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 4 potential catalysts to soak in this second. Following along...
No. 1 CTXR Potential Catalyst - A $10 Analyst Target Paints The Possibility For An Exceptionally Bright Future
Back in December, Jason Kolbert, an analyst with Dawson James Securities, tagged CTXR with a $10.00 target.
That provides CTXR with a mind-blowing potential upside over 650% from Wednesday's close.
Here's some key highlights from the report:
Mino-Lok is approaching the finish line: Management stated in the press release: “we 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 view this as positive and representing the key catalyst for the stock to appreciate.
ONTAK Too. We also take note that management highlighted a July PDUFA date for ONTAK. We believe this sets the stage for the company to spin-out and then raise capital for NEWCO to support the drug's commercialization. This should translate into the company unlocking the value around the product's original acquisition (Citius paid $40M upfront and has an obligation for $40M in milestones, and we assume a 10% royalty).
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. 2 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.
No. 3 CTXR Potential Catalyst - FDA Accepts Company's BLA For E7777, Target Action Date For PDUFA In September
Citius Pharmaceuticals, Inc. Announces U.S. Food and Drug Administration Acceptance of Biologics License Application of Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma
Prescription Drug User Fee Act (PDUFA) target action date is September 28, 2023
CRANFORD, N.J., Dec. 1, 2022 /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 the U.S. Food and Drug Administration (FDA) has accepted the Company's Biologics License Application (BLA) for denileukin diftitox ("I/ONTAK" or "E7777"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK®. The PDUFA target action date is September 28, 2023. The BLA is supported by a pivotal Phase 3 study (NCT01871727).
"The acceptance of the previously announced BLA submission for I/ONTAK is another important regulatory milestone for our oncology program. With an anticipated PDUFA date of September 28, 2023, we look forward to the potential approval of this therapeutic for patients with persistent or recurrent cutaneous T-cell lymphoma, a rare disease for which patients with advanced disease have limited treatment options," stated Leonard Mazur, Chairman and CEO of Citius.
Read the full article here.
No. 4 CTXR Potential Catalyst - Trading Above Key Support Lines Could Mean Big Things Ahead Near Term
Take a look at CTXR's 6-month chart real quick: