Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage
biopharmaceutical company developing innovative, targeted
therapeutics for the treatment of cancer, announced financial
results for the three and nine months ended September 30, 2018.
“This quarter, Rexahn achieved important milestones in our
RX-3117 and RX-5902 clinical development programs. First, we
presented clinical data from our ongoing Phase 2a trial of RX-3117
in combination with ABRAXANE® (nab-paclitaxel) in newly diagnosed
metastatic pancreatic cancer patients. We are encouraged by the
preliminary data reflecting a disease control rate of 86% and an
overall response rate of 29%. In addition, one patient achieved a
complete response (CR) that has been maintained for almost five
months, demonstrating the durability of the treatment effect. We
look forward to completing the study enrollment and plan to report
the final data in 2019,” said Peter D. Suzdak, Ph.D., chief
executive officer of Rexahn.
“Second, we announced a clinical trial collaboration agreement
with Merck to evaluate the combination of RX-5902 and its anti-PD-1
therapy, KEYTRUDA® (pembrolizumab), in a Phase 2 trial of patients
with metastatic triple negative breast cancer (mTNBC). Based on the
mechanism of action of RX-5902 and our observations in preclinical
studies, we are optimistic that this combination may provide
meaningful clinical benefit in patients with mTNBC,” continued Dr.
Suzdak.
Recent Highlights:
- Presented preliminary safety and efficacy data from an ongoing
Phase 2a clinical trial of RX-3117 in combination with ABRAXANE in
patients newly diagnosed with metastatic pancreatic cancer at the
5th NCI Pancreatic Cancer Symposium. The combination appears to be
safe and well tolerated (no dose limiting toxicities) and exhibited
evidence of clinical activity. Of the 14 subjects that had at least
one on-study scan (after 2 cycles of therapy): one complete
response (CR: 100% reduction in tumor volume), three partial
responses (PR: greater than 30% reduction in tumor volume) and
eight patients with stable disease (SD) who had tumor reductions of
up to 16%. These patients are still being dosed in the study.
Pancreatic tumor marker (CA19-9) reductions were seen ranging
between 43%-69%. The disease control rate (CR+PR+SD) for evaluable
patients was 86% and the overall response rate (CR+PR) was
29%.
- Entered into a clinical trial collaboration agreement with
Merck (known as MSD outside the United States and Canada) to
evaluate the combination of Rexahn’s RX-5902 and Merck’s anti-PD-1
therapy, KEYTRUDA (pembrolizumab), in a Phase 2 trial in patients
with mTNBC. mTNBC is difficult to treat and anti-PD-1 monotherapies
have shown limited benefit due to the limited immunogenic nature of
this tumor. RX-5902 has been shown to increase tumor infiltrating
lymphocyte migration into the tumor, transforming a “cold” tumor
into a “hot” tumor, which can then be recognized by the immune
system and make the tumor more susceptible to the anti-tumor
effects of anti-PD-1 therapy.
- In the ongoing Phase 2 monotherapy trial in mTNBC, RX-5902 has
been preliminarily shown to be safe and well-tolerated with six
patients showing clinical responses (stable disease for two or more
months), including one patient who has had stable disease for 320
days.
- Completed a registered direct offering with institutional
investors to purchase approximately 5.8 million shares of its
common stock and warrants exercisable for up to 5.8 million shares
of its common stock for gross proceeds of $7.5 million. The net
proceeds of the offering will be used to advance Rexahn's clinical
development programs and for working capital and general corporate
purposes.
- As of November 2, 2018, had $18.0 million in cash, cash
equivalents and investments (unaudited). Rexahn expects that its
cash, cash equivalents and investments will be sufficient to fund
the company’s currently expected cash flow requirements for its
activities through the third quarter of 2019.
Q3 2018 Financial Results:
R&D Expenses: Research and development
expenses were $2.9 million for the three months ended September 30,
2018, compared to $2.6 million for the three months ended September
30, 2017. Research and development expenses were $10.4 million for
the nine months ended September 30, 2018, compared to $7.5 million
for the nine months ended September 30, 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 new campaigns.
G&A Expenses: General and administrative
expenses were $1.8 million for the three months ended September 30,
2018, compared to $1.6 million for the three months ended September
30, 2017. General and administrative expenses were $5.2
million for the nine months ended September 30, 2018, compared to
$5.0 million for the nine months ended September 30, 2017.
