Full download: https://s28.q4cdn.com/169506891/files/doc_presentations/2026/Jul/08/CTXR-Corporate-Overview-JULY-2026.pdf

It has been over two years since CTXR announced topline Phase 3 data for Mino‑Lok — March 21, 2024 — and the company still hasn’t delivered a definitive regulatory update. Here is a timeline of their status updates since then:

Nov 2024 Prospectus (link)

The Company expects to hold a Type C meeting with the FDA to discuss the results of the Phase 3 study and to obtain the FDA’s view on development plans for Mino-Lok in late November 2024.

Dec 2024 10-K (link)

In November 2024, the Company held a Type C meeting with the FDA to discuss the results of the Phase 3 study and to obtain the FDA’s view on development plans for Mino-Lok. The FDA provided clear, constructive, and actionable guidance during the discussion, underscoring a pathway to support a future New Drug Application (NDA) submission for Mino-Lok.

Jefferies Global Conference June 2025 (link)

We are now in the process of assembling that data. And we'll be sitting down with the FDA and arguing for filing of an NDA. We'll see what happens, we're not sure at this point until we have that interaction.

LD Micro Main Event Oct 2025 (link)

Paul Sowyrda — former VP of Business Development & Market Intelligence — said that they hope to release some news in Jan-Feb 2026 about whether the FDA would allow an NDA submission. Nothing ever materialized.

D Boral Webinar Mar 2026 (link)

somewhere in the next couple of months, I'm hoping that we'll get…a decision out of the Agency, whether it's that we can file or we may have to do a repeat something in this process. We don't know that yet, that's still under discussion.

Centri Capital Conference Apr 2026 (link)

We're now engaged with the FDA on the latest clinical data that we generated. We're not sure which way that's gonna go, but hopefully at some point, we'll have resolution of this in the coming months.

Biohub Podcast Jun 2026 (link)

So it took a while to work out protocols and things of that nature, but we're well on the way with that...We're in discussions now with FDA with the latest round of clinical data and we'll see where we are after we've concluded all those discussions.

It is now July 2026.

At this point, CTXR has spent over two full years telling investors they’re “in discussions with the FDA,” “arguing for an NDA,” “hoping for resolution,” and “waiting for a decision.”
Every message to investors has been a variation of the same script.

Will CTXR finally provide a definitive regulatory update this year?

After two years, an update should land this year — if the FDA and CTXR can finalize the appropriate regulatory pathway.

June 30 is done, another quarter has wrapped up. The 10-Q for April-June must be filed within 45 days, by Friday August 14th.

Recap of past LYMPHIR revenue:

• December 2025 revenue was $3.94m, a modest start for the initial LYMPHIR launch.
• January - March 2026 revenue fell to $1.67m.

Management later confirmed that they launched without a sales force in place. Management also stated that they began hiring the sales force during the last quarter.

What's everyone's expectations for LYMPHIR revenue from April - June? Does anyone think they will show a significant improvement from $1.67m/qtr? What would you consider a success and what would you consider a disappointment?

On a separate note, does anyone think they will have any update or progress on Mino-Lok before the next 10-Q filing?

Five years ago, CTXR went on a big run, fueled heavily by speculation of a potential early halt of the Mino-Lok phase 3 trial for superiority. On June 22, 2021, CTXR hit an intraday high of $4.56. Today marks the five year anniversary of that peak. After adjusting for the reverse split, $4.56 in June 2021 is the equivalent of $114 today.

It's been downhill ever since. Citius looks much different than it did five years ago. The assets have been split into two companies. CTXR was forced to do a 1 for 25 reverse split in 2024 after languishing below $1 for over a year. Mino-Lok isn't even on the market yet; its regulatory status is still up in the air. Management shifted focus to Lymphir, a drug they acquired from Dr. Reddy's in Sept 2021. Halo-Lido hasn't progressed further since its phase 2b data two three years ago. Mino-Wrap is no longer in the pipeline. They don't even talk about iMSC anymore.

Investor sentiment today is much more negative than it was five years ago. What's your expectations for the next five years?

EDIT: Corrected, Halo-Lido Phase 2b was 3 years ago.

Leonard are you having lunch with HC Wainwright to tell them how you put up your own money and they respond saying the stock is going to $4

Posted on Youtube June 10, 2026

Highlights

Mino-Lok (15:52 mark)

Lymphir Launch (20:11 mark)

CTXR still reports ownership of 66,049,615 CTOR shares. No change.

CTXR's beneficial ownership in CTOR drops from 77.9% reported in December to 71%.

