UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For
the month of August 2023
Commission
File Number: 001-38064
Aeterna
Zentaris 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 [X] 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):
Exhibits
99.1 and 99.2 included with this report on Form 6-K are hereby incorporated by reference into the Registrant’s Registration Statements
on Forms S-8 (No. 333-224737, No. 333-210561 and No. 333-200834), Forms F-3 (No. 333-254680) and Forms F-1 (No.333-239264, No. 333-248561
and No. 333-239019) and shall be deemed to be a part thereof from the date on which this report is furnished, to the extent not superseded
by documents or reports subsequently filed or furnished.
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.
|
|
AETERNA
ZENTARIS INC. |
|
|
|
|
Date:
August 9, 2023 |
|
By: |
/s/
Klaus Paulini |
|
|
|
Klaus
Paulini |
|
|
|
President
and Chief Executive Officer |
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Exhibit 99.1
Aeterna
Zentaris Inc.
Condensed Interim Consolidated Financial Statements
As of June 30, 2023, and for the three and six months ended
June 30, 2023, and 2022
(In thousands of US dollars)
(Unaudited)
Aeterna
Zentaris Inc.
Condensed
Interim Consolidated Statements of Financial Position
(In
thousands of US dollars)
(Unaudited)
| |
As of
June 30,
2023 | | |
As of
December 31,
2022 | |
| |
$ | | |
$ | |
ASSETS | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
| 42,186 | | |
| 50,611 | |
Trade and other receivables | |
| 185 | | |
| 732 | |
Inventory | |
| 93 | | |
| 229 | |
Income taxes receivable | |
| 792 | | |
| 1,428 | |
Prepaid expenses and other current assets | |
| 2,637 | | |
| 2,488 | |
Total current assets | |
| 45,893 | | |
| 55,488 | |
| |
| | | |
| | |
Non-current assets | |
| | | |
| | |
Restricted cash equivalents | |
| 325 | | |
| 322 | |
Property and equipment | |
| 265 | | |
| 216 | |
Total non-current assets | |
| 591 | | |
| 538 | |
Total assets | |
| 46,483 | | |
| 56,026 | |
| |
| | | |
| | |
LIABILITIES | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Payables and accrued liabilities | |
| 3,572 | | |
| 3,828 | |
Provisions | |
| 49 | | |
| 45 | |
Income taxes payable | |
| 109 | | |
| 108 | |
Deferred revenues (note 3) | |
| 202 | | |
| 2,949 | |
Lease liabilities | |
| 145 | | |
| 114 | |
Total current liabilities | |
| 4,077 | | |
| 7,044 | |
| |
| | | |
| | |
Non-current liabilities | |
| | | |
| | |
Deferred revenues (note 3) | |
| 1,580 | | |
| 1,684 | |
Deferred gain | |
| 111 | | |
| 110 | |
Lease liabilities | |
| 85 | | |
| 65 | |
Employee future benefits (note 4) | |
| 11,381 | | |
| 11,159 | |
Provisions | |
| 170 | | |
| 188 | |
Total non-current liabilities | |
| 13,327 | | |
| 13,206 | |
Total liabilities | |
| 17,404 | | |
| 20,250 | |
| |
| | | |
| | |
Shareholders’ equity | |
| | | |
| | |
Share capital (note 5) | |
| 293,410 | | |
| 293,410 | |
Warrants | |
| 5,085 | | |
| 5,085 | |
Contributed surplus | |
| 90,654 | | |
| 90,332 | |
Deficit | |
| (358,936 | ) | |
| (352,084 | ) |
Accumulated other comprehensive loss | |
| (1,134 | ) | |
| (967 | ) |
Total Shareholders’ equity | |
| 29,079 | | |
| 35,776 | |
Total liabilities and shareholders’ equity | |
| 46,483 | | |
| 56,026 | |
Commitments
(note 9)
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
Approved
by the Board of Directors
/s/
Carolyn Egbert |
|
/s/
Dennis Turpin |
Carolyn Egbert, Chair of
the Board |
|
Dennis Turpin, Director |
Aeterna
Zentaris Inc.
Condensed
Interim Consolidated Statements of Changes in Shareholders’ Equity
For
the six months ended June 30, 2023, and 2022
(In
thousands of US dollars)
(Unaudited)
| |
Share capital | | |
Warrants | | |
Contributed surplus | | |
Deficit | | |
Accumulated other comprehensive loss | | |
Total | |
| |
$ | | |
$ | | |
$ | | |
$ | | |
$ | | |
$ | |
Balance – January 1, 2023 | |
| 293,410 | | |
| 5,085 | | |
| 90,332 | | |
| (352,084 | ) | |
| (967 | ) | |
| 35,776 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (6,772 | ) | |
| - | | |
| (6,772 | ) |
Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation adjustments | |
| - | | |
| - | | |
| - | | |
| - | | |
| (167 | ) | |
| (167 | ) |
Actuarial loss on defined benefit plans (note 4) | |
| - | | |
| - | | |
| - | | |
| (80 | ) | |
| - | | |
| (80 | ) |
Comprehensive loss | |
| | | |
| | | |
| | | |
| (6,852 | ) | |
| (167 | ) | |
| (7,019 | ) |
Share-based compensation costs | |
| - | | |
| - | | |
| 322 | | |
| - | | |
| - | | |
| 322 | |
Balance – June 30, 2023 | |
| 293,410 | | |
| 5,085 | | |
| 90,654 | | |
| (358,936 | ) | |
| (1,134 | ) | |
| 29,079 | |
| |
Share capital | | |
Warrants | | |
Contributed surplus | | |
Deficit | | |
Accumulated other comprehensive loss | | |
Total | |
| |
$ | | |
$ | | |
$ | | |
$ | | |
$ | | |
$ | |
Balance – January 1, 2022 | |
| 293,410 | | |
| 5,085 | | |
| 89,788 | | |
| (334,619 | ) | |
| (678 | ) | |
| 52,986 | |
Balance – Value | |
| 293,410 | | |
| 5,085 | | |
| 89,788 | | |
| (334,619 | ) | |
| (678 | ) | |
| 52,986 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (6,856 | ) | |
| - | | |
| (6,856 | ) |
Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation adjustments | |
| - | | |
| - | | |
| - | | |
| - | | |
| 79 | | |
| 79 | |
Actuarial gain on defined benefit plans | |
| - | | |
| - | | |
| - | | |
| 8,025 | | |
| - | | |
| 8,025 | |
Comprehensive income | |
| | | |
| | | |
| | | |
| 1,169 | | |
| 79 | | |
| 1,248 | |
Comprehensive income (loss) | |
| | | |
| | | |
| | | |
| 1,169 | | |
| 79 | | |
| 1,248 | |
Share-based compensation costs | |
| - | | |
| - | | |
| 60 | | |
| - | | |
| - | | |
| 60 | |
Balance – June 30, 2022 | |
| 293,410 | | |
| 5,085 | | |
| 89,848 | | |
| (333,450 | ) | |
| (599 | ) | |
| 54,294 | |
Balance – Value | |
| 293,410 | | |
| 5,085 | | |
| 89,848 | | |
| (333,450 | ) | |
| (599 | ) | |
| 54,294 | |
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
Aeterna
Zentaris Inc.
Condensed
Interim Consolidated Statements of Loss and Comprehensive Loss
For
the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data)
(Unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended
June 30, | | |
Six months ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Revenues (note 3) | |
| 2,246 | | |
| (222 | ) | |
| 4,374 | | |
| 1,295 | |
| |
| | | |
| | | |
| | | |
| | |
Expenses | |
| | | |
| | | |
| | | |
| | |
Cost of sales | |
| 139 | | |
| 13 | | |
| 156 | | |
| 92 | |
Research and development | |
| 2,929 | | |
| 2,398 | | |
| 6,941 | | |
| 4,788 | |
Selling, general and administrative | |
| 2,033 | | |
| 2,083 | | |
| 4,339 | | |
| 3,944 | |
Total expenses | |
| 5,101 | | |
| 4,494 | | |
| 11,436 | | |
| 8,824 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (2,855 | ) | |
| (4,716 | ) | |
| (7,062 | ) | |
| (7,529 | ) |
| |
| | | |
| | | |
| | | |
| | |
Gain (loss) due to changes in foreign currency exchange rates | |
| 27 | | |
| 502 | | |
| (32 | ) | |
| 676 | |
Interest income | |
| 307 | | |
| - | | |
| 320 | | |
| - | |
Other finance income (costs) | |
| 3 | | |
| (2 | ) | |
| 2 | | |
| (3 | ) |
Net finance income | |
| 337 | | |
| 500 | | |
| 290 | | |
| 673 | |
| |
| | | |
| | | |
| | | |
| | |
Loss before income taxes | |
| (2,518 | ) | |
| (4,216 | ) | |
| (6,772 | ) | |
| (6,856 | ) |
| |
| | | |
| | | |
| | | |
| | |
Income tax recovery | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
| (2,518 | ) | |
| (4,216 | ) | |
| (6,772 | ) | |
| (6,856 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
Items that may be reclassified subsequently to profit or loss: | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation adjustments | |
| 3 | | |
| 42 | | |
| (167 | ) | |
| 79 | |
Items that will not be reclassified to profit or loss: | |
| | | |
| | | |
| | | |
| | |
Actuarial gain on defined benefit plans (note 4) | |
| 83 | | |
| 5,276 | | |
| (80 | ) | |
| 8,025 | |
Comprehensive (loss) income | |
| (2,432 | ) | |
| 1,102 | | |
| (7,019 | ) | |
| 1,248 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share (note 7) | |
| (0.52 | ) | |
| (0.87 | ) | |
| (1.39 | ) | |
| (1.41 | ) |
Basic loss per share (note 7) | |
| (0.52 | ) | |
| (0.87 | ) | |
| (1.39 | ) | |
| (1.41 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of shares outstanding (basic and diluted) | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | |
Weighted average number of shares outstanding, basic | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | |
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
Aeterna
Zentaris Inc.
Condensed
Interim Consolidated Statements of Cash Flows
For
the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars)
(Unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Cash flows from operating activities | |
| | | |
| | | |
| | | |
| | |
Net loss for the period | |
| (2,518 | ) | |
| (4,216 | ) | |
| (6,772 | ) | |
| (6,856 | ) |
Items not affecting cash and cash equivalents: | |
| | | |
| | | |
| | | |
| | |
Provisions | |
| 18 | | |
| 7 | | |
| 10 | | |
| 5 | |
Depreciation and amortization | |
| 44 | | |
| 35 | | |
| 84 | | |
| 71 | |
Share-based compensation costs | |
| 306 | | |
| 33 | | |
| 323 | | |
| 60 | |
Employee future benefits | |
| 130 | | |
| 98 | | |
| 265 | | |
| 197 | |
Amortization of deferred revenues | |
| (794 | ) | |
| 124 | | |
| (1,554 | ) | |
| (704 | ) |
Net foreign exchange differences | |
| (9 | ) | |
| (513 | ) | |
| (1 | ) | |
| (687 | ) |
Other non-cash items | |
| 5 | | |
| 495 | | |
| 5 | | |
| 509 | |
Refund (payment) of income taxes | |
| 647 | | |
| (51 | ) | |
| 647 | | |
| 830 | |
Changes in operating assets and liabilities (note 6) | |
| (2,122 | ) | |
| (862 | ) | |
| (1,361 | ) | |
| 264 | |
Net cash used in operating activities | |
| (4,293 | ) | |
| (4,850 | ) | |
| (8,354 | ) | |
| (6,311 | ) |
| |
| | | |
| | | |
| | | |
| | |
Cash flows from financing activities | |
| | | |
| | | |
| | | |
| | |
Payments on lease liabilities | |
| (42 | ) | |
| (34 | ) | |
| (80 | ) | |
| (68 | ) |
Net cash used in financing activities | |
| (42 | ) | |
| (34 | ) | |
| (80 | ) | |
| (68 | ) |
| |
| | | |
| | | |
| | | |
| | |
Cash flows from investing activities | |
| | | |
| | | |
| | | |
| | |
Purchase of property and equipment | |
| (3 | ) | |
| (42 | ) | |
| (5 | ) | |
| (48 | ) |
Net cash used in investing activities | |
| (3 | ) | |
| (42 | ) | |
| (5 | ) | |
| (48 | ) |
| |
| | | |
| | | |
| | | |
| | |
Effect of exchange rate changes on cash and cash equivalents | |
| (36 | ) | |
| (513 | ) | |
| 14 | | |
| (716 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net change in cash and cash equivalents | |
| (4,374 | ) | |
| (5,439 | ) | |
| (8,425 | ) | |
| (7,143 | ) |
Cash and cash equivalents – Beginning of period | |
| 46,560 | | |
| 63,596 | | |
| 50,611 | | |
| 65,300 | |
Cash and cash equivalents – End of period | |
| 42,186 | | |
| 58,157 | | |
| 42,186 | | |
| 58,157 | |
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
1. Business overview
Summary
of business
Aeterna
Zentaris is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s
lead product, Macrilen® (macimorelin), is the first and only U.S. Food and Drug Administration (“FDA”) and
European Medicines Agency (“EMA”) approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency
(“AGHD”). Macimorelin is currently marketed under the tradename Ghryvelin™ in the European Economic Area and the United
Kingdom through an exclusive licensing agreement with Pharmanovia. The Company’s several other license and commercialization partners
are also seeking approval for commercialization of macimorelin in Israel and the Palestinian Authority, the Republic of Korea, Turkey
and several non-European Union Balkan countries. The Company is actively pursuing business development opportunities for the commercialization
of macimorelin in North America, Asia and the rest of the world.
The
Company is also dedicated to the development of therapeutic assets and has taken steps to establish a pre-clinical pipeline to potentially
address unmet medical needs across several indications with a focus on rare or orphan indications.
These
unaudited condensed interim consolidated financial statements were approved by the Board of Directors (the “Board”) on August
8, 2023.
2. Basis of presentation
These
unaudited condensed interim consolidated financial statements have been prepared in accordance with IAS 34, Interim Financial Reporting
as issued by the International Accounting Standards Board.
The
unaudited condensed interim consolidated financial statements do not include all the notes normally included in annual consolidated financial
statements. Accordingly, these unaudited condensed interim consolidated financial statements should be read in conjunction with the Company’s
annual consolidated financial statements as of and for the year ended December 31, 2022.
The
accounting policies used in these condensed interim consolidated financial statements are consistent with those presented in the Company’s
annual consolidated financial statements.
New
standards and amendments
Effective
January 1, 2023, the Company adopted the Disclosure of Accounting Policies (amendments to IAS 1 and IFRS Practice Statement 2). The amendments
to IAS 1 require that the Company discloses its material accounting policies instead of its significant accounting policies. As a result
of the adoption of these amendments, there were no adjustments to the presentation or amounts recognized in the interim financial statements.
Critical
accounting estimates and judgements
The
preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgements, estimates
and assumptions that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and related disclosures.
Judgements, estimates and assumptions are based on historical experience, expectations, current trends and other factors that management
believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements are prepared.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Management
reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgements in order to ensure that the
condensed interim consolidated financial statements are presented fairly and in accordance with IFRS applicable to interim financial
statements. Critical accounting estimates and assumptions, as well as critical judgements used in applying accounting policies in the
preparation of the Company’s condensed interim consolidated financial statements, were the same as those applied to the Company’s
annual consolidated financial statements as of and for the year ended December 31, 2022.
3. Revenue
The
Company derives revenue from the transfer of goods and services over time and at a point in time in the following categories:
Summary
of revenue from transfer of goods and services
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
License fees | |
| 795 | | |
| (206 | ) | |
| 1,554 | | |
| 226 | |
Development services | |
| 1,402 | | |
| (77 | ) | |
| 2,741 | | |
| 889 | |
Product sales | |
| - | | |
| - | | |
| - | | |
| 57 | |
Royalties | |
| 7 | | |
| 24 | | |
| 26 | | |
| 43 | |
Supply chain | |
| 42 | | |
| 37 | | |
| 53 | | |
| 80 | |
Total | |
| 2,246 | | |
| (222 | ) | |
| 4,374 | | |
| 1,295 | |
The
Company recorded revenue for the transfer of services over time for the three-months ended June 30, 2023, of $2,197 (2022 – ($283))
and the six-months ended June 30, 2023, of $4,295 (2022 - $1,115). While revenue recorded at a point in time for the three-months ended
June 30, 2023, was $49 (2022 – $61) and the six-months ended June 30, 2023, was $79 (2022 - $180).
