VANCOUVER, Aug. 12, 2016 /PRNewswire/ - ProNAi Therapeutics,
Inc. (NASDAQ: DNAI), a drug development company focused on
advancing targeted therapeutics for the treatment of patients with
cancer, today reported its financial and operational results for
the second quarter of 2016.
"During the second quarter, we successfully licensed our first
new asset, PNT141, a potent, selective and orally bioavailable
small molecule inhibitor of the Cdc7 kinase," said Dr. Nick Glover, President and CEO of ProNAi
Therapeutics. "Our goal is to build a broad pipeline consisting
primarily of assets that leverage discoveries on the leading edge
of cancer biology. PNT141 highlights this strategy as Cdc7 has a
central function in both DNA replication and DNA damage response,
two mechanisms that are increasingly recognized as having critical
roles in driving cancer. In addition to toxicology and
manufacturing work, we are conducting a robust preclinical
assessment of PNT141 aimed at further informing our clinical
development plans and patient selection strategies as we prepare
this product candidate for clinical trials."
In June 2016, the company reported
that it had suspended development of the cancer drug PNT2258. This
decision was informed by a review of the interim data from the
Wolverine Phase 2 trial of PNT2258. Although modest efficacy was
observed from PNT2258 in this interim analysis, the company did not
view these data as robust enough to justify continued development
of the drug. The company continues to review these data in order to
determine next steps with the asset and technology; however, no
further investment in PNT2258 or the underlying DNAi platform by
ProNAi is contemplated and the company subsequently has closed its
research facility based in Plymouth,
Michigan, which supported these programs.
Second Quarter 2016 Financial Results (all amounts reported
in U.S. currency)
Total operating expenses for the three months ended June 30, 2016 were $12.9
million compared to $6.6
million for the three months ended June 30, 2015. Total operating expenses for the
six months ended June 30, 2016 were
$23.6 million compared to
$13.3 million for the six months
ended June 30, 2015. Total operating
expenses included non-cash stock based compensation of $1.3 million and $2.7
million for the three and six months ended June 30, 2016 and of $0.4 and $0.6 for
the three and six months ended June 30,
2015, respectively.
Research and development expenses increased to $9.1 million for the three months ended
June 30, 2016 from $4.7 million for the three months ended
June 30, 2015. Research and
development expenses increased to $15.8
million for the six months ended June
30, 2016 from $10.0 million
for the six months ended June 30,
2015. These increases were primarily due to a non-recurring
$2.8 million restructuring charge
related to estimated close-out expenses for PNT2258, a $0.9 million upfront payment for the exclusive
license of PNT141 and an increase in personnel-related costs. These
increased costs were partially offset by a decrease in third-party
manufacturing costs.
General and administrative expenses increased to $3.8 million for the three months ended
June 30, 2016 from $1.9 million for the three months ended
June 30, 2015. General and
administrative expenses increased to $7.8
million for the six months ended June
30, 2016 from $3.3 million for
the six months ended June 30, 2015.
These increases were primarily due to a $0.3
million non-recurring restructuring charge, increased
personnel-related costs and fees incurred in support of activities
as a public company and corporate growth and costs pertaining to
business development activities.
For the three months ended June 30,
2016, ProNAi incurred a net loss of $12.9 million compared to a net loss of
$15.2 million for the three months
ended June 30, 2015. For the
six months ended June 30, 2016,
ProNAi incurred a net loss of $23.4
million compared to a net loss of $23.3 million for the six months ended
June 30, 2015. During the three
and six months ended June 30, 2015,
net loss included a non-cash charge related to the change in fair
value of preferred stock warrants of $8.6
million and $10.0 million.
At June 30, 2016, ProNAi had
$130.6 million in cash and cash
equivalents compared to $150.2
million in cash and cash equivalents at December 31, 2015.
At June 30, 2016, there were
30,220,083 shares of common stock issued and outstanding and stock
options to purchase 4,409,724 shares of common stock issued and
outstanding.
About ProNAi Therapeutics
ProNAi Therapeutics is a drug development company focused on
advancing targeted therapeutics for the treatment of patients with
cancer. ProNAi is developing PNT141, a potent, selective and
orally bioavailable small molecule inhibitor of the Cdc7 kinase.
