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 November 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 ☒ 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333-239019) and shall be deemed to be a part thereof from the date on which this report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.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

 

Exhibit   Description
99.1   Aeterna Zentaris’ Condensed Interim Consolidated Financial Statements – Third Quarter 2023 (Q3)
99.2   Aeterna Zentaris’ Management’s Discussion and Analysis of Financial Condition and Results of Operations – Third Quarter 2023 (Q3)
99.3   Certification of the Chief Executive Officer pursuant to National Instrument 52-109
99.4   Certification of the Principal Financial Officer pursuant to National Instrument 52-109

 

(2)
 

 

 

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: November 8, 2023 By: /s/ Klaus Paulini
    Klaus Paulini
    President and Chief Executive Officer

 

(3)

 

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Exhibit 99.1

 

 

Aeterna Zentaris Inc.

Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 30, 2023, and 2022

(In thousands of US dollars)

(Unaudited)

 

Condensed Interim Consolidated Statements of Financial Position 2
Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity 3
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss 4
Condensed Interim Consolidated Statements of Cash Flows 5
Notes to Condensed Interim Consolidated Financial Statements 6

 

1
 

 

Aeterna Zentaris Inc.

Condensed Interim Consolidated Statements of Financial Position

(In thousands of US dollars)

(Unaudited)

 

   As of September 30, 2023   As of December 31, 2022 
   $   $ 
ASSETS          
Current assets          
Cash and cash equivalents   38,756    50,611 
Trade and other receivables   546    732 
Inventory   91    229 
Income taxes receivable   116    1,428 
Prepaid expenses and other current assets   2,402    2,488 
Total current assets   41,911    55,488 
           
Non-current assets          
Restricted cash equivalents   320    322 
Property and equipment   255    216 
Total non-current assets   575    538 
Total assets   42,486    56,026 
           
LIABILITIES          
Current liabilities          
Payables and accrued liabilities   3,300    3,828 
Provisions   56    45 
Income taxes payable   106    108 
Deferred revenues (note 3)   90    2,949 
Deferred gain (note 4)   529    - 
Lease liabilities   147    114 
Total current liabilities   4,228    7,044 
Non-current liabilities          
Deferred revenues (note 3)   1,647    1,684 
Deferred gain (note 4)   -    110 
Lease liabilities   70    65 
Employee future benefits (note 5)   10,105    11,159 
Provisions   158    188 
Total non-current liabilities   11,980    13,206 
Total liabilities   16,208    20,250 
           
Shareholders’ equity          
Share capital (note 6)   293,410    293,410 
Warrants   5,085    5,085 
Contributed surplus   90,682    90,332 
Deficit   (362,088)   (352,084)
Accumulated other comprehensive loss   (811)   (967)
Total Shareholders’ equity   26,278    35,776 
Total liabilities and shareholders’ equity   42,486    56,026 

Commitments (note 10)

 

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

 

2
 

 

Aeterna Zentaris Inc.

Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity

For the nine months ended September 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   -    -    -    (10,917)   -    (10,917)
Other comprehensive loss:                              
Foreign currency translation adjustments   -    -    -    -    156    156 
Actuarial gain on defined benefit plans (note 5)   -    -    -    913    -    913 
Comprehensive loss                  (10,004)   156    (9,848)
Share-based compensation costs   -    -    350    -    -    350 
Balance – September 30, 2023   293,410    5,085    90,682    (362,088)   (811)   26,278 

 

   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 
Net loss   -    -    -    (10,276)   -    (10,276)
Other comprehensive loss:                              
Foreign currency translation adjustments   -    -    -    -    (26)   (26)
Actuarial gain on defined benefit plans   -    -    -    6,231    -    6,231 
Comprehensive income                  (4,045)   (26)   (4,071)
Share-based compensation costs   -    -    503    -    -    503 
Balance – September 30, 2022   293,410    5,085    90,291    (338,664)   (704)   49,418 

 

The accompanying notes are an integral part of these condensed interim consolidated financial statements.

 

3
 

 

Aeterna Zentaris Inc.

Condensed Interim Consolidated Statements of Loss and Comprehensive Loss

For the three and nine months ended September 30, 2023, and 2022

(In thousands of US dollars, except share and per share data)

(Unaudited)

 

   2023   2022   2023   2022 
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
    $    $    $    $ 
Revenues (note 3)   3    1,860    4,377    3,155 
                     
Expenses                    
Cost of sales   11    14    167    106 
Research and development   2,751    3,293    9,692    8,081 
Selling, general and administrative   1,791    2,274    6,130    6,218 
Total expenses   4,553    5,581    15,989    14,405 
                     
Loss from operations   (4,550)   (3,721)   (11,612)   (11,250)
                     
Gain (loss) due to changes in foreign currency exchange rates   (12)   301    (44)   977 
Interest income   419    -    739    - 
Other finance costs   (2)   -    -    (3)
Net finance income   405    301    695    974 
                     
Loss before income taxes   (4,145)   (3,420)   (10,917)   (10,276)
                     
Income tax recovery   -    -    -    - 
Net loss   (4,145)   (3,420)   (10,917)   (10,276)
                     
Other comprehensive loss:                    
Items that may be reclassified subsequently to profit or loss:                    
Foreign currency translation adjustments   323    (105)   156    (26)
Items that will not be reclassified to profit or loss:                    
Actuarial gain (loss) on defined benefit plans (note 5)   993    (1,794)   913    6,231 
Comprehensive loss   (2,829)   (5,319)   (9,848)   (4,071)
                     
Basic and diluted loss per share (note 8)   (0.85)   (0.70)   (2.25)   (2.12)
                     
Weighted average number of shares outstanding (basic and diluted)   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.

 

4
 

 

Aeterna Zentaris Inc.

Condensed Interim Consolidated Statements of Cash Flows

As of September 30, 2023, and for the three and nine months ended September 30, 2023, and 2022

(In thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

   2023   2022   2023   2022 
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
    $    $    $    $ 
Cash flows from operating activities                    
Net loss for the period   (4,145)   (3,420)   (10,917)   (10,276)
Items not affecting cash and cash equivalents:                    
Provisions   (20)   7    (10)   12 
Depreciation and amortization   42    33    126    104 
Share-based compensation costs   27    443    350    503 
Employee future benefits   132    69    397    266 
Amortization of deferred revenues   -    (1,248)   (1,554)   (1,952)
Net foreign exchange differences   (3)   -    (4)   - 
Other non-cash items   2    3    7    3 
Refund of income taxes   675    -    1,322    830 
Changes in operating assets and liabilities (note 7)   (94)   168    (1,455)   254 
Net cash used in operating activities   (3,384)   (3,945)   (11,738)   (10,256)
                     
Cash flows from financing activities                    
Payments on lease liabilities   (33)   (33)   (113)   (101)
Net cash used in financing activities   (33)   (33)   (113)   (101)
                     
Cash flows from investing activities                    
Purchase of property and equipment   (9)   (9)   (14)   (57)
Change in restricted cash equivalents   (1)   4    (1)   4 
Net cash used in investing activities   (10)   (5)   (15)   (53)
Effect of exchange rate changes on cash and cash equivalents   (3)   (358)   11    (1,074)
                     
Net change in cash and cash equivalents   (3,430)   (4,341)   (11,855)   (11,484)
Cash and cash equivalents – Beginning of period   42,186    58,157    50,611    65,300 
Cash and cash equivalents – End of period   38,756    53,816    38,756    53,816 

 

The accompanying notes are an integral part of these condensed interim consolidated financial statements.

