Full Press Release Details
LETTER TO SHAREHOLDERS
Dear Fellow Shareholders,
Citius Pharmaceuticals, Inc. ("Company")
has made considerable progress in 2020 with recent developments designed to contribute to increased value for our shareholders.
Additionally, there are many upcoming milestones that could be catalysts for further acceleration to corporate advancement.
Our Mino-Lok product, which is a
project with MD Anderson Cancer Center that is in Phase 3, is in our opinion well positioned for entry into a $1.5 billion market
and has the potential to save the lives of many critical care patients. Our second project with MD Anderson Cancer Center is the
development of Mino-Wrap, which is a novel approach to dramatically reduce the rate of infection in post-mastectomy patients
who elect to undergo reconstructive breast surgery. We believe that this serious condition affects about 100,000 women in the U.S.
and many more in the rest of the world.
Our Halo-Lido product has an addressable
market of more than $2 billion. Based on National Institutes of Health reports, hemorrhoids affect approximately 12.5 million adults
in the U.S. (approximately 5% of the adult U.S. population). Halo-Lido could be the first prescription medication approved by FDA
for hemorrhoids and is moving toward its Phase 2b trial.
We recently executed our option from Novellus
Therapeutics Limited and licensed a very significant cellular therapy to treat acute respiratory distress syndrome (ARDS). ARDS
is devastating in its own right but it is also a major complication of the SARS-CoV-2 viral infection (COVID-19) and has led to
the majority of COVID-19 patient deaths. Combined, all these positive events demonstrate the value creation we are building for
While the COVID-19 pandemic has affected
the patient recruitment in almost all clinical trials, including our own, the Company continues to make progress. Recently we had
our second interim analysis and report from the independent Drug Monitoring Committee (DMC) for the Mino-Lok pivotal Phase 3 trial.
We will soon reach the 75% point (event-based end point) in the trial, when the DMC and the Company could decide to stop the trial
and file the NDA (New Drug Application). For Mino-Wrap, we have submitted a pre-investigational new drug (PIND) consultation request,
have been issued an IND (Investigational New Drug) number, and expect a written response and guidance from the FDA in November
2020. For Halo-Lido, we have completed our patient survey to develop a patient reported outcome (PRO) instrument and plan to initiate
a Phase 2b trial in the first quarter of 2021.
| 11 Commerce Drive | www.citiuspharma.com |
| First Floor | |
| Cranford, NJ 07016 |
Stem-Cell Therapy for ARDS Due
to COVID-19 - We Licensed a Promising Novel Therapy from Novellus Therapeutics Limited
On October 7, we announced that we signed
an exclusive worldwide licensing agreement with Novellus Therapeutics Limited, to in-license second-generation cellular therapy
for acute inflammatory respiratory conditions including COVID-related acute respiratory distress syndrome (ARDS).
This technology is based on a unique and
patented approach of engineering mesenchymal stem cells (MSCs) from an induced pluripotent stem cell (iPSC) bank. We call these
cells induced mesenchymal stem cells (iMSCs). The starting point in this semi-synthetic process is a patented,
non-immunogenic, mRNA gene programming and editing procedure to create mutation-free, extensively characterized iPSCs that provide
an unlimited source of pristine MSCs. Currently, donor-derived MSCs are sourced from human bone marrow, adipose tissue, placenta,
umbilical tissue, etc. and have significant challenges; e.g., variable donor and tissue sources, limited supply, low potency, and
inefficient and expensive manufacturing processes. Our iMSCs overcome these challenges because they:
ARDS patients experience widespread inflammation
in the lungs and symptoms of shortness of breath, rapid breathing and heart rate, chest pain (especially while inhaling), and bluish
skin coloration. As you may know, ARDS is the most common cause of respiratory failure and mortality in COVID-19 patients, with
a 30-50% mortality rate. The pandemic has increased the ARDS population well beyond the baseline of 200,000 patients. There is
no currently approved drug therapy available, and mechanical ventilation and supportive care measures are typically used in the
most difficult cases of COVID-related ARDS.