Pharmanovia:
On
March 15, 2023, with the Company’s consent, Consilient Health (“CH”) entered into an assignment agreement with Pharmanovia
to transfer the current licensing agreement for the commercialization of macimorelin in the European Economic Area and the United Kingdom
to Pharmanovia, as well as the current supply agreement pursuant to which the Company agreed to provide the licensed product (together,
the “Assignment Agreement”). Also on March 15, 2023, the Company and Pharmanovia entered into an amendment agreement, pursuant
to which the Company provided its acknowledgement and consent to the Assignment Agreement and agreed to certain amended terms which do
not materially differ from the previous license and supply agreement with CH. Subsequent to the execution of the Assignment Agreement,
the aggregate amount of the transaction price allocated to the Company’s unsatisfied performance obligations was $1,658 (€1,540),
comprised of; the combined adult indication performance obligation of $1,233 (€1,145), and the combined pediatric indication performance
obligation of $425 (€395). The Company will continue to recognize revenue over time using an output method based on units of licensed
product supplied to Pharmanovia. The total units that the Company expects to supply to Pharmanovia is an estimate, based on current projections
and anticipated market demand, and therefore will be a significant judgement that will be relied upon when using the outputs method to
recognize revenue.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Novo
Nordisk Health Care AG:
On
August 26, 2022, Novo provided the Company with a notice of termination of the Novo Amendment. Under the terms of the Novo Amendment,
the termination was effective May 23, 2023, upon the completion of a 270-day notice period (“notice period”). Upon termination,
the rights and licenses granted by the Company to Novo under the Novo Amendment returned to the Company, and the Company regained full
rights to continue the clinical development and future commercialization of Macrilen™. Following the notice of termination and
throughout the 270-day notice period, as per the terms of the Novo Amendment, Novo continued to fund DETECT-trial costs up to $10.1 million
(€9.4 million). As of May 23, 2023, the Company recognized all remaining license fees associated with the Pediatric indication and
development services revenue previously recorded in deferred revenue.
Liabilities
related to contracts with customers
The
following table provides a summary of deferred revenue balances:
Summary
of deferred revenue
| |
June 30, 2023 | |
| |
Current | | |
Non-current | | |
Total | |
| |
$ | | |
$ | | |
$ | |
Novo Nordisk Health Care | |
| - | | |
| - | | |
| - | |
Pharmanovia | |
| 193 | | |
| 1,459 | | |
| 1,652 | |
NK Meditech | |
| 9 | | |
| 121 | | |
| 130 | |
| |
| 202 | | |
| 1,580 | | |
| 1,782 | |
| |
December 31, 2022 | |
| |
Current | | |
Non-current | | |
Total | |
| |
$ | | |
$ | | |
$ | |
Novo Nordisk Health Care | |
| 2,914 | | |
| - | | |
| 2,914 | |
Consilient Health | |
| 35 | | |
| 1,556 | | |
| 1,591 | |
NK Meditech | |
| - | | |
| 128 | | |
| 128 | |
| |
| 2,949 | | |
| 1,684 | | |
| 4,633 | |
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
4. Employee future benefits
The
change in the Company’s employee future benefit obligations is summarized as follows:
Summary
of net defined benefit liability asset
| |
benefit plans | | |
benefit plans | | |
Total | | |
Total | |
| |
Six months ended June 30, 2023 | | |
Year ended
December 31,
2022 | |
| |
Pension | | |
Other | | |
| | |
| |
| |
benefit plans | | |
benefit plans | | |
Total | | |
Total | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Change in plan liabilities | |
| | | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| 21,657 | | |
| 93 | | |
| 21,750 | | |
| 29,412 | |
Current service cost | |
| 63 | | |
| 6 | | |
| 69 | | |
| 142 | |
Interest cost | |
| 400 | | |
| 2 | | |
| 402 | | |
| 295 | |
Actuarial loss (gain) from changes in financial assumptions | |
| 143 | | |
| - | | |
| 143 | | |
| (5,915 | ) |
Benefits paid | |
| (380 | ) | |
| - | | |
| (380 | ) | |
| (752 | ) |
Impact of foreign exchange rate changes | |
| 261 | | |
| 1 | | |
| 262 | | |
| (1,432 | ) |
Balances – End of the period | |
| 22,144 | | |
| 102 | | |
| 22,246 | | |
| 21,750 | |
| |
| | | |
| | | |
| | | |
| | |
Change in plan assets | |
| | | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| 10,591 | | |
| - | | |
| 10,591 | | |
| 11,927 | |
Interest income from plan assets | |
| 198 | | |
| - | | |
| 198 | | |
| 120 | |
Employer contributions | |
| 14 | | |
| - | | |
| 14 | | |
| 45 | |
Employee contributions | |
| 8 | | |
| - | | |
| 8 | | |
| 10 | |
Benefits paid | |
| (136 | ) | |
| - | | |
| (136 | ) | |
| (247 | ) |
Remeasurement of plan assets | |
| 63 | | |
| - | | |
| 63 | | |
| (641 | ) |
Impact of foreign exchange rate changes | |
| 127 | | |
| - | | |
| 127 | | |
| (623 | ) |
Balances – End of the period | |
| 10,865 | | |
| - | | |
| 10,865 | | |
| 10,591 | |
| |
| | | |
| | | |
| | | |
| | |
Net liability of the unfunded plans | |
| 10,867 | | |
| 102 | | |
| 10,969 | | |
| 10,787 | |
Net liability of the funded plans | |
| 412 | | |
| - | | |
| 412 | | |
| 372 | |
Net amount recognized as Employee future benefits | |
| 11,279 | | |
| 102 | | |
| 11,381 | | |
| 11,159 | |
| |
| | | |
| | | |
| | | |
| | |
Amounts recognized: | |
| | | |
| | | |
| | | |
| | |
In net loss | |
| 257 | | |
| 8 | | |
| 265 | | |
| 295 | |
Actuarial (loss) gain on defined benefit plans in other comprehensive (loss) income | |
| (80 | ) | |
| - | | |
| (80 | ) | |
| 5,262 | |
The
calculation of the employee future benefit obligation is sensitive to the discount rate assumption and other assumptions such as the
rate of the pension benefit increase. Discount rates were 3.70% as of June 30, 2023, and 3.75% as of December 31, 2022, causing the variances
in the actuarial loss (gain) on defined benefit plan during the six months ended June 30, 2023.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
5. Shareholders’ equity
Share
capital
The
Company has authorized an unlimited number of common shares (being voting and participating shares) with no par value, as well as an
unlimited number of preferred, first and second ranking shares, issuable in series, with rights and privileges specific to each class,
with no par value.
Summary
of share capital
| |
Common shares | | |
Amount | |
| |
# | | |
$ | |
Balance – December 31, 2022 | |
| 4,855,876 | | |
| 293,410 | |
| |
| | | |
| | |
| |
| - | | |
| - | |
Balance – June 30, 2023 | |
| 4,855,876 | | |
| 293,410 | |
On
July 15, 2022, the Company’s shareholders and board of directors approved an amendment to the Company’s articles of incorporation
to effect a 1-for-25 share consolidation (reverse split) of the Company’s common shares. The Company’s outstanding stock
options, DSUs and warrants were also adjusted to reflect the 1-for-25 share consolidation (reverse split) of the Company’s common
shares. Accordingly, all common shares, DSU, warrants, stock options and per share amounts in these
interim condensed consolidated financial statements have been retroactively adjusted for all periods presented to give effect to the
share consolidation (reverse split). Outstanding warrant and stock options were proportionately reduced and the respective exercise
prices, if applicable, were proportionately increased. The share consolidation (reverse split) was affected on July 21, 2022.
Share-based
compensation
On
January 17, 2023, the Company granted 14,000 (2022 – 2,000) stock options under the Long-Term Incentive Plan. The stock options
have a term of seven years and will vest over a period of three years. The fair value at grant date is estimated using a Black-Scholes
option pricing model, considering the terms and conditions upon which the options were granted, using the following assumptions:
Summary of assumptions to determine share-based compensation costs over the life of awards
| |
June 30,
2023 | | |
June 30,
2022 | |
Expected dividend yield | |
$ | 0.00 | | |
$ | 0.00 | |
Expected volatility | |
| 104.46 | % | |
| 115.75 | % |
Risk-free annual interest rate | |
| 3.56 | % | |
| 1.59 | % |
Expected life (years) | |
| 5.45 | | |
| 5.72 | |
Share price | |
$ | 3.75 | | |
$ | 8.88 | |
Exercise price | |
$ | 3.75 | | |
$ | 8.88 | |
Grant date fair value | |
$ | 2.99 | | |
$ | 7.47 | |
The
expected volatility of these stock options was determined using historical volatility rates and the expected life was determined using
the weighted average life of past options issued.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
compensation expense for the three months ended June 30, 2023, was $22 (2022 – $33) and the six months ended June 30, 2023, was
$39 (2022 – $60) recognized over the vesting period. Option activity for the six months ended June 30, 2023, and 2022, was as follows:
Summary of number and weighted average exercise prices of share options
| |
Stock options | | |
Weighted average exercise price | |
| |
# | | |
$ | |
Balance – January 1, 2023 | |
| 42,030 | | |
| 20.05 | |
Granted | |
| 14,000 | | |
| 3.75 | |
Cancelled / Forfeited | |
| - | | |
| - | |
Balance – June 30, 2023 | |
| 56,030 | | |
| 15.98 | |
| |
Stock options | | |
Weighted average exercise price | |
| |
# | | |
$ | |
Balance – January 1, 2022 | |
| 43,455 | | |
| 22.00 | |
Granted | |
| 2,000 | | |
| 8.88 | |
Cancelled / Forfeited | |
| (2,399 | ) | |
| 10.98 | |
Balance – June 30, 2022 | |
| 43,056 | | |
| 21.95 | |
Deferred
share units
On
June 14, 2023, the Company granted 100,000 (2022 – nil) DSUs under the Long-Term Incentive Plan. The compensation expense for the
three and six months ended June 30, 2023, was $284 (2022 - $nil) and is presented in selling, general and administrative expenses. DSU
activity for the six months ended June 30, 2023, are:
Summary
of DSU activity
| |
2023 | | |
2022 | |
| |
# | | |
# | |
Balance – January 1, | |
| 96,920 | | |
| 16,920 | |
Granted | |
| 100,000 | | |
| - | |
Balance – June 30, | |
| 196,920 | | |
| 16,920 | |
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
6. Supplemental disclosure of cash flow information
Disclosure
of changes in operating assets and liabilities
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Changes in operating assets and liabilities: | |
| | | |
| | | |
| | | |
| | |
Trade and other receivables | |
| 199 | | |
| (255 | ) | |
| 402 | | |
| 220 | |
Inventory | |
| 135 | | |
| - | | |
| 140 | | |
| (206 | ) |
Prepaid expenses and other current assets | |
| (748 | ) | |
| (1,471 | ) | |
| (122 | ) | |
| (759 | ) |
Payables and accrued liabilities | |
| (398 | ) | |
| (40 | ) | |
| (163 | ) | |
| 119 | |
Deferred revenues | |
| (1,205 | ) | |
| 1,001 | | |
| (1,359 | ) | |
| 1,008 | |
Provision for restructuring and other costs | |
| 4 | | |
| - | | |
| (5 | ) | |
| - | |
Employee future benefits | |
| (109 | ) | |
| (97 | ) | |
| (254 | ) | |
| (118 | ) |
Increase (decrease) in
operating assets and liabilities | |
| (2,122 | ) | |
| (862 | ) | |
| (1,361 | ) | |
| 264 | |
7. Net loss per share
The
following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common
shareholders.
Summary of pertinent data relating to computation of basic and diluted net loss per share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Net loss | |
| (2,518 | ) | |
| (4,216 | ) | |
| (6,772 | ) | |
| (6,856 | ) |
Basic and diluted weighted-average shares outstanding | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | |
Basic weighted-average shares outstanding | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
| (0.52 | ) | |
| (0.87 | ) | |
| (1.39 | ) | |
| (1.41 | ) |
Basic loss per share | |
| (0.52 | ) | |
| (0.87 | ) | |
| (1.39 | ) | |
| (1.41 | ) |
| |
| | | |
| | | |
| | | |
| | |
Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: | |
| | | |
| | | |
| | | |
| | |
Stock options and DSUs | |
| 252,950 | | |
| 62,375 | | |
| 252,950 | | |
| 62,375 | |
Warrants | |
| 457,648 | | |
| 457,648 | | |
| 457,648 | | |
| 457,648 | |
Anti-dilutive shares | |
| | | |
| | | |
| | | |
| | |
8. Segment information
The
Company operates in a single operating segment, being the biopharmaceutical segment.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
9. Commitments
Significant
expenditure contracted for at the end of the reporting period but not recognized as liabilities is as follows:
Schedule
of expected future minimum lease payments
| |
TOTAL | |
| |
$ | |
Less than 1 year | |
| 7,586 | |
1 - 3 years | |
| 151 | |
4 - 5 years | |
| 37 | |
More than 5 years | |
| - | |
Total | |
| 7,774 | |
In
2021, the Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements
may require the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company
generally has the right to terminate these agreements at no penalty. The Company may have to pay up to $38,887 upon achieving certain
sales volumes, regulatory or other milestones related to specific products.
Exhibit
99.2
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
Introduction
This
Management’s Discussion and Analysis (“MD&A”) provides a review of the results of operations, financial condition
and cash flows of Aeterna Zentaris Inc. for the three and six-month periods ended June 30, 2023. In this MD&A, “Aeterna Zentaris”,
“Aeterna”, the “Company”, “we”, “us” and “our” mean Aeterna Zentaris Inc.
and its subsidiaries. This discussion should be read in conjunction with the information contained in the Company’s unaudited condensed
interim consolidated financial statements and the notes thereto as of June 30, 2023, and for the three and six-month periods ended June
30, 2023 and 2022. Our unaudited condensed interim consolidated financial statements have been prepared in accordance with International
Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) applicable
to the preparation of interim financial statements, including IAS 34 interim financial reporting.
The
Company’s common shares are listed on both The Nasdaq Capital Market (“Nasdaq”) and on the Toronto Stock Exchange (“TSX”)
under the symbol “AEZS”. All amounts in this MD&A are presented in thousands of United States (“U.S.”) dollars,
except for share and per share data, or as otherwise noted. This MD&A was approved by the Company’s Board of Directors (the
“Board”) on August 8, 2023. This MD&A is dated August 8, 2023.
About
Forward-Looking Statements
This
document contains statements that may constitute forward-looking statements within the meaning of U.S. and Canadian securities legislation
and regulations, and such statements are made pursuant to the safe-harbor provision of the U.S. Private Securities Litigation Reform
Act of 1995. In some cases, these forward-looking statements can be identified by words or phrases such as “forecast”, “may”,
“will”, “expect”, anticipate”, “estimate”, “intend”, “plan”, “indicate”,
“believe”, “direct”, or “likely”, or the negative of these terms, or other similar expressions intended
to identify forward-looking statements. In addition, any statements that refer to expectations, intentions, projections and other characterizations
of future events or circumstances contain forward-looking information.
Forward-looking
statements are based on the opinions and estimates of the Company as of the date of this MD&A, and they are subject to known and
unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements
to be materially different from those expressed or implied by such forward-looking statements, including but not limited to the factors
described under Item 3, D. – “Risk factors” in our most
recent Annual Report on Form 20-F and those relating to: Aeterna’s expectations with respect to the DETECT-trial (as defined below)
(including regarding the enrollment of subjects in the DETECT-trial, the application of the macimorelin growth hormone stimulation tests
and the completion of the DETECT-trial); Aeterna’s expectations regarding conducting pre-clinical research to identify and characterize
an AIM Biologicals-based development candidate for the treatment of neuromyelitis optica spectrum disorder (“NMOSD”), as
well as Parkinson’s disease (“PD”), and developing a manufacturing process for selected candidates; Aeterna’s
expectations regarding conducting assessments in relevant PD models; the University of Queensland’s undertaking a subsequent investigator
initiated clinical trial evaluating macimorelin as a potential therapeutic for the treatment of amyotrophic lateral sclerosis (“ALS”),
also known as Lou Gehrig’s disease, and Aeterna’s formulating a pre-clinical development plan for same; the commencement
of Aeterna’s formal pre-clinical development of AEZS-150 (as a potential therapeutic in chronic hypoparathyroidism as defined below)
in preparation for a potential investigational new drug (“IND”) filing for conducting the first in-human clinical study of
AEZS-150; and the impacts associated with the termination of the license agreement with Novo Nordisk Healthcare AG (“Novo Nordisk”
or “Novo”), as discussed below.
Forward-looking
statements involve known and unknown risks and uncertainties and other factors which may cause the actual results, performance or achievements
stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking
information. Such risks and uncertainties include, among others: our reliance on the success of the pediatric clinical trial in the European
Union and U.S. for Macrilen® (macimorelin); potential delays associated with the completion of the DETECT-trial; we may
be unable to enroll the expected number of subjects in the DETECT-trial, and the result of the DETECT-trial may not support receipt of
regulatory approval in childhood-onset growth hormone deficiency (“CGHD”); results from ongoing or planned pre-clinical studies
of macimorelin by the University of Queensland or for our other products under development may not be successful or may not support advancing
the product to human clinical trials; our ability to raise capital and obtain financing to continue our currently planned operations;
our dependence on the success of Macrilen® (macimorelin) and related out-licensing arrangements, including the continued
availability of funds and resources to successfully commercialize the product; our ability to enter into additional out-licensing, development,
manufacturing, marketing and distribution agreements with other pharmaceutical companies and to keep such agreements in effect; and our
ability to continue to list our common shares on the Nasdaq or the TSX. These risk factors are not intended to represent a complete list
of the risk factors that could affect the Company. These factors and assumptions, however, should be considered carefully. More detailed
information about these and other factors is included under Item 3, D. – “Risk
factors” in our most recent Annual Report on Form 20-F.
Although
the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in
forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. Many of these
factors are beyond our control. There can be no assurance that such statements will prove to be accurate, as actual results and future
events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking
statements. The Company does not undertake to update any forward-looking statements contained herein, except as required by applicable
securities laws. New factors emerge from time to time, and it is not possible for the Company to predict all of these factors, or to
assess in advance the impact of each such factor on the Company’s business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those contained in any forward-looking statement.
