On March 10, 2026 Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers, reported financial results for the full year ended December 31, 2025, and highlighted recent progress.

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"2025 was a year of strong execution as we advanced our AlloNK program, successfully enrolling patients in community settings across autoimmune indications and prioritizing refractory RA as our lead indication," said Fred Aslan, M.D., president and chief executive officer of Artiva Biotherapeutics. "AlloNK has the potential to redefine the treatment paradigm for refractory RA by combining the durable efficacy of deep B-cell depletion with an outpatient-ready profile suitable for community rheumatology practices."

Dr. Aslan continued, "In 2026, our focus is to advance AlloNK from an early clinical program in the deep B-cell depletion space to what could become the first therapy in this class to initiate a registrational trial in RA, the autoimmune disease with the largest refractory population. We look forward to sharing initial clinical response data and engaging with the FDA on a potential pivotal trial design in refractory RA in the first half of 2026."

Recent Business Highlights

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Prioritized refractory RA as lead indication: Received FDA Fast Track designation for AlloNK in refractory RA and prioritized RA as the program’s lead autoimmune indication.
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Despite multiple approved biologic and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs), there are more than 150,000 RA patients in the U.S. who have failed at least two prior therapies. Real-world data suggest ACR50 response rates at six months are typically in the 10 – 20% range, underscoring the significant unmet need and opportunity for AlloNK plus rituximab to drive deeper and more durable responses with a single treatment cycle.
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Artiva has successfully enrolled refractory RA patients across dose levels and will provide initial clinical response data from at least 15 patients, most of whom are expected to have six or more months of follow-up, in the first half of 2026.
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Demonstrated deep and consistent B-cell depletion supporting intended mechanism of action: Across patients analyzed, AlloNK plus rituximab resulted in non-quantifiable peripheral CD19+ B-cell levels by Day 13. These findings were confirmed using a high-sensitivity assay with 10- to 50-fold greater sensitivity than standard assays. Early reconstitution data demonstrated predominantly naïve and transitional B cells, consistent with immune reconstitution patterns observed with CD19-directed autologous CAR-T therapies.
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Established favorable safety and outpatient feasibility profile in autoimmune disease, leading to strong enrollment: As of the Oct. 1, 2025 data cutoff, 32 patients were treated with AlloNK plus rituximab across refractory RA, Sjögren’s disease, systemic lupus erythematosus (SLE), lupus nephritis and systemic sclerosis, entirely in the outpatient setting, with the majority treated in community rheumatology clinics. The regimen was well tolerated, with no reported cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease or hypogammaglobulinemia.
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Reported continued durability in Phase 1/2 oncology trial: Presented longer-term data from the completed Phase 1/2 trial of AlloNK plus rituximab in relapsed/refractory B-cell non-Hodgkin lymphoma demonstrating a 64% complete response rate and a median duration of response not yet reached, exceeding 19.4 months at data cutoff, in line with commercially approved auto-CAR-T results in a comparable patient population.

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Enhanced executive leadership to support late-stage development and capital strategy: Appointed Subhashis Banerjee, M.D. as chief medical officer and Thad Huston as chief financial officer, adding deep rheumatology development expertise, regulatory experience and global financial leadership as AlloNK advances toward potential registrational development.
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Strengthened board leadership with deep immunology and commercial expertise: Appointed Dan Baker, M.D. and Elaine Sorg to the board of directors, adding extensive experience in autoimmune drug development, regulatory strategy and large-scale immunology commercialization, including leadership roles supporting major therapies for rheumatoid arthritis and other immune-mediated diseases in multibillion dollar franchises.
Upcoming Milestones

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Initial clinical response data in refractory RA expected in the first half of 2026: Artiva expects to report initial clinical response data in at least 15 patients, most of whom are expected to have six or more months of follow-up.
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Planned FDA interaction in the first half of 2026 to discuss potential pivotal trial design in refractory RA: Subject to feedback and alignment with the FDA, AlloNK has the potential to become the first deep B-cell depleting therapy to initiate a pivotal trial in patients with refractory RA.
Full Year 2025 Financial Results

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Cash, Cash Equivalents and Investments. As of December 31, 2025, Artiva had cash, cash equivalents, and investments of $108.0 million, which is expected to fund operations into Q2 2027.
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License and Development Support Revenue. License and development support revenue was zero for the year ended December 31, 2025, compared to $0.3 million for the year ended December 31, 2024.
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Research and Development Expenses. Research and development expenses were $69.5 million for the year ended December 31, 2025, compared to $50.3 million for the year ended December 31, 2024.
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General and Administrative Expenses. General and administrative expenses were $20.3 million for the year ended December 31, 2025, compared to $17.2 million for the year ended December 31, 2024.
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Other Income, net. Other income, net, was $5.9 million for the year ended December 31, 2025, compared to other income, net, of $1.9 million for the year ended December 31, 2024.
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Net Loss. Net loss totaled $83.9 million for the year ended December 31, 2025, as compared to net loss of $65.4 million for the year ended December 31, 2024, with non-cash stock-based compensation expense of $6.8 million and $7.0 million for the years ended December 31, 2025 and 2024, respectively.

