– Pivotal Section three security and efficacy research AEZS-130-P02 (“Examine P02”) anticipated to start in Q1 2021
– Proceed to advance discussions to safe a commercialization companion for macimorelin in Europe and different key world markets
– Ongoing evaluations to develop pipeline past macimorelin alternative
– Money runway to fund operations and anticipated to offer vital optionality for progress
CHARLESTON, S.C., Nov. 06, 2020 (GLOBE NEWSWIRE) — Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Firm”), a specialty biopharmaceutical firm commercializing and growing therapeutics and diagnostic checks, as we speak reported its monetary and working outcomes for the third quarter ended September 30, 2020.
The Firm additionally supplied an replace on its medical program to develop using macimorelin for the analysis of childhood-onset progress hormone deficiency (“CGHD”), an space of serious unmet want, and its plans to develop macimorelin for the analysis of grownup progress hormone deficiency (“AGHD”) in Europe and different key markets.
“We stay centered on advancing our technique with the intention to unlock the Firm’s full potential. Trying to the rest of the 12 months, we’re executing on the preparations for our pivotal Section three security and efficacy research, AEZS-130-P02 (“Examine P02”), to guage macimorelin for the analysis of childhood-onset progress hormone deficiency, and count on to start this research within the first quarter of 2021,” commented Dr. Klaus Paulini, Chief Govt Officer of Aeterna.
“Moreover we proceed to guage macimorelin for brand spanking new therapeutic usages, in addition to assess the potential of the event candidates from our earlier packages to be re-purposed for various indications primarily based on prior key findings from information already out there to us. We sit up for offering further updates as we discover these alternatives,” added Dr. Paulini.
- Raised a complete of $19 million, together with a registered direct providing priced at-the-market below Nasdaq guidelines for gross proceeds of $7.zero million and a public providing for gross proceeds of $12 million to the Firm;
- Regained compliance with minimal stockholders’ fairness requirement for continued itemizing on Nasdaq;
- Expanded mental property portfolio for macimorelin with the submitting of two further patent functions; and
- Introduced outcomes of the Firm’s first pediatric research of macimorelin on the 22nd European Congress of Endocrinology (e-ECE 2020) held September 5-9, 2020.
Macimorelin Medical Program Replace
The Firm’s lead product, macimorelin, is the one United States Meals and Drug Administration (“FDA”) accredited oral drug indicated for the analysis of AGHD and is at present marketed in the USA (“U.S.”) below the tradename Macrilen™, by Novo Nordisk. Aeterna is at present growing macimorelin for the analysis of CGHD, an space of serious unmet want, in collaboration with Novo Nordisk.
Preparations are underway to provoke Examine P02, an open-label, single dose, multicenter and multinational research anticipated to enroll roughly 100 topics worldwide, with a minimum of 40 pre-pubertal and 40 pubertal topics and a minimal of 25 topics anticipated to be enrolled within the USA. The research design is predicted to be appropriate to help a declare for potential stand-alone testing, if profitable.
Upcoming Anticipated Program Milestones
- Start CGHD security and efficacy research, Examine P02 (multi-national, together with U.S.); and
- Advance enterprise improvement efforts in direction of securing a possible advertising companion for macimorelin for the analysis of AGHD in Europe and different key markets.
Aeterna has additionally begun exploring the potential therapeutic use of macimorelin in numerous different indications. The Firm plans to guage the event of different formulations or administration routes with the purpose of making certain enough bioavailability and expects to offer updates on its progress as outcomes turn into out there over the course of the following a number of months.
Pipeline Growth Alternatives
Aeterna Zentaris intends to steadiness dangers and safe progress alternatives by re-establishing a diversified, but centered, improvement pipeline to which the Firm can greatest leverage its experience and expertise. The Firm is concentrated on opportunistically using its community with universities in Europe and the U.S. which supplies, what the Firm believes will probably be, very important entry to progressive improvement candidates in numerous indications, with a deal with uncommon or orphan indications and potential for pediatric use.
Financings Accomplished Throughout the Third Quarter 2020
On July 7, 2020, the Firm closed a public providing of 26,666,666 items at a value to the general public of $zero.45 per unit, for gross proceeds of $12 million, earlier than deducting placement agent charges and different providing bills payable by the Firm, within the quantity of $1.four million. Every unit contained one widespread share (or widespread share equal in lieu thereof) and one investor share buy warrant to buy one widespread share. In complete, 26,666,666 widespread shares, 26,666,666 investor share buy warrants with an train value of $zero.45 per share expiring July 7, 2025 and 1,866,667 placement agent warrants with an train value of $zero.5625 per share expiring July 1, 2025 had been issued.
