(all figures are in Canadian dollars unless otherwise
noted)
BELLEVILLE, ON,
Nov. 12, 2014 /PRNewswire/ - Bioniche
Life Sciences Inc. (TSX: BNC: PNK:BNHLF), a late-stage
biotechnology company, today announced financial results for the
first quarter of Fiscal 2015 (3 months ended September 30, 2014), as well as a comprehensive
update on the state of its bladder cancer therapeutic,
Mycobacterium phlei cell-wall - nucleic acid complex
(MCNA).
MCNA Business Update
- On track for calendar Q1/2015 filing of a Biologics License
Application (BLA) for MCNA
- Pre-BLA meeting scheduled with the U.S. Food and Drug
Administration (FDA)
- MCNA patent protection expected in major jurisdictions to at
least 2031
- Partnering process initiated and progressing well
- Strategic product launch planning initiated
- Regulatory pathways in other jurisdictions to be explored
At this point, the Company remains on track with
its internal objective of filing the U.S. BLA prior to March 31, 2015. Two key activities are currently
underway that could have an impact on this timing. The
Company is subjecting its Montreal
manufacturing site to a "mock FDA audit" to ensure its level of
preparation for the actual FDA manufacturing audit, which would be
initiated by the FDA some time after the filing of the BLA for
MCNA. In addition, at the FDA's request, the Company has scheduled
a face-to-face pre-BLA meeting with the FDA later this month.
The Company continues to work with its
intellectual property advisors to move forward the prosecution of
its broad coverage of the key MCNA patent family covering
composition of matter, methods of production and methods of use. At
this point in time, the Company expects to have strong patent
coverage in all of the key global markets through to 2031. In
addition, as MCNA is a novel biologic, the Company will
automatically benefit from 12 years of market exclusivity upon BLA
approval in the United States
under the Patient Protection and Affordable Care Act's Biologics
Price Competition and Innovation Act.
The Company has initiated a comprehensive
process to identify a strategic partner for MCNA commercialization
in the United States. Commenting
on the ultimate choice of a strategic partner, Dr. Michael Berendt, Chief Executive Officer and
Chief Scientist of Bioniche, noted, "MCNA has the potential to be a
"perfect specialty pharma product", as it is offers a real
treatment alternative for patients with high-risk,
non-muscle-invasive bladder cancer who have failed first-line BCG
therapy, many of whom have no alternative than cystectomy (bladder
removal). This market can be addressed with a reasonably small
sales force and we expect that it will be well received by
prescribing physicians, patients and, ultimately, by the
payers. To that end, we have initiated discussions with
potential partners and consultants related to product launch
planning, to ensure that we begin to address all long lead time
items that must be in place to ensure a successful launch. We will
strategically explore whether establishing our own commercial
capabilities in the U.S. may potentially be the most advantageous
path forward for our shareholders."
As previously reported, the Company will
re-initiate its dialogue with Health Canada with regard to
potential regulatory options in Canada, once the U.S. BLA has been filed. In
addition, the Company has begun discussions with potential partners
covering key territories outside the U.S. and Canada, while investigating the most
appropriate next steps for gaining regulatory approval in those
jurisdictions.
Fiscal 2015 First Quarter Financial Results
Highlights - Continuing Operations
- The closing of a Canadian equity offering and related private
placement with net proceeds of $5.1
million
- The reduction of average monthly burn rate from $1.3 million to $0.6 million
- Continued visits by potential purchasers of the One Health
Vaccine Manufacturing Centre
The Company's continuing operations recorded
revenue in the quarter of $0.2
million, as compared to nil in the same period in Fiscal
2014. The fiscal Q1 2015 revenue relates to rental income for a
portion of the Company's Belleville,
Ontario facility.
Cash from continuing operations amounted to
$11.0 million at September 30, 2014, as compared to $10.5 million at June 30,
2014.
The Company's total liabilities and
shareholders' equity at September 30,
2014 is $33.5 million, the
same as at June 30, 2014.
The Company's consolidated cash flow used in
operations for the quarter ended September
30, 2014 was $2.8 million, as
compared to cash used in operations of $4.7
million in Q1, Fiscal 2014. The average monthly burn rate,
based on cash used in operations, was approximately $0.9 million, and approximately $0.6 million before changes in non-cash working
capital. This compares to $1.6
million and $1.3 million
respectively for the same quarter in Fiscal 2014.
Administration expenses for continuing
operations were $1.2 million in the
first quarter of Fiscal 2015, as compared to $1.3 million in the first quarter of Fiscal 2014.
The decrease reflects the Company's cost reduction efforts of about
$0.7 million that started in Fiscal
2014, offset by reclassification of certain administrative expenses
previously directed to support other operations in the area of
research that have now been discontinued. Property management
expenses were $0.4 million in Q1,
Fiscal 2015, as compared to nil in Q1, Fiscal 2014. Marketing and
selling expenses were nil in the first quarter of Fiscal 2015, as
compared to $0.2 million in Q1,
Fiscal 2014.