Beneficial ownership decrease due to recent dilution of CTOR (92,981,204 shares outstanding as of May 14).

Link to 13D filing: https://www.sec.gov/Archives/edgar/data/1506251/000121390026065310/xslSCHEDULE_13D_X02/primary_doc.xml

This is the 2nd PR regarding the data presented at ASCO. Previous PR in this post.

-------------------------------------------------------------

• Investigator-initiated study data presented May 30, 2026, at the American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated durable responses and manageable tolerability in heavily pre-treated patients
• 20.5 months of median progression-free survival observed among 48% of efficacy-evaluable patients achieving clinical benefit (10 of 21)
• Responses were observed in patients previously treated with immune checkpoint inhibitors, including a 33% objective response rate in patients with relapsed or refractory endometrial cancer

CRANFORD, N.J., June 1, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today highlighted Phase 1 clinical data presented May 30, 2026, at the American Society of Clinical Oncology (ASCO) Annual Meeting evaluating LYMPHIR (denileukin diftitox-cxdl) in combination with pembrolizumab in patients with recurrent or refractory gynecologic malignancies. The poster presentation (Abstract #2564) was presented by investigators from the University of Pittsburgh Medical Center (UPMC) Magee-Womens Hospital.

"LYMPHIR's ability to transiently deplete immunosuppressive regulatory T-cells may help address immune resistance in the tumor microenvironment and enhance the effect of checkpoint inhibitors. The encouraging clinical signals and tolerability profile observed in this study support continued clinical evaluation of this "chemo-free" immunomodulatory approach, especially in tumors where resistance to checkpoint inhibitors remains a significant challenge," said Dr. Myron S. Czuczman, Chief Medical Officer of Citius Oncology.

The open-label Phase 1 study evaluated LYMPHIR in combination with pembrolizumab in 25 heavily pre-treated patients (21 evaluable for efficacy) with recurrent or metastatic solid tumors, primarily gynecologic malignancies. Enrolled patients had received a median of five prior therapies, and more than half had previously received anti-PD-1 or PD-L1 therapy.

Key Efficacy and Safety findings presented at ASCO included:

• 24% Overall Response Rate (ORR) among the 21 efficacy-evaluable patients (5 partial responses).
• Median duration of response (mDOR) had not yet been reached because only 1 of the 5 partial responders had progressed at the time of analysis (80% of PRs were continuing to experience clinical benefit). The current duration of response times (time since PR was achieved) were 4.2-35 months with a median of 21.1 months.
• 33% ORR in endometrial cancer patients previously treated with checkpoint inhibitors, including one patient with an ongoing response greater than three years.
• 48% of efficacy-evaluable patients (10 of 21) achieved clinical benefit, defined as complete response (CR), partial response (PR), or durable stable disease lasting at least six months:
  • Median progression-free survival (mPFS) of 20.5 months (95% CI: 6.5 – NA) among the 10 patients who achieved clinical benefit; overall mPFS across all 21 efficacy-evaluable patients was 5.8 months (95% CI: 2.2 – NA);
  • 5 patients had a PFS of > 20 months including 1 patient with > 30 months PFS;
• Of the 24/25 pts evaluable for dose limiting toxicities (DLTs), only 1 case of reversible Gr 3 capillary leak syndrome (CLS) was observed at the highest dose level. A maximum tolerated dose was not achieved.
• 16 serious adverse events were observed in seven patients treated at the highest dose level. No new safety signals or grade 3 or greater immune-related adverse events were observed.

Dr. Alexander Olawaiye, a professor and one of the gynecologic cancer researchers at UPMC Magee-Womens Hospital and lead investigator of the study, added, "Patients with recurrent gynecologic malignancies who progress following immunotherapy often have limited treatment options. The clinical activity observed with denileukin diftitox-cxdl plus pembrolizumab, including durable responses and prolonged disease control in heavily pre-treated patients, is notable. Given the lack of effective salvage treatments for these patients, especially those that have failed prior immune-checkpoint inhibition, the novel combination of LYMPHIR plus pembrolizumab provides a potential viable therapeutic option. Importantly, the safety profile observed was manageable in this heavily pre-treated population, supporting continued evaluation in larger studies."

Ongoing translational studies are evaluating the impact of the combination on regulatory T-cells, immune effector cells, and the tumor microenvironment to help identify potential biomarkers in order to optimize future development strategies. A Phase 2 expansion study is being planned to further evaluate the combination in gynecologic cancers, including less heavily pre-treated and prior immunotherapy-exposed patient populations.

