Tuesday Update: Key Details On Nasdaq Profile (CTXR)
Maxim Group - $4.00 Price Target
CTXR put together a very nice Monday.
Trending green all day, CTXR may be in the throes of a healthy reversal near term.
The potential catalyst that could be kicking off such a move dropped yesterday right before the morning's opening bell.
That potential catalyst is major P3 news. Check it out:
Citius Pharmaceuticals Completes Enrollment in the Pivotal Phase 3 Study of its Cancer Immunotherapy I/ONTAK for the Treatment of Cutaneous T-Cell Lymphoma
When the day was all said and done, CTXR still had several technicals indicators that were leaning towards oversold which means yesterday may be just the start of something big.
Could we see CTXR attempt to run down previous highs?
At close Monday, CTXR was trading above its 5-Day Simple Moving Average which signals this profile has been trending up in recent days.
Take a second and read my initial report below and get CTXR on your radar.
*Citius Pharmaceuticals, Inc. (CTXR)*
Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care.
Now, pay close attention...
I brought this profile to your attention back on the morning of April 19th. That day, CTXR opened at $1.99. Fast-forward to June 22nd and CTXR had raced to a high of $4.56.
With that $2.00+ move, CTXR crushed a chart blazing run of approximately 129%.
Now, here's where things get interesting...
CTXR And Its 2 "De-Risked" Phase 3 Lead Assets
Antibiotic lock therapy for salvaging catheters that cause bloodstream infections
Mino-Lok® is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) and central line associated bloodstream infections (CLABSIs). CRBSIs/CLABSIs are life-threatening conditions, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge.
Mino-Lok® is intended to salvage the CVC, avoiding the need to remove and replace the infected catheter. Currently, there are few alternatives to removing and replacing a CVC once it becomes infected. Studies show that removal and reinsertion of CVCs have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture. Mino-Lok® is being developed to address the complications, discomfort and cost of CVC removal and replacement. There are currently no FDA-approved products to salvage infected CVCs.
- Mino-Lok® is the first & only therapy under investigation to salvage infected CVCs.
- A multicenter Phase 3 pivotal superiority trial is currently underway.
- Mino-Lok® was granted QIDP and Fast Track designation by the FDA and has patent protection through 2024 and formulation patent protection through 2036.
- Citius licensed the worldwide rights to Mino-Lok® from The University of Texas MD Anderson Cancer Center.
How it works
Mino-Lok® contains a proprietary combination of minocycline, edetate (disodium EDTA), and ethyl alcohol, all of which act synergistically to break down bacterial biofilms, eradicate the bacteria, provide anti-clotting properties to maintain patency in CVCs, and salvage the indwelling catheter. Mino-Lok® is used in two-hour locking cycles, allowing the CVC to be used for its intended purposes for the remaining 22 hours each day.
CTXR Lead Asset #2
I/ONTAK (E7777). Citius’ other lead asset, I/ONTAK, is an IL-2 recombinant fusion protein for the treatment of advanced or refractory CTCL. As was the case with the old ONTAK, I/ONTAK binds to IL-2 receptors to deliver the diphtheria toxin into tumor cells expressing the CD25 high affinity receptor. Diphtheria toxin is an exotoxin, the pathogenic bacterium Corynebacterium diphtheriae known to cause diphtheria. Unlike the old ONTAK, I/ONTAK is a purified reformulation that removed the manufacturing contaminant, thus resolving the misfolded protein issue. I/ONTAK maintains the same amino acid sequence of ONTAK but features markedly improved purity and 1.5x-2x greater bioactivity; all while maintaining the safety and efficacy profile of ONTAK that physicians viewed favorably.
Mechanism of Action. Much like the old ONTAK, I/ONTAK is a fusion protein designed to direct the cytocidal action of diphtheria toxin to cells that express the IL-2 receptor. After binding to the IL-2 receptor on the tumor cell surface, I/ONTAK is internalized by receptormediated endocytosis. The fusion protein is subsequently cleaved, releasing diphtheria toxin from the IL-2 fragment, in turn inhibiting protein synthesis and causing cell death.
Clinical Development. Two clinical studies for I/ONTAK(E7777) have been completed, both in Japan. A Phase 1 study in N= 13 patients with relapsed of refractory CTCL and PTCL evaluated doses of 6, 12, and 9g/kg/day IV on 5 consecutive days per 21-day cycle. The maximum tolerated and recommended dose of E7777 was 9mcg/kg/d IV for five consecutive days per 21-day cycle. Overall, safety was well tolerated. The next study completed was a multi-center, open-label, single-arm Phase 2 study for relapsed of refractory CTC and PTCL. N= 19 in CTCL patients and N=17 in PTCL patients. The efficacy of the drug was evaluated in N=36 of patients with CTCL or PTCL, and safety was evaluated in N=37 patients. E7777 was administered 9mcg/kg/d IV for 5 consecutive days for a 21-day cycle of up to 8 cycles. The study achieved the primary endpoint with ORR of 31.6% (n=19) for CTCL, and ORR of 41.2% (n=17) for PTCL. The most common adverse events (AEs) were increased aspartate aminotransferase (AST), alanine aminotransferase (ALT), hypoalbuminemia, lymphopenia, and pyrexia.
Phase 3 Trial Design. The trial design is multicenter, open-label single-arm study in patients with relapsed or refractory CTCL. The lead in study, N= 21 patients found optimal dosing to be 9mcg/kg/d administered intravenously. Data from the lead in were encouraging, with an objective response rate (ORR) of 38% in the ITT population. Given the previous data from the old ONTAK and E7777 in Japan, which have demonstrated response rates of mid-high 30% and a favorable safety profile, we consider the trial to be de-risked and see favorable odds of success for the primary endpoint of ORR. The primary end point for the pivot is ORR. The trial initiated in 2Q16 and is expected to report top-line data in 1H22.
