Citius Pharmaceuticals Inc (CTXR) |
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Price: $0.4115
$0.03
7.666%
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Day's High:
| $0.441
| Week Perf:
| 17.91 %
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Day's Low: |
$ 0.39 |
30 Day Perf: |
2.85 % |
Volume (M): |
2,426 |
52 Wk High: |
$ 1.07 |
Volume (M$): |
$ 998 |
52 Wk Avg: |
$0.68 |
Open: |
$0.42 |
52 Wk Low: |
$0.31 |
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Market Capitalization (Millions $) |
72 |
Shares
Outstanding (Millions) |
174 |
Employees |
1 |
Revenues (TTM) (Millions $) |
- |
Net Income (TTM) (Millions $) |
-40 |
Cash Flow (TTM) (Millions $) |
-15 |
Capital Exp. (TTM) (Millions $) |
0 |
Citius Pharmaceuticals Inc
The Company was formed in the state of Nevada on September 9, 2010 as Trail
One, Inc. On September 12, 2014, we entered into a Share Exchange and Reorganization
Agreement (the "Exchange Agreement"), among Trail One, Inc., Citius
Pharmaceuticals, LLC, a Massachusetts limited liability company ("Citius"),
and the beneficial holders of the membership interests of Citius (the "Citius
Stockholders"). On September 12, 2014, Trail One, Inc. had no assets, no
liabilities, and 5,000,000 shares of issued and outstanding common stock.
Pursuant to the Exchange Agreement, (i) Trail One, Inc. issued 21,625,219 shares
of common stock to the Citius Stockholders, which represented approximately
72.0% of the outstanding shares of common stock following the closing of the
Exchange Agreement (the "Reverse Acquisition") and the first closing
of the Private Offering described below. The Trail One, Inc. existing shareholders
before the Reverse Acquisition and the first closing of the Private Offering
owned 5,000,000 shares of common stock or 16.7% of the outstanding shares of
common stock following the closing of the Exchange Agreement.
Citius Pharmaceuticals, LLC, founded on January 23, 2007 as a Massachusetts
limited liability company is a specialty pharmaceutical company dedicated to
the development and commercialization of therapeutic products for large and
growing markets using innovative, patented or proprietary formulations and modified
drug delivery technology. We seek new and expanded indications for previously
approved pharmaceutical products as a means to achieving differentiated market
positions or market exclusivity. Our goal is to build a successful pharmaceutical
company through the development and commercialization of low-risk, innovative,
efficacious and cost-effective products that address compelling market opportunities.
4
We seek to achieve our business objectives by utilizing the U.S. Food and Drug
Administrations, or FDAs, 505(b)(2) pathway for our new drug approvals. We
believe this pathway is faster, has lower risk and is less expensive than the
FDAs traditional new drug approval pathway. Although this pathway is less risky
and less expensive compared to developing newly discovered drugs, we believe
that development, clinical trials and FDA filing fees for our hydrocortisone
and lidocaine combination product will require $20 million of additional capital.
Following the Companys year-end and the release of its financial statements,
the Companys Chief Executive Officer and President, Leonard Mazur, anticipates
meeting with investment banking firms and certain other investors to raise additional
capital to fund the Companys research and development efforts; however, there
can be no assurance that the Company will be able to obtain financing or anticipate
the terms of such financing. In addition to focusing on new drug approvals,
we focus on obtaining intellectual property protection with the objective of
listing relevant patents in the FDA Orange Book in order to limit generic competition.
By using previously approved drugs with substantial safety and efficacy data
already available, we seek to reduce the risks associated with pharmaceutical
product development. We have already successfully employed this strategy to
obtain FDA approval for Suprenza, our approved and marketed product for the
treatment of obesity. We also plan to utilize this strategy to seek approval
for other new drug product candidates for obesity. We also have a development
candidate completing Phase 2 trials for the treatment of hemorrhoids. In addition,
we are developing a topical cream product containing both hydrocortisone and
lidocaine for the treatment of mild to moderate hemorrhoids. We have recently
completed dosing 200 patients with the topical cream product in a Phase 2a study
and are waiting for results from that study. If our Phase 2a study is positive,
we will conduct a Phase 2b study followed by Phase 3 studies. We will conduct
additional non-clinical and human safety studies to support our New Drug Application
("NDA"). If all of our studies are positive, we anticipate filing
the NDA three to four years from the date of this Annual Report. Although both
hydrocortisone and lidocaine are FDA approved drugs, we will not be permitted
to market our product candidates in the United States until we receive approval
from the FDA of our NDA. We believe the markets for obesity and hemorrhoid treatments
are both large and underserved by innovative, efficacious and cost-effective
new products. The U.S. Centers for Disease Control, or CDC, estimates that more
than 35% of U.S. adult men and women, or approximately 78 million U.S. adults,
were obese in 2009-2010. In addition, it is estimated that hemorrhoids affect
nearly 5% of the U.S. population, with approximately 10 million persons annually
reporting to be suffering from the symptoms of hemorrhoidal disease.