This kinase is a key regulator of both DNA replication and DNA
damage response, making it a compelling emerging target for the
potential treatment of a broad range of tumor types. For more
information, please visit www.pronai.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995, including, but not
limited to, statements regarding ProNAi's anticipated clinical
development and potential business development strategies. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements. These statements
are based on management's current expectations and beliefs and are
subject to a number of risks, uncertainties and assumptions that
could cause actual results to differ materially from those
described in the forward-looking statements. Such forward-looking
statements are subject to risks and uncertainties, including, among
others, the risk that ProNAi may be unable to successfully develop
and commercialize PNT141 or any other future product candidates,
PNT141 is at a very early stage of development and may fail to
demonstrate safety and efficacy or may not otherwise produce
positive results, ProNAi may experience delays in preclinical and
clinical development, ProNAi's third-party manufacturers may cause
its supply of materials to become limited or interrupted or fail to
be of satisfactory quantity or quality, ProNAi's cash resources may
be insufficient to fund its current operating plans and it may be
unable to raise additional capital when needed, ProNAi may be
unable to obtain and enforce intellectual property protection for
its technologies and product candidates and the other factors
described under the heading "Risk Factors" set forth in ProNAi's
filings with the Securities and Exchange Commission from time to
time. ProNAi undertakes no obligation to update the forward-looking
statements contained herein or to reflect events or circumstances
occurring after the date hereof, other than as may be required by
applicable law.
|
PRONAI THERAPEUTICS,
INC.
|
|
Condensed Consolidated
Balance
Sheets
|
(unaudited)
|
(in
thousands)
|
|
|
|
June 30,
2016
|
|
December 31,
2015
|
|
|
|
|
ASSETS:
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
Cash and cash
equivalents
|
$
|
130,550
|
|
$
|
150,180
|
|
Prepaid expenses and other current
assets
|
543
|
|
1,673
|
|
|
Total current
assets
|
131,093
|
|
151,853
|
Property and equipment,
net
|
401
|
|
566
|
Other
assets
|
200
|
|
349
|
TOTAL
ASSETS
|
$
|
131,694
|
|
$
|
152,768
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
Accrued
liabilities
|
$
|
6,190
|
|
$
|
7,016
|
|
Accounts
payable
|
734
|
|
358
|
|
Other current
liabilities
|
-
|
|
23
|
|
|
Total current
liabilities
|
6,924
|
|
7,397
|
TOTAL
LIABILITIES
|
6,924
|
|
7,397
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY
(DEFICIT):
|
|
|
|
|
|
|
|
Common
stock
|
30
|
|
30
|
Additional paid-in
capital
|
682,337
|
|
679,528
|
Accumulated
deficit
|
(557,597)
|
|
(534,187)
|
TOTAL STOCKHOLDERS'
EQUITY
|
124,770
|
|
145,371
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY
|
$
|
131,694
|
|
$
|
152,768
|
|
|
|
|
|
PRONAI THERAPEUTICS,
INC.
|
|
Condensed Consolidated
Statements of
Operations
|
(unaudited)
|
(in thousands,
except share and per share
data)
|
|
|
|
Three Months Ended
June
30,
|
|
Six Months Ended
June
30,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
9,115
|
|
$
|
4,738
|
|
$
|
15,751
|
|
$
|
10,034
|
|
General and
administrative
|
3,831
|
|
1,874
|
|
7,808
|
|
3,315
|
|
|
Total operating
expenses
|
12,946
|
|
6,612
|
|
23,559
|
|
13,349
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(12,946)
|
|
(6,612)
|
|
(23,559)
|
|
(13,349)
|
Other income (expense),
net:
|
|
|
|
|
|
|
|
|
Change in fair value of preferred stock
warrants
|
-
|
|
(8,630)
|
|
-
|
|
(9,956)
|
|
Other income
(expense)
|
88
|
|
(6)
|
|
171
|
|
19
|
|
|
Total other income (expense),
net
|
88
|
|
(8,636)
|
|
171
|
|
(9,937)
|
|
|
|
|
|
|
|
|
Loss before provision for income
taxes
|
(12,858)
|
|
(15,248)
|
|
(23,388)
|
|
(23,286)
|
Provision for income
tax
|
14
|
|
1
|
|
22
|
|
11
|
|
|
|
|
|
|
|
|
Net
loss
|
(12,872)
|
|
(15,249)
|
|
(23,410)
|
|
(23,297)
|
Adjustment to redemption value on redeemable
convertible preferred
stock
|
-
|
|
(140,880)
|
|
-
|
|
(151,885)
|
|
|
|
|
|
|
|
|
Net loss attributable to common
stockholders
|
$
|
(12,872)
|
|
$
|
(156,129)
|
|
$
|
(23,410)
|
|
$
|
(175,182)
|
Net loss per share attributable to common
stockholders, basic and
diluted
|
$
|
(0.43)
|
|
$
|
(104.10)
|
|
$
|
(0.78)
|
|
$
|
(117.35)
|
Weighted-average shares used in computing net loss
per share attributable to
common stockholders, basic and
diluted
|
30,191,093
|
|
1,499,840
|
|
30,130,660
|
|
1,492,764
|
|
|
|
|
|
|
|
|
SOURCE ProNAi Therapeutics Inc.