 

5
 

 

Aeterna Zentaris Inc.

Notes to the Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 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 November 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.

 

6
 

 

Aeterna Zentaris Inc.

Notes to the Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 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:

 

   2023   2022   2023   2022 
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
    $    $    $    $ 
License fees   -    605    1,554    831 
Development services   -    1,202    2,741    2,091 
Product sales   -    -    -    57 
Royalties   3    14    29    57 
Supply chain   -    39    53    119 
Total revenue   3    1,860    4,377    3,155 

 

The Company recorded revenue for the transfer of services over time for the three months ended September 30, 2023, nil (2022 – $1,807) and the nine months ended September 30, 2023, of $4,295 (2022 - $2,922). Revenue recorded at a point in time for the three months ended September 30, 2023, was $3 (2022 – $53) and the nine months ended September 30, 2023, was $82 (2022 - $233).

 

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.

 

7
 

 

Aeterna Zentaris Inc.

Notes to the Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 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:

 

   September 30, 2023 
   Current   Non-current   Total 
    $    $     $  
Novo Nordisk Health Care   -    -    - 
Pharmanovia   82    1,528    1,610 
NK Meditech   8    119    127 
    90    1,647    1,737 

 

   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 

 

4. Deferred gain

 

On August 10, 2021, the Company entered into a trademark maintenance and assignment option agreement with ARES Trading SA, a subsidiary of Merck KGaA (“Merck”), with respect to the trademarks owned by the Company on Cetrotide® (cetrorelix acetate for injection). As consideration for having been granted the option, Merck has agreed to pay the Company a total of $529 (€0.5 million) a portion of which is to be calculated as a reimbursement of all internal and external trademark fees incurred by the Company for all years beginning with 2020 until the transfer date. The transfer of the trademarks, which is expected to take place within the next 12 months, shall constitute a sale, after which the Company will no longer have any ownership in or obligations related to the Cetrotide trademarks.

 

8
 

 

Aeterna Zentaris Inc.

Notes to the Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 30, 2023, and 2022

(In thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

5. Employee future benefits

 

The change in the Company’s employee future benefit obligations is summarized as follows:

 

   benefit plans   benefit plans   Total   Total 
  

Nine months ended

September 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   89    11    100    142 
Interest cost   599    1    600    295 
Actuarial gain from changes in financial assumptions   (1,249)   (1)   (1,250)   (5,915)
Benefits paid   (560)   -    (560)   (752)
Impact of foreign exchange rate changes   (295)   (2)   (297)   (1,432)
Balances – End of the period   20,241    102    20,343    21,750 
                     
Change in plan assets                    
Balances – Beginning of the period   10,591    -    10,591    11,927 
Interest income from plan assets   296    -    296    120 
Employer contributions   25    -    25    45 
Employee contributions   7    -    7    10 
Benefits paid   (198)   -    (198)   (247)
Remeasurement of plan assets   -    -    -    (641)
Change in asset ceiling   (337)   -    (337)   - 
Impact of foreign exchange rate changes   (146)   -    (146)   (623)
Balances – End of the period   10,238    -    10,238    10,591 
                     
Net liability of the unfunded plans   10,003    102    10,105    10,787 
Net liability of the funded plans   -    -    -    372 
Net amount recognized as Employee future benefits   10,003    102    10,105    11,159 
                     
Amounts recognized:                    
In net loss   385    12    397    295 
Actuarial gain on defined benefit plans in other comprehensive loss   912    1    913    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 4.20% as of September 30, 2023, and 3.75% as of December 31, 2022, causing the variances in the actuarial gain on defined benefit plan during the nine months ended September 30, 2023.

 

9
 

 

Aeterna Zentaris Inc.

Notes to the Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 30, 2023, and 2022

(In thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

6. 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.

 

   Common shares   Amount 
   #   $ 
Balance – December 31, 2022   4,855,876    293,410 
           
    -    - 
Balance – September 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:

 

   September 30, 2023   September 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.

 

10
 

 

Aeterna Zentaris Inc.

Notes to the Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 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 September 30, 2023, was $27 (2022 – $43) and for the nine months ended September 30, 2023, was $66 (2022 – $101) recognized over the vesting period. Option activity for the nine months ended September 30, 2023, and 2022, was as follows:

 

   Stock options   Weighted average exercise price 
   #   $ 
Balance – January 1, 2023   42,030    20.05 
Granted   14,000    3.75 
Cancelled / Forfeited   (400)   87.00 
Balance – September 30, 2023   55,630    15.47 

 

    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 – September 30, 2022   43,056    21.95 

 

Deferred share units

 

On June 14, 2023, the Company granted 100,000 (2022 – 80,000) DSUs under the Long-Term Incentive Plan. The compensation expense for the nine months ended September 30, 2023, was $284 (2022 - $402) and is presented in selling, general and administrative expenses. DSU activity for the nine months ended September 30, 2023, was as follows:

 

   2023   2022 
   #   # 
Balance – January 1,   96,920    16,920 
Granted   100,000    80,000 
Balance – September 30,   196,920    96,920 

 

11
 

 

Aeterna Zentaris Inc.

Notes to the Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 30, 2023, and 2022

(In thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

7. Supplemental disclosure of cash flow information

 

   2023   2022   2023   2022 
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
   $   $   $   $ 
Changes in operating assets and liabilities:                    
Trade and other receivables   (411)   205    (9)   425 
Inventory   (1)   41    139    (165)
Prepaid expenses and other current assets   186    (481)   64    (1,240)
Payables and accrued liabilities   (159)   (133)   (322)   (14)
Deferred revenues   (27)   595    (1,386)   1,425 
Taxes payable   -    210    -    210 
Provision for restructuring and other costs   (6)   -    (11)   - 
Employee future benefits   (142)   (269)   (396)   (387)
Deferred gain   466    -    466    - 
Increase (decrease) in operating assets and liabilities   (94)   168    (1,455)   254 

 

8. 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.

 

   2023   2022   2023   2022 
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
   $   $   $   $ 
Net loss   (4,145)   (3,420)   (10,917)   (10,276)
Basic and diluted weighted-average shares outstanding   4,855,876    4,855,876    4,855,876    4,855,876 
                     
Basic and diluted loss per share   (0.85)   (0.70)   (2.25)   (2.12)
                     
Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:                    
Stock options and DSUs   252,550    142,375    252,550    142,375 
Warrants   457,648    457,648    457,648    457,648 

 

9. Segment information

 

The Company operates in a single operating segment, being the biopharmaceutical segment.

 

12
 

 

Aeterna Zentaris Inc.

Notes to the Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 30, 2023, and 2022

(In thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

10. Commitments

 

Significant expenditure contracted for at the end of the reporting period but not recognized as liabilities is as follows:

 

   TOTAL 
   $ 
Less than 1 year   6,857 
1 - 3 years   131 
4 - 5 years   36 
More than 5 years   - 
Total   7,024 

 

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 $38,127 upon achieving certain sales volumes, regulatory or other milestones related to specific products.

 

13

 

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 nine-month periods ended September 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 September 30, 2023, and for the three and nine-month periods ended September 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 November 8, 2023. This MD&A is dated November 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 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.

 

1

 

 

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.ca and www.sec.gov.

 

2

 

 

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 under the tradename “Macimorelin 60 mg granules for oral suspension in sachet” in 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 and/or orphan indications, including, Neuromyelitis Optica Spectrum Disorder (NMOSD), Parkinson’s Disease (PD), chronic hypoparathyroidism and ALS (Lou Gehrig’s Disease).

