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spk07: Greetings and welcome to the Cellulite Oncology first half 2022 financial results. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now turn the conference over to your host, Sarah Zelkovic, Director of Communications and Investor Relations for Cellulite Oncology. Thank you. You may begin.
spk01: Thank you all for joining us today. Before we begin, I would like to remind everyone that today's event may contain forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may involve known and unknown risks and insurgencies, which might cause actual results, financial conditions, performance, or achievements of the company to differ materially materially from those expressed or implied by such forward-looking statements. A list and description of these risks, uncertainties, and other risks can be found in the company's U.S. Securities and Exchange Commission filings and reports, including an annual report on 20F filed with the FCC on March 24, 2022, and subsequent filings and reports by the company. These forward-looking statements speak only as of the date of the of this call and the company's actual results may differ materially from those expressed or implied by these forward-looking statements. The company expressly disclaims any obligation to update any such forward-looking statements made on this call to reflect any change in its expectations with regard thereto or any change in events, conditions, or circumstances on which any such statement is based unless required by law or regulation. Let me now turn the call over to Michelle Lussier, Interim Chief Executive Officer of Cellular Oncology. Michel, the floor is yours.
spk08: Thank you, Sarah. And thank you, everyone, for joining us today for our financial results and operational results update call for the first half of 2022. Joining me today from the executive committee team is our chief medical officer, Dr. Charlie Morris, and our vice president of finance and administration, David George. We will start today with an operational and clinical update. followed by an overview of the financials and outline the expected key milestones of the company over the next several months. We will then open the line for your questions. So there have been many changes to the company in terms of the clinical candidates and leadership in the first half of the year. Importantly, we say goodbye to our previous CEO, Filippo Petti, who stepped down in June to seek other opportunities I must say we've had a very smooth transition over the past month, and I've taken over as interim CEO. And I want to thank dearly Filippo for his broad contributions to cellulite oncology over the past years. We have begun the search for a new CEO and are targeting a European-based person to helm our headquarters in Belgium. We're also happy to announce that the board of directors, as named Hilda Wendel's, Hilda has been on our board for a number of years and will now be the chair of our board directors because I stepped down as chairman to take the CEO helm. She is a prominent board member in the European biotech industry and we look forward to continuing our work under her guidance. In addition, Dr. David Gilham, our former chief scientific officer, also resigned to seek other opportunities David has been with the company almost eight years, and he felt this timing was a natural transition as the new head of R&D, Dr. Eitan Bremen, takes over to continue our work on our shRNA platform and discovery CAR-T programs. I also thank David for his significant reshaping of our R&D efforts as we shifted our approach in the field of CAR-T towards allogenic therapies underpinning biomechanics. underpinned by SHRNA technology. So while we've had many changes in the past few months, we look forward to focusing our efforts on four major pillars of the business to maximize all potential value drivers of the company in the coming months and years. Our first pillar is our research and development efforts. A main focus will be on research that will utilize our SHARC or SHRNA-armored CAR-T franchise. We introduced this platform last year, and although we did make the decision in April to stop development of CIAD2 or 3, our allogenic, SHRNA-based IL-10-armored NKG2D CAR-T candidates, I want to note that we're making promising progress in multiple discovery programs focused on the co-expression of IL-18, including the exploration of backup allogeneic NKG2D receptor CAR T candidates, which leverage this platform. Currently, our armored CAR Ts are engineered to release IL-18, providing the opportunity to drive increased potency of our cell therapy by impacting the CAR T and the local tumor microenvironment, especially important for the treatment of solid tumors. We think that this is an ideal platform for developing unique CAR T products for difficult-to-treat diseases and could overcome the challenges related to treating solid tumors. Moving to our pipeline, our next pillar, we've had challenges and opportunities related to our allogenic CAR T candidates this year and are happy to announce that our trials are getting back on track where they should be, At the end of July, we received notification from the FDA that they are lifting the clinical hold put on our investigational candidate, CIAD 101. This is a significant milestone for the company, and we're very excited at the potential development of CIAD 101 and other product candidates using our TIM technology. Patient safety continues to be our biggest priority, and we're proud to have safely tested many people with cancer using our TIM technology and NKG2D targeting CARs in clinical trials. I'd like to take this time to thank the team for their hard work and dedication to providing timely responses to the FDA in order to get this hold lifted as quickly as possible. In addition, enrollment for the dose escalation portion of Immuni-C trial with CI-211 has been steady with one patient enrolled per month, and we're excited about the data we're generating and will share this year. Immuni-C1 has been an invaluable way for us to showcase the benefits of our proprietary shRNA technology in a real-world clinical setting. We truly believe that this non-gene editing technology offers great opportunity to drive differentiated candidates for both solid tumors and hematological malignancies. The third pillar and a value driver that has been underutilized so far in the company relates to our unique intellectual property within the CAR-T landscape. Our U.S. patents around allogeneic CAR-T therapy and NKG2B 2D-based technologies provides an avenue for the company to develop its own programs and to partner with outside parties around the licensing of these patents. We are planning a renewed strategic focus to leverage additional potential licenses. And finally, the last pillar of a renewed strategy, as we see a significant opportunity, is for in-house manufacturing expertise. This facility has been a great investment for us over the past decade, and we are currently evaluating opportunities on how we can further leverage this core asset within the overall strategy of our business. So let me stop here and turn the call over to Dr. Charlie Morris, our Chief Medical Officer, to provide more detail. Charlie?
