FDA has placed a partial clinical hold on the LINNET study, and no new patients are being enrolled while the hold remains in effect. MacroGenics is working closely with the FDA to resolve the partial clinical hold as soon as possible. MacroGenics continues to plan for a clinical update in mid-2026.

Partnership Updates

Gilead. MacroGenics and Gilead are advancing three programs, including (1) MGD024, a clinical-stage CD123 × CD3 bispecific DART molecule being evaluated in an ongoing dose escalation study in AML and MDS, (2) a preclinical TRIDENT molecule program, and (3) a preclinical DART molecule program. The Company remains eligible to receive up to $1.6 billion in future milestones as well as royalties related to these three product candidates.

Sanofi. Sanofi is progressing the worldwide development and commercialization of TZIELD (teplizumab-mzwv), an antibody targeting CD3 that the Company sold in 2018 to a partner that was subsequently acquired by Sanofi S.A. (Sanofi). In October 2025, Sanofi announced that TZIELD had been accepted for expedited review in the U.S. for stage 3 type 1 diabetes through the FDA Commissioner’s National Priority Voucher pilot program. MacroGenics remains eligible to receive up to $330 million in additional milestones related to TZIELD.

Incyte. Incyte is progressing the worldwide development and commercialization of ZYNYZ (retifanlimab-dlwr), a humanized PD-1 antibody originally developed in collaboration with MacroGenics that is approved in the U.S. for the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma and for first-line and subsequent-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC). In December 2025, Japan’s Ministry of Health, Labour and Welfare approved ZYNYZ as first-line therapy for adults with locally recurrent or metastatic SCAC. In addition, Incyte recently disclosed that the European Commission approved ZYNYZ in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or inoperable locally recurrent SCAC. MacroGenics remains eligible to receive up to $540 million in additional milestones related to ZYNYZ.
2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities balance as of December 31, 2025, was $189.9 million, compared to $201.7 million as of December 31, 2024.

Revenue: Total revenue was $149.5 million for the year ended December 31, 2025, compared to $150.0 million for the year ended December 31, 2024. Total revenue included contract manufacturing revenue of $52.6 million for the year ended December 31, 2025, compared to $13.1 million for the year ended December 31, 2024, reflecting increased production for external clients in 2025.

R&D Expenses: Research and development expenses were $147.2 million for the year ended December 31, 2025, compared to $177.2 million for the year ended December 31, 2024. The decrease was primarily attributable to decreased costs related to programs that were terminated or sold as well as decreased manufacturing and IND-enabling costs related to MGC028, partially offset by increased clinical trial costs related to MGC026 and MGC028 as well as increased development costs related to MGC030.

Cost of Manufacturing Services: Cost of manufacturing services was $36.0 million for the year ended December 31, 2025, compared to $11.5 million for the year ended December 31, 2024. The increase was due to increased production for external clients in 2025.

SG&A Expenses: Selling, general and administrative expenses were $39.2 million for the year ended December 31, 2025, compared to $71.0 million for the year ended December 31, 2024. The decrease was primarily due to lower stock-based compensation expense and reduced professional fees.

Net Loss: Net loss was $74.6 million for the year ended December 31, 2025, compared to $67.0 million for the year ended December 31, 2024, which included a $36.3 million gain on sale of MARGENZA.

Shares Outstanding: Shares of common stock outstanding as of December 31, 2025, were 63,318,613.

Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $189.9 million as of December 31, 2025, in addition to anticipated and future payments from partners and anticipated savings from the Company’s cost-reduction initiatives, is expected to support its cash runway into late 2027.

MACROGENICS, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)

December 31, 2025 December 31, 2024

Cash, cash equivalents and marketable securities $ 189,913 $ 201,667
Total assets 256,846 261,655
Deferred revenue 66,424 71,822
Total stockholders’ equity 55,591 116,057

MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share data)

Year Ended December 31,
2025 2024 2023
Revenues:
Collaborative and other agreements $ 87,183 $ 119,918 $ 30,546
Contract manufacturing 52,631 13,057 9,833
Product sales, net — 16,426 17,939
Royalty revenue 9,686 561 431
Total revenues 149,500 149,962 58,749
Costs and expenses:
Cost of product sales — 847 619
Cost of manufacturing services 36,009 11,452 7,603
Research and development 147,172 177,194 166,583
Selling, general and administrative 39,160 71,047 52,188
Total costs and expenses 222,341 260,540 226,993
Loss from operations (72,841 ) (110,578 ) (168,244 )
Gain on royalty monetization arrangement — — 150,930
Gain on sale of MARGENZA — 36,250 —
Interest and other income 6,057 9,421 9,686
Interest and other expense (8,508 ) (1,115 ) (1,430 )
Loss before income taxes (75,292 ) (66,022 ) (9,058 )
Income tax (benefit) expense (672 ) 944 —
Net loss (74,620 ) (66,966 ) (9,058 )
Other comprehensive income (loss):
Unrealized gain (loss) on investments 28 10 (1 )
Comprehensive loss $ (74,592 ) $ (66,956 ) $ (9,059 )

Basic and diluted net loss per common share $ (1.18 ) $ (1.07 ) $ (0.15 )
Basic and diluted weighted average common shares outstanding 63,155,096 62,621,185 61,929,198

(Press release, MacroGenics, MAR 9, 2026, View Source [SID1234663369])

On March 9, 2026 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that clinical data and updates from key programs within its hemato‑oncology pipeline will be presented at the 2026 EBMT Annual Meeting, taking place March 22–25, 2026 in Madrid, Spain.