Since inception, we have focused on product development, have not generated
any revenues and incurred losses in each period of our operations, and we expect
to continue to incur losses for the foreseeable future. As of September 30,
2015, our accumulated deficit was $9,040,549 and our capital working deficit
was $640,614. These losses are likely to continue to adversely affect our working
capital, total assets and shareholders deficit, and are attributable to the
process of developing our products which requires significant clinical, development
and laboratory testing and clinical trials. In addition, commercialization of
our product candidates will require that we obtain necessary regulatory approvals
and establish sales, marketing and manufacturing capabilities, either through
internal hiring or through contractual relationships with third parties. Due
to our financial condition, our independent registered accountants have indicated,
in their report for the year ended September 30, 2015, that there is substantial
doubt about our ability to continue as a going concern. All the aforementioned
factors may have a material, adverse effect on our ability to raise additional
capital.
In November 2011, the Company entered into an agreement with Prenzamax LLC ("Prenzamax")
pursuant to which the Company granted Prenzamax an exclusive, royalty-bearing,
transferable license to use and sell Suprenza in the United States and to manufacture
or have Suprenza manufactured by third parties for subsequent sale in the United
States (the "Exclusive License Agreement"). Prenzamax is a specialty
pharmaceutical company focused on providing innovative and advanced ethical
prescription medications which have differential and therapeutically meaningful
advantages to health care professionals and their patients. Prenzamax is an
affiliate of Akrimax LLC ("Akrimax"), a privately-held pharmaceutical
company which acquires and develops and markets advanced ethical prescription
medications. Prenzamax was formed for the purpose of managing the license granted
pursuant to the Exclusive License Agreement. Pursuant to the terms of the Exclusive
License Agreement, Prenzamax purchases Suprenza from our manufacturer, Alpex
Pharma S.A., and is responsible for arranging import and custom requirements.
Once Suprenza is in the U.S., it is delivered to Prenzamaxs third party logistics
provider for warehousing, order processing and shipping to the end customers.
Prenzamax is responsible for all costs related to manufacturing, warehousing
and distribution. In addition, Prenzamax is also solely responsible for the
sales and marketing costs associated with Suprenza. These costs include, but
are not limited to, preparation of marketing materials such as brochures and
electronic media as well as other advertising and promotional costs including
providing samples of Suprenza to physicians and patients. A major cost component
for Prenzamax is sales force salaries, training and travel expenses. Akrimax
has agreed to act as a guarantor of Prenzamaxs obligations owed to the Company
pursuant to the Exclusive License Agreement. Specifically, the Exclusive License
Agreement provides that Akrimax unconditionally guarantees the full and prompt
performance of all obligations of Prenzamax pursuant to the terms and conditions
of the Exclusive License Agreement, including the payment of all amounts that
become due and payable by Prenzamax. In addition, Akrimax prepares estimates
of time and costs with respect to selling Suprenza and allocates those costs
to calculate the Product EBITDA. Product EBITDA is defined as Sales less the
Cost of Goods sold, Marketing Expenses and regulatory expenses. All terms which
are not defined herein are defined in the Exclusive License Agreement by and
between Citius and Prenzamax dated November 15, 2011 which has been filed with
the SEC.
Since the launch of Suprenza in 2012, Prenzamax has been unable to generate
revenues sufficient to cover its costs and generate profits. Costs include,
but are not limited to, the cost of goods from Alpex, FDA facility and product
fees, the cost of marketing materials including samples provided to physicians
and patients and product literature and the cost of its sales force including
travel and out of pocket expenses. These costs are significantly higher than
revenue derived from the sale of Suprenza and therefore, Prenzamax has thus
far been unable to generate profits from such sales. Based upon the revenue
to cost ratio, we do not believe that we will receive any Profit Share Payments
from Prenzamax in the foreseeable future. We anticipate that we will receive
Profit Share Payments from Prenzamax at such time as the revenues generated
from the sale of Suprenza exceed Prenzamaxs costs associated with the sale
of the product.
