Dr. Klaus Paulini reports

AETERNA ZENTARIS REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS AND ANNOUNCES COMPLETION OF ENROLLMENT IN ONGOING PIVOTAL DETECT-TRIAL FOR THE DIAGNOSIS OF CHILDHOOD-ONSET GROWTH HORMONE DEFICIENCY

Aeterna Zentaris Inc. has released its financial and operating results for the year ended Dec. 31, 2023, and provided an update on the completion of enrolment for its continuing phase 3 safety and efficacy study AEZS-130-P02 (the Detect trial) evaluating macimorelin for the diagnosis of childhood-onset growth hormone deficiency (CGHD). All amounts are in U.S. dollars.

The company completed enrolment of all patients in the Detect trial and expects that the last patient will receive the patient's first growth hormone stimulation test using macimorelin in April, 2024. The Detect trial is a multicentre, open-label trial to investigate the efficacy and safety of a single oral dose of one milligram/kilogram macimorelin acetate as growth hormone stimulation test in pediatric patients with suspected CGHD. The study included approximately 100 subjects in Europe and North America.

In addition, as previously announced, at their respective shareholder meetings held on March 12, 2024, the shareholders of each of Aeterna and Ceapro Inc. approved an all-stock merger of equals transaction which is expected to be effected by way of a plan of arrangement under the Canada Business Corporations Act in the second quarter of 2024 and subject to completion of various conditions, including stock exchange approvals.

Dr. Klaus Paulini, chief executive officer of Aeterna, commented: "With enrolment now completed in the Detect trial, we expect the completion of the Detect trial in the second quarter and top-line data in the third quarter of this year. In addition to achieving an important milestone for macimorelin in CGHD, we are also looking forward to closing the merger with Ceapro in the second quarter of 2024."

Summary of fourth quarter and full-year 2023 financial results

Cash and cash equivalents

The company had $34-million in cash and cash equivalents at Dec. 31, 2023.

Results of operations for the three-month period ended Dec. 31, 2023

For the three-month period ended Dec. 31, 2023, the company reported a net loss of $5.6-million, or $1.16 loss per common share, as compared with a net loss of $12.5-million, or $2.56 loss per common share for the three-month period ended Dec. 31, 2022. The $6.9-million decrease in net loss is primarily due to the non-recurring $8.3-million impairment of goodwill and intangible assets in the prior year as well as an increase in net other income of $900,000. This was offset by a $2.4-million decrease in revenues.

Revenues:

• Aeterna's total revenue for the three-month period ended Dec. 31, 2023, was $100,000 as compared with $2.5-million for the same period in 2022, representing a decrease of $2.4-million. This decrease is primarily due to a $2.5-million decrease as a result of the termination of the company's agreement with Novo Nordisk Healthcare in May, 2023, offset by a $100,000 increase in product sales.

Operating expenses:

• Aeterna's total operating expenses for the three-month period ended Dec. 31, 2023, was $6.5-million as compared with $14.8-million for the same period in 2022, representing a decrease of $8.3-million. This decrease was primarily from a $600,000 decrease in cost of sales and research and development expenses, a $8.3-million charge for the impairment of goodwill, intangible assets and other assets in 2022 that was not repeated in 2023, offset by a $600,000 increase in selling, general and administrative expenses.

Net other income (costs):

• For the three-month period ended Dec. 31, 2023, Aeterna's net other income was $800,000 as compared with $100,000 for the three-month period ended Dec. 31, 2022. This $900,000 increase arises primarily from the $500,000 gain on the sale of an intangible asset and a $400,000 increase in interest income.

Results of operations for the full year ended Dec. 31, 2023:

• For the 12-month period ended Dec. 31, 2023, Aeterna reported a net loss of $16.6-million, or $3.41 loss per common share, as compared with a net loss of $22.7-million, or $4.68 loss per common share, for the 12-month period ended Dec. 31, 2022. The $6.1-million decrease in net loss is primarily due to the non-recurring $8.3-million impairment of goodwill and intangible assets in the prior year as well as a $500,000 increase in net other income. This was offset by a decrease of $1.1-million in revenues and a combined $1.6-million increase in research and development and selling, general and administrative expenses.

Revenues:

• Aeterna's total revenue for the 12-month period ended Dec. 31, 2023, was $4.5-million as compared with $5.6-million for the same period in 2022, representing a decrease of $1.1-million. The decrease is due to a $1-million associated to the termination of the company's agreement with Novo Nordisk Healthcare in May, 2023, and a $100,000 decrease in product sales.

Operating expense:

• Aeterna's total operating expenses for the 12-month period ended Dec. 31, 2023, was $22.5-million as compared with $29.2-million for the same period in 2022, representing a decrease of $6.7-million. This decrease arises primarily from $8.3-million charge for the impairment of goodwill, intangible assets and other assets in 2022 that was not repeated in 2023 offset by a $1.1-million increase research and development expenses and $500,000 increase in selling, general and administrative expenses.

Net other income (costs):

• Aeterna's net other income for the 12-month period ended Dec. 31, 2023, was $1.4-million as compared with $900,000 for the same period in 2022, representing an increase of $500,000. This is primarily due to a $500,000 gain on the sale of an intangible asset and $1.1-million from interest income offset by $1.1-million loss increase from loss due to foreign currency exchange rates.

Consolidated financial statements and management's discussion and analysis

For reference, the management's discussion and analysis of financial condition and results of operations for the fourth quarter and full year 2023, as well as the company's consolidated financial statements as of Dec. 31, 2023, will be available on the company's website in the investors section or at the company's profile on SEDAR+ and EDGAR.

About macimorelin (Macrilen; Ghryvelin)

Macimorelin, an oral drug used for the diagnosis of adult growth hormone deficiency (AGHD), is approved for marketing under the brand name Ghryvelin in the European economic area and Macrilen in the United States. In addition, Aeterna Zentaris is currently conducting the phase 3 safety and efficacy study AEZS-130-P02 (the Detect trial) evaluating macimorelin for the diagnosis of childhood-onset growth hormone deficiency (CGHD).

Macimorelin (Macrilen; Ghryvelin), a ghrelin receptor agonist, is an orally active peptidomimetic molecule that stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples taken after oral administration of macimorelin for the assessment of AGHD. Approval of macimorelin for use in adult was granted by the Food and Drug Administration in 2017 and by the European Medicines Agency in 2019, based on phase 3 data showing that oral macimorelin provides accuracy comparable to that of standard insulin tolerance testing (ITT), but has a more favourable safety profile compared with ITT. Oral macimorelin also reduces false positive test results, helping to avoid unnecessary treatment of patients.

About Aeterna Zentaris Inc.

Aeterna is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. Aeterna's lead product, macimorelin (Macrilen; Ghryvelin), is the first and only U.S. FDA- and European Commission-approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Aeterna is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need.

We seek Safe Harbor.