 

Key Operational Developments

 

 

3

 

 

Macimorelin Commercialization Program

 

On March 15, 2023, with the Company’s consent, Consilient Health Limited (“Consilient” or “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™/Macimorelin 60 mg approved list prices in the United Kingdom, Germany and Spain. We shipped initial batches of macimorelin (Ghryvelin™/Macimorelin 60 mg) 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 the 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 for use to diagnose GHD in adults. In the meantime, the related PCT patent application has been granted in Canada, Japan, South Korea, Eurasia and New Zealand.

 

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.

 

4

 

 

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 has funded 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 Q4, 2023. We expect enrollment in our DETECT-trial to be completed around the end of 2023.

 

5

 

 

Pipeline Expansion Opportunities

 

 

AIM Biologicals: Targeted, highly specific autoimmunity modifying therapeutics for the potential treatment of neuromyelitis optica spectrum disorder (NMOSD) and Parkinson’s disease

 

AIM Biologicals are 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 on 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.

 

6

 

 

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. Up to now there is no pharmacological therapy available to prevent or delay disease progression. Alternate treatments, such as deep brain stimulation with short electric bursts, are being investigated for the treatment of symptoms. For the development of AIM Biologicals as potential PD therapeutics, Aeterna 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.

 

7

 

 

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

 

(in thousands of US dollars, except loss per share)  Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
   $   $   $   $ 
Revenues   3    1,860    4,377    3,155 
                     
Expenses                    
Cost of sales   11    14    167    106 
Research and development   2,751    3,293    9,692    8,081 
Selling, general and administrative   1,791    2,274    6,130    6,218 
Total expenses   4,553    5,581    15,989    14,405 
                     
Loss from operations   (4,550)   (3,721)   (11,612)   (11,250)
                     
Gain (loss) due to changes in foreign currency exchange rates   (12)   301    (44)   977 
Interest income   419    -    739    - 
Other finance costs   (2)   -    -    (3)
Net finance income   405    301    695    974 
                     
Loss before income taxes   (4,145)   (3,420)   (10,917)   (10,276)
                     
Income tax recovery        -    -    - 
Net loss   (4,145)   (3,420)   (10,917)   (10,276)
                     
Other comprehensive loss:                    
Foreign currency translation adjustments   323    (105)   156    (26)
Actuarial gain (loss) on defined benefit plans   993    (1,794)   913    6,231 
Comprehensive (loss) income   (2,829)   (5,319)   (9,848)   (4,071)
                     
Basic and diluted loss per share   (0.85)   (0.70)   (2.25)   (2.12)

 

8

 

 

Summarized Interim Consolidated Statements of Financial Position Data

 

(in thousands of US dollars)  September 30, 2023   December 31, 2022 
         
    $    $  
Cash and cash equivalents   38,756    50,611 
Trade and other receivables and other current assets   3,064    4,648 
Inventory   91    229 
Restricted cash equivalents   320    322 
Property and equipment   255    216 
Total assets   42,486    56,026 
Payables and accrued liabilities and income taxes payable   3,406    3,936 
Current portion of provisions   56    45 
Current portion of deferred revenues   90    2,949 
Current portion of deferred gain   529    - 
Lease liabilities   147    114 
Non-financial non-current liabilities (1)   11,980    13,206 
Total liabilities   16,208    20,250 
Shareholders’ equity   26,278    35,776 
Total liabilities and shareholders’ equity   42,486    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 nine-month periods ended September 30, 2023, as compared to the December 31, 2022, disclosures.

 

9

 

 

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 of US dollars, except percentages)  Three months ended September 30, 
   2023   2022   Change   Change 
   $   $   $   % 
Revenue                    
License fees   -    605    (605)   -100%
Development services   -    1,202    (1,202)   -100%
Royalties   3    14    (11)   -79%
Supply chain   -    39    (39)   -100%
Total revenue   3    1,860    (1,857)   -100%

 

Our total revenue for the three-month period ended September 30, 2023, decreased by $1.9 million. The decrease was due to the termination of the Company’s amended agreement with Novo Nordisk Healthcare in May 2023 and as a result, no license fee or development services revenue was recognized in Q3, 2023.

 

(in thousands of US dollars, except percentages)  Nine months ended September 30, 
   2023   2022   Change   Change 
   $   $   $   % 
Revenue                    
License fees   1,554    831    723    87%
Development services   2,741    2,091    650    31%
Product sales   29    57    (28)   -49%
Royalties   53    57    (4)   -7%
Supply chain   -    119    (119)   -100%
Total revenue   4,377    3,155    1,222    39%

 

Our total revenue for the nine-month period ended September 30, 2023, was $4.4 million as compared to $3.2 million for the same period in 2022, representing an increase of $1.2 million. The increase is due to an increase in license fee revenue recognized of $0.7 million and development services revenue of $0.7 million relating to the Company’s amended agreement with Novo Nordisk Healthcare, offset by a combined $0.2 million decrease in all other revenues.

 

10

 

 

Research and development expenses

 

The following table summarizes our research and development expenses incurred during the periods indicated:

 

(in thousands of US dollars, except percentages)  Three months ended September 30, 
   2023   2022   Change   Change 
   $   $   $   % 
Direct research and development expenses:                    
Macimorelin pediatric DETECT-trial   1,179    974    205    21%
AEZS-130 – Macimorelin ALS   318    757    (439)   -58%
AEZS-150 – DC-PTH   374    587    (213)   -36%
Aim Biologics - Parkinson’s Disease   160    152    8    5%
Aim Biologics - NMOSD   255    113    142    126%
Bacterial Vaccine Platform - Covid-19   -    111    (111)   -100%
Bacterial Vaccine Platform - Chlamydia   -    103    (103)   -100%
Additional programs   77    145    (68)   -47%
Total direct research and development expenses   2,363    2,942    (579)   -20%
Employee-related expenses   314    270    44    16%
Facilities, depreciation, and other expenses   74    81    (7)   -9%
Total research and development expenses   2,751    3,293    (542)   -16%

 

Research and development expenses decreased by $0.5 million for the three months ended September 30, 2023, compared to the three months ended September 30, 2022, primarily driven by a $0.6 million decrease 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 increase of $0.2 million in costs for the DETECT-trial is the result of an increase in the number of testing sites opened and the recruitment of patients for the DETECT-trial from the comparative period.

 

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 of these projects, in particular the ALS 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 September 30, 2023, compared to the three months ended September 30, 2022.

 

11

 

 

The following table summarizes our research and development expenses incurred during the periods indicated:

 

(in thousands of US dollars, except percentages)  Nine months ended September 30, 
   2023   2022   Change   Change 
   $   $   $   % 
Direct research and development expenses:                    
Macimorelin pediatric DETECT-trial   3,456    2,521    935    37%
AEZS-130 – Macimorelin ALS   1,966    1,453    513    35%
AEZS-150 – DC-PTH   1,339    1,302    37    3%
Aim Biologics - Parkinson’s Disease   519    502    17    3%
Aim Biologics - NMOSD   722    317    405    128%
Bacterial Vaccine Platform - Covid-19   113    305    (192)   -63%
Bacterial Vaccine Platform - Chlamydia   221    328    (107)   -33%
Additional programs   164    292    (128)   -44%
Total direct research and development expenses   8,500    7,020    1,480    21%
Employee-related expenses   953    888    65    7%
Facilities, depreciation, and other expenses   239    173    66    38%
Total research and development expenses   9,692    8,081    1,611    20%

 

Research and development expenses increased by $1.6 million for the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022, primarily driven by a $1.5 million increase in direct research and development expenses. The $1.5 million increase in total direct research and development expenses for the nine months ended September 30, 2023, was primarily due to a $0.9 million increase in costs for the DETECT-trial. The Company has seen an 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 $0.5 million for the nine-month period ended September 30, 2023 compared to the period ended September 30, 2022 for the AEZS-130, ALS program, relates to an increase in the Company’s 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 nine months ended September 30, 2023, compared to the nine months ended September 30, 2022.

 

12

 

 

Selling, general and administrative expenses

 

The following table summarizes our Selling, general and administrative expenses incurred during the periods indicated:

 

(in thousands of US dollars, except percentages)  Three months ended September 30, 
   2023   2022   Change   Change 
   $   $   $   % 
Selling, general and administrative expenses:                    
Salaries & benefits   717    1,059    (342)   -32%
Insurance   247    416    (169)   -41%
Professional fees   474    124    350    282%
Other office & general expenses   353    675    (322)   -48%
Total selling, general and administrative expenses   1,791    2,274    (483)   162%

 

Our total Selling, general and administrative expenses for the three-month period ended September 30, 2023, were $1.8 million as compared to $2.3 million for the same period in 2022 representing a decrease of $0.5 million. This decrease arose primarily from a $0.3 million decrease in salaries and benefits, a $0.2 million decline in insurance costs and a $0.3 million decrease in other office & general expenses, offset by a $0.4 million increase in Professional fees. The decrease in salaries and benefits expense primarily relates to the timing of the non-cash 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 $0.4 million issued in 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 of US dollars, except percentages)  Nine months ended September 30, 
   2023   2022   Change   Change 
   $   $   $   % 
Selling, general and administrative expenses:                    
Salaries & benefits   2,478    2,097    381    18%
Insurance   925    1,258    (333)   -26%
Professional fees   1,657    1,642    15    1%
Other office & general expenses   1,070    1,221    (151)   -12%
Total selling, general and administrative expenses   6,130    6,218    (88)   10%

 

Our total Selling, general and administrative expenses for the nine-month period ended September 30, 2023, were $6.1 million as compared to $6.2 million for the same period in 2022 representing a decrease of $0.1 million. This decrease arose primarily from a $0.3 million decrease in insurance expenses and a $0.2 million decrease in other office & general expenses offset by a $0.4 million increase in salaries & benefits due primarily to the timing of 3 new full-time employees.

 

13

 

 

Net finance income

 

(in thousands of US dollars, except percentages)  Three months ended September 30, 
   2023   2022   Change   Change 
   $   $   $   % 
Gain (loss) due to changes in foreign currency rates   (12)   301    (313)   -104%
Interest income   419    -    419    100%
Other finance income (costs)   (2)   -    (2)   -100%
Net finance income   405    301    104    -104%

 

For the three-month period ended September 30, 2023, our net finance cost was $0.4 million as compared to a net finance income of $0.3 million for the three-month period ended September 30, 2022. This is primarily due to a $0.3 million decrease in our gain (loss) due to changes in foreign currency offset by an increase in interest earned on bank deposits of $0.4 million.

 

(in thousands of US dollars, except percentages)  Nine months ended September 30, 
   2023   2022   Change   Change 
   $   $   $   % 
Gain (loss) due to changes in foreign currency rates   (44)   977    (1,021)   -105%
Interest income   739    -    739    100%
Other finance income (costs)   -    (3)   3    -100%
Net finance income   695    974    (279)   -29%

 

Our net finance income for the nine-month period ended September 30, 2023, was $0.7 million as compared to $1.0 million for the same period in 2022, representing a decrease of $0.3 million. This is primarily due to a $1.0 million decrease in gain (loss) due to changes in foreign currency offset by an increase in interest earned on bank deposits of $0.7 million.

 

Net loss

 

For the three-month period ended September 30, 2023, we reported a consolidated net loss of $4.1 million, or $0.85 loss per common share (basic), as compared with a consolidated net loss of $3.4 million, or $0.70 loss per common share (basic) for the three-month period ended September 30, 2022. The $0.7 million increase in net loss is primarily due to a $1.9 million decrease in revenue offset by a reduction of $1.1 million in expenses and an increase of $0.1 million in finance income.

 

For the nine-month period ended September 30, 2023, we reported a consolidated net loss of $10.9 million, or $2.25 loss per common share (basic), as compared with a consolidated net loss of $10.3 million, or $2.12 loss per common share (basic) for the nine-month period ended September 30, 2022. The $0.6 million increase in net loss is primarily from a $1.6 million increase in total expenses and a $0.3 million decrease in net finance income off-set by a $1.2 million increase in revenue.

 

14

 

 

Selected quarterly financial data

 

   Three months ended 
(in thousands of US dollars, except for per share data) 

September 30,

2023

  

June 30,

2023

  

March 31,

2023

  

December 31,

2022

 
   $   $   $   $ 
Revenues   3    2,246    2,128    2,485 
Net loss   (4,145)   (2,518)   (4,255)   (12,451)
Net loss per share (basic and diluted) (1)   (0.85)   (0.52)   (0.88)   (2.56)

 

   Three months ended 
(in thousands of US dollars, except for per share data) 

September 30,

2022

  

June 30,

2022

  

March 31,

2022

  

December 31,

2021

 
   $   $   $   $ 
Revenues   1,860    (222)   1,517    956 
Net loss   (3,420)   (4,216)   (2,640)   (2,894)
Net loss per share (basic and diluted) (1)   (0.70)   (0.87)   (0.54)   (0.63)

 

(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 decrease in revenue in Q3, 2023, is due to the termination of the Company’s amended agreement with Novo Nordisk Healthcare in May 2023 and as a result, no license fee or development services revenue was recognized in Q3, 2023.

 

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 months 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 of US dollars)  Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
   $   $   $   $ 
Cash and cash equivalents – Beginning of period   42,186    58,157    50,611    65,300 
Net cash used in operating activities   (3,384)   (3,945)   (11,738)   (10,256)
Net cash used in financing activities   (33)   (33)   (113)   (101)
Net cash used in investing activities   (10)   (5)   (15)   (53)
Effect of exchange rate changes on cash & cash equivalents   (3)   (358)   11    (1,074)
Cash and cash equivalents – End of period   38,756    53,816    38,756    53,816 

 

15

 

 

Operating Activities

 

Cash used by operating activities totaled $3.4 million for the three-month period ended September 30, 2023, as compared to $3.9 million in the same period in 2022. This $0.5 million decrease in operating cash outflows is attributed primarily to receiving a $0.7 million income tax refund and a $0.5 million decrease in other non-cash outflows offset by $0.7 million increase in net loss.

 

Cash used by operating activities totaled $11.7 million for the nine-month period ended September 30, 2023, as compared to $10.3 million in the same period in 2022. This $1.4 million increase in operating cash outflows is attributed primarily to a $0.6 million increase in net loss and a $1.3 million increase in other non-cash outflows offset by a $0.5 million increase in income tax refunds.

 

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 September 30, 2023, the Company had an accumulated deficit of $362.1 million. The Company also had a net loss of $10.9 million and negative cash flows from operations of $11.7 million for the nine-month period ended September 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.

