UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE Ai-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For
the month of August, 2024
Commission
File Number: 001-38064
COSCIENS
Biopharma Inc.
(Translation
of registrant’s name into English)
c/o
Norton Rose Fulbright Canada, LLP, 222 Bay Street, Suite 3000, PO Box 53, Toronto ON M5K 1E7
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form
20-F ☒ Form 40-F ☐
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Exhibit
99.1 included with this Report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statements on Form
S-8 (No. 333-224737, No. 333-210561, No. 333-200834 and No. 333-279844) (collectively, the “Registration Statements”) and
shall be deemed to be a part thereof from the date on which this Report on Form 6-K is furnished, to the extent not superseded by documents
or reports subsequently filed or furnished. The information contained on any websites referenced in Exhibit 99.1 included with this Report
on Form 6-K is not incorporated by reference or deemed to be a part of this Report on Form 6-K or any of the Registration Statements.
Forward-Looking
Statements
The
information in this Report on Form 6-K and the exhibit attached hereto and incorporated herein by reference include forward-looking statements
within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, specifically Section 27A of the U.S. Securities Act
of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These forward-looking statements involve
a number of known and unknown risks, uncertainties and other factors that could cause actual results and outcomes to be materially different
from historical results or from any future results expressed or implied by such forward-looking statements.
Forward-looking
statements include, but are not limited to, those relating to the Company’s expectations regarding the anticipated benefits and
synergies as well as the assets, cost structure, financial position, cash flows and growth prospects of the combined company.
Risks
and factors that could cause actual results or outcomes to differ materially from expectations include, among others, the following:
| ● |
the
Company’s ability to raise capital and obtain financing to continue its currently planned operations; |
| ● |
the
Company’s ability to maintain compliance with the continued listing requirements of the NASDAQ and to maintain the listing
of its common shares on the NASDAQ; |
| ● |
the
Company’s ability to continue as a going concern, which is dependent, in part, on its ability to transfer cash from Aeterna
Zentaris GmbH to the Company and its U.S. subsidiary and to secure additional financing; |
| ● |
the
Company’s now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the
continued availability of funds and resources to successfully commercialize the product, including its heavy reliance on the success
of the license and assignment agreement with Novo Nordisk A/S; |
| ● |
the
Company’s ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other
pharmaceutical companies and keep such agreements in effect; |
| ● |
the
Company’s reliance on third parties for the manufacturing and commercialization of Macrilen™ (macimorelin); |
| ● |
potential
disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization
of the Company’s product candidates, or resulting in significant litigation or arbitration; |
| ● |
uncertainties
related to the regulatory process; |
| ● |
unforeseen
global instability, including the instability due to the global pandemic of the novel coronavirus; |
| ● |
the
Company’s ability to efficiently commercialize or out-license Macrilen™ (macimorelin); |
| ● |
the
Company’s reliance on the success of the pediatric clinical trial in the European Union (“E.U.”) and U.S. for Macrilen™
(macimorelin); |
| ● |
the
degree of market acceptance of Macrilen™ (macimorelin); |
| ● |
the
Company’s ability to obtain necessary approvals from the relevant regulatory authorities to enable it to use the desired brand
names for its product; |
| ● |
the
Company’s ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen™ (macimorelin); |
| ● |
any
evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such
alternative being pursued, and even if pursued, may not result in the anticipated benefits; |
| ● |
the
Company’s ability to protect its intellectual property; and |
| ● |
the
potential of liability arising from shareholder lawsuits and general changes in economic conditions. |
Additional
risk factors that could cause actual results to differ materially include those risks identified in Item 3. “Key Information –
Risk Factors” contained in the Company’s most recent Annual Report on Form 20-F filed with the SEC and its other filings
and submissions from time to time, including those containing its quarterly and annual results, with the SEC, which are available on
the Company’s website located at www.aeterna.com.
Many
of these risks and factors are beyond the Company’s control. The Company cautions you not to place undue reliance on these forward-looking
statements. All written and oral forward-looking statements attributable to the Company and/or Ceapro, Inc. or persons acting on their
behalf, are qualified in their entirety by these cautionary statements. Moreover, unless required by law to update these statements,
the Company will not necessarily update any of these statements after the date hereof, either to conform them to actual results or to
changes in their expectation.
