- $101 million of new 2017 cash
inflows closed from debt, equity & corporate
transactions
- On-going review of plasminogen BLA with the U.S.
FDA
- 48-week clinical data from plasminogen phase 2/3 trial
confirms no recurrence of lesions, no safety or tolerability issues
observed.
- Concurrence from the FDA on the design of PBI-4050's planned
phase 2/3 pivotal clinical trial for Idiopathic Pulmonary
Fibrosis
- 24-week clinical data confirm efficacy and safety of
PBI-4050 maintained in metabolic syndrome & diabetic
patients
LAVAL, QC, Aug. 14, 2017 /CNW Telbec/ - Prometic
Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic)
announced today its unaudited financial results for the quarter and
the six month ended June 30,
2017.
"We are extremely pleased with the longer term clinical
performance of our plasminogen drug candidate in patients with
plasminogen deficiency. Proving sustained efficacy in 100% of these
patients in the trial also bodes well for the health economics
profile of Ryplazimâ„¢", stated Mr. Pierre
Laurin, President and Chief Executive Officer of Prometic.
"The performance of PBI-4050 in our IPF phase 2 clinical trial and
the efficacy also observed in other phase 2 trials with even longer
treatment exposure, support our chosen clinical indications and
regulatory pathways, and the initiation of our forthcoming Phase
2/3 pivotal clinical trials in IPF".
"Our second quarter 2017 financial results are in line with our
expectations and last few quarters. We have and will continue to
concentrate our efforts and resources on lower-risk clinical
programs and activities with the shortest possible regulatory
pathways and fastest timelines to value creation", mentioned Mr.
Bruce Pritchard, Prometic's Chief
Operating Officer and interim Chief Financial Officer. "The current
level of R&D and selling and marketing expenses is reflective
of the extensive commercial and manufacturing infrastructure
required to maximize commercial opportunities arising from our deep
product pipeline".
Following the departure of Mr. Greg
Weaver as Prometic's Chief Financial Officer, Mr.
Bruce Pritchard, Prometic's current
Chief Operating Officer, will also resume the Chief Financial
Officer's responsibilities in the interim until the appointment of
a new Chief Financial Officer, the search for whom is already
underway. Mr. Pritchard previously held the Chief Financial
Officer Position for 9 years.
Second Quarter 2017 Therapeutic Highlights
Plasma-Derived Therapeutics:
Plasminogen:
- The Corporation is responding diligently to all FDA requests in
relation to the BLA review. The Corporation will provide further
updates on the expected timeline of regulatory approval as soon as
available; and
- The Corporation provided further data to the FDA to support its
claims that the serious and life-threatening clinical
manifestations associated with congenital plasminogen deficiency
occurs predominantly in pediatric patients, as required to qualify
for a rare pediatric disease designation.
Small Molecule Therapeutics:
PBI-4050:
Idiopathic Pulmonary Fibrosis (IPF):
- The Corporation received concurrence from the FDA on the design
of the first of its PBI-4050's planned phase 2/3 clinical trials
for IPF based on the efficacy data generated in the recently
completed 40-patient Phase 2 open-label study.
Metabolic Syndrome
- The Corporation presented new results at the International
Liver Congress 2017 of the European Association for the Study of
the Liver on the positive effects of PBI-4050 on reduction of
non-alcoholic steatohepatitis ("NASH") in a mouse model of obesity
and metabolic syndrome; and
- The Corporation presented new data at the 2017 American
Diabetes Association's (ADA) 77th Scientific Sessions in
San Diego from the completed
metabolic syndrome Phase 2 trial which also showed that, after 12
weeks of treatment with PBI-4050, a statistically significant
reduction of microparticles shedding from the kidney in the
patients' urine was observed. Additional data demonstrated that the
positive clinical benefits observed at 12 weeks were sustained
after 24 weeks of treatment.
Second Quarter 2017 Corporate and Operational
Highlights
Corporate:
- The Corporation received a $9.5
million purchase order for the supply of affinity resin to
an existing client, a global leader in the biopharmaceutical
industry;
- The Corporation closed the follow-on investment from Structured
Alpha LP, an affiliate of Peter J.
Thomson's investment firm, Thomvest Asset Management Inc.,
consisting of a $25 million loan;
and
- The Corporation announced an agreement with Cantor Fitzgerald
Canada Corporation acting as a lead underwriter and sole
bookrunner, on its own behalf and on behalf of a syndicate of
underwriters under which the underwriters agreed to buy on a bought
deal basis, 31,250,000 common shares in the capital of the
Corporation at a price of $1.70 per
share for gross proceeds of $53.1
million. The offering closed on July
6, 2017 with substantial U.S. institutional investor
participation.
Subsequent highlights to Second Quarter 2017:
- The Corporation presented new long term clinical data from its
pivotal Phase 2/3 trial of Ryplazimâ„¢ (Plasminogen IV) regarding the
additional 36-week treatment period. The new data demonstrated that
its plasminogen treatment prevented the recurrence of lesions in
the 10 patients treated with RyplazimTM for a total of
48 weeks. No safety or tolerability issues related to this
longer-term dosing were observed; and
- The Corporation executed definitive agreements in relation to
the previously announced joint venture with affiliates of Shenzhen
Royal Asset Management Co., Ltd. (SRAM).
2017 Second Quarter Financial Results
The Corporation incurred a net loss of $31.5 million for the quarter ended June 30, 2017, compared to a net loss of
$24.6 million for the quarter ended
June 30, 2016 and to a net loss of
$29.1 million for the quarter ended
March 31, 2017. The
Corporation incurred a net loss of $60.6
million during the six months ended June 30, 2017 compared to $42.6 million during the six months ended
June 30, 2016. The increase in net
loss as compared to the second quarter of 2016 is mainly
attributable to higher R&D and Administrative, selling and
marketing expenses.