 

16

 

 

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 September 30, 2023

 

Significant expenditure contracted for at the end of the reporting period but not recognized as liabilities is as follows:

 

(in thousands of US dollars)  TOTAL 
   $ 
Less than 1 year   6,857 
1 - 3 years   131 
4 - 5 years   36 
More than 5 years   - 
    7,024 

 

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 $38,127 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 September 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.

 

17

 

 

Our most recent Annual Report on Form 20-F was filed with the relevant Canadian and U.S. securities’ regulatory authorities at www.sedarplus.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 (as such term is defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act and Canadian securities legislation).  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 required to be disclosed by us in the reports that we file or submit under the Exchange Act 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 nine-month period ended September 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 (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act and Canadian securities legislation). 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 as issued by the IASB, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the issuer; 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 September 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls over financial reporting.

 

18

 

 

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 September 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.
   
5.2 N/A
   
5.3 N/A
   
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 July 1, 2023 and ended on September 30, 2023 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.

 

Date: November 8, 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 September 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.
   
5.2 N/A
   
5.3 N/A
   
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 July 1, 2023 and ended on September 30, 2023 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.

 

Date: November 8, 2023  
   
/s/ Giuliano La Fratta  
Giuliano La Fratta  
Chief Financial Officer  

 

   

 

v3.23.3
Cover
9 Months Ended
Sep. 30, 2023
Cover [Abstract]  
Document Type 6-K
Amendment Flag false
Document Period End Date Sep. 30, 2023
Document Fiscal Period Focus Q3
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
v3.23.3
Condensed Interim Consolidated Statements of Financial Position (Unaudited)
$ in Thousands, € in Millions
Sep. 30, 2023
USD ($)
Dec. 31, 2022
USD ($)
Current assets    
Cash and cash equivalents $ 38,756 $ 50,611
Trade and other receivables 546 732
Inventory 91 229
Income taxes receivable 116 1,428
Prepaid expenses and other current assets 2,402 2,488
Total current assets 41,911 55,488
Non-current assets    
Restricted cash equivalents 320 322
Property and equipment 255 216
Total non-current assets 575 538
Total assets 42,486 56,026
Current liabilities    
Payables and accrued liabilities 3,300 3,828
Provisions 56 45
Income taxes payable 106 108
Deferred revenues (note 3) 90 2,949
Deferred gain (note 4) 529
Lease liabilities 147 114
Total current liabilities 4,228 7,044
Non-current liabilities    
Deferred revenues (note 3) 1,647 1,684
Deferred gain (note 4) 110
Lease liabilities 70 65
Employee future benefits (note 5) 10,105 11,159
Provisions 158 188
Total non-current liabilities 11,980 13,206
Total liabilities 16,208 20,250
Shareholders’ equity    
Share capital (note 6) 293,410 293,410
Warrants 5,085 5,085
Contributed surplus 90,682 90,332
Deficit (362,088) (352,084)
Accumulated other comprehensive loss (811) (967)
Total Shareholders’ equity 26,278 35,776
Total liabilities and shareholders’ equity $ 42,486 $ 56,026
v3.23.3
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 at Dec. 31, 2021 $ 293,410 $ 5,085 $ 89,788 $ (334,619) $ (678) $ 52,986
IfrsStatementLineItems [Line Items]            
Net loss (10,276) (10,276)
Foreign currency translation adjustments (26) (26)
Actuarial gain on defined benefit plans 6,231 6,231
Comprehensive income (loss)       (4,045) (26) (4,071)
Share-based compensation costs 503 503
Balance at Sep. 30, 2022 293,410 5,085 90,291 (338,664) (704) 49,418
Balance at Dec. 31, 2022 293,410 5,085 90,332 (352,084) (967) 35,776
IfrsStatementLineItems [Line Items]            
Net loss (10,917) (10,917)
Foreign currency translation adjustments 156 156
Actuarial gain on defined benefit plans 913 913
Comprehensive income (loss)       (10,004) 156 (9,848)
Share-based compensation costs 350 350
Balance at Sep. 30, 2023 $ 293,410 $ 5,085 $ 90,682 $ (362,088) $ (811) $ 26,278
v3.23.3
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Profit or loss [abstract]        
Revenues (note 3) $ 3 $ 1,860 $ 4,377 $ 3,155
Expenses        
Cost of sales 11 14 167 106
Research and development 2,751 3,293 9,692 8,081
Selling, general and administrative 1,791 2,274 6,130 6,218
Total expenses 4,553 5,581 15,989 14,405
Loss from operations (4,550) (3,721) (11,612) (11,250)
Gain (loss) due to changes in foreign currency exchange rates (12) 301 (44) 977
Interest income 419 739
Other finance costs (2) (3)
Net finance income 405 301 695 974
Loss before income taxes (4,145) (3,420) (10,917) (10,276)
Income tax recovery
Net loss (4,145) (3,420) (10,917) (10,276)
Items that may be reclassified subsequently to profit or loss:        
Foreign currency translation adjustments 323 (105) 156 (26)
Items that will not be reclassified to profit or loss:        
Actuarial gain (loss) on defined benefit plans (note 5) 993 (1,794) 913 6,231
Comprehensive loss $ (2,829) $ (5,319) $ (9,848) $ (4,071)
Basic loss per share (note 7) $ (0.85) $ (0.70) $ (2.25) $ (2.12)
Diluted loss per share (note 7) $ (0.85) $ (0.70) $ (2.25) $ (2.12)
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
v3.23.3
Condensed Interim Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Cash flows from operating activities        
Net loss for the period $ (4,145) $ (3,420) $ (10,917) $ (10,276)
Items not affecting cash and cash equivalents:        
Provisions (20) 7 (10) 12
Depreciation and amortization 42 33 126 104
Share-based compensation costs 27 443 350 503
Employee future benefits 132 69 397 266
Amortization of deferred revenues (1,248) (1,554) (1,952)
Net foreign exchange differences (3) (4)
Other non-cash items 2 3 7 3
Refund of income taxes 675 1,322 830
Changes in operating assets and liabilities (note 7) (94) 168 (1,455) 254
Net cash used in operating activities (3,384) (3,945) (11,738) (10,256)
Cash flows from financing activities        
Payments on lease liabilities (33) (33) (113) (101)
Net cash used in financing activities (33) (33) (113) (101)
Cash flows from investing activities        
Purchase of property and equipment (9) (9) (14) (57)
Change in restricted cash equivalents (1) 4 (1) 4
Net cash used in investing activities (10) (5) (15) (53)
Effect of exchange rate changes on cash and cash equivalents (3) (358) 11 (1,074)
Net change in cash and cash equivalents (3,430) (4,341) (11,855) (11,484)
Cash and cash equivalents – Beginning of period 42,186 58,157 50,611 65,300
Cash and cash equivalents – End of period $ 38,756 $ 53,816 $ 38,756 $ 53,816
v3.23.3
Business overview
9 Months Ended
Sep. 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 November 8, 2023.

 

v3.23.3
Basis of presentation
9 Months Ended
Sep. 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 September 30, 2023, and for the three and nine months ended September 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.

 

v3.23.3
Revenue
9 Months Ended
Sep. 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:

 

   2023   2022   2023   2022 
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
    $    $    $    $ 
License fees   -    605    1,554    831 
Development services   -    1,202    2,741    2,091 
Product sales   -    -    -    57 
Royalties   3    14    29    57 
Supply chain   -    39    53    119 
Total revenue   3    1,860    4,377    3,155 

 

The Company recorded revenue for the transfer of services over time for the three months ended September 30, 2023, nil (2022 – $1,807) and the nine months ended September 30, 2023, of $4,295 (2022 - $2,922). Revenue recorded at a point in time for the three months ended September 30, 2023, was $3 (2022 – $53) and the nine months ended September 30, 2023, was $82 (2022 - $233).