Net Loss: Rexahn’s loss from operations was
$4.7 million and $4.2 million for the three months ended September
30, 2018 and 2017, respectively. Rexahn's net loss was $5.3
million, or $0.17 per share, for the three months ended September
30, 2018, compared to a net loss of $1.0 million, or $0.04 per
share, for the three months ended September 30, 2017. The net loss
for the three-month periods ended September 30, 2018 and 2017
includes an unrealized (loss) gain on the fair value of warrants of
($0.7 million) and $3.1 million, respectively. For the nine-month
period ended September 30, 2018, Rexahn’s net loss was $11.3
million, or $0.35 per share, compared to a net loss of $21.7
million, or $0.83 per share, for the nine months ended September
30, 2017. Included in the net loss for the nine months ended
September 30, 2018 and 2017 is an unrealized gain (loss) on the
fair value of warrants of $3.8 million and ($9.0 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 dedicated to developing novel,
targeted therapeutics for the treatment of cancer. 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-0201. 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, statements
about Rexahn’s plans, objectives, expectations and intentions with
respect to cash flow requirements, future operations and products,
enrollments in clinical trials, the path of clinical trials and
development activities, and other statements identified by words
such as “will,” “potential,” “could,” “can,” “believe,” “intends,”
“continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,”
and other words of similar meaning or the use of future dates.
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; the availability and access to capital; and the
expected 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 reports 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 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 |
(unaudited) |
|
|
For the Three Months
EndedSeptember 30, |
For the Nine Months EndedSeptember
30, |
|
2018 |
2017 |
2018 |
2017 |
Revenues: |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
General and administrative |
|
1,795,952 |
|
|
1,574,323 |
|
|
5,192,122 |
|
|
5,004,832 |
|
Research and development |
|
2,887,955 |
|
|
2,644,999 |
|
|
10,379,081 |
|
|
7,451,656 |
|
Total Expenses |
|
4,683,907 |
|
|
4,219,322 |
|
|
15,571,203 |
|
|
12,456,488 |
|
|
|
|
|
|
|
|
|
|
Loss from Operations |
|
(4,683,907 |
) |
|
(4,219,322 |
) |
|
(15,571,203 |
) |
|
(12,456,488 |
) |
|
|
|
|
|
|
|
|
|
Other Income (Expense) |
|
|
|
|
|
|
|
|
Interest
income |
|
55,153 |
|
|
60,750 |
|
|
198,362 |
|
|
135,329 |
|
Other
income |
|
- |
|
|
- |
|
|
368,750 |
|
|
- |
|
Unrealized (loss) gain on fair value of warrants |
|
(710,065 |
) |
|
3,120,500 |
|
|
3,752,131 |
|
|
(9,047,831 |
) |
Financing
expense |
|
- |
|
|
- |
|
|
- |
|
|
(333,050 |
) |
Total Other Income (Expense) |
|
(654,912 |
) |
|
3,181,250 |
|
|
4,319,243 |
|
|
(9,245,552 |
) |
|
|
|
|
|
|
|
|
|
Net Loss Before Provision for Income Taxes |
|
(5,338,819 |
) |
|
(1,038,072 |
) |
|
(11,251,960 |
) |
|
(21,702,040 |
) |
Provision for income taxes |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Net Loss |
$ |
(5,338,819 |
) |
$ |
(1,038,072 |
) |
$ |
(11,251,960 |
) |
$ |
(21,702,040 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.17 |
) |
$ |
(0.04 |
) |
$ |
(0.35 |
) |
$ |
(0.83 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding, basic
and diluted |
|
31,751,450 |
|
|
28,459,316 |
|
|
31,742,531 |
|
|
26,121,160 |
|
Rexahn Pharmaceuticals, Inc. |
Selected Balance Sheet Information |
(unaudited) |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2018 |
|
2017 |
Cash, Cash Equivalents and Marketable Securities |
$ |
12,565,732 |
$ |
26,831,095 |
Working Capital(1) |
$ |
10,388,984 |
$ |
24,901,710 |
Total Assets |
$ |
13,874,895 |
$ |
28,287,881 |
Total Liabilities |
$ |
7,463,000 |
$ |
11,519,285 |
Stockholders’ Equity |
$ |
6,411,895 |
$ |
16,768,596 |
(1) Working Capital defined as current assets less current
liabilities
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