Hello and welcome to BioInvent's Q3 report 2022. Throughout the call, all participants will be on listen only mode, and afterwards there will be an opportunity to ask questions. If you have any questions, please press zero one on your telephone keypad. Today I am pleased to present CEO Martin Welschof and CFO Stefan Ericsson. Please go ahead.
Thank you very much and welcome everybody to our call. I will jump right into the presentation. On Slide three, we have summarized the events during the third quarter, and we had actually quite some things. We did successfully a direct share issue of approximately SEK 300 million. We added two new members to the board, Natalie Berner of Redmile and Nanna Lüneborg from Forbion. They were elected as new board members of BioInvent. We received also an upfront payment of $25 million from the option and license agreement with Exelixis. We pushed ahead with our clinical program. We have the first patient enrolled in the phase 1/2a evaluating our second anti-FcγRIIB 1607 for the treatment of HER2-positive solid tumors.
We also completed as planned the dose escalation in the phase 1/2 a trial of BI-1808, which is our first and lead antibody against TNF receptor two. We test this in advanced malignancies. We're very happy that we could move ahead with our first patient of BI-1206 in China. Together with our collaborator, CASI Pharmaceuticals, we basically started the clinical trial focusing on relapsed and refractory non-Hodgkin lymphoma in China. On the following slides, I will basically cover the programs, give you a short status, and then at the end also an outlook of the news flow to come. Our lead is BI-1206, which we're developing for the treatment of non-Hodgkin lymphoma and solid tumors.
We try to reestablish the clinical effect of existing cancer treatments such as rituximab for non-Hodgkin lymphoma and pembrolizumab for solid cancers. We have two separate clinical phase 1/2a trials ongoing. One for non-Hodgkin and then the other one for a number of different solid tumors. In the boxes at the bottom of the slide, you see the current status. With BI-1206 in non-Hodgkin lymphoma, we had first positive data during the dose escalation. Now we'll come back to that a little bit more in detail later. We're now moving into the expansion phase. For BI-1206 in solid tumors in combination with pembrolizumab, we obtained early signs of efficacy during the dose escalation and the dose escalation study is still ongoing.
On this Slide five , we have then summarized the status of BI-1206 in non-Hodgkin lymphoma. That's based on the readout of Q4 2021. The combination with rituximab has demonstrated a nice objective response above 50%. We are particularly proud or excited, I should say, about the complete responses that we've seen. We've seen three complete responses, four partial responses, and especially the complete responses are very long-lasting, high-quality complete responses. As you can see here, we have long-lasting complete response beyond 12 months, 24 months and 36 months in three patients, which means for the longer complete response, it is two years after the end of treatment with BI-1206 in combination with rituximab, which is very exciting.
Those patients obviously, needless to say, had progressed after previous rituximab-containing treatments, without BI-1206. In addition, BI-1206 has a very good safety profile. We position it as a chemo-free therapy, and, you know, targeting a patient with high unmet need that would not tolerate any toxicity. We had some infusion-related reactions, but we could manage them with a novel steroid regimen that we have developed at BioInvent. All in all, we can say that BI-1206 shows a highly promising response rate in patients with a high medical need. Here on this slide you see the key milestones listed. We have selected the dose for part 2. We had a successful constructive end of phase 1 meeting with the FDA.
As already mentioned, we have started things with China on our global clinical development strategy, and that is also running quite well. On the lower part you see what is next, and I didn't mention it on the summary slide. We have started actually early last year to develop our own subcutaneous formulation for BI-1206, and that is ready now to go into the clinic during the end of this year. A quick summary also for BI-1206 in solid tumors. Based on the latest readout Q4 2021. As I already mentioned, we had early observations that we may reverse metastatic disease progression in patients who have previously progressed on PD-1 and PD-L1 containing therapies.
So far we had 11 patients in three dose cohorts that we have treated with BI-1206 in combination with pembrolizumab, and we have observed positive responses in two patients. Here also, we had to control the infusion-related reactions, but other than that we didn't have any major safety concerns and the dose escalation will continue. The current patient cohort is dosed at 2 mg per kg. At the bottom, on the bottom of this slide, you see what is next. Obviously, we are about to determine the recommended phase 2 dose, and then we'll also introduce the subcutaneous formulation, and that will happen first half of next year. I would like to cover briefly our second anti-FcγRIIB antibody, which is BI-1607.