We are currently conducting a proof-of-concept
large-animal ARDS study with promising results thus far. We have submitted a PIND to the FDA and have received their guidance and
feedback to our development plans.
Mino-Lok (FDA Phase III)
- Interim Data Analysis Update
our lead product, is an antibiotic lock solution for use in treating catheter-related bloodstream infections (CRBSIs). We recently
held an independent Data Monitoring Committee (DMC) meeting to review data and evaluate the progress of the trial. The DMC reported
to the Company that there were no safety concerns, and all the endpoints were being met to continue with the trial. Following
the ad-hoc meeting, the DMC recommended that another interim analysis was warranted, and encouraged us to determine if the trial
will meet the interim superiority threshold at 69 events, and therefore be able to be halted earlier than anticipated. It is difficult
to predict the further impact of the pandemic on the recruitment of patients in the trial; however, we expect that the trial will
make significant progress through the first half of 2021.
The antibiotic lock therapy is greater
than a $750 million annual market in the U.S. and is expected to reach $1.84 billion worldwide by 2028. We also believe Mino-Lok
may help eliminate as many as 500,000 procedures each year to remove and replace infected central venous catheters (CVCs), reducing
patient discomfort and saving large amounts of money throughout the healthcare system. We are not aware of any competitive products
in development to treat and salvage indwelling, infected CVCs. Our company has worldwide rights to this technology and will have
more than 10 years of exclusivity at the time of anticipated launch, which is estimated to be in 2022.
| 11 Commerce Drive | www.citiuspharma.com |
| First Floor | |
| Cranford, NJ 07016 |
- Post-Mastectomy Infection Prevention, a $400 Million Market Opportunity
Mino-Wrap is a bio-absorbable, antimicrobial
semi-solid gel that is wrapped around a tissue expander and placed in the surgical pocket following a mastectomy to prevent post-surgical
infections. Once installed, Mino-Wrap slowly liquefies in situ for a specified period of time, providing extended protection
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.
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 life-saving chemo-radiation therapy, which can be a devastating consequence for the patient,
and can also lead to a delay in permanent breast implantation. The market for Mino-Wrap in preventing infections following breast
implant surgeries following mastectomies is estimated to be $400 million.
pre-investigational new drug (PIND) consultation request with the FDA. They assigned an IND number, which is a positive sign.
The next step is for us to receive written comments from the FDA in November 2020, in which they will respond to our
questions and provide direction about the clinical development program that we submitted.
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.
Halo-Lido - Aiming to Be
the First FDA-Approved Prescription Product to Treat Hemorrhoids in the U.S.
Halo-Lido is targeted to the symptomatic
relief of hemorrhoidal symptoms and combines the high-potency steroid halobetasol with lidocaine. Based on results of previous
clinical work, we selected a gel formulation combining the potent steroid halobetasol propionate and lidocaine HCl to move forward
in clinical development. The manufacturing scale-up is complete and the formulation has met chemical, physical, and stability criteria.
This formulation will be used in a Phase 2b study expected to start in the first quarter of 2021.
Most importantly, we have just completed
a rigorous study of the severity and impact of symptoms of Grade 2 and 3 hemorrhoids in order to create a patient reported outcome
(PRO) instrument. We are preparing for our Phase 2b trial to test our new formulation and validate the PRO. This innovative trial
will use hand-held devices specifically programmed to record patient diaries in electronic form, which should improve the quality
of the data and the speed with which they are processed.
Over 10 million patients in the U.S. admit
to symptoms of hemorrhoidal disease, and one-third of them seek physician treatment, yet there are no FDA-approved prescription
products available. Over-the-counter hemorrhoid product sales are approximately 20 million units annually, equivalent to an annual
$2 billion market. Our formulation, if approved, would be the first prescription product to treat hemorrhoids approved by the FDA
While there are some commonly used prescription
products, none have been reviewed or approved by the FDA because they entered the market prior to 1962, and are considered Drug