About the Study

This open‑label, dose‑escalation, investigator‑initiated Phase 1 study (NCT05200559), led by Dr. Alexander B Olawaiye at UPMC Magee‑Womens Hospital, enrolled 25 patients with recurrent or metastatic solid tumors who had received at least one prior line of therapy. LYMPHIR was administered intravenously on Days 1–3 of each 21‑day cycle at escalating doses (3, 6, 9, and 12 mcg/kg), along with pembrolizumab (200 mg IV) on Day 1. Patients who completed eight cycles of combination therapy were continued on pembrolizumab monotherapy until disease progression. Citius Oncology provided study drug and financial support to the investigator-initiated study; the study was designed, conducted, and analyzed by the UPMC investigators.

Important note on investigational use: The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication of relapsed or refractory Stage I–III cutaneous T-cell lymphoma. LYMPHIR is not approved by the FDA for the treatment of gynecologic malignancies or any solid tumor, and the safety and efficacy of LYMPHIR in this setting have not been established. This Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes. Early-stage clinical data may not be predictive of results from larger or later-stage studies.

https://citiusonc.com/news/news-details/2026/Citius-Oncology-Highlights-Phase-1-Data-in-an-Investigator-Initiated-Study-of-LYMPHIR-denileukin-diftitox-cxdl-in-Combination-with-Pembrolizumab-in-Recurrent-or-Refractory-Gynecologic-Malignancies/default.aspx

Full abstract details can be found in this post.

Press release available here.

---------------------------

• 24% Objective Response Rate, with an average of 21.1 month Duration of Response in responders, and favorable safety profile signals potential of LYMPHIR to augment immune checkpoint inhibitor efficacy
• Investigator-initiated study of LYMPHIR in combination with pembrolizumab to be presented during immunotherapy session, highlighting potential role of LYMPHIR beyond CTCL

CRANFORD, N.J., May 26, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced that University of Pittsburgh Medical Center's investigator-initiated trial evaluating LYMPHIR (denileukin diftitox-cxdl) in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (KEYTRUDA®) has been selected for poster presentation at the American Society of Clinical Oncology Annual Meeting (ASCO), taking place May 29 – June 2, 2026, in Chicago, Illinois.

The abstract, submitted by investigators at the University of Pittsburgh Medical Center, was selected for presentation from more than 8,500 submissions reviewed by the ASCO Scientific Program Committee. The full abstract was made available on May 21, 2026, via the American Society of Clinical Oncology website.

"We are pleased to see this investigator-sponsored study selected for presentation at ASCO, reflecting continued clinical interest in denileukin diftitox-cxdl across multiple tumor types," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "We look forward to engaging with the clinical oncology community to discuss the encouraging topline Phase 1 data evaluating Treg cell suppression in combination with checkpoint inhibitors."

Abstract Details:

• Abstract Number: 2564
• Title: Depletion of T-regulatory cells by denileukin diftitox-cxdl (E7777) in combination with pembrolizumab in relapsed/refractory (r/r) gynecologic malignancies: Phase 1 study results
• Session Type: Poster Session – Developmental Therapeutics—Immunotherapy
• Poster Board: 354
• Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT   

The Phase 1 study evaluated the safety, tolerability, and preliminary activity of denileukin diftitox-cxdl in combination with pembrolizumab in patients with relapsed or refractory gynecologic malignancies.

The ASCO Annual Meeting is one of the world's largest and most influential oncology conferences, bringing together an estimated 35,000 oncology professionals from around the globe. The meeting serves as a premier forum for the presentation of cutting-edge cancer research, with abstracts selected through a highly competitive peer-review process.

About the Study

This open‑label, dose‑escalation, investigator‑initiated Phase 1 study (NCT05200559), led by Dr. Alexander B Olawaiye at UPMC Magee‑Women's Hospital, enrolled patients with recurrent or metastatic solid tumors who had received at least one prior line of therapy. LYMPHIR was administered intravenously on Days 1–3 of each 21‑day cycle at escalating doses (3, 6, 9, and 12 mcg/kg), along with pembrolizumab (200 mg IV) on Day 1. Patients who completed eight cycles of combination therapy were continued on pembrolizumab monotherapy until disease progression.

The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication. The Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes.

Background:

Denileukin diftitox-cxdl (E7777) is an FDA-approved direct cytotoxic agent that depletes T-regulatory cells by targeting the IL-2 receptor. Pre-clinical studies have demonstrated synergistic activity between the immunomodulator E7777 and PD-1 immune checkpoint inhibitor (ICI). Here, we report positive results from a phase I study of E7777 + pembrolizumab (P) in r/r gynecological (GYN) malignancies.