(Press release, Artiva Biotherapeutics, MAR 10, 2026, View Source [SID1234663452])

On March 9, 2026 Hoffmann-La Roche reported results from the phase III persevERA Breast Cancer study evaluating investigational giredestrant in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The study did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed. The adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of each individual treatment.

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"While persevERA didn’t meet its primary objective, we are confident in the potential of giredestrant to become a new standard-of-care endocrine therapy in early and advanced ER-positive breast cancer," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "We believe there is a path forward for combining giredestrant with a CDK4/6 inhibitor in the adjuvant setting and we are conducting further studies. The efficacy demonstrated in evERA and lidERA provides clear validation of the clinical activity of giredestrant and reinforces the strength of our expanding clinical development programme."
The giredestrant clinical development programme is made up of distinct studies designed to reflect the specific disease biology of each stage of breast cancer.3-7 Roche will continue to advance the clinical development programme to identify the people with ER-positive breast cancer who can derive the greatest benefit from giredestrant.

Giredestrant phase III clinical development programme

Trial Indication Regimen
lidERA Breast Cancer5 Adjuvant ER+/HER2- breast cancer Giredestrant vs. standard-of-care endocrine therapy (SoC ET)
persevERA Breast Cancer3 1L ER+/HER2- metastatic breast cancer
(endocrine-sensitive) Giredestrant + palbociclib vs. letrozole plus palbociclib
pionERA Breast Cancer4 1L ER+/HER2- metastatic breast cancer
(endocrine-resistant) Giredestrant + physician’s choice of CDK4/6 inhibitor vs. fulvestrant + physician’s choice of CDK4/6 inhibitor
evERA Breast Cancer6 2L+ ER+/HER2- metastatic breast cancer Giredestrant + everolimus vs. SoC ET + everolimus
heredERA Breast Cancer7 1L maintenance ER+/HER2+ metastatic breast cancer Giredestrant + Phesgo (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) vs. Phesgo
evERA was the first positive phase III readout for giredestrant, followed by lidERA in the early-stage setting.8,9 The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the phase II coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels).10 This growing body of evidence underscores the potential of giredestrant to become a new standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer.

persevERA is the first of two distinct phase III studies in the first-line setting; the pionERA study of giredestrant in combination with physician’s choice of cyclin-dependent kinase (CDK)4/6 inhibitor in endocrine-resistant ER-positive, HER2-negative breast cancer is expected to readout in 2027.3,4

The United States Food and Drug Administration (FDA) recently accepted the New Drug Application based on the evERA data. In the coming weeks, Roche will submit the giredestrant phase III lidERA data in early-stage breast cancer to the FDA.

The full results from persevERA will be presented at an upcoming medical meeting.

About the persevERA Breast Cancer study
persevERA Breast Cancer [NCT04546009] is a phase III, randomised, double-blind, placebo-controlled, multicentre study evaluating the efficacy and safety of giredestrant plus palbociclib versus letrozole plus palbociclib as first-line treatment for people with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer.3 The study enrolled 992 patients globally.3

The primary endpoint is investigator-assessed progression-free survival.3 Key secondary endpoints include overall survival, objective response rate, duration of response and safety.3

About giredestrant
Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader and full antagonist.11

Giredestrant is designed to block oestrogen from binding to the oestrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.12

Giredestrant has an extensive clinical development programme and is being investigated in five company-sponsored phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)5
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)6
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)3
Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK)4/6 inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)4
Giredestrant plus Phesgo (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) versus Phesgo in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)7
About oestrogen receptor (ER)-positive breast cancer
Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year.13 Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.14

ER-positive breast cancer accounts for approximately 70% of breast cancer cases.15 In the US and EU5, an estimated 273,000 people are diagnosed in the early-stage setting, 88,000 people are diagnosed in first-line and 106,000 in the second and third-line setting combined.16

A defining feature of ER-positive breast cancer is that its tumour cells have receptors that attach to oestrogen, which can contribute to tumour growth.17

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity.18 In the early-stage setting, up to a third of people eventually experience disease recurrence on or after adjuvant endocrine therapy treatment.19-21 Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death.22 In advanced settings, resistance to endocrine therapy – particularly following treatment with cyclin-dependent kinase inhibitors – increases the risk of disease progression an is associated with poor outcomes.15,23

There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.18,20,22-24

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years, and it continues to be a major focus of research and development. Our legacy began with the development of the first targeted therapy for human epidermal growth factor receptor 2-positive breast cancer, and we continue to push the boundaries of science to address the complexities of all breast cancer subtypes.

