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The company ended the quarter with $29.5 million in cash.
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Recruitment for the DETECT trial is complete. The Company continues to expect the trial to be completed in the second quarter of 2024, with top-line data completed in the third quarter.
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The all-stock merger transaction with Ceapro Inc. is expected to close in the second quarter of 2024.
TORONTO, ON, May 14, 2024 (Globe Newswire) — Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company that develops and commercializes a diverse portfolio of pharmaceutical and diagnostic products, today announced its financial and Reported business results. For the quarter ended March 31, 2024.
Giuliano La Fratta, Chief Financial Officer of Aeterna, commented: Our cash position remains strong and we remain on track to complete the DETECT trial and our previously announced merger with Ceapro Inc. (“Ceapro”) in the second quarter. ”
Summary of first quarter 2024 financial results
All amounts are shown in US dollars.
cash and cash equivalents
The Company had cash and cash equivalents of $29.5 million as of March 31, 2024.
Business results for the three months ending March 31, 2024
For the three months ended March 31, 2024, the Company reported a net loss of $5.8 million, or a loss of $4.74 per common share. In comparison, the three companies had a net loss of $4.3 million, or a loss of $3.51 per common share (basic). The $1.5 million increase in net loss was primarily due to a $2.1 million decrease in revenue and a $1.2 million increase in selling, general and administrative expenses, primarily due to non-recurring expenses incurred for our operations. is. Anticipated merger. This was offset by his $1.4 million decrease in research and development expenses and his $0.4 million increase in financial net income.
revenue
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Our total revenue for the three months ended March 31, 2024 decreased $2.1 million. This decrease was due to the termination of our amended agreement with Novo Nordisk Healthcare in May 2023, which resulted in no license fees or development services revenue being recognized in the first quarter of 2024.
Operating expenses
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Total operating expenses for the three months ended March 31, 2024 were $6.1 million, a decrease of $0.2 million compared to $6.3 million for the same period in 2023. This decrease was primarily due to his $1.4 million decrease in research and development expenses offset by his $1.2 million increase in selling, general and administrative expenses.
Consolidated Financial Statements and Management Discussion and Analysis
For your reference, management's discussion and analysis of our financial condition and results of operations for the first quarter of 2024 and our consolidated financial statements as of March 31, 2024 are available on our website at www.zentaris.com. Available. Please visit the “Investors” section or our SEDAR+ and EDGAR profiles at www.sedarplus.ca and www.sec.gov, respectively.
About Masimimorelin (Macrilene)®; Glyberin™)
Macimorelin, an oral drug used to diagnose Adult Growth Hormone Deficiency (AGHD), is approved for sale under the brand name “Glyberin”™ In the European Economic Area and McLillen® In the US. Additionally, Aeterna Zentaris is currently conducting a Phase 3 safety and efficacy study, AEZS-130-P02 (the “DETECT study”), evaluating macimorelin for the diagnosis of childhood-onset growth hormone deficiency (CGHD) .
Masimi Morelin (Macrilene)®; Glybelin™) is an orally active peptidomimetic molecule that is a ghrelin receptor agonist and stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples taken after oral administration of matimorelin for the evaluation of AGHD. Approval of matimorelin for adults was approved by the FDA in 2017 and in 2019 based on Phase III data showing that oral matimorelin provides comparable accuracy to standard insulin tolerance tests (ITTs) and has a more favorable safety profile. Approved by EMEA. Profile compared to ITT. Oral matimorelin also reduces false-positive test results and helps patients avoid unnecessary treatment.
About Aeterna Zentaris Co., Ltd.
Aeterna is a specialty biopharmaceutical company that develops and commercializes a diverse portfolio of pharmaceutical and diagnostic products focused on areas of unmet medical need. Aeterna's flagship product, macimorelin (macrilene, gliberin), is the first and only oral test approved by the U.S. Food and Drug Administration and the European Commission for the diagnosis of adult growth hormone deficiency (AGHD). Aeterna is leveraging Macimorelin's clinical success and compelling safety profile to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need. Masu.
Aeterna is also focused on developing therapeutic assets to address unmet medical needs across many indications, including neuromyelitis optica spectrum disorders (NMOSD), Parkinson's disease (PD), hypoparathyroidism, and muscular atrophy. We have established a preclinical development pipeline to potentially address the need. Lateral sclerosis (ALS; Lou Gehrig's disease).
For more information, please visit www.zentaris.com and connect with us on Twitter, LinkedIn, and Facebook.
