Earnings Labs

Addex Therapeutics Ltd (ADXN)

Q1 2023 Earnings Call· Fri, May 12, 2023

$6.58

-0.15%

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Transcript

Timothy Dyer

Management

Hello, everyone. I would like to thank you all for attending our First Quarter 2023 Financial Results Conference Call. I'm here with Robert Lütjens, our Head of Discovery Biology. I draw your attention to the press release and the financial statements issued earlier today, which are available on our website. I also draw your attention to our disclaimer. We will be making certain forward-looking statements that are based on the knowledge we have today. I will start this conference call by giving a quick overview of our recent achievements before handing over to Robert, who will review our clinical and preclinical pipeline. I will then review our Q1 2023 financial results. Following that, we will open the call for questions. Our partner, Janssen, continues to make excellent progress in executing their global Phase 2 study in epilepsy patients with ADX71149. Cohort 1 of 60 patients has completed Part 1 of the study and progressed to Part 2. An independent interim review committee has been established by Janssen to review the unblinded data from Part 1 and recently made its recommendation to continue the study. The recommendation of the independent interim review committee and the decision of our partner, Janssen, to continue the study is very encouraging, and suggests ADX71149 is potentially safe and well tolerated and may have a positive impact on this patient population. We look forward to providing further updates on the progression of this important clinical study in the second half of this year. We continue to believe there is value in dipraglurant and have substantially completed our evaluation for future development. We have identified post-stroke recovery and pain as interesting areas for future development in addition to PD-LID. However, we are currently pursuing collaborative arrangements to advance future development. We continue to be excited by our…

Timothy Dyer

Management

Thanks Robert. I'll now switch to an overview of the financials. Starting with the income statement. We recognized CHF0.5 million of income in Q1 compared to CHF0.2 million in Q1 of 2022. The primary source of revenue is our research funding from our collaboration with Indivior. In terms of expenses, R&D expenses were CHF1.7 million in Q1 2023 compared to CHF3.8 million in Q1 2022. The significant decrease of CHF2.1 million is primarily due to decreased dipraglurant related external research and development activities. G&A expenses were CHF1.2 million in Q1 2023 compared to CHF2.2 million in Q1 of 2022. The decrease of CHF1 million is primarily driven by reduced share-based compensation costs. The finance result is primarily related to positive interest on U.S. dollar cash deposits. Now, to the balance sheet. Our assets are primarily held in cash, and we completed Q1 with CHF5.6 million of cash held in Swiss francs and U.S. dollars. Other current assets amount to CHF1.3 million and primarily related to prepayment of retirement benefits as well as trade receivables that mainly relate to a search agreement with Indivior. Current liabilities of CHF2.2 million are stable and primarily related to R&D payables and accruals, non-current liabilities relate to lease liabilities. Now, to summarize the development of 71149 in epilepsy is going well with Cohort 2 recruiting patients. And we are encouraged by the recommendation of the independent interim review committee to continue this study. We continue to believe in the value of dipraglurant and are evaluating its future development with a focus on post-stroke recovery. In parallel, we are pursuing collaborative arrangements to advance development and look forward to sharing more information in the future. Our preclinical program continued to make solid progress towards delivering drug candidates for future clinical studies in important therapeutic areas, including: stress-related disorders, chronic cough, cognition and schizophrenia. As a reminder, our portfolio was discovered in-house from our pioneering allosteric modulated drug discovery platform and constantly we have significant intellectual property in all programs. We have a track record of securing partnerships at preclinical stage and support of top-tier investors. We recognize the 2023 stock performance and current market capitalization is very disappointing. However, we are having multiple business discussions across our portfolio and strongly believe that if we are successful at executing our near-term partnering strategy, then our stock price should move to recognize the value of our portfolio. This concludes the presentation, and we will now open the call for questions.

Operator

Operator

Thank you. Please stand by for your first question. Your first question comes from Boobalan Pachaiyappan from H.C. Wainwright. Boobalan, your line is open. Please go ahead.

Boobalan Pachaiyappan

Analyst

Hi. This is Boobalan. I'm dialing in for Ram Selvaraju, and thanks for taking our questions. So two from us. Firstly, how does the recommendation to continue the Phase 2 trial of ADX71149 potentially increase the likelihood of a positive final outcome?