Certain
forward-looking statements contained herein about prospective results of operations, financial position or cash flows may constitute
a financial outlook. Such statements are based on assumptions about future events, are given as of the date hereof and are based on economic
conditions, proposed courses of action and management’s assessment of currently available relevant information. The Company’s
management has approved the financial outlook as of the date hereof. Readers are cautioned that such financial outlook information contained
herein should not be used for purposes other than for which it is disclosed herein.
About
Material Information
This
MD&A includes information that we believe to be material to investors after considering all circumstances. We consider information
and disclosures to be material if they result in, or would reasonably be expected to result in, a significant change in the market price
or value of our securities, or where it is likely that a reasonable investor would consider the information and disclosures to be important
in making an investment decision.
We
are a reporting issuer under the securities legislation of all of the provinces of Canada, and our securities are registered with the
U.S. Securities and Exchange Commission (“SEC”). We are therefore required to file or furnish continuous disclosure information,
such as interim and annual financial statements, management’s discussion and analysis, proxy or information circulars, annual reports
on Form 20-F, material change reports and press releases with the appropriate securities regulatory authorities. Additional information
about the Company and copies of these documents may be obtained free of charge upon request from our Corporate Secretary or on the Internet
at the following addresses: www.zentaris.com, www.sedarplus.caand www.sec.gov.
Company
Overview
Aeterna
Zentaris is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s
lead product, Macrilen® (macimorelin), is the first and only U.S. Food and Drug Administration (“FDA”) and
European Medicines Agency (“EMA”) approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency
(“AGHD”). Macimorelin is currently marketed under the tradename Ghryvelin™ in the European Economic Area and the United
Kingdom through an exclusive licensing agreement with Pharmanovia. The Company’s several other license and commercialization partners
are also seeking approval for commercialization of macimorelin in Israel and the Palestinian Authority, the Republic of Korea, Turkey
and several non-European Union Balkan countries. The Company is actively pursuing business development opportunities for the commercialization
of macimorelin in North America, Asia and the rest of the world. We are also leveraging the clinical success and compelling safety profile
of macimorelin to develop the compound for the diagnosis of CGHD, an area of significant unmet need.
The
Company is also dedicated to the development of therapeutic assets and has established a pre-clinical development pipeline to potentially
address unmet medical needs across a number of indications, with a focus on rare or orphan indications, including, Neuromyelitis Optica
Spectrum Disorder (NMOSD), Parkinson’s Disease (PD), chronic hypoparathyroidism and ALS (Lou Gehrig’s Disease).
Key
Operational Developments
Macimorelin
Commercialization Program
On
March 15, 2023, with the Company’s consent, Consilient Health Limited (“CH”) entered into an assignment agreement with
Atnahs Pharma UK Ltd. (Pharmanovia) to transfer the current licensing agreement for the commercialization of macimorelin in the European
Economic Area and the United Kingdom to Pharmanovia, as well as the current supply agreement pursuant to which the Company agreed to
provide the licensed product. Also on March 15, 2023, the Company and Pharmanovia entered into an amendment agreement, pursuant to which
the Company provided its acknowledgement and consent to the Assignment Agreement and agreed to certain amended terms which do not materially
differ from the previous license and supply agreement with CH. To date, we have received total pricing milestone payments from CH of
$0.5 million (€0.5 million) relating to Ghryvelin™ approved list prices in the United Kingdom, German and Spain. We shipped
initial batches of macimorelin (Ghryvelin™) to Consilient in the first quarter of 2022. Consilient launched the product meanwhile
in the United Kingdom, Sweden, Denmark, Finland, Germany and Austria. More EU countries will follow pending re-imbursement negotiations.
On April 19, 2022, we announced that European Patent Office had issued a patent providing intellectual property protection of macimorelin
in 27 countries within the European Union as well as additional European non-EU countries, such as the UK and Turkey, for macimorelin
(Ghryvelin™; Macrilen®) for use to diagnose GHD in adults.
On
May 9, 2023, the USPTO issued patent US11,644,474 to the Company protecting the use of macimorelin for the diagnosis of GHD in pediatrics.
Since
November 2020, Novo marketed macimorelin under the tradename Macrilen® through a license agreement and an amended license
agreement (collectively the “Novo Amendment”) for the diagnosis of AGHD. On August 26, 2022, the Company announced that Novo
had exercised its right to terminate the Novo Amendment. Following a 270-day notice period, Aeterna regained full rights to Macrilen®
in the U.S. and Canada on May 23, 2023, and the sales of Macrilen® are temporarily discontinued in the U.S. commercial market
for the diagnosis of AGHD, until an anticipated re-launch with an alternate commercialization partner. The Company continues to actively
strategize and seek alternate development and commercialization partners for Macrilen® in the U.S. and other territories. The decision
to temporarily discontinue sales of Macrilen® in the United States does not have any impact on the sales and commercialization efforts
in the UK and European Economic Area.
On
June 25, 2020, we announced that we entered into an exclusive distribution and related quality agreement with MegaPharm Ltd., a leading
Israel-based biopharmaceutical company, for the commercialization in Israel and in the Palestinian Authority of macimorelin, to be used
in the diagnosis of patients with AGHD and in clinical development for the diagnosis of CGHD. Under the terms of the agreement, MegaPharm
Ltd. will be responsible for obtaining registration to market macimorelin in Israel and the Palestinian Authority, while the Company
will be responsible for manufacturing, product supply, quality assurance and control, regulatory support, and maintenance of the relevant
intellectual property. In June 2021, MegaPharm Ltd. filed an application to the Ministry of Health of Israel for regulatory approval
of macimorelin in Israel, which was approved in November 2022.
We
entered into license and supply agreements with NK Meditech Ltd. (“NK”), a subsidiary of PharmBio Korea, effective November
30, 2021, and a distribution and commercialization agreement with ER Kim Pharmaceuticals Bulgaria Eood (“ER-Kim”), effective
February 1, 2022. The agreements with NK are related to the development and commercialization of macimorelin for the diagnosis of AGHD
and CGHD in the Republic of Korea, while the agreement with ER-Kim is related to the commercialization of macimorelin for the diagnosis
of growth hormone deficiency in children and adults in Turkey and some non-European Union Balkan countries.
Macimorelin
Clinical Program
On
January 28, 2020, we announced the successful completion of patient recruitment for the first pediatric study of macimorelin as a growth
hormone stimulation test for the evaluation of GHD in children. This study, AEZS-130-P01 (“Study P01”), was the first of
two studies as agreed with the EMA in our Pediatric Investigation Plan (the “PIP”) for macimorelin as a GHD diagnostic. Macimorelin,
a ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone from the pituitary gland into the
circulatory system. The goal of Study P01 was to establish a dose that can both be safely administered to pediatric patients and cause
a clear rise in growth hormone concentration in subjects ultimately diagnosed as not having GHD. The recommended dose derived from Study
P01 is being evaluated in the pivotal second study, Study P02, on diagnostic efficacy and safety (the “DETECT-trial”). Study
P01 was an international, multicenter study, which was conducted in Hungary, Poland, Ukraine, Serbia, Belarus and Russia. Study P01 was
an open label, group comparison, dose escalation trial designed to investigate the safety, tolerability, and pharmacokinetic/pharmacodynamic
(“PK/PD”) of macimorelin acetate after ascending single oral doses of macimorelin at 0.25, 0.5, and 1.0 milligram per kilogram
body weight in pediatric patients from 2 to less than 18 years of age with suspected CGHD. We enrolled a total of 24 pediatric patients
across the three cohorts of the study. Per study protocol, all enrolled patients completed four study visits after successful completion
of the screening period. At Visit 1 and Visit 3, a provocative growth hormone stimulation test was conducted according to the study sites’
local practices. At Visit 2, the macimorelin test was performed, and following the oral administration of the macimorelin solution, blood
samples were taken at predefined times for PK/PD assessment. Visit 4 was a safety follow-up visit at study end.
The
final study results from Study P01 were published in the second quarter of 2020 indicating positive safety and tolerability data for
use of macimorelin in CGHD, as well as PK/PD data observed in a range as expected from the adult studies.
On
April 7, 2020, we announced the decision of the EMA to accept our modification request of our PIP as originally approved in March 2017,
which covered the conduct of two pediatric studies and defined relevant key elements in the outline of these studies. We believe this
EMA decision supports the development of one globally harmonized study protocol for test validation, specifically Study P02, which we
expect to be accepted both in Europe and the U.S.
In
late 2020, we entered into the start-up phase for the clinical safety and efficacy study, AEZS-130-P02 (“DETECT-trial”),
evaluating macimorelin for the diagnosis of CGHD. The DETECT-trial is an open-label, single dose, multicenter and multinational study
expected to enroll approximately 100 subjects worldwide (incl. sites in U.S: and EU), with at least 40 pre-pubertal and 40 pubertal subjects.
The study design is expected to be suitable to support a claim for potential stand-alone testing, if successful. On April 22, 2021, the
U.S. FDA Investigational New Drug Application associated with this clinical trial became active, (see: https://clinicaltrials.gov/ct2/show/NCT04786873),
and on May 13, 2021, we announced the opening of the first clinical site in the U.S. Under the Novo Amendment, and following Novo’s
notice to terminate the Novo Amendment, Novo will fund DETECT-trial costs up to $10.1 million (€9.4 million). Any additional trial
costs incurred over $10.1 million (€9.4 million) will be paid by Aeterna.
On
January 26, 2022, we announced that the DETECT-trial had experienced unavoidable delays in site initiation and patient enrollment due
to the rise of the Omicron variant in the COVID-19 pandemic. Furthermore, in February 2022, due to the Russian invasion of Ukraine, the
clinical trial activities planned in both Russia and Ukraine were halted and consequently, no patients have been enrolled in either of
these countries’ clinical sites to date. On January 17, 2023, we provided a business update, highlighting that bolstered enrollment
was expected by the engagement of an additional Clinical Research Organization (CRO) and the replacement of inactive countries and sites
with three new countries (Armenia, Slovakia, and Turkey) as well as additional sites in the U.S. In March 2023, we received approval
for and activated our first site in Slovakia and expect the approval and activation of sites in Armenia and Turkey to follow in Q3, 2023.
We expect enrollment in our DETECT-trial to be completed by the end of 2023.
Pipeline
Expansion Opportunities
AIM
Biologicals: Targeted, highly specific autoimmunity modifying therapeutics for the potential treatment of neuromyelitis optica spectrum
disorder and Parkinson’s disease
AIM
Biologicals is based on a natural process during pregnancy, which induces immunogenic tolerance of the maternal immune system to the
partially foreign fetal antigens. Fetal proteins are processed and presented on certain immunosuppressive major histocompatibility complex
class I molecules to induce this tolerance. In an autoimmune disease the immune system is misdirected and targets the body’s own
protein. With AIM Biologicals, we aim to restore the tolerance against such proteins to treat autoimmune diseases. Our AIM Biologics
program is focused on the rare and orphan indication NMOSD and the second most common neurodegenerative disorder, Parkinson’s disease.
In
January 2021, we entered into an exclusive patent license and research agreement with the University of Wuerzburg, Germany, for worldwide
rights to develop, manufacture, and commercialize AIM Biologicals for the potential treatment of NMOSD. Additionally, we have engaged
Prof. Dr. Joerg Wischhusen from the University Hospital in Wuerzburg as well as neuro-immunologist Dr. Michael Levy from the Massachusetts
General Hospital in Boston as consultants for scientific support and advice in the field of inflammatory central nervous system “CNS”
disorders, autoimmune diseases of the nervous system, and NMOSD. In September 2021, we entered into an additional exclusive license with
the University of Wuerzburg for early pre-clinical development towards the potential treatment of Parkinson’s disease. On May 12,
2022 we announced positive pre-clinical results in an innovative mouse model of Parkinson’s disease, where treatment with α-Synuclein
specific AIM Biologicals showed a trend towards improved motoric function, as well as significant induction of regulatory T cells and
rescue of substantia nigra neurons. The data were presented at IMMUNOLOGY2022™, the annual event of the American Association of
Immunologists, held on May 6-10, 2022 in Portland, Oregon. On June 13, 2022, we announced that we had achieved proof-of-concept for the
treatment of NMOSD in both in-vitro and in mouse models. These findings were presented at the 13th International Congress on Autoimmunity
on June 10-13, 2022, in Athens, Greece. In October 2022, we entered into a research and development agreement with Massachusetts General
Hospital (MGH) in Boston and Dr. Michael Levy, to conduct pre-clinical ex-vivo and in-vivo studies in NMOSD.
NMOSD
is an autoimmune disease targeting the protein aquaporin 4, primarily found in optic nerves and the spinal cord. The disease leading
to blindness and paralysis has a prevalence of 0.7-10 in 100,000, more common in persons with Asian or African compared to European ancestors,
and nine times more prevalent among women compared to men. NMOSD progresses in often life-threatening relapses, which are aggressively
treated with high-dose steroids and plasmapheresis. Current treatment options include treatment with immunosuppressive monoclonal antibodies,
which carries risk of serious infections. Our pre-clinical plans include expanding the already available proof-of-concept data for the
treatment of NMOSD in both in-vitro and in-vivo assessments to select an AIM Biologicals-based development candidate; and
manufacturing process development for the selected candidate.
Parkinson’s
disease is a neurological disease commonly associated with motoric problems with a slow and fast progression form. It is the second most
common neurodegenerative disease affecting 10 million people worldwide. The hallmark of PD is the neuronal inclusion of mainly α-synuclein
protein (αSyn) associated with the death of dopamine-producing cells. Dopaminergic medication is the mainstay treatment of PD symptoms,
but currently there is no pharmacological therapy to prevent or delay disease progression leading to alternate treatments, such as deep
brain stimulation with short electric bursts, being investigated for the treatment of symptoms. For the development of AIM Biologicals
as potential PD therapeutics, Aeterna plans utilizes, among others, an innovative animal model on neurodegeneration by α-synuclein-specific
T cells in AAV-A53T-α-synuclein Parkinson’s disease mice, which has recently been published by University of Wuerzburg researchers.
We are continuing in-vitro and in-vivo testing of antigen-specific AIM Biologics candidate molecules for the potential
treatment of Parkinson’s disease.
AEZS-150
- Delayed Clearance (“DC”) Parathyroid Hormone (“PTH”) (“DC-PTH”) Fusion Polypeptides: Potential
treatment for chronic hypoparathyroidism
On
March 11, 2021, we entered into an exclusive license agreement with The University of Sheffield, United Kingdom, for the intellectual
property relating to PTH fusion polypeptides covering the field of human use, which will initially be studied by Aeterna for the potential
therapeutic treatment of chronic hypoparathyroidism (“HypoPT”). Under the terms of the exclusive patent and know-how license
agreement entered into with the University of Sheffield, we obtained worldwide rights to develop, manufacture and commercialize PTH fusion
polypeptides covered by the licensed patent applications for all human uses for an up-front cash payment, and milestone payments to be
paid upon the achievement of certain development, regulatory and sales milestones, as well as low single digit royalty payments on net
sales of those products and certain fees payable in connection with sublicensing. We will be responsible for the further development,
manufacturing, approval, and commercialization of the licensed products. We also engaged the University of Sheffield under a research
contract to conduct certain research activities to be funded by Aeterna, the results of which will be included within the scope of the
license granted to Aeterna.
The
researchers at the University of Sheffield have developed a method to increase the serum clearance time of peptides, which the Company
is applying to the development of a treatment for HypoPT. HypoPT is an orphan disease where the PTH level is abnormally low or absent,
with a prevalence per 100,000 of 37 in the U.S., 22 in Denmark, 9.4 in Norway, and 5.3 to 27 in Italy. Standard treatment is calcium
and vitamin D supplementation. In consultation with The University of Sheffield, Aeterna has selected AEZS-150 as the lead candidate
in its DC-PTH program. AEZS-150 is being developed to provide a weekly treatment option of chronic hypoparathyroidism in adults. Recent
progress includes the successful verification and reproduction of previous in-vivo data from the University of Sheffield, in a rat model
of hypoparathyroidism, as well as ongoing development of the manufacturing process for AEZS-150 with the Company’s contract development
and manufacturing organization, establishment of a master cell bank for a cell line expressing AEZS-150 and the development of a production
process suitable for larger scale good manufacturing practices. Our next steps include working with The University of Sheffield to continue
with in depth characterization of development candidate (in-vitro and in-vivo); meeting with regulatory authorities to
formalize the pre-clinical development of AEZS-150 in preparation for a potential IND filing for conducting the first in-human clinical
study.
AEZS-130
- Macimorelin Pre-clinical Program
On
January 13, 2021, we entered into a material transfer agreement with Queensland University to provide macimorelin for the conduct of
preclinical and clinical studies evaluating macimorelin as a therapeutic for the treatment of ALS. ALS is a rare progressive neurological
disease primarily affecting the neurons controlling voluntary movement, leading to the disability to control movements such as walking,
talking, and chewing. Most people with ALS die from respiratory failure, usually between 3-5 years after diagnosis. Currently there is
no cure for ALS and no effective treatment to halt or reverse the progression of the disease. Ghrelin is a hormone with wide-ranging
biological actions, most known for stimulating growth hormone release, which is demonstrating emerging evidence as therapeutic for ALS.
As a ghrelin agonist, macimorelin has the potential as a treatment for ALS, which is evaluated in this research collaboration.
