Thank you for joining this 2022 presentation. I'm Ludvik Sandnes, and I will, on behalf of the former board of directors and the CEO, explain what happened last year. They had a very active year with 27 board meetings. My presentation will be recorded, so I therefore only take questions at the end. I hope the details given in this presentation will answer most of the questions you might have.
As an update, last year became an annus horribilis for Nordic Nanovector. Betalutin PARADIGME had to be discontinued, as you know, due to continued severe difficulties in the enrolling of patients, the impact of COVID-19 as for many other studies, disappointing regulatory feasibility evaluation and poor efficacy data. Below threshold values set for the study and non-competitive profile in a crowded market going forward.
Independent review concluded that the efficacy data would not give Betalutin a competitive profile in third line follicular lymphoma. The company restructured was initiated in the second half and nearly finalized before the year ran, and it's all taken care of in the accounts, which I will show you later on. Carnegie has explored strategic options, but the APIM merger deal was declined, as you know, at the EGM on the first of December. The cash at the end of the year was NOK 98.7 million, but the free cash going forward is around NOK 60 million and will last into 2024. I need to talk a little bit about the history of PARADIGME, and I hope you will appreciate the line of details that we have presented in this, in this, presentation.
There was an optimistic sentiment since 2020 based on LYMRIT 37-01, the phase I,II-A clinical trial. The part one I will show you later down on the page. On 1st April 2020, the new strategy was announced. All focus was directed on PARADIGME. The type C meeting was requested with the FDA. Protocol was amended to broaden the inclusion criteria and help enrollment, staff was to be reduced by 20%. They were cost-conscious at that time too. On 29th June the FDA grants a fast track for marginal zone lymphoma, MZL for patients, which was an optimistic in-input. On August 6, interim analysis recommended one arm, 40/15 dose, that's then to become the PARADIGME study.
The board of directors was encouraged by the response data at the time, and it was optimistic that the enrollment rate would increase. On the 3rd of September, same year, Arne Kolstad presented Part A trial publications. That was the 1st part, as you remember. The efficacy rates were fantastic, 61 and 30, as you can see on the screen here. The medium duration was 13.6 months. 18th of February, the year after, significant increase in recruitment was reported. I will for the 1st time show you the recruitment rates on the next page. You will see here how Part B and C of the patient accrual from January 2020 to July, when it was stopped last year.
Part A, the Arne Kolstad figures, was ceased recruitment in February 2018, so his publication was announced later on with those good results. If you look at these curves, the mid one is actually the PARADIGME with the 40/15. You can see here how it increased after the when it says V 14 up there was approved. That was the 14th amendment of the protocol, which was accepted by the FDA and the other governments agencies. The enrollment picked up. Even at the 15th, at a later stage, it also kind of increased. The top line is, as you will see from the ledger, how it was the total number of patients were included.
It was actually the mid one, the green in the middle, who is the PARADIGME study with 72 patients at the end there. At the far bottom, you can see how they tried actually at the time to include other groups of patients, but they didn't succeed in recruitment. That was very flat in those part C populations, which were maybe more fragile older patients. That was part of the, kind of the end game in order to receive an approval. They had to try to move over in that kind of type of patients because of the competition, which you will see on the next page. Here, when I was responsible in 2015 as chairman to take the company to the stock exchange, in the prospectus, there were four approved products.
In the prospectus you saw, last year in 2022, there were 15 or 16 and including the last one there, who was approved in June 2022, with a complete response rate of 60%. No doubt, the competition had increased over the last quite few years actually. I've also looked at the FDA interaction for PARADIGME. I know many of you are very concerned about how the interaction went on and if things could have been different. As you see here, in March, FDA recommended a randomized controlled trial adequate to characterize the efficacy and safety of Betalutin. In September 2017, comparative study design was accepted. Sustainability of results and accelerated approval will depend on available therapy at the time of application. Yes, it will always depend on other available therapy, of course, the competition.
June 2020, as late as that, there was a change in the independent pre-assessment planning accepted. Regional trials for phase III required maybe SS 2 to progression-free survival. Prior to this, the very pre-treated patients that was also accepted. That's what you saw on the curves where they tried to include other types of patients to pick up the enrollment. As late as March 2021, Nano board was very encouraged by the results and still hoped to get a breakthrough therapy designation, but was told by the FDA that the bar is very high in terms of efficacy than the requirements for a potential accelerated approval, which they hoped for would come later.
For BDA, the drug need to be kind of landscape changing. FDA give feedback that they acknowledged the single administration, the toxicity profile, the activity in double refractory patients, and found that encouraging, and gave us positive feedback that regardless of BTD, the agency was willing to support the drug and provide more frequent guidance to help us move forward in the program. As late as that, kind of positive news, of course, competition was increasing.
A summary of this independent traffic light assessment, which was made by the board last spring, there were 61 patients who received the 40/15 dose. That's on the, on the mid graph you saw. They were included in this analysis. 19 of those patients had an objective response at three months of. with an overall response rate of only 31.1%, the median duration was 6.4 months. nine out of the 61 had a complete response of only 14.8%, and the median response complete was 8.5 months.