DOCUMENTS
INDEX
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
| |
COSCIENS
Biopharma Inc. |
| |
|
|
| Date:
August 27, 2024 |
By: |
/s/
Giuliano La Fratta |
| |
|
Giuliano
La Fratta |
| |
|
Chief
Financial Officer |
Exhibit
99.1
COSCIENS
Biopharma Inc. Announces Top-Line Results of Phase 3 DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency
- Top-line data with unexpected results requiring further clarification, did not meet primary endpoint as per protocol
- Potent growth hormone release following macimorelin stimulation
- Safety of macimorelin confirmed in the pediatric population
TORONTO,
ONTARIO, August 27, 2024 – COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”),
a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products
and active ingredients for healthcare and cosmetics industries, today announced the top-line results of its Phase 3 safety and efficacy
study AEZS-130-P02 (the “DETECT-trial”) evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency
(“CGHD”).
While
top-line data show that macimorelin repeatedly demonstrated its capacity to stimulate growth hormone release as required to perform a
growth hormone stimulation test, the primary efficacy endpoint for the DETECT-trial has not been met according to the definitions in
the study protocol. In the study, the macimorelin test was compared to current standard growth hormone stimulation tests (arginine and
clonidine). Although further analysis of the study results is required, initial review of the results indicates that the comparator tests
may have led to a high false positive rate which impacted macimorelin’s ability to reach the primary efficacy endpoint. These unexpected
results require further clarification and some re-analyses with the aim to consider the trial outcome and the strategy moving forward.
The
DETECT-trial was an international, multicenter safety and efficacy trial on macimorelin in a dose of 1.0 mg/kg body weight. The trial
was conducted at clinical sites across the USA, Armenia, Georgia, Germany, Italy, Serbia, Slovakia, Poland, Romania, and Turkey. Following
the screening period of Visit 1, the macimorelin test was conducted at Visit 2 and repeated at Visit 5, with blood samples being taken
for Pharmacokinetic (PK) and Pharmacodynamic (PD) data at predefined times. At Visit 3 and Visit 4, an arginine test and a clonidine
test were performed in a randomized order as standard growth hormone stimulation tests (GHSTs) to be compared with macimorelin. Visit
6 was a safety follow-up at study end. An independent external expert panel had been established to adjudicate the final growth hormone
deficiency status of a child (i.e., child ill or child healthy) based on all medical data collected as well as the outcome of the two
standard GHSTs.
“The
top-line results confirm the excellent safety of macimorelin, similar to what was demonstrated in our clinical and commercial experience
with the use of macimorelin to diagnose adult growth hormone deficiency (AGHD). However, it was surprising to see that many subjects,
who had been adjudicated as ill (growth hormone deficient) according to the comparator tests arginine and clonidine, showed high growth
hormone stimulation following macimorelin. Our team will be further analyzing the detailed data from the DETECT-trial to gain insights
into the reasons behind these unexpected results” commented Nicola Ammer, Chief Medical Officer of the Company.
The
completed study enrolled 102 subjects aged 3 to 17 years. The outcome of an independent adjudication of each subject was used to define
the “true” GHD status (i.e., child ill or child healthy) at the end of the trial. Based on this, top-line data present an
‘optimal’ growth hormone (GH) cut-off point of 25.59 ng/mL, which is substantially higher than the standard cut-off points
of 7-10 ng/mL as defined in current guidelines with existing tests. This surprisingly high cut-off point leads to a failure in the sensitivity
and specificity assessments. Sensitivity as well as specificity are important parameters characterizing the performance of a diagnostic
test, as they show a test’s capabilities to identify ill subjects as being ill (sensitivity) and to identify healthy subjects as
being healthy (specificity), respectively.
“While
we expect the top-line data of our DETECT-trial to be further analyzed and discussed with health authorities, macimorelin is approved
in the USA and continues to be marketed in Europe for AGHD. As we get the results of further analysis of the DETECT-trial we will be
considering our action plan for macimorelin. In addition, we will continue our ongoing review and prioritization process for COSCIENS’
pipeline. Our goal remains to focus our resources and cash on those programs and products that we believe will propel the Company to
its next phase of growth as a diversified biopharmaceutical company,” added Gilles Gagnon, Chief Executive Officer of the Company.
“We would like to thank everyone involved in the DETECT-trial and especially the extraordinary engagement of the children enrolled
in the study and their parents, as well as the excellent efforts of the clinical sites and our team members involved.”
The
DETECT-trial was the second study needed to evaluate the potential use of macimorelin as diagnostic test in children as agreed upon with
the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the Company’s Pediatric Investigation Plan.
Full trial result reporting is expected to occur later this year.
For
more information about the DETECT-trial, please visit EU Clinical Trials Register and reference EudraCT #2018-001988-23 and clinicaltrials.gov
identifier NCT04786873.
About
Macimorelin (Macrilen®; GHRYVELIN®)
Macimorelin,
an oral drug used for the diagnosis of adult growth hormone deficiency (AGHD) is approved for marketing under the brand name GHRYVELIN®
in the European Economic Area and Macrilen® in the United States, South Korea and Israel.