spk02: Thank you, Michel, and thank you everyone again for joining us today. As Michelle just discussed, we have several updates related to our pipeline in the first part of 2022. Let's first turn to SIAD 101, CELIAD's first-in-class non-gene-edited clinical candidate that co-expresses the NKG2D receptor and the novel TCR inhibitory molecule, or TIM, which interferes with native CD3 zeta, I'm sorry, reducing the signaling of the TCR complex. Of note, SIAD 101 is the only investigational candidate from the company using the TIM technology. We completed our previous SIAD 101 trial called AlloShrink last year, and in December 2021 began the SIAD 101-002, otherwise known as Keynote B79 clinical trial. This Phase 1B trial is evaluating SIAD 101, followed by Merck's anti-PD-1 therapy, Keytruda, refractory metastatic colorectal patients with microsatellite stable mismatch repair proficient disease a difficult indication for immunotherapies to date as Michelle just mentioned the FDA has lifted the clinical hold previously put on this trial the amendments that we suggested that were accepted by the FDA states that we will exclude patients with bilateral lung metastases and prior history of anti-EGFR antibodies within nine months of recruitment to the trial. We are continuing to evaluate the use of NKG2D receptors in our research, along with our unique proprietary non-gene-edited technologies. Our second phase one trial evaluates SIAD211, a potential first-in-class allogeneic CAR-T candidate engineered to co-express a BCMA-targeting CAR and a single shRNA, which interferes with the expression of the CD3 zeta component of the TCR complex. SIAD-211 is currently in the dose escalation portion of the Phase I Immunity I trial, which is evaluating the tolerability and clinical activity of a single infusion of SIAD-211, following preconditioning with cyclophosphide and fludarabine, known as CyFlu, in patients with relapsed and refractory multiple myeloma. Initial data from Immunity 1 showed all patients had detectable SIAD211 cells in the peripheral blood, although engraftment to date has been short-lasting. These findings suggest that deeper and more durable lymphodepletion may maximize engraftment and persistence of the cells. Now, our current segment of Immunity 1 follows an enhanced lymphodepletion regimen with the aim of improving cell expansion and persistence and to potentially maximize the clinical activity of SIAD211. In addition, we are also evaluating increased dose of SIAD211 within the Immunity 1 protocol, which might help drive additional clinically beneficial responses. For this trial, we plan to share additional clinical data during the second half of 2022. We truly feel that our technologies offer potential benefits over other approaches in space and help us to lead the way in developing innovative allogeneic therapies for the treatment of cancer. We've made great progress, particularly with our shRNA technology in previous and current clinical candidates. We have continued to expand our research efforts into how to best leverage the dynamic potential of the shRNA platform including multiplexing and targeting immune evasion, and its potential to serve as a backbone for armored cars using our proprietary Shark franchise. With that, let me turn the call to our VP of Finance, David Georges.
spk03: Thank you, Charlie. Turning to our financials, I would just like to remind you all that full financial details are available on the Celiad Oncology website in both French and English language. Our research and development expenses were €10.5 million for the first half of 2022 compared to €10 million for the first half of 2021. The €1.5 million increase was mainly driven by intellectual property filing and maintenance fees to strengthen intellectual property prosecution and also by the increase of employees' expenses related to movement of employees through the year 2021 and 2022 to support the group's free clinical and clinical programs. These increases have been partly compensated by the decrease of clinical activities, mainly due to the Phase 1b SIAD-101-002 Keynote Trial, which was on clinical hold during the second quarter of 2022. General and administrative expenses were 6.2 million euros for the first half of 2022, compared to 4.8 million euros for the first half of 2021. The increase was associated with an increase in insurance costs combined with the increase of employee expenses mainly related to movements of employees through the six-month period ended June 30, 2022. Net order income for the first half of 2022 was 1.6 million euros compared to a net order income of 1.8 billion euros for the first half of 2021. For net order income for the first half of 2022, was associated with grants received from the Walloon region for €1.4 million. Net loss for the first half of 2022 was €14.1 million, or €0.62 per share, compared to a net loss of €14.9 million, or €1.02 per share, for the same period in 2021. Net cash used in the operations amounted to 16.3 million euros for the first half of 2022, as compared to its 12.2 million euros for the first half of 2021. As of June 30, 2022, the company had a treasury position of approximately 14.4 million euros, or $15 million. As of June 30, 2022, the total number of basic shares outstanding were 22.6 million, which is similar to the situation of 31st of December, 2021. With that, I will now turn the call back to Michel for closing statements.
