Ceapro Inc. (TSX-V: CZO, OTCQX: CRPOF)
(“Ceapro” or the “Company”), a growth-stage biotechnology
company focused on the development and commercialization of active
ingredients for healthcare and cosmetic industries, today announced
operational highlights and financial results for the fourth quarter
and full year ended December 31, 2023.
“While the base business was significantly
impacted during 2023 due to various economic factors and
organizational changes within one major customer, we expect renewed
growth with our active ingredients base business and will continue
to focus our efforts in expanding our business model towards
nutraceutical and pharmaceutical sectors. We are very pleased with
progress made in the development of new products and technologies
such as the ongoing Phase 1-2a clinical trial with avenanthramides
and the very well-advanced 50L scale-up of the PGX Technology which
will enable the development and production of yeast beta glucan as
an immune modulator. Lastly, with our recent announcement of the
merger of equals with Aeterna Zentaris, we believe we are, more
than ever, positioned to significantly propel Ceapro into its next
phase of growth and unlock value as a biopharmaceutical company,”
stated Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro.
2023 Corporate and Operational
Highlights
Focus has been on development of
Avenanthramides, scale-up of the PGX Technology and development of
PGX-processed products.
Avenanthramides:
Clinical
- Significantly advanced
Phase 1 safety and tolerability study with healthy volunteers at
Montreal Heart Institute (MHI). Since commencing the dosing of
first patients in December 2023, five groups of 8 subjects per
group have completed the first arm of the Phase 1 with single
ascending doses (SAD) ranging from 30mg to 480mg per day. A Data
Safety Monitoring Board is to decide shortly regarding the
administration of the highest dose (960mg) as per approved protocol
by Health Canada. As no significant adverse reactions have been
observed so far, the Company expects to initiate the multiple
ascending dose (MAD) arm during the summer 2024 with three
additional groups of 8 subjects per group. This is the
first-in-human clinical study to assess safety, tolerability, and
pharmacokinetics of single and multiple ascending oral doses of
avenanthramides.
Formulation & Analytics
- In planning for the extension into
a Phase 2a clinical study, a second GMP clinical batch of the
selected 30mg and 240mg pill formulation of the drug product was
manufactured by Corealis Inc. GMP Manufacturing Services
(“Corealis”). Stability studies are ongoing.
- Bioassays for the detection of
avenanthramides in the blood and urine were successfully developed
with Altasciences Inc. Ceapro is the owner of these bioassays
currently used for the pharmacokinetics profile of
avenanthramides.
Pre-Clinical
- Announced positive findings
demonstrating oat derived beta glucan and avenanthramides promote
wound healing and tissue regeneration. These data were presented at
the 2023 Annual Meeting of the Wound Healing Society and were
published in the scientific journals “Current Developments in
Nutrition” in July 2023 and “Advances in Wound Care” in March
2024.
Avenanthramides Malted Technology
- Successfully scaled up the Malting
Technology at commercial-scale level. This will enable the
production of large quantities of avenanthramides powder for solid
formulations.
Technology:
PGX
- Decision made to use a stepwise
approach to ensure standardization of product specifications at
each scale level from 10 Liters to 50-100 Liters vessels. Scale-up
being done at the following locations:
- Edmonton Main Facility - PGX
Scale-Up 50 Liters Vessel: This project is almost completed. Three
trial runs of yeast beta glucan have been performed as part of the
last commissioning phase. Given that the Edmonton site license is
for natural products, yeast beta glucan produced from this facility
will be offered as a nutraceutical. Subject to approval by Health
Canada, this product could be launched by end of 2024.
- Natex Facility, Austria - PGX
Scale-Up 100 Liters Vessel: The project is on schedule. PGX
pressure vessel design is 100% completed. Initial safety and
regulatory risk assessment has also been completed. Commissioning
is expected to be completed by end of Q3 2024
PGX-Processed Products
Yeast Beta Glucan (YBG):
- Fully defined
specifications for the product to be further assessed and produced
for immune modulation properties as well as for potential inhalable
therapeutic for lung fibrotic diseases. Identified process
conditions for YBG improving morphology of YBG-processed using PGX
Technology (PGX-YBG) to boost immunomodulating activity. Progress
achieved for the pre-processing of YBG to ensure homogeneous
dispersion and deagglomeration of polymers and batch-to-batch
consistency. YBG is the product being used for the scale-up of the
PGX Technology.
- Announced on May
23, 2023 the completion of CHRP collaboration with McMaster
University with encouraging results evaluating PGX-processed YBG
for interstitial lung diseases. These results triggered
presentations at International scientific conferences confirming
that PGX-YBG is suitable for inhalation and can act through a newly
discovered mechanism of action through specific binding on white
blood cells (macrophages) involved in the inflammation and fibrotic
process. A comprehensive scientific article was recently submitted
to the Biomaterials scientific journal.
