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Item 1. Business

2025-12-23 compared with 2024-12-27 · 766 added, 663 removed, 987 unchanged (59% of the section changed)

Citius Pharmaceuticals, Inc.

(“Citius Pharma”,

and together with its subsidiaries, the “Company” or “we”), headquartered in Cranford, New Jersey, is a biopharmaceutical

company dedicated to the development and commercialization of first-in-class critical care products.

Our goal generally is to achieve

leading market positions by providing therapeutic products that address unmet medical needs yet have a lower development risk than usually

is associated with new chemical entities.

New formulations of previously approved drugs with substantial existing safety and efficacy

data are a core focus.

We seek to reduce development and clinical risks associated with drug development, yet still focus on innovative

applications.

Our strategy centers on products that have intellectual property and regulatory exclusivity protection, while providing

competitive advantages over other existing therapeutic approaches.

Since its inception, the Company has devoted substantially

all of its efforts to business planning, acquiring our proprietary technology, research and development, recruiting management and technical

staff, and raising capital.

We are developing three proprietary products Mino-Lok, an antibiotic lock solution used to treat patients

with catheter-related bloodstream infections by salvaging the infected catheter;

Halo-Lido, a corticosteroid-lidocaine topical formulation

that is intended to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids;

and NoveCite, a mesenchymal

stem cell therapy for the treatment of ARDS.

Citius Oncology achieved the approval from the FDA for LYMPHIR, in-licensed by Citius Pharma

in September 2021 (now owned by Citius Oncology), an engineered IL-2 diphtheria toxin fusion protein, for the treatment of patients with

persistent or recurrent cutaneous T-cell lymphoma (“CTCL”).

We believe these unique markets for our products are large, growing,

and underserved by the current prescription products or procedures.

Citius Pharmaceuticals, Inc., headquartered in

Cranford, New Jersey, is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care

products, with a focus on oncology, anti-infectives in adjunct cancer care and unique prescription products.

Our goal generally is to

achieve leading market positions by providing therapeutic products that address unmet medical needs yet have a lower development risk

than usually is associated with new chemical entities.

New formulations of previously approved drugs with substantial existing safety

and efficacy data are a core focus.

We seek to reduce development and clinical risks associated with drug development, yet still focus

on innovative applications.

Our strategy centers on products that have intellectual property and regulatory exclusivity protection, while

providing competitive advantages over other existing therapeutic approaches.

In December 2025, we became a commercial company

with the launch of LYMPHIR by our majority owned subsidiary Citius Oncology.

We also have late-stage product candidates in development.

Since its inception, the Company has devoted

substantially all of its efforts to business planning, acquiring our proprietary technology, research and development, recruiting management

and technical staff, and raising capital.

We are developing three proprietary products Mino-Lok, an antibiotic lock solution used to

treat patients with catheter-related bloodstream infections by salvaging the infected catheter;

Halo-Lido, a corticosteroid-lidocaine

topical formulation that is intended to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids;

and NoveCite,

a mesenchymal stem cell therapy for the treatment of ARDS.

Citius Oncology achieved the approval from the FDA for LYMPHIR, in-licensed

by Citius Pharma in September 2021 (now owned by Citius Oncology), an engineered IL-2 diphtheria toxin fusion protein, for the treatment

of patients with persistent or recurrent cutaneous T-cell lymphoma (“CTCL”).

We believe these unique markets for our products

are large, growing, and underserved by the current prescription products or procedures.

We are subject to a number of risks common to

companies in the pharmaceutical industry including, but not limited to, risks related to the development by us or our competitors of research

and development stage products, market acceptance of its products that receive regulatory approval, competition from larger companies,

dependence on key personnel, dependence on key suppliers and strategic partners, the Company’s ability to obtain additional financing

and the Company’s compliance with governmental and other regulations.

companies in the pharmaceutical industry including, but not limited to, risks related to the development by us or our competitors of

research and development stage products, market acceptance of our products that receive regulatory approval, competition from larger

companies, dependence on key personnel, dependence on key suppliers and strategic partners, the Company’s ability to obtain additional

financing and the Company’s compliance with governmental and other regulations.

The Company was founded as Citius Pharmaceuticals,

LLC, a Massachusetts limited liability company, on January 23, 2007.

On September 12, 2014, Citius Pharmaceuticals, LLC entered into a

Share Exchange and Reorganization Agreement, with Citius Pharma (formerly Trail One, Inc.), a publicly traded company incorporated under

the laws of the State of Nevada.

On September 12, 2014, Citius Pharmaceuticals, LLC entered into

a Share Exchange and Reorganization Agreement, with Citius Pharma (formerly Trail One, Inc.), a publicly traded company incorporated

under the laws of the State of Nevada.

Citius Pharmaceuticals, LLC became a wholly-owned subsidiary of Citius Pharma.

On March 30, 2016, Citius

Pharma acquired Leonard-Meron Biosciences, Inc.

On March 30, 2016,

Citius Pharma acquired Leonard-Meron Biosciences, Inc.

(“LMB”) as a wholly-owned subsidiary.

LMB was a pharmaceutical company focused

on the development and commercialization of critical care products with a concentration on anti-infectives.

On September 11, 2020, we

formed NoveCite, Inc.

(“NoveCite”), a Delaware corporation, of which we own 75% of the issued and outstanding capital stock.

NoveCite is focused on the development and commercialization of its proprietary mesenchymal stem cells for the treatment of acute respiratory

disease syndrome (“ARDS”).

LMB was a pharmaceutical company

focused on the development and commercialization of critical care products with a concentration on anti-infectives.

On September 11,

2020, we formed NoveCite, Inc.

(“NoveCite”), a Delaware corporation, of which we own 75% of the issued and outstanding capital

NoveCite is focused on the development and commercialization of its proprietary mesenchymal stem cells for the treatment of acute

respiratory disease syndrome (“ARDS”).

Citius Oncology and the Merger

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(“SpinCo”) as a wholly-owned subsidiary in conjunction with the acquisition of LYMPHIR.

SpinCo began operations in April

2022, when Citius Pharma transferred the assets related to LYMPHIR to SpinCo, including the related license agreement with Eisai Co.,

SpinCo began operations in

April 2022, when Citius Pharma transferred the assets related to LYMPHIR to SpinCo, including the related license agreement with Eisai

(“Eisai”) and the related asset purchase agreement with Dr.

Reddy’s Laboratories SA, a subsidiary of Dr.

Laboratories, Ltd.

Reddy’s Laboratories, Ltd.

(collectively, “Dr.

At this time, SpinCo was renamed Citius Oncology, Inc.

On October 23, 2023, Citius Pharma and SpinCo

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On August 12, 2024, pursuant to the terms and conditions of the Merger Agreement, Merger Sub merged with and

into SpinCo, with SpinCo surviving as a wholly owned subsidiary of TenX (the “Merger”).

Prior to closing of the Merger (the

“Closing”), TenX migrated to and domesticated as a Delaware corporation in accordance with Section 388 of the General Corporation

Law of the State of Delaware and the Cayman Islands Companies Act (As Revised) (the “Domestication”).

As part of the Domestication,

TenX changed its name to “Citius Oncology, Inc.” (“Citius Oncology”) (Nasdaq:

into SpinCo, with SpinCo surviving as a wholly owned subsidiary of TenX, which was subsequently renamed Citius Oncology Sub.

the closing of the Merger (the “Closing”), TenX migrated to and domesticated as a Delaware corporation in accordance with

Section 388 of the General Corporation Law of the State of Delaware and the Cayman Islands Companies Act (As Revised) (the “Domestication”).

As part of the Domestication, TenX changed its name to “Citius Oncology, Inc.” (Nasdaq:

Immediately after the closing

of the Merger, Citius Pharma owned approximately 92% of the outstanding shares of common stock of Citius Oncology.

As of December 17,

2025, Citius Pharma owned approximately 77.9% of Citius Oncology (excluding pre-funded warrants to purchase up to 15,229,358 shares of

Citius Oncology common stock in a transaction that closed on December 10, 2025).

Since its inception, Citius Pharma has funded

and continues to fund Citius Oncology, and Citius Pharma and Citius Oncology are party to an amended and restated shared services agreement

which governs certain management and scientific services that Citius Pharma provides Citius Oncology.

(the “A&R Shared Services Agreement”), which governs certain management and scientific services that Citius Pharma provides

Citius Oncology.

LYMPHIR TM (denileukin diftitox-cdxl)

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Denileukin diftitox is referred to in this report as E7777, I/ONTAK or LYMPHIR, depending on the period of time and context that is being

In April of 2022 LYMPHIR was assigned to Citius Oncology.

LYMPHIR is recombinant DNA-derived fusion protein

In April 2022 LYMPHIR was assigned to Citius Oncology.

LYMPHIR is a recombinant DNA-derived fusion protein

designed to direct the cytocidal action of diphtheria toxin (DT) to cells which express the IL-2 receptor.

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agent, ONTAK®, which was previously approved by the FDA for the treatment of patients with persistent or recurrent CTCL.

marketed in the US previously.

marketed in the U.S.

The manufacturing formulation improvements were substantial enough that the FDA required a new clinical

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which served as the basis for the full approval of ONTAK.

Study E7777-G000-302, a global, multicenter, open-label single-arm pivotal clinical

trial for the treatment of patients with persistent or recurrent CTCL, commenced (first subject consented) in May 2013 and completed (data

cutoff for primary analysis) in December 2021.

The study was sponsored by Eisai and was conducted at 17 sites in the United States and

three sites in Australia.

Inclusion criteria for the study were to evaluate patients in advanced stage CTCL (Mycosis Fungoides or Sézary

Syndrome), who received at least one prior CTCL therapy.

The objectives were met for Study E7777-G000-302, in both the lead-in phase and

the main phase.

Overall, the primary and secondary endpoints of Study E7777-G000-302 demonstrate the tolerability and clinical benefit

of 9 µg/kg/day LYMPHIR for the treatment of adult patients with relapsed or refractory Stage I-III CTCL.

No new safety signals were

identified compared to ONTAK.

Study E7777-G000-302, a global, multicenter, open-label single-arm pivotal

clinical trial for the treatment of patients with persistent or recurrent CTCL, commenced (first subject consented) in May 2013 and completed

(data cutoff for primary analysis) in December 2021.

The study was sponsored by Eisai and was conducted at 17 sites in the United States

and three sites in Australia.

Inclusion criteria for the study were to evaluate patients in advanced stage CTCL (Mycosis Fungoides or

Sézary Syndrome), who received at least one prior CTCL therapy.

The objectives were met for Study E7777-G000-302, in both the

lead-in phase and the main phase.

Overall, the primary and secondary endpoints of Study E7777-G000-302 demonstrate the tolerability and

clinical benefit of 9 µg/kg/day LYMPHIR for the treatment of adult patients with relapsed or refractory Stage I-III CTCL.

safety signals were identified compared to ONTAK.

The pivotal trial of E7777 was divided into two

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In the lead-in phase, the main objectives were to determine

the maximum tolerated dose (MTD) of LYMPHIR and to select the dose of LYMPHIR to be used in the main phase (subjects were treated at doses

ranging from 6 to 15 µg/kg/day).

The MTD was 12 µg/kg/day and, based on data of the lead-in phase, 9 µg/kg/day was selected

for the main phase of the study.

The objectives of the main phase were to evaluate the efficacy and safety of LYMPHIR (at the dose determined

in the lead-in phase of 9 µg/kg/day).

the maximum tolerated dose (MTD) of LYMPHIR and to select the dose of LYMPHIR to be used in the main phase (subjects were treated at

doses ranging from 6 to 15 µg/kg/day).

The MTD was 12 µg/kg/day and, based on data of the lead-in phase, 9 µg/kg/day

was selected for the main phase of the study.

The objectives of the main phase were to evaluate the efficacy and safety of LYMPHIR (at

the dose determined in the lead-in phase of 9 µg/kg/day).

The primary efficacy endpoint was tumor response

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The secondary efficacy endpoints were:

of response (DOR) based on GRS

to response based on GRS

assessed by investigator using GRS

response assessed by IRC using Prince (Prince, et al., 2010)

response (according to modified Severity Weighted Assessment Tool [mSWAT])

of skin response

to skin response

Duration of response (DOR)

based on GRS;

Time to response based

ORR assessed by investigator

Objective response assessed

by IRC using Prince (Prince, et al., 2010);

Skin response (according

to modified Severity Weighted Assessment Tool [mSWAT]);

Duration of skin response;

Time to skin response.

Overall, there were 25 responders out of 69 subjects

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36.2% (25.0%, 48.7%) (25 of 69 subjects).