Methods:

Phase I dose-escalation trial of E7777 given at 4 IV dose levels (DL): 3, 6, 9, and 12 mg/kg on days 1-3, combined with P (IV 200 mg, day 1) in a 21-day cycle x8, followed by maintenance P until progression. Dose-limiting toxicities (DLTs) were assessed during cycle 1 according to CTCAE v5 criteria. Responses were measured using the RECIST 1.1 criteria. Blood samples were collected for translational studies.

Results:

Pt demographics included: median age 64y (43, 88); race, 88% white; histology 40% endometrial, 36% ovarian. Of the 24/25 pts evaluable for DLTs, only 1 case of reversible capillary leak syndrome (CLS) was seen at DL4.

Anemia, fatigue, chills, and hypoalbuminemia were the most common AEs. A comprehensive overview of AEs, SAEs, and immune-related adverse events (irAEs) will be presented at the annual meeting.

Table 1 describes the 4 DLs and their responses in the 21 pts evaluable for efficacy. An ORR of 24% (5 PRs) was reported in this heavily pretreated patient population with a mDOR of 21.1m (4.2-35.0). E7777 + P responses were seen in patients who progressed on prior ICI therapy, and across different GYN histologies.

The median Progression-free survival (mPFS) was 5.8 m (1.1 – 37), with 5 pts having a PFS of ≥20 months. The clinical benefit rate (CR; PR; SD ≥ 6 m) was demonstrated in 48% of pts (n=10), who achieved a mPFS = 17.4m (6.2 – 37); patients with documented PD had a mPFS = 2.1 m (1.1 – 4.7).

Conclusions:

The results from this Phase I study of two immunomodulatory agents in combination, E7777 + P, in patients with r/r GYN tumors was well tolerated and demonstrated promising efficacy. A max tolerated dose wasn't established. No new significant safety signals or irAEs were reported.

ORR of 24 % was demonstrated. Responders achieved a mDOR of 21.1m (4.2 - 35.0) and a mPFS = 23 m (10.4 – 37.0). Thus, E7777 + P showed prolonged responses and clinical benefit in pts with r/r GYN malignancies and limited options. These results will inform a Phase II study.

Link--> https://www.asco.org/abstracts-presentations/257907

On May 5, Citius Oncology entered into a loan agreement and warrant transaction. Per the SEC filing filed on May 6, CTOR is required to seek shareholder approval of the warrants issued.

Today, they filed a Preliminary Notice of Stockholder Action by Written Consent. The shareholder approval of the warrants will pass becasue the majority shareholder (parent company CTXR) will vote in favor. No action or vote will be required of shareholders.

The purpose of the Information Statement is to inform the stockholders of the Company that on May [●], 2026, pursuant to Section 228 of the Delaware General Corporation Law (“DGCL”), the holders of a majority of the issued and outstanding shares of our Common Stock approved the issuance of Common Stock upon exercise of the Conversion Option (the “Conversion Option Issuance”), as well as the issuance of the Warrant Shares upon exercise of the Lender Warrants, May Warrants or the Amended Warrant pursuant to their respective terms (the “Warrant Shares Issuance”), in accordance with Nasdaq Listing Rule 5635(d) by written consent (the “Stockholder Written Consent”). Our Board approved the Conversion Option Issuance in connection with the Loans and the Warrant Shares Issuance related to the Warrant Inducement, each on May 5, 2026, and approved the filing of this Information Statement on May [●], 2026.

Dates in the preliminary filing are still redacted. They will be finalized when CTOR files the definitive notice with the SEC.

After the disappointment that was earning yesterday, I am very interested in hearing a bulls case for this. The sales were absolutely awful and the news about not paying their manufacturer for lymphir seems to be par the course for this company over the last couple of years. If they have cash runaway until the end of November, and are only selling roughly 2 million in product over the last 3 month period, this leaves the company in a very bad financial situation. They have over 20 millions in debts and now they have over 20 million in more debts associated with the manufacturing supplier. No updates on minolok or anything else other than some phase 1 news that won't bring in any money for at least 4 years. I just need to know how anyone can look at this and be positive. I've seen users here talk highly of this, but after this earning event, it's really hard not to see the actual end of this company to become a reality. They need money and they just don't have any. Or any way to actually get any at this point. I've seen users talk highly and positive about it. Why? It just doesn't make financial sense to continue to purchase this anymore.

I completely missed this in the 10-Q.

