Aeterna Zentaris Experiences First Quarter 2024 Monetary Outcomes

Article content material

• Firm ended the quarter with $29.5 million in money
• DETECT-trial recruitment accomplished; Firm continues to anticipate the completion of the trial within the second quarter and top-line knowledge within the third quarter of 2024
• All-stock merger of equals transaction with Ceapro Inc. anticipated to shut within the second quarter of 2024

TORONTO, ONTARIO, Could 14, 2024 (GLOBE NEWSWIRE) — Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Firm”), a specialty biopharmaceutical firm growing and commercializing a diversified portfolio of pharmaceutical and diagnostic merchandise, right this moment reported its monetary and working outcomes for the quarter ended March 31, 2024.

Article content material

Article content material

Mr. Giuliano La Fratta, Chief Monetary Officer of Aeterna commented, “This yr stays thrilling for Aeterna. Our money place stays robust and we proceed to be on observe to finish each the DETECT-trial and the beforehand introduced merger with Ceapro Inc. (“Ceapro”) within the second quarter.”

Abstract of First Quarter 2024 Monetary Outcomes

All quantities are in U.S. {dollars}.

Money and money equivalents

The Firm had $29.5 million in money and money equivalents at March 31, 2024.

Outcomes of operations for the three-month interval ended March 31, 2024

For the three-month interval ended March 31, 2024, we reported a internet lack of $5.8 million, or $4.74 loss per frequent share, as in contrast with a internet lack of $4.3 million, or $3.51 loss per frequent share (primary) for the three-month interval ended March 31, 2023. The $1.5 million improve in internet loss is primarily on account of a $2.1 million lower in income mixed with a $1.2 million improve in promoting, basic and administrative bills, largely on account of non-recurring bills incurred for the anticipated merger. This was offset by a $1.4 million lower in analysis and improvement bills and a $0.4 million improve in internet finance earnings.

Article content material

Revenues

• Our complete income for the three-month interval ended March 31, 2024, decreased by $2.1 million. The lower was because of the termination of the Firm’s amended settlement with Novo Nordisk Healthcare in Could 2023 and in consequence, no license payment or improvement providers income was acknowledged in Q1, 2024.

Working Bills

• Our complete working bills for the three-month interval ended March 31, 2024, was $6.1 million as in contrast with $6.3 million for a similar interval in 2023, representing a lower of $0.2 million. This lower was primarily from a $1.4 million lower in analysis and improvement bills offset by a $1.2 million improve within the promoting, basic and administrative bills.

Consolidated Monetary Statements and Administration’s Dialogue and Evaluation

For reference, the Administration’s Dialogue and Evaluation of Monetary Situation and Outcomes of Operations for the primary quarter 2024, in addition to the Firm’s consolidated monetary statements as of March 31, 2024, will probably be out there on the Firm’s web site (www.zentaris.com) within the Buyers part or on the Firm’s SEDAR+ and EDGAR profiles at www.sedarplus.ca and www.sec.gov, respectively.

Article content material

Article content material

About Macimorelin (Macrilen^®; GHRYVELIN™)

Macimorelin, an oral drug used for the prognosis of grownup progress hormone deficiency (AGHD) is permitted for advertising and marketing below the model title GHRYVELIN^™ within the European Financial Space and Macrilen^® in the US. As well as, Aeterna Zentaris is at the moment conducting the Part 3 security and efficacy examine AEZS-130-P02 (the “DETECT-trial”) evaluating macimorelin for the prognosis of childhood-onset progress hormone deficiency (CGHD).

Macimorelin (Macrilen^®; GHRYVELIN^™), a ghrelin receptor agonist, is an orally energetic peptidomimetic molecule that stimulates the secretion of progress hormone from the pituitary gland. Stimulated progress hormone ranges are measured in blood samples taken after oral administration of macimorelin for the evaluation of AGHD. Approval of macimorelin to be used in grownup was granted by the FDA in 2017 and by the EMEA in 2019, primarily based on Part III knowledge exhibiting that oral macimorelin gives accuracy similar to that of normal insulin tolerance testing (ITT), however has a extra favorable security profile in comparison with ITT. Oral macimorelin additionally reduces false optimistic check outcomes, serving to to keep away from pointless therapy of sufferers.

Article content material

About Aeterna Zentaris Inc.

Aeterna is a specialty biopharmaceutical firm growing and commercializing a diversified portfolio of pharmaceutical and diagnostic merchandise targeted on areas of great unmet medical want. Aeterna’s lead product, macimorelin (Macrilen; Ghryvelin), is the primary and solely U.S. FDA and European Fee permitted oral check indicated for the prognosis of grownup progress hormone deficiency (AGHD). Aeterna is leveraging the medical success and compelling security profile of macimorelin to develop it for the prognosis of childhood-onset progress hormone deficiency (CGHD), an space of great unmet want.

Aeterna can also be devoted to the event of its therapeutic belongings and has established a pre-clinical improvement pipeline to probably deal with unmet medical wants throughout quite a lot of indications, together with neuromyelitis optica spectrum dysfunction (NMOSD), Parkinson’s illness (PD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig’s illness).

For extra info, please go to www.zentaris.com and join with the Firm on Twitter, LinkedIn and Fb.

