(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.
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.