We are going to develop or have started to develop this for the treatment of solid tumors. The difference between BI-1607 and BI-1206 is basically that, BI-1607 has been engineered for reduced Fc binding, which results in a different mode of action. The first-in-human clinical trial, a phase 1/2a study, is ongoing since July this year. Part 1 of the study will evaluate BI-1607 in combination with trastuzumab for the treatment of HER2-positive advanced or metastatic solid tumors. The phase 1 part will run in Spain, U.K., Germany, and the U.S. During the phase 2a part, we aim to recruit about 30 patients in 2 cohorts, 15 patients each. 1 cohort in breast and 1 cohort in gastric and gastroesophageal cancer.
This has been started this summer and is ongoing and it's recruiting very well. Coming to BI-1808, which is our lead anti-TNFR2 antibody for the treatment of different solid cancers and one actually a liquid cancer as well. As you might remember, since we observed a strong single-agent activity, but also very good synergies between BI-1808 and pembrolizumab, we are testing both. On the left-hand side, you see the dose escalation part A, which has been finished 25 up to 675 mg. Where we have tested BI-1808 as a single agent, and we have decided, now we'll have a summary on the next slide. We'll move one higher dose, and I'll come back to that.
Once we have finished the dose escalation for the complete dose escalation for part A, we'll move into the expansion, and there we will focus on non-small cell lung cancer, ovarian cancer and CTCL, which is a rare T-cell lymphoma. We have kicked off already the dose escalation for part B, the combination with pembrolizumab, and that will be then tested in those two different dose expansion cohorts, one for non-small cell lung cancer and the other one for ovarian cancer. Here you see the summary, and that's based on the latest readout Q3 this year. As I already mentioned on the previous slide, the single-agent dose escalation has been completed. We could show that BI-1808 is safe, well-tolerated, no serious adverse events.
Since we have this very positive safety and tolerability profile, we will explore higher doses and the next dose level is 1,000 mg, as already indicated on the previous slide. During the dose escalation, we have seen three disease stabilizations, and we have a very nice correlation between dose, receptor occupancy, and soluble TNFR2 in patients in the ongoing phase 1/2a clinical trial. The cohorts to explore potential synergistic activity in combination with Keytruda pembrolizumab is now enrolling patients as already mentioned. The next step here would be to determine the recommended phase 2 dose as a single agent as well as a combination. Last but not least, BT-001, which is our 50/50 joint venture with Transgene.
This is the oncolytic virus armed with anti-CTLA-4, and the virus platform is from Transgene, and the anti-CTLA-4 antibody is our proprietary anti-CTLA-4 antibody. We're currently in part A, where we test single agent BT-001 intratumoral administration at ascending doses. I come back to the data, the summary of the data a little bit later on the next slide. Once we have done that, we go into part B, which is the intratumoral administration combination with pembrolizumab. The summary. In June this year, we announced good progress and safety data in the ongoing trial evaluating BT-001 in patients with solid tumors, including melanoma.
The initial data from the phase 1 part A has demonstrated that BT-001 alone is well tolerated with first signs of antitumor activity in a hard-to-treat population and confirmed the mechanism of action of BT-001 as a single agent. The initial findings are as follows. We could detect the virus in the tumor several days after administration, which suggests that BT-001 is able to persist and replicate within tumors. The expression of anti-CTLA-4 observed in the tumor with no detectable systemic exposure, and that's exactly what we wanted. That's why we went for this approach because we wanted to have a high concentration of anti-CTLA-4 only in the solid tumor environment but not in the blood.
We didn't see any spreading in blood or biological fluids, and which suggests indeed a high tumor specificity, as I already have said. We observed a tumor shrinkage in one of the patients in the first cohort. The next steps are to complete this part A, which is the single agent dose escalation of the phase 1 and then move to this phase 1 part B, which then would be the combination of BT-001 with pembrolizumab. I think those were the overviews that I wanted to provide, and I'll hand over to Stefan to go briefly over the financials.
Thanks. I will present the financial overview for Q3 and the nine months period, January to September. All amounts are in SEK million unless otherwise stated. Net sales were SEK 17.9 million in Q3 2022, compared to SEK 3 million in Q3 2021. That's SEK 15 million higher in 2022. The increase is related to that, revenues from production of antibodies for customers was SEK 11 million higher in 2022. Also, we had research funding in 2022, SEK 4 million. Net sales for January to September 2022 were SEK 305.5 million. For the same period in 2021, we had net sales of SEK 14.5 million. That's an increase of SEK 291 million.
That increase is related to that we in 2022 received an upfront payment of $25 million when we signed an agreement with Exelixis. We also received a EUR 0.5 million milestone from Bayer. The increase in 2022 is also related to that revenue from production of antibodies for customers. That was SEK 26 million higher, and we also had some research funding. When it comes to operating costs, they increased from SEK 65.4 million in Q3 2021 to SEK 87.1 million in Q3 2022. That's an increase of SEK 22 million. We had quite higher costs in BI-1910 and somewhat higher costs in BI-1206, and also somewhat higher costs for production of antibodies for customers. We had quite higher costs for personnel costs.
For January to September, the increase of operating costs was SEK 63 million, from SEK 214 million to SEK 277 million. During the period, we had quite higher costs in BI-1910, BI-1607, and also higher costs for production of antibodies for customers. We also had somewhat higher costs in BI-1808. We had quite lower costs in BI-1206. Found that personnel costs were quite higher compared to 2021. The loss for Q3 2022 was -SEK 63.9 million, and we had a profit for January to September 2022 of SEK 35.8 million. The share issue completed in July amounted to SEK 299 million before issue costs.
Finally, liquid funds, current and long-term investments, end of September amounted to in total SEK 1,664 million. That was my summary.
Thank you, Stefan. I would like to end the presentation with a brief overview regarding the key milestones for next year. I will start from the top. Basically what will happen during the first half of 2023. First of all, BI-1206 plus rituximab will have preliminary results from the phase 1 subcutaneous. Then also during the first half of 2023, we'll start the phase 1 subcutaneous for BI-1206 in combination with pembrolizumab. Also during the first half of next year, BI-1808 as a single agent, we'll have first results there as well. We will kick off BT-001, the combination with Keytruda that will also happen first half of next year.
During the second half, we have three key milestones. One is BI-1808 plus pembro, preliminary results of the phase 1. Then also preliminary results of the phase 1 for BI-1607 plus dostarlimab. Last but not least, we'll also kick off our second anti-TNFR2, which is BI-1910. That will also start or happen during the second half of next year, which will be the initiation of the phase 1/2a clinical trial. I will end my presentation here and give back to the operator or hand back to the operator for questions. Thank you very much.
Thank you. Ladies and gentlemen, if you do wish to ask a question, please press zero one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two to cancel. Our first question comes from the line of Richard Ramanius from Redeye. Please go ahead. Your line is now open.
Good afternoon. I had a first question about recruitment. Do you have any issues with the recruitment rate or everything going smooth? Or do you see any difference in interest between your indications?
In principle. Hi, Richard. In principle, I would say recruitment is going well according to, you know, the area. As you could see, for instance, for BI-1808 there we exactly finished the dose escalation as planned, no problems at all. For BI-1206 we had, you know, a little bit of a delay because it is a much more competitive area and there is a lot of late-stage clinical development, specifically for non-Hodgkin lymphoma, not so much for the solid cancer ongoing. That could impact or have an impact on your recruitment. I would say all in all, so far for the different clinical programs recruitment is going as planned, more or less.
I was also thinking about your subcutaneous formulation. Could you tell us how the regulatory development looks like? How will it be used with the intravenous formulation?
Basically, what we're doing, as I said in my presentation, we will introduce, or we'll start clinical development for the subcu this year. It will be a very short dose escalation. We have discussed obviously with the regulatory authorities, there should be no problem. We've got only positive feedback. As mentioned on the news flow slide, it will, you know, start to produce data already during next year for the non-Hodgkin lymphoma. We will update the markets about this. That was during the first half. You know, we'll start a little bit later with solid cancer. Obviously, the combination for the non-Hodgkin lymphoma is rather simple because rituximab and probably also other versions of anti-CD20 are available subcutaneously.
Since we developed it in combination with rituximab, we will use rituximab obviously. For the solid cancer, I know that there's also, you know, that has been started to develop a subcu for pembrolizumab. Once this is available, we'll combine those two. Of course, this is much easier. First of all, we do this for two reasons. First of all, I think it's a much better product because you're independent from infusion centers. Secondly, since we have seen preclinically, we might eliminate the steroid treatment that we have implemented in order to control the infusion-related reactions with the IV. Because preclinically, we see that we probably don't need it for subcu, and that would of course make life much easier and much more convenient.
Okay. Makes sense. The last question also about BI-1206. Can you give any more details about the phase 2 design that you discussed with the FDA?
Well, we didn't disclose anything yet, so there will be when we come out with the update, that will be early next year or during the first half of next year, I should say. Not early next year, during the first half of next year, we'll provide some more details.
Okay, thanks.
Thank you. Just as a reminder, if you do wish to ask a question, please press zero one on your telephone keypad. Our next question comes from the line of Dan Akschuti from Pareto Securities. Please go ahead. Your line is now open.
Hi, Martin. Thank you for taking the questions. One more general question is that we see that in general, in the development of immunology drugs, the kind of new companies like yours need to enroll the very late patients that have been pretreated massively as well, and that have obviously their immune system is not as functional as earlier patients. Considering the mild safety profile that you demonstrated for BI-1206 and also now BI-1607 and BI-1808, is there any possibility that we could get to earlier lines of treatments already at this stage, and with that probably also increase the chance for better responses.
Thank you, Dan. That's obviously, you know, for, as you say, for all the developers of cancer agents in immunotherapy, it's for all the same. This would kind of address a little bit the neoadjuvant situation. The only thing that I can say today is that we are considering it, that we're discussing it. Of course, you know, in order to make sure that we get patients where we have a higher chance of success. Currently, of course, we have to follow the same rules as everybody else. As we could see also with the solid cancer, you know, BI-1206 in combination with pembrolizumab, we have only seen first responses.
Even though those are patients that are very, very late lines of both responses that we're seeing there, where these have received two or three lines of anti-PD-1 or anti-PD-L1 containing regimens. We're aware about it, and we are considering it. We are discussing it. That's the only thing that I can say at the moment.
Okay. Thank you. Of course, very interesting if you have any update on that situation later on. This would be if the market is informed about that. Another question would be, so we got these responses from twenty-one December there in solid tumors as well as non-Hodgkin lymphoma. Can we expect a follow-up of at least those patients? I'm aware that you're switching to a more competitive formulation with the subcu. But the patients that you treated already, could we expect a follow-up on the R&D day on the eighth of December?
Yeah. We're currently putting all the data slides together for the R&D day. In case you know the analysis is complete, then we can share it. But at the latest we were thinking that we share it also when we come out with the results of the subcu. We're looking into this. You know, what we always try to do is to have complete data sets and rather than just preliminary data. That could be potentially a possibility that we give some updates on the R&D day. Absolutely.
Okay. Thank you very much. That was all from my side. Thank you. Bye.
Thank you. As there are currently no further questions, I will hand the word back to the speakers. Please go ahead.
Yeah. Thank you very much. I think, there's not so much more to say from my end. I think, BioInvent is at a very interesting point of its development. Obviously we're well-funded, so there's almost no financial risk. I think we're kind of distinct in that sense that we not only have one or maybe two programs, but we have now five programs with four different compounds, and then, hopefully next year, six programs with five different compounds. We all know the inherent risk of translating new mode of action into the clinic. It doesn't translate one to one, but we have done very careful preclinical development and characterization. Also the portfolio aspect, of course, is de-risking to a certain degree.
What I always say that obviously the first platform still runs in the back. So we, as we speak, are also developing new compounds that hopefully at some time point will go into the clinic. So as I said, I think it's a very interesting and very unique combination combined with a very solid financing. And those are kind of my final words. So in case there not any further questions, I think we can conclude the call.
This now concludes today's conference call. Thank you all for attending. You may now disconnect your line.