Tillkännagivande • Mar 11

Citius Oncology, Inc. Announces Positive Topline Results from Investigator-Initiated Phase 1 Study of LYMPHIR™ in Combination with Pembrolizumab in Relapsed or Refractory Gynecologic Cancers

Citius Oncology, Inc. announced positive topline results from a completed investigator-initiated Phase 1 clinical trial conducted by University of Pittsburgh investigators. This study evaluated the direct T-regulatory (Treg) cell depletion activity of LYMPHIR™ (denileukin diftitox-cxdl) in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (KEYTRUDA®) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies. Patients with relapsed or refractory gynecological cancer have poor prognoses and very limited treatment options. This dose-escalation Phase 1 non-chemotherapy based clinical study aimed to establish a recommended dose of LYMPHIR in combination with pembrolizumab for a Phase 2 study. In 25 evaluable patients, no unexpected safety signals or serious immune-related adverse events were observed at any dose level. The trial explored efficacy and demonstrated a 24% objective response rate (ORR) and a 48% clinical benefit rate (CBR, defined as complete response, partial response and/or stable disease for six months or greater) among 21 evaluable patients. Full safety and clinical efficacy results are expected to be presented at an international cancer conference later this year. This open-label, dose-escalation, investigator-initiated Phase 1 study (NCT05200559), led by Dr. Alexander B Olawaiye at UPMC Magee-Women's Hospital, enrolled patients with recurrent or metastatic solid tumors who had received at least one prior line of therapy. LYMPHIR was administered intravenously on Days 1–3 of each 21-day cycle at escalating doses (3, 6, 9, and 12 mcg/kg), along with pembrolizumab (200 mg IV) on Day 1. Patients who completed eight cycles of combination therapy were continued on pembrolizumab monotherapy until disease progression. The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication. The Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes. Recurrent or metastatic ovarian and endometrial cancers are two of the most common gynecologic malignancies in the United States. Endometrial cancer is the most frequently diagnosed gynecologic cancer, with an estimated 70,000 new cases expected in 2026, while ovarian cancer remains the deadliest with approximately 12,700 deaths per year (51.6% 5 year survival) and approximately 20,000 new diagnoses each year. These cancers are often detected at advanced stages, and although many patients initially respond to platinum-based chemotherapy, most experience relapse and develop resistance. Survival rates in the recurrent setting remain poor, and responses to current immunotherapies such as PD-1 inhibitors are limited, highlighting a significant unmet need for novel treatment approaches. LYMPHIR's transient depletion of regulatory T-cells may enhance anti-tumor immune responses and help overcome immunotherapy resistance in these difficult-to-treat tumors. LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors. In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025. LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity. LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin Risk Summary. Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox. Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. No data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose. Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR. Advise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose. Based on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown. Safety and effectiveness of LYMPHIR in pediatric patients have not been established. Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

VD-lön i procent	4.39%
Anställning som VD	1.8yrs
Ägande av VD	n/a
Ledningens genomsnittliga anställningstid	1.8yrs
Styrelsens genomsnittliga mandatperiod	1.8yrs

Datum	Total ersättning	Lön	Företagets resultat
Mar 31 2026	n/a	n/a	-US$43m
Dec 31 2025	n/a	n/a	-US$24m
Sep 30 2025	US$4m	US$166k	-US$25m
Jun 30 2025	n/a	n/a	-US$27m
Mar 31 2025	n/a	n/a	-US$26m
Dec 31 2024	n/a	n/a	-US$23m
Sep 30 2024	US$2m	US$166k	-US$21m
Jun 30 2024	n/a	n/a	-US$20m
Mar 31 2024	n/a	n/a	-US$17m
Dec 31 2023	n/a	n/a	-US$16m
Sep 30 2023	US$662k	US$153k	-US$13m