- Ongoing assessment as a potential
drug candidate for a Phase 1 clinical trial.
Whey Proteins:
- Using its PGX Technology, Ceapro
and University of Alberta researchers successfully processed in one
economical step a very complex mixture containing animal-based
proteins, and in particular whey proteins that are typically found
in liquid that remains after cheese production. While these
proteins are widely used in sport drinks, baked goods, meal
replacements, protein supplements and infant formulas due to their
recognized nutritional and functional properties, current
commercial purification processes require many steps and
considerable amounts of water. PGX Technology can be a very
efficient and economical alternative for this product
offering.
- Results from this ground-breaking
study were published in the Journal of Food Engineering in an
article titled “Single-step concentration of whey proteins using
the pressurized gas eXpanded (PGX) liquid technology: Effect on
physicochemical properties and scale-up,”. They will be presented
at the 20th European meeting on supercritical fluids being held May
26-29, 2024 in Maribor, Slovenia.
New Product - Chewable Oat Beta Glucan
(OBG):
- Ceapro’s team has successfully
developed a unique, standardized formulation for a healthy
confection which includes a high concentration of OBG with daily
dosage according to approved claims in 10 developed countries.
- Health Canada has approved Ceapro’s
Novel Nutraceutical Product (NPN 80127493). The substantive claims
derived from this approval include reduction of LDL cholesterol,
supporting cardiovascular health reduction of Type 2 diabetes
risks, source of fiber for the maintenance of general good health
and support of a healthy digestive system.
- Ceapro’s team anticipates the
official commercial launch of its approved natural health product
in H2 2024, marking an important chapter in the Company's journey
toward promoting wellness while expanding its business model.
Corporate
- Re-affirmed our partnership with
Symrise by extending a supply and distribution agreement until
December 31, 2026, and therefore securing the long-term
sustainability of Ceapro’s base business which should regrow.
- Appointed Mr. Michel Regnier as
Senior Vice-President, Technical Operations. Mr. Regnier is an
experienced and respected Operations Executive and Professional
Engineer with 20+ years of progressive technical and leadership
experience in the medical device, pharmaceutical and aerospace
materials manufacturing industries.
- Announced technical collaboration
with Austrian based NATEX Prozesstechnologie GmbH for the larger
scale-up of PGX Technology using yeast beta glucan.
- Announced merger of equals with Aeterna Zentaris to create a
diversified biopharmaceutical company.
Subsequent to Year End
- Announced on March
12, 2024 approval of merger with Aeterna Zentaris by
Securityholders at special meeting.
- Received on March
28, 2024 the final court approval for merger with Aeterna
Zentaris.
Financial Highlights for the Fourth
Quarter and Full Year 2023 Ended December 31, 2023
- Total sales of $1,650,000 for the
fourth quarter of 2023 and $9,633,000 for the full year of 2023
compared to $3,322,000 and $18,840,000 for the comparative periods
in 2022. The Company revenues have been significantly impacted by
the re-organization associated with the spinoff of the consumer
division of one major customer, which resulted in lag of new
ordering. In the first quarter of 2024, the customer has resumed
ordering from Ceapro.
- Net loss of $2,131,000 for the
fourth quarter of 2023 and a net loss of $4,710,000 for the full
year of 2023 compared to a net loss of $231,000 for the fourth
quarter 2022 and a net profit of 4,398,000 for the full year
2022.
- Cash used in operations of
$3,623,000 for the full year 2023 compared to Cash generated from
operations of $6,637,000 in 2022.
- Positive working capital balance of
$13,108,600 as of December 31, 2023.
“We expect to continue leveraging our base
business for the development of new products and technologies and
subject to the closing and successful integration with Aeterna
Zentaris, we expect to benefit from complementary competencies,
additional financial resources and expanded portfolio with revenue
generation product to accelerate the completion of our prioritized
projects while continuing to assess different market initiatives to
bring new business and unlock value in the near and long term,”
concluded Mr. Gagnon.