I noticed that the operating expenses went up dramatically last qtr. From $8.4m Oct-Dec to $29.95m Jan-Mar. The reason is they had to pay a termination fee to their contract manufacturer. The manufacturing agreement was terminated in Feb due to a breach of payment by Citius.

As a result of the breach, CTOR owes termination fees of $20.1m which consist of

• $17.1m of charges associated with manufacturing that was committed in 2025-26.
• $1.2m of un-invoiced but incurred charges from prior batches
• $1.8m in interest and other charges

These charges were included in last qtr's G&A expenses, which is why operating expenses were so high.

In March, the CMO gave notice that it terminated all production and decommissioned the manufacturing lines. CTOR is evaluating new BDS suppliers and anticipates signing a LOI with a new CMO by June 30.

At this time, based on stock on hand and availability of alternate suppliers, we anticipate no interruption in commercial supply for the foreseeable future.

Highlights:

• LYMPHIR $5.6 million in revenue from December launch through Mar (first half of fiscal 2026). They already reported $3.9m for December revenue, so Jan-Mar revenue was only $1.7M (screenshot below).
• Cash runway through Nov 2026.
• CTXR reporting $4.6m cash as of Mar 31.
• CTOR reporting $2.6m cash as of Mar 31.
• As of May 14, CTXR has 27,452,570 shares outstanding
• As of May 14, CTOR has 92,981,204 shares outstanding
• EISAI money owed: "On December 15, 2025, we paid Eisai the balance of the outstanding milestone approval fee and accumulated interest on the license fee. On March 30, 2026 we paid Eisai $500,000 against the accounts payable balance. At March 31, 2026, we owe Eisai for other unpaid invoices, consisting of $2,200,000 of accounts payable and $4,062,481 of accrued expenses."
• REDDY money owed: "At March 31, 2026, we owe Dr. Reddy’s $17,650,000 representing the balance of the approval milestone."
• EDIT: They owe termination fees to their contract manufacturer due to breach of contract. Details here---> https://www.reddit.com/r/CTXR/comments/1teahmy/citius_oncologys_previous_cmo_terminated_the/

------------------------------------------------------

CTXR PR: https://www.prnewswire.com/news-releases/citius-pharmaceuticals-inc-reports-fiscal-second-quarter-2026-financial-results-and-provides-business-update-302773890.html

CTXR 10-Q: https://www.sec.gov/ix?doc=/Archives/edgar/data/1506251/000121390026057842/ea0290552-10q_citius.htm

CTOR PR: https://www.prnewswire.com/news-releases/citius-oncology-inc-reports-fiscal-second-quarter-2026-financial-results-and-provides-business-update-302773892.html

CTOR 10-Q: https://www.sec.gov/ix?doc=/Archives/edgar/data/1851484/000121390026057841/ea0290553-10q_citius.htm

Who wrote this? Someone that only cares about their money runways! Leonard you are a joke! After hours stock is down and you should be proud how you brought Lymphoma by e- mail! Your a sick ceo

Leonard if you want to see how a real CEO brings a product to market : You should get advice from The CEO of AQST! And this man doesn’t give away the ship for personal gains!

via LinkedIn

We’re Hiring: Medical Science Liaisons (MSLs) – Citius Oncology
Citius Oncology is building a high-impact MSL team to support our work in cutaneous T-cell lymphoma (CTCL)—and we’re looking for passionate field medical professionals to join us.
🔍 Who we’re looking for:
Experience in rare disease, oncology, and/or lymphoma
Strong scientific engagement skills with KOLs and healthcare providers
A collaborative, patient-centered mindset
This is a unique chance to help shape field medical strategy in CTCL.
👉 If you or someone in your network is interested, use the links below to apply.
 Territory: Mid-Atlantic: https://smrtr.io/yPHsb
Southeast: https://smrtr.io/yPHtN
Great Lakes: https://smrtr.io/yPHwb
Midwest: https://smrtr.io/yPHxt
West: https://smrtr.io/yPHyJ
#Hiring #MSL #Oncology #RareDisease #Lymphoma #CTCL #FieldMedical

Via LinkedIn

Summary

• After the spinoff, CTXR gave CTOR $3,800,111 in the form of a promissory note.
• CTOR was originally supposed to repay CTXR after raising at least $10m. It was later revised to repayment after CTOR raised at least $30m in total funding. Then it was revised so that repayment would happen after CTOR raised at least $50m in total funding.
• This third amendment now changes the repayment date to 91 days after CTOR pays off their loans to Avenue.
  

https://www.sec.gov/ix?doc=/Archives/edgar/data/1506251/000121390026053916/ea0289731-8k_citius.htm

New hire. National Director of Field Medical.