Rexahn Pharmaceuticals Reports 2018 Financial Results
March 08 2019 - 8:00AM
Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage
biopharmaceutical company developing innovative therapies to
improve patient outcomes in cancers that are difficult to treat,
today announced financial results for year ended December 31, 2018.
2018 and Recent Corporate Highlights:
RX-3117 – Orally administered targeted nucleoside
analogue
- Completed enrollment in the Phase 2a clinical trial of RX-3117
in combination with ABRAXANE® (paclitaxel protein-bound particles
for injectable suspension) in first-line metastatic pancreatic
cancer patients in February 2019. Interim data from the trial
presented at the 2019 American Society of Clinical Oncology (ASCO)
Gastrointestinal Cancers Symposium showed an overall response rate
of 38% in the first 24 patients who had at least one scan on
treatment.
- Presented updated interim data from the Phase 2a clinical trial
of RX-3117 in advanced bladder cancer at the 2019 ASCO
Genitourinary Cancers Symposium. Encouraging preliminary signs of
efficacy, including one complete response, were observed in
patients with advanced bladder cancer who have progressed on
multiple prior treatments including immunotherapy and
gemcitabine.
RX-5902 – Potential first-in-class orally administered
modulator of the β-catenin pathway
- Announced a clinical collaboration with Merck in August 2018 to
evaluate RX-5902 in combination with KEYTRUDA® (pembrolizumab) for
triple negative breast cancer (TNBC). Rexahn is currently
evaluating the development strategy for RX-5902 and may or may not
proceed with this trial.
- Presented preliminary data from a Phase 2a clinical trial of
RX-5902 in metastatic TNBC at the ASCO 2018 annual meeting in June
2018. An interim analysis of the first 10 evaluable patients in a
Phase 2a trial of RX-5902 in TNBC showed five patients exhibited a
clinical response including one patient who had an 18% reduction in
tumor size and two patients experiencing progression free survival
greater than 200 days. These patients had at least two prior
treatments for refractory TNBC.
RX-0301 – Highly specific Akt-1 inhibitor
- Entered into a research and development collaboration with
Zhejiang Haichang Biotechnology Co., Ltd. (Haichang) for the
development of RX-0301. Under the agreement, Haichang will develop
RX-0301, a nano-liposomal formulation of RX-0201, using its
proprietary QTsome™ technology and will conduct certain preclinical
and clinical activities through completion of a Phase 2a clinical
trial for the treatment of hepatocellular carcinoma (HCC). Haichang
is funding development activities through completion of the Phase
2a clinical trial up to an aggregate amount of $10,000,000. Rexahn
and Haichang will share in an agreed ratio downstream licensing
fees and royalties paid by third parties in connection with the
further development and commercialization of RX-0301 for the
treatment of HCC.
Corporate
- Strengthened our board of directors with the addition of Gil
Price, M.D. in November 2018 and Lara Sullivan, M.D. in February
2019.
- Strengthened our balance sheet through two financings resulting
in aggregate gross proceeds of $16.1 million in October 2018 and
January 2019.
- In November 2018, Douglas J. Swirsky was named President and
CEO and appointed to the board of directors following the departure
of Peter D. Suzdak, Ph.D.
- In December 2018, announced an operational restructuring to
enable more efficient development of our clinical stage oncology
pipeline. In connection with the restructuring, Rexahn’s workforce
was reduced to 10 and certain preclinical activities were
eliminated.
- As of March 8, 2019, had $19.8 million in cash, cash
equivalents, and marketable securities (unaudited). Rexahn expects
that its cash, cash equivalents and marketable securities will be
sufficient to fund the company’s currently expected cash flow
requirements for its activities for at least the next 12
months.
“Rexahn undertook several optimization initiatives in 2018 and
early 2019, including streamlining our operations and enhancing the
management team and board in order focus our efforts on our highest
value opportunities. Our priorities in 2019 will be the continued
evaluation of our programs with the goal of building long-term
value for our shareholders,” said Douglas J. Swirsky, president and
executive officer of Rexahn. “Having completed the enrollment of
the Phase 2a combination trial of RX-3117 with ABRAXANE in newly
diagnosed metastatic pancreatic cancer patients, we look forward to
reporting additional safety and efficacy data later this year.”
2018 Financial Results:
R&D Expenses: Research and development
expenses were $13.1 million for the year ended December 31, 2018,
compared to $10.7 million for the year ended December 31, 2017. The
increase in research and development expenses is primarily
attributable to increases in clinical trial costs and patient
enrollment costs from the advancement of our RX-3117 and RX-5902
clinical trials, as well as drug manufacturing costs for
manufacturing campaigns.
G&A Expenses: General and administrative
expenses were $7.4 million for the year ended December 31, 2018
compared to $6.6 million for the year ended December 31, 2017. The
increase is primarily attributable to an increase in personnel
expenses and severance payments.
Net Loss: Rexahn’s loss from operations was
$20.5 million and $17.4 million for the years ended December 31,
2018 and 2017, respectively. Rexahn's net loss was $14.4 million,
or $0.44 per share, for the year ended December 31, 2018, compared
to a net loss of $25.3 million, or $0.92 per share, for the year
ended December 31, 2017. The net loss for the years ended December
31, 2018 and 2017 includes an unrealized gain (loss) on the fair
value of warrants of $5.5 million and ($7.6 million), respectively.