Timothy Dyer

Management

Yes, thanks for the question. So yes, so Janssen has established an independent review committee because to look at Part 1 – the unblinded Part I data from Cohort 1. Now, if you've been following this study, I mean the study was originally established just to have one cohort, and then it was modified to have up to three cohorts looking at multiple doses with 160 patients. Now, they do not want to unblind the study. So this is why they've established this committee. Now, the remit of the committee was to really give a no-go decision recommendation, I should say, for Janssen then to take a decision. So what we know is that the committee has made a recommendation to continue the study. So this suggests that they must be seeing something positive from the data they looked at. Now, based on the recommendation, Janssen have then decided to continue the study, which we, again, see as very positive. And we certainly believe that this is now, gives us more, I would say increases the probability of a successful outcome of the study. But again, I – this is a clinical study, and I think we all know that lots and lots of things can go wrong in clinical studies. And this is only the data from Part 1 of Cohort 1. So this is 60 patients, which were 2:1 randomized, and it's the data from the first four-week period.

Boobalan Pachaiyappan

Analyst

All right. Thanks for the detailed color. And secondly, in addition to what is stated in your prepared remarks, has there been any progress in your efforts to identify a potential collaboration partner or maybe license fee for dipraglurant? Thanks.

Timothy Dyer

Management

Yes. So we continue to have discussions with multiple potential partners across the portfolio. We know when we start the discussion, very difficult to predict where we end the discussion, and we continue to advance the programs. We continue to generate interesting data, and we continue to have very encouraging discussions with potential partners. And that's all I can really say at this point in time.

Boobalan Pachaiyappan

Analyst

All right. Thanks again for taking our questions, and congrats on the progress.

Operator

Operator

The next question comes from Leonildo Delgado of Baader Helvea. Leonildo, your line is open. Please go ahead.

Leonildo Delgado

Analyst

Hi. Good afternoon. This is Leonildo speaking. Thanks lot for taking our questions. With the current burn rate, it looks to me that cash will only take you through 3Q 3023, but you mentioned 2024 in your opening remarks. Does it mean that you're going to stop all the R&D activities, including the IND-enabling studies? Or should we expect rather a personal reduction?

Timothy Dyer

Management

We have no plans to restructure the company. And I'm not quite sure where you get your position around Q3. We finished the quarter with CHF5.6 million, and we've raised CHF4.5 million, and I think what you have to realize – if you look at the cash burn in 2022, you've got to remember we had an ongoing Phase 3 study with an open-label study, and so this got closed out. We continue to have certain costs related to the closing out of the dipraglurant PD-LID development in Q1. And so R&D expenses are continuing to come down. So this is why our guidance is that we have cash through into 2024.

Leonildo Delgado

Analyst

Okay. Thank you. And so this, the positive opinion on the epilepsy study facilitate in your view, some of the partnering conversations. And so do you have something concrete, for example, term sheets on the table? Could you maybe provide some details there? Thank you.

Timothy Dyer

Management

Look, we have multiple discussions with multiple parties across the portfolio. We are not giving this sort of granularity around our business discussions. But I think if you look at the portfolio, if you look at the programs, we have a track record of doing deals at the preclinical stage. And we have some very exciting first-in-class programs. The mGlu7, we have a clinical candidate. We have multiple backups. We have a very, very young IP portfolio in an exciting area. This is first-in-class and we have an M4 PAM program on an extremely exciting target. The GABAB chronic cough program is particularly interesting. We're very close to having a molecule that's going to be ready to go into IND-enabling studies. We recently saw the takeout of Bellus for $2 billion by GSK in the chronic cough space. I think there's plenty of exciting programs that can drive business development within the Addex portfolio.

Leonildo Delgado

Analyst

Thank you.

Timothy Dyer

Management

Thank you.

Operator

Operator

[Operator Instructions] We currently have no further telephone questions. Just to confirm, we currently have no further telephone questions. I will now hand back to you for any web questions.

Timothy Dyer

Management

Yes. So we have a web question about the expected readout of data from J&J. So as I said, Part 1 of Cohort 1 has completed. There are patients in Part 2. We're expecting them to complete quite soon. We know that Cohort 2 is recruiting patients, and we're expecting Cohort 2 to recruit in the coming months, and then it will go into – they'll be in Part 1, and then they'll move into Part 2. So we would expect Cohort 2 to be completed probably around the end of the year. But we are not giving any firm guidance on when data will be reading out because if you read clinicaltrials.gov, you'll see that J&J are ready to go up to three cohorts. And certainly, if they introduce a third cohort after Cohort 2 has completed recruitment, then the reporting of data will be pushed out until Cohort 3 is completed. So I think you can appreciate that it would be extremely unwise to try and speculate on when the data will be read out or when we will be able to read out the data from J&J.

Operator

Operator

There are no more telephone questions in the queue. Thank you. That ends today's call.