"Shareholders will note a substantial drop in
financial expenses in this quarter," said Mr. Brian Ford, Chief Financial Officer of Bioniche.
"Such expenses reduced by 85% - from $2.5
million in Q1, Fiscal 2014 to $0.4
million in Q1, Fiscal 2015. Proceeds from the sale of the
Company's Animal Health business unit in April, 2014 allowed the
Company to repay $50.3 million of
high-cost secured and unsecured debt by the end of Fiscal 2014,
resulting in significantly reduced financial expenses in the first
quarter of Fiscal 2015."
At September 30,
2014, the Company's long-term debt and repayable government
assistance, including the current portions, were $2.7 million and $18.4
million respectively. All of the long-term debt and
$7.2 million of the repayable
government assistance relate to non-core assets, consisting
primarily of the Belleville
facility, including the Vaccine Manufacturing Centre. These
obligations are expected to be settled in connection with the
future sale of that facility. The Company continues to work with
its advisor, PharmaBioSource (www.pharmabiosource.com) to identify
an acquirer for the assets of One Health, including the new and
unused Vaccine Manufacturing Centre. Buyer interest, in terms
of site visits, was very active in the first quarter of Fiscal
2015.
Net research and development (R&D)
expenditures for continuing operations were $1.1 million in the first quarter of Fiscal 2015,
as compared to $3.0 million in Q1,
Fiscal 2014. In Fiscal 2015, One Health R&D activities were
reduced to nil from $0.8 million and
Human Health R&D activities were reduced to $1.1 million from $2.1
million a year earlier. Current R&D activity includes
the continued investment in the staffing and infrastructure
associated with the GMP production of the Company's MCNA bladder
cancer therapy that has completed Phase III clinical development,
as well as ongoing activities related to the filing of a BLA with
the U.S. FDA.
The basic and fully diluted net loss per Share
for the Company's continuing operations for Q1, Fiscal 2015 is
($0.02), as compared to a basic and
fully diluted net loss per Share of ($0.07) in Q1, Fiscal 2014.
Discontinued Operations
It should be noted that the Company completed
the divestiture of its Animal Health business unit on April 15, 2014. Animal Health was a reportable
segment for business and reporting purposes that had been
classified as held for sale and as a discontinued operation at
June 30, 2013. In the Fiscal 2015 Q1
financial statements for the three-month period ended September 30, 2014, there is no reportable
activity for this business unit, however, there is reportable
activity for the three-month period ended September 30, 2013.
Q1, Fiscal 2015 Summary
The Company has 167,854,018 Common Shares
outstanding at November 11, 2014. In
addition, the Company has 36,541,812 outstanding Warrants and
8,694,864 outstanding Options, exchangeable for one Common Share
upon exercise.
More information on the Company's financial
results is provided in the Company's Q1, Fiscal 2015 Management's
Discussion and Analysis.
Annual and Special Meeting of
Shareholders
The Company's Annual & Special Meeting of
Shareholders is scheduled to take place on today at
10:00 a.m. Eastern in
Toronto, Ontario, Canada. At this
meeting, Company management will provide a comprehensive review of
the past year, and discuss the vision for the Company going
forward.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a late clinical
stage Canadian biopharmaceutical company focused on the
development, manufacturing, marketing and licensing/acquisition of
proprietary and innovative therapies for the global human health
market. The Company's primary goal is to develop and commercialize
products that advance human health and increase shareholder value.
For more information, please visit www.Bioniche.com.
Except for historical information, this news
release may contain "forward-looking statements" and
"forward-looking information" within the meaning of applicable
securities laws that reflect the Company's current expectation
regarding future events. Forward-looking statements and information
are necessarily based upon a number of estimates and assumptions
that, while, considered reasonable by management, are inherently
subject to significant business, economic and competitive
uncertainties and contingencies. Readers are cautioned that any
such forward-looking statements and information are not guarantees
and there can be no assurance that such statements and information
will prove to be accurate, and actual results and future events
could differ materially from those anticipated in such statements
and information. These forward-looking statements and information
involve risk and uncertainties, which may cause, but are not
limited to, changing market conditions, the successful and timely
completion of clinical studies, the establishment of corporate
alliances, the impact of competitive products and pricing, new
product development, uncertainties related to the regulatory
approval process, and other risks detailed from time to time in the
Company's ongoing quarterly and annual reporting. The Company
expressly disclaims any intention or obligation to update or revise
any forward-looking statements and information whether as a result
of new information, future events or otherwise. All written and
oral forward-looking statements and information attributable to us
or persons acting on our behalf are expressly qualified in their
entirety by the foregoing cautionary statements.
SOURCE Bioniche Life Sciences Inc.