Hello, and welcome to the Alligator Bioscience Q3 Report 2021. Throughout the call, all participants will be in a listen-only mode, and afterwards there will be a question and answer session. Today, I'm pleased to present Julie Silber, Senior Director of Investor Relations. Please go ahead with your meeting. Thank you. Hello, and welcome to Alligator Bioscience's third quarter 2021 interim call. This is Julie Silber, Senior Director of Communications and Investor Relations, and I will be introducing today's call. On the call with me today is CEO Søren Bregenholt and CFO Marie Svensson. After a brief company statement by management, we will open up the call for Q&A. Slide 2, please. Before we begin, I would like to share a quick reminder with our listeners that during today's call, management may make forward-looking statements that involve known and unknown risks, uncertainties, and other important factors beyond the company's control that could cause the company's actual results, performance, or achievements to be materially different from that expected results, performance, and achievements expressed or implied by such forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those contained in the forward-looking statement. Actual results and the timing of certain events may differ materially from the results or timing predicted or implied by such forward-looking statements, and reported results should not be considered as an indication of future performance. Please note that these forward-looking statements made during this call speak only as of today's date, and the company undertakes no obligation to update them to reflect subsequent events or circumstances other to the extent required by law. This call is being webcast and will also be made available through the investor relations website. With these formalities out of the way, I would like to turn the call now over to Søren. Søren, you can begin. Thank you, Julie. Good afternoon, and welcome to Alligator Bioscience third quarter call. I'm Søren Bregenholt, the CEO of Alligator Bioscience. Slide 3, please. Q3 was my 1st full quarter as CEO of Alligator Bioscience, and I would like to express my gratitude and thanks to not only the Alligator staff but also our investors and all the other stakeholders for the opportunity to get up to speed and for the continued support during this transitional phase of the company. Alligator has a dedicated, competent, and ambitious staff that shares the goal with me to make difference for patients suffering from hard-to-treat cancers. We started off the third quarter making great strides with a renewed aspiration and strategy to develop our game-changing therapies through phase II clinical development to proof of concept and potentially beyond. We are currently refocusing our company behind our key assets to be sure that we execute on our clinical trials to generate value in these key assets. Alligator has a robust and diversified best-in-class pipeline of second-generation agonistic antibodies that we developed for the treatment of hard-to-treat cancers. We also have a cutting-edge technology, which is reflected in our third generation platform, Neo-X-Prime. We believe this pipeline provides the company with a number of value drivers in the short, mid, and long term. Slide 3 shows the highlights for the quarter. I will give you, in the coming slides, more detail on these Q3 accomplishments. Slide 4, please. As I just said, we remain focused to invest and advance our key assets, mitazalimab and 1017. We continue to believe that we are well-positioned for future growth and value creation. Our antibodies address key immune activation pathways and are designed with optimal efficacy safety profiles, key features that make them complementary to existing cancer therapies. We therefore believe that our antibodies have a unique position as part of tomorrow's combination therapies, thereby helping patients, with hard-to-treat cancers, like for instance, pancreatic cancer. During the quarter, we announced a key milestone for mitazalimab as we dosed the first patient in OPTIMIZE-1. OPTIMIZE-1 is a phase II clinical trial where we evaluate mitazalimab in combination with FOLFIRINOX standard of care chemotherapy in first-line metastatic pancreatic cancer. This is definitely a major milestone for Alligator to be able to take mitazalimab, our CD40 agonistic antibody, into phase II. OPTIMIZE-1 is an open-label, multi-center study that will enroll up to 67 patients at clinical sites in Belgium and France. The trial reinforces our commitment to developing tumor-directed immuno-oncology drugs in solid tumors like pancreatic cancer. We expect to read out interim safety data in Q1 2022, and we expect to provide an interim efficacy readout from the trial in Q4, also 2022. Slide 5, please. To give you a brief update on our second asset, 1017, which is a 4-1BB second generation agonistic antibody. In June, we reported the reassuring mechanism of action and safety data from the ongoing phase I study. We continue to dose escalate in this trial to find the optimal phase II dose, and we expect to report data from the phase I trial during Q1 2022. Slide 6, please. I would also like to provide a short update on