On August 5, 2020, the Firm closed a securities buy settlement with a number of institutional traders in the USA offering for the sale and issuance of 12,427,876 widespread shares at a purchase order value of $zero.56325 per widespread share in a registered direct providing priced at-the-market below NASDAQ guidelines. The providing resulted in gross proceeds of $7 million. Concurrently, the Firm issued to the purchasers unregistered warrants to buy as much as an combination of 9,320,907 widespread shares. The warrants are exercisable for a interval of 5 and one-half years, exercisable instantly following the issuance date and have an train value of $zero.47 per widespread share. As well as, the Firm issued unregistered warrants to the position agent to buy as much as an combination of 869,952 widespread shares, with an train value of $zero.7040625 per share and an expiration date of August three, 2025. The online money proceeds to the Firm from the providing totaled $6.three million. Efficient September 14, 2020, the Firm registered the widespread shares underlying the 9,320,907 investor warrants and 869,952 placement agent warrants issued on August three, 2020 by the use of a registration assertion which eliminated the cashless train possibility for registered warrants.
As of September 30, 2020 the Firm had roughly $21.7 million money and money equivalents. Primarily based on present expectations, administration believes it has enough capital to fund its present operations by 2023.
Abstract of Third Quarter 2020 Monetary Outcomes
All quantities are in U.S. dollars
For the three-month interval ended September 30, 2020, the Firm reported a consolidated internet lack of $1.1 million, or $zero.02 loss per widespread share (primary), as in contrast with a consolidated internet lack of $zero.three million, or $zero.02 loss per widespread share for the three-month interval ended September 30, 2019. The $zero.eight million decline in internet outcomes is primarily from a change in honest worth of warrant legal responsibility of $1.three million partially offset by a discount of $zero.2 million in working bills.
- The Firm reported that complete income for the three-month interval ended September 30, 2020 was $zero.1 million as in contrast with $zero.three million for a similar interval in 2019, representing a lower of $zero.2 million. The 2020 income was comprised of $zero.02 million in royalty income (2019 – $zero.01 million), $zero.09 million in provide chain income (2019 – $zero.three million) and $zero.02 million in licensing income (2019 – $zero.02 million).
- The Firm reported that complete working expense for the three-month interval ended September 30, 2020 was $1.9 million as in contrast with $2.1 million for a similar interval in 2019, representing a lower of $zero.2 million. This lower arises primarily from a $zero.2million decline usually and administrative, a $zero.1 million decline in analysis and improvement prices, and a $zero.1 million decline in promoting bills. The influence of the Firm’s June 2019 restructuring in its German subsidiary, specifically for payroll and share primarily based compensation prices, is a key affect within the declines usually and administrative bills, promoting and analysis and improvement bills.
- The additional influence on the decline in analysis and improvement prices is attributed to the totally different phases of exercise of Examine P01. Throughout 2019, research actions included research begin with doc improvement, treatment manufacturing, research feasibility testing at totally different websites and medical trial functions in Hungary, Poland, Belarus, Russia, Ukraine and Serbia, whereas in 2020, all websites had accomplished their enrollment and medical actions.
Web Finance Earnings
- The Firm reported internet finance earnings for the three-month interval ended September 30, 2020 was $ zero.6 million as in contrast with a internet finance earnings of $1.5 million for a similar interval in 2019, representing a lower of $zero.9 million. That is primarily on account of a $1.three million decrease acquire within the change in honest worth of warrant legal responsibility offset by a $zero.2 million from modifications in foreign money change charges and $zero.2 million from different finance prices. Efficient September 14, 2020, the Firm registered the widespread shares underlying the 9,320,907 investor warrants and 869,952 placement agent warrants issued on August three, 2020 by the use of a registration assertion which eliminated the cashless train possibility for registered warrants.
