Yes. Thank you. Thank you, and welcome to this Q2 report call. If we go to the slide, Slide number 2, our forward looking statement. So in Slide 3, I'll take you through the significant events in Q2.
Most importantly, we at the ASCO meeting on June 4, presented new encouraging data from our 4 1BB agonistic antibody ATOR1017 showing solid proof of mechanism data combined with strong safety data really giving us a strong belief in the potential of this 2nd generation 4 1BB agonist in immuno oncology. We also recently presented preclinical collaboration data I'll preclinical data from our collaboration with the Skandion Oncology combining our CD40 agonist, the metoselumab with chemotherapy and the scandion agent in chemoresistant tumors. From Alligator's point of view, the most important data coming out of that study was evidence that mitralazimab also synergizes with chemotherapy even in chemotherapy resistant tumor cell lines in this preclinical model. Continuing on the mitasalumab, of our CD40 agonistic antibodies. We presented 2 papers during the quarter, 1 on preclinical data With the mitralizumab, again showing the synergy with other agents, again demonstrating the excellent combination properties of CD40 imidazalumab and then a peer reviewed review on the CD40 agonist class and It's promised as a future immuno oncology agent.
On the business development side, we presented our collaboration with the U. S. Based Microgenics aimed at exploiting our Neo X Prime platform to develop a bispecific antibodies against 2, at this point in time, undisclosed targets and that program is progressing according to plan. And during the quarter, we also presented and announced our research collaboration with BioArctic aiming at discovering antibodies in neurodegenerative space. On the company side, I Joined the company as CEO on June 1.
And also on June 1, Alligator has its Annual General Meeting and established a new Board of Directors with Anders Ekblom as reelected and elected as Chairman Hans Peter Osler, elected to the Board as Vice Chairman, reelection of Graham Dixon and then election of Roni Carvaline and Eva Seres to the Board. Then moving to the next slide, Slide number 4 in your deck, let me just spend 2 minutes on introducing myself. My name is Soren Reinhold. I'm a Danish national. Did my PhD at University of Copenhagen, Did my post doctoral training at the Pasteur Institute in Paris and has then for the last more than 20 years been holding various executive in International Biotech and Pharma, working in research, management, leadership in Business Development, Alliance Management and Strategy, most lately as CEO of U.
K.-basedmacrophage pharma. And as I said, I joined the company June 1. On Slide 5, you'll see an overview of our pipeline, and I thought it would be valuable just to reiterate that. As you can see, we are just on the brink of bringing our CD40 agonist mesothelumab into Phase II clinical trials. The OPTIMIZE-one file, which is expected to start any day now and definitely before the end of July.
2nd in line, we have 10/17, our 4 1BP monoclonal agonistic antibody. As I said before, we are in the late part of the Phase I dose escalation study, and we presented data at go on this molecule. The 3rd molecule in the pipeline slide here is 527, which we are co owning and co developing with the U. S.-based Aptivo. This is a bispecific antibody binding 4 1BB on one arm and 5 T4 tumor associated antigen at the second.
And together with Aptivo, we are getting ready to bring this T cell engager into Phase I clinical trials, and we are in the process of submitting that require regulatory documents. Then you will see an internal Neo X Prime molecule that we are taking forward. Neo X Prime is our 3rd generation proprietary immune therapy platform. Here the concept is that we with one set of the binding sites in gate CD40 on the dendritic cells and on the other antibody arm bind tumor associated antigens in order to both stimulate the MORI life function, antigen presenting function of dendritic cells in the tumor and at the same time bringing tumor specific antigens to the immune machinery, thereby stimulating the immune system in a patient specific way. The promise of this technology was validated in the quarter by the aforementioned collaboration agreement with MacroGenics, where we are moving ahead with a set of undisclosed targets.
And the company is really seeing a huge potential in Neo X Spline, both in order to build our internal pipeline in the future, but also for out license or partnered programs. And latest but not least, we have AC-one hundred and one, which is a HER2 specific monoclonal antibody that was originally out license to Aptone and is now being developed by Chinese Health Neoscience. And then we have a preclinical collaboration or out license program with the BioPhyris in China, targeting on disclosed EBITDA in a bispecific program. So now if we then Shift to the next slide, Slide 6. Mitofelumab, our CD40 agonist It's our most advanced program.