our candidate drug, ALG.APV-527 or just 527, which is a bispecific antibody targeting both 4-1BB and the tumor-associated antigen 5T4. This molecule is co-developed with our partner Aptevo Therapeutics in the U.S., we are preparing for clinical trials, phase I, and expect to file an IND application with the U.S. FDA during the fourth quarter of 2021. Slide 7, please. During Q3, we announced the conclusion of our collaboration with Scandion Oncology. We reported from the trial positive results of the ability of mitazalimab to enhance chemotherapy treatment, even in chemotherapy-resistant tumor cell lines. Data that further supports the effort to assess the efficacy of mitazalimab in combination with chemotherapy, like fluorouracil, as we are exactly doing in OPTIMIZE-1, the phase II study that I described previously. Slide 8, please. In August, we entered into a research and collaboration and licensing agreement with Finnish biopharma company Orion Corporation, to discover novel bispecific antibodies against the undisclosed immuno-oncology targets. The agreement covers, in addition to the initial project, an option for two additional projects, and under the agreement, Alligator Bioscience will employ our proprietary phage display technologies as well as our proprietary RUBY bispecific format. During the initial research period of the collaboration, Alligator will receive upfront payments, research support payments, and additionally, as part of the agreement, Alligator Bioscience is eligible to development, approval, and sales milestones and royalties. The milestones and fees sum up to a total of EUR 169 million in addition to the royalties. Before we go into the financials, I'm also proud to report that at the end of September this year, Alligator was awarded the prize for the best small cap annual report by FRR Nasdaq Stockholm, Sweden's Financial Analytics Association, and the Sweden's Communication Association. This is, of course, a testimony not only to the diligence and professionalism of our financial team but the dedication shared by the entire team at Alligator. With that, I think it's very appropriate that I let Marie review our financial results. Marie, over to you. Thank you, Søren. Now move to slide 9. I will begin with a review of our third quarter 2021 financial results. Net sales for the third quarter amounted to SEK 3.3 million, up from 0 sales in prior year period. This is a result of the research and license agreement we mentioned already with Orion and BioArctic. Operating loss for the quarter resulted in SEK 37.7 million, a slight increase from SEK 30.6 million in prior year period. This is due to a slight increase in personnel costs, but mainly to the ongoing clinical trial for mitazalimab in ATOR-1017. Cash flow for the quarter amounted to negative SEK 30.4 million compared to negative SEK 32.7 million in the prior year period. For the 9-month period, January to September, net sales amounted to SEK 7.4 million, up from SEK 4.4 million. The increase is due to the revenue from the research and the license agreement. Operating loss for the nine months resulted in SEK 104.7 million, a slightly down increase from SEK 110.2 million in the prior year period. Operating expenses during the first nine months consists mainly of external costs related to the ongoing phase I clinical study with ATOR-1017 and starting the clinical phase II study with mitazalimab. In total, around SEK 62 million. Personnel cost for the same period amounted to SEK 42 million. Cash flow for the first nine months amounted to negative SEK 24 million compared to SEK 42.6 million in the prior year period. This year, the main inflow of cash was coming from the right issue in beginning of 2021, and in 2020, from divesting of corporate bonds and interest funds. Move on to slide 10. As previously announced in the second quarter 2020, Alligator took a strategic decision to focus the company's resources on the projects that have the prospect of generating greatest value, our clinical program. The reduction in costs came into full effect in the third quarter 2020, which is reflected in the diagram to the left, showing total expenses on rolling 12-month basis. In the third quarter 2021, the company expenses increased slightly as we now are running two clinical programs, mitazalimab in phase II and ATOR-1017 in phase I. At the end of September 2021, Alligator's cash at hand amounted to SEK 79 million. In order to support the continued development of our key assets, the company is continuously working on opportunities for partnerships, out-licensing deals, and equity financing. In beginning of October, the company announced a fully guaranteed rights issue to be completed in November 2021 amounting to SEK 257 million before transaction costs. With this rights issue, the company's financial resources are sufficient for the planned activities for the upcoming 12 months. Now I hand over back to you, Søren. Thank you, Marie. If we could have slide 11, which is a recapitulation of Marie's comment that in the beginning of October, we decided to execute this fully guaranteed rights issue of shares with preferential rights for our existing shareholders of approximately SEK 257 million. If we move to the