And, an ORR of 38.1% in the intent to treat population and 44.4% in the efficacy evaluable populations

were observed.

Further, an ORR of 38.1% in the intent to treat population and 44.4% in the efficacy evaluable

populations were observed.

The 2-sided, exact 95% CI of ORR was calculated using the Clopper-Pearson method.

Per protocol, LYMPHIR demonstrated clinical

benefit if the lower bound of the 2-sided 95% exact CI of the ORR exceeded 25%.

Per protocol, LYMPHIR demonstrated

clinical benefit if the lower bound of the 2-sided 95% exact CI of the ORR exceeded 25%.

Skin responses were the same as GRS objective

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Median Time to Response, months

ORR, Objective Response Rate per Olsen, et all (2011) Global Response Score (GRS), by Independent Review Committee (IRC)

ORR, Objective Response

Rate per Olsen, et all (2011) Global Response Score (GRS), by Independent Review Committee (IRC)

CI = confidence interval

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tolerability and clinical benefit.

Overall, LYMPHIR was well-tolerated with the use

of pre-medications, close patient monitoring, and prompt initiation of supportive measures and drug management.

Overall, LYMPHIR was well-tolerated with the

use of pre-medications, close patient monitoring, and prompt initiation of supportive measures and drug management.

There was no evidence

of cumulative toxicity and most patients experienced low grade 1 or 2 treatment emergent adverse events.

Serious adverse reactions occurred in 38% of patients

who received LYMPHIR.

Serious adverse reactions in > 2% of patients included capillary leak syndrome (10%), infusion-related reaction

(9%), sepsis (7%), skin infection (2.9%), pyrexia (2.9%), and rash (2.9%).

There were no Grade 5 adverse events in the Study E7777-G000-302,

Stage I-III Safety Set (which is the safety set FDA required for inclusion in the package insert/label).

Serious adverse reactions occurred in 38% of

patients who received LYMPHIR.

Serious adverse reactions in > 2% of patients included capillary leak syndrome (10%), infusion-related

reaction (9%), sepsis (7%), skin infection (2.9%), pyrexia (2.9%), and rash (2.9%).

There were no Grade 5 adverse events in the Study

E7777-G000-302, Stage I-III Safety Set (which is the safety set FDA required for inclusion in the package insert/label).

Adverse Reactions (≥ 10%) in Patients with

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Musculoskeletal and connective tissue disorders

Musculoskeletal pain d

Musculoskeletal

Nervous system disorders

Mental status changes g

status changes g

Injury, poisoning and procedural complications

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Eye disorders

Vision changes j

Investigations

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Psychiatric disorders

Includes fatigue, asthenia, and lethargy.

Includes edema, edema peripheral generalized edema, face edema, swelling face, peripheral swelling.

Includes fever, pyrexia, tumor associated fever.

Includes musculoskeletal pain, back pain, neck pain, pain in extremity, myalgia, bone pain, flank pain.

Includes arthralgia, joint swelling, joint range of motion decreased, musculoskeletal stiffness.

Includes fatigue, asthenia,

and lethargy.

Includes edema, edema peripheral

generalized edema, face edema, swelling face, peripheral swelling.

Includes fever, pyrexia,

tumor associated fever.

Includes musculoskeletal

pain, back pain, neck pain, pain in extremity, myalgia, bone pain, flank pain.

Includes arthralgia, joint

swelling, joint range of motion decreased, musculoskeletal stiffness.

Includes headache, migraine.

Includes mental status changes, amnesia, confusional state, delirium, altered state of consciousness, hallucinations (including auditory), memory impairment, disturbance in attention, somnolence, cognitive disorder.

Includes rash, dermatitis, drug eruption, erythema, palmar erythema, toxic skin eruption, rash maculo-papular, rash papular, rash pustular, rash pruritic, dermatitis exfoliative generalized, acute generalized exanthematous pustulosis.

Includes mental status

changes, amnesia, confusional state, delirium, altered state of consciousness, hallucinations (including auditory), memory impairment,

disturbance in attention, somnolence, cognitive disorder.

Includes rash, dermatitis,

drug eruption, erythema, palmar erythema, toxic skin eruption, rash maculo-papular, rash papular, rash pustular, rash pruritic, dermatitis

exfoliative generalized, acute generalized exanthematous pustulosis.

Includes pruritis, itching.

Includes vision blurred, photopsia, visual impairment.

Includes skin infection, skin bacterial infection, staphylococcal skin infection, cellulitis, impetigo.

Includes renal failure, nephropathy, acute kidney injury, blood creatinine increased, renal impairment.

Includes vision blurred,

photopsia, visual impairment.

Includes skin infection,

skin bacterial infection, staphylococcal skin infection, cellulitis, impetigo.

Includes renal failure,

nephropathy, acute kidney injury, blood creatinine increased, renal impairment.

Grade refers to the severity of the adverse reaction.

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Grade 1 - Mild;

asymptomatic or mild symptoms;

or mild symptoms;

clinical or diagnostic observations only;

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Grade 2 - Moderate;

minimal, local or noninvasive

intervention indicated;

local or noninvasive intervention indicated;

limiting age-appropriate instrumental activities of daily living.

● Grade 3 - Severe or medically significant but

not immediately life-threatening;

Grade 3 - Severe or medically

significant but not immediately life-threatening;

hospitalization or prolongation of hospitalization indicated;

limiting self care activities

of daily living.

● Grade 4 - Life-threatening consequences;

intervention indicated.

● Grade 5 - Death related to the adverse reaction.

self-care activities of daily living.

Grade 4 - Life-threatening

consequences;

urgent intervention indicated.

Grade 5 - Death related

to the adverse reaction.

Investigator Initiated Trials

We believe there is an opportunity in the field

of immuno-oncology and have undertaken two investigator-initiated trials to evaluate the potential safety and efficacy of LYMPHIR as an

immuno-oncology combination therapy.

of immuno-oncology and have undertaken two investigator-initiated trials to evaluate the potential safety and efficacy of LYMPHIR as

an immuno-oncology combination therapy.

A Phase 1 trial was initiated in June 2021 at

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20 participants who will be administered denileukin diftitox prior to Chimeric Antigen Receptor (“CAR-T”) therapies.

1 study consists of two components:

dose finding to establish a maximum tolerated dose (“MTD”) of denileukin diftitox in combination

with CART-T therapies, and an extension component to provide an estimate of efficacy at that MTD.

Phase I/II Trial Using E7777

to Enhance Regulatory T-Cell Depletion Prior to CAR-T Therapy for Relapsed/Refractory B-Cell Lymphoma (DLBCL).

Phase 1 study consists of two components:

dose finding to establish a maximum tolerated dose (“MTD”) of denileukin diftitox

in combination with CART-T therapies, and an extension component to provide an estimate of efficacy at that MTD.

Phase I/II Trial

Using E7777 to Enhance Regulatory T-Cell Depletion Prior to CAR-T Therapy for Relapsed/Refractory B-Cell Lymphoma (DLBCL).

NCT04855253).

Preliminary results are anticipated in the first quarter of 2026.

A second Phase 1 Study was initiated in September

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with recurrent or metastatic solid tumors in the second line setting.

The efficacy of T-regulatory cell depletion with E7777 combined

with immune checkpoint inhibitor, pembrolizumab, in recurrent or metastatic solid tumors:

The efficacy of T-regulatory cell depletion with E7777

combined with immune checkpoint inhibitor, pembrolizumab, in recurrent or metastatic solid tumors:

Phase I/II Study.

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The study consists of two parts.

Part I is a dose

escalation study of four cohorts (3,6,9,12 mcg of LYMPHIR) and is expected to enroll 18-30 patients.

Part II is a dose expansion study

of approximately 40 patients to evaluate the safety and tolerability of the recommended combination dose of LYMPHIR and pembrolizumab

dose escalation study of four cohorts (3,6,9,12 mcg of LYMPHIR) and is expected to enroll 18-30 patients.

Part II is a dose expansion

study of approximately 40 patients to evaluate the safety and tolerability of the recommended combination dose of LYMPHIR and pembrolizumab

(to include ovarian cancer and MSI-H cancer cohorts).

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survival, and overall survival.

Trials at both the University of Minnesota, Masonic

Cancer Center and the University of Pittsburgh Medical Center, Hillman Cancer Center are enrolling patients and progressing.

In November 2024, the Company announced promising

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combining two immuno-modulator agents, pembrolizumab (anti-PD-1) and LYMPHIR (transient Treg depletion) demonstrated:

● An overall response rate (ORR) of 27% (4/15)

and a clinical benefit rate of 33% (5/15) among evaluable patients;

● Median progression-free survival (PFS) for patients

achieving clinical benefit of 57 weeks, with a range of 30 to 96 weeks.

● Notably, two of the four patients who achieved

partial remission had received prior checkpoint inhibitors (i.e.

An overall response rate

(ORR) of 27% (4/15) and a clinical benefit rate of 33% (5/15) among evaluable patients;

Median progression-free

survival (PFS) for patients achieving clinical benefit of 57 weeks, with a range of 30 to 96 weeks.

of the four patients who achieved partial remission had received prior checkpoint inhibitors (i.e.

anti-PD-1 therapy).

This highlights the therapeutic potential of LYMPHIR

plus immune checkpoint inhibitors to be effective in patients who fail prior anti-PD-1/L1 therapy.

This highlights

the therapeutic potential of LYMPHIR plus immune checkpoint inhibitors to be effective in patients who fail prior anti-PD-1/L1 therapy.

The trial enrolled 21 patients with recurrent

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to the patients’ underlying disease.

Importantly, no significant immune-related adverse events were observed, and only one case of dose-limiting

toxicity (capillary leak syndrome) was reported at the highest dose level (12 mcg/kg).

Importantly, no significant immune-related adverse events were observed, and only one case

of dose-limiting toxicity (capillary leak syndrome) was reported at the highest dose level (12 mcg/kg).

Efficacy Data

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Dose-Limiting Toxicities (DLTs)

1 (Capillary Leak Syndrome at 12 mcg/kg)

Leak Syndrome at 12 mcg/kg)

Immune-Related Adverse Events (irAEs)

None documented (≥ Grade 3)

documented (≥ Grade 3)

Adverse Events (Grade ≥ 3)

Most related to underlying disease

related to underlying disease

Regulatory Development

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this a new product, an Investigational New Drug Application (“IND”) was filed.

As a part of ensuing discussions, the FDA agreed

to a development plan that included a single arm, open label study to confirm the safety and efficacy of E7777 and a chemistry, manufacturing,

and controls (“CMC”) development plan that demonstrates the new process results in a comparable drug product.

As a part of ensuing discussions, the FDA

agreed to a development plan that included a single arm, open label study to confirm the safety and efficacy of E7777 and a chemistry,

manufacturing, and controls (“CMC”) development plan that demonstrates the new process results in a comparable drug product.

In 2011, the FDA Office of Orphan Products Development

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of Orphan Products Development granted E7777 orphan drug designation status for the treatment of CTCL.

In 2013, the first patient was enrolled into the

lead-in phase of the pivotal study for the E7777 United States (“U.S.”) CTCL clinical trial.

In 2013, the first patient was enrolled into

the lead-in phase of the pivotal study for the E7777 U.S.

CTCL clinical trial.

In 2014, commercial sales of ONTAK were discontinued

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In March 2016, Dr.

Reddy’s exclusively licensed

the global rights to E7777 from Eisai, other than the rights in countries retained by Eisai, which consists of Japan, China, Korea, Taiwan,

Hong Kong, Macau, Indonesia, Thailand, Malaysia, Brunei, Singapore, India, Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar, Cambodia,

Laos, Afghanistan, Bangladesh, Bhutan, Nepal, Mongolia and Papua New Guinea.

The license included an option on the right to develop and

market the product in India prior to FDA approval.

In June 2016, the first patient was enrolled in

the main phase of the Phase 3 U.S.

Reddy’s exclusively

licensed the global rights to E7777 from Eisai, other than the rights in countries retained by Eisai, which consists of Japan, China,

Korea, Taiwan, Hong Kong, Macau, Indonesia, Thailand, Malaysia, Brunei, Singapore, India, Pakistan, Sri Lanka, Philippines, Vietnam,

Myanmar, Cambodia, Laos, Afghanistan, Bangladesh, Bhutan, Nepal, Mongolia and Papua New Guinea.

The license included an option on the

right to develop and market the product in India prior to FDA approval.

In June 2016, the first patient was enrolled

in the main phase of the Phase 3 U.S.

CTCL clinical trial for E7777.

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Moreover, no new safety signals were identified.

