In addition to E-7777, it’s currently advancing three proprietary product candidates in total:
- CITI-002 (Halo-Lido), a topical formulation of halobetasol, a corticosteroid, and lidocaine to provide anti-inflammatory and anesthetic symptomatic relief to hemorrhoids victims. It is currently gearing up for a Phase IIb trial.
- CITI-101 (Mino-Wrap), a liquefying gel-based wrap containing minocycline and rifampin designed to provide inflammatory tissue protection and prevent infection and biofilm formation in tissue expanders and breast implants post-mastectomy. In December 2020, Citius received a written response and guidance from the USFDA for Mino-Wrap development. Citius expects to file for an IND by the end of this year.
- Mino-Lok, an antibiotic lock solution developed as adjunctive therapy for patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). If approved, Citius believes that Mino-Lok could enter a $1.5Bn worth market and prove to be a blockbuster without any immediate competition.
And right now, CTXR has 5 potential catalysts to soak in this second. Following along...
No. 1 CTXR Potential Catalyst - Could Multiple Triggered Technicals Signal Something Big On The Horizon?
I'm telling you right now... Don't discount CTXR's bullish technical indicators.
At close on Friday, CTXR was displaying several triggered technical indicators across the short, medium term, and long term.
Barchart was reporting these as triggered:
Short Term Indicators
- 20 Day Moving Average
- 20 - 50 Day MACD Oscillator
- 20 - 100 Day MACD Oscillator
- 20 - 200 Day MACD Oscillator
Medium Term Indicators
- 50 Day Moving Average
- 50 - 100 Day MACD Oscillator
- 50 - 150 Day MACD Oscillator
- 50-200 Day MACD Oscillator
Long Term Indicators
- 100 Day Moving Average
- 150 Day Moving Average
- 200 Day Moving Average
- 100 - 200 Day MACD Oscillator
The website also shares its all-important "Trend Seeker" composite indicator is triggered.
Watch these technicals closely this week.
No. 2 CTXR Potential Catalyst - A $10 Analyst Target Paints The Possibility For An Exceptionally Bright Future
Back in March, Jason Kolbert, an analyst with Dawson James Securities, reiterated a $10.00 target on CTXR.
That provides CTXR with a mind-blowing potential upside over 500% from Friday's close.
Here's some key highlights from the report:
Mino-Lok is approaching the finish line: Management did not update the number of catheter failure events but previously stated that they “expected to achieve 92 catheter failure events with 144 patients by the end of 2022”, and “We have now exceeded our targeted enrollment and have achieved 72 of the required catheter failure events” , “we anticipate that the 92-event threshold required to complete the trial is achievable in the coming months." We will look for an update on the trial enrollment soon.
ONTAK BLA Under Review. The U.S. Food and Drug Administration (FDA) is currently reviewing a biologics license application (BLA) for I/ONTAK and has set a targeted decision date (PDUFA) of July 28, 2023. As we have stated in the past, management is now planning to spin-out IONTAK into a new company and raise capital to support the product’s commercialization. Recall that Citius paid $40M upfront and has an obligation for $40M in milestones, and we assume a 10% royalty. Given the opportunity, combined with what we view as a low-risk therapeutic, we believe management can realize a significant return on its in-vest-ment.
Valuation. Our valuation is based on our therapeutic models and associated assumptions projected to 2028. The lead product, Mini-Lok, is now in a Phase 3 trial, as is E7777. We use a 30% risk rate in our free cash flow to the Firm (FCFF), our discounted EPS (dEPS), and sum-of-the-parts (SOP) models on top of a 15% risk rate in our therapeutic models for both products. We equal weight and average these metrics and then round to the nearest whole number to derive our $10.00 price target.
No. 3 CTXR Potential Catalyst - Halo-Lido Phase 2b Study Continues To Move Forward
Citius Pharmaceuticals Completes Enrollment in Phase 2b Study of Halo-Lido for the Prescription Treatment of Hemorrhoids
Topline Results anticipated by the end of Q2 2023CRANFORD, N.J., April 3, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) today announced that the last patient has been enrolled in the Company's Phase 2b clinical study of Halo-Lido (CITI-002), a topical formulation for the relief of hemorrhoids. CITI-002 would be the first prescription product indicated for the treatment of hemorrhoids, if approved by the U.S. Food and Drug Administration (FDA).