The study met, therefore, one of the so-called red light criteria, which has been put up, and where the complete rate was below the 25%, which they'd set up as a threshold, and the duration of response 8.5 compared to nine months. It appears highly unlikely, it says in the report, that the criteria for one green light, where they could move on with a benefit risk ratio of 40- 55 and a complete rate between 25% and 35% and duration of response 8-10 months would be achieved in the future.
It was highly unlikely because you would need then to see the 17th responders out of the remaining 26 patients would have to be an overall response rate of 65%. Very unlikely. That would double in the remaining patients. These are the facts from the reports which was made on the data with the independent committee bringing that to the board and to the safety committee of the board that says, "Sorry guys, this will not fly." The PARADIGME conclusion was that there is no viable path to generate value from Betalutin in the 3rd line follicular lymphoma. The primary results of Betalutin in non-Hodgkin's lymphoma part A, which Arne Kolstad conducted, was very attractive. They were obtained at the time treatment options were limited and minimally pre-treated population at the time and that when the study started.
That's what gave us an optimism in many years. Those very good results. It was good efficacy. It functioned. Part B, the PARADIGME results over time due to lower enrollment rates, et cetera, in heavily pre-treated populations are not clinically meaningful considering the treatment armamentary now currently available, i.e., the competition that had come up from the big pharmas over the last very few years, and not to say the last year. That was the conclusion the board had to take. We need to stop this. It will cost too much money to actually continue enrolling patients, and it will take too long time. As you remember also from the graph, there were no patients enrolled hardly in the last spring. Yeah, that was the conclusion as you all know.
Sorry as it was, the board really had to take some actions to save money and to save the company. They're not here to defend themselves, I'd rather tell you what happened and show some figures there. The actions taken was that 34 staff members out of the 40 was made redundant, 85% of the staff. Leadership team was reduced from 8- 2. And there was an interim CEO, CFO, and CSO, Jostein Dahle is still there. On the 15th of December, the board was reduced from 6- 3, and more than 300 contracts and vendors were terminated. They closed down all international offices. Carnegie reviewed 25+ strategic options, as you know. On 1st December APIM merger was declined at the EGM.
On the 9th of December, the new EGM was announced as the former board would resign and the interim CEO, CFO Malene would transition out of the company. Yeah, here you can see the number of employees, how that was taken care of. The red ones are the employed in termination. That happened very quickly. You can see these are the figures all the way through to April this year when the last people will leave now in March. The eight people there is actually not full-time employees. There's also part-time employees, which we have now for the time being. It's only the research department, five people. It's the accounting and a secretary and myself. Cash development, it picked up in January because of the issue which was done at the time.
It came down to NOK 99 million at the end of the year, as you see. Since there are people redundant who will receive money and some contracts which will also not expire until the end of March, money is still running out. As we've said in the report, there are around NOK 60 million available for the budget of this year and into 2024. These are the summary of the results, which you've seen many years. It was taken down quite heavily, net cash from operation activities compared to earlier. The cash runway also came down. As you can see, the NOK 99 million was the last around the year end. These are the financial figures which you will find also in the report and explained in the notes to the report. Yes.
Going forward, we still have a CD37 targeted immuno-oncology pipeline, but none of them are in the clinical phase. It's all preclinical. It's difficult to see that we will be able to raise money on this portfolio, but it can be out licensed and it can be developed if we and when we get a new partner in who can contribute to that development. Here are the patents and the applications we've had over the years. There is some value in the company, of course, but it's hard to say how that can be kind of given a future as a standalone company. In 2023 events, you know, on the 3rd of January, the EGM elects a new board. On the 19th of January, one of the board members resigned. On 1st of February, I was appointed.
The new board, as you will see in the report and from the quotes of the chairman also, prioritized four important tasks was to get a new CEO, CFO in place, reduce burn rate, map the CD37 platform and early stage solid tumor projects, and to find strategic solutions that safeguard the interests of the shareholders together with Carnegie. I'm sorry to say that we can give no assurance to the outcome of the timing on the ongoing process, but the updates and recommendations will, of course, be put forward to shareholders when relevant and in due course. The burn rate now has been significantly reduced and current cash is expected to finance an ongoing operations well into the 2024. That's my presentation.
Before you raise your questions, I can read up a few of the questions we already received on the IR at Nordic Nanovector.com. Maybe that would answer some of your questions as well. I can start with one question saying, are you in any negotiations with any potential partners? Yes, we are. I cannot tell you how many, but yes, we have interesting parties that we will see how we can manage to get a deal with. The next question is, if you don't find a new partner, can Nano operate on its own in the future? I can hardly see that because we are not able to raise money in this market. I know I've been criticized for saying that the market was closed, but then I can remind you that we've talked to a number of people in the market.
There was an interview recently with the Sarsia partner, Even Enger, who was interviewed in MedWatch at 24th of February. He says also it's impossible to find new investors to the biotech industry. We spent all our funding funds on existing portfolio companies. When we talk to other people, we hear that there are three cases in the market the companies in the clinical stage where their key investors had to make convertible bond loans so that they could continue their investments and where the exchange rate will be determined equal to the next issue price when the market again opens up. Sorry to say, Nano has no longer any key investors interested in the biotech or with the funds needed.
When other companies in our market struggle that much, I'm sure you will realize that we do the same for the time being. If you wanna listen in to Targovax's death spiral long, which they published a few days ago, there's another webcast at 10 o'clock where you can hear much about how they actually struggle to also find finance their treatment. Yes. Then other questions say, "Why do you believe that you will be able to execute transactions with and will be more favorable to the shareholders than the APIM deal?" That outcome of a strategic process is not possible to predict. We cannot predict that it will be more favorable.
We just hope that we will bring along something that we think is sensible and that you, as shareholders, will hopefully understand and accept that the proposal will make the company survive. Question again, "Do you believe the APIM proposal was sensible, one, and would you have recommended it to the shareholders at the time?" I think you will remember that I was at the 1st December EGM and couldn't understand why they would close it down because it would give you at least a clinical trial company, NOK 55 million more of cash, and one of the major investors in Norway as a backbone, and hopefully that will bring the company into times in a year or two when the stock market was back on track. Yes, I haven't changed my mind. I think that was the best deal, at least at the time.
Now we're looking for something else, and I hope I can come back in due course, i.e., hopefully before the AGM at the end of April. Question, "Is there any chance the APIM deal could resurrect?" I would say no. I mean, then when it was negotiated, the share price was NOK 1.5. Now it's half that price, so. You decline the 24% shareholding for Nano investors, so of course they wouldn't improve the exchange rate. So that's unrealistic. Yeah. A few other questions here. "What would happen if no alternative deal can be found?" Yeah. We'll run out of money in 2024. "Do you think Nanovector has a future as a standalone company?" No, hardly, because of the market.
If the market changes very quickly, or we can find investors or some out there who is interested to buy or outlicense our technologies. Yes, can be. We need new money coming in. Right. Yeah. Major question maybe. "Do you agree with the decision to stop PARADIGME?" I think I have explained, and hopefully also through the facts that I've given you, that I don't think the board had any choice, in my opinion. I mean, they tried for as long as they saw positive signs there. I could also say that when a study has failed, all companies, big or small, would say that they should have stopped earlier. All continued hoping for success until hard facts and figures told them differently.
In Nano's case, I have great respect for the very qualified, experienced CMOs, the board members, which I know personally and have spoken to recently, and the key opinion leaders who have followed the study for years. I mean, so many really qualified people made those decision going forward, but also finally had to accept when the figures really hit them hard that, yeah, the study had to stop. Yeah, it's hindsight to say that, yeah, they could have stopped earlier. Yes. Everyone says that, even the big ones who have more projects to or a bigger portfolio. I also got a question on the solid tumor project and what that is. I can only say for the time being, it's still in progress.
We have no patent yet. We're continuing to have a look at that as an interesting potential. Yeah. There was also a question why I took the job. Well, I was asked. I was available, and I think I was cheaper. Anyway, why did Eddie Berglund resign as a board member in January after such a short tenure? You need to ask him. I think he disagreed with the board majority. I don't know any more reasons. You have to put that question to him. Last question, do you have contact with North Energy? If so, what are their intentions? Yes, of course. I introduced myself the very first day I joined. We have contact. Of course, we speak to our largest shareholders.
As soon as I have a proposal, I will talk to them again and see if they can support it. I haven't received any, let's say, input from them, I'm very open, we are very open to see any good ideas that what we can do with the company. Last question, what is your intention or how will you regard a success from your tenure at Nordic Nanovector? That is to make the company survive. Let's hope we can do that together. Thank you. If there are any other questions, I'm happy to try to answer them. I would kindly ask you to send us your questions.
If they are concerned with, you know, technology or any specific items, I will not pretend that I am an expert on all that, so we would need to be able to also answer you in writing or at least prepare the answers, let's say for the next time we meet. We're due to publish our annual report on the 23rd, I think, of March, and then we meet again at the AGM on the 26th of April. Are there any questions, Kai? On the screen?
there's only one question actually, and that is: how has the cooperation between the new board and the employees worked?
Very well. Very well. We have It's a very small company. It's kind of funny to come into that beautiful surrounding in the cantina, and we make our own food and the board when they visit, and there are good interactions between the board and the members. Yes, we're all very excited about doing this together. And the board has been very active, I must say, and very constructive. Tina with her expertise within the biological industry has been very valuable and Jon Magne as well, very active and taking care of certain aspects of the. We've shared, let's say, the burdens and work very well together. I'm very pleased actually with the team and the employees.
I've interviewed all of the employees, and I'm really, must say they are a fantastically qualified group of people, very complementary to each other and very loyal to and very enthusiastic about what they're doing. The labs we have are first class, and there seems to be a lack of labs in the country. We hope also to kind of utilize that in a way to make money. Yes, we hope there is a bright future here if we can only find a partner who is willing to finance us, going forward. Thank you. Thank you for joining us, and, looking forward to seeing you next time.