By leveraging our dual expertise in pharmaceuticals and diagnostics, we are dedicated to providing tailored treatment approaches and improving outcomes for every patient, from early to advanced stages of the disease. Together with our partners, we are relentlessly pursuing a cure, as we strive for a future where no one dies from breast cancer.

(Press release, Hoffmann-La Roche, MAR 9, 2026, View Source [SID1234663346])

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 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported publication of efficacy and safety results from the PIK3CA wild-type ("WT") cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in the Journal of Clinical Oncology. The cohort consists of patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-") PIK3CA WT advanced breast cancer ("ABC"), following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor.

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The publication is titled "VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer."

"VIKTORIA-1 is the first Phase 3 study to show a significant improvement in median progression-free survival with inhibition of the PI3K/AKT/mTOR pathway in patients with PIK3CA wild-type HR+/HER2- advanced breast cancer who previously received a CDK4/6 inhibitor," said Sara Hurvitz, MD, lead study author and Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women’s Health, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine.

In the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 trial, median progression-free survival ("PFS") with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective response rate ("ORR") of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response ("DOR") was 17.5 months. For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). The ORR of the gedatolisib doublet was 28.3% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response.

The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0%) rash (4.6%, 5.4%, and 0%); and hyperglycemia (2.3%, 2.3%, and 0%). The primary grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia (10.0% and 0.8%, respectively), leukopenia (0.8% in the gedatolisib triplet group), and pneumonitis (0.8% in gedatolisib doublet group). TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group, 3.1% in the gedatolisib doublet group, and 0% in the fulvestrant group.

"The efficacy data from the VIKTORIA-1 PIK3CA wild-type cohort represent an important addition to the clinical evidence in HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "Importantly, these findings are potentially practice changing for patients with limited options."

The U.S. Food and Drug Administration has granted Priority Review of Celcuity’s New Drug Application for gedatolisib and assigned a Prescription Drug User Fee Act goal date of July 17, 2026.

About HR+/HER2- 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 globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer.3 Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

About the VIKTORIA-1 Phase 3 Trial

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant, with or without palbociclib, in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is fully enrolled. The trial enrolled subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who met eligibility criteria and did not have confirmed PI3KCA mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who met eligibility criteria and had confirmed PI3KCA mutations (MT) were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet.

About Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and wild-type breast tumor cells in nonclinical studies and early clinical data.

(Press release, Celcuity, MAR 9, 2026, View Source [SID1234663388])

On March 9, 2026 Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported the closing of its previously announced underwritten public offering and the exercise in full of the underwriters’ over-allotment option for gross proceeds of approximately $6.0 million, prior to deducting underwriting commissions and offering expenses.

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In connection with the offering, the Company sold 12,094,631 shares of common stock (or pre-funded warrants in lieu thereof) Series J warrants to purchase 12,094,631 shares of common stock, Series K warrants to purchase 12,094,631 shares of common stock, and Series L warrants to purchase 12,094,631 shares of common stock, including the full exercise of the underwriter’s option to purchase 1,575,000 shares of common stock and accompanying warrants..

Ladenburg Thalmann & Co. Inc. acted as sole book-running manager for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-284229), which was declared effective by the United States Securities and Exchange Commission ("SEC") on February 7, 2025 and the related registration statement filed under Rule 462(b) of the Securities Act of 1933, as amended, which became automatically effective upon filing. A final prospectus supplement was filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the final prospectus may also be obtained by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

The Series J warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring five years from issuance. The Series K warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring one year from issuance. The Series L warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring six months from issuance. The warrants issued in this offering each include a reset of the exercise price on two separate occasions: (i) on the forty-fifth (45th) calendar day following the date of issuance and (ii) the sixth (6th) trading day immediately following the date on which a reverse stock split is approved and deemed effective during the fiscal year ended December 31, 2026.

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

(Press release, Calidi Biotherapeutics, MAR 9, 2026, View Source [SID1234663488])