 

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 September 30, 2023, and for the three and nine months ended September 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:

 

   September 30, 2023 
   Current   Non-current   Total 
    $    $     $  
Novo Nordisk Health Care   -    -    - 
Pharmanovia   82    1,528    1,610 
NK Meditech   8    119    127 
    90    1,647    1,737 

 

   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 

 

v3.23.3
Deferred gain
9 Months Ended
Sep. 30, 2023
Deferred Gain  
Deferred gain

4. Deferred gain

 

On August 10, 2021, the Company entered into a trademark maintenance and assignment option agreement with ARES Trading SA, a subsidiary of Merck KGaA (“Merck”), with respect to the trademarks owned by the Company on Cetrotide® (cetrorelix acetate for injection). As consideration for having been granted the option, Merck has agreed to pay the Company a total of $529 (€0.5 million) a portion of which is to be calculated as a reimbursement of all internal and external trademark fees incurred by the Company for all years beginning with 2020 until the transfer date. The transfer of the trademarks, which is expected to take place within the next 12 months, shall constitute a sale, after which the Company will no longer have any ownership in or obligations related to the Cetrotide trademarks.

 

 

Aeterna Zentaris Inc.

Notes to the Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 30, 2023, and 2022

(In thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

v3.23.3
Employee future benefits
9 Months Ended
Sep. 30, 2023
Employee Future Benefits  
Employee future benefits

5. Employee future benefits

 

The change in the Company’s employee future benefit obligations is summarized as follows:

 

   benefit plans   benefit plans   Total   Total 
  

Nine months ended

September 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   89    11    100    142 
Interest cost   599    1    600    295 
Actuarial gain from changes in financial assumptions   (1,249)   (1)   (1,250)   (5,915)
Benefits paid   (560)   -    (560)   (752)
Impact of foreign exchange rate changes   (295)   (2)   (297)   (1,432)
Balances – End of the period   20,241    102    20,343    21,750 
                     
Change in plan assets                    
Balances – Beginning of the period   10,591    -    10,591    11,927 
Interest income from plan assets   296    -    296    120 
Employer contributions   25    -    25    45 
Employee contributions   7    -    7    10 
Benefits paid   (198)   -    (198)   (247)
Remeasurement of plan assets   -    -    -    (641)
Change in asset ceiling   (337)   -    (337)   - 
Impact of foreign exchange rate changes   (146)   -    (146)   (623)
Balances – End of the period   10,238    -    10,238    10,591 
                     
Net liability of the unfunded plans   10,003    102    10,105    10,787 
Net liability of the funded plans   -    -    -    372 
Net amount recognized as Employee future benefits   10,003    102    10,105    11,159 
                     
Amounts recognized:                    
In net loss   385    12    397    295 
Actuarial gain on defined benefit plans in other comprehensive loss   912    1    913    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 4.20% as of September 30, 2023, and 3.75% as of December 31, 2022, causing the variances in the actuarial gain on defined benefit plan during the nine months ended September 30, 2023.

 

 

Aeterna Zentaris Inc.

Notes to the Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 30, 2023, and 2022

(In thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

v3.23.3
Shareholders’ equity
9 Months Ended
Sep. 30, 2023
Shareholders Equity  
Shareholders’ equity

6. 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.

 

   Common shares   Amount 
   #   $ 
Balance – December 31, 2022   4,855,876    293,410 
           
    -    - 
Balance – September 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:

 

   September 30, 2023   September 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 September 30, 2023, and for the three and nine months ended September 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 September 30, 2023, was $27 (2022 – $43) and for the nine months ended September 30, 2023, was $66 (2022 – $101) recognized over the vesting period. Option activity for the nine months ended September 30, 2023, and 2022, was as follows:

 

   Stock options   Weighted average exercise price 
   #   $ 
Balance – January 1, 2023   42,030    20.05 
Granted   14,000    3.75 
Cancelled / Forfeited   (400)   87.00 
Balance – September 30, 2023   55,630    15.47 

 

    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 – September 30, 2022   43,056    21.95 

 

Deferred share units

 

On June 14, 2023, the Company granted 100,000 (2022 – 80,000) DSUs under the Long-Term Incentive Plan. The compensation expense for the nine months ended September 30, 2023, was $284 (2022 - $402) and is presented in selling, general and administrative expenses. DSU activity for the nine months ended September 30, 2023, was as follows:

 

   2023   2022 
   #   # 
Balance – January 1,   96,920    16,920 
Granted   100,000    80,000 
Balance – September 30,   196,920    96,920 

 

 

Aeterna Zentaris Inc.

Notes to the Condensed Interim Consolidated Financial Statements

As of September 30, 2023, and for the three and nine months ended September 30, 2023, and 2022

(In thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

v3.23.3
Supplemental disclosure of cash flow information
9 Months Ended
Sep. 30, 2023
Supplemental Disclosure Of Cash Flow Information  
Supplemental disclosure of cash flow information

7. Supplemental disclosure of cash flow information

 

   2023   2022   2023   2022 
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
   $   $   $   $ 
Changes in operating assets and liabilities:                    
Trade and other receivables   (411)   205    (9)   425 
Inventory   (1)   41    139    (165)
Prepaid expenses and other current assets   186    (481)   64    (1,240)
Payables and accrued liabilities   (159)   (133)   (322)   (14)
Deferred revenues   (27)   595    (1,386)   1,425 
Taxes payable   -    210    -    210 
Provision for restructuring and other costs   (6)   -    (11)   - 
Employee future benefits   (142)   (269)   (396)   (387)
Deferred gain   466    -    466    - 
Increase (decrease) in operating assets and liabilities   (94)   168    (1,455)   254 

 

v3.23.3
Net loss per share
9 Months Ended
Sep. 30, 2023
Net Loss Per Share  
Net loss per share

8. 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.

 

   2023   2022   2023   2022 
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
   $   $   $   $ 
Net loss   (4,145)   (3,420)   (10,917)   (10,276)
Basic and diluted weighted-average shares outstanding   4,855,876    4,855,876    4,855,876    4,855,876 
                     
Basic and diluted loss per share   (0.85)   (0.70)   (2.25)   (2.12)
                     
Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:                    
Stock options and DSUs   252,550    142,375    252,550    142,375 
Warrants   457,648    457,648    457,648    457,648 

 

v3.23.3
Segment information
9 Months Ended
Sep. 30, 2023
Segment Information  
Segment information

9. 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 September 30, 2023, and for the three and nine months ended September 30, 2023, and 2022

(In thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

v3.23.3
Commitments
9 Months Ended
Sep. 30, 2023
Commitments  
Commitments

10. Commitments

 

Significant expenditure contracted for at the end of the reporting period but not recognized as liabilities is as follows:

 

   TOTAL 
   $ 
Less than 1 year   6,857 
1 - 3 years   131 
4 - 5 years   36 
More than 5 years   - 
Total   7,024 

 

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 $38,127 upon achieving certain sales volumes, regulatory or other milestones related to specific products.

v3.23.3
Basis of presentation (Policies)
9 Months Ended
Sep. 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 September 30, 2023, and for the three and nine months ended September 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.