In addition, we have entered into an agreement with Alpex pursuant to which
Alpex may use clinical data generated by the Company to file for regulatory
approval in markets where we are not licensed to sell the product. If Alpex
sells the product directly to such markets, we shall receive thirteen percent
(13%) of the net sales as royalty; provided, however, if Alpex does not market
the product in such markets and licenses the product to third parties for resale,
we shall receive twenty five percent (25%) of the net sales as royalty. Pursuant
to the Exclusive License Agreement with Prenzamax, we are required to pay Prenzamax
thirty five percent (35%) of the royalty payments which we receive from Alpex.
To date, we have not received any payments from Alpex pursuant to the agreement
because Alpex has not filed for regulatory approval in any countries, and we
do not anticipate that Alpex will file for such approval in the near future.
After we received approval and launched Suprenza in 2012, we planned to make
improvements to our Suprenza formulation. In addition, we planned to use profits
generated from the sale of Suprenza for the development and clinical testing
program. However, sales of Suprenza have so far been minimal and we have been
unable to obtain sufficient funding and therefore, currently, we suspended our
plans for the next generation of Suprenza. Currently, we are only developing
our hemorrhoid treatment product.
As a condition to obtaining approval for Suprenza, the FDA required us to conduct
a post-marketing study on the pharmacokinectic, or PK, parameters of Suprenza
ODT in subjects with renal impairment. Drug exposure increases can be expected
in patients with renal impairment who are treated with phentermine. However,
Suprenza ODTs pharmacokinetics has not been assessed in renal impaired patients.
Since obesity can lead to renal failure, there exists a possibility that patients
with mild or moderate renal failure may be prescribed Suprenza ODT. Therefore,
it is important to assess the changes in the PK parameters of Suprenza ODT in
patients with renal impairment. The primary endpoint of this study is the pharmacokinetic
assessment of Suprenza ODT in renal impaired patients, and the results of this
study would provide important new information to prescribing physicians regarding
phentermine dosing and dose adjustments for these at-risk patients.
A clinical research organization has indicated that it will cost approximately
$400,000 and 18 months to conduct the renal impairment study. Due to the limited
current sales of Suprenza, we requested the FDA waive the renal PK study. In
the FDAs letter dated August 28, 2015, the FDA notified us that our request
to waive the study was denied because financial hardship was an inadequate reason
to justify a waiver of the study. In addition, the FDA restated the FDAs concern
that there is a signal of serious risk of increased drug exposure in patients
with decreased renal function. If we fail to conduct the post-marketing renal
PK study, the FDA may ask us to discontinue selling the product or impose other
penalties which they deem suitable.
In general the FDA allows companies to continue selling their product while
post-marketing studies are being conducted. Based upon limited sales and usage
of our product, we intend to reapply for a waiver of the post-marketing study.
However, there can be no assurance that the FDA will release us from such requirement.
If our next request to waive the post-marketing studying is denied and we do
not have sufficient funding to conduct the study, we will likely discontinue
the sale of Suprenza. If we receive sufficient funding and determine to proceed
with the renal impairment study, and the results of such study demonstrate safety
concerns, we may have to add additional disclosures to our label or alternatively,
discontinue the sale of the product.
The co-founder and vice Chairman of Akrimax is Leonard Mazur who is our President,
Chief Executive Officer and Chief Operating Officer. Pursuant to the terms of
the license agreement, Prenzamax will be solely responsible for the pricing
of Suprenza and will have the option to participate in the future development
program of Suprenza which may result in a conflict of interest. Although Mr.
Mazur does not have any direct management role in Akrimax or Prenzamax, there
can be no assurance that Prenzamax will conduct its business affairs in a manner
which is beneficial to our company.
Our goal is to build a successful pharmaceutical company through the development
and commercialization of low-risk, innovative, efficacious and cost-effective
products that address compelling market opportunities. We will seek to achieve
this goal by:
Identifying new drug product candidates that are typically prescribed by a relatively
small number of specialist physicians and can therefore be successfully commercialized
by a small, specialty sales force;
Obtaining licenses for the most relevant and advanced technologies to provide
our new product candidates with superior product characteristics and intellectual
property protection;
Outsourcing formulation development and manufacturing in order to reduce our
required capital investment;
Leveraging our in-house clinical and regulatory expertise to more rapidly advance
the development of product candidates in our pipeline;
Establishing strategic relationships with marketing partners to maximize sales
potential for our products that require significant commercial support; and
Managing our business in a financially disciplined and cost-conscious manner.