The
University of Queensland researchers have filed for supportive grants to conduct such clinical studies. In July 2022, we entered a research
and option to license agreement with UniQuest Pty Ltd., the commercialization company of The University of Queensland (UQ), Brisbane,
Australia, to advance the development of macimorelin as a potential therapeutic for the treatment of ALS. We have developed an alternative
formulation suitable for use in ALS patients and are accumulating data for positive effects of AEZS-130 treatment on survival of motor-neurons.
We are continuing to evaluate AEZS-130 in transgenic mouse ALS models as well as in human patient-derived neuron cultures to demonstrate
the therapeutic potential of macimorelin in this indication. Our next steps include completion of the ongoing toxicology and safety studies
to support treatment over prolonged periods and following potential achievement of proof-of-concept, scientific advice with regulatory
authorities to discuss program development to support first in human studies.
Condensed
Interim Consolidated Statements of Loss and Comprehensive Loss Data
| |
Three months ended
June 30, | | |
Six months ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Revenues | |
| 2,246 | | |
| (222 | ) | |
| 4,374 | | |
| 1,295 | |
| |
| | | |
| | | |
| | | |
| | |
Expenses | |
| | | |
| | | |
| | | |
| | |
Cost of sales | |
| 139 | | |
| 13 | | |
| 156 | | |
| 92 | |
Research and development | |
| 2,929 | | |
| 2,398 | | |
| 6,941 | | |
| 4,788 | |
Selling, general and administrative | |
| 2,033 | | |
| 2,083 | | |
| 4,339 | | |
| 3,944 | |
Total expenses | |
| 5,101 | | |
| 4,494 | | |
| 11,436 | | |
| 8,824 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (2,855 | ) | |
| (4,716 | ) | |
| (7,062 | ) | |
| (7,529 | ) |
| |
| | | |
| | | |
| | | |
| | |
Gain (loss) due to changes in foreign currency exchange rates | |
| 27 | | |
| 502 | | |
| (32 | ) | |
| 676 | |
Interest income | |
| 307 | | |
| - | | |
| 320 | | |
| - | |
Other finance income (costs) | |
| 3 | | |
| (2 | ) | |
| 2 | | |
| (3 | ) |
Net finance income | |
| 337 | | |
| 500 | | |
| 290 | | |
| 673 | |
| |
| | | |
| | | |
| | | |
| | |
Loss before income taxes | |
| (2,518 | ) | |
| (4,216 | ) | |
| (6,772 | ) | |
| (6,856 | ) |
| |
| | | |
| | | |
| | | |
| | |
Income tax recovery | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
| (2,518 | ) | |
| (4,216 | ) | |
| (6,772 | ) | |
| (6,856 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation adjustments | |
| 3 | | |
| 42 | | |
| (167 | ) | |
| 79 | |
Actuarial gain on defined benefit plans | |
| 83 | | |
| 5,276 | | |
| (80 | ) | |
| 8,025 | |
Comprehensive (loss) income | |
| (2,432 | ) | |
| 1,102 | | |
| (7,019 | ) | |
| 1,248 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
| (0.52 | ) | |
| (0.87 | ) | |
| (1.39 | ) | |
| (1.41 | ) |
Summarized
Interim Consolidated Statements of Financial Position Data
(in thousands) | |
June 30, 2023 | | |
December 31,
2022 | |
| |
$ | | |
$ | |
Cash and cash equivalents | |
| 42,186 | | |
| 50,611 | |
Trade and other receivables and other current assets | |
| 3,614 | | |
| 4,648 | |
Inventory | |
| 93 | | |
| 229 | |
Restricted cash equivalents | |
| 325 | | |
| 322 | |
Property and equipment | |
| 265 | | |
| 216 | |
Total assets | |
| 46,483 | | |
| 56,026 | |
Payables and accrued liabilities and income taxes payable | |
| 3,681 | | |
| 3,936 | |
Current portion of provisions | |
| 49 | | |
| 45 | |
Current portion of deferred revenues | |
| 202 | | |
| 2,949 | |
Lease liabilities | |
| 145 | | |
| 114 | |
Non-financial non-current liabilities (1) | |
| 13,327 | | |
| 13,206 | |
Total liabilities | |
| 17,404 | | |
| 20,250 | |
Shareholders’ equity | |
| 29,079 | | |
| 35,776 | |
Total liabilities and shareholders’ equity | |
| 46,483 | | |
| 56,026 | |
(1) |
Comprised mainly
of employee future benefits, provisions and non-current portion of deferred revenues. |
Critical
Accounting Policies, Estimates and Judgments
The
preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgments, estimates
and assumptions that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and related disclosures.
Judgments, estimates and assumptions are based on historical experience, expectations, current trends and other factors that management
believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements are prepared.
Management
reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgments in order to ensure that the
consolidated financial statements are presented fairly and in accordance with IFRS applicable to interim financial statements. Revisions
to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Critical
accounting estimates and assumptions, as well as critical judgments used in applying accounting policies in the preparation of the Company’s
condensed interim consolidated financial statements, were the same as those applied to the Company’s annual consolidated financial
statements for the year ended December 31, 2022.
Financial
Risk Factors and Other Financial Instruments
The
nature and extent of our exposure to risks arising from financial instruments, including credit risk, liquidity risk and market risk
and how we manage those risks are described in note 24 to the Company’s audited consolidated financial statements for the year
ended December 31, 2022. There were no significant changes in the three and six-month periods ended June 30, 2023, as compared to the
December 31, 2022, disclosures.
Revenues
We
generate revenue from license and collaboration agreements with customers (license fees, milestone revenue, royalties), the provision
of development services, the sale of certain active pharmaceutical ingredients (“API”), semi-finished goods and finished
goods, and from certain supply chain activities, which are comprised largely of oversight or supervisory support services related to
stability studies or development activities carried out with respect to API batch production as specified in underlying contracts with
customers.
(in thousands, except percentages) | |
Three month ended June 30, | |
| |
2023 | | |
2022 | | |
Change | | |
Change | |
| |
| $ | | |
| $ | | |
| $ | | |
| % | |
Revenue | |
| | | |
| | | |
| | | |
| | |
License fees | |
| 795 | | |
| (206 | ) | |
| 1,001 | | |
| 486 | % |
Development services | |
| 1,402 | | |
| (77 | ) | |
| 1,479 | | |
| 1,921 | % |
Royalties | |
| 7 | | |
| 24 | | |
| (17 | ) | |
| -71 | % |
Supply chain | |
| 42 | | |
| 37 | | |
| 5 | | |
| 14 | % |
Total revenue | |
| 2,246 | | |
| (222 | ) | |
| 2,468 | | |
| 1,112 | % |
Our
total revenue for the three-month period ended June 30, 2023, was $2.2 million as compared to ($0.2) million for the same period in 2022,
representing an increase of $2.5 million. The increase is due to an increase in license fee revenue recognized of $1.0 million and development
services revenue of $1.5 million relating to the Company’s amended agreement with Novo Nordisk Healthcare.
The
negative revenue of $0.2 million for the three-month ended June 30, 2022, was driven by the reversal of revenue of $0.4 million in license
fees and $0.8 million in development services in Q2, 2022 as a result of a change in management’s best estimate of additional costs
associated to the DETECT-trial.
(in thousands, except percentages) | |
Six month ended June 30, | |
| |
2023 | | |
2022 | | |
Change | | |
Change | |
| |
| $ | | |
| $ | | |
| $ | | |
| % | |
Revenue | |
| | | |
| | | |
| | | |
| | |
License fees | |
| 1,554 | | |
| 226 | | |
| 1,328 | | |
| 588 | % |
Development services | |
| 2,741 | | |
| 889 | | |
| 1,852 | | |
| 208 | % |
Product sales | |
| - | | |
| 57 | | |
| (57 | ) | |
| -100 | % |
Royalties | |
| 26 | | |
| 43 | | |
| (17 | ) | |
| -40 | % |
Supply chain | |
| 53 | | |
| 80 | | |
| (27 | ) | |
| -34 | % |
Total revenue | |
| 4,374 | | |
| 1,295 | | |
| 3,079 | | |
| 238 | % |
Our
total revenue for the six-month period ended June 30, 2023, was $4.4 million as compared to $1.3 million for the same period in 2022,
representing an increase of $3.1 million. The increase is due to an increase in license fee revenue recognized of $1.3 million and development
services revenue of $1.9 million relating to the Company’s amended agreement with Novo Nordisk Healthcare, offset by a $0.1 million
decrease in product sales.
Research
and development expenses
The
following table summarizes our research and development expenses incurred during the periods indicated:
(in thousands, except percentages) | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
Change | | |
Change | |
| |
| $ | | |
| $ | | |
| $ | | |
| % | |
Direct research and development expenses: | |
| | | |
| | | |
| | | |
| | |
Macimorelin pediatric DETECT-trial | |
| 1,154 | | |
| 651 | | |
| 503 | | |
| 77 | % |
AEZS-130 – Macimorelin ALS | |
| 550 | | |
| 419 | | |
| 131 | | |
| 31 | % |
AEZS-150 – DC-PTH | |
| 396 | | |
| 447 | | |
| (51 | ) | |
| -11 | % |
Aim Biologics - Parkinson’s Disease | |
| 168 | | |
| 161 | | |
| 7 | | |
| 4 | % |
Aim Biologics - NMOSD | |
| 213 | | |
| 115 | | |
| 98 | | |
| 85 | % |
Bacterial Vaccine Platform - Covid-19 | |
| (5 | ) | |
| 146 | | |
| (151 | ) | |
| -103 | % |
Bacterial Vaccine Platform - Chlamydia | |
| 3 | | |
| 107 | | |
| (104 | ) | |
| -97 | % |
Additional programs | |
| 56 | | |
| 11 | | |
| 45 | | |
| 409 | % |
Total direct research and development expenses | |
| 2,535 | | |
| 2,057 | | |
| 478 | | |
| 23 | % |
Employee-related expenses | |
| 311 | | |
| 294 | | |
| 17 | | |
| 6 | % |
Facilities, depreciation, and other expenses | |
| 83 | | |
| 47 | | |
| 36 | | |
| 77 | % |
Total research and development expenses | |
| 2,929 | | |
| 2,398 | | |
| 531 | | |
| 22 | % |
Research
and development expenses increased by $0.5 million for the three months ended June 30, 2023, compared to the three months ended June
30, 2022, primarily driven by a $0.5 million increase in direct research and development expenses. Direct research and development expenses
include expenses incurred under arrangements with third parties, such as contract research organizations, contract manufacturers, and
consultants. The $0.5 million increase in total direct research and development expenses for the three months ended June 30, 2023, was
primarily due to a $0.5 million increase in costs for the DETECT-trial. The Company has seen a significant increase in the number of
testing sites opened and the recruitment of patients for the DETECT-trial leading to the increase in cost from the comparative period
when the company was primarily focused on establishing testing sites for patient enrollment.
In
addition to the DETECT-trial, the Company was actively working with its university research partners on the named pre-clinical programs.
The fluctuation in spend on these programs from the prior year is primarily driven by the timing of various pre-clinical activities and
the advancement of these projects, in particular the AEZS-150 and DC-PTH projects which were in licensed in 2021.
Lastly,
the Company ceased its development of both the COVID-19 and Chlamydia vaccine trials in Q1, 2023, resulting in the decrease in spending
on these two projects for the three months ended June 30, 2023, compared to the three months ended June 30, 2022.
The
following table summarizes our research and development expenses incurred during the periods indicated:
(in thousands, except percentages) | |
Six months ended June 30, | |
| |
2023 | | |
2022 | | |
Change | | |
Change | |
| |
| $ | | |
| $ | | |
| $ | | |
| % | |
Direct research and development expenses: | |
| | | |
| | | |
| | | |
| | |
Macimorelin pediatric DETECT-trial | |
| 2,245 | | |
| 1,547 | | |
| 698 | | |
| 45 | % |
AEZS-130 – Macimorelin ALS | |
| 1,644 | | |
| 696 | | |
| 948 | | |
| 136 | % |
AEZS-150 – DC-PTH | |
| 959 | | |
| 715 | | |
| 244 | | |
| 34 | % |
Aim Biologics - Parkinson’s Disease | |
| 358 | | |
| 350 | | |
| 8 | | |
| 2 | % |
Aim Biologics - NMOSD | |
| 459 | | |
| 204 | | |
| 255 | | |
| 125 | % |
Bacterial Vaccine Platform - Covid-19 | |
| 113 | | |
| 194 | | |
| (81 | ) | |
| -42 | % |
Bacterial Vaccine Platform - Chlamydia | |
| 221 | | |
| 225 | | |
| (4 | ) | |
| -2 | % |
Additional programs | |
| 127 | | |
| 147 | | |
| (20 | ) | |
| -14 | % |
Total direct research and development expenses | |
| 6,126 | | |
| 4,078 | | |
| 2,048 | | |
| 50 | % |
Employee-related expenses | |
| 639 | | |
| 618 | | |
| 21 | | |
| 3 | % |
Facilities, depreciation, and other expenses | |
| 176 | | |
| 92 | | |
| 84 | | |
| 91 | % |
Total research and development expenses | |
| 6,941 | | |
| 4,788 | | |
| 2,153 | | |
| 45 | % |
Research
and development expenses increased by $2.2 million for the six months ended June 30, 2023, compared to the six months ended June 30,
2022, primarily driven by a $2.0 million increase in direct research and development expenses. Direct research and development expenses
include expenses incurred under arrangements with third parties, such as contract research organizations, contract manufacturers, and
consultants. The $2.0 million increase in total direct research and development expenses for the six months ended June 30, 2023, was
primarily due to a $0.7 million increase in costs for the DETECT-trial. The Company has seen a significant increase in the number of
testing sites opened and the recruitment of patients for the DETECT-trial leading to the increase in cost from the previous year when
the company was primarily focused on establishing testing sites for patient enrollment.
In
addition to the DETECT-trial, the Company was actively working with its university research partners on the named pre-clinical programs.
The increase in spend of $0.9 million for the six-month period ended June 30, 2023 compared to the period ended June 30, 2022 for the
AEZS-130, ALS program, relates to an increase in the companies pre-clinical activities, primarily the ongoing toxicology and safety studies.
The fluctuation in spending on the DC-PTH and the two Aim Biologic projects from the prior year is primarily driven by the timing of
various pre-clinical activities and the advancement of these projects.
Lastly,
the Company ceased its development of both the COVID-19 and Chlamydia vaccine trials in Q1, 2023, resulting in the decrease in spending
on these two projects for the six months ended June 30, 2023, compared to the six months ended June 30, 2022.
Selling,
general and administrative expenses
The
following table summarizes our Selling, general and administrative expenses incurred during the periods indicated:
(in thousands, except percentages) | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
Change | | |
Change | |
| |
| $ | | |
| $ | | |
| $ | | |
| % | |
Selling, general and administrative expenses: | |
| | | |
| | | |
| | | |
| | |
Salaries & benefits | |
| 1,002 | | |
| 455 | | |
| 547 | | |
| 120 | % |
Insurance | |
| 250 | | |
| 423 | | |
| (173 | ) | |
| -41 | % |
Professional fees | |
| 434 | | |
| 939 | | |
| (505 | ) | |
| -54 | % |
Other office & general expenses | |
| 347 | | |
| 266 | | |
| 81 | | |
| 30 | % |
Total selling, general and administrative expenses | |
| 2,033 | | |
| 2,083 | | |
| (50 | ) | |
| -2 | % |
Our
total Selling, general and administrative expenses for the three-month period ended June 30, 2023, were $2.0 million as compared to $2.1
million for the same period in 2022 representing a decrease of $0.1 million. This decrease arose primarily from a $0.5 million decline
in Professional fees and a $0.2 million decline in insurance costs offset by a $0.5 million increase in salaries and benefits and a $0.1
million increase in other office & general expenses. The increase in salaries and benefits expense primarily relates to the timing
of the issuance of deferred share units of $0.3 million to the Company’s Board of Directors, which were issued in June 2023 for
the current year entitlement, compared with August 2022 for the entitlement in the prior year.
The
following table summarizes our Selling, general and administrative expenses incurred during the periods indicated:
(in thousands, except percentages) | |
Six months ended June 30, | |
| |
2023 | | |
2022 | | |
Change | | |
Change | |
| |
| $ | | |
| $ | | |
| $ | | |
| % | |
Selling, general and administrative expenses: | |
| | | |
| | | |
| | | |
| | |
Salaries & benefits | |
| 1,761 | | |
| 1,038 | | |
| 723 | | |
| 70 | % |
Insurance | |
| 678 | | |
| 842 | | |
| (164 | ) | |
| -19 | % |
Professional fees | |
| 1,183 | | |
| 1,518 | | |
| (335 | ) | |
| -22 | % |
Other office & general expenses | |
| 717 | | |
| 546 | | |
| 171 | | |
| 31 | % |
Total selling, general and administrative expenses | |
| 4,339 | | |
| 3,944 | | |
| 395 | | |
| 10 | % |
Our
total Selling, general and administrative expenses for the six-month period ended June 30, 2023, were $4.3 million as compared to
$3.9 million for the same period in 2022 representing an increase of $0.4 million. The $0.7 million increase in salaries and
benefits primarily relates to the timing of the issuance of deferred share units of $0.3 million to the Company’s Board of
Directors, which were issued in June 2023 for the current year entitlement, compared with August 2022 for the entitlement in the
prior year. The remaining increase is due to a $0.2 million increase in other office & general expenses offset by a $0.3 million
decline in professional fees and a $0.2 million decline in insurance costs.