More key details and sources here.
And with these two potential lead assets nearing possible commercialization, CTXR may not fly under Wall Street's radar for much longer.
But if you're looking at what could be more immediate term potential catalysts, take these in:
No. 1 CTXR Potential Catalyst - Analyst Coverage With Major P.T.
Maxim Group - $4.00 Price Target
Here is part of the summary from the November 30th Maxim Group analyst report:
- Citius Pharmaceuticals is a late-stage company with two 'de-risked' P3 assets: Mino-Lok in catheter-related bloodstream infection (CRBSI) and I/ONTAK in cutaneous T-cell lymphoma (CTCL).
- Mino-Lok is currently in P3 with a readout expected in C1H22 and an NDA to follow. The dr-ug itself has demonstrated 100% clearance of infection-causing biofilms in P2b and has the potential to salvage catheters, avoiding a $10K remove and replace procedure.
- Conclusion. With ~$70M in cash, Citius is funded through pivotal readouts in C1H22, which represent potentially transformative catalysts, in our view. Both assets address areas of high unmet need, and have commercial synergies due to a shared target customer (oncology). With prior data supporting I/ONTAK and Mino-Lok, we consider the risk/reward profile favorable.
From Friday's close, this $4.00 price target provides upside potential over 100%.
Now, I'm not saying CTXR is going to go soaring to $4.00 today, but you need to be aware of this analyst provided potential upside.
No. 2 CTXR Potential Catalyst - Oversold Leaning Technicals, Bounce Potential
As of close on Friday, Barchart was reporting this profile to have several oversold leaning technicals.
These technicals could be signaling a healthy reversal in the near term for CTXR.
Here's the definition of a "reversal" from Investopedia:
"A reversal is a change in the price direction of an asset. A reversal can occur to the upside or downside. Following an uptrend, a reversal would be to the downside. Following a downtrend, a reversal would be to the upside. Reversals are based on overall price direction and are not typically based on one or two periods/bars on a chart."
Now, here are some key technicals (as of close Friday) that could signal CTXR to be leaning oversold and on the verge of a potential reversal.
- 9-Day Relative Strength Index: 23.72%
- 14-Day Relative Strength Index: 27.32%
When these numbers drop down to the 30% range and lower, they can be viewed as being in oversold territory. While in this territory, they can paint the picture of a profile that is undervalued.
- 14-Day Raw Stochastic: 2.94%
- 14-Day Williams %R: 97.06%
As the Raw Stochastic nears the 10% range and lower and the Williams %R nears the 90% range or higher, these technical indicators may also be viewed as oversold and undervalued.
Keep an eye on these technicals closely.
No. 3 CTXR Potential Catalyst - Reporting Of Major Institutional Buying
Over at WhaleWisdom, some interesting developments have been reported over the last 30 days.
Here's a quick breakdown:
(1.) Wells Fargo & Company added a big time position to their portfolio.
Reported on 11/15/21, the company purchased approximately 6.44K+ shares at a market value of approximately $1.31Mn.
(2.) American in-vestment ad-visor, Vanguard Group, added to their position with a purchase of approximately 125K shares (approx. 5.77Mn overall) as reported on 11/12/21.
(3.) Also adding to their position was in-vestment management company, BlackRock Inc., who further increased their totals to an amount of approx. 8.15Mn shares (reported on 11/9/21).
Don't think twice about this. This is huge news and only the tip of the iceberg.
Just take a look at WhaleWisdom's site and you'll see how many different institutions are taking positions in CTXR.
Could it be that these institutions see a big future for this Nasdaq profile?
No. 4 CTXR Potential Catalyst - Experienced Hire Could Add Serious Value To Company
Citius Pharmaceuticals Expands Management Team with Appointment of Kelly Creighton, PhD as Executive Vice President of Chemistry, Manufacturing and Controls
CRANFORD, N.J., Nov. 5, 2021 /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 with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, today announced the appointment of pharmaceutical industry veteran Kelly Creighton, PhD as Executive Vice President of Chemistry, Manufacturing and Controls (CMC). Mr. Creighton will be responsible for the global strategic regulatory and manufacturing development plans for Citius's five pipeline programs.
Read the full article here.
No. 5 CTXR Potential Catalyst - Company Being Added To Russell 2000® Index
Citius Pharmaceuticals to be Added to Russell 2000® Index
CRANFORD, N.J., June 7, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today announced that it is set to be added to the Russell 2000® Index at the conclusion of the Russell US Indexes annual reconstitution, effective at the opening of the U.S. equity markets on June 28, 2021.
"Our inclusion in the Russell index is an important milestone for Citius that reflects the continued progress we are making to develop and commercialize first-in-class treatment options for patients around the world. We welcome the enhanced visibility of our diversified pipeline and long-term growth potential, and look forward to sharing our future milestones with a broader investment community," said Myron Holubiak, President and Chief Executive Officer of Citius.
FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes. Membership in the small-cap Russell 2000® Index, which remains in place for one year, is based on membership in the broad-market Russell 3000® Index. Citius st-ock will also be automatically added to the appropriate growth and value indexes.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9Tn in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.
Read the full article here.
CTXR Recap: Top 5 Potential Breakout Driver Indicators
No. 1 - Analyst Coverage With Major $4.00 P.T.
No. 2 - Oversold Leaning Technicals, Bounce Potential
No. 3 - Reporting Of Significant Institutional Buying
No. 4 - Experienced Hire Could Add Serious Value To Company
No. 5 - Company Being Added To Russell 2000® Index
Coverage is officially reinitiated on CTXR. Also, when you have a moment later on, do this: