Aeterna Zentaris(US:AEZS)2024-03-27 12:05Financial Performance - Total revenues for Q4 2023 were $0.1 million, a decrease of 95% from $2.5 million in Q4 2022, primarily due to the termination of the agreement with Novo Nordisk Healthcare [305]. - Research and development expenses for Q4 2023 were $3.9 million, down 13% from $4.4 million in Q4 2022, with direct expenses decreasing by 19% [308]. - Selling, general, and administrative expenses for Q4 2023 increased by 29% to $2.6 million compared to $2.0 million in Q4 2022, driven by a significant rise in professional fees [312]. - The net loss for the twelve months ended December 31, 2023, was $16.6 million, compared to a net loss of $22.7 million for the same period in 2022 [304]. - Total assets decreased to $37.0 million in 2023 from $56.0 million in 2022, reflecting a significant reduction in cash and cash equivalents [294]. - Shareholders' equity fell to $18.2 million in 2023, down from $35.8 million in 2022, indicating a decline in the company's financial position [294]. - Research and development expenses for the twelve months ended December 31, 2023, increased by 8% to $13.6 million compared to $12.5 million in 2022, mainly due to higher costs associated with the DETECT-trial [310]. - The company reported a comprehensive loss of $17.96 million for the twelve months ended December 31, 2023, compared to a comprehensive loss of $17.75 million in 2022 [304]. - The basic and diluted loss per share for the twelve months ended December 31, 2023, was $3.41, an improvement from $4.68 in 2022 [304]. - The company experienced a 100% increase in product sales in Q4 2023, totaling $0.1 million, compared to no sales in Q4 2022 [305]. - Total Selling, general and administrative expenses for the twelve-month period ended December 31, 2023, were $8.7 million, an increase of 6% from $8.2 million in 2022 [313]. - The net loss for the twelve-month period ended December 31, 2023, was $16.6 million, a decrease of $6.1 million from a net loss of $22.7 million in 2022 [319]. - Cash used in operating activities totaled $17.1 million for the twelve-month period ended December 31, 2023, compared to $13.7 million in the same period in 2022, reflecting a $3.4 million increase in operating cash outflows [329]. - The company reported a net other income of $1.5 million for the twelve-month period ended December 31, 2023, an increase of $0.6 million from $0.9 million in 2022, primarily due to a $1.1 million increase in interest income [318]. - As of December 31, 2023, the company had an accumulated deficit of $369.8 million [333]. - 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 [332]. - The company had cash and cash equivalents of $34.0 million at the end of 2023, down from $50.6 million at the end of 2022 [328]. - The company recorded an impairment charge of $7.6 million on goodwill and $0.4 million on intangible assets in the prior year due to the cessation of vaccine trials [316]. - The company plans to finance future operations primarily through existing cash on hand, which is expected to be sufficient for the next 12 months [333]. - The company has contractual obligations totaling $5.7 million, with $5.6 million due within one year [335]. - As of December 31, 2023, the company has $34,016 in cash and cash equivalents, indicating sufficient liquidity to meet obligations for the next 12 months [642]. Business Development - Aeterna Zentaris reported total pricing milestone payments of $0.5 million (€0.5 million) related to the approved list prices of Ghryvelin™/Macimorelin 60 mg in the UK, Germany, and Spain [271]. - The company is actively pursuing business development opportunities for the commercialization of macimorelin in North America, Asia, and other regions [261]. - Aeterna Zentaris entered into an arrangement agreement to acquire 100% of Ceapro Inc., which will result in Ceapro becoming a wholly-owned subsidiary [263]. - Upon closing of the arrangement, existing shareholders of Aeterna Zentaris and former shareholders of Ceapro will own approximately 50% of the outstanding common shares [264]. - Aeterna Zentaris has applied to list all common shares issuable upon the exercise of new warrants on the TSX and filed an initial listing application with Nasdaq [265]. - The arrangement agreement includes customary representations and warranties and is subject to customary conditions to closing [268]. - The South Korean marketing authorization for macimorelin was granted in September 2023, following agreements with NK Meditech Ltd. and ER Kim Pharmaceuticals [275]. - A license agreement was recently established with NK Meditech Ltd. for macimorelin in South Korea, and a distribution agreement with Er-Kim Pharmaceuticals for Turkey and some Balkan countries [343]. Clinical Development - Aeterna Zentaris has received FDA and EMA approval for Macrilen (macimorelin), the first oral test for diagnosing adult growth hormone deficiency [261]. - The company is leveraging the clinical success of macimorelin to develop the compound for the diagnosis of childhood-onset growth hormone deficiency (CGHD) [261]. - The DETECT-trial for macimorelin, evaluating its efficacy for diagnosing CGHD, is expected to conclude its active phase in Q2 2024, with top-line results anticipated in Q3 2024 [280]. - The DETECT-trial costs have been funded by Novo up to $10.1 million (€9.4 million), with Aeterna responsible for any additional costs [279]. - The company is conducting a pivotal Phase 3 safety and efficacy study (DETECT-trial) for macimorelin, expecting to complete enrollment by Q1 2024 with approximately 100 subjects [342]. - The DETECT-trial faced delays due to the COVID-19 pandemic and geopolitical issues, but enrollment is expected to be bolstered by engaging an additional CRO [342]. - Aeterna has entered into exclusive agreements for AIM Biologicals targeting neuromyelitis optica spectrum disorder (NMOSD) and Parkinson's disease, with positive pre-clinical results announced in May 2022 [283]. - AEZS-150, a potential treatment for chronic hypoparathyroidism, is being developed with a focus on increasing serum clearance time of peptides, with a prevalence of 37 per 100,000 in the U.S. [288]. - The company is advancing macimorelin as a potential therapeutic for ALS, with ongoing toxicology and safety studies to support prolonged treatment [290]. - The company is developing AEZS-150 as a potential treatment for primary hypoparathyroidism in adults, with plans for pre-clinical development [347]. Market Insights - The prevalence of NMOSD is estimated at 0.7-10 in 100,000, with a higher incidence in women and certain ethnic groups [284]. - Parkinson's disease affects approximately 10 million people worldwide, with no current pharmacological therapy available to prevent or delay disease progression [285]. Other Information - The USPTO issued patent US11,644,474 protecting the use of macimorelin for diagnosing growth hormone deficiency (GHD) in pediatrics on May 9, 2023 [272]. - Aeterna regained full rights to Macrilen in the U.S. and Canada on May 23, 2023, after Novo terminated the license agreement, leading to a temporary discontinuation of sales in the U.S. [273]. - The company has provided for all outstanding and unpaid amounts relating to its operations, with trade accounts receivable totaling approximately $67 as of December 31, 2023 [638]. - If the US dollar had increased or decreased by 10% against the Euro, the net loss for the year ended December 31, 2023, would have been affected by approximately $1,055 [644]. - The company has sufficient cash to scale its research and development activities based on cash availability, despite ongoing needs for additional capital resources [642]. - The company has terminated its existing vaccine development programs for COVID-19 and Chlamydia due to changes in the global situation [349].