January 5, 2022

 

To All Our Shareholders,

 

My mandate as CEO of Aeterna Zentaris is ultimately a transformational one.  As we look back on the last year with this update on our operational progress and financial position, it is clear that we have made significant strides toward this goal, even in the face of unprecedented global challenges. In 2021, we built upon our established foundation as a specialized biopharmaceutical company by advancing one approved product, macimorelin, for Adult Growth Hormone Deficiency and further commencing our pivotal Phase 3 safety and efficacy study, AEZS-130-P02 (the DETECT-trial), evaluating macimorelin for the diagnosis of Childhood-Onset Growth Hormone Deficiency. We can now look to 2022 with not only these two programs in our arsenal, but also with a robust development pipeline on the horizon that we believe provides multiple opportunities for success and the potential to fuel the Company’s growth for many years to come.

 

In 2021, we in-licensed six new preclinical development programs, four potential therapeutics and two potential vaccines, all of which we believe represent significant individual market opportunities if they continue to advance through further preclinical and clinical studies. We were able to do this by leveraging our deep network of industry and academic relationships, searching through many programs and countless patents, and identifying programs that we felt met our strict criteria and were worthy of our time and resources.

 

I hope you can appreciate the intricate pace involved with drug development – it takes time. Since bringing these assets in-house in early 2021, our team has been working diligently to prepare preclinical development plans with the goal of advancing each program into the clinic as quickly as possible, depending on the outcome of those preclinical studies and our ongoing evaluations of the results. The early preclinical studies are very important in not only guiding but de-risking potential clinical development plans. Not only are we following stringent development guidelines, but we are also working to develop manufacturing processes to ensure we have enough material to be able to carry out the required preclinical and, if conducted, early clinical studies.

 

Many of you have wished to hear more frequent updates about these programs, particularly around our COVID-19 vaccine program. However, I remind you that we must balance competitive risks when providing updates and while we have met, and will continue to meet, our disclosure obligations, I can assure you all of our programs are advancing. Given the nature of research, these advancements don’t happen in just weeks or a few months. Be assured that our team continues to work hard behind the scenes, and that when there is material news to share, we will be sharing it.

 

On the financial front, our financings in early 2021 placed us in a position of strength, and we believe that we have the necessary capital to fund operations beyond 2023, based on our current plans and expectations. We understand and share the frustration of shareholders with the current stock price and potential for delisting from NASDAQ. I will note that that we are not alone in this. Many biotech companies saw a significant decline in share price over the second half of 2021. With that said, we are working tirelessly with the goal of addressing the minimum bid requirements and are evaluating all options. We believe that we are doing everything we can to rectify our situation, in spite of the broader market conditions creating significant headwinds.

Throughout 2022 we expect that there will be many opportunities for us to build on the momentum we created in 2021. I believe we have the right team in place to execute on our milestones and to keep moving us forward. We are committed to continually evaluating the scientific results and the business and competitive landscape as we look to drive our programs forward and believe that we are poised for an exciting future.

 

We are truly grateful for all the patients, families, clinical staff, partners and our shareholders and thank you for your continued support. We wish you and your loved ones a happy and healthy 2022!  We look forward to sharing more as material updates become available over the course of this year.

 

Best,

 

 

Dr. Klaus Paulini

President and Chief Executive Officer

Aeterna Zentaris, Inc.

 

 

Forward-Looking Statements

This letter contains statements that may constitute forward-looking statements within the meaning of U.S. and Canadian securities legislation and regulations and such statements are made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements are frequently, but not always, identified by words such as “expects,” “anticipates,” “believes,” “intends,” “potential,” “possible,” and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainties and assumptions, known and unknown, many of which are beyond our control. Forward-looking statements in this press release include, but are not limited to, those relating to: Aeterna’s expectations with respect to its current programs in pre-clinical and clinical development; Aeterna’s plans with respect to advancing programs into clinical development and to establish a manufacturing process for its products in development; Aeterna’s expectations with respect to the Nasdaq minimum bid requirements; and Aeterna’s expectations regarding its ability to continue to fund its operations through 2023.

Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks and uncertainties include, among others, our reliance on the success of the DETECT trial; we may be unable to enroll the expected number of subjects in the DETECT trial and the result of the DETECT trial may not support receipt of regulatory approval in CGHD; our other pre-clinical and clinical studies may be unsuccessful; the development timelines for each of our programs may be longer than expected and/or may cost more than expected; our heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements for macimorelin and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo Nordisk; the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; and our ability to continue to list our common shares on the NASDAQ. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those risks discussed in our Annual Report on Form 40-F and annual information form, under the caption "Risk Factors". Given the uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

No securities regulatory authority has either approved or disapproved of the contents of this letter. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this letter.