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 third quarter of 2020, in addition to the Firm’s audited consolidated monetary statements as of December 31, 2019, will probably be out there at www.zentaris.com within the Investors part or on the Firm’s profile at www.sedar.com and www.sec.gov.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty biopharmaceutical firm commercializing and growing therapeutics and diagnostic checks. The Firm’s lead product, macimorelin, is the primary and solely U.S. FDA and European Fee accredited oral take a look at indicated for the analysis of grownup progress hormone deficiency (AGHD). Macimorelin is at present marketed in the USA below the tradename Macrilen™ by a license settlement with Novo Nordisk the place Aeterna Zentaris receives royalties on gross sales. Aeterna Zentaris owns all rights to macimorelin outdoors of the U.S. and Canada.
Aeterna Zentaris can also be leveraging the medical success and compelling security profile of macimorelin to develop it for the analysis of childhood-onset progress hormone deficiency (CGHD), an space of serious unmet want.
The Firm is actively pursuing enterprise improvement alternatives for the commercialization of macimorelin in Europe and the remainder of the world, along with different non-strategic belongings to monetize their worth. For extra data, please go to www.zentaris.com and join with the Firm on Twitter, LinkedIn and Facebook.
This press launch accommodates forward-looking statements (as outlined by relevant securities laws) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which replicate our present expectations concerning future occasions. Ahead-looking statements embody these referring to the Firm acquiring approval of macimorelin for CGHD and the ensuing potential to considerably enhance the out there affected person inhabitants for macimorelin, the Firm’s means to safe advertising companions for macimorelin for GHD in Europe and elsewhere, the graduation of the CGHD Examine P02, the flexibility of the Firm to determine and develop therapeutic makes use of for macimorelin in new indications, the flexibility of the Firm to develop its pipeline of merchandise and the flexibility of the Firm to have enough funding for its operations by 2023, and will embody, however are usually not restricted to statements preceded by, adopted by, or that embody the phrases “will,” “expects,” “believes,” “intends,” “would,” “may,” “could,” “anticipates,” and comparable phrases that relate to future occasions, efficiency, or our outcomes. Ahead-looking statements contain identified and unknown dangers and uncertainties, together with these mentioned on this press launch and in our Annual Report on Kind 20-F, below the caption “Key Info – Threat Components” filed with the related Canadian securities regulatory authorities in lieu of an annual data kind and with the U.S. Securities and Trade Fee. Recognized and unknown dangers and uncertainties may trigger our precise outcomes to vary materially from these in forward-looking statements. Such dangers and uncertainties embody, amongst others, our means to lift capital and procure financing to proceed our at present deliberate operations, our means to proceed to listing our Widespread Shares on the NASDAQ, 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, together with our heavy reliance on the success of the License Settlement with Novo, the worldwide instability because of the world pandemic of COVID-19, and its unknown potential impact on our deliberate operations, together with research, our means to enter into out-licensing, improvement, manufacturing, advertising and distribution agreements with different pharmaceutical corporations and hold such agreements in impact, our reliance on third events for the manufacturing and commercialization of Macrilen™ (macimorelin), potential disputes with third events, resulting in delays in or termination of the manufacturing, improvement, out-licensing or commercialization of our product candidates, or leading to vital litigation or arbitration, uncertainties associated to the regulatory course of, unexpected world instability, together with the instability because of the world pandemic of the novel coronavirus, our means to effectively commercialize or out-license Macrilen™ (macimorelin), our reliance on the success of the pediatric medical trial within the European Union (“E.U.”) and U.S. for Macrilen™ (macimorelin), the diploma of market acceptance of Macrilen™ (macimorelin), our means to acquire obligatory approvals from the related regulatory authorities to allow us to make use of the specified model names for our product, our means to efficiently negotiate pricing and reimbursement in key markets within the E.U. for Macrilen™ (macimorelin), any analysis of potential strategic options to maximise potential future progress and shareholder worth could not lead to any such various being pursued, and even when pursued, could not consequence within the anticipated advantages, our means to benefit from enterprise alternatives within the pharmaceutical business, our means to guard our mental property, and the potential of legal responsibility arising from shareholder lawsuits and basic modifications in financial situations. Traders ought to seek the advice of our quarterly and annual filings with the Canadian and U.S. securities commissions for extra data on dangers and uncertainties. Given these uncertainties and threat elements, readers are cautioned to not place undue reliance on these forward-looking statements. We disclaim any obligation to replace any such elements or to publicly announce any revisions to any of the forward-looking statements contained herein to replicate future outcomes, occasions or developments, except required to take action by a governmental authority or relevant legislation.
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