CEAPRO
INC. |
|
|
|
Consolidated
Balance Sheets |
|
|
|
|
|
|
|
|
December
31, |
December
31, |
|
|
2023 |
2022 |
|
|
$ |
$ |
|
|
|
|
|
ASSETS |
|
|
|
Current
Assets |
|
|
|
Cash |
8,843,742 |
13,810,998 |
|
Trade receivables |
167,295 |
2,820,300 |
|
Other receivables |
216,763 |
64,808 |
|
Inventories (note 3) |
5,308,987 |
3,757,040 |
|
Prepaid expenses and deposits |
310,191 |
135,133 |
|
|
|
|
|
Total Current Assets |
14,846,978 |
20,588,279 |
|
|
|
|
|
Non-Current
Assets |
|
|
|
Restricted cash |
10,000 |
- |
|
Investment tax credits receivable |
984,200 |
854,895 |
|
Deposits |
74,369 |
76,954 |
|
Licences (note 4) |
9,625 |
12,588 |
|
Property and equipment (note 5) |
15,421,884 |
16,201,755 |
|
Deferred tax assets (note 12 (b)) |
98,778 |
- |
|
|
|
|
|
Total Non-Current Assets |
16,598,856 |
17,146,192 |
|
|
|
|
|
TOTAL ASSETS |
31,445,834 |
37,734,471 |
|
|
|
|
|
LIABILITIES
AND EQUITY |
|
|
|
Current
Liabilities |
|
|
|
Accounts payable and accrued liabilities |
1,342,156 |
1,730,377 |
|
Current portion of lease liabilities (note 6) |
396,232 |
370,460 |
|
|
|
|
|
Total Current Liabilities |
1,738,388 |
2,100,837 |
|
|
|
|
|
Non-Current
Liabilities |
|
|
|
Long-term lease liabilities (note 6) |
1,852,345 |
2,248,577 |
|
Deferred tax liabilities (note 12 (b)) |
- |
1,095,968 |
|
|
|
|
|
Total Non-Current Liabilities |
1,852,345 |
3,344,545 |
|
|
|
|
|
TOTAL LIABILITIES |
3,590,733 |
5,445,382 |
|
|
|
|
|
Equity |
|
|
|
Share capital (note 7 (b)) |
16,721,867 |
16,694,625 |
|
Contributed surplus |
4,963,067 |
4,714,404 |
|
Retained earnings |
6,170,167 |
10,880,060 |
|
|
|
|
|
Total Equity |
27,855,101 |
32,289,089 |
|
|
|
|
|
TOTAL LIABILITIES AND EQUITY |
31,445,834 |
37,734,471 |
|
|
|
|
|
CEAPRO
INC. |
|
|
|
Consolidated Statements of Net (Loss) Income and Comprehensive
(Loss) Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
|
|
Years Ended December 31, |
$ |
$ |
|
|
|
|
|
Revenue
(note 14) |
9,633,400 |
|
18,839,607 |
|
|
Cost of goods sold |
5,677,211 |
|
7,821,908 |
|
|
|
|
|
|
Gross
margin |
3,956,189 |
|
11,017,699 |
|
|
|
|
|
|
Research and
product development |
2,751,473 |
|
1,788,666 |
|
|
General and
administration |
7,419,593 |
|
3,700,498 |
|
|
Sales and
marketing |
40,484 |
|
29,558 |
|
|
Finance costs (note 9) |
183,130 |
|
184,967 |
|
|
|
|
|
|
(Loss)
income from operations |
(6,438,491 |
) |
5,314,010 |
|
|
|
|
|
|
Other income (note 10) |
(533,852 |
) |
(462,905 |
) |
|
|
|
|
|
(Loss)
income before income taxes |
(5,904,639 |
) |
5,776,915 |
|
|
|
|
|
|
Deferred tax (benefit) expense (note 12 (a)) |
(1,194,746 |
) |
1,378,817 |
|
|
|
|
|
|
Net (loss) income and comprehensive (loss) income for the year |
(4,709,893 |
) |
4,398,098 |
|
|
|
|
|
|
Net (loss) income per common share (note 19): |
|
|
|
Basic |
(0.06 |
) |
0.06 |
|
|
Diluted |
(0.06 |
) |
0.06 |
|
|
|
|
|
|
Weighted average number of common shares outstanding (note
19): |
|
|
|
Basic |
78,272,574 |
|
77,961,714 |
|
|
Diluted |
78,272,574 |
|
78,582,083 |
|
|
|
|
|
|
CEAPRO
INC. |
|
|
Consolidated
Statements of Cash Flows |
|
|
|
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
|
Year Ended December 31, |
$ |
$ |
OPERATING
ACTIVITIES |
|
|
Net (loss) income for the year |
(4,709,893 |
) |
4,398,098 |
|
Adjustments for items not involving cash |
|
|
Finance costs |
128,130 |
|
129,967 |
|
Depreciation and amortization |
1,946,776 |
|
1,911,278 |
|
Deferred income tax (benefit) expense |
(1,194,746 |
) |
1,378,817 |
|
Share-based payments |
259,005 |
|
89,648 |
|
|
(3,570,728 |
) |
7,907,808 |
|
CHANGES IN
NON-CASH WORKING CAPITAL ITEMS |
|
|
Trade receivables |
2,653,005 |
|
(727,458 |
) |
Other receivables |
(151,955 |
) |
(18,958 |
) |
Investment tax credits receivable |
(129,305 |
) |
(88,266 |
) |
Inventories |
(1,551,947 |
) |
(1,432,955 |
) |
Prepaid expenses and deposits |
(172,473 |
) |
30,371 |
|
Accounts payable and accrued liabilities relating to operating
activities |
(571,430 |
) |
1,096,074 |
|
|
75,895 |
|
(1,141,192 |
) |
Net (loss) income for the year adjusted for non-cash and working
capital items |
(3,494,833 |
) |
6,766,616 |
|
Interest paid |
(128,130 |
) |
(129,967 |
) |
CASH (USED IN) GENERATED FROM OPERATIONS |
(3,622,963 |
) |
6,636,649 |
|
INVESTING
ACTIVITIES |
|
|
Purchase of property and equipment |
(980,733 |
) |