 

v3.23.3
Revenue (Tables)
9 Months Ended
Sep. 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:

 

   2023   2022   2023   2022 
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
    $    $    $    $ 
License fees   -    605    1,554    831 
Development services   -    1,202    2,741    2,091 
Product sales   -    -    -    57 
Royalties   3    14    29    57 
Supply chain   -    39    53    119 
Total revenue   3    1,860    4,377    3,155 
Summary of deferred revenue

The following table provides a summary of deferred revenue balances:

 

   September 30, 2023 
   Current   Non-current   Total 
    $    $     $  
Novo Nordisk Health Care   -    -    - 
Pharmanovia   82    1,528    1,610 
NK Meditech   8    119    127 
    90    1,647    1,737 

 

   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 
v3.23.3
Employee future benefits (Tables)
9 Months Ended
Sep. 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:

 

   benefit plans   benefit plans   Total   Total 
  

Nine months ended

September 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   89    11    100    142 
Interest cost   599    1    600    295 
Actuarial gain from changes in financial assumptions   (1,249)   (1)   (1,250)   (5,915)
Benefits paid   (560)   -    (560)   (752)
Impact of foreign exchange rate changes   (295)   (2)   (297)   (1,432)
Balances – End of the period   20,241    102    20,343    21,750 
                     
Change in plan assets                    
Balances – Beginning of the period   10,591    -    10,591    11,927 
Interest income from plan assets   296    -    296    120 
Employer contributions   25    -    25    45 
Employee contributions   7    -    7    10 
Benefits paid   (198)   -    (198)   (247)
Remeasurement of plan assets   -    -    -    (641)
Change in asset ceiling   (337)   -    (337)   - 
Impact of foreign exchange rate changes   (146)   -    (146)   (623)
Balances – End of the period   10,238    -    10,238    10,591 
                     
Net liability of the unfunded plans   10,003    102    10,105    10,787 
Net liability of the funded plans   -    -    -    372 
Net amount recognized as Employee future benefits   10,003    102    10,105    11,159 
                     
Amounts recognized:                    
In net loss   385    12    397    295 
Actuarial gain on defined benefit plans in other comprehensive loss   912    1    913    5,262 
v3.23.3
Shareholders’ equity (Tables)
9 Months Ended
Sep. 30, 2023
Shareholders Equity  
Summary of share capital

 

   Common shares   Amount 
   #   $ 
Balance – December 31, 2022   4,855,876    293,410 
           
    -    - 
Balance – September 30, 2023   4,855,876    293,410 
Summary of assumptions to determine share-based compensation costs over the life of awards

 

   September 30, 2023   September 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

 

   Stock options   Weighted average exercise price 
   #   $ 
Balance – January 1, 2023   42,030    20.05 
Granted   14,000    3.75 
Cancelled / Forfeited   (400)   87.00 
Balance – September 30, 2023   55,630    15.47 

 

    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 – September 30, 2022   43,056    21.95 
Summary of DSU activity

 

   2023   2022 
   #   # 
Balance – January 1,   96,920    16,920 
Granted   100,000    80,000 
Balance – September 30,   196,920    96,920 
v3.23.3
Supplemental disclosure of cash flow information (Tables)
9 Months Ended
Sep. 30, 2023
Supplemental Disclosure Of Cash Flow Information  
Disclosure of changes in operating assets and liabilities

 

   2023   2022   2023   2022 
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
   $   $   $   $ 
Changes in operating assets and liabilities:                    
Trade and other receivables   (411)   205    (9)   425 
Inventory   (1)   41    139    (165)
Prepaid expenses and other current assets   186    (481)   64    (1,240)
Payables and accrued liabilities   (159)   (133)   (322)   (14)
Deferred revenues   (27)   595    (1,386)   1,425 
Taxes payable   -    210    -    210 
Provision for restructuring and other costs   (6)   -    (11)   - 
Employee future benefits   (142)   (269)   (396)   (387)
Deferred gain   466    -    466    - 
Increase (decrease) in operating assets and liabilities   (94)   168    (1,455)   254 
v3.23.3
Net loss per share (Tables)
9 Months Ended
Sep. 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.

 

   2023   2022   2023   2022 
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
   $   $   $   $ 
Net loss   (4,145)   (3,420)   (10,917)   (10,276)
Basic and diluted weighted-average shares outstanding   4,855,876    4,855,876    4,855,876    4,855,876 
                     
Basic and diluted loss per share   (0.85)   (0.70)   (2.25)   (2.12)
                     
Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:                    
Stock options and DSUs   252,550    142,375    252,550    142,375 
Warrants   457,648    457,648    457,648    457,648 
v3.23.3
Commitments (Tables)
9 Months Ended
Sep. 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:

 