In December 2022, a biologics

license application (“BLA”) for LYMPHIR was accepted for filing with the FDA and a PDUFA goal date was set for July 28, 2023.

In December 2022, a

Biologics License Application (“BLA”) for LYMPHIR was accepted for filing with the FDA and a PDUFA goal date was set for

July 28, 2023.

In July 2023, the FDA

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In September 2023, we

announced that the FDA has agreed with the plans to address the requirements outlined in the complete response letter, which guidance

has provided the Company with a path for completing the necessary activities to support the resubmission of the BLA for LYMPHIR.

In February 2024, based on the feedback from the

FDA, Citius Pharma completed the CRL remediation activities and filed the resubmission.

announced that the FDA agreed with the plans to address the requirements outlined in the CRL, which guidance provided the Company with

a path for completing the necessary activities to support the resubmission of the BLA for LYMPHIR.

In February 2024, based on the feedback from

the FDA, Citius Pharma completed the CRL remediation activities and filed the resubmission.

In March 2024, Citius Pharma announced the acceptance

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The FDA assigned a PDUFA goal date of August 13, 2024 and approved LYMPHIR on August 8, 2024.

In August 2024, Citius Pharma announced that the

FDA had approved LYMPHIR.

In August 2024, Citius Pharma announced that

the FDA had approved LYMPHIR.

Citius Oncology launched LYMPHIR in December 2025.

Market Opportunity

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In light of the overlap between MF and SS, and

considering that many of the systemic therapy options for the two neoplasms are the same, some consider the treatment approach to MF and

SS as if they were a single disease entity (MF/SS).

However, some of the drugs currently in use, or in development, for MF/SS appear to

be more effective in clearing different anatomical compartments (skin versus blood, for example) and therefore have differential efficacy

considering that many of the systemic therapy options for the two neoplasms are the same, some consider the treatment approach to MF

and SS as if they were a single disease entity (MF/SS).

However, some of the drugs currently in use, or in development, for MF/SS appear

to be more effective in clearing different anatomical compartments (skin versus blood, for example) and therefore have differential efficacy

in MF and SS.

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the addressable U.S.

market for LYMPHIR exceeds $400,000,000 and may further expand with the introduction of a new therapeutic.

market for LYMPHIR exceeds $400 million and may further expand with the introduction of a new therapeutic.

Mino-Lok is a patented solution containing minocycline,

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CVC-related bloodstream infection were enrolled at MDACC in a prospective Phase 2b study.

Patients received Mino-Lok therapy for two hours

once daily for a minimum of five days within the first week, followed by two additional locks within the next two weeks.

Patients were

followed for one month post-lock therapy.

Demographic information, clinical characteristics, laboratory data, therapy, as well as adverse

events and outcome were collected for each patient.

Patients received Mino-Lok therapy for two

hours once daily for a minimum of five days within the first week, followed by two additional locks within the next two weeks.

were followed for one month post-lock therapy.

Demographic information, clinical characteristics, laboratory data, therapy, as well as

adverse events and outcome were collected for each patient.

Median age at diagnosis was 56 years (range:

21-73 years).

In all patients, prior

to the use of lock therapy, systemic treatment with a culture-directed, first-line intravenous antibiotic was started.

In all patients,

prior to the use of lock therapy, systemic treatment with a culture-directed, first-line intravenous antibiotic was started.

Microbiological

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Overall Complication Rate

1 Polymicrobial patient had a Gram+ and a Gram- organism cultured

1 Polymicrobial patient

had a Gram+ and a Gram- organism cultured

6 Patients had > 1 complication

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Phase 3 Trial

In November 2016, the Company initiated site recruitment

for Phase 3 clinical trials.

From initiation through the first quarter of 2017, the Company received input from several sites related

to the control arm as being less than standard-of-care for some of the respective institutions.

The Company worked closely with the FDA

with respect to the design of the Phase 3 trial and received feedback on August 17, 2017.

The FDA stated that they recognized that there

is an unmet medical need in salvaging infected catheters and agreed that an open label, superiority design would address the Company’s

concerns and would be acceptable to meet the requirements of a new drug application.

The Company amended the Phase 3 study design to remove

the saline and heparin placebo control arm and to use an active control arm that conforms with today’s current standard-of-care.

In November 2016, the Company initiated site

recruitment for Phase 3 clinical trials.

From initiation through the first quarter of 2017, the Company received input from several sites

related to the control arm as being less than standard-of-care for some of the respective institutions.

The Company worked closely with

the FDA with respect to the design of the Phase 3 trial and received feedback on August 17, 2017.

The FDA stated that they recognized

that there is an unmet medical need in salvaging infected catheters and agreed that an open label, superiority design would address the

Company’s concerns and would be acceptable to meet the requirements of a new drug application.

The Company amended the Phase 3

study design to remove the saline and heparin placebo control arm and to use an active control arm that conforms with today’s current

standard-of-care.

Patient enrollment commenced in February 2018.

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to enroll 700 patients in 50 participating institutions, all located in the U.S.

There were interim analyses at both the 50% and 75% points

of the trial as measured by the number of patients treated.

In September 2019, the Company announced that

the FDA agreed to a new primary efficacy endpoint of “time to catheter failure” in comparing Mino-Lok to the antibiotic lock

This change in the trial design reduced the required patient sample size of the trial from 700 subjects to approximately

144 available subjects to achieve the pre-specified 92 catheter failure events needed to conclude the trial.

Additionally, the Company

submitted a response to the FDA that it would implement this change in the primary endpoint and expected it to result in less than 150

subjects needed in its Phase 3 trial.

The new primary endpoints require that the time to catheter failure be at least 38 days for Mino-Lok

versus 21 days for the standard of care antibiotic locks.

There were interim analyses at both the 50% and 75%

points of the trial as measured by the number of patients treated.

In September 2019, the Company announced that the FDA agreed

to a new primary efficacy endpoint of “time to catheter failure” in comparing Mino-Lok to the antibiotic lock control arm.

This change in the trial design reduced the required patient sample size of the trial from 700 subjects to approximately 144 available

subjects to achieve the pre-specified 92 catheter failure events needed to conclude the trial.

Additionally, the Company submitted a

response to the FDA that it would implement this change in the primary endpoint and expected it to result in less than 150 subjects needed

in its Phase 3 trial.

The new primary endpoints require that the time to catheter failure be at least 38 days for Mino-Lok versus 21

days for the standard of care antibiotic locks.

In October 2019, the FDA agreed that the patient

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free access to Mino-Lok for healthcare providers under an Expanded Access protocol to ease the burden associated with the COVID-19 pandemic.

Through the Expanded Access protocol, an infected central venous catheter can now be treated with Mino-Lok, potentially avoiding the need

for the removal and replacement procedure.

Through the Expanded Access protocol, an infected central venous catheter can now be treated with Mino-Lok, potentially avoiding the

need for the removal and replacement procedure.

In June 2020, we announced that we had received

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The studies, if and when successfully completed,

should allow Mino-Lok to be labeled for use with all commercially available CVCs and peripherally inserted central catheters (PICCs) on

should allow Mino-Lok to be labeled for use with all commercially available CVCs and peripherally inserted central catheters (PICCs)

We further assume that these studies will meet European and world standards.

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lock therapy for central line associated blood stream infections (“CLABSIs”).

In September 2020, we announced that another DMC

meeting was held to review the data being generated and analyzed in the Mino-Lok Phase 3 trial based on progress to date, and to make

recommendations to us as to any action that may be necessary regarding the study.

After reviewing these data, the DMC members stated that

they did not find any safety signals;

In September 2020, we announced that another

DMC meeting was held to review the data being generated and analyzed in the Mino-Lok Phase 3 trial based on progress to date, and to

make recommendations to us as to any action that may be necessary regarding the study.

After reviewing these data, the DMC members stated

that they did not find any safety signals;

and they also recommended continuing the trial without any modifications.

The DMC further conducted

an ad hoc meeting and agreed with the Company that a 75% interim analysis be conducted as planned in which superior efficacy is

The DMC further

conducted an ad hoc meeting and agreed with the Company that a 75% interim analysis be conducted as planned in which superior

efficacy is evaluated.

The 75% interim analysis was subsequently changed to a 65% interim analysis by the Company.

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the three registration batches for all components of Mino Lok were manufactured and that clinical sites were resupplied with registration

In November 2020, the Company announced that the

three components of Mino-Lok, minocycline, disodium edetate (“EDTA”), and ethanol, were superior to EDTA and ethanol in their

ability to eradicate resistant staphylococcal biofilms.

In November 2020, the Company announced that

the three components of Mino-Lok, minocycline, disodium edetate (“EDTA”), and ethanol, were superior to EDTA and ethanol

in their ability to eradicate resistant staphylococcal biofilms.

The 65% interim analysis was completed in June

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(“Biorasi”), a global clinical research organization (“CRO”), to help expand the Company’s Phase 3 Mino-Lok

trial by implementing additional sites outside the U.S.

As of December 15, 2023, there are 12 active sites in the U.S.

currently including

such academic centers as Henry Ford Health Center, Georgetown University Medical Center, and others.

There currently are 16 sites active

in India, making a total of 28 participating Mino-Lok institutions globally.

In August 2023, the Company announced all 92 events

required to complete the trial have been achieved.

Several patients remain in active treatment, which may result in additional events.

trial by implementing additional sites outside the U.S The Mino-Lok Phase 3 study enrolled 241 patients across 34 sites in the U.S.

Eligible patients were randomized 1:1 to receive either Mino-Lok or site-specific standard-of-care lock solution plus systemic

In August 2023, the Company announced all 92

events required to complete the trial had been achieved.

Several patients remain in active treatment, which may result in additional

In late December 2023, the Company determined

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that Mino-Lok is well-tolerated.

Key findings include:

time to catheter failure in the Mino-Lok arm was significantly prolonged in both the intent-to-treat

(ITT) and modified ITT populations ( p ≤ 0.0006 );

retention was achieved in 57% of patients treated with Mino-Lok versus 38% in the control

arm ( p = 0.0025 );

of clinical failure and microbiological failure were significantly lower in the Mino-Lok

arm ( p = 0.0058 and p = 0.012 , respectively);

drug-related serious adverse events (SAEs) were reported;

the safety profile was comparable

between groups.

A subset analysis of the Phase 3 trial, focused

on hemodialysis patients, examined the impact of Mino-Lok in this subgroup and found favorable outcomes for catheter salvage and infection

control compared to the overall study population.

Key findings in this hemodialysis population include:

catheter survival with Mino-Lok:

Patients receiving standard-of-care (SOC) therapy experienced

a significantly shorter time to catheter failure compared with those treated with Mino-Lok

25% of catheters failed by Day

6, 50% failed by Day 22;

o Mino-Lok arm:

25% catheter failure delayed

until Day 37.

catheter failure rate with Mino-Lok:

o 57% (16/28) of SOC patients experienced

catheter failure;

o 31% (8/26) of Mino-Lok patients experienced

catheter failure.

events and serious adverse events were comparable between groups, and no drug-related SAEs

These outcomes demonstrate that the differentiated

efficacy and safety profile of Mino-Lok extends into an important hemodialysis subgroup of patients who often have limited vascular access

and face increased risk from catheter removal and replacement.

Moreover, this subset reinforces Mino-Lok’s potential clinical utility

in one of the most vulnerable patient populations.

In November 2024, the Company held a Type C meeting

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(NDA) submission for Mino-Lok.

Citius continues to engage with the FDA to define the regulatory path forward.

No FDA-approved alternative

currently exists to salvage infected indwelling central venous catheters.

Fast Track Designation

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A drug that receives Fast Track designation is eligible for the following:

More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;

More frequent written correspondence from the FDA about the design of the clinical trials;

Priority review to shorten the FDA review process for a new drug from ten months to six months;

Rolling review, which means we can submit completed sections of our NDA for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be submitted for review.

More frequent meetings

with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;

More frequent written correspondence

from the FDA about the design of the clinical trials;

Priority review to shorten

the FDA review process for a new drug from ten months to six months;

Rolling review, which means

we can submit completed sections of our NDA for review by the FDA, rather than waiting until every section of the application is

completed before the entire application can be submitted for review.

Mino-Lok International Study

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because of physical and/or chemical factors, thus limiting the stability of the post-mix solutions.

The scientists and technologists at

MDACC have been able to improve the stability of the post-mixed solutions through adjustments of the post-mixed pH of the solution.

may allow for longer storage time of the ready-to-use solution.

Citius Pharma holds the exclusive worldwide license which provides access

to this patented technology for development and commercialization of Mino-Lok.