(388,821 |
) |
CASH USED IN INVESTING ACTIVITIES |
(980,733 |
) |
(388,821 |
) |
FINANCING
ACTIVITIES |
|
|
Stock options exercised |
16,900 |
|
81,290 |
|
Increase in restricted cash |
(10,000 |
) |
- |
|
Repayment of lease liabilities |
(370,460 |
) |
(299,109 |
) |
CASH USED IN FINANCING ACTIVITIES |
(363,560 |
) |
(217,819 |
) |
(Decrease)
increase in cash |
(4,967,256 |
) |
6,030,009 |
|
|
|
|
Cash at beginning of the year |
13,810,998 |
|
7,780,989 |
|
|
|
|
Cash at end of the year |
8,843,742 |
|
13,810,998 |
|
|
|
|
The complete financial statements are available
for review on SEDAR at https://sedar.com/Ceapro and on the
Company’s website at www.ceapro.com.
About Ceapro Inc.
Ceapro Inc. is a Canadian biotechnology company
involved in the development of proprietary extraction technology
and the application of this technology to the production of
extracts and “active ingredients” from oats and other renewable
plant resources. Ceapro adds further value to its extracts by
supporting their use in cosmeceutical, nutraceutical, and
therapeutics products for humans and animals. The Company has a
broad range of expertise in natural product chemistry,
microbiology, biochemistry, immunology and process engineering.
These skills merge in the fields of active ingredients,
biopharmaceuticals and drug-delivery solutions. For more
information on Ceapro, please visit the Company’s website at
www.ceapro.com.
Forward-looking information
The information in this news release has been
prepared as at April 24, 2024. Certain statements made herein,
including statements relating to matters that are not historical
facts and statements of the Company’s beliefs, intentions and
expectations about developments, results and events which will or
may occur in the future, constitute “forward-looking information”
within the meaning of applicable Canadian securities legislation.
Forward-looking information relates to future events or future
performance, reflect current expectations or beliefs regarding
future events and is typically identified by words such as “aim”,
“anticipate”, “assume”, “believe”, “continue”, “could”, “expect”,
“forecast”, “future”, “intend”, “maintain”, “may”, “outlook”,
“plan”, “potential”, “project”, “synergies”, “will”, and similar
expressions suggesting future outcomes or statements regarding an
outlook. Forward-looking information includes, but is not limited
to, statements with respect to the Arrangement, including the
expected timing and outcome of the Meeting, closing and various
other steps to be completed in connection with the Arrangement, and
other statements that are not historical facts, including the
Company’s ability to obtain regulatory approvals, including those
from health authorities, and to develop, introduce, and implement
new products as well as enhancements for existing products that
meet customer needs and product requirements in a timely
manner.
Forward-looking information is based upon
certain assumptions and other important factors that, if untrue,
could cause the actual results, performance or achievements of the
Company or the combined company to be materially different from
future results, performance or achievements expressed or implied by
such information. There can be no assurance that such information
will prove to be accurate. Such information being based on numerous
assumptions.
Readers are cautioned not to place undue
reliance on forward-looking information, which speak only as of the
date made. For a more detailed discussion of such risks and other
factors that may affect Ceapro’s ability to achieve the
expectations set forth in the forward-looking information contained
in this news release, see Ceapro’s management information circular
dated February 9, 2024, MD&A filed under Ceapro’s profile on
SEDAR+ at www.sedarplus.ca, as well as Ceapro’s other filings with
the Canadian securities regulators. Other than as required by law,
the Company does not intend, and does not assume any obligation to,
update the forward-looking information in this news release.
For more information contact:
Issuer:Gilles R. Gagnon, M.Sc., MBAPresident & CEOT:
780-421-4555
Neither TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release
Ceapro (TSXV:CZO)
過去 株価チャート
から 10 2024 まで 11 2024
Ceapro (TSXV:CZO)
過去 株価チャート
から 11 2023 まで 11 2024