Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN), a clinical stage
biopharmaceutical company developing best-in-class therapeutics for the
treatment of cancer, is providing an overview of its three clinical
development programs and financial results for the quarter ended June
30, 2014.
“We are pleased with the continued progress of the RX-3117, Supinoxin™
and Archexin® clinical development programs,”
stated Rexahn’s Chief Executive Officer Peter D. Suzdak, PhD. “Positive
data from these studies would be major milestones and will help direct
the next steps for the Company.”
Pipeline Update:
Supinoxin™ (RX-5902)
In August 2013, Rexahn initiated a Phase I dose-escalation study of
Supinoxin designed to evaluate the safety, tolerability, dose-limiting
toxicities and maximal tolerated dose (MTD) in cancer patients with
solid tumors that have previously failed treatment with approved
therapies. Secondary endpoints include pharmacokinetic analysis and
evaluating the preliminary anti-tumor effects of Supinoxin. In July,
Rexahn announced that four dose groups (25, 50, 100 and 150 mg) had been
enrolled. The Company is currently enrolling patients for its fifth dose
group (225 mg), and the MTD has not yet been achieved. Depending upon
the number of dose groups needed to determine the MTD, Rexahn expects to
complete this trial in the fourth quarter of 2014.
RX-3117
Rexahn initiated a Phase Ib clinical trial of RX-3117 in cancer patients
with solid tumors in January 2014. The Phase Ib clinical trial is a
multi-center dose-escalation study that will evaluate the safety,
tolerability, dose-limiting toxicities and MTD of RX-3117 in patients
with solid tumors. Secondary endpoints will include characterizing the
pharmacokinetic profile of RX-3117 and evaluating the preliminary
anti-tumor effects of RX-3117. Patient enrollment has been completed in
three dose groups (30, 60 and 100 mg) and is in the middle of
recruitment for the fourth dose group (150 mg). The MTD of RX-3117 has
not yet been achieved. The Company expects to complete patient
enrollment of the RX-3117 Phase Ib clinical trial late in the fourth
quarter of 2014 or early 2015. Based on the progress of the RX-3117
clinical development program and the level of interest expressed from a
number of oncology-focused pharmaceutical companies, Rexahn is
continuing its discussions with multiple companies to explore
collaborative business structures in an effort to maximize the potential
upside value of the program.
Archexin®
The Phase IIa proof-of-concept clinical trial of Archexin in metastatic
renal cell carcinoma (RCC) patients is ongoing. The first stage of this
study is dose ranging, with up to three dose groups with three RCC
patients each, to determine its MTD of Archexin in combination with
everolimus, an FDA approved drug for the treatment of RCC. Once the MTD
has been determined, thirty RCC patients will be randomized to either
Archexin in combination with everolimus or everolimus alone, in a ratio
of 2:1. Rexahn expects to complete the initial safety component of this
study late in the fourth quarter of 2014 or early 2015.
Additional Highlights from Second Quarter 2014:
-
Presented preclinical results for RX-21101, the Company's first
development candidate derived from its Nano-Polymer-Drug Conjugate
System (NPDCS) platform at the American Association for Cancer
Research (AACR) Annual Meeting 2014.
-
Announced additional data from preclinical studies on the anti-tumor
effects of RX-3117, demonstrating that oral administration of RX-3117
inhibited tumor growth in 12 different human cancer xenograft models.
Financial Update:
Cash Position - Rexahn's cash and investments totaled
$38.3 million as of June 30, 2014, compared to $40.3 million as of March
31, 2014. The decrease of $2.0 million was primarily due to $2.9 million
of net cash used in operating activities, which amount was offset by
$0.9 million from the exercise of stock warrants and options to purchase
common stock. Rexahn expects that its cash and cash equivalents as of
June 30, 2014 will be sufficient to fund the Company's cash flow
requirements for its current activities into the second half of 2016.
R&D Expenses - Research and development expenses were
approximately $1.7 million for the second quarter of 2014, compared to
approximately $1.3 million for the first quarter of 2014. The increase
is primarily attributable to the clinical trials that were started in
the first quarter, but continued into the second quarter. Research and
development expenses were $3.0 million for the six months ended June 30,
2014, compared to $1.5 million for the six months ended June 30, 2013.
The increase was primarily attributable to expenses related to
additional clinical studies in 2014.