The scientists and technologists

at MDACC have been able to improve the stability of the post-mixed solutions through adjustments of the post-mixed pH of the solution.

This may allow for longer storage time of the ready-to-use solution.

Citius Pharma holds the exclusive worldwide license which provides

access to this patented technology for development and commercialization of Mino-Lok.

Market Opportunity

In spite of best clinical practice, catheters

contribute to approximately 70% of blood stream infections that occur in the intensive care unit or are associated with hemodialysis or

cancer patients (approximately 470,000 per year).

contribute to approximately 70% of blood stream infections that occur in the intensive care unit or are associated with hemodialysis

or cancer patients (approximately 470,000 per year).

Bacteria enter the catheter either from the skin or intraluminally through the catheter

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patients consists of removing the infected CVC and replacing it with a new catheter at a different vascular access site.

However, in cancer

and hemodialysis patients with long-term surgically implantable silicone catheters, removal of the CVC and reinsertion of a new one at

a different site might be difficult, or even impossible, because of the unavailability of other accessible vascular sites and the need

to maintain infusion therapy.

Furthermore, critically ill patients with short-term catheters often have underlying coagulopathy, which

makes reinsertion of a new CVC at a different site, in the setting of CRBSIs, risky in terms of mechanical complications, such as pneumothorax,

misplacement, or arterial puncture.

Studies have also revealed that CRBSI patients may be associated with serious complications, including

septic thrombosis, endocarditis and disseminated infection, particularly if caused by Staphylococcus aureus or Candida species.

Furthermore, catheter retention in patients with CRBSIs is associated with a higher risk of relapse and poor response to antimicrobial

cancer and hemodialysis patients with long-term surgically implantable silicone catheters, removal of the CVC and reinsertion of a new

one at a different site might be difficult, or even impossible, because of the unavailability of other accessible vascular sites and

the need to maintain infusion therapy.

Furthermore, critically ill patients with short-term catheters often have underlying coagulopathy,

which makes reinsertion of a new CVC at a different site, in the setting of CRBSIs, risky in terms of mechanical complications, such

as pneumothorax, misplacement, or arterial puncture.

Studies have also revealed that CRBSI patients may be associated with serious complications,

including septic thrombosis, endocarditis and disseminated infection, particularly if caused by Staphylococcus aureus or Candida

Furthermore, catheter retention in patients with CRBSIs is associated with a higher risk of relapse and poor response to

antimicrobial therapy.

According to Maki et al., published in the Mayo

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ranged upwards to over 450,000 CLABSIs annually (see analysis in the table below).

CRBSIs are associated with a 12% to 35% mortality rate

and an attributable cost of $35,000 to $56,000 per episode.

CRBSIs are associated with a 12% to 35% mortality

rate and an attributable cost of $35,000 to $56,000 per episode.

We estimate that the potential market for Mino-Lok

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78(1):10-17, JAVA 2007;

12(1):17-27, J Inf Nurs 2004;27(4):245-250, Joint Commission website Monograph, CLABSI and

Internal Estimates.

12(1):17-27, J Inf Nurs 2004;

27(4):245-250, Joint Commission website Monograph, CLABSI

and Internal Estimates.

Under various plausible pricing scenarios, we

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propionate, a corticosteroid, and lidocaine that is intended for the treatment of hemorrhoids.

To our knowledge, there are currently no

FDA-approved prescription drug products for the treatment of hemorrhoids.

Some physicians are known to prescribe topical steroids for

the treatment of hemorrhoids.

To our knowledge, there are currently

no FDA-approved prescription drug products for the treatment of hemorrhoids.

Some physicians are known to prescribe topical steroids

for the treatment of hemorrhoids.

In addition, there are various topical combination prescription products containing halobetasol propionate

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Caucasian populations are affected

significantly more frequently than African Americans, and increased prevalence rates are associated with higher socioeconomic status in

men but not women.

significantly more frequently than African Americans, and increased prevalence rates are associated with higher socioeconomic status

in men but not women.

Development of hemorrhoids before age 20 is unusual.

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Accordingly, physicians use the following grading system referred to as the Goligher’s classification of internal hemorrhoids:

Hemorrhoids not prolapsed but bleeding.

Hemorrhoids prolapse and reduce spontaneously with or without bleeding.

Prolapsed hemorrhoids that require reduction manually.

Prolapsed and cannot be reduced including both internal and external hemorrhoids that are confluent from skin tag to inner anal canal.

Hemorrhoids not prolapsed

but bleeding.

Hemorrhoids prolapse and

reduce spontaneously with or without bleeding.

Prolapsed hemorrhoids that

require reduction manually.

Prolapsed and cannot be

reduced including both internal and external hemorrhoids that are confluent from skin tag to inner anal canal.

Development Activities to Date

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or lidocaine alone) in achieving ‘almost symptom free’ or ’symptom free’ status according to the GSDS scale.

differences suggested the possibility of a benefit for the combination product formulation.

As a result of this study, we determined that

the performance of the active arms of the study relative to the vehicle could be improved by re-formulating our topical preparation.

we initiated work on vehicle formulation and evaluation of higher potency steroids.

These differences suggested the possibility of a benefit for the combination product formulation.

As a result of this study, we determined

that the performance of the active arms of the study relative to the vehicle could be improved by re-formulating our topical preparation.

Therefore, we initiated work on vehicle formulation and evaluation of higher potency steroids.

Overall, results from adverse event reporting

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and symptoms.

We developed this assessment tool as well as other

patient reported outcome endpoints for use in the recently begun Phase 2b trial and in subsequent trials.

In June and July 2016, we engaged

the Dominion Group, a leading provider of healthcare and pharmaceutical marketing research services.

The primary market research was conducted

to understand the symptoms that are most bothersome to patients better in order to develop meaningful endpoints for the clinical trials.

We also learned about the factors that drive patients to seek medical attention for hemorrhoids in an effort to understand the disease

impact on quality of life.

The results of this survey, along with the information from the Phase 2b trial, allowed us to develop our patient

reported outcome evaluation tool, ePro.

This tool can be used in clinical trials to evaluate the patients’ conditions and to assess

the performance of the test articles.

We developed this assessment tool as well as

other patient reported outcome endpoints for use in the Phase 2b trial begun in April 2022 and in subsequent trials.

In June and July

2016, we engaged the Dominion Group, a leading provider of healthcare and pharmaceutical marketing research services.

The primary market

research was conducted to understand the symptoms that are most bothersome to patients better in order to develop meaningful endpoints

for the clinical trials.

We also learned about the factors that drive patients to seek medical attention for hemorrhoids in an effort

to understand the disease impact on quality of life.

The results of this survey, along with the information from the Phase 2b trial,

allowed us to develop our patient reported outcome evaluation tool, ePro.

This tool can be used in clinical trials to evaluate the patients’

conditions and to assess the performance of the test articles.

In March 2018, we announced that we had selected

a higher potency corticosteroid in our steroid/anesthetic topical formulation program for the treatment of hemorrhoids.

The original topical

preparation, which we referred to as Hydro-Lido or CITI-001, which was used in the Phase 2a study, was a combination of hydrocortisone

topical preparation, which we referred to as Hydro-Lido or CITI-001, which was used in the Phase 2a study, was a combination of hydrocortisone

acetate and lidocaine hydrochloride.

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parallel group comparison clinical trial, which was initiated in April 2022.

The study assessed a high dose (CITI-002H) and low dose (CITI-002L)

formulation of the combination drug products in comparison to the single active drug monads:

high dose halobetasol, low dose halobetasol

and lidocaine.

there has been a shift from the use of traditional clinical analysis and outcomes to patients’ perspectives and patients’

experiences in assessing treatment efficacy.

Following the 21 st Century Cures Act, higher emphasis is placed on using

Patient Reported Outcome (“PRO”) instruments in clinical trials.

Currently, for hemorrhoidal disease, there are no

validated clinical outcomes assessment (“COA”) tools available in the U.S.

The FDA directed Citius Pharma to develop a “fit

for purpose” PRO instrument to assess the efficacy of treatments in this disease.

Symptom intensity and impact data (Hemorrhoid

Quality of Life Index or “HQLI”) were recorded by patients utilizing a proprietary mobile-enabled PRO instrument developed

by the Company for this study.

The study assessed a high dose (CITI-002H) and low dose

(CITI-002L) formulation of the combination drug products in comparison to the single active drug monads:

high dose halobetasol, low dose

halobetasol and lidocaine.

Recently, there has been a shift from the use

of traditional clinical analysis and outcomes to patients’ perspectives and patients’ experiences in assessing treatment

Following the 21 st Century Cures Act, higher emphasis is placed on using Patient Reported Outcome (“PRO”)

instruments in clinical trials.

Currently, for hemorrhoidal disease, there are no validated clinical outcomes assessment (“COA”)

tools available in the U.S.

The FDA directed Citius Pharma to develop a “fit for purpose” PRO instrument to assess the efficacy

of treatments in this disease.

Symptom intensity and impact data (Hemorrhoid Quality of Life Index or “HQLI”) were recorded

by patients utilizing a proprietary mobile-enabled PRO instrument developed by the Company for this study.

Data collected using the HQLI was analyzed to

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Based on the positive clinical results utilizing

the Meaningful Change Threshold analysis, Citius Pharma had a Phase 2 meeting with the FDA in April 2024 to

discuss the go-forward path for the program .

the Meaningful Change Threshold analysis, Citius Pharma had a Phase 2 meeting with the FDA in April 2024 to discuss the go-forward path

for the program.

Citius Pharma will continue to have ongoing engagement with the FDA regarding the next steps of development.

Market Opportunity

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lidocaine in strengths ranging from 1.0% to 3.0%.

The various topical formulations include creams, ointments, gels, lotions, enemas, pads,

and suppositories.

The most commonly prescribed topical combination gel is sold as a branded generic product and contains 2.5% hydrocortisone

and 3.0% lidocaine.

The various topical formulations include creams, ointments, gels, lotions, enemas,

pads, and suppositories.

The most commonly prescribed topical combination gel is sold as a branded generic product and contains 2.5%

hydrocortisone and 3.0% lidocaine.

We believe there are currently no FDA-approved

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that our Halo-Lido product represents an attractive, low-risk product opportunity with meaningful upside potential.

Citius Pharma intends to monetize the value of

Halo-Lido by seeking a strategic or financial partner.

Market Exclusivity

We believe that we will be the first company to

conduct rigorous clinical trials and receive FDA approval of a topical corticosteroid-lidocaine combination product for the treatment

We believe that we will be the first company

to conduct rigorous clinical trials and receive FDA approval of a topical corticosteroid-lidocaine combination product for the treatment

of hemorrhoids.

If we receive FDA approval, we will qualify for three years of market exclusivity for our dosage strength and formulation.

In addition, we will also be the only product on the market specifically proven to be safe and effective for the treatment of hemorrhoids.

Generally, if a company conducts clinical trials and receives FDA approval of a product for which there are similar, but non FDA-approved,

prescription products on the market, the manufacturers of the unapproved but marketed products are required to withdraw them from the

However, the FDA has significant latitude in determining how to enforce its regulatory powers in these circumstances.

not had any communication with the FDA regarding this matter and cannot predict what action, if any, the FDA will take with respect to

the unapproved products.

In addition, to our knowledge as of the date of this report, we would also be the only product on the market specifically proven to be

safe and effective for the treatment of hemorrhoids.

Generally, if a company conducts clinical trials and receives FDA approval of a

product for which there are similar, but non FDA-approved, prescription products on the market, the manufacturers of the unapproved but

marketed products are required to withdraw them from the market.

However, the FDA has significant latitude in determining how to enforce

its regulatory powers in these circumstances.

We have not had any communication with the FDA regarding this matter and cannot predict

what action, if any, the FDA would take with respect to the unapproved products.

We believe that should Halo-Lido demonstrate

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for topical combination prescription products for the treatment of hemorrhoids.

In October 2020, we, through our subsidiary, NoveCite,

signed an exclusive agreement with Novellus Therapeutics Limited (“Novellus”) to license iPSC-derived mesenchymal stem cells

In October 2020, we, through our subsidiary,

NoveCite, signed an exclusive agreement with Novellus Therapeutics Limited (“Novellus”) to license iPSC-derived mesenchymal

stem cells (iMSCs).

Under this worldwide exclusive license, we are focused on developing cellular therapies.

Specifically, we are seeking to develop

and commercialize the NoveCite mesenchymal stem cells (“NC- i MSCs”) to treat acute respiratory conditions with a near

term focus on ARDS.

Specifically, we are seeking

to develop and commercialize the NoveCite mesenchymal stem cells (“NC- i MSCs”) to treat acute respiratory conditions

with a near term focus on ARDS.