spk08: Thank you, David. So in closing, we're looking forward to this renewed sense of focus and strategy for Celiac Oncology. As mentioned previously, we will be exploring four main pillars of strategy to further leverage all possible value drivers for the company, These include examining the way we're using our manufacturing expertise, our intellectual property portfolio, our clinical pipeline candidates, and our current R&D endeavors. We hope to provide additional thoughts on these topics over the coming months and year as we execute on these strategies. We look forward to reporting additional data for the CIAD211 Immunity 1 Phase 1 trial by the end of the year, and make additional announcements regarding our clinical program as a whole over the coming months. And with that, I'll turn the call over for your questions. Operator?
spk07: Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Raju Prasad with William Blair. Please proceed with your question.
spk05: Thanks for taking the question. I'm curious to know the reasoning behind the nine months lead in on EGFR therapies. as an exclusion criteria for taking up the clinical hold.
spk06: Thanks. Hi, Raj.
spk02: Yeah, so both of the patients who had passed had a history of exposure to anti-EGFR1 around about six months away. So we felt, having seen that, we should use six months, if you like, as a baseline, because obviously we had other patients who had been treated within six months who had not had severe adverse effects. But if we take six months as a baseline and then a conservative sort of washout time, five half-lives of Stuximab, for example, takes you out to about 10 weeks. So you're then out to about nine months.
spk06: Okay, great.
spk05: And you mentioned a little bit around business development strategy and IP. Can you give us a little more color on that? Would that be partnering at assets? Would that be licensing patents? How much of the IP estate or products are you looking to potentially partner? Thanks.
spk08: So thanks, Raj. And short answer is all of the above. We're having a very broad IP portfolio ranging from allogenic patents to NKGD, SHRNA. A lot of patents also developed internally, organically at Celiac. And for those, our wish is to have patients to be treated and partners of the industry to be able to benefit from this IP through licensing or any other
spk06: mutually beneficial situation that we will come up with. Great. Thank you.
spk07: Thank you. Ladies and gentlemen, as a reminder, if you'd like to join the question queue, please press star 1 on your telephone keypad.
spk06: We'll pause a moment to allow for questions.
spk07: Thank you. Our next question comes from the line of Reid McCullough with Wells Fargo. Please proceed with your question.
spk04: Hi. Thank you for taking my question. This is Reid on for Nick. Can you provide any more color on the manufacturing that you're trying to proceed with and help expand here in the space? Thank you.
spk08: Yes, Reid. Good afternoon, and I'd be happy to do that. Well, basically, if you get back years ago when Celiac and even previously Cardio 3 got engaged in cell therapy, it was very difficult for early stage companies not to have a GMP facility because it was not available. So we took the major endeavor at that point to be fully integrated with a GMP facility that has been very helpful recently. both when we were in the cardiac field and more recently in the CAR-T space. And in the past, we've come through periods where, because of timing of clinical studies, our resources were underutilized. And we have this history in the past of, for example, having other companies in the cell therapy to rent some of our space. So now we are entering in a phase where also We may have an overcapacity in our manufacturing capacity. So we have the chance to have other projects. So what is the exact modus operandi of making this capacity available to others is under development right now. But there are a number of ways that we can make this manufacturing unit as well as the QA and all of our great trained personnel to benefit to other technologies as well.
spk06: Great. Thank you. My pleasure.
spk07: Thank you. Ladies and gentlemen, this concludes our question and answer session. I'll turn the floor back to Mr. Lussier for any final comments.
spk08: Thank you, Operator, and I'd like to thank everyone for joining us today. and your interest in celiac oncology. We remain steadfast in our mission to bring novel and innovative CAR T therapies to cancer patients with unmet medical needs, and we're looking forward to speaking to you all again soon. Thank you.
spk07: Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
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