Net
finance income
(in thousands, except percentages) | |
Three months ended June 30, | |
| |
2023 | | |
2022 | | |
Change | | |
Change | |
| |
| $ | | |
| $ | | |
| $ | | |
| % | |
Gain (loss) due to changes in foreign currency rates | |
| 27 | | |
| 502 | | |
| (475 | ) | |
| -95 | % |
Interest income | |
| 307 | | |
| - | | |
| 307 | | |
| 100 | % |
Other finance income (costs) | |
| 3 | | |
| (2 | ) | |
| 5 | | |
| -250 | % |
Net finance income | |
| 337 | | |
| 500 | | |
| (163 | ) | |
| -33 | % |
For
the three-month period ended June 30, 2023, our net finance cost was $0.3 million as compared to a net finance income of $0.5 million
for the three-month period ended June 30, 2022. This is primarily due to a $0.5 million decrease in our gain (loss) due to changes in
foreign currency offset by an increase in interest earned on bank deposits of $0.3 million.
(in thousands, except percentages) | |
Six months ended June 30, | |
| |
2023 | | |
2022 | | |
Change | | |
Change | |
| |
| $ | | |
| $ | | |
| $ | | |
| % | |
Gain (loss) due to changes in foreign currency rates | |
| (32 | ) | |
| 676 | | |
| (708 | ) | |
| -105 | % |
Interest income | |
| 320 | | |
| - | | |
| 320 | | |
| 100 | % |
Other finance income (costs) | |
| 2 | | |
| (3 | ) | |
| 5 | | |
| -167 | % |
Net finance income | |
| 290 | | |
| 673 | | |
| (383 | ) | |
| -57 | % |
Our
net finance income for the six-month period ended June 30, 2023, was $0.3 million as compared to $0.7 million for the same period in
2022, representing a decrease of $0.4 million. This is primarily due to a $0.7 million decrease in gain (loss) due to changes in foreign
currency offset by an increase in interest earned on bank deposits of $0.3 million.
Net
loss
For
the three-month period ended June 30, 2023, we reported a consolidated net loss of $2.5 million, or $0.52 loss per common share (basic),
as compared with a consolidated net loss of $4.2 million, or $0.87 loss per common share (basic) for the three-month period ended June
30, 2022. The $1.7 million decrease in net loss is primarily due to a $2.5 million increase in revenue, offset by a $0.5 million increase
in research and development expenses, a $0.1 million increase in cost of sales and a $0.2 million decrease in net finance income.
For
the six-month period ended June 30, 2023, we reported a consolidated net loss of $6.8 million, or $1.39 loss per common share (basic),
as compared with a consolidated net loss of $6.9 million, or $1.41 loss per common share (basic) for the six-month period ended June
30, 2022. The $0.1 million decrease in net loss is primarily from a $3.1 million increase in revenue off-set by a $0.1 million increase
in cost of sales, a $2.2 million in research and development expenses, a $0.4 million increase in selling, general and administrative
expenses, and a $0.4 million decrease in net finance income.
Selected
quarterly financial data
| |
Three months ended | |
(in thousands, except for per share data) | |
June 30, 2023 | | |
March 31, 2023 | | |
December 31,
2022 | | |
September 30,
2022 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Revenues | |
| 2,246 | | |
| 2,128 | | |
| 2,485 | | |
| 1,860 | |
Net loss | |
| (2,518 | ) | |
| (4,255 | ) | |
| (12,451 | ) | |
| (3,420 | ) |
Net loss per share (basic and diluted) (1) | |
| (0.52 | ) | |
| (0.88 | ) | |
| (2.56 | ) | |
| (0.70 | ) |
| |
Three months ended | |
(in thousands, except for per share data) | |
June 30, 2022 | | |
March 31, 2022 | | |
December 31, 2021 | | |
September 30, 2021 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Revenues | |
| (222 | ) | |
| 1,517 | | |
| 956 | | |
| 1,052 | |
Net loss | |
| (4,216 | ) | |
| (2,640 | ) | |
| (2,894 | ) | |
| (1,932 | ) |
Net loss per share (basic and diluted) (1) | |
| (0.87 | ) | |
| (0.54 | ) | |
| (0.63 | ) | |
| (0.40 | ) |
(1) |
Net loss per
share is based on the weighted average number of shares outstanding during each reporting period, which may differ on a quarter-to-quarter
basis. As such, the sum of the quarterly net loss per share amounts may not equal full-year net loss per share. |
Historical
quarterly results of operations and net loss cannot be taken as reflective of recurring revenue or expenditure patterns of predictable
trends, largely given the non-recurring nature of certain components of our historical revenues, the impact of costs associated with
launching a number of significant preclinical research and development programs in 2021, and of foreign exchange gains and losses. In
addition, we cannot predict what the revenues from royalties will be earned from licensing agreements.
The
increase in net loss for the three-month period ended December 31, 2022, was due to the recording of an impairment charge on the Company’s
goodwill and intangible assets for an amount of $7,642 and $372 respectively.
The
decrease in revenue and increase in net loss for the three-month ended June 30, 2022 was driven by the reversal of revenue of $0.4 million
in license fees and $0.8 million in development services which took place in Q2, 2022 as a result of a change in management’s best
estimate of additional costs associated to the DETECT-trial.
Cash
flows
The
following table shows a summary of our consolidated cash flows for the periods indicated:
(in thousands) | |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
Cash and cash equivalents – Beginning of period | |
| 46,560 | | |
| 63,596 | | |
| 50,611 | | |
| 65,300 | |
Net cash used in operating activities | |
| (4,293 | ) | |
| (4,850 | ) | |
| (8,354 | ) | |
| (6,311 | ) |
Net cash used in financing activities | |
| (42 | ) | |
| (34 | ) | |
| (80 | ) | |
| (68 | ) |
Net cash used in investing activities | |
| (3 | ) | |
| (42 | ) | |
| (5 | ) | |
| (48 | ) |
Effect of exchange rate changes on cash & cash equivalents | |
| (36 | ) | |
| (513 | ) | |
| 14 | | |
| (716 | ) |
Cash and cash equivalents – End of period | |
| 42,186 | | |
| 58,157 | | |
| 42,186 | | |
| 58,157 | |
Operating
Activities
Cash used by operating activities
totaled $4.3 million for the three-month periods ended June 30, 2023, as compared to $4.9 million in the same periods in 2022. This $0.6
million decrease in the three-month periods ended June 30, 2023, in use of cash in operating activities is attributed primarily
to increase in interest income combined with decrease in selling, general and administrative expenses offset by an increase in research
and development expenses, as described above.
Cash
used by operating activities totaled $8.4 million for the six-month periods ended June 30, 2023, as compared to $6.3 million in the same
periods in 2022. This $2.1 million increase in the six-months periods ended June 30, 2023, in use of cash in operating activities
is attributed primarily to increased research and development and selling, general and administrative expenses offset by increases in
revenue, as described above.
Liquidity
and capital resources
The
Company’s objective in managing capital, consisting of shareholders’ equity, with cash and cash equivalents being its primary
components, is to ensure sufficient liquidity to fund research and development costs, selling expenses, general and administrative expenses
and working capital requirements. Over the past several years, we have raised capital via public and private equity offerings and issuances
and have entered licensing and collaborative arrangements, consideration from which, together with
proceeds from equity issuances, has been our primary source of liquidity. The capital management objective of the Company remains
the same as that in previous periods. The policy on dividends is to retain cash to keep funds available, to finance the activities required
to advance the Company’s product development portfolio and to pursue appropriate commercial opportunities as they may arise. The
Company is not subject to any capital requirements imposed by any regulators or by any other external source.
Adequacy
of financial resources
Since
inception, the Company has incurred significant expenses in its efforts to develop and co-promote products. Our current business focus
is to: investigate further therapeutic uses of Macrilen™, expand pipeline development activities, further expand the commercialization
of macimorelin in available territories and fund ongoing clinical trial costs. Consequently, the Company has incurred operating losses
and has generated negative cash flow from operations and in each of the last several years except for the year ended December 31, 2018,
when the Company earned revenue from the sale of a license for the adult indication of Macrilen™ in the U.S. and Canada. The Company
expects to incur significant expenses and operating losses for the foreseeable future as it advances its product candidates through preclinical
and clinical development, seeks regulatory approval, and pursues commercialization of any approved product candidates. We expect that
our research and development costs will increase in connection with our planned research and development activities.
As
of June 30, 2023, the Company had an accumulated deficit of $358.9 million. The Company also had a net loss of $6.9 million and negative
cash flows from operations of $8.4 million for the six-month period ended June 30, 2023. We believe that our existing cash on hand will
be sufficient to fund our anticipated operating and capital expenditure requirements for at least the next 12 months. We plan to finance
our future operations and capital expenditures primarily through cash on hand. We also believe that our existing cash on hand will be
sufficient to fund our anticipated operating and capital expenditure requirements beyond the next 12 months and through 2025. We have
based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect. We may
also require additional capital to pursue in-licenses or acquisitions of other product candidates.
Our
forecast of the period through which our financial resources will be adequate to support our operations is a forward-looking statement
that involves risks and uncertainties, and actual results could vary materially as a result of a number of factors. Our future capital
requirements are difficult to forecast and will depend on many factors, including:
|
● |
the terms and timing of any
other collaboration, licensing, and other arrangements that we may establish; |
|
● |
the initiation, progress,
timing, and completion of preclinical studies and clinical trials for our current and future potential product candidates; |
|
● |
our alignment with the FDA
on regulatory approval requirements; |
|
● |
the number and characteristics
of product candidates that we pursue; |
|
● |
the outcome, timing, and cost
of regulatory approvals; |
|
● |
delays that may be caused
by changing regulatory requirements; |
|
● |
the cost and timing of hiring
new employees to support our continued growth; |
|
● |
the ability to manage inflation,
including rising interest rates and increased labor costs associated with attracting and retaining employees; |
|
● |
the costs involved in filing
and prosecuting patent applications and enforcing and defending patent claims; |
|
● |
the costs of filing and prosecuting
intellectual property rights and enforcing and defending any intellectual property-related claims; |
|
● |
the costs of responding to
and defending ourselves against complaints and potential litigation; |
|
● |
the costs and timing of procuring
clinical and commercial supplies for our product candidates; and |
|
● |
the extent to which we acquire
or in-license other product candidates and technologies. |
Contractual
obligations and commitments as of June 30, 2023
Significant
expenditure contracted for at the end of the reporting period but not recognized as liabilities is as follows:
(in thousands) | |
TOTAL | |
| |
| $ | |
Less than 1 year | |
| 7,586 | |
1 - 3 years | |
| 151 | |
4 - 5 years | |
| 37 | |
More than 5 years | |
| - | |
| |
| 7,774 | |
In
2021, the Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements
may require the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company
generally has the right to terminate these agreements at no penalty. The Company may have to pay up to $38,887 upon achieving certain
sales volumes, regulatory or other milestones related to specific products.
Contingencies
In
the normal course of operations, the Company may become involved in various claims and legal proceedings related to, for example, contract
terminations and employee-related and other matters.
Related
Party Transactions and Off-Balance Sheet Arrangements
Other
than employment agreements and indemnification agreements with our management, there are no related party transactions.
As
of June 30, 2023, we did not have any interests in special purpose entities or any other off-balance sheet arrangements.
Risk
Factors and Uncertainties
An
investment in our securities involves a high degree of risk. In addition to the other information included in this MD&A and in the
related consolidated financial statements, investors are urged to carefully consider the risks described under the caption “Risk
Factors” in our most recent Annual Report on Form 20-F for the year ended December 31, 2022, for a discussion of the various risks
that may materially affect our business. The risks and uncertainties not presently known to us or that we currently deem immaterial may
also materially harm our business, operating results and financial condition and could result in a complete loss of your investment.
Our
most recent Annual Report on Form 20-F was filed with the relevant Canadian and U.S. securities’ regulatory authorities at www.sedar.com
and with the SEC at www.sec.gov. Investors are urged to consult the risk factors in these documents.
Disclosure
Controls and Procedures
The
Chief Executive Officer and the Chief Financial Officer of the Corporation are responsible for establishing and maintaining our disclosure
controls and procedures. Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the
reports we file or submit under U.S. and Canadian securities legislation is recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated
to our management, including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required
disclosures.
Any
controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control
objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
There have been no significant changes to our disclosure controls and procedures for the six-month period ended June 30, 2023, that have
materially affected, or are reasonably likely to materially affect, the disclosure controls and procedures.
Internal
Controls over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over
financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with IFRS as issued by the IASB.
Our
internal control over financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that,
in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of Aeterna Zentaris; (ii) provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with IFRS,
and that receipts and expenditures of the Company are being made only in accordance with authorizations of Company management; and (iii)
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of Company assets
that could have a material effect on the financial statements.
Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of
any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions,
or that the degree of compliance with the policies or procedures may deteriorate.
Changes
in Internal Controls over Financial Reporting
There
have been no significant changes to our internal controls over financial reporting for the three-month period ended June 30, 2023, that
have materially affected, or are reasonably likely to materially affect, internal controls over financial reporting.
Exhibit
99.3
FORM
52-109F2
CERTIFICATION
OF INTERIM FILINGS
FULL
CERTIFICATE
I,
Klaus Paulini, Chief Executive Officer, Aeterna Zentaris Inc., certify the following:
| 1. | Review:
I have reviewed the interim financial report and interim MD&A (together, the
“interim filings”) of Aeterna Zentaris Inc. (the “issuer”) for the
interim period ended June 30, 2023. |
| 2. | No
misrepresentations: Based on my knowledge, having exercised reasonable diligence,
the interim filings do not contain any untrue statement of a material fact or omit to state
a material fact required to be stated or that is necessary to make a statement not misleading
in light of the circumstances under which it was made, with respect to the period covered
by the interim filings. |
| 3. | Fair
presentation: Based on my knowledge, having exercised reasonable diligence, the interim
financial report together with the other financial information included in the interim filings
fairly present in all material respects the financial condition, financial performance and
cash flows of the issuer, as of the date of and for the periods presented in the interim
filings. |
| 4. | Responsibility:
The issuer’s other certifying officer(s) and I are responsible for establishing
and maintaining disclosure controls and procedures (DC&P) and internal control over financial
reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification
of Disclosure in Issuers’ Annual and Interim Filings, for the issuer. |
| 5. | Design:
Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s
other certifying officer(s) and I have, as at the end of the period covered by the interim
filings |
| (a) | designed
DC&P, or caused it to be designed under our supervision, to provide reasonable assurance
that |
| (i) | material
information relating to the issuer is made known to us by others, particularly during the
period in which the interim filings are being prepared; and |
| (ii) | information
required to be disclosed by the issuer in its annual filings, interim filings or other reports
filed or submitted by it under securities legislation is recorded, processed, summarized
and reported within the time periods specified in securities legislation; and |
| (b) | designed
ICFR, or caused it to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with the issuer’s GAAP. |
| 5.1 | Control
framework: The control framework the issuer’s other certifying officer(s) and
I used to design the issuer’s ICFR is Internal Control – Integrated Framework:
2013, issued by the Committee of Sponsoring Organizations of the Treadway Commission. |
| 6. | Reporting
changes in ICFR: The issuer has disclosed in its interim MD&A any change in the
issuer’s ICFR that occurred during the period beginning on January 1, 2023 and ended
on June 30, 2023 that has materially affected, or is reasonably likely to materially affect,
the issuer’s ICFR. |
Date:
August 9, 2023
/s/
Klaus Paulini |
|
Klaus Paulini | |
Chief
Executive Officer |
|
Exhibit
99.4
FORM
52-109F2
CERTIFICATION
OF INTERIM FILINGS
FULL
CERTIFICATE
I,
Giuliano La Fratta, Chief Financial Officer, Aeterna Zentaris Inc., certify the following:
1. | Review:
I have reviewed the interim financial report and interim MD&A (together, the
“interim filings”) of Aeterna Zentaris Inc. (the “issuer”) for the
interim period ended June 30, 2023. |
| |
2. | No
misrepresentations: Based on my knowledge, having exercised reasonable diligence,
the interim filings do not contain any untrue statement of a material fact or omit to state
a material fact required to be stated or that is necessary to make a statement not misleading
in light of the circumstances under which it was made, with respect to the period covered
by the interim filings. |
| |
3. | Fair
presentation: Based on my knowledge, having exercised reasonable diligence, the interim
financial report together with the other financial information included in the interim filings
fairly present in all material respects the financial condition, financial performance and
cash flows of the issuer, as of the date of and for the periods presented in the interim
filings. |
| |
4. | Responsibility:
The issuer’s other certifying officer(s) and I are responsible for establishing
and maintaining disclosure controls and procedures (DC&P) and internal control over financial
reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification
of Disclosure in Issuers’ Annual and Interim Filings, for the issuer. |
| |
5. | Design:
Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s
other certifying officer(s) and I have, as at the end of the period covered by the interim
filings |
| (a) | designed
DC&P, or caused it to be designed under our supervision, to provide reasonable assurance
that |
| (i) | material
information relating to the issuer is made known to us by others, particularly during the
period in which the interim filings are being prepared; and |
| | |
| (ii) | information
required to be disclosed by the issuer in its annual filings, interim filings or other reports
filed or submitted by it under securities legislation is recorded, processed, summarized
and reported within the time periods specified in securities legislation; and |
|
(b) | designed
ICFR, or caused it to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with the issuer’s GAAP. |
5.1 | Control
framework: The control framework the issuer’s other certifying officer(s) and
I used to design the issuer’s ICFR is Internal Control – Integrated Framework:
2013, issued by the Committee of Sponsoring Organizations of the Treadway Commission. |
6. | Reporting
changes in ICFR: The issuer has disclosed in its interim MD&A any change in the
issuer’s ICFR that occurred during the period beginning on January 1, 2023 and ended
on June 30, 2023 that has materially affected, or is reasonably likely to materially affect,
the issuer’s ICFR. |
Date:
August 9, 2023 |
|
|
|
/s/
Giuliano La Fratta |
|
Giuliano
La Fratta |
|
Chief
Financial Officer |
|
v3.23.2
Cover
|
6 Months Ended |
Jun. 30, 2023 |
Cover [Abstract] |
|
Document Type |
6-K
|
Amendment Flag |
false
|
Document Period End Date |
Jun. 30, 2023
|
Document Fiscal Period Focus |
Q2
|
Document Fiscal Year Focus |
2023
|
Current Fiscal Year End Date |
--12-31
|
Entity File Number |
001-38064
|
Entity Registrant Name |
Aeterna
Zentaris Inc.