As I said, we expect to enter Phase II clinical trial in OPTIMIZE 1 later this month. OPTIMIZE 1 is going to assess the efficacy and safety of mitralumab in combination with the standard of care chemotherapy for Forinox in pancreatic cancer. The molecule, as you know, has been in Phase I clinical trials showing signs of efficacy, have proved mechanism of action and also showed a very promising safety profile. And we are going to utilize that proactively in OPTIMIZE-one design being able to dose more frequently and also at higher doses in this indication compared to other CD40 agonists. As I said, the CTA is approved both in France and Belgium, and we expect the first patient in the study by the end of July this year, so this month.
We are, at the same time, looking at to fine tune the regulatory strategy for mitralizumab, and we are also in the process of assessing Potential secondary indications for the antibody to balance out the risk in the portfolio and also optimize the value of the molecule in the future. 10/17, our 4 1BB agonist, is again a very promising molecule, IO specific target on T cells and the mechanism of action includes extended durability of T cell responses. The 4 1BB anti agonistic antibodies have been marred by high bad toxicity profiles. We believe with 10/17 that we have found the right balance between efficacy and safety, allowing us to develop this as a very potent agonistic antibody, either in combination with chemotherapy or more likely with PD-one molecules. The promise of the molecule was reiterated by the data that we showed in at ASCO with very good tolerability and favorable PK profile, together with the biomarker data demonstrating the proof of mechanism through T cell activation as you would expect for a molecule like 2017.
Dose escalation is continuing. The company is committed to find the highest possible dose for 1017 to go into Phase II clinical trials to really optimize the change of success for the molecule in that Phase II trial. And as the slide says, Phase 2 preparations are ongoing. The next slide on Neo Fine. Let's just to reiterate that this is our 3rd generation innovative new therapy concepts.
We are developing our own internal program, as I just said, and we are moving ahead with our collaboration with MacroGenics, and that is progressing according to plan. And just to reiterate, we see a strong potential for building both a proprietary and partner pipeline. And with these words, I will give the word to you, Marie.
Okay. Thank you. So next slide, Slide number 9 then. The net sales for the first 6 months amounted to SEK 4,400,000, which pertain primarily to the license agreement with the BioSears and the joint research agreement with the Biarctic. Operating expenses during the 1st 6 months cost is mainly cost related to the ongoing Phase 1 clinical study with 10/17 and startup of the clinical Phase 2 study with metasalumab in total around SEK 38,000,000.
Personnel costs for the same period summarize to €28,000,000 In total, operating loss for the quarter amounted to €34,500,000 €67,000,000 for the 1st 2 quarters. Cash flow for the quarter amounted to negative €34,000,000 But due to the write issue in January, we had a positive cash flow for the 1st two quarters at €6,400,000. Slide number 10. Investors that follow-up might remember that during Q2 2020, Allegheny took a strategic decision to focus company's resources on the projects that have the prospects of generating the greatest value of our clinical programs. The reduction in cost came into full effect in the Q3 2020, which is reflected in the diagram to the left showing total expenses within 12 months.
At the end of June, allocated cash at hand amounted to SEK 110,000,000. It's our assessment that the financial resources are sufficient for the upcoming 12 months. In order to support the continued development of our key assets, Yes. That was my part.
Thank you, Marie. And before we'll open up the Q and A session, I'll just reiterate that the new management is assessing, of course, the company's strategy on especially how to advance in the most optimal way our clinical assets. And we are also in process of strengthening the organization to ensure the right operational capabilities in taking our molecules into Phase II clinical development. And with this, I think it's prudent to open the session for Q and A.
Thank We have one question from the line of Jacob Munkael from Kempen. Please go ahead.
Hi, there. Thank you for taking my question. Are you able to hear me?
Absolutely.
Yes. Okay. Thank you. So is it possible for you to provide more granular guidance on your cash runway and expenses Page 2?
Marie? Yes. I'm sorry. Can you repeat the question?
Yes, sure. So is it possible to provide more granular guidance on your expected cash runway and operating expenses for H2? Should we expect the latest to be in line with H1?
Do you say Phase 1 or Phase 2 for is it meet Yes.
I think you can expect The Q3 cash burn should be approximately as you have in Q2. Right, Marie?
Yes, yes, yes. It is. It depends on, Of course, where we are in the clinical programs. And I would say that We don't put that much money in 10, 15 right now. And so that will lower the cost.