next slide, which must be slide 12. The intention of the company is to allocate the majority of the proceeds to continue to support our clinical development program of mitazalimab, expand and accelerate our program there, our ongoing OPTIMIZE-1 study, but also expand the program to include a second-generation for mitazalimab, a second indication for mitazalimab, the exact nature of which is currently being analyzed. In addition, we will allocate the funds to complete the ongoing phase I study with ATOR-1017 and prepare for phase II. Lastly, we will invest part of the proceed in advancing other pipeline candidates like our Neo-X-Prime platform and molecules. Before we head into the QA, let me just summarize that at Alligator we are committed to deliver on our vision of developing meaningful therapies for patients with hard-to-treat cancer. We do this through a continued focus on our key clinical programs and working with a dedicated team to provide benefits for the patients, thereby creating true value for these patients, for the company shareholders, including also our investors. With my first full quarter under the helm of this fantastic company, I continue to look forward to keeping you updated on Alligator's developments on the exciting journey ahead of us. On behalf of myself and the board of directors, I would like to take this opportunity to extend a sincere thank you to our staff for their achievements. I also want to thank you, the annual shareholders, for your continued confidence in the company. With those final words, I will turn the call over to the operator to open it for Q&A. Thank you. Thank you. If you do wish to ask a question, please press 01 on your telephone keypad. If you wish to withdraw your question, you may do so by pressing 02 to cancel. Once again, it is 01 on your telephone keypad to ask any questions. Our first question comes from the line of Richard Ramanius from Redeye. Please go ahead. Your line is open. Hello. Thank you for your presentation. I had 3 questions, 2 of them financial. Let's start. Yeah with the first question. Do you expect a meaningful revenue going forward? In connection to that, can you comment on any milestones from Henlius? Yeah. If we expect meaningful income in the company? We certainly do. We think we have three major opportunities in the midterm to generate income. Definitely mitazalimab. Once we are able to generate meaningful proof-of-concept data on mitazalimab, we believe that that is a prime candidate for a BD transaction, whether it will be mid or at the end of phase II, that remains to be seen. Once we have the complete data from our 1017 phase I trial in Q1 next year, we will assess our strategic options with that molecule, and one of them is definitely to get a partnership with an appropriate pharmaceutical company to develop the molecule and thereby also generate income for the company. Thirdly, we have high hopes in our Neo-X-Prime platform, where we have already a partnership with MacroGenics that is validating the platform and the opportunity to generate transactions, and we will pursue the opportunity there in the near and midterm to get partnerships and related income into the company. On your second question, Henlius entered into phase II. Under the current agreement, we will receive a part of the milestone payments at the completion of phase II that the Korean company AbClon will receive. That is a couple of years out in the future. Okay. Marie, do you have things to add here? No, I think it is fine. Yeah. I have some questions on the cost side of things. Do you expect costs to increase now that you will initiate more advanced clinical programs? Also, how did you calculate how much money to raise now that you're raising SEK 25 million? Do you have any clinical milestones in mind that it should last till, so to speak, that you can cover with this money? Yes. Of course, we would like to have some type of interim readout from mitazalimab for phase II study too. That's, of course, our main goal, to have sufficient capital to fund the company's activities to that. Yes, there will be an increase as we are enrolling patients in mitazalimab. Depending on how fast we can recruit patients, the cost can move. In general, we say it costs SEK 1.8 million per patient coming in the study. That's normally over a couple of years then. Okay. I was curious about the mitazalimab trial. If I understand it correctly, the readout will be an objective response rate in the fourth quarter last year. Will you continue the trial and watch over survival or other efficacy measures as well? Yeah. The trial will enroll a total of 67 patients. We expect our enrollment to be completed during 2023. We will, of course, continue to those patients that show a response and either have an objective response or stable disease as we should be doing in a phase II trial. Absolutely, yes. Okay. Thank you. Those were all my questions. Okay. Thank you. As we have no more questions registered, I'll hand back to our speakers. We will thank you for listening, and let's conclude the call. Thank you. Thank you. This now concludes our conference. Thank you for attending. You may now disconnect.
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