|
Entity Central Index Key |
0001113423
|
Entity Address, Address Line One |
c/o
Norton Rose Fulbright Canada, LLP
|
Entity Address, Address Line Two |
222 Bay Street
|
Entity Address, Address Line Three |
Suite 3000, PO Box 53,
|
Entity Address, City or Town |
Toronto ON
|
Entity Address, Country |
CA
|
Entity Address, Postal Zip Code |
M5K 1E7
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v3.23.2
Condensed Interim Consolidated Statements of Financial Position (Unaudited) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets |
|
|
Cash and cash equivalents |
$ 42,186
|
$ 50,611
|
Trade and other receivables |
185
|
732
|
Inventory |
93
|
229
|
Income taxes receivable |
792
|
1,428
|
Prepaid expenses and other current assets |
2,637
|
2,488
|
Total current assets |
45,893
|
55,488
|
Non-current assets |
|
|
Restricted cash equivalents |
325
|
322
|
Property and equipment |
265
|
216
|
Total non-current assets |
591
|
538
|
Total assets |
46,483
|
56,026
|
Current liabilities |
|
|
Payables and accrued liabilities |
3,572
|
3,828
|
Provisions |
49
|
45
|
Income taxes payable |
109
|
108
|
Deferred revenues (note 3) |
202
|
2,949
|
Lease liabilities |
145
|
114
|
Total current liabilities |
4,077
|
7,044
|
Non-current liabilities |
|
|
Deferred revenues (note 3) |
1,580
|
1,684
|
Deferred gain |
111
|
110
|
Lease liabilities |
85
|
65
|
Employee future benefits (note 4) |
11,381
|
11,159
|
Provisions |
170
|
188
|
Total non-current liabilities |
13,327
|
13,206
|
Total liabilities |
17,404
|
20,250
|
Shareholders’ equity |
|
|
Share capital (note 5) |
293,410
|
293,410
|
Warrants |
5,085
|
5,085
|
Contributed surplus |
90,654
|
90,332
|
Deficit |
(358,936)
|
(352,084)
|
Accumulated other comprehensive loss |
(1,134)
|
(967)
|
Total Shareholders’ equity |
29,079
|
35,776
|
Total liabilities and shareholders’ equity |
$ 46,483
|
$ 56,026
|
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Effective 2023-01-01: The amount of liabilities that: (a) the entity expects to settle in its normal operating cycle; (b) the entity holds primarily for the purpose of trading; (c) are due to be settled within twelve months after the reporting period; or (d) the entity does not have the right at the end of the reporting period to defer settlement for at least twelve months after the reporting period.
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v3.23.2
Condensed Interim Consolidated Statements of Changes in Shareholders' Equity (Unaudited) - USD ($) $ in Thousands |
Issued capital [member] |
Warrants [member] |
Other equity interest [member] |
Retained earnings [member] |
Accumulated other comprehensive income [member] |
Total |
Balance – Value at Dec. 31, 2021 |
$ 293,410
|
$ 5,085
|
$ 89,788
|
$ (334,619)
|
$ (678)
|
$ 52,986
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
Net loss |
|
|
|
(6,856)
|
|
(6,856)
|
Foreign currency translation adjustments |
|
|
|
|
79
|
79
|
Actuarial gain on defined benefit plans |
|
|
|
8,025
|
|
8,025
|
Comprehensive income (loss) |
|
|
|
1,169
|
79
|
1,248
|
Share-based compensation costs |
|
|
60
|
|
|
60
|
Balance – Value at Jun. 30, 2022 |
293,410
|
5,085
|
89,848
|
(333,450)
|
(599)
|
54,294
|
Balance – Value at Dec. 31, 2022 |
293,410
|
5,085
|
90,332
|
(352,084)
|
(967)
|
35,776
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
Net loss |
|
|
|
(6,772)
|
|
(6,772)
|
Foreign currency translation adjustments |
|
|
|
|
(167)
|
(167)
|
Actuarial gain on defined benefit plans |
|
|
|
(80)
|
|
(80)
|
Comprehensive income (loss) |
|
|
|
(6,852)
|
(167)
|
(7,019)
|
Share-based compensation costs |
|
|
322
|
|
|
322
|
Balance – Value at Jun. 30, 2023 |
$ 293,410
|
$ 5,085
|
$ 90,654
|
$ (358,936)
|
$ (1,134)
|
$ 29,079
|
X |
- DefinitionThe amount of change in equity resulting from transactions and other events, other than those changes resulting from transactions with owners in their capacity as owners.
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v3.23.2
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Profit or loss [abstract] |
|
|
|
|
Revenues (note 3) |
$ 2,246
|
$ (222)
|
$ 4,374
|
$ 1,295
|
Expenses |
|
|
|
|
Cost of sales |
139
|
13
|
156
|
92
|
Research and development |
2,929
|
2,398
|
6,941
|
4,788
|
Selling, general and administrative |
2,033
|
2,083
|
4,339
|
3,944
|
Total expenses |
5,101
|
4,494
|
11,436
|
8,824
|
Loss from operations |
(2,855)
|
(4,716)
|
(7,062)
|
(7,529)
|
Gain (loss) due to changes in foreign currency exchange rates |
27
|
502
|
(32)
|
676
|
Interest income |
307
|
|
320
|
|
Other finance income (costs) |
3
|
(2)
|
2
|
(3)
|
Net finance income |
337
|
500
|
290
|
673
|
Loss before income taxes |
(2,518)
|
(4,216)
|
(6,772)
|
(6,856)
|
Income tax recovery |
|
|
|
|
Net loss |
(2,518)
|
(4,216)
|
(6,772)
|
(6,856)
|
Items that may be reclassified subsequently to profit or loss: |
|
|
|
|
Foreign currency translation adjustments |
3
|
42
|
(167)
|
79
|
Items that will not be reclassified to profit or loss: |
|
|
|
|
Actuarial gain on defined benefit plans (note 4) |
83
|
5,276
|
(80)
|
8,025
|
Comprehensive (loss) income |
$ (2,432)
|
$ 1,102
|
$ (7,019)
|
$ 1,248
|
Basic loss per share (note 7) |
$ (0.52)
|
$ (0.87)
|
$ (1.39)
|
$ (1.41)
|
Diluted loss per share (note 7) |
$ (0.52)
|
$ (0.87)
|
$ (1.39)
|
$ (1.41)
|
Weighted average number of shares outstanding, basic |
4,855,876
|
4,855,876
|
4,855,876
|
4,855,876
|
Weighted average number of shares outstanding, diluted |
4,855,876
|
4,855,876
|
4,855,876
|
4,855,876
|
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v3.23.2
Condensed Interim Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash flows from operating activities |
|
|
|
|
Net loss for the period |
$ (2,518)
|
$ (4,216)
|
$ (6,772)
|
$ (6,856)
|
Items not affecting cash and cash equivalents: |
|
|
|
|
Provisions |
18
|
7
|
10
|
5
|
Depreciation and amortization |
44
|
35
|
84
|
71
|
Share-based compensation costs |
306
|
33
|
323
|
60
|
Employee future benefits |
130
|
98
|
265
|
197
|
Amortization of deferred revenues |
(794)
|
124
|
(1,554)
|
(704)
|
Net foreign exchange differences |
(9)
|
(513)
|
(1)
|
(687)
|
Other non-cash items |
5
|
495
|
5
|
509
|
Refund (payment) of income taxes |
647
|
(51)
|
647
|
830
|
Changes in operating assets and liabilities (note 6) |
(2,122)
|
(862)
|
(1,361)
|
264
|
Net cash used in operating activities |
(4,293)
|
(4,850)
|
(8,354)
|
(6,311)
|
Cash flows from financing activities |
|
|
|
|
Payments on lease liabilities |
(42)
|
(34)
|
(80)
|
(68)
|
Net cash used in financing activities |
(42)
|
(34)
|
(80)
|
(68)
|
Cash flows from investing activities |
|
|
|
|
Purchase of property and equipment |
(3)
|
(42)
|
(5)
|
(48)
|
Net cash used in investing activities |
(3)
|
(42)
|
(5)
|
(48)
|
Effect of exchange rate changes on cash and cash equivalents |
(36)
|
(513)
|
14
|
(716)
|
Net change in cash and cash equivalents |
(4,374)
|
(5,439)
|
(8,425)
|
(7,143)
|
Cash and cash equivalents – Beginning of period |
46,560
|
63,596
|
50,611
|
65,300
|
Cash and cash equivalents – End of period |
$ 42,186
|
$ 58,157
|
$ 42,186
|
$ 58,157
|
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v3.23.2
Business overview
|
6 Months Ended |
Jun. 30, 2023 |
Business Overview |
|
Business overview |
1. Business overview
Summary
of business
Aeterna
Zentaris is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s
lead product, Macrilen® (macimorelin), is the first and only U.S. Food and Drug Administration (“FDA”) and
European Medicines Agency (“EMA”) approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency
(“AGHD”). Macimorelin is currently marketed under the tradename Ghryvelin™ in the European Economic Area and the United
Kingdom through an exclusive licensing agreement with Pharmanovia. The Company’s several other license and commercialization partners
are also seeking approval for commercialization of macimorelin in Israel and the Palestinian Authority, the Republic of Korea, Turkey
and several non-European Union Balkan countries. The Company is actively pursuing business development opportunities for the commercialization
of macimorelin in North America, Asia and the rest of the world.
The
Company is also dedicated to the development of therapeutic assets and has taken steps to establish a pre-clinical pipeline to potentially
address unmet medical needs across several indications with a focus on rare or orphan indications.
These
unaudited condensed interim consolidated financial statements were approved by the Board of Directors (the “Board”) on August
8, 2023.
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v3.23.2
Basis of presentation
|
6 Months Ended |
Jun. 30, 2023 |
Basis Of Presentation |
|
Basis of presentation |
2. Basis of presentation
These
unaudited condensed interim consolidated financial statements have been prepared in accordance with IAS 34, Interim Financial Reporting
as issued by the International Accounting Standards Board.
The
unaudited condensed interim consolidated financial statements do not include all the notes normally included in annual consolidated financial
statements. Accordingly, these unaudited condensed interim consolidated financial statements should be read in conjunction with the Company’s
annual consolidated financial statements as of and for the year ended December 31, 2022.
The
accounting policies used in these condensed interim consolidated financial statements are consistent with those presented in the Company’s
annual consolidated financial statements.
New
standards and amendments
Effective
January 1, 2023, the Company adopted the Disclosure of Accounting Policies (amendments to IAS 1 and IFRS Practice Statement 2). The amendments
to IAS 1 require that the Company discloses its material accounting policies instead of its significant accounting policies. As a result
of the adoption of these amendments, there were no adjustments to the presentation or amounts recognized in the interim financial statements.
Critical
accounting estimates and judgements
The
preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgements, estimates
and assumptions that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and related disclosures.
Judgements, estimates and assumptions are based on historical experience, expectations, current trends and other factors that management
believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements are prepared.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Management
reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgements in order to ensure that the
condensed interim consolidated financial statements are presented fairly and in accordance with IFRS applicable to interim financial
statements. Critical accounting estimates and assumptions, as well as critical judgements used in applying accounting policies in the
preparation of the Company’s condensed interim consolidated financial statements, were the same as those applied to the Company’s
annual consolidated financial statements as of and for the year ended December 31, 2022.
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v3.23.2
Revenue
|
6 Months Ended |
Jun. 30, 2023 |
Revenue [abstract] |
|
Revenue |
3. Revenue
The
Company derives revenue from the transfer of goods and services over time and at a point in time in the following categories:
Summary
of revenue from transfer of goods and services
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
License fees | |
| 795 | | |
| (206 | ) | |
| 1,554 | | |
| 226 | |
Development services | |
| 1,402 | | |
| (77 | ) | |
| 2,741 | | |
| 889 | |
Product sales | |
| - | | |
| - | | |
| - | | |
| 57 | |
Royalties | |
| 7 | | |
| 24 | | |
| 26 | | |
| 43 | |
Supply chain | |
| 42 | | |
| 37 | | |
| 53 | | |
| 80 | |
Total | |
| 2,246 | | |
| (222 | ) | |
| 4,374 | | |
| 1,295 | |
The
Company recorded revenue for the transfer of services over time for the three-months ended June 30, 2023, of $2,197 (2022 – ($283))
and the six-months ended June 30, 2023, of $4,295 (2022 - $1,115). While revenue recorded at a point in time for the three-months ended
June 30, 2023, was $49 (2022 – $61) and the six-months ended June 30, 2023, was $79 (2022 - $180).
Pharmanovia:
On
March 15, 2023, with the Company’s consent, Consilient Health (“CH”) entered into an assignment agreement with Pharmanovia
to transfer the current licensing agreement for the commercialization of macimorelin in the European Economic Area and the United Kingdom
to Pharmanovia, as well as the current supply agreement pursuant to which the Company agreed to provide the licensed product (together,
the “Assignment Agreement”). Also on March 15, 2023, the Company and Pharmanovia entered into an amendment agreement, pursuant
to which the Company provided its acknowledgement and consent to the Assignment Agreement and agreed to certain amended terms which do
not materially differ from the previous license and supply agreement with CH. Subsequent to the execution of the Assignment Agreement,
the aggregate amount of the transaction price allocated to the Company’s unsatisfied performance obligations was $1,658 (€1,540),
comprised of; the combined adult indication performance obligation of $1,233 (€1,145), and the combined pediatric indication performance
obligation of $425 (€395). The Company will continue to recognize revenue over time using an output method based on units of licensed
product supplied to Pharmanovia. The total units that the Company expects to supply to Pharmanovia is an estimate, based on current projections
and anticipated market demand, and therefore will be a significant judgement that will be relied upon when using the outputs method to
recognize revenue.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Novo
Nordisk Health Care AG:
On
August 26, 2022, Novo provided the Company with a notice of termination of the Novo Amendment. Under the terms of the Novo Amendment,
the termination was effective May 23, 2023, upon the completion of a 270-day notice period (“notice period”). Upon termination,
the rights and licenses granted by the Company to Novo under the Novo Amendment returned to the Company, and the Company regained full
rights to continue the clinical development and future commercialization of Macrilen™. Following the notice of termination and
throughout the 270-day notice period, as per the terms of the Novo Amendment, Novo continued to fund DETECT-trial costs up to $10.1 million
(€9.4 million). As of May 23, 2023, the Company recognized all remaining license fees associated with the Pediatric indication and
development services revenue previously recorded in deferred revenue.
Liabilities
related to contracts with customers
The
following table provides a summary of deferred revenue balances:
Summary
of deferred revenue
| |
June 30, 2023 | |
| |
Current | | |
Non-current | | |
Total | |
| |
$ | | |
$ | | |
$ | |
Novo Nordisk Health Care | |
| - | | |
| - | | |
| - | |
Pharmanovia | |
| 193 | | |
| 1,459 | | |
| 1,652 | |
NK Meditech | |
| 9 | | |
| 121 | | |
| 130 | |
| |
| 202 | | |
| 1,580 | | |
| 1,782 | |
| |
December 31, 2022 | |
| |
Current | | |
Non-current | | |
Total | |
| |
$ | | |
$ | | |
$ | |
Novo Nordisk Health Care | |
| 2,914 | | |
| - | | |
| 2,914 | |
Consilient Health | |
| 35 | | |
| 1,556 | | |
| 1,591 | |
NK Meditech | |
| - | | |
| 128 | | |
| 128 | |
| |
| 2,949 | | |
| 1,684 | | |
| 4,633 | |
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
X |
- DefinitionThe entire disclosure for revenue.