But on the other hand, I think NIIPA will pick up a bit. So but in general, I would say more or less the same. Then for longer term, it's up to where we where Would we like to go with 10/17 after the Phase 1? So that will be for the next year to decide and how to move forward there and what kind of expenses that will come with?
Okay. Thank you. That's all clear. On 10/17, actually, I'm just curious about your current thinking for the Phase Q design. Have you given us some thoughts?
And what are you thinking to do?
Yes. I think that is a very good question. What I can tell you is that we are I mean, I've been now 42 days or something in the company. And one of the things that we have Started to take a deeper dive in is the clinical regulatory strategy for each of our programs. So this work is ongoing.
It's ongoing with key opinion leaders and external experts in the field together with our internal team. And I think it would be better to have this discussion maybe in the beginning of September when the team have had a chance to look at all the data and look at the I mean, the plan is now to continue dosing in Phase 1 to give us a clue of the most or sort of concern the most optimal dose for Phase 2. And alongside with that, they're moving into the protocol for the Phase 2 study, including also the specific indication that we wish to target there. So I think we'll have to defer that discussion a month or so.
Okay. Nice. Thank you. That's good to hear. Okay.
That is it from me. Thank you. Thank you very much for answering.
And the next question comes from the line of Patrick Linge from DNB Markets. Please go ahead.
Thank you, guys. Can you hear me? Yes. Great. First question, regarding Optimize One, you said that we could expect or you wrote that in the report that we could expect some interim data in the second half of this year.
Could you just elaborate a little bit on what we could expect there? Will it be safety only? Or Will you have some other data for us? So that is an excellent question, yes. So the study is Designed with safety run-in testing 609 100 milligrams of metasalumab on top of fafarinox.
And once safety have been established, we will then move into the sort of the proper part of the Phase 2 study. So these are the data from the safety run-in that we expect to be able to present by the end of the year. So that will be safety. Pancreatic cancer It's an RP disease with pretty short survival rates. We may be able to, if I'm the equivalent like that, benefit from that in Optimize 1 by maybe having some early signs of efficacy by the end of the year.
But I would probably keep just expecting safety data by the end of the year. Okay. And just remind me about the design here. If both doses, both 600 milligram looks good, will you proceed with a higher dose than in the rest of the Phase That would if they are equal, that will always be my recommendation as we want to push as much efficacy on within the safety window that we have. Okay, great.
Then my second question is maybe a little bit broader. I mean, If you could give us some of the highlights from your point of view after your first 42 days now as CEO, what has been sort of the positive surprises coming into Alligator? What has been maybe the not so positive? Are there things that you would like to change in the way that the company have operated before, processes, anything like that? Is there anything that you can give us some flavor on?
Yes, absolutely. Absolutely. So first of all, I have been and I knew that before joining. I think mitaxelomab is a promising program. It has what you can expect from a moelite The agonist tested in a single agent study.
It has signs of on the efficacy, it has a proven mechanism, it has a good tolerability profile and relatively large database, which sort of gives us a good foundation to move that study into or that molecule into Phase 2. 10/17 has also been a pleasant surprise. I We're sort of lucky to be able to announce the ASCO data after just 4 days in the seat. I think there's great promise there. NeoH Prime is really, really interesting.
I think that now having a more light engager rather than a T cell engager actually could add a new sort of perspective or a new angle to the IO toolbox in the years to come. I have been extremely sort of simply surprised by the spirit and the engagement of both employees. So I would say all the basics, they are right. I think what my some of my answers to the previous questions about clinical strategies And regulatory strategy, I think Alligator going forward needs to be focused on moving our prioritized assets faster through clinical development, getting us to efficacy readouts within sort of a more biotech like horizon. So we are working with that, and we need to be more engaged in our dialogues with regulators to allow us to navigate towards these efficacy points as good as possible.
And I think one of the things that and you can say whether it's a criticism or whether it's just sort of a reflection of the world that we live in and what we have seen from the pandemic is that the alligator We'll need to and is already working to expand our sort of talent base. We need to be able to recruit, attract and retain experts from outside the region, from outside Sweden and potentially also from outside Europe to be able to be on both on the technology forefront, to remain on the technology forefront and also become at the forefront of IO Block Development. So that was sort of a couple of perspectives there. And I mean, please feel free if you have specifics that you want to interrogate here. No, I was just curious because sometimes, I mean, I would assume that if you compare mitasalumab with they are, I wouldn't say cutting corners, but they are maybe prioritizing in a different way than what a big pharma company do.