The Corporation incurred total R&D costs of $24.5 million for the quarter ended June 30, 2017 compared to $19.4 million for the second quarter of 2016 and
$24.3 million for the quarter ended
March 31, 2017. The Corporation
incurred total R&D costs of $48.8
million during the six months ended June 30, 2017 compared to $35.8 million during the six months ended
June 30, 2016. The overall R&D
expense is primarily driven by the plasma protein business, where
the Corporation is operating as its own proprietary end-to-end
source and supply, while the small molecule business is a much
smaller contributor to the expense growth.
The increase in R&D expense as compared to the second
quarter of 2016 is primarily due to the higher expenses related to
the manufacturing cost of therapeutics to be used in clinical
trials and for contract research organizations and investigators
reflecting the increase in patient enrollment; the costs incurred
in relation to the filing of the plasminogen BLA; the increase in
employee compensation costs and pre-clinical expenditures. The
manufacturing costs for therapeutics to be used in the
plasma-derived therapeutics phase 3 clinical trials represents
approximately 32% of the R&D expenses reported during the
quarter ended June 30, 2017.
Administrative, selling and marketing expenses amounted to
$8.1 million during the second
quarter of 2017, compared to $5.2
million for the quarter ended June
30, 2016 and $6.9 million
during the first quarter of 2017. Administrative, selling and
marketing expenses amounted to $15.0
million during the six months ended June 30, 2017 compared to $10.0 million during the six months ended
June 30, 2016. The increase as
compared to the second quarter of 2016 is due to an increase in
headcount and the related operating costs and an increase in
consulting expenses incurred in preparation for the plasminogen
launch.
Total revenues for the second quarter ended June 30, 2017 were $3.6
million compared to $3.3
million for the second quarter ended June 30, 2016, and total revenues of $4.9 million for the first quarter ended
March 31, 2017. Revenues from the
sale of goods amounted to $2.7
million for the second quarter ended June 30, 2017, compared to $2.5 million for the quarter ended June 30, 2016 and $4.4
million for the first quarter ended March 31, 2017. Total revenues for the six months
ended June 30, 2017 were $8.5 million at the same level as the comparative
period of 2016. The Corporation continues to anticipate revenue
growth from the sale of goods segment based on solid business
fundamentals and attributes quarter-to-quarter revenue variability
on the timing and scale of core customer orders.
Conference Call Information
Prometic will host a conference call at 11:00 am (EST) on Tuesday
August 15, 2017. The telephone numbers to access the
conference call are (647) 427-7450 and 1-888-231-8191 (Toll-free).
A replay of the call will be available from Tuesday August 15, 2017 at 2:00 pm until August 22,
2017. The numbers to access the replay are 1-416-849-0833
(passcode: 65097120) and 1-855-859-2056 (passcode: 65097120). A
live audio webcast of the conference call will be available through
the following :
http://event.on24.com/r.htm?e=1479907&s=1&k=35DE47AF154E64327899FF3DF5DB6903
Additional Information in Respect to the Second Quarter
2017
Prometic's MD&A and condensed interim consolidated financial
statements for the quarter ended June 30,
2017 will be filed on SEDAR (http://www.sedar.com) and will
be available on the Corporation's website at www.prometic.com.
About Prometic Life Sciences Inc.
Prometic Life Sciences Inc. (www.prometic.com) is a
long-established biopharmaceutical company with globally recognized
expertise in bioseparations, plasma-derived therapeutics and
small-molecule drug development. Prometic is also active in
developing its own novel small-molecule therapeutic products
targeting unmet medical needs in the field of fibrosis, cancer and
autoimmune diseases/inflammation. A number of plasma-derived and
small molecule products are under development for orphan drug
indications. Prometic offers its state of the art technologies for
large-scale purification of biologics, drug development, proteomics
and the elimination of pathogens to a growing base of industry
leaders and uses its own affinity technology that provides for
highly efficient extraction and purification of therapeutic
proteins from human plasma in order to develop best-in-class
therapeutics and orphan drugs. Headquartered in Laval (Canada), Prometic has R&D facilities
in the U.K., the U.S. and Canada, manufacturing facilities in the
U.K. and commercial activities in the U.S., Canada, Europe and Asia.
Forward Looking
Statements
This press release contains forward-looking statements about
Prometic's objectives, strategies and businesses that involve risks
and uncertainties. These statements are "forward-looking" because
they are based on our current expectations about the markets we
operate in and on various estimates and assumptions. Actual events
or results may differ materially from those anticipated in these
forward-looking statements if known or unknown risks affect our
business, or if our estimates or assumptions turn out to be
inaccurate. Such risks and assumptions include, but are not limited
to, Prometic's ability to develop, manufacture, and successfully
commercialize value-added pharmaceutical products, the availability
of funds and resources to pursue R&D projects, the successful
and timely completion of clinical studies, the ability of Prometic
to take advantage of business opportunities in the pharmaceutical
industry, uncertainties related to the regulatory process and
general changes in economic conditions. You will find a more
detailed assessment of the risks that could cause actual events or
results to materially differ from our current expectations in
Prometic's Annual Information Form for the year ended December 31, 2016, under the heading "Risk and
Uncertainties related to Prometic's business". As a result,
we cannot guarantee that any forward-looking statement will
materialize. We assume no obligation to update any forward-looking
statement even if new information becomes available, as a result of
future events or for any other reason, unless required by
applicable securities laws and regulations. All amounts are in
Canadian dollars unless indicated otherwise.
SOURCE ProMetic Life Sciences Inc.