Rexahn Pharmaceuticals Reports First Quarter 2019 Financial Results
May 13 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 the first quarter ended March
31, 2019.
First Quarter 2019 and Recent Highlights:
- 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. 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.
- Announced a collaboration and license agreement with BioSense
Global LLC, a New Jersey- and Suzhou, China-based biopharmaceutical
company, to advance the development and commercialization of
RX-3117 for pancreatic and other cancers in Greater China. Under
the agreement, Rexahn will receive an upfront payment and will be
eligible to receive additional development, regulatory and
commercial milestones up to a total of $226 million contingent on
achieving development, regulatory and commercial goals.
- Strengthened our board of directors with the addition of Lara
Sullivan, M.D. in February 2019.
- Enhanced our balance sheet through a financing resulting in
aggregate gross proceeds of $8.6 million in January.
- As of May 10, 2019, had $18.3 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 had a strong start to 2019, including the completion of
enrollment in our Phase 2a study of RX-3117 in combination with
ABRAXANE in newly diagnosed metastatic pancreatic cancer patients.
Our recent efforts to primarily focus our near-term efforts on this
study and to restructure our operations, along with the proceeds
from the January financing and the BioSense Global collaboration,
have greatly enhanced our cash position and runway as we continue
to evaluate the development paths for our programs,” said Douglas
J. Swirsky president and chief executive officer of Rexahn. “We
look forward to presenting additional safety and efficacy data on
RX-3117 later this year or early next year.”
2019 Financial Results:
R&D Expenses: Research and development
expenses were $2.2 million for the three months ended March 31,
2019, compared to $4.1 million for the three months ended March 31,
2018. The decrease in research and development expenses is
primarily attributable to decreases in drug manufacturing and
clinical trial costs and a reduction in preclinical programs and
headcount.
G&A Expenses: General and administrative
expenses were $1.7 million for the three months ended March 31,
2019 compared to $1.8 million for the three months ended March 31,
2018. The decrease is primarily attributable to a decrease in
personnel expenses, offset by increases in professional fees.
Net Loss: Rexahn’s loss from operations was
$3.9 million and $5.9 million for the three months ended March 31,
2019 and 2018, respectively. Rexahn's net loss was $2.3 million, or
$0.62 per share, for the three months ended March 31, 2019,
compared to a net loss of $2.1 million, or $0.79 per share, for the
three months ended March 31, 2018. The net loss for the three
months ended March 31, 2019 and 2018 includes unrealized gains on
the fair value of warrants of $1.5 million and $3.4 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, the
sufficiency of the Company’s cash, cash equivalents, and marketable
securities as of May 10, 2019, 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. Additional information and disclosures
would be required for a more complete understanding of the
Company’s financial position and results of operations as of May
10, 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 and subsequent quarterly report on Form
10-Q. 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 and Investor Contact:ir@rexahn.com
(Tables to follow)
|
|
Rexahn Pharmaceuticals, Inc. |
Condensed Statement of Operations |
(unaudited) |
|
|
|
For the Three Months Ended March 31, |
|
|
2019 |
|
2018 |
|
Revenues: |
$ |
- |
|
$ |
- |
|
|
|
|
|
|
Expenses: |
|
|
|
|
General and administrative |
|
1,695,523 |
|
|
1,827,322 |
|
Research and development |
|
2,242,229 |
|
|
4,058,533 |
|
Total Expenses |
|
3,937,752 |
|
|
5,885,855 |
|
|
|
|
|
|
Loss from Operations |
|
(3,937,752 |
) |
|
(5,885,855 |
) |
|
|
|
|
|
Other Income |
|
|
|
|
Interest income |
|
81,385 |
|
|
75,736 |
|
Other income |
|
- |
|
|
368,750 |
|
Unrealized gain on fair value of warrants |
|
1,513,371 |
|
|
3,366,496 |
|
Total Other Income |
|
1,594,756 |
|
|
3,810,982 |
|
|
|
|
|
|
Net Loss Before Provision for
Income Taxes |
|
(2,342,996 |
) |
|
(2,074,873 |
) |
Provision for income
taxes |
|
- |
|
|
- |
|
Net Loss |
$ |
(2,342,996 |
) |
$ |
(2,074,873 |
) |
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.62 |
) |
$ |
(0.79 |
) |
|
|
|
|
|
Weighted average number of shares outstanding, basic and
diluted |
|
3,779,953 |
|
|
2,639,849 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rexahn Pharmaceuticals, Inc. |
Selected Balance Sheet Information |
(unaudited) |
|
|
|
March 31, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
Cash, Cash Equivalents and
Marketable Securities |
$ |
18,015,606 |
|
$ |
14,725,821 |
Working Capital(1) |
$ |
16,482,753 |
|
$ |
12,747,118 |
Total Assets |
$ |
19,425,392 |
|
$ |
16,042,926 |
Total Liabilities |
$ |
3,485,436 |
|
$ |
5,480,036 |
Stockholders’ Equity |
$ |
15,939,956 |
|
$ |
10,562,890 |
(1) Working
Capital defined as current assets less current liabilities |
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