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v3.23.2
Employee future benefits
|
6 Months Ended |
Jun. 30, 2023 |
Employee Future Benefits |
|
Employee future benefits |
4. Employee future benefits
The
change in the Company’s employee future benefit obligations is summarized as follows:
Summary
of net defined benefit liability asset
| |
benefit plans | | |
benefit plans | | |
Total | | |
Total | |
| |
Six months ended June 30, 2023 | | |
Year ended
December 31,
2022 | |
| |
Pension | | |
Other | | |
| | |
| |
| |
benefit plans | | |
benefit plans | | |
Total | | |
Total | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Change in plan liabilities | |
| | | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| 21,657 | | |
| 93 | | |
| 21,750 | | |
| 29,412 | |
Current service cost | |
| 63 | | |
| 6 | | |
| 69 | | |
| 142 | |
Interest cost | |
| 400 | | |
| 2 | | |
| 402 | | |
| 295 | |
Actuarial loss (gain) from changes in financial assumptions | |
| 143 | | |
| - | | |
| 143 | | |
| (5,915 | ) |
Benefits paid | |
| (380 | ) | |
| - | | |
| (380 | ) | |
| (752 | ) |
Impact of foreign exchange rate changes | |
| 261 | | |
| 1 | | |
| 262 | | |
| (1,432 | ) |
Balances – End of the period | |
| 22,144 | | |
| 102 | | |
| 22,246 | | |
| 21,750 | |
| |
| | | |
| | | |
| | | |
| | |
Change in plan assets | |
| | | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| 10,591 | | |
| - | | |
| 10,591 | | |
| 11,927 | |
Interest income from plan assets | |
| 198 | | |
| - | | |
| 198 | | |
| 120 | |
Employer contributions | |
| 14 | | |
| - | | |
| 14 | | |
| 45 | |
Employee contributions | |
| 8 | | |
| - | | |
| 8 | | |
| 10 | |
Benefits paid | |
| (136 | ) | |
| - | | |
| (136 | ) | |
| (247 | ) |
Remeasurement of plan assets | |
| 63 | | |
| - | | |
| 63 | | |
| (641 | ) |
Impact of foreign exchange rate changes | |
| 127 | | |
| - | | |
| 127 | | |
| (623 | ) |
Balances – End of the period | |
| 10,865 | | |
| - | | |
| 10,865 | | |
| 10,591 | |
| |
| | | |
| | | |
| | | |
| | |
Net liability of the unfunded plans | |
| 10,867 | | |
| 102 | | |
| 10,969 | | |
| 10,787 | |
Net liability of the funded plans | |
| 412 | | |
| - | | |
| 412 | | |
| 372 | |
Net amount recognized as Employee future benefits | |
| 11,279 | | |
| 102 | | |
| 11,381 | | |
| 11,159 | |
| |
| | | |
| | | |
| | | |
| | |
Amounts recognized: | |
| | | |
| | | |
| | | |
| | |
In net loss | |
| 257 | | |
| 8 | | |
| 265 | | |
| 295 | |
Actuarial (loss) gain on defined benefit plans in other comprehensive (loss) income | |
| (80 | ) | |
| - | | |
| (80 | ) | |
| 5,262 | |
The
calculation of the employee future benefit obligation is sensitive to the discount rate assumption and other assumptions such as the
rate of the pension benefit increase. Discount rates were 3.70% as of June 30, 2023, and 3.75% as of December 31, 2022, causing the variances
in the actuarial loss (gain) on defined benefit plan during the six months ended June 30, 2023.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
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v3.23.2
Shareholders’ equity
|
6 Months Ended |
Jun. 30, 2023 |
Shareholders Equity |
|
Shareholders’ equity |
5. Shareholders’ equity
Share
capital
The
Company has authorized an unlimited number of common shares (being voting and participating shares) with no par value, as well as an
unlimited number of preferred, first and second ranking shares, issuable in series, with rights and privileges specific to each class,
with no par value.
Summary
of share capital
| |
Common shares | | |
Amount | |
| |
# | | |
$ | |
Balance – December 31, 2022 | |
| 4,855,876 | | |
| 293,410 | |
| |
| | | |
| | |
| |
| - | | |
| - | |
Balance – June 30, 2023 | |
| 4,855,876 | | |
| 293,410 | |
On
July 15, 2022, the Company’s shareholders and board of directors approved an amendment to the Company’s articles of incorporation
to effect a 1-for-25 share consolidation (reverse split) of the Company’s common shares. The Company’s outstanding stock
options, DSUs and warrants were also adjusted to reflect the 1-for-25 share consolidation (reverse split) of the Company’s common
shares. Accordingly, all common shares, DSU, warrants, stock options and per share amounts in these
interim condensed consolidated financial statements have been retroactively adjusted for all periods presented to give effect to the
share consolidation (reverse split). Outstanding warrant and stock options were proportionately reduced and the respective exercise
prices, if applicable, were proportionately increased. The share consolidation (reverse split) was affected on July 21, 2022.
Share-based
compensation
On
January 17, 2023, the Company granted 14,000 (2022 – 2,000) stock options under the Long-Term Incentive Plan. The stock options
have a term of seven years and will vest over a period of three years. The fair value at grant date is estimated using a Black-Scholes
option pricing model, considering the terms and conditions upon which the options were granted, using the following assumptions:
Summary of assumptions to determine share-based compensation costs over the life of awards
| |
June 30,
2023 | | |
June 30,
2022 | |
Expected dividend yield | |
$ | 0.00 | | |
$ | 0.00 | |
Expected volatility | |
| 104.46 | % | |
| 115.75 | % |
Risk-free annual interest rate | |
| 3.56 | % | |
| 1.59 | % |
Expected life (years) | |
| 5.45 | | |
| 5.72 | |
Share price | |
$ | 3.75 | | |
$ | 8.88 | |
Exercise price | |
$ | 3.75 | | |
$ | 8.88 | |
Grant date fair value | |
$ | 2.99 | | |
$ | 7.47 | |
The
expected volatility of these stock options was determined using historical volatility rates and the expected life was determined using
the weighted average life of past options issued.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
compensation expense for the three months ended June 30, 2023, was $22 (2022 – $33) and the six months ended June 30, 2023, was
$39 (2022 – $60) recognized over the vesting period. Option activity for the six months ended June 30, 2023, and 2022, was as follows:
Summary of number and weighted average exercise prices of share options
| |
Stock options | | |
Weighted average exercise price | |
| |
# | | |
$ | |
Balance – January 1, 2023 | |
| 42,030 | | |
| 20.05 | |
Granted | |
| 14,000 | | |
| 3.75 | |
Cancelled / Forfeited | |
| - | | |
| - | |
Balance – June 30, 2023 | |
| 56,030 | | |
| 15.98 | |
| |
Stock options | | |
Weighted average exercise price | |
| |
# | | |
$ | |
Balance – January 1, 2022 | |
| 43,455 | | |
| 22.00 | |
Granted | |
| 2,000 | | |
| 8.88 | |
Cancelled / Forfeited | |
| (2,399 | ) | |
| 10.98 | |
Balance – June 30, 2022 | |
| 43,056 | | |
| 21.95 | |
Deferred
share units
On
June 14, 2023, the Company granted 100,000 (2022 – nil) DSUs under the Long-Term Incentive Plan. The compensation expense for the
three and six months ended June 30, 2023, was $284 (2022 - $nil) and is presented in selling, general and administrative expenses. DSU
activity for the six months ended June 30, 2023, are:
Summary
of DSU activity
| |
2023 | | |
2022 | |
| |
# | | |
# | |
Balance – January 1, | |
| 96,920 | | |
| 16,920 | |
Granted | |
| 100,000 | | |
| - | |
Balance – June 30, | |
| 196,920 | | |
| 16,920 | |
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
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v3.23.2
Supplemental disclosure of cash flow information
|
6 Months Ended |
Jun. 30, 2023 |
Supplemental Disclosure Of Cash Flow Information |
|
Supplemental disclosure of cash flow information |
6. Supplemental disclosure of cash flow information
Disclosure
of changes in operating assets and liabilities
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Changes in operating assets and liabilities: | |
| | | |
| | | |
| | | |
| | |
Trade and other receivables | |
| 199 | | |
| (255 | ) | |
| 402 | | |
| 220 | |
Inventory | |
| 135 | | |
| - | | |
| 140 | | |
| (206 | ) |
Prepaid expenses and other current assets | |
| (748 | ) | |
| (1,471 | ) | |
| (122 | ) | |
| (759 | ) |
Payables and accrued liabilities | |
| (398 | ) | |
| (40 | ) | |
| (163 | ) | |
| 119 | |
Deferred revenues | |
| (1,205 | ) | |
| 1,001 | | |
| (1,359 | ) | |
| 1,008 | |
Provision for restructuring and other costs | |
| 4 | | |
| - | | |
| (5 | ) | |
| - | |
Employee future benefits | |
| (109 | ) | |
| (97 | ) | |
| (254 | ) | |
| (118 | ) |
Increase (decrease) in
operating assets and liabilities | |
| (2,122 | ) | |
| (862 | ) | |
| (1,361 | ) | |
| 264 | |
|
X |
- DefinitionThe entire disclosure for a statement of cash flows.
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v3.23.2
Net loss per share
|
6 Months Ended |
Jun. 30, 2023 |
Net Loss Per Share |
|
Net loss per share |
7. Net loss per share
The
following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common
shareholders.
Summary of pertinent data relating to computation of basic and diluted net loss per share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Net loss | |
| (2,518 | ) | |
| (4,216 | ) | |
| (6,772 | ) | |
| (6,856 | ) |
Basic and diluted weighted-average shares outstanding | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | |
Basic weighted-average shares outstanding | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
| (0.52 | ) | |
| (0.87 | ) | |
| (1.39 | ) | |
| (1.41 | ) |
Basic loss per share | |
| (0.52 | ) | |
| (0.87 | ) | |
| (1.39 | ) | |
| (1.41 | ) |
| |
| | | |
| | | |
| | | |
| | |
Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: | |
| | | |
| | | |
| | | |
| | |
Stock options and DSUs | |
| 252,950 | | |
| 62,375 | | |
| 252,950 | | |
| 62,375 | |
Warrants | |
| 457,648 | | |
| 457,648 | | |
| 457,648 | | |
| 457,648 | |
Anti-dilutive shares | |
| | | |
| | | |
| | | |
| | |
|
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v3.23.2
Segment information
|
6 Months Ended |
Jun. 30, 2023 |
Segment Information |
|
Segment information |
8. Segment information
The
Company operates in a single operating segment, being the biopharmaceutical segment.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
|
X |
- DefinitionThe entire disclosure for operating segments.
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v3.23.2
Commitments
|
6 Months Ended |
Jun. 30, 2023 |
Commitments |
|
Commitments |
9. Commitments
Significant
expenditure contracted for at the end of the reporting period but not recognized as liabilities is as follows:
Schedule
of expected future minimum lease payments
| |
TOTAL | |
| |
$ | |
Less than 1 year | |
| 7,586 | |
1 - 3 years | |
| 151 | |
4 - 5 years | |
| 37 | |
More than 5 years | |
| - | |
Total | |
| 7,774 | |
In
2021, the Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements
may require the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company
generally has the right to terminate these agreements at no penalty. The Company may have to pay up to $38,887 upon achieving certain
sales volumes, regulatory or other milestones related to specific products.
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v3.23.2
Basis of presentation (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Basis Of Presentation |
|
New standards and amendments |
New
standards and amendments
Effective
January 1, 2023, the Company adopted the Disclosure of Accounting Policies (amendments to IAS 1 and IFRS Practice Statement 2). The amendments
to IAS 1 require that the Company discloses its material accounting policies instead of its significant accounting policies. As a result
of the adoption of these amendments, there were no adjustments to the presentation or amounts recognized in the interim financial statements.
|
Critical accounting estimates and judgements |
Critical
accounting estimates and judgements
The
preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgements, estimates
and assumptions that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and related disclosures.
Judgements, estimates and assumptions are based on historical experience, expectations, current trends and other factors that management
believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements are prepared.
Aeterna
Zentaris Inc.
Notes
to the Condensed Interim Consolidated Financial Statements
As
of June 30, 2023, and for the three and six months ended June 30, 2023, and 2022
(In
thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Management
reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgements in order to ensure that the
condensed interim consolidated financial statements are presented fairly and in accordance with IFRS applicable to interim financial
statements. Critical accounting estimates and assumptions, as well as critical judgements used in applying accounting policies in the
preparation of the Company’s condensed interim consolidated financial statements, were the same as those applied to the Company’s
annual consolidated financial statements as of and for the year ended December 31, 2022.
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v3.23.2
Revenue (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Revenue [abstract] |
|
Summary of revenue from transfer of goods and services |
The
Company derives revenue from the transfer of goods and services over time and at a point in time in the following categories:
Summary
of revenue from transfer of goods and services
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| $ | | |
| $ | | |
| $ | | |
| $ | |
License fees | |
| 795 | | |
| (206 | ) | |
| 1,554 | | |
| 226 | |
Development services | |
| 1,402 | | |
| (77 | ) | |
| 2,741 | | |
| 889 | |
Product sales | |
| - | | |
| - | | |
| - | | |
| 57 | |
Royalties | |
| 7 | | |
| 24 | | |
| 26 | | |
| 43 | |
Supply chain | |
| 42 | | |
| 37 | | |
| 53 | | |
| 80 | |
Total | |
| 2,246 | | |
| (222 | ) | |
| 4,374 | | |
| 1,295 | |
|
Summary of deferred revenue |
The
following table provides a summary of deferred revenue balances:
Summary
of deferred revenue
| |
June 30, 2023 | |
| |
Current | | |
Non-current | | |
Total | |
| |
$ | | |
$ | | |
$ | |
Novo Nordisk Health Care | |
| - | | |
| - | | |
| - | |
Pharmanovia | |
| 193 | | |
| 1,459 | | |
| 1,652 | |
NK Meditech | |
| 9 | | |
| 121 | | |
| 130 | |
| |
| 202 | | |
| 1,580 | | |
| 1,782 | |
| |
December 31, 2022 | |
| |
Current | | |
Non-current | | |
Total | |
| |
$ | | |
$ | | |
$ | |
Novo Nordisk Health Care | |
| 2,914 | | |
| - | | |
| 2,914 | |
Consilient Health | |
| 35 | | |
| 1,556 | | |
| 1,591 | |
NK Meditech | |
| - | | |
| 128 | | |
| 128 | |
| |
| 2,949 | | |
| 1,684 | | |
| 4,633 | |
|
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v3.23.2
Employee future benefits (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Employee Future Benefits |
|
Summary of net defined benefit liability asset |
The
change in the Company’s employee future benefit obligations is summarized as follows:
Summary
of net defined benefit liability asset
| |
benefit plans | | |
benefit plans | | |
Total | | |
Total | |
| |
Six months ended June 30, 2023 | | |
Year ended
December 31,
2022 | |
| |
Pension | | |
Other | | |
| | |
| |
| |
benefit plans | | |
benefit plans | | |
Total | | |
Total | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Change in plan liabilities | |
| | | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| 21,657 | | |
| 93 | | |
| 21,750 | | |
| 29,412 | |
Current service cost | |
| 63 | | |
| 6 | | |
| 69 | | |
| 142 | |
Interest cost | |
| 400 | | |
| 2 | | |
| 402 | | |
| 295 | |
Actuarial loss (gain) from changes in financial assumptions | |
| 143 | | |
| - | | |
| 143 | | |
| (5,915 | ) |
Benefits paid | |
| (380 | ) | |
| - | | |
| (380 | ) | |
| (752 | ) |
Impact of foreign exchange rate changes | |
| 261 | | |
| 1 | | |
| 262 | | |
| (1,432 | ) |
Balances – End of the period | |
| 22,144 | | |
| 102 | | |
| 22,246 | | |
| 21,750 | |
| |
| | | |
| | | |
| | | |
| | |
Change in plan assets | |
| | | |
| | | |
| | | |
| | |
Balances – Beginning of the period | |
| 10,591 | | |
| - | | |
| 10,591 | | |
| 11,927 | |
Interest income from plan assets | |
| 198 | | |
| - | | |
| 198 | | |
| 120 | |
Employer contributions | |
| 14 | | |
| - | | |
| 14 | | |
| 45 | |
Employee contributions | |
| 8 | | |
| - | | |
| 8 | | |
| 10 | |
Benefits paid | |
| (136 | ) | |
| - | | |
| (136 | ) | |
| (247 | ) |
Remeasurement of plan assets | |
| 63 | | |
| - | | |
| 63 | | |
| (641 | ) |
Impact of foreign exchange rate changes | |
| 127 | | |
| - | | |
| 127 | | |
| (623 | ) |
Balances – End of the period | |
| 10,865 | | |
| - | | |
| 10,865 | | |
| 10,591 | |
| |
| | | |
| | | |
| | | |
| | |
Net liability of the unfunded plans | |
| 10,867 | | |
| 102 | | |
| 10,969 | | |
| 10,787 | |
Net liability of the funded plans | |
| 412 | | |
| - | | |
| 412 | | |
| 372 | |
Net amount recognized as Employee future benefits | |
| 11,279 | | |
| 102 | | |
| 11,381 | | |
| 11,159 | |
| |
| | | |
| | | |
| | | |
| | |
Amounts recognized: | |
| | | |
| | | |
| | | |
| | |
In net loss | |
| 257 | | |
| 8 | | |
| 265 | | |
| 295 | |
Actuarial (loss) gain on defined benefit plans in other comprehensive (loss) income | |
| (80 | ) | |
| - | | |
| (80 | ) | |
| 5,262 | |
|
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v3.23.2
Shareholders’ equity (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Shareholders Equity |
|
Summary of share capital |
Summary
of share capital
| |
Common shares | | |
Amount | |
| |
# | | |
$ | |
Balance – December 31, 2022 | |
| 4,855,876 | | |
| 293,410 | |
| |
| | | |
| | |
| |
| - | | |
| - | |
Balance – June 30, 2023 | |
| 4,855,876 | | |
| 293,410 | |
|
Summary of assumptions to determine share-based compensation costs over the life of awards |
Summary of assumptions to determine share-based compensation costs over the life of awards
| |
June 30,
2023 | | |
June 30,
2022 | |
Expected dividend yield | |
$ | 0.00 | | |
$ | 0.00 | |
Expected volatility | |
| 104.46 | % | |
| 115.75 | % |
Risk-free annual interest rate | |
| 3.56 | % | |
| 1.59 | % |
Expected life (years) | |
| 5.45 | | |
| 5.72 | |
Share price | |
$ | 3.75 | | |
$ | 8.88 | |
Exercise price | |
$ | 3.75 | | |
$ | 8.88 | |
Grant date fair value | |
$ | 2.99 | | |
$ | 7.47 | |
|
Summary of number and weighted average exercise prices of share options |
Summary of number and weighted average exercise prices of share options
| |
Stock options | | |
Weighted average exercise price | |
| |
# | | |
$ | |
Balance – January 1, 2023 | |
| 42,030 | | |
| 20.05 | |
Granted | |
| 14,000 | | |
| 3.75 | |
Cancelled / Forfeited | |
| - | | |
| - | |
Balance – June 30, 2023 | |
| 56,030 | | |
| 15.98 | |
| |
Stock options | | |
Weighted average exercise price | |
| |
# | | |
$ | |
Balance – January 1, 2022 | |
| 43,455 | | |
| 22.00 | |
Granted | |
| 2,000 | | |
| 8.88 | |
Cancelled / Forfeited | |
| (2,399 | ) | |
| 10.98 | |
Balance – June 30, 2022 | |
| 43,056 | | |
| 21.95 | |
|
Summary of DSU activity |
Summary
of DSU activity
| |
2023 | | |
2022 | |
| |
# | | |
# | |
Balance – January 1, | |
| 96,920 | | |
| 16,920 | |
Granted | |
| 100,000 | | |
| - | |
Balance – June 30, | |
| 196,920 | | |
| 16,920 | |
|
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v3.23.2
Supplemental disclosure of cash flow information (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Supplemental Disclosure Of Cash Flow Information |
|
Disclosure of changes in operating assets and liabilities |
Disclosure
of changes in operating assets and liabilities
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Changes in operating assets and liabilities: | |
| | | |
| | | |
| | | |
| | |
Trade and other receivables | |
| 199 | | |
| (255 | ) | |
| 402 | | |
| 220 | |
Inventory | |
| 135 | | |
| - | | |
| 140 | | |
| (206 | ) |
Prepaid expenses and other current assets | |
| (748 | ) | |
| (1,471 | ) | |
| (122 | ) | |
| (759 | ) |
Payables and accrued liabilities | |
| (398 | ) | |
| (40 | ) | |
| (163 | ) | |
| 119 | |
Deferred revenues | |
| (1,205 | ) | |
| 1,001 | | |
| (1,359 | ) | |
| 1,008 | |
Provision for restructuring and other costs | |
| 4 | | |
| - | | |
| (5 | ) | |
| - | |
Employee future benefits | |
| (109 | ) | |
| (97 | ) | |
| (254 | ) | |
| (118 | ) |
Increase (decrease) in
operating assets and liabilities | |
| (2,122 | ) | |
| (862 | ) | |
| (1,361 | ) | |
| 264 | |
|
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v3.23.2
Net loss per share (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Net Loss Per Share |
|
Summary of pertinent data relating to computation of basic and diluted net loss per share |
The
following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common
shareholders.