   TOTAL 
   $ 
Less than 1 year   6,857 
1 - 3 years   131 
4 - 5 years   36 
More than 5 years   - 
Total   7,024 
v3.23.3
Summary of revenue from transfer of goods and services (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
IfrsStatementLineItems [Line Items]        
Total revenue $ 3 $ 1,860 $ 4,377 $ 3,155
License Fees [Member]        
IfrsStatementLineItems [Line Items]        
Total revenue 605 1,554 831
Development Services [Member]        
IfrsStatementLineItems [Line Items]        
Total revenue 1,202 2,741 2,091
Product Sales [Member]        
IfrsStatementLineItems [Line Items]        
Total revenue 57
Royalties [Member]        
IfrsStatementLineItems [Line Items]        
Total revenue 3 14 29 57
Supply Chain [Member]        
IfrsStatementLineItems [Line Items]        
Total revenue $ 39 $ 53 $ 119
v3.23.3
Summary of deferred revenue (Details) - USD ($)
$ in Thousands
Sep. 30, 2023
Dec. 31, 2022
IfrsStatementLineItems [Line Items]    
Total Current Deferred Revenues $ 90 $ 2,949
Total Deferred Revenues Non Current 1,647 1,684
Total Deferred Revenues 1,737 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 82  
Total Deferred Revenues Non Current 1,528  
Total Deferred Revenues 1,610  
NK Meditech [member]    
IfrsStatementLineItems [Line Items]    
Total Current Deferred Revenues 8
Total Deferred Revenues Non Current 119 128
Total Deferred Revenues $ 127 128
Consilient Health [member]    
IfrsStatementLineItems [Line Items]    
Total Current Deferred Revenues   35
Total Deferred Revenues Non Current   1,556
Total Deferred Revenues   $ 1,591
v3.23.3
Revenue (Details Narrative)
€ in Thousands, $ in Thousands
3 Months Ended 9 Months Ended
May 23, 2023
USD ($)
May 23, 2023
EUR (€)
Sep. 30, 2023
USD ($)
Sep. 30, 2022
USD ($)
Sep. 30, 2023
USD ($)
Sep. 30, 2022
USD ($)
Mar. 15, 2023
USD ($)
Mar. 15, 2023
EUR (€)
IfrsStatementLineItems [Line Items]                
Revenue     $ 3 $ 1,860 $ 4,377 $ 3,155    
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       1,807 4,295 2,922    
Goods or services transferred at point in time [member]                
IfrsStatementLineItems [Line Items]                
Revenue     $ 3 $ 53 $ 82 $ 233    
v3.23.3
Deferred gain (Details Narrative)
$ in Thousands, € in Millions
Sep. 30, 2023
USD ($)
Dec. 31, 2022
USD ($)
Aug. 10, 2021
USD ($)
Aug. 10, 2021
EUR (€)
Deferred Gain        
Deferred gain $ 529 $ 529 € 0.5
v3.23.3
Summary of net defined benefit liability asset (Details) - USD ($)
$ in Thousands
9 Months Ended 12 Months Ended
Sep. 30, 2023
Dec. 31, 2022
Change in plan liabilities    
Balances – Beginning of the period $ 21,750 $ 29,412
Current service cost 100 142
Interest cost 600 295
Actuarial gain from changes in financial assumptions 1,250 5,915
Benefits paid (560) (752)
Impact of foreign exchange rate changes (297) (1,432)
Balances – End of the period 20,343 21,750
Change in plan assets    
Balances – Beginning of the period 10,591 11,927
Interest income from plan assets 296 120
Employer contributions 25 45
Employee contributions 7 10
Benefits paid (198) (247)
Remeasurement of plan assets (641)
Change in asset ceiling (337)
Impact of foreign exchange rate changes (146) (623)
Balances – End of the period 10,238 10,591
Net liability of the unfunded plans 10,105 10,787
Net liability of the funded plans 372
Net amount recognized as Employee future benefits 10,105 11,159
Amounts recognized:    
In net loss 397 295
Actuarial gain on defined benefit plans in other comprehensive loss 913 5,262
Pension defined benefit plans [member]    
Change in plan liabilities    
Balances – Beginning of the period 21,657  
Current service cost 89  
Interest cost 599  
Actuarial gain from changes in financial assumptions 1,249  
Benefits paid (560)  
Impact of foreign exchange rate changes (295)  
Balances – End of the period 20,241 21,657
Change in plan assets    
Balances – Beginning of the period 10,591  
Interest income from plan assets 296  
Employer contributions 25  
Employee contributions 7  
Benefits paid (198)  
Remeasurement of plan assets  
Change in asset ceiling (337)  
Impact of foreign exchange rate changes (146)  
Balances – End of the period 10,238 10,591
Net liability of the unfunded plans 10,003  
Net liability of the funded plans  
Net amount recognized as Employee future benefits 10,003  
Amounts recognized:    
In net loss 385  
Actuarial gain on defined benefit plans in other comprehensive loss 912  
Other benefit plans [member]    
Change in plan liabilities    
Balances – Beginning of the period 93  
Current service cost 11  
Interest cost 1  
Actuarial gain from changes in financial assumptions 1  
Benefits paid  
Impact of foreign exchange rate changes (2)  
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  
Change in asset ceiling  
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 12  
Actuarial gain on defined benefit plans in other comprehensive loss $ 1  
v3.23.3
Employee future benefits (Details Narrative)
Sep. 30, 2023
Dec. 31, 2022
Employee Future Benefits    
Employee future benefit obligation 4.20% 3.75%
v3.23.3
Summary of share capital (Details) - USD ($)
$ in Thousands
Sep. 30, 2023
Dec. 31, 2022
Sep. 30, 2022
IfrsStatementLineItems [Line Items]      
Balance $ 35,776 $ 49,418 $ 52,986
Balance $ 26,278 35,776 49,418
Issued capital [member]      
IfrsStatementLineItems [Line Items]      
Number of shares issued 4,855,876    
Balance $ 293,410 $ 293,410 293,410
Number of shares issued 4,855,876 4,855,876  
Balance $ 293,410 $ 293,410 $ 293,410
v3.23.3
Summary of assumptions to determine share-based compensation costs over the life of awards (Details) - $ / shares
9 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Shareholders Equity    
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 years 5 months 12 days 5 years 8 months 19 days
Share price $ 3.75 $ 8.88
Exercise price 3.75 8.88
Grant date fair value $ 2.99 $ 7.47
v3.23.3
Summary of number and weighted average exercise prices of share options (Details)
9 Months Ended
Sep. 30, 2023
shares
$ / shares
Sep. 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 (400) (2,399)
Weighted average exercise price, cancelled/forfeited | $ / shares $ 87.00 $ 10.98
Number of options, ending | shares 55,630 43,056
Weighted average exercise price, ending | $ / shares $ 15.47 $ 21.95
v3.23.3
Summary of DSU activity (Details) - Deferred Share Unit [member] - shares
9 Months Ended
Jun. 14, 2023
Jun. 14, 2022
Sep. 30, 2023
Sep. 30, 2022
IfrsStatementLineItems [Line Items]        
Balance – January 1,     96,920 16,920
Granted 100,000 80,000 100,000 80,000
Balance – September 30,     196,920 96,920
v3.23.3
Shareholders’ equity (Details Narrative)
$ in Thousands
3 Months Ended 9 Months Ended
Jun. 14, 2023
shares
Jan. 17, 2023
shares
Jul. 15, 2022
Jun. 14, 2022
shares
Jan. 17, 2022
shares
Sep. 30, 2023
USD ($)
Sep. 30, 2022
USD ($)
Sep. 30, 2023
USD ($)
shares
Sep. 30, 2022
USD ($)
shares
IfrsStatementLineItems [Line Items]                  
Number of options, granted               14,000 2,000
Compensation expenses | $           $ 27 $ 43 $ 66 $ 101
Deferred Share Unit [member]                  
IfrsStatementLineItems [Line Items]                  
Compensation expenses | $               $ 284 $ 402
Number of share units granted 100,000     80,000       100,000 80,000
2018 Long Term Incentive Plan [member]                  
IfrsStatementLineItems [Line Items]                  
Number of options, granted   14,000     2,000        
Key management personnel of entity or parent [member]                  
IfrsStatementLineItems [Line Items]                  
Reverse stock split     1-for-25            
Deferred Stock Units [member]                  
IfrsStatementLineItems [Line Items]                  
Reverse stock split     1-for-25            
v3.23.3
Disclosure of changes in operating assets and liabilities (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Supplemental Disclosure Of Cash Flow Information        
Trade and other receivables $ (411) $ 205 $ (9) $ 425
Inventory (1) 41 139 (165)
Prepaid expenses and other current assets 186 (481) 64 (1,240)
Payables and accrued liabilities (159) (133) (322) (14)
Deferred revenues (27) 595 (1,386) 1,425
Taxes payable 210 210
Provision for restructuring and other costs (6) (11)
Employee future benefits (142) (269) (396) (387)
Deferred gain 466 466
Increase (decrease) in operating assets and liabilities $ (94) $ 168 $ (1,455) $ 254
v3.23.3
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 9 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
IfrsStatementLineItems [Line Items]        
Net loss $ (4,145) $ (3,420) $ (10,917) $ (10,276)
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 $ (0.85) $ (0.70) $ (2.25) $ (2.12)
Diluted loss per share $ (0.85) $ (0.70) $ (2.25) $ (2.12)
Employee Stock Option One Deferred Stock Units [Member]        
Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:        
Anti-dilutive shares 252,550 142,375 252,550 142,375
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
v3.23.3
Schedule of expected future minimum lease payments (Details)
$ in Thousands
Sep. 30, 2023
USD ($)
IfrsStatementLineItems [Line Items]  
Total $ 7,024
Not later than one year [member]  
IfrsStatementLineItems [Line Items]  
Total 6,857
One To Three Years [Member]  
IfrsStatementLineItems [Line Items]  
Total 131
Four To Five Years [Member]  
IfrsStatementLineItems [Line Items]  
Total 36
Later than five years [member]  
IfrsStatementLineItems [Line Items]  
Total
v3.23.3
Commitments (Details Narrative) - USD ($)
$ in Thousands
Sep. 30, 2023
Dec. 31, 2021
IfrsStatementLineItems [Line Items]    
Minimum lease payments net $ 7,024  
Top of range [member]    
IfrsStatementLineItems [Line Items]    
Minimum lease payments net   $ 38,127

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