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An oral presentation, scheduled during the Presidential Plenary Session, will detail the final results, including overall survival data, from the Company’s lead asset MaaT013, which is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025.

In addition, MaaT Pharma will present three poster communications, featuring:

Key results from CHRONOS, a multicenter retrospective cohort study describing real‑world outcomes in third‑line acute gastrointestinal GvHD, and
The study designs of two clinical trials (PHOEBUS and THRASSA – pediatric study announced in March 2025) advancing the Company’s therapeutic pipeline.
With this broad clinical data presentation at the 2026 EBMT Annual Meeting, MaaT Pharma reaffirms its position in hemato‑oncology across the full care continuum of HCT and its commitment to improving outcomes for patients undergoing allogeneic transplantation.

During this year’s Congress, Clinigen, MaaT Pharma’s strategic commercial partner for MaaT013’s Early Access Program and commercialization in Europe pending EMA approval, will host a dedicated symposium on Advancing Management of Steroid Refractory aGvHD with GI Involvement: From Unmet Need to a Potential Third Line Option. MaaT013 is currently under regulatory review and not yet approved.

The symposium will be chaired by Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and Fabio Ciceri, MD, PhD, Associate Professor of Hematology, University Vita-Salute San Raffaele. It will also feature renowned hematology experts such as Zinaida Peric, MD, hematologist University of Rijeka (Croatia); Chair, GvHD Subcommittee, Transplant Complications Working Party, EBMT, Ernst Holler, Professor at University Medical Center Regensburg (Germany) and Jaime Sanz, MD, hematologist and coordinator of the Bone Marrow Transplant Unit at the University Hospital La Fe in Valencia (Spain). The details of the Symposium are below:

Title: Advancing Management of Steroid Refractory aGvHD with GI Involvement: From Unmet Need to a Potential Third Line Option
Date: Sunday, March 22, 2026
Time: 12:30 – 14:00 CET
Room: N101–102
Professor Malard will also speak at a workshop session dedicated to the Current state of microbiota transplantation in allogeneic HCT, independently from any activities related to the Company, on Monday, March 23, 2026, from 11:00am – 11:20am CET in Velazquez location (W02 Workshop | GVHD beyond immunosuppression – Regulation, repair, and innovation).

EBMT abstracts are now available at www.ebmt.org. Details of the MaaT Pharma presentations are as follow:

Oral presentation:

Title: MaaT013 for Ruxolitinib-Refractory Acute Graft-versus-Host Disease with Gastrointestinal Involvement: Final Results from the ARES Phase III Trial
Abstract number: GS2-8
Session: GS2 Presidential Symposium
Session Date/Time: Monday, March 23, 2026 – 17:33 – 17:42 CET
Location: VELAZQUEZ
Presenter: Prof. Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and ARES Trial lead investigator
Poster Presentations:

PHOEBUS

Title: MaaT033 for Gut Microbiota Optimization To Improve Survival after Allogeneic HCT: the Phoebus Trial
Abstract number: A093
Session: Transplant and Cellular Therapies – Clinical
Session Date/Time: Monday, March 23, 2026 – 18:00 – 19:00 CET
Location: VELAZQUEZ
Presenter: Prof. Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and PHOEBUS Trial lead investigator
CHRONOS

Title: Key results from CHRONOS, a multicenter retrospective cohort study describing real-world outcomes in third-line acute gastrointestinal GvHD
Abstract number: B005
Session: Graft-versus-Host Disease – Clinical
Session Date/Time: Tuesday, March 24, 2026 – 18:00 – 19:00
Location: VELAZQUEZ
Presenter: Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria
THRASSA

Title: THRASSA, a Multicenter Open-label Study Evaluating the Safety, Tolerability and Efficacy of MaaT013 in Ruxolitinib-Refractory or Intolerant Paediatric/Adolescent Participants with Gastrointestinal Acute Graft-versus-Host Disease
Abstract number: P222
Session: Paediatrics – Clinical
Session Date/Time: Sunday, March 22, 08:30 – 18:00 CET
Location: e-Poster area
Presenter: Marion Bruelle, Clinical Scientist at MaaT Pharma

(Press release, MaaT Pharma, MAR 9, 2026, View Source [SID1234663368])

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])