Article content material

Ahead-Wanting Statements

This press launch incorporates statements that will represent forward-looking statements throughout the that means of U.S. and Canadian securities laws and laws, and such statements are made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995. Ahead-looking statements are incessantly, however not at all times, recognized by phrases equivalent to “expects,” “aiming”, “anticipates,” “believes,” “intends,” “potential,” “attainable,” and related expressions. Such statements, primarily based as they’re on present expectations of administration, inherently contain quite a few dangers, uncertainty and assumptions, identified and unknown, a lot of that are past our management.

Ahead-looking statements on this press launch embody, however should not restricted to, these referring to Aeterna’s expectations relating to: the power of its money place, the completion of the DETECT-trial, the flexibility of Aeterna and Ceapro to finish the merger transaction with Ceapro (the “Transaction”) on the phrases described herein, or in any respect, and and the timing of the closing of the Transaction.

Article content material

Ahead-looking statements contain identified and unknown dangers and uncertainties, and different components which can trigger the precise outcomes, efficiency or achievements acknowledged herein to be materially totally different from any future outcomes, efficiency or achievements expressed or implied by the forward-looking info. Such dangers and uncertainties embody, amongst others, our reliance on the success of the DETECT medical trial within the European Union and U.S. for Macrilen™ (macimorelin) in CGHD; outcomes from our ongoing or deliberate pre-clinical research and our DETECT medical trial below improvement will not be profitable or might not assist advancing the product additional in pre-clinical research, to human medical trials or regulatory approval; our capability to boost capital and procure financing to proceed our at the moment deliberate operations; our now heavy dependence on the success of Macrilen™ (macimorelin) and associated out-licensing preparations and the continued availability of funds and assets to efficiently commercialize the product; the worldwide instability because of the world pandemic of COVID-19 and the battle within the Ukraine, and their unknown potential impact on our deliberate operations; our capability to enter into out-licensing, improvement, manufacturing, advertising and marketing and distribution agreements with different pharmaceutical firms and hold such agreements in impact; our capability to proceed to record our frequent shares on the NASDAQ; and the supply and timing of required inventory change, regulatory and different approvals for the completion of the transaction with Ceapro. Buyers ought to seek the advice of our quarterly and annual filings with the Canadian and U.S. securities commissions for extra info on dangers and uncertainties, together with these dangers mentioned below the caption “Threat Elements” in our Annual Report on Type 20-F, which is out there on the Firm’s EDGAR profile at www.sec.gov. Given the uncertainties and danger components, readers are cautioned to not place undue reliance on these forward-looking statements. We disclaim any obligation to replace any such components or to publicly announce any revisions to any of the forward-looking statements contained herein to mirror future outcomes, occasions or developments, except required to take action by a governmental authority or relevant regulation.

Article content material

Info In regards to the Registration Assertion

Aeterna filed a Registration Assertion on Type F-1 (together with a prospectus) (File No. 333-277115) (the “Registration Assertion”) with the U.S. Securities and Alternate Fee (the “SEC”) for the issuance of frequent share buy warrants and customary shares issuable upon train thereof in reference to the Transaction, however it has not but turn into efficient. The frequent share buy warrants and customary shares issuable upon train thereof will not be offered nor might affords to purchase them be accepted previous to the time the Registration Assertion turns into efficient. Earlier than you spend money on any Aeterna frequent shares, you need to learn the prospectus within the Registration Assertion and the opposite paperwork included by reference therein for extra full details about Aeterna, Ceapro, the Transaction and the frequent share buy warrant providing.

It’s possible you’ll get copies of the Registration Assertion without cost by visiting EDGAR on the SEC web site at www.sec.gov or at SEDAR+ at www.sedarplus.ca. Alternatively, you could receive copies of them by contacting Aeterna’s investor contact on the particulars offered under. Aside from as famous above, not one of the securities to be issued pursuant to or in reference to the Transaction have been or will probably be registered below the US Securities Act of 1933, as amended (the “U.S. Securities Act”), or any U.S. state securities legal guidelines, and such securities are anticipated to be issued in reliance on the exemption from the registration necessities of the U.S. Securities Act offered by Part 3(a)(10) thereof and related exemptions below relevant state securities legal guidelines.

Article content material

No Provide or Solicitation

This information launch and the data contained herein should not, and don’t, represent a suggestion to promote any securities or a solicitation of a suggestion to purchase any securities in the US or another state or jurisdiction, nor shall any securities of Aeterna be provided or offered in any jurisdiction during which such a suggestion, solicitation or sale can be illegal. Neither the SEC nor any state securities fee has permitted or disapproved of the transactions described herein or decided if this communication is truthful or full. Any illustration on the contrary is a prison offense.

You shouldn’t construe the contents of this communication as authorized, tax, accounting or funding recommendation or a advice. You must seek the advice of your individual counsel and tax and monetary advisors as to authorized and associated issues in regards to the issues described herein.

No securities regulatory authority has both permitted or disapproved of the contents of this information launch. The Toronto Inventory Alternate accepts no duty for the adequacy or accuracy of this launch.

Investor Contact:

Jenene Thomas
JTC Crew
T : +1 (833) 475-8247
E: aezs@jtcir.com

Article content material