NC- i MSCs are the next generation mesenchymal

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human bone marrow, adipose tissue, placenta, umbilical tissue, etc.

and have significant challenges (e.g., variable donor and tissue sources,

limited supply, low potency, inefficient and expensive manufacturing).

and have significant challenges (e.g., variable donor and tissue

sources, limited supply, low potency, inefficient and expensive manufacturing).

NC-iMSCs overcome these challenges because they:

Are more potent and secrete exponentially higher levels of immunomodulatory proteins;

Have practically unlimited supply for high doses and repeat doses;

Are from a single donor and clonal so they are economically produced at scale with consistent quality and potency, as well as being footprint free (compared to viral reprogramming methods);

Have a significantly higher expansion capability.

Are more potent and secrete

exponentially higher levels of immunomodulatory proteins;

Have practically unlimited

supply for high doses and repeat doses;

Are from a single donor

and clonal so they are economically produced at scale with consistent quality and potency, as well as being footprint free (compared

to viral reprogramming methods);

Have a significantly higher

expansion capability.

Several cell therapy companies using donor-derived

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Eterna Therapeutics Inc.

At this time the Company has paused most development

initiatives for NoveCite to prioritize LYMPHIR and its other product candidates.

Market Opportunity

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year, out of which approximately 200,000 cases are in the U.S.

The COVID-19 outbreak has added significantly to the number of ARDS cases.

The COVID-19 outbreak added significantly to the number of ARDS cases

during that pandemic.

Once COVID-19 patients advance to ARDS, they are put on mechanical ventilators.

Death rate among patients on ventilators can be as high

as 50% depending on associated co-morbidities.

There are no approved treatments for ARDS, and the current standard of care only attempts

to provide symptomatic relief.

Death rate among patients on ventilators

can be as high as 50% depending on associated co-morbidities.

There are no approved treatments for ARDS, and the current standard of

care only attempts to provide symptomatic relief.

Sales and Marketing

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Citius Oncology does not currently have its own

commercial infrastructure and is in the process of developing its sales or marketing capability by contracting with a large third-party

commercial sales and marketing organization with an existing commercial infrastructure and product launch experience to assist in its

commercial efforts.

Citius Oncology intends to utilize a dedicated field force combined with various marketing programs which will be

tailored to both physicians and patients to launch LYMPHIR and grow its market share.

We, through Citius Oncology, plan to focus our commercial

efforts on a concentrated group of prescribing hematologists, oncologists and dermatologist-oncologists, along with key opinion leaders

and advocacy groups who play an important role in the CTCL treatment regimen.

In September 2024, the Company announced the inclusion

of LYMPHIR in the National Comprehensive Cancer Network (“NCCN”) guidelines and compendia.

LYMPHIR was included bases on an

NCCN Category 2A recommendation which indicates a uniform NCCN consensus that LYMPHIR is appropriate as an option for patients with CTCL.

commercial infrastructure and has finalized its initial sales and marketing capabilities by contracting with a large third-party commercial

sales and marketing organization with an existing commercial infrastructure and product launch experience to assist in its commercial

Through this third-party organization, Citius Oncology has developed a dedicated field force combined with various marketing

programs which will be tailored to both physicians and patients to facilitate the successful launch of LYMPHIR and grow its market share.

We, through Citius Oncology, plan to focus our commercial efforts on a concentrated group of prescribing hematologists, oncologists and

dermatologist-oncologists, along with key opinion leaders and advocacy groups who play an important role in the CTCL treatment regimen.

To support the launch and commercialization of

LYMPHIR, Citius Oncology has entered into distribution agreements with Cardinal Health, Cencora and McKesson Corporation.

Citius Oncology has contracted with EVERSANA an innovative AI platform, to support the launch and commercialization of LYMPHIR whereby

EVERSANA provides an integrated suite of pre- and post-launch services, including medical information, pharmacovigilance, revenue cycle

management, program management, data and analytics, and channel management.

In addition, in October 2025, Citius Oncology announced that

it is actively engaging with regional distribution partners to make LYMPHIR available to eligible patients through country-specific

Named Patient Programs (NPPs) in Europe, South America and the Middle East.

As part of its NPP strategy, Citius Oncology has entered

into an exclusive distribution agreement with Integris Pharma S.A., headquartered in Athens, Greece.

The partnership covers Greece, Cyprus,

Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia.

In September 2024, the Company announced the

inclusion of LYMPHIR in the National Comprehensive Cancer Network (“NCCN”) guidelines and compendia.

LYMPHIR was included

bases on an NCCN Category 2A recommendation which indicates a uniform NCCN consensus that LYMPHIR is appropriate as an option for patients

The Company believes that LYMPHIR’s addition to the NCCN guidelines will assist LYMPHIR in obtaining coverage and reimbursement

from the Centers for Medicare and Medicaid Services (“CMS”).

In February 2025, Citius Pharma announced that

LYMPHIR had been assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) by CMS.

Intellectual Property

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LYMPHIR Intellectual Property

On September 3, 2021, Citius Pharma acquired the

exclusive license of E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, from Dr.

who had exclusively licensed it previously from Eisai.

On September 3, 2021, Citius Pharma acquired

the exclusive license of E7777 (denileukin diftitox), an oncology immunotherapy for the treatment of CTCL, from Dr.

had exclusively licensed it previously from Eisai.

The exclusive license, which was amended as part of the transaction, is with Eisai

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Bhutan, Nepal, Mongolia, and Papua New Guinea.

The license includes an option on the right to develop and market the product in India.

Citius Pharma renamed E7777 as I/ONTAK and also obtained the trade name LYMPHIR for the product.

In April 2022, Citius Pharma assigned

the license agreement to SpinCo, at which time SpinCo began operations.

Upon the completion of the Merger, SpinCo became a wholly owned

subsidiary of Citius Oncology.

Citius Pharma remains a guarantor on all of Citius Oncology’s payment obligations thereunder.

Obligations to Eisai under the License Agreement

Citius Pharma renamed E7777 as I/ONTAK and also obtained the trade name LYMPHIR for the

In April 2022, Citius Pharma assigned the license agreement to SpinCo, at which time SpinCo began operations.

Upon the completion

of the Merger, SpinCo became a wholly owned subsidiary of Citius Oncology.

Citius Pharma remains a guarantor on all of Citius Oncology’s

payment obligations thereunder.

Obligations to Eisai under the License

Under the license agreement, Eisai is to receive

a $5.9 million development milestone payment upon initial approval by the FDA of LYMPHIR for the CTCL indication (which increases to $6.9

million in the event the Company exercises the option to add India to the licensed territory) and an aggregate of up to $22 million related

to the achievement of net product sales thresholds.

Pursuant to the terms of the license agreement, through 2022, Citius Pharma reimbursed

Eisai for approximately $2.65 million of Eisai’s costs to complete the ongoing Phase 3 pivotal clinical trial for LYMPHIR for the

CTCL indication and for all reasonable costs associated with the preparation of a BLA for LYMPHIR.

The Company has accrued the $5.9 million

development milestone payment as of September 30, 2024.

a $5.9 million development milestone payment upon initial approval by the FDA of LYMPHIR for the CTCL indication and an aggregate of

up to $22 million related to the achievement of net product sales thresholds.

Pursuant to the terms of the license agreement, through

2022, Citius Pharma reimbursed Eisai for approximately $2.65 million of Eisai’s costs to complete the ongoing Phase 3 pivotal clinical

trial for LYMPHIR for the CTCL indication and for all reasonable costs associated with the preparation of a BLA for LYMPHIR.

has accrued the $2.9 million unpaid balance of the development milestone payment as of September 30, 2025.

Pursuant to the terms of the license agreement,

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additional indications.

On March 28, 2025, Citius

Oncology and Eisai entered into a letter agreement that amended the license agreement to provide for a payment schedule to Eisai for

the milestone payment and certain unpaid invoices.

We agreed to pay Eisai on or before July 15, 2025, an aggregate amount of $2,535,318

and thereafter on the 15th of each of the next four months to pay Eisai $2.35 million and make a final payment of $2,197,892 to Eisai

on or before December 15, 2025, in each case with interest on each obligation from its original due date through the date of actual payment

under the letter agreement at the rate of 2% per annum.

During the year ended September 30, 2025, we recorded $218,032 in interest expense

under the agreement.

The parties released each other from any and all claims, losses, damages, costs and expenses that arise from or

related to our failure to pay the milestone payment or the other incurred costs under the license agreement except for any claims arising

out of a breach of the letter agreement.

All other terms of the license agreement remain in full force and effect.

During the year ended

September 30, 2025, we paid $3 million of the development milestone and the balance of $2.9 million is included in license fee payable

at September 30, 2025.

On July 21, 2025, we made a payment to Eisai of $1,616,522 for other invoices and accumulated interest associated

with the letter agreement.

The term of the license agreement will continue

until (i) March 30, 2026, if there has not been a commercial sale of a licensed product in the territory, or (ii) if there has been a

first commercial sale of a licensed product in the territory by March 30, 2026, the 10-year anniversary of the first commercial sale on

a country-by-country basis.

The term of the license may be extended for additional 10-year periods for all countries in the territory

by notifying Eisai and paying an extension fee equal to $10 million.

Either party may terminate the license agreement upon written notice

if the other party is in material breach of the agreement, subject to cure within the designated time periods.

Either party also may terminate

the license agreement immediately upon written notice if the other party files for bankruptcy or takes related actions or is unable to

pay its debts as they become due.

Additionally, either party will have the right to terminate the agreement if the other party directly

or indirectly challenges the patentability, enforceability, or validity of any licensed patent.

first commercial sale of a licensed product in the territory by March 30, 2026, the 10-year anniversary of the first commercial sale

on a country-by-country basis.

Citius Oncology expects the first commercial sale to occur in the December 2025.

The term of the license

may be extended for additional 10-year periods for all countries in the territory by notifying Eisai and paying an extension fee equal

to $10 million.

Either party may terminate the license agreement upon written notice if the other party is in material breach of the

agreement, subject to cure within the designated time periods.

Either party also may terminate the license agreement immediately upon

written notice if the other party files for bankruptcy or takes related actions or is unable to pay its debts as they become due.

Additionally,

either party will have the right to terminate the agreement if the other party directly or indirectly challenges the patentability, enforceability,

or validity of any licensed patent.

The Company, through its subsidiary, is responsible

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Reddy’s development

Under the terms of the asset purchase agreement with Dr.

Reddy’s and subsequent to the April 2022 assignment to SpinCo,

Citius Oncology, as guaranteed by Citius Pharma, will be obligated to pay up to an aggregate of $40 million related to CTCL approvals

and other markets, up to $70 million in development milestones for additional indications, and up to $300 million for commercial

sales milestones.

Citius Oncology will also be obligated to pay on a fiscal quarter basis tiered royalties equal to low double-digit percentages

of net product sales (within a range of 10% to 15%).

The royalties will end on the earlier of (i) the 15-year anniversary of the first

commercial sale of the latest indication that received regulatory approval in the applicable country and (ii) the date on which a biosimilar

product results in the reduction of net sales in the applicable product by 50% in two consecutive quarters, as compared to the four quarters

prior to the first commercial sale of the biosimilar product.

The agreement was assigned to Citius Oncology in April 2022.

Under the terms of the asset purchase agreement

Reddy’s and subsequent to the April 2022 assignment to SpinCo, Citius Oncology, as guaranteed by Citius Pharma, will be

obligated to pay up to an aggregate of $40 million related to CTCL approvals in the U.S.

and other markets, up to $70 million in development

milestones for additional indications, and up to $300 million for commercial sales milestones.

Citius Oncology will also be obligated

to pay on a fiscal quarter basis tiered royalties equal to low double-digit percentages of net product sales (within a range of 10% to

The royalties will end on the earlier of (i) the 15-year anniversary of the first commercial sale of the latest indication that

received regulatory approval in the applicable country and (ii) the date on which a biosimilar product results in the reduction of net

sales in the applicable product by 50% in two consecutive quarters, as compared to the four quarters prior to the first commercial sale

of the biosimilar product.

Citius Oncology will also pay to Dr.

Reddy’s an amount equal to a

low-thirties percentage of any sublicense upfront consideration or milestone payments (or the like) received by Citius Oncology and the

greater of (i) a low-thirties percentage of any sublicensee sales-based royalties or (ii) a mid-single digit percentage of such licensee’s

Reddy’s an amount equal to a low-thirties percentage of any sublicense

upfront consideration or milestone payments (or the like) received by Citius Oncology and the greater of (i) a low-thirties percentage

of any sublicensee sales-based royalties or (ii) a mid-single digit percentage of such licensee’s net sales.