G&A Expenses - General and administrative expenses
were approximately $1.7 million for the second quarter of 2014, compared
to approximately $1.4 million for the first quarter of 2014. The
increase is primarily related to expenses related to the shareholder
meeting held in the second quarter, and an increase in legal and
professional fees related to corporate organizational matters. General
and administrative expenses for the six months ended June 30, 2014 were
approximately $3.1 million compared to $2.1 million in the six months
ended June 30, 2013. The increase was primarily attributable to an
increase in investor relations and financial advisory services relating
to the Company's financing activities and additional legal and
professional fees.
Net Income (Loss) - Rexahn's net income was $0.2 million,
or $0.00 per share, for the three months ended June 30, 2014, compared
to a net loss of $14.6 million, or $0.09 per share, for the three months
ended March 31, 2014. Included in net income (loss) for the three months
ended June 30 and March 31, 2014 is an unrealized gain (loss) on the
fair value of warrants of $3.7 million and ($11.7 million),
respectively. The fair value adjustments are primarily a result of the
changes in the stock price between reporting periods. Rexahn’s loss from
operations was $3.5 million and $2.8 million for the three months ended
June 30 and March 31, 2014, respectively.
About Supinoxin™ (RX-5902)
Supinoxin is an orally administered, first-in-class, small molecule
inhibitor of phosphorylated-p68 RNA helicase (P-p68). P-p68, which is
selectively expressed in cancer cells and is absent in normal tissue,
increases the activity of multiple cancer related genes including cyclin
D1, c-jun and c-myc, and plays a role in tumor progression and
metastasis. Over-expression of P-p68 has been observed in solid tumors
such as melanoma, colon, ovarian and lung.
About RX-3117
RX-3117 is a novel small molecule anti-metabolite that is incorporated
into DNA or RNA of cells and inhibits both DNA and RNA synthesis which
induces apoptotic cell death of tumor cells. RX-3117 also mediates the
downregulation of DNA methyltransferase 1 (DNMT1), an enzyme responsible
for the methylation of cytosine residues on newly synthesized DNA and
also a target for anticancer therapies. Preclinical studies have shown
RX-3117 to be effective in both inhibiting the growth of various human
cancer xenograft models, including colon, lung, renal and pancreas, as
well as overcoming chemotherapeutic drug resistance.
RX-3117 has demonstrated a broad spectrum anti-tumor activity against 50
different human cancer cell lines and efficacy in 12 different mouse
xenograft models. The efficacy in the mouse xenograft models was
superior to that of gemcitabine. In addition, RX-3117 still retains its
full anti-tumor activity in human cancer cell lines made resistant to
the anti-tumor effects of gemcitabine. These findings have either been
previously presented at the American Association of Cancer Research
Meeting in 2012 or will be the subject of a peer reviewed publication to
be published in early 2014. In August 2012, Rexahn reported the
completion of an exploratory Phase I clinical trial of RX-3117 in cancer
patients conducted in Europe, to investigate the oral bioavailability,
safety and tolerability of the compound. In this study, oral
administration of RX-3117 demonstrated an oral bioavailability of 56%
and a plasma half-life (T1/2) of 14 hours. In addition,
RX-3117 was safe and well tolerated in all subjects throughout the dose
range tested.
About Archexin®
Archexin® is a unique anti-cancer drug candidate that inhibits the
cancer cell signaling protein Akt-1, which is involved in cancer cell
growth, survival, angiogenesis, and drug resistance. Archexin has
completed a Phase I clinical trial in cancer patients with solid tumors
and was shown to be safe and well tolerated. The dose-limiting toxicity
was a grade 3 fatigue. In a small Phase IIa trial in advanced pancreatic
cancer patients, Archexin in combination with gemcitabine was shown to
be safe and well tolerated and demonstrated a preliminary efficacy
signal with a median survival of 9.1 months in evaluable patients.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals is a clinical stage biopharmaceutical company
dedicated to developing best-in-class therapeutics for the treatment of
cancer. Rexahn currently has three clinical stage oncology candidates,
Archexin®, RX-3117 and SupinoxinTM (RX-5902) and a
robust pipeline of preclinical compounds to treat multiple types of
cancer. Rexahn has also developed proprietary drug discovery platform
technologies in the areas of Nano-Polymer-Drug Conjugate Systems
(NPDCS), nano-medicines, 3D-GOLD, and TIMES. For more information,
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,” 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,
the difficulty of developing pharmaceutical products, obtaining
regulatory and other approvals and achieving market acceptance; the
success and design of clinical testing; and Rexahn’s need for and
ability to obtain additional financing. 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.
Copyright Business Wire 2014