Summary of pertinent data relating to computation of basic and diluted net loss per share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
$ | | |
$ | | |
$ | | |
$ | |
Net loss | |
| (2,518 | ) | |
| (4,216 | ) | |
| (6,772 | ) | |
| (6,856 | ) |
Basic and diluted weighted-average shares outstanding | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | |
Basic weighted-average shares outstanding | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | | |
| 4,855,876 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
| (0.52 | ) | |
| (0.87 | ) | |
| (1.39 | ) | |
| (1.41 | ) |
Basic loss per share | |
| (0.52 | ) | |
| (0.87 | ) | |
| (1.39 | ) | |
| (1.41 | ) |
| |
| | | |
| | | |
| | | |
| | |
Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: | |
| | | |
| | | |
| | | |
| | |
Stock options and DSUs | |
| 252,950 | | |
| 62,375 | | |
| 252,950 | | |
| 62,375 | |
Warrants | |
| 457,648 | | |
| 457,648 | | |
| 457,648 | | |
| 457,648 | |
Anti-dilutive shares | |
| | | |
| | | |
| | | |
| | |
|
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v3.23.2
Commitments (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Commitments |
|
Schedule of expected future minimum lease payments |
Significant
expenditure contracted for at the end of the reporting period but not recognized as liabilities is as follows:
Schedule
of expected future minimum lease payments
| |
TOTAL | |
| |
$ | |
Less than 1 year | |
| 7,586 | |
1 - 3 years | |
| 151 | |
4 - 5 years | |
| 37 | |
More than 5 years | |
| - | |
Total | |
| 7,774 | |
|
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v3.23.2
Summary of revenue from transfer of goods and services (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
IfrsStatementLineItems [Line Items] |
|
|
|
|
Total |
$ 2,246
|
$ (222)
|
$ 4,374
|
$ 1,295
|
License Fees [Member] |
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
Total |
795
|
(206)
|
1,554
|
226
|
Development Services [Member] |
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
Total |
1,402
|
(77)
|
2,741
|
889
|
Product Sales [Member] |
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
Total |
|
|
|
57
|
Royalties [Member] |
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
Total |
7
|
24
|
26
|
43
|
Supply Chain [Member] |
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
Total |
$ 42
|
$ 37
|
$ 53
|
$ 80
|
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v3.23.2
Summary of deferred revenue (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
IfrsStatementLineItems [Line Items] |
|
|
Total Current Deferred Revenues |
$ 202
|
$ 2,949
|
Total Deferred Revenues Non Current |
1,580
|
1,684
|
Total Deferred Revenues |
1,782
|
4,633
|
Novo Nordisk Health Care [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Total Current Deferred Revenues |
|
2,914
|
Total Deferred Revenues Non Current |
|
|
Total Deferred Revenues |
|
2,914
|
Pharmanovia [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Total Current Deferred Revenues |
193
|
|
Total Deferred Revenues Non Current |
1,459
|
|
Total Deferred Revenues |
1,652
|
|
NK Meditech [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Total Current Deferred Revenues |
9
|
|
Total Deferred Revenues Non Current |
121
|
128
|
Total Deferred Revenues |
$ 130
|
128
|
Consilient Health [member] |
|
|
IfrsStatementLineItems [Line Items] |
|
|
Total Current Deferred Revenues |
|
35
|
Total Deferred Revenues Non Current |
|
1,556
|
Total Deferred Revenues |
|
$ 1,591
|
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v3.23.2
Revenue (Details Narrative) € in Thousands, $ in Thousands |
|
3 Months Ended |
6 Months Ended |
|
May 23, 2023
USD ($)
|
May 23, 2023
EUR (€)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Mar. 15, 2023
USD ($)
|
Mar. 15, 2023
EUR (€)
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
Revenue |
|
|
$ 2,246
|
$ (222)
|
$ 4,374
|
$ 1,295
|
|
|
Novo Nordisk Health Care AG [member] |
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
Detect trial costs |
$ 10,100
|
€ 9,400
|
|
|
|
|
|
|
Unsatisfied performance obligations [member] |
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
Performance obligations |
|
|
|
|
|
|
$ 1,658
|
€ 1,540
|
Indication performance obligation [member] |
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
Performance obligations |
|
|
|
|
|
|
1,233
|
1,145
|
Pediatric indication performance [member] |
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
Performance obligations |
|
|
|
|
|
|
$ 425
|
€ 395
|
Goods or services transferred over time [member] |
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
Revenue |
|
|
2,197
|
283
|
4,295
|
1,115
|
|
|
Goods or services transferred at point in time [member] |
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
Revenue |
|
|
$ 49
|
$ 61
|
$ 79
|
$ 180
|
|
|
X |
- DefinitionThe income arising in the course of an entity's ordinary activities. Income is increases in assets, or decreases in liabilities, that result in increases in equity, other than those relating to contributions from holders of equity claims.
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v3.23.2
Summary of net defined benefit liability asset (Details) - USD ($) $ in Thousands |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Change in plan liabilities |
|
|
Balances – Beginning of the period |
$ 21,750
|
$ 29,412
|
Current service cost |
69
|
142
|
Interest cost |
402
|
295
|
Actuarial loss (gain) from changes in financial assumptions |
(143)
|
5,915
|
Benefits paid |
(380)
|
(752)
|
Impact of foreign exchange rate changes |
262
|
(1,432)
|
Balances – End of the period |
22,246
|
21,750
|
Change in plan assets |
|
|
Balances – Beginning of the period |
10,591
|
11,927
|
Interest income from plan assets |
198
|
120
|
Employer contributions |
14
|
45
|
Employee contributions |
8
|
10
|
Benefits paid |
(136)
|
(247)
|
Remeasurement of plan assets |
63
|
(641)
|
Impact of foreign exchange rate changes |
127
|
(623)
|
Balances – End of the period |
10,865
|
10,591
|
Net liability of the unfunded plans |
10,969
|
10,787
|
Net liability of the funded plans |
412
|
372
|
Net amount recognized as Employee future benefits |
11,381
|
11,159
|
Amounts recognized: |
|
|
In net loss |
265
|
295
|
Actuarial (loss) gain on defined benefit plans in other comprehensive (loss) income |
(80)
|
5,262
|
Pension defined benefit plans [member] |
|
|
Change in plan liabilities |
|
|
Balances – Beginning of the period |
21,657
|
|
Current service cost |
63
|
|
Interest cost |
400
|
|
Actuarial loss (gain) from changes in financial assumptions |
(143)
|
|
Benefits paid |
(380)
|
|
Impact of foreign exchange rate changes |
261
|
|
Balances – End of the period |
22,144
|
21,657
|
Change in plan assets |
|
|
Balances – Beginning of the period |
10,591
|
|
Interest income from plan assets |
198
|
|
Employer contributions |
14
|
|
Employee contributions |
8
|
|
Benefits paid |
(136)
|
|
Remeasurement of plan assets |
63
|
|
Impact of foreign exchange rate changes |
127
|
|
Balances – End of the period |
10,865
|
10,591
|
Net liability of the unfunded plans |
10,867
|
|
Net liability of the funded plans |
412
|
|
Net amount recognized as Employee future benefits |
11,279
|
|
Amounts recognized: |
|
|
In net loss |
257
|
|
Actuarial (loss) gain on defined benefit plans in other comprehensive (loss) income |
(80)
|
|
Other benefit plans [member] |
|
|
Change in plan liabilities |
|
|
Balances – Beginning of the period |
93
|
|
Current service cost |
6
|
|
Interest cost |
2
|
|
Actuarial loss (gain) from changes in financial assumptions |
|
|
Benefits paid |
|
|
Impact of foreign exchange rate changes |
1
|
|
Balances – End of the period |
102
|
93
|
Change in plan assets |
|
|
Balances – Beginning of the period |
|
|
Interest income from plan assets |
|
|
Employer contributions |
|
|
Employee contributions |
|
|
Benefits paid |
|
|
Remeasurement of plan assets |
|
|
Impact of foreign exchange rate changes |
|
|
Balances – End of the period |
|
|
Net liability of the unfunded plans |
102
|
|
Net liability of the funded plans |
|
|
Net amount recognized as Employee future benefits |
102
|
|
Amounts recognized: |
|
|
In net loss |
8
|
|
Actuarial (loss) gain on defined benefit plans in other comprehensive (loss) income |
|
|
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v3.23.2
Summary of share capital (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2022 |
IfrsStatementLineItems [Line Items] |
|
|
|
Balance – Value |
$ 35,776
|
$ 54,294
|
$ 52,986
|
Balance – Value |
$ 29,079
|
35,776
|
54,294
|
Issued capital [member] |
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
Number of shares issued |
4,855,876
|
|
|
Balance – Value |
$ 293,410
|
$ 293,410
|
293,410
|
Number of shares issued |
4,855,876
|
4,855,876
|
|
Balance – Value |
$ 293,410
|
$ 293,410
|
$ 293,410
|
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Summary of number and weighted average exercise prices of share options (Details)
|
6 Months Ended |
Jun. 30, 2023
shares
$ / shares
|
Jun. 30, 2022
shares
$ / shares
|
Shareholders Equity |
|
|
Number of Options, Beginning | shares |
42,030
|
43,455
|
Weighted average exercise price, beginning | $ / shares |
$ 20.05
|
$ 22.00
|
Number of Options, Granted | shares |
14,000
|
2,000
|
Weighted average exercise price, granted | $ / shares |
$ 3.75
|
$ 8.88
|
Number of Options, Canceled/Forfeited | shares |
|
(2,399)
|
Weighted average exercise price, cancelled/forfeited | $ / shares |
|
$ 10.98
|
Number of Options, Ending | shares |
56,030
|
43,056
|
Weighted average exercise price, ending | $ / shares |
$ 15.98
|
$ 21.95
|
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v3.23.2
Summary of DSU activity (Details) - Deferred Share Unit [member] - shares
|
|
|
6 Months Ended |
Jun. 14, 2023 |
Jun. 14, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
IfrsStatementLineItems [Line Items] |
|
|
|
|
Balance – January 1, |
|
|
96,920
|
16,920
|
Granted |
100,000
|
|
100,000
|
|
Balance – June 30, |
|
|
196,920
|
16,920
|
X |
- DefinitionThe number of other equity instruments (ie other than share options) granted in a share-based payment arrangement.
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v3.23.2
Shareholders’ equity (Details Narrative) $ in Thousands |
|
|
|
|
|
3 Months Ended |
6 Months Ended |
Jun. 14, 2023
shares
|
Jan. 17, 2023
shares
|
Jul. 15, 2022 |
Jun. 14, 2022
shares
|
Jan. 17, 2022
shares
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
shares
|
Jun. 30, 2022
USD ($)
shares
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
|
Number of options, granted |
|
|
|
|
|
|
|
14,000
|
2,000
|
Compensation expenses | $ |
|
|
|
|
|
$ 22
|
$ 33
|
$ 39
|
$ 60
|
Deferred Share Unit [member] |
|
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
|
Compensation expenses | $ |
|
|
|
|
|
$ 284
|
|
$ 284
|
|
Number of share units granted |
100,000
|
|
|
|
|
|
|
100,000
|
|
2018 Long Term Incentive Plan [member] |
|
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
|
Number of options, granted |
|
14,000
|
|
|
2,000
|
|
|
|
|
Shareholders and Board of Directors [member] |
|
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
|
Reverse stock split |
|
|
1-for-25
|
|
|
|
|
|
|
Deferred Stock Units [member] |
|
|
|
|
|
|
|
|
|
IfrsStatementLineItems [Line Items] |
|
|
|
|
|
|
|
|
|
Reverse stock split |
|
|
1-for-25
|
|
|
|
|
|
|
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v3.23.2
Disclosure of changes in operating assets and liabilities (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Supplemental Disclosure Of Cash Flow Information |
|
|
|
|
Trade and other receivables |
$ 199
|
$ (255)
|
$ 402
|
$ 220
|
Inventory |
135
|
|
140
|
(206)
|
Prepaid expenses and other current assets |
(748)
|
(1,471)
|
(122)
|
(759)
|
Payables and accrued liabilities |
(398)
|
(40)
|
(163)
|
119
|
Deferred revenues |
(1,205)
|
1,001
|
(1,359)
|
1,008
|
Provision for restructuring and other costs |
4
|
|
(5)
|
|
Employee future benefits |
(109)
|
(97)
|
(254)
|
(118)
|
Increase (decrease) in operating assets and liabilities |
$ (2,122)
|
$ (862)
|
$ (1,361)
|
$ 264
|
X |
- DefinitionAdjustments for decrease increase in current prepayments and other current assets.
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v3.23.2
Summary of pertinent data relating to computation of basic and diluted net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
IfrsStatementLineItems [Line Items] |
|
|
|
|
Net loss |
$ (2,518)
|
$ (4,216)
|
$ (6,772)
|
$ (6,856)
|
Basic weighted-average shares outstanding |
4,855,876
|
4,855,876
|
4,855,876
|
4,855,876
|
Diluted weighted-average shares outstanding |
4,855,876
|
4,855,876
|
4,855,876
|
4,855,876
|
Basic loss per share |
$ (0.52)
|
$ (0.87)
|
$ (1.39)
|
$ (1.41)
|
Diluted loss per share |
$ (0.52)
|
$ (0.87)
|
$ (1.39)
|
$ (1.41)
|
Employee Stock Option 1 Deferred Stock Units [member] |
|
|
|
|
Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: |
|
|
|
|
Anti-dilutive shares |
252,950
|
62,375
|
252,950
|
62,375
|
Warrants [member] |
|
|
|
|
Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: |
|
|
|
|
Anti-dilutive shares |
457,648
|
457,648
|
457,648
|
457,648
|
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