The fair value adjustments are non-cash charges and are primarily a
result of changes in stock price between reporting periods.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals Inc. (NYSE American: RNN) is a clinical
stage biopharmaceutical company developing innovative therapies to
improve patient outcomes in cancers that are difficult to treat.
The Company’s mission is to improve the lives of cancer patients by
developing next-generation cancer therapies that are designed to
maximize efficacy while minimizing the toxicity and side effects
traditionally associated with cancer treatment. Rexahn’s product
candidates work by targeting and neutralizing specific proteins
believed to be involved in the complex biological cascade that
leads to cancer cell growth. Preclinical studies show that several
of Rexahn’s product candidates may be effective against multiple
types of cancer, including drug resistant cancers, and
difficult-to-treat cancers and others may augment the effectiveness
of current FDA-approved cancer treatments. The Company has two
oncology product candidates, RX-3117 and RX-5902, in Phase 2
clinical development and additional compounds in preclinical
development, including RX-0301. For more information about the
Company and its oncology programs, please
visit www.rexahn.com.
Safe Harbor
To the extent any statements made in this press release deal
with information that is not historical, these are forward-looking
statements under the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to, future
operations and products, the path of clinical trials and
development activities, expected cash flow requirements, and other
statements identified by words such as “will,” “potential,”
“could,” “can,” “believe,” “intends,” “continue,” “plans,”
“expects,” “anticipates,” “estimates,” “may,” other words of
similar meaning or the use of future dates. These statements
also include statements about cash, cash equivalents, and
marketable securities as of March 8, 2019 and the sufficiency of
those amounts; additional information and disclosures would be
required for a more complete understanding of the Company’s
financial position and results of operations as of March 8, 2019.
Forward-looking statements by their nature address matters
that are, to different degrees, uncertain. Uncertainties and risks
may cause Rexahn’s actual results to be materially different than
those expressed in or implied by Rexahn’s forward-looking
statements. For Rexahn, particular uncertainties and risks include,
among others, understandings and beliefs regarding the role of
certain biological mechanisms and processes in cancer; drug
candidates being in early stages of development, including clinical
development; the ability to initially develop drug candidates for
orphan indications to reduce the time-to-market and take advantage
of certain incentives provided by the U.S. Food and Drug
Administration; the ability to transition from our initial focus on
developing drug candidates for orphan indications to candidates for
more highly prevalent indications; and the expecting timing of
results from our clinical trials. More detailed information on
these and additional factors that could affect Rexahn’s actual
results are described in Rexahn’s filings with the Securities and
Exchange Commission, including its most recent annual report on
Form 10-K. All forward-looking statements in this news release
speak only as of the date of this news release. Rexahn undertakes
no obligation to update or revise any forward-looking statement,
whether as a result of new information, future events or
otherwise.
Media Contact:DGI CommSusan Forman or Laura
Radocaj+1-212-825-3210sforman@dgicomm.comlradocaj@dgicomm.com
Investor Contact:ir@rexahn.com
(Tables to follow)
Rexahn Pharmaceuticals, Inc.Condensed
Statement of Operations
|
|
For the Year Ended December 31, |
|
|
2018 |
|
|
2017 |
|
Revenues: |
$ |
- |
|
$ |
- |
|
|
|
|
|
|
Expenses: |
|
|
|
|
General and administrative |
|
7,428,615 |
|
|
6,639,421 |
|
Research and development |
|
13,109,058 |
|
|
10,715,296 |
|
Total Expenses |
|
20,537,673 |
|
|
17,354,717 |
|
|
|
|
|
|
Loss from Operations |
|
(20,537,673 |
) |
|
(17,354,717 |
) |
|
|
|
|
|
Other Income (Expense) |
|
|
|
|
Interest income |
|
254,344 |
|
|
207,003 |
|
Other income |
|
368,750 |
|
|
- |
|
Unrealized gain (loss) on fair
value of warrants |
|
5,546,049 |
|
|
(7,594,162 |
) |
Financing expense |
|
- |
|
|
(552,627 |
) |
Total Other Income (Expense) |
|
6,169,143 |
|
|
(7,939,786 |
) |
|
|
|
|
|
Net Loss Before Provision for Income Taxes |
|
(14,368,530 |
) |
|
(25,294,503 |
) |
Provision for income taxes |
|
- |
|
|
- |
|
Net Loss |
$ |
(14,368,530 |
) |
$ |
(25,294,503 |
) |
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.44 |
) |
$ |
(0.92 |
) |
|
|
|
|
|
Weighted average number of shares
outstanding, basic and diluted |
|
32,915,377 |
|
|
27,390,527 |
|
|
|
|
|
|
|
|
Rexahn Pharmaceuticals,
Inc.Selected Balance Sheet
Information
|
|
December 31, |
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
Cash, Cash Equivalents and Marketable
Securities |
$ |
14,725,821 |
|
$ |
26,831,095 |
|
Working Capital(1) |
$ |
12,747,118 |
|
$ |
24,901,710 |
|
Total Assets |
$ |
16,042,926 |
|
$ |
28,287,881 |
|
Total Liabilities |
$ |
5,480,036 |
|
$ |
11,519,285 |
|
Stockholders’ Equity |
$ |
10,562,890 |
|
$ |
16,768,596 |
|
|
|
|
|
|
|
|
- Working Capital defined as current assets less current
liabilities
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