So if you think that there are items that might be missing from the preclinical package or if there are items that have been done that might be not necessary to be doing in the future. But I think that you as a company have to be sort of finding the right balance between what resources and the time you have and sort of the, what can we say, the certainty by which you are moving forward. Having worked in both biotecs like SYMPEGEN and also in big companies like Novo Nordisk. I can see that there are big differences here between how you approach this. And I think we are going to find the right balance in Alligator.
And going back to your comment about mitralazimab having been in the hands of Johnson and Johnson, I definitely don't think that is a bad thing. I think mitralumab has the virtues of an antibody that should be developed. It needs to be given the right change in the right setting, and we're doing that now in Optimize 1, and I think that molecule has great potential. Okay, great. Good to hear.
And I didn't mean it as something negative rather than obviously no, no, no, no, but the 2nd question has been in the hands of a big pharma company. Great. Thank you. You're welcome. Okay.
Thank you. That's all for me. Thanks.
And we have one more audio question from the line of Niklas Elenhamer from Redeye. Please go ahead.
Hi, Niklas. Hi, good afternoon. Thank you. I have a question regarding TAN17. You said that you're looking for the highest Possible dose, sir.
Is it possible to comment on what dose levels you're investigating currently and sort of the timeline for Completing the Phase 1? Yes. You mentioned that. Yes. So you could say we are currently dosing patients at 360 milligrams, The dose that we reported on at ASCO was 200.
We have now had dosed all patients in 360. And if the safety committee or the data review committee allows us to continue. We will then initiate the 600 milligram dose and expect to start dosing patients in August for the 600 milligram dose. And then Once we have the data the safety excuse me, once we have the safety data From that cohort, we will reassess our strategic opportunities, whether we see signs that this is the dose or whether we will have to continue to the next dose level. And I think going back to the previous question, this is an important point.
For me, oncology drug development is about pushing as much efficacy out of the molecule for within sort of the limits of manageable safety. So stopping now at 360 and move fast into Phase 2 Could have been a corner that you might that might be tempting to cut, but that's not a mistake that we are going to do in Alligator. We are going to dose at least to 600 and potentially also to 900. But that 900 dose will, of course, depend on what we see with 600,000,000 and 600,000,000 will depend on the data review committee's recommendation, I guess, the next week of July. Okay.
Great. Thank you. And regarding Nuex Prime and the collaboration with MacroGenics. If you could comment on sort of activities right now? What is the next development step you see here?
So I mean, it's still early days. I think the next year will be sort of a discovery type collaboration, combining I mean, finding the binders, identifying the binders, identifying the right combination of binders to get the nation of binders to get the right affinity of the bispecific and then start validating in vitro and maybe towards the end of the period, also early in vivo studies to validate the molecule. But it's early days. Yes. Okay.
I understand. And then finally, a little bit about striking the balance between you. You have a strong research team and And also you're pushing ahead in the clinic. So are you happy with the balance in the organization and given Sort of always limited resources or how do you say That's a very important question. You can say, if you look at it from a scientific point of view, all the exciting stuff might be the one that's going on in Discovery, and you might have a natural tendency to sort of overload that with resources.
I think that the alligator needs its discovery. We need to focus on exploiting NeoX prime, extraordinary the biology that we can address by this platform. There are many tumor associated antigens that will allow us to develop targeted therapies in the future. Having a platform is also very expensive, and I guess that's what you're alluding to. And the plan here is to While we will likely to take proprietary molecules forward in the years to come, We are also in the process, in the continuous process of negotiating potential collaborations with companies like Microgenics and others to sort of build a partnered and licensed pipeline for the future.
But there are no plans to cut the discovery part of Alligator. I just want to reemphasize that. Okay, great. That's clear. And thank you and Thank you.
I hope you have a great quarter. Thank you. Thank you. Q2.
And as there are no further questions, I'll hand it back to the speakers.
Yes. So thank you. This concludes our Q2 report call. It's been a pleasure. Thank you for all the engaged, insightful and interesting questions.
And I look forward to further interactions and our next call. So thank you and have a Good day and good summer as yes. Thank you.
Thank you.