Company Address: 11 Commerce Drive Cranford 7016 NJ
Company Phone Number: 967-6677 Stock Exchange / Ticker: NASDAQ CTXR
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Stock Performances by Major Competitors |
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Citius Pharmaceuticals Inc
Citius Pharmaceuticals Inc (CTXR) recently disclosed an operating shortfall of $-9.340823 million for the most recent fiscal period, as part of the ongoing earnings season for the October to December 31 period in 2023. While the company has faced a widening deficit over the expanding period, going from $-3.594 million in the first quarter of 2023 to $-9.231 million for the most recent period, investors remain optimistic about the company's future revenue sources. The Major Pharmaceutical Preparations sector has seen several companies declare their earnings, and CTXR is one of them. However, shareholders are less concerned with the company's recent operational behavior and more interested in the CEO's financial plans to ensure the company's steady growth.
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Citius Pharmaceuticals Inc
In the shadow of prominent players in the Major Pharmaceutical Preparations sector, Citius Pharmaceuticals Inc has revealed its recent financial results, which paint a concerning picture for the company. With increasing operating deficits and a persistent absence of revenue, it becomes crucial to analyze how these results might impact the company's future prospects. Operating Deficits and Net Deficit Growth: Citius Pharmaceuticals Inc reported an operating deficit of $-10.124723 million in the fourth quarter of 2023, significantly larger than the operating deficit of $-7.549566 million in the previous year's fourth quarter. This expansion of the deficit raises questions about the company's ability to control costs effectively and generate sustainable growth.
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Citius Pharmaceuticals Inc
During the past 5 trading days, Citius Pharmaceuticals Inc (CTXR) has experienced a decline in its shares by -12.7%. This decrease in value has brought the company's year-to-date performance to a positive 25.36%. Additionally, the company's shares are currently trading 27% above its 52-week low. These notable changes in stock price have raised concerns and prompted analysis from industry advisors. The industry advisors, who specialize in Major Pharmaceutical Preparations, have begun interpreting the third quarter of 2023's performance for Citius Pharmaceuticals Inc. In their observation, they have noted an operating loss of $-8.672112 million from CTXR. However, the company has not yet disclosed any specific top-line figures for its financial reporting period from April to June 30, 2023.
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Citius Pharmaceuticals Inc
Citius Pharmaceuticals Inc is an American-based biotechnology company that is focused on developing and commercializing therapeutic products for critical care patients with unmet medical needs. The company was founded in 2007 and is headquartered in Cranford, New Jersey. As of the reporting season of January to March 31 2023, the operating loss of Citius Pharmaceuticals Inc was announced as $-10.6853 million. The company, which is a constituent of the Major Pharmaceutical Preparations sector, has been working on different business models to ensure new business. This follows the announcement during the second quarter of 2022 where the company reported an operating loss of $-7.590625 million. Although the respective revenue is yet to be announced by Citius Pharmaceuticals Inc, the management has been taking strategic measures to ensure growth in the future. One of the significant problems that Citius Pharmaceuticals Inc has faced recently is the extension of net loss during the expanding cycle. In the same period, the company has recorded an increase in net loss from $-7.561 million to $-10.526 million. It is expected that Citius Pharmaceuticals Inc will share their next financial results on August 10, 2023. Citius Pharmaceuticals Inc recorded a cumulative net loss of $-31 million during the twelve months ending in the second quarter of 2023. It is the response of the company management to these challenges that will determine Citius Pharmaceuticals Inc?s future performance.
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Per Share |
Current |
Earnings (TTM) |
-0.24 $ |
Revenues (TTM) |
-
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Cash Flow (TTM) |
- |
Cash |
0.1 $
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Book Value |
0.5 $
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Dividend (TTM) |
0 $ |
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Per Share |
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Earnings (TTM) |
-0.24 $
|
Revenues (TTM) |
- |
Cash Flow (TTM) |
- |
Cash |
0.1 $
|
Book Value |
0.5 $ |
Dividend (TTM) |
0 $ |
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