Approximately 300 adults with a clinical diagnosis of symptomatic hemorrhoids were enrolled in the Halo-Lido Phase 2b study (NCT05348200), a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial. The primary outcome of the study is the change in hemorrhoidal symptoms as reported by the patients following treatment. Efficacy and safety data are recorded by patients utilizing a proprietary mobile-enabled Patient Reported Outcome (ePRO) instrument. The results of the study are anticipated by the end of the second quarter of 2023 and are expected to provide the foundation for development of the Phase 3 study.
"The completion of the Phase 2b enrollment is an important milestone for Citius. We are hopeful that analysis of the study data will support further evaluation of the potential of CITI-002 to provide relief for hemorrhoid patients. We congratulate our clinical management team, our CRO staff and the principal investigators who helped us achieve this milestone in a timely fashion. The study was fully enrolled within one year from initiation. We continue to believe that the global market for a prescription topical treatment for hemorrhoids is large and underserved. Contingent on the trial data, we expect to continue to advance this program to maximize its value," stated Leonard Mazur, Executive Chairman of Citius.
Read the full article here.
No. 4 CTXR Potential Catalyst - Company Aims To Maximize Value Of I/ONTAK While Advancing Pipeline
Citius Pharmaceuticals Advances Efforts to Spin Off Oncology Asset, I/ONTAK, into a Standalone Public Company
CRANFORD, N.J., March 30, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) , a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that Maxim Group LLC will serve as fi-nan-cial advisor to its wholly-owned subsidiary, Citius Acquisition Corp. Inc., in connection with the intended formation of a separate publicly-traded entity to commercialize and grow Citius' oncology asset, I/ONTAK. The U.S. Food and Drug Administration (FDA) is currently reviewing a biologics license application (BLA) for I/ONTAK and has set a targeted decision date (PDUFA) of July 28, 2023.
"Citius is committed to maximizing the value of I/ONTAK and advancing our pipeline. Maxim Group has a strong track record of executing strategic and fi-nan-cial transactions in the life science sector, and we look forward to working closely with them to optimize the structure and timing of contemplated I/ONTAK transactions," stated Leonard Mazur, Chairman and CEO of Citius.
Any transactions would be subject to the satisfaction of customary conditions, including final approval from the Citius Board of Directors, regulatory approvals, and SEC filings. Upon closing of the transactions, Citius would continue to trade on the Nasdaq exchange under its current ticker CTXR.
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation, or sale in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction. There can be no assurance regarding the ultimate timing of proposed transactions or that the transactions will be completed at all.
Read the full article here.
No. 5 CTXR Potential Catalyst - Corporate Update Provides Glimpse Of How Big 2023 Could Be For CTXR
Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2022 Fi-nan-cial Results and Provides Business Update
$41.7Mn in cash and cash equivalents as of September 30, 2022; extends runway through December 2023
Mino-Lok® Phase 3 trial closer to completion with 169 patients recruited, 72 failure events and 17 patients in active treatment or pending data review
I/ONTAK BLA accepted for filing by the FDA; updated PDUFA target action date is July 28, 2023
Halo-Lido Phase 2b trial progressed; data readout expected 2H 2023
Multiple value-driving catalysts anticipated in 2023, including a potential drug approval and two trial completions
CRANFORD, N.J., Dec. 22, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and fi-nan-cial results for the fiscal full year ended September 30, 2022.
Fiscal Full Year 2022 Business Highlights and Subsequent Developments
- Completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA);
- FDA confirmed Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2023;
- Advanced Mino-Lok® Phase 3 trial;
- Initiated Phase 2b trial of Halo-Lido for the treatment of hemorrhoids in April 2022; patient enrollment ongoing with data readout expected 2H 2023;
- Initiated clinical collaboration with the University of Pittsburgh to evaluate regulatory T-cell (T-reg) depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid cancer tumors in a Phase 1 investigator-initiated trial, with first patient enrolled in November 2022; and,
- Approved for $3.6Mn in non-dilutive capital through the New Jersey Economic Development Program to support ongoing research and development efforts.
Read the full article here.
CTXR Recap - 5 Key Potential Catalysts For This Nasdaq Past Champ
No. 1 - Could Multiple Triggered Technicals Signal Something Big On The Horizon?
No. 2 - A $10 Analyst Target Paints The Possibility For An Exceptionally Bright Future
No. 3 - Halo-Lido Phase 2b Study Continues To Move Forward
No. 4 - Company Aims To Maximize Value Of I/ONTAK While Advancing Pipeline
No. 5 - Corporate Update Provides Glimpse Of How Big 2023 Could Be For CTXR
Coverage is officially reinitiated on CTXR. When you have time later, do this: