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Citius Corporate Update November 2019 Dear Investors: Citius Pharmaceuticals, Inc. ("Company") has had a very productive and encouraging quarter. On

Key Takeaway: Citius Corporate Update Citius Pharmaceuticals, Inc. ("Company") has had a very productive and encouraging quarter. We are currently advancing three proprietary product candidates into large markets that are underserved by the current standards of care: Mino-Lok (FDA Phase I

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Citius Corporate Update
Citius Pharmaceuticals, Inc. ("Company")
has had a very productive and encouraging quarter.
We are currently advancing three proprietary
product candidates into large markets that are underserved by the current standards of care:
Mino-Lok (FDA Phase III)
- Very Positive Progress, Reached the Interim Analysis, Change in End Point, Substantial Savings in Clinical Trial Costs
Following a series of discussions with
the FDA regarding the Mino-Lok trial, we recently announced a change in the pivotal study's primary endpoint to the agreed-upon
"time to catheter failure." This change in study design substantially reduced the required sample size of the trial
from 700 subjects to approximately 144 evaluable subjects to achieve the pre-specified 92 catheter failure events needed to conclude
Citius Pharmaceuticals, Inc. Tel: (908) 967-6677
11 Commerce Drive, First Floor Email: info@citiuspharma.com
Cranford, NJ 07016
It is believed that the median time to
catheter failure for the antibiotic lock therapy ("ALT") arm, or the control arm in the trial, is estimated to be 21
days, based on our evaluation of the applicable published studies. The median time to catheter failure for the Mino-Lok therapy
("MLT") arm is expected to be greater than 38 days. Allowing these subjects to keep the catheter for 21 days or longer
is clinically meaningful, as it eliminates the need for patients to undergo often painful removal and replacement procedures of
CVCs. Replacement procedures of CVCs are inherently costly and risky, given the typically high-risk patient population being treated.
Importantly, patients would have continuous venous access for therapy for their underlying disease, and this would represent a
major step forward in the treatment of CRBSIs.
In addition to the significant reduction
in patients now required to complete the trial, the new trial protocol also incorporates two interim analyses, a futility analysis
and a superiority analysis. We recently announced that we reached the first interim analysis of the trial, the futility analysis.
The trial data is being gathered, analyzed, and sent to our drug monitoring committee ("DMC"), composed of three independent
experts and an unblinded statistician, for the standard futility analysis. The outcome of the futility analysis is expected by
Management is confident that Mino-Lok has
$750+ million/year potential in the U.S. market and at least that in the rest of the world, bringing worldwide market potential
to $1.5+ billion/year. We feel there is tremendous value in the Company's assets and commercial outlook, as witnessed by
our repeated investments in each financing round and our total investment of nearly $27 million to date.
Citius Pharmaceuticals, Inc. Tel: (908) 967-6677
11 Commerce Drive, First Floor Email: info@citiuspharma.com
Cranford, NJ 07016
Post-Mastectomy Infection Prevention, Unmet Need, Jurisdictional Status Determined, Preparations for Pre-IND Meeting
The reported rate of tissue expander-related
infections is between 2.5% and 24%, depending on the extent of surgery, duration of post-operative drainage, and many other factors.
Our own research suggests that the post-mastectomy infection rate is approximately 14% even when following the standard prophylaxis
protocol. Once the tissue expander becomes infected, the patient is hospitalized, and the tissue expander may need to be removed.
These serious infections may lead to a delay in lifesaving chemo-radiation therapy, which can be a devastating consequence for
Mino-Wrap is designed to allow the temporary
tissue expander to be inflated without any restrictions and to prevent infection and biofilm formation surrounding the tissue expander
over a longer duration than that from the current treatment regimen. Mino-Wrap could also be used with breast implants during reconstruction
following removal of the tissue expander.
Conclusions from the pre-clinical work
with Mino-Wrap are as follows:
Essentially, we believe that Mino-Wrap
has the characteristics necessary for an advance in the protection of human implants from subsequent infection.
Citius Pharmaceuticals, Inc. Tel: (908) 967-6677
11 Commerce Drive, First Floor Email: info@citiuspharma.com
Cranford, NJ 07016
In late June 2019, the FDA determined that
Mino-Wrap is considered a drug, not a medical device, due to its perceived antibacterial benefits, and will be reviewed by the
FDA's Center for Drug Evaluation and Research ("CDER") division. The Company has begun to prepare for a pre-IND
meeting with the FDA, which we expect to occur in early 2020.
Halo-Lido - Reformulated,
Vasoconstrictor Assay Completed
The Company initiated a program to develop
a topical formulation containing a corticosteroid and topical anesthetic to treat symptoms of hemorrhoids. We initially selected
a combination of hydrocortisone acetate, a low-potency steroid, and lidocaine hydrochloride, a well-characterized topical anesthetic,
as our lead formulation. The Company collected valuable data from the Phase II study to modify and further develop the program.
Specifically, we concluded that, compared to hydrocortisone, a higher potency steroid would contribute higher efficacy in combination
with lidocaine hydrochloride.
We subsequently selected halobetasol propionate,
a highly potent steroid, and have reformulated combinations of lidocaine hydrochloride and halobetasol propionate. Several clinical
formulations were successfully manufactured at a 20-kg scale under Good Manufacturing Practice ("GMP") conditions.
Additionally, the specifications and analytical procedures used to release the product and assess stability have been developed
After testing various formulations in
vitro, we selected two formulations for an in vivo study in healthy volunteers to assess their vasoconstrictive properties
and compare them to commercially available formulations. Dosing has been completed, and there were no serious adverse events reported
in any tested formulation. We will use the results from this study to select one formulation and expect to initiate an acute toxicology
study by year-end before initiating a planned expanded Phase II study in 2020.
Other Corporate Activities -
Industry Events and Investor Outreach
In early October, the Company held an in-person
Scientific Advisory Board ("SAB") meeting where we were fortunate to gain strategic insight from our SAB members, who
are leaders in the field of infectious disease. Their guidance will be pivotal as we continue to advance our Mino-Lok Phase III
trial along with plans for the development of Mino-Wrap.
In early October, we also held an investigator
meeting where an update on the Mino-Lok trial was provided to a set of principal investigators and their staff. The consensus
of the attendees confirms the Company's belief that Mino-Lok therapy has the potential to change the standard of care and
would be a welcome addition for the adjunctive treatment of CRBSIs.
We continue an aggressive investor outreach
campaign. In the fourth quarter of 2019, we attended or plan on attending the H.C. Wainwright, Dawson James, BioFlorida, and LD
Microcap conferences. Additionally, we often meet with microcap and/or healthcare investors at roadshows and luncheons in a number
of cities, including New York, Boston, Philadelphia, and West Palm Beach.
Citius Pharmaceuticals, Inc. Tel: (908) 967-6677
11 Commerce Drive, First Floor Email: info@citiuspharma.com
Cranford, NJ 07016
disclosed that the Company no longer complies with the $1.00 minimum bid price requirement for continued listing on the Nasdaq
Capital Market. Importantly, this noncompliance has no immediate effect on the listing or trading of the Company's common
stock. We have until April 27, 2020 to regain compliance with the minimum bid price requirement and intend to consider all available
alternatives that would allow for continued listing of the common stock on the Nasdaq Capital Market.
Moving Forward into Fiscal Year
Looking ahead, we view our corporate road
map with a renewed sense of confidence. In the coming months, our primary focus will be on Mino-Lok and finalizing the futility
analysis from the pivotal trial, reaching the second interim analysis (testing for the superiority) in the trial, and successfully
concluding the trial. These are key milestones for the Company, and we are quite eager to reach them.
Management has conviction in our strategy
and assets and has expressed such with our repeated financial commitment to invest tens of millions of dollars alongside our investors.
We are extremely excited about our Mino-Lok pivotal trial, especially now that we are reaching important clinical milestone events.
We believe that we clearly see the light at the end of the tunnel.
On behalf of the Citius Pharmaceutical
team, we thank you for your continued support and look forward to developing breakthrough technologies that will significantly
enhance and improve the lives of patients.
Chief Executive Officer, President, and
Chairman of the Board
This communication may contain "forward-looking statements" within the meaning of Section 27A of the Securities
Last updated: Nov 5, 2019