Also under the agreement with Dr.

the Company, through Citius Oncology, is required to (i) use commercially reasonable efforts to make commercially available products in

the CTCL indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two investigator initiated immuno-oncology

trials, (iii) use commercially reasonable efforts to achieve each of the approval milestones, and (iv) complete each specified immuno-oncology

investigator trial on or before the four-year anniversary of the effective date of the definitive agreement.

Additionally, the Company,

through Citius Oncology, is required to commercially launch a product in a territory within six months of receiving regulatory approval

for such product in each such jurisdiction.

The Company, through Citius Oncology, is responsible for these and any and all further developmental

activities relating to LYMPHIR.

the Company, through Citius Oncology, is required to (i) use commercially reasonable efforts to make commercially available products

in the CTCL indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two investigator initiated

immuno-oncology trials, (iii) use commercially reasonable efforts to achieve each of the approval milestones, and (iv) complete each

specified immuno-oncology investigator trial on or before the four-year anniversary of the effective date of the definitive agreement.

Additionally, the Company, through Citius Oncology, is required to commercially launch a product in a territory within six months of

receiving regulatory approval for such product in each such jurisdiction.

The Company, through Citius Oncology, is responsible for these

and any and all further developmental activities relating to LYMPHIR.

Reddy’s agreed to not compete against

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closing of the transaction, which was in effect until March 2022.

At the time of the FDA approval for LYMPHIR, a

$27.5 million milestone payment became payable for which a balance of $22.5 million remains due as of September 30, 2024.

At the time of the FDA

approval for LYMPHIR, a $27.5 million milestone became payable to Dr.

Reddy’s, of which a balance of $19.75 million included in

license fee payable, remained due as of September 30, 2025.

After discussions, Dr.

Reddy’s agreed to a partial deferral without

penalty of this milestone payment.

During the years ended September 30, 2025 and 2024, we paid $2,750,000 and $5,000,000, respectively,

against the outstanding milestone fee.

LYMPHIR Patents

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were acquired:

Provisional Application No.

63/070,645, which

was filed on August 26, 2020, and subsequently published as US 2022/0062390 A1 on March 3, 2022, entitled Methods of Treating Cancer.

Expiration date of August 23, 2041.

● International Patent Application Number:

PCT/IB2021/0576733,

which was filed with the World Intellectual Property Organization on August 23, 2021 for Europe, and subsequently published as WO 2022/043863

A1 on March 3, 2022, entitled, Combination for Use in Methods of Treating Cancer.

Provisional Application

63/070,645, which was filed on August 26, 2020, and subsequently published as US 2022/0062390 A1 on March 3, 2022, entitled Methods

of Treating Cancer.

Expiration date of August 23, 2041.

International Patent Application

PCT/IB2021/0576733, which was filed with the World Intellectual Property Organization on August 23, 2021 for Europe, and

subsequently published as WO 2022/043863 A1 on March 3, 2022, entitled, Combination for Use in Methods of Treating Cancer.

date of August 23, 2041.

Mino-Lok Intellectual Property

In May 2014, our subsidiary LMB entered into a

patent and technology license agreement with Novel Anti-Infective Therapeutics, Inc.

In May 2014, our subsidiary LMB entered into

a patent and technology license agreement with Novel Anti-Infective Therapeutics, Inc.

(“NAT”), who licensed the intellectual

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that increase annually until reaching a designated amount, which we must pay until the first sale of product.

We also must pay up to an

aggregate of approximately $1.1 million in milestone payments, depending on the achievement of various regulatory and commercial milestones.

We also must pay up to

an aggregate of approximately $1.1 million in milestone payments, depending on the achievement of various regulatory and commercial milestones.

Under the terms of the license agreement, we also must pay a royalty equal to mid-single digit percentages to low-double digit percentages

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After the first sale of product, we

will owe an annual minimum royalty payment that will increase annually until reaching a designated amount, which we must pay for the duration

We will be responsible for all patent expenses for the term of the agreement although MDACC is responsible for filing, prosecution

and maintenance of all patents.

will owe an annual minimum royalty payment that will increase annually until reaching a designated amount, which we must pay for the

duration of the term.

We will be responsible for all patent expenses for the term of the agreement although MDACC is responsible for

filing, prosecution and maintenance of all patents.

Unless earlier terminated by NAT based on the

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of these patents strengthens the intellectual property protection for Mino-Lok through November 2036.

While the original patents for Mino-Lok

(discussed above) cover the basic composition, this invention overcomes limitations in mixing antimicrobial solutions in which components

have precipitated because of physical and/or chemical factors, thus limiting the stability of the post-mix solutions.

The scientists and

technologists at MDACC have been able to improve the stability of the post-mixed solutions through adjustments of the post-mixed pH of

the solution.

While the original patents for

Mino-Lok (discussed above) cover the basic composition, this invention overcomes limitations in mixing antimicrobial solutions in which

components have precipitated because of physical and/or chemical factors, thus limiting the stability of the post-mix solutions.

scientists and technologists at MDACC have been able to improve the stability of the post-mixed solutions through adjustments of the

post-mixed pH of the solution.

This may allow for longer storage time of the ready-to-use solution.

As such, the patents claiming the enhanced stability

may effectively extend patent protection for Mino-Lok beyond the 2024 expiration of the original patents since it is expected that the

compositions providing enhanced stability would be preferred over any non-stabilized versions that a competitor may introduce after June

Citius Pharma holds the exclusive worldwide license which provides access to this patented technology for development and commercialization

Mino-Lok has received a Qualified Infectious Disease

Product (“QIDP”) designation.

The QIDP designation provides New Drug Applications an additional five years of market exclusivity,

which together with the potential three years of exclusivity for the new strength and formulation of Mino-Lok, would result in a combined

total of eight years of market exclusivity regardless of patent protection.

As such, the patents claiming the

enhanced stability may effectively extend patent protection for Mino-Lok beyond the 2024 expiration of the original patents since it

is expected that the compositions providing enhanced stability would be preferred over any non-stabilized versions that a competitor

may introduce after June 7, 2024.

Citius Pharma holds the exclusive worldwide license which provides access to this patented technology

for development and commercialization of Mino-Lok.

Mino-Lok has received a Qualified Infectious

Disease Product (“QIDP”) designation.

The QIDP designation provides New Drug Applications an additional five years of market

exclusivity, which together with the potential three years of exclusivity for the new strength and formulation of Mino-Lok, would result

in a combined total of eight years of market exclusivity regardless of patent protection.

Halo-Lido Intellectual Property

We are developing Halo-Lido to have a unique combination

of excipients as well as unique concentrations of the active ingredients.

The goal is to have a product that is optimized for stability

and activity.

Once the formulation development is completed and data is obtained, we intend to apply for a patent on this new topical

We seek to achieve approval for Halo-Lido by utilizing

the FDA’s 505(b)(2) pathway.

This pathway allows an applicant to file an NDA that contains full reports of investigations of safety

and effectiveness, but where at least some of the information required for approval comes from prior studies not conducted by or for the

applicant and for which the applicant has not obtained a right of reference to such prior third-party studies.

This pathway would provide

three years of market exclusivity.

We are developing Halo-Lido to have a unique

combination of excipients as well as unique concentrations of the active ingredients.

The goal is to have a product that is optimized

for stability and activity.

Once the formulation development is completed and data is obtained, we intend to apply for a patent on this

new topical formulation.

We seek to achieve approval for Halo-Lido by

utilizing the FDA’s 505(b)(2) pathway.

This pathway allows an applicant to file an NDA that contains full reports of investigations

of safety and effectiveness, but where at least some of the information required for approval comes from prior studies not conducted

by or for the applicant and for which the applicant has not obtained a right of reference to such prior third-party studies.

would provide three years of market exclusivity.

NoveCite Intellectual Property

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Inc., entered into a license agreement with Novellus Therapeutics Limited, whereby NoveCite acquired an exclusive, worldwide license,

with the right to sublicense, to develop and commercialize a stem cell therapy based on Novellus’s patented technology for the treatment

of acute pneumonitis of any etiology in which inflammation is a major agent in humans.

The patented technology consists of mesenchymal

stem cells (“MSCs”) derived from an induced pluripotent stem cell line that is made by Novellus using the mRNA cell reprogramming

methods in the patents covering the licensed technology.

with the right to sublicense, to develop and commercialize a stem cell therapy based on Novellus’s patented technology for the

treatment of acute pneumonitis of any etiology in which inflammation is a major agent in humans.

The patented technology consists of

mesenchymal stem cells (“MSCs”) derived from an induced pluripotent stem cell line that is made by Novellus using the mRNA

cell reprogramming methods in the patents covering the licensed technology.

Upon execution of the license agreement, NoveCite

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of the last-to-expire valid patent claim in that country.

In the case of a country where no licensed patent ever exists, the royalty will

end on the later of (i) the date of expiry of such licensed product’s regulatory exclusivity and (ii) the 10-year anniversary of

the date of the first commercial sale of the licensed product in the applicable country.

In addition, NoveCite will pay to Novellus an

amount equal to a mid-twenties percentage of any sublicensee fees it receives.

In the case of a country where no licensed patent ever exists, the royalty

will end on the later of (i) the date of expiry of such licensed product’s regulatory exclusivity and (ii) the 10-year anniversary

of the date of the first commercial sale of the licensed product in the applicable country.

In addition, NoveCite will pay to Novellus

an amount equal to a mid-twenties percentage of any sublicensee fees it receives.

During the term of the license agreement, NoveCite

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Novellus of the new product opportunity, NoveCite has 30 days to notify Novellus of its desire to negotiate a license agreement for the

If such notice is given by NoveCite, the parties shall then have a period of 150 days from the date of Novellus’s notice

to NoveCite to negotiate, exclusively and in good faith, the terms and conditions for the new product license agreement.

If such notice is given by NoveCite, the parties shall then have a period of 150 days from the date of Novellus’s

notice to NoveCite to negotiate, exclusively and in good faith, the terms and conditions for the new product license agreement.

The term of the license agreement will continue

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prosecuting and maintaining all patent applications and patents included in the licensed patents in the territory.

Provided however, that

if Novellus decides that it is not interested in maintaining a particular licensed patent or in preparing, filing, or prosecuting a licensed

patent, it will promptly advise NoveCite in writing and NoveCite will have the right, but not the obligation, to assume such responsibilities

in the territory at NoveCite’s sole cost and expense.

Provided however,

that if Novellus decides that it is not interested in maintaining a particular licensed patent or in preparing, filing, or prosecuting

a licensed patent, it will promptly advise NoveCite in writing and NoveCite will have the right, but not the obligation, to assume such

responsibilities in the territory at NoveCite’s sole cost and expense.

During the term of the license agreement, Novellus

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Pursuant to this transaction, the NoveCite license was assumed by Brooklyn with all of its original terms and conditions.

In October 2021,

2021, Brooklyn changed its name to Eterna Therapeutics Inc.

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therapeutics for patients with persistent or recurrent CTCL.

However, there are limitations to these targeted therapies, which often are

However, there are limitations to these targeted therapies, which are often

discontinued due to toxicity, adverse events, or a limited duration of response due to resistance over time.

Consequently, we believe

there continues to be an unmet medical need for patients with CTCL and an opportunity for LYMPHIR to be included among the treatment armamentarium

for advanced-stage CTCL.

there continues to be an unmet medical need for patients with CTCL and an opportunity for LYMPHIR to be included among the treatment

armamentarium for advanced-stage CTCL.

The following products are approved for the systemic

treatment of advanced CTCL:

Mogamulizumab, sold under the brand name Poteligeo, is a humanized, afucosylated monoclonal antibody targeting CC chemokine receptor 4.

The FDA approved it for treatment of relapsed or refractory mycosis fungoides and Sézary disease.

Brentuximab vedotin, sold under the brand name Adcetris, is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma, a type of T-cell non-Hodgkin lymphoma.

It selectively targets tumor cells expressing the CD30 antigen, a defining marker of Hodgkin lymphoma and ALC.

Romidepsin sold under the brand name Istodax, is a histone deacetylase (“HDAC”) inhibitor indicated for the treatment of CTCL in adult patients who have received at least one prior systemic therapy.

Vorinostat sold under the brand name Zolinza, is a HDAC inhibitor indicated for the treatment of cutaneous manifestations in patients with CTCL who have progressive, persistent or recurrent disease on or following two systemic therapies.

Mogamulizumab, sold under

the brand name Poteligeo, is a humanized, afucosylated monoclonal antibody targeting CC chemokine receptor 4.

The FDA approved it

for treatment of relapsed or refractory mycosis fungoides and Sézary disease.

Brentuximab vedotin, sold

under the brand name Adcetris, is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma and

systemic anaplastic large cell lymphoma, a type of T-cell non-Hodgkin lymphoma.

It selectively targets tumor cells expressing the

CD30 antigen, a defining marker of Hodgkin lymphoma and ALC.

Romidepsin sold under the

brand name Istodax, is a histone deacetylase (“HDAC”) inhibitor indicated for the treatment of CTCL in adult patients

who have received at least one prior systemic therapy.

Vorinostat sold under the

brand name Zolinza, is a HDAC inhibitor indicated for the treatment of cutaneous manifestations in patients with CTCL who have progressive,

persistent or recurrent disease on or following two systemic therapies.

Mino-Lok Competition

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The Company is aware that there

are several agents in development for prevention but none for salvage.

The most prominent of these appear to be Defencath from CorMedix

and B-Lock from Great Lakes Pharmaceuticals, Inc.

Neither of these lock solutions have been shown to be effective

in salvaging catheters in bacteremic patients as Mino-Lok is intended to do, and Citius Pharma does not expect that either would be pursued

for this indication.

are several agents either approved or in development for prevention but none for salvage.

The most prominent of these appear to be Defencath

from CorMedix Inc.

(“Cormedix”) and B-Lock from Great Lakes Pharmaceuticals, Inc.

Neither of these lock

solutions have been shown to be effective in salvaging catheters in bacteremic patients as Mino-Lok is intended to do, and Citius Pharma

does not expect that either would be pursued for this indication.

Defencath TM (CorMedix Inc.)

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in a Phase 3 clinical study.

The FDA approved Defencath in November 2023 and Cormedix, launched Defencath in April 2024.

B-Lock™ (Great Lakes Pharmaceuticals,

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We are unaware as to the progress or results of these studies.

In addition, we are not aware of any IND being filed in

In addition, we are not aware of any IND being filed

for B-Lock, nor are we aware of any clinical studies to support salvage of infected catheters in bacteremic patients.

There has been no further public information available

There has been no further public information

available on GLP.

GLP’s web site and phone number are no longer active and the Company believes that they have ceased operations.

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is non-prescription OTC products.

If approved by the FDA, Halo-Lido would be the only prescription product for the treatment of hemorrhoids.

If approved by the FDA, to our knowledge as of the date of this report, Halo-Lido would be the only

prescription product for the treatment of hemorrhoids.

NoveCite Competition

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field both in the U.S.

We believe that the following companies most directly compete with NoveCite in our licensed field of

acute pneumonitis treatment.

Cynata Therapeutics Limited develops and commercializes

a proprietary mesenchymal stem cell technology under the Cymerus brand for human therapeutic use in Australia.

The company’s lead

therapeutic product candidate is CYP-001, which has completed a Phase 1 clinical trial for the treatment of graft versus host disease.

Cynata also develops products for the treatment of asthma, heart attack, diabetic wounds, coronary artery disease, acute respiratory distress

syndrome, brain cancer, melanoma, sepsis, osteoarthritis, and critical limb ischemia, which are in a preclinical model.

Athersys, Inc.

is a biotechnology company that

focuses on the research and development activities in the field of regenerative medicine.

Its clinical development programs are focused

on treating neurological conditions, cardiovascular diseases, inflammatory and immune disorders, and pulmonary and other conditions.

company’s lead platform product includes MultiStem cell therapy, an allogeneic stem cell product, which has an ongoing Phase 2/3

clinical trial for the treatment of ARDS and has an ongoing clinical trial in Japan for the treatment of RDS.

The MultiStem therapy also

is in a Phase 3 clinical study for the treatment of patients suffering from neurological damage from an ischemic stroke, as well as in

a Phase 2 clinical study for the treatment of patients with acute myocardial infarction, and has completed a Phase 1 clinical study for

the treatment of patients suffering from leukemia or various other blood-borne cancers.

The company has license and collaboration agreements

with Healios K.K.

to develop and commercialize MultiStem cell therapy for ischemic stroke, acute respiratory distress syndrome, and ophthalmological

indications, as well as for the treatment of liver, kidney, pancreas, and intestinal tissue diseases;

and the University of Minnesota

to develop MultiStem cell therapy platform.

Pluristem Therapeutics Inc.

operates as a bio-therapeutics

company in Israel.

It focuses on the research, development, clinical trial, and manufacture of placental expanded (PLX) based cell therapeutic

products and related technologies for the treatment of various ischemic, inflammatory, and hematologic conditions, as well as autoimmune

A Phase 2 study of PLX cells as a treatment for severe COVID-19 cases complicated by acute respiratory distress syndrome has

been initiated in the U.S.

as well as in Europe and Israel.

We believe that the following companies most directly compete with NoveCite in our licensed field

of acute pneumonitis treatment.

Cynata Therapeutics Limited (“Cynata”)

develops and commercializes a proprietary mesenchymal stem cell technology under the Cymerus brand for human therapeutic use in Australia.

The company’s lead therapeutic product candidate is CYP-001, which has completed a Phase 1 clinical trial and for which Cynata

is actively recruiting patients for a Phase 2 clinical trial for the treatment of graft versus host disease.

Cynata also develops products

for the treatment of asthma, heart attack, diabetic wounds, coronary artery disease, acute respiratory distress syndrome, brain cancer,

melanoma, sepsis, osteoarthritis, and critical limb ischemia, which are in a preclinical model.

is a biotechnology company that focuses

on the research and development activities in the field of regenerative medicine.

Its clinical development programs are focused on treating

neurological conditions, cardiovascular diseases, inflammatory and immune disorders, and pulmonary and other conditions.

The company’s

lead platform product includes MultiStem cell therapy, an allogeneic stem cell product, for which it is preparing for a Phase 3 clinical

trial for the treatment of ARDS and has an ongoing clinical trial in Japan for the treatment of RDS.

The MultiStem therapy also is in

a Phase 3 clinical study for the treatment of patients suffering from neurological damage from an ischemic stroke.

Mesoblast Limited is a biopharmaceutical company

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mesenchymal stromal cells for the treatment of moderate to severe COVID-19 acute respiratory distress syndrome.

The trial was halted in

December 2020 after the Data Safety Monitoring Board (DSMB) performed a third interim analysis on the trial’s first 180 patients,

The trial was halted

in December 2020 after the Data Safety Monitoring Board (DSMB) performed a third interim analysis on the trial’s first 180 patients,

noting that the trial was not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment.

The trial was

powered to achieve a primary endpoint of 43% reduction in mortality at 30 days for treatment with remestemcelL on top of maximal care.

was powered to achieve a primary endpoint of 43% reduction in mortality at 30 days for treatment with remestemcelL on top of maximal

The DSMB recommended that the trial complete with the enrolled 222 patients, and that all be followed-up as planned.

At follow-up through

day 60, remestemcel-L showed a positive but non-significant trend in overall mortality reduction across the entire population of treated

patients (n=217).

In the pre-specified population of patients under age 65 (n=123), remestemcel-L reduced mortality through day 60 by

46%, but not in patients 65 or older (n=94).

In an exploratory analysis through day 60, remestemcelL reduced mortality by 75% and increased

days alive off mechanical ventilation in patients under age 65 when combined with dexamethasone, in comparison with controls on dexamethasone.

through day 60, remestemcel-L showed a positive but non-significant trend in overall mortality reduction across the entire population

of treated patients (n=217).

In the pre-specified population of patients under age 65 (n=123), remestemcel-L reduced mortality through

day 60 by 46%, but not in patients 65 or older (n=94).

In an exploratory analysis through day 60, remestemcelL reduced mortality by 75%

and increased days alive off mechanical ventilation in patients under age 65 when combined with dexamethasone, in comparison with controls

on dexamethasone.

Supply and Manufacturing

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source of supply would not have a material adverse effect on us.

If we elect to conduct product development and

manufacturing, we will be subject to regulation under various federal and state laws, including the Food, Drug and Cosmetic Act, Occupational

Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act,

the Controlled Substances Act and other present and potential future federal, state or local regulations.

We have contracted with proven suppliers and manufacturers

for active pharmaceutical ingredients, development and packaging.

We are confident that all materials meet or will meet specifications

discussed at the chemistry, manufacturing and controls meeting with the FDA.

Our product development and manufacturing for

LYMPHIR is subject to regulation under various federal and state laws, including the Food, Drug and Cosmetic Act, Occupational Safety

and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, the Controlled

Substances Act and other present and potential future federal, state or local regulations.

We have contracted with proven suppliers and

manufacturers for active pharmaceutical ingredients, commercial supply, development and packaging.

We are confident that all materials

meet or will meet specifications discussed at the chemistry, manufacturing and controls meeting with the FDA.

If we fail to raise additional capital, and as

a result are unable to abide by our contractual obligations with these third-party manufacturers and suppliers, including making timely

payment, the necessary third-party support to commercialize LYMPHIR could be delayed or terminated.

payment, the necessary third-party support to continue to commercialize LYMPHIR could be delayed or terminated.

Supply and Manufacturing of LYMPHIR

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comply with the applicable U.S.

requirements at any time during the product development process, including clinical testing, as well as

at any time before and after the approval process, we may become subject to administrative or judicial sanctions, or other actions, such

as the FDA’s delay in review of or refusal to approve a pending NDA or BLA, withdrawal of an approval, imposition of a clinical

requirements at any time during the product development process, including clinical testing, as well

as at any time before and after the approval process, we may become subject to administrative or judicial sanctions, or other actions,

such as the FDA’s delay in review of or refusal to approve a pending NDA or BLA, withdrawal of an approval, imposition of a clinical

hold or study termination, issuance of Warning Letters or Untitled Letters, mandated modifications to promotional materials or issuance

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product seizures or detentions, refusal to allow product import or export, total or partial suspension of or restriction of or imposition

of other requirements relating to production or distribution, injunctions, fines, debarment from government contracts and refusal of future

orders under existing contracts, exclusion from participation in federal and state healthcare programs, FDA debarment, restitution, disgorgement

or civil or criminal penalties, including fines and imprisonment.

Any enforcement action could have a material adverse effect on the Company

and our operations.

of other requirements relating to production or distribution, injunctions, fines, debarment from government contracts and refusal of

future orders under existing contracts, exclusion from participation in federal and state healthcare programs, FDA debarment, restitution,

disgorgement or civil or criminal penalties, including fines and imprisonment.

Any enforcement action could have a material adverse effect

on the Company and our operations.

FDA Marketing Approval

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candidates may be marketed in the U.S., it must be approved by the FDA.

Obtaining FDA marketing approval for new products may take many

years and require the expenditure of substantial financial resources.

In order for the FDA to determine that a product is safe and effective

for the proposed indication, the product must first undergo testing in animals (nonclinical studies).

The data generated from nonclinical

studies is used to support the filing of an IND under which human studies are conducted.

Human testing is generally conducted under an

IND in three phases following Good Clinical Practices (“GCP”) regulations:

● Phase 1 studies evaluate the safety and tolerability

of the drug, generally in normal, healthy volunteers;

● Phase 2 studies evaluate safety and efficacy,

as well as appropriate doses;

these studies are typically conducted in patient volunteers who suffer from the particular disease condition

that the drug is designed to treat;

● Phase 3 studies evaluate safety and efficacy

of the product at specific doses in one or more larger pivotal trials.

Obtaining FDA marketing approval for new products requires substantial

time, effort and financial resources.

In order for the FDA to determine that a product is safe and effective for the proposed indication,

the product must first undergo testing in animals (nonclinical studies).

The data generated from nonclinical studies is used to support

the filing of an IND under which human studies are conducted.

Human testing is generally conducted under an IND in three phases following

Good Clinical Practices (“GCP”) regulations:

Phase 1 studies evaluate

the safety and tolerability of the drug, generally in normal, healthy volunteers;

Phase 2 studies evaluate

safety and efficacy, as well as appropriate doses;

these studies are typically conducted in patient volunteers who suffer from the

particular disease condition that the drug is designed to treat;

Phase 3 studies evaluate

safety and efficacy of the product at specific doses in one or more larger pivotal trials.

In addition to human testing, the manufacturing

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information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and

clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter (“CRL”).

A CRL generally

contains a statement of specific conditions that must be met in order to secure final approval of the NDA or BLA and may require additional

clinical or preclinical studies, or other information, in order for FDA approval.

Even with submission of this additional information,

the FDA may decide that the NDA or BLA does not satisfy the regulatory criteria for approval.