Namn	Position	Anställning	Kompensation	Ägarskap
Leonard Mazur	CEO, President & Executive Chairman	1.8yrs	US$3.79m	inga uppgifter
Myron Holubiak	Secretary & Executive Vice Chairman	1.8yrs	US$2.18m	0% $ 0
Myron Czuczman	Executive VP & Chief Medical Officer	1.8yrs	US$1.99m	0% $ 0
Jaime Bartushak	Chief Financial Officer & Treasurer	1.8yrs	inga uppgifter	inga uppgifter

Namn	Position	Anställning	Kompensation	Ägarskap
Leonard Mazur	CEO, President & Executive Chairman	1.8yrs	US$3.79m	inga uppgifter
Myron Holubiak	Secretary & Executive Vice Chairman	1.8yrs	US$2.18m	0% $ 0
Dennis McGrath	Independent Director	1.8yrs	US$620.81k	0% $ 0
Suren Dutia	Lead Independent Director	1.8yrs	US$620.81k	0% $ 0
Joel Mayersohn	Independent Director	3.7yrs	US$726.63k	0.024% $ 15.0k
Robert Smith	Independent Director	1.8yrs	US$620.81k	0% $ 0
Carol Webb	Independent Director	1.8yrs	US$620.81k	0% $ 0
Eugene Holuka	Independent Director	1.8yrs	US$620.81k	0% $ 0

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/06/22 21:48
Aktiekurs vid dagens slut	2026/06/22 00:00
Intäkter	2026/03/31
Årlig intjäning	2025/09/30

Citius Oncology Förvaltning

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Viktig information

Senaste uppdateringar av ledningen

Citius Oncology, Inc., Annual General Meeting, Oct 27, 2025

Recent updates

Citius Oncology, Inc. announced that it expects to receive $36.5 million in funding

Citius Oncology, Inc. Receives Notice of Non-Compliance with Nasdaq Listing Rule

Citius Oncology, Inc. Provides Commercial Update on Lymphir Launch Highlighting Early Adoption and Expanding Clinical Development

Citius Oncology, Inc. Announces Positive Topline Results from Investigator-Initiated Phase 1 Study of LYMPHIR™ in Combination with Pembrolizumab in Relapsed or Refractory Gynecologic Cancers

Citius Oncology, Inc. Announces Preliminary Topline Phase 1 Data from Study of LYMPHIR (E7777) Dosing Prior to Commercial CAR-T Therapy in High-Risk Diffuse Large B-Cell Lymphoma

New major risk - Financial position

Citius Oncology, Inc. announced that it has received $16.6 million in funding

Citius Oncology, Inc. has filed a Follow-on Equity Offering in the amount of $1.4 million.

New minor risk - Share price stability

Citius Oncology to Advance Commercial Launch of LYMPHIR with Verix AI Integration

New minor risk - Market cap size

Citius Oncology, Inc., Annual General Meeting, Oct 27, 2025

Forecast breakeven date pushed back to 2027

New minor risk - Shareholder dilution

Citius Oncology, Inc. has completed a Follow-on Equity Offering in the amount of $9.000002 million.

Citius Oncology, Inc. has filed a Follow-on Equity Offering in the amount of $9.000002 million.

Citius Oncology Deploys AI Platform to Amplify the Performance of its Commercial Team Ahead of LYMPHIR Launch

Citius Oncology, Inc. has filed a Follow-on Equity Offering in the amount of $15 million.

Citius Oncology, Inc. Anticipates Commercial Launch of LYMPHIR in 2025

Citius Oncology Announces Non-Compliance Notice Regarding Bid Price Rule

Citius Pharmaceuticals, Inc. and Citius Oncology, Inc. Announce Unique Permanent J-Code Issued for LYMPHIR by Centers for Medicare & Medicaid Services

New major risk - Financial data availability

Citius Pharmaceuticals and Citius Oncology Highlight LYMPHIR Commercial Launch Planned for the First Half of 2025

Citius Pharmaceuticals, Inc. and Citius Oncology, Inc. Announce Promising Preliminary Results of an Investigator-Initiated Phase I Clinical Trial of Pembrolizumab (Keytruda®) and Lymphir™ in Cancer Patients with Recurrent Solid Tumors

New minor risk - Market cap size

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Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K