Macimorelin
(Macrilen®; GHRYVELIN®), a ghrelin receptor agonist, is an orally administered peptidomimetic molecule
that stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples
taken after oral administration of macimorelin for the assessment of AGHD. Approval of macimorelin for use in adult was granted by the
FDA in 2017 and by the EMEA in 2019, based on Phase III data showing that oral macimorelin provides accuracy comparable to that of standard
insulin tolerance testing (ITT), but has a more favorable safety profile compared to ITT. Oral macimorelin also reduces false positive
test results, helping to avoid unnecessary treatment of patients.
About
COSCIENS Biopharma Inc.
COSCIENS
is a specialty biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of pharmaceutical and
diagnostic products, including those focused on areas of significant unmet medical need. One of CONSCIENS’ lead products is macimorelin
(Macrilen®; Ghryvelin®), the first and only U.S. FDA and European Medicines Agency approved
oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). COSCIENS is also engaged in the development of therapeutic
assets and proprietary extraction technology, which is applied to the production of active ingredients from renewable plant resources
currently used in cosmeceutical products (i.e., oat beta glucan and avenanthramides which are found in leading skincare product brands
like Aveeno and Burt’s Bees formulations) and being developed as potential nutraceuticals and/or pharmaceuticals.
The
company is listed on the NASDAQ Capital Market and the Toronto Stock Exchange, and trades on both exchanges under the ticker symbol “CSCI”.
For more information, please visit COSCIENS’ website at www.cosciensbio.com.
Forward-Looking
Statements
The
information in this news release has been prepared as of August 27, 2024. Certain statements in this news release, referred to herein
as “forward-looking statements”, constitute “forward-looking statements” within the meaning of the United States
Private Securities Litigation Reform Act of 1995, as amended, and “forward-looking information” under the provisions of Canadian
securities laws. All statements, other than statements of historical fact, that address circumstances, events, activities, or developments
that could or may or will occur are forward-looking statements. When used in this news release, words such as “anticipate”,
“assume”, “believe”, “could”, “expect”, “forecast”, “future”,
“goal”, “guidance”, “intend”, “likely”, “may”, “would” or the
negative or comparable terminology as well as terms usually used in the future and the conditional are generally intended to identify
forward-looking statements, although not all forward-looking statements include such words. Forward-looking statements in this news release
include, but are not limited to, statements relating to: the timing for the release of the full results from the DETECT-trial; our consideration
of our action plan for macimorelin; and our ongoing review and prioritization process for COSCIENS’ pipeline.
Forward-looking
statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by the Company as of the
date of such statements, are inherently subject to significant business, economic, operational and other risks, uncertainties, contingencies
and other factors, including those described below, which could cause actual results, performance or achievements of the combined Company
to be materially different from results, performance or achievements expressed or implied by such forward-looking statements and, as
such, undue reliance must not be placed on them.
Forward-looking
statements involve known and unknown risks and uncertainties which include, among others: the combined Company’s present and future
business strategies; operations and performance within expected ranges; anticipated future cash flows; local and global economic conditions
and the environment in which the combined Company operates; anticipated capital and operating costs; uncertainty in our revenue generation
from our marketed products, product development and related clinical trials and validation studies, including as a result of the DETECT-trial
for Macrilen™ (macimorelin) not meeting its primary endpoint; results from our other products under development may not be successful
or may not support advancing the product; our ability to raise capital and obtain financing to continue our currently planned operations;
our now heavy dependence on sales by and revenue from our main distributor of our legacy Ceapro products (including AVA and OBG) and
its customers; the continued availability of funds and resources to successfully commercialize products; the ability to secure strategic
partners for late stage development, marketing, and distribution of our products, including our ability to enter into a new license agreement
or similar arrangement following the termination of the license agreement with Novo Nordisk AG for rights to Macrilen™ in North
America; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical
companies and keep such agreements in effect; our ability to protect and enforce our patent portfolio and intellectual property; and
our ability to continue to list our common shares on the NASDAQ Capital Market.
Investors
should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks
and uncertainties, including those discussed in our Annual Report on Form 20-F and MD&A filed under the Company’s profile on
SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. We disclaim any obligation to update any such risks or uncertainties or to publicly
announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless
required to do so by a governmental authority or applicable law.
No
securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts
no responsibility for the adequacy or accuracy of this news release.
Issuer:
Gilles
R. Gagnon
President
& CEO
ggagnon@ceapro.com
+1
(780) 421-4555
Investor
Contact:
Jenene
Thomas
JTC
Team
T
(US): +1 (833) 475-8247
E:
csci@jtcir.com
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