If and when those conditions have been met

to the FDA’s satisfaction, the FDA may issue an approval letter.

An approval letter authorizes commercial marketing of the drug

with specific prescribing information for specific indications.

The development and approval of new drugs requires

substantial time, effort and financial resources.

Data obtained from the development program are not always conclusive and may be susceptible

to varying interpretations.

clinical trial sites, the FDA may issue an approval letter, or, in some cases, a CRL.

A CRL generally contains a statement of specific

conditions that must be met in order to secure final approval of the NDA or BLA and may require additional clinical or preclinical studies,

or other information, in order for FDA approval.

Even with submission of this additional information, the FDA may decide that the NDA

or BLA does not satisfy the regulatory criteria for approval.

If and when those conditions have been met to the FDA’s satisfaction,

the FDA may issue an approval letter.

An approval letter authorizes commercial marketing of the drug with specific prescribing information

for specific indications.

Data obtained from the development program are

not always conclusive and may be susceptible to varying interpretations.

These instances may delay, limit or prevent regulatory approval.

The FDA may not grant approval on a timely

basis, or at all.

We may encounter difficulties or unanticipated costs in our efforts to secure necessary governmental approvals, which

could delay or preclude us from marketing our products.

The FDA may limit the indications for use or place other conditions on any approvals

that could restrict the commercial application of the product.

The FDA may not grant approval on a timely basis, or at all.

We may encounter difficulties or unanticipated costs in our efforts to secure

necessary governmental approvals, which could delay or preclude us from marketing our products.

The FDA may limit the indications for

use or place other conditions on any approvals that could restrict the commercial application of the product.

FDA Post - Approval Considerations

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occur after the product becomes available in the market.

After approval, most changes to the approved product,

such as manufacturing changes and adding new indications or other labeling claims, are subject to FDA review and approval.

There are also

annual user fee requirements for any marketed product and new application fees for supplemental applications with clinical data.

Additionally,

the FDA strictly regulates the labeling, advertising and promotion of products under an approved NDA or BLA.

The FDA and other agencies

actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly

marketed or promoted off-label uses may be subject to significant liability, including criminal and civil penalties under the FDCA and

False Claims Act, exclusion from participation in federal healthcare programs, debarment from government contracts, refusal of future

orders under existing contracts and mandatory compliance programs under corporate integrity agreements or deferred prosecution agreements.

After approval, most changes to the approved

product, such as manufacturing changes and adding new indications or other labeling claims, are subject to FDA review and approval.

are also annual user fee requirements for any marketed product and new application fees for supplemental applications with clinical data.

Additionally, the FDA strictly regulates the labeling, advertising and promotion of products under an approved NDA or BLA.

other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to

have improperly marketed or promoted off-label uses may be subject to significant liability, including criminal and civil penalties under

the FDCA and False Claims Act, exclusion from participation in federal healthcare programs, debarment from government contracts, refusal

of future orders under existing contracts and mandatory compliance programs under corporate integrity agreements or deferred prosecution

Other Regulations of the Healthcare Industry

In addition to FDA regulations governing the marketing

of pharmaceutical products, there are various other state and federal laws that may restrict business practices in the biopharmaceutical

In addition to FDA regulations governing the

marketing of pharmaceutical products, there are various state and federal laws that may restrict business practices in the biopharmaceutical

These include the following:

● The federal Anti-Kickback laws and implementing

regulations, which prohibit persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or

indirectly, in cash or in kind, to induce either the referral of an individual, or furnishing or arranging for a good or service, for

which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

● Other Medicare laws, regulations, rules, manual

provisions and policies that prescribe the requirements for coverage and payment for services performed by our customers, including the

amount of such payment;

● The federal False Claims Act, which imposes civil

and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent claims for payment to the

● The Foreign Corrupt Practices Act (“FCPA”),

which prohibits certain payments made to foreign government officials;

● State and foreign law equivalents of the foregoing

and state laws regarding pharmaceutical company marketing compliance, reporting and disclosure obligations;

● The Patient Protection and Affordable Care Act

of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the “Affordable Care

Act” or “ACA”), which among other things:

changes access to healthcare products and services;

creates new fees for the

pharmaceutical and medical device industries;

changes rebates and prices for health care products and services;

and requires additional

reporting and disclosure;

● The Health Insurance Portability and Accountability

Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations

(collectively, “HIPAA”), which creates federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit

program and which also imposes certain obligations on entities with respect to the privacy, security and transmission of individually

identifiable health information;

● The federal Physician Payment Sunshine Act, which

requires certain pharmaceutical and biological manufacturers to engage in extensive tracking of payments or transfers of value to physicians

and teaching hospitals and public reporting of the payment data.

The federal Anti-Kickback

laws and implementing regulations, which prohibit persons from knowingly and willfully soliciting, offering, receiving or providing

remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual, or furnishing or arranging

for a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

Other Medicare laws, regulations,

rules, manual provisions and policies that prescribe the requirements for coverage and payment for services performed by our customers,

including the amount of such payment;

The federal False Claims

Act, which imposes civil and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent

claims for payment to the government;

The Foreign Corrupt Practices

Act (“FCPA”), which prohibits certain payments made to foreign government officials;

State and foreign law equivalents

of the foregoing and state laws regarding pharmaceutical company marketing compliance, reporting and disclosure obligations;

The Patient Protection

and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (collectively,

the “Affordable Care Act” or “ACA”), which among other things:

changes access to healthcare products and

creates new fees for the pharmaceutical and medical device industries;

changes rebates and prices for health care products

and services;

and requires additional reporting and disclosure;

The Health Insurance Portability

and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and

its implementing regulations (collectively, “HIPAA”), which creates federal criminal laws that prohibit executing a scheme

to defraud any healthcare benefit program and which also imposes certain obligations on entities with respect to the privacy, security

and transmission of individually identifiable health information;

The federal Physician Payment

Sunshine Act, which requires certain pharmaceutical and biological manufacturers to engage in extensive tracking of payments or transfers

of value to physicians and teaching hospitals and public reporting of the payment data.

If our operations are found to be in violation

of any of these laws, regulations, rules or policies or any other law or governmental regulation, or if interpretations of the foregoing

change, we may be subject to civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the curtailment

or restructuring of our operations.

change, we may be subject to civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the

curtailment or restructuring of our operations.

To the extent that any of our products are sold

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This is currently not applicable as our only approved product is not currently

sold in a foreign country.

sold in a foreign country nor have we applied for any foreign approvals.

Citius Oncology has signed international distribution agreements

covering Greece, Cyprus other Balkan countries as well as Turkey, Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the UAE through named

patient programs which allows access to LYMPHIR where permitted by local law without constituting commercial approval outside the United

Coverage and Reimbursement

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in Medicare reimbursement levels for drugs administered by physicians.

Further, the Center for Medicare & Medicaid Services (“CMS”),

the agency that administers the Medicare and Medicaid programs, also has authority to revise reimbursement rates and to implement coverage

restrictions for some drugs.

Cost reduction initiatives and changes in coverage implemented through legislation or regulation could decrease

utilization of and reimbursement for any approved products.

While Medicare regulations apply only to drug benefits for Medicare beneficiaries,

private payers often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates.

Therefore, any

reduction in reimbursement that results from federal legislation or regulation may result in a similar reduction in payments from private

Further, CMS, the agency that administers the Medicare and Medicaid

programs, also has authority to revise reimbursement rates and to implement coverage restrictions for some drugs.

Cost reduction initiatives

and changes in coverage implemented through legislation or regulation could decrease utilization of and reimbursement for any approved

While Medicare regulations apply only to drug benefits for Medicare beneficiaries, private payers often follow Medicare coverage

policy and payment limitations in setting their own reimbursement rates.

Therefore, any reduction in reimbursement that results from

federal legislation or regulation may result in a similar reduction in payments from private payers.

The ACA substantially changed the way healthcare

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The ACA was intended to

broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and

abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical and

medical device manufacturers, and impose additional health policy reforms.

Since its passage, there have been significant ongoing efforts

to modify or eliminate the ACA.

The Trump administration pushed for modifications

broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud

and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical

and medical device manufacturers, and impose additional health policy reforms.

Since its passage, there have been significant ongoing

efforts to modify or eliminate the ACA.

The first Trump administration pushed for modifications

In addition, the Tax Cuts and Jobs Act (the “TCJA”), enacted on December 22, 2017, repealed the shared responsibility

payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, as amended

(the “IRC”), as amended, commonly referred to as the individual mandate.

While the Biden administration has rolled back many

of the executive orders issued by former President Trump and has stated that it intends to build on the ACA and to expand coverage thereunder,

ongoing repeal and reform efforts impacting the ACA and the healthcare sector more broadly are likely under the upcoming Trump administration.

Other legislative changes have been proposed and

adopted since passage of the ACA.

These have, among other things, reduced Medicare payments to several types of providers, including hospitals,

imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments

to providers.

payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, as

amended (the “IRC”), as amended, commonly referred to as the individual mandate.

While the Biden administration rolled back

many of the executive orders issued by President Trump in his first term, ongoing repeal and reform efforts impacting the ACA and the

healthcare sector more broadly are being sought and are likely under the current Trump administration.

Other legislative changes have been proposed

and adopted since passage of the ACA.

These have, among other things, reduced Medicare payments to several types of providers, including

hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover

overpayments to providers.

Further legislative and regulatory changes under

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It is unknown what form any future changes or any

law would take under the upcoming Trump Administration and how or whether it may affect our business in the future.

law would take under the current Trump administration and how or whether it may affect our business in the future.

We expect that changes

or additions to the ACA, the Medicare and Medicaid programs, changes allowing the federal government to directly negotiate drug prices

and changes stemming from other healthcare reform measures, especially with regard to healthcare access, financing or other legislation

in individual states, could have a material adverse effect on the healthcare industry.

In addition, the Affordable Care Act has also been

subject to challenges in the courts, which remain ongoing.

(which becomes effective in January 2026 for 10 prescription drugs) and changes stemming from other healthcare reform measures, especially

with regard to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the healthcare

In addition, the Affordable Care Act has also been subject to challenges in the courts, which remain ongoing.

Payment methodologies may be subject to changes

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regulations, and may pass additional legislation, designed to control pharmaceutical product pricing, including price or patient reimbursement

constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases,

designed to encourage importation from other countries and bulk purchasing.

We expect that additional federal, state and foreign

healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will

pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products,

constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some

cases, designed to encourage importation from other countries and bulk purchasing.

We expect that additional federal, state and

foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments

will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products,

once approved, or additional pricing pressures.

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Executive Officers of Citius Pharma

Leonard Mazur , Chief Executive Officer,

Chairman and Secretary – Mr.

Mazur, 79, was appointed Chief Executive Officer effective May 1, 2022, and has been a member of the

Board since September 2014.

Mazur previously served as Chief Executive Officer, President, and Chief Operating Officer from September

2014 until March 2016.

Myron Holubiak, Executive Vice Chairman

and Director – Mr.

Holubiak, 77, was appointed Executive Vice Chairman effective May 1, 2022, and has been a member of the Board

since October 2015.

Leonard Mazur , Chief Executive

Officer, Chairman and Secretary – Mr.

Mazur, 80, was appointed Chief Executive Officer effective May 1, 2022, and has been a member

of the Board since September 2014.

Mazur previously served as Chief Executive Officer, President, and Chief Operating Officer from

September 2014 until March 2016.

Myron Holubiak, Executive Vice

Chairman and Director – Mr.

Holubiak, 78, was appointed Executive Vice Chairman effective May 1, 2022, and has been a member of

the Board since October 2015.

He previously served as President and Chief Executive Officer from March 2016 through April 2022.

He was also the

founder and Chief Executive Officer and President of Leonard-Meron Biosciences, Inc., an acquired subsidiary of Citius Pharma, from March

2013 until March 2016.

also the founder and Chief Executive Officer and President of Leonard-Meron Biosciences, Inc., an acquired subsidiary of Citius Pharma,

from March 2013 until March 2016.

Jaime Bartushak , Chief Business

Officer, Chief Financial Officer and Principal Financial Officer – Mr.

Bartushak, 57, was appointed as Chief Financial Officer in

November 2017.

Previously, he was one of the founders and Chief Financial Officer of Leonard-Meron Biosciences, Inc., an acquired subsidiary

of Citius Pharma.

Bartushak, 58, was appointed as Chief Financial Officer

in November 2017.

Previously, he was one of the founders and Chief Financial Officer of Leonard-Meron Biosciences, Inc., an acquired

subsidiary of Citius Pharma.

Myron Czuczman , Chief Medical Officer

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business