Rexahn Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Update on RX-3117 Development
August 07 2019 - 6:30AM
Rexahn Pharmaceuticals, Inc. (NasdaqCM: REXN), 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 three and six months
ended June 30, 2019 and provided an update on RX-3117 development.
Recent Highlights and RX-3117 Development
Updates:
- 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, a portion of
which has been paid, and will be eligible to receive up to $126
million in development and regulatory milestones and up to $100
million in commercial milestones for each product containing
RX-3117, contingent on achieving commercial goals.
- As of July 24, 2019, an overall response rate of 23% has been
observed in 40 patients that have had at least one scan on
treatment in the Phase 2a study of RX-3117 in combination with
ABRAXANE® (paclitaxel protein-bound particles for injectable
suspension) in patients newly diagnosed with metastatic pancreatic
cancer. The Company previously reported in January 2019 an overall
response rate of 38% in the first 24 patients who had at least one
scan on treatment. Preliminary and unaudited data indicates that
the median progression free survival for patients in the study is
approximately 5.4 months. Patients currently active in the
study will continue to be treated and final data from the trial is
expected to be available in 2020.
- Transferred its stock exchange listing to the Nasdaq Capital
Market from its previous listing on NYSE American.
- Effected a 1-for-12 reverse stock split of outstanding shares
on April 12, 2019.
- As of August 7, 2019, had approximately $15.3 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.
“We are surprised and disappointed with the most recent
preliminary data from the ongoing Phase 2a trial of RX-3117 in
combination with ABRAXANE in first line metastatic pancreatic
cancer patients,” said Douglas J. Swirsky president and chief
executive officer of Rexahn. “RX-3117 appears to be well tolerated
and we are evaluating development options for RX-3117 in other
indications, including through our collaboration with
BioSense. In the near term, we are focused on supporting our
collaborations with BioSense and Zhejiang Haichang Biotechnology
Co., Ltd. as we evaluate the best path forward for our
programs.”
See the discussion below under Important Cautionary Statements
regarding our cash balance and the other forward-looking statements
in this release.
Q2 2019 Financial Results:
R&D Expenses: Research and development
expenses were $1.6 million for the three months ended June 30,
2019, compared to $3.4 million for the three months ended June 30,
2018. Research and development expenses were $3.9 million for the
six months ended June 30, 2019, compared to $7.5 million for the
six months ended June 30, 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 $1.3 million for the three months ended June 30, 2019
compared to $1.6 million for the three months ended June 30, 2018.
General and administrative expenses were $3.0 million for the six
months ended June 30, 2019 compared to $3.4 million for the six
months ended June 30, 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
$3.0 million and $5.0 million for the three months ended June 30,
2019 and 2018, respectively. Rexahn's net loss was $2.5 million, or
$0.61 per share, for the three months ended June 30, 2019, compared
to a net loss of $3.8 million, or $1.45 per share, for the three
months ended June 30, 2018. For the six-month period ended
June 30, 2019, Rexahn’s net loss was $4.8 million, or $1.23 per
share, compared to a net loss of $5.9 million, or $2.24 per share
for the six months ended June 30, 2018. The net loss
for the six months ended June 30, 2019 and 2018 includes unrealized
gains on the fair value of warrants of $1.9 million and $4.5
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. (NasdaqCM: REXN) 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 a
pipeline of oncology product candidates in clinical and preclinical
development including RX-3117, RX-5902, and RX-0301. For more
information about the Company and its oncology programs, please
visit www.rexahn.com.
Important Cautionary Statements
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, statements
about future operations and products, the path of clinical trials
and development activities (including our current evaluation of the
paths for our programs), expected cash flow requirements, the
sufficiency of the Company’s cash, cash equivalents, and marketable
securities as of August 7, 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 August
7, 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, our understandings and beliefs regarding the role of
certain biological mechanisms and processes in cancer; our drug
candidates being in early stages of development, including clinical
development; our reliance on third-party collaborators for research
and development activities, and their compliance with the terms of
our agreements with them; our reliance on contract research
organizations and other investigators for certain research and
development activities; 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 expected timing of results from our
clinical trials; the ability to identify other potential
indications for RX-3117 we or others are able or willing to invest
in given the pre-clinical and clinical data we have available at
this time; and the uncertainty about the paths of our programs and
our ability to evaluate and identify a path forward for those
programs, particularly given the constraints we have as a small
company with limited financial, personnel and other operating
resources (including with respect to the allocation of our limited
capital and the sufficiency of our capital in the near term for any
path we do select). 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 EndedJune 30, |
For the Six Months EndedJune 30, |
|
2019 |
2018 |
2019 |
2018 |
Revenues: |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
General and administrative |
|
1,340,016 |
|
|
1,568,848 |
|
|
3,035,538 |
|
|
3,396,170 |
|
Research and development |
|
1,648,401 |
|
|
3,432,593 |
|
|
3,890,631 |
|
|
7,491,126 |
|
Total Expenses |
|
2,988,417 |
|
|
5,001,441 |
|
|
6,926,169 |
|
|
10,887,296 |
|
|
|
|
|
|
|
|
|
|
Loss from Operations |
|
(2,988,417 |
) |
|
(5,001,441 |
) |
|
(6,926,169 |
) |
|
(10,887,296 |
) |
|
|
|
|
|
|
|
|
|
Other Income (Expense) |
|
|
|
|
|
|
|
|
Interest income |
|
96,650 |
|
|
67,473 |
|
|
178,035 |
|
|
143,209 |
|
Other income |
|
- |
|
|
- |
|
|
- |
|
|
368,750 |
|
Unrealized gain on fair value of warrants |
|
427,483 |
|
|
1,095,700 |
|
|
1,940,854 |
|
|
4,462,196 |
|
Total Other Income (Expense) |
|
524,133 |
|
|
1,163,173 |
|
|
2,118,889 |
|
|
4,974,155 |
|
|
|
|
|
|
|
|
|
|
Net Loss Before Provision for Income Taxes |
|
(2,464,284 |
) |
|
(3,838,268 |
) |
|
(4,807,280 |
) |
|
(5,913,141 |
) |
Provision for income taxes |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Net Loss |
$ |
(2,464,284 |
) |
$ |
(3,838,268 |
) |
$ |
(4,807,280 |
) |
$ |
(5,913,141 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.61 |
) |
$ |
(1.45 |
) |
$ |
(1.23 |
) |
$ |
(2.24 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding, basic and
diluted |
|
4,019,141 |
|
|
2,640,927 |
|
|
3,900,208 |
|
|
2,640,391 |
|
Rexahn
Pharmaceuticals, Inc. |
Selected
Balance Sheet Information |
(unaudited) |
|
|
|
|
|
|
June 30, |
December 31, |
|
2019 |
2018 |
Cash, Cash Equivalents and Marketable Securities |
$ |
16,260,169 |
$ |
14,725,821 |
Working Capital(1) |
$ |
13,742,010 |
$ |
12,747,118 |
Total Assets |
$ |
17,677,234 |
$ |
16,042,926 |
Total Liabilities |
$ |
4,054,128 |
$ |
5,480,036 |
Stockholders’ Equity |
$ |
13,623,106 |
$ |
10,562,890 |
(1) Working Capital defined as current assets less current
liabilities |
|
|
|
|
Rexahn Pharmaceuticals (NASDAQ:REXN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Rexahn Pharmaceuticals (NASDAQ:REXN)
Historical Stock Chart
From Apr 2023 to Apr 2024