Forward-looking statements
This press release contains statements that may constitute forward-looking statements within the meaning of U.S. and Canadian securities laws and regulations, and such statements are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. It has been created. Often, but not always, “expects,” “aims,” ”anticipates,” “believes,” “intends,” “could,” “could” ”, and similar expressions. Such statements are based on management's current expectations and are therefore inherently subject to a number of known and unknown risks, uncertainties and assumptions, many of which are beyond the Company's control.
Forward-looking statements in this press release include, without limitation, statements regarding Aeterna's expectations regarding: the strength of Aeterna's cash position, the completion of the DETECT trial, and the ability of Aeterna and Ceapro to complete the merger transaction; Ceapro (the “Transaction”) is responsible for any or all of the terms and conditions herein and the timing of the completion of the Transaction.
Forward-looking statements involve known and unknown risks and uncertainties and future results expressed or implied by such forward-looking information; There are other factors that may cause the results to differ materially. Such risks and uncertainties include, among other things, our dependence on the success of our DETECT clinical trials in the European Union and the United States for Macrilen™ (macimorelin) for CGHD; The results of ongoing or planned preclinical studies and his DETECT clinical trials in development may not be successful or the product may not be further advanced from preclinical studies toward human clinical trials or regulatory approval. We may not be able to support you in proceeding. our ability to raise capital and obtain financing to continue our currently planned operations; We currently rely heavily on the success of Macrilen™ (macimorelin) and related licensing agreements and the continued availability of funding and resources to successfully commercialize the product. global instability resulting from the global coronavirus disease (COVID-19) pandemic and the war in Ukraine and their potential unknown impact on planned operations; our ability to enter into license-out, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and to maintain such agreements in force; the ability to continue listing our common stock on the Nasdaq; the availability and timing of any stock exchange, regulatory or other approvals required to complete the transaction with Ceapro; Investors should refer to our quarterly and annual reports filed with the Canadian and U.S. securities commissions for additional information regarding risks and uncertainties. This includes the risks discussed under the heading “Risk Factors” in our Annual Report on Form 20-F. EDGAR's profile can be found at www.sec.gov. Given the uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to update such factors or publicly release any revisions to the forward-looking statements contained herein to reflect future results, events or developments, unless required by governmental authorities or applicable law. I am not responsible.
Information regarding registration statement
Aeterna has filed a registration statement (the “Registration Statement”) on Form F-1 (including prospectus) (File No. 333-277115) with the U.S. Securities and Exchange Commission (the “SEC”) for the purchase issuance of its common stock. ) was submitted. Warrants and shares of common stock are issuable but have not yet become effective when exercised in connection with the transaction. The common stock purchase warrants and the common stock issued upon their exercise may not be sold or offers to purchase may be accepted prior to the effective date of the registration statement. Before investing in Aeterna common stock, please read the registration statement prospectus and other documents incorporated by reference therein for more complete information regarding Aeterna, Seapro, the transaction and the offering of common stock purchase warrants. you need to check.
You may obtain a free copy of the registration statement by visiting EDGAR or SEDAR+ (www.sedarplus.ca) on the SEC website (www.sec.gov). Alternatively, he may obtain a copy of them by contacting Aeterna's Investor Representative with the details provided below. Except as noted above, the securities issued pursuant to or in connection with the Transactions have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”) or the U.S. Securities Act. , or will not be registered. These securities are expected to be issued pursuant to an exemption from the registration requirements set forth in Section 3(a)(10) of the Securities Act and similar exemptions under applicable state securities laws.
Prohibition of offers and solicitations
This news release and the information contained herein shall not constitute, nor shall it constitute, an offer to sell, or the solicitation of an offer to buy, any securities in the United States or any other state or jurisdiction. It won't. Nor are any securities of Aeterna. any offer or sale in any jurisdiction where such offer, solicitation or sale is unlawful; Neither the SEC nor any state securities commission has approved or disapproved the transactions described herein or determined whether this communication is truthful or complete. Any statement to the contrary is a criminal offense.
Nothing in this communication should be construed as legal, tax, accounting, or investment advice or recommendations. You should consult your own legal, tax and financial advisors regarding legal and related matters relating to the matters discussed herein.
No securities regulatory authority has approved or disapproved the contents of this news release. The Toronto Stock Exchange assumes no responsibility for the adequacy or accuracy of this release.
Investor contact information:
genen thomas
JTC team
Phone: +1 (833) 475-8247
E: aezs@jtcir.com
