Q&A

General

Update on the SME II EU-grant for the PDAC (pancreatic cancer) study?

Modified

19.Mar 20

Q: Congratulations to the previous grant of 5 million DK from the Danish Innovation Fund. Can we expect to get an update regarding the SME II EU-grant for the PDAC (pancreatic cancer) study?

A: We have not yet applied for the SME II grant. The reason is that the next application date has been allocated to environmental studies so we expect to apply in October 2020. For your information we are actively pursuing any opportunity regarding soft money

Is it likely that Peter Høngaard acquire more shares in Scandion Oncology?

Modified

25.Feb 20

Q: Dear Peter Høngaard you acquired shares at an early stage. It was truly a signal too the market. Will we see you on the buy-button once again!

 

A: It was definitively not the last time I acquire shares in Scandion Oncology. I think the share price is very low, corresponding to a market cap around 300 mill SEK. In my mind, it’s far too low for a company with an advanced phase II asset. Thus, one of the challenges we have in our business development activities is to on the one hand “catch” the interest of potential, future buyers and on the other hand, wait by striking a deal until the value of the company is at the right level.

 

Can Scandion Oncology utilize the contact network of Peter Høngaard?

Modified

25.Feb 20

Q: Dear Peter Høngaard will you be able to utilize previous contacts within the industry in order to search for a potential upcoming partner?

 

A: Yes, more or less all meetings we have had the last 3 – 4 months are based on my and Nils’ network. We are now extending this further by participating in different international partnering meetings, scientific cancer meetings and other activities.

Did the interest in Scandion Oncology increase after Peter Høngaard joined Scandion Oncology?

Modified

25.Feb 20

Q: Dear Peter Høngaard did the high interest for Scandion Oncology come after your entrance to the company?

 

A: Not really, Scandion Oncology had already initiated contacts with a few interested companies. However, as we have increased our business development activities we meet a lot more companies and have experienced quite a bit of interest from potential buyer following these meetings.

Dialogue with potential partners during the clinical studies?

Modified

25.Feb 20

Q: Dear Peter Høngaard are you hopeful that you will continue to have a close dialogue with potential partners during the clinical studies?

 

A: Absolutely, all the companies we have talked to since we started to organize these meetings have requested frequent updates and emphasized that they wanted to see data already after the first part of our first phase II study.

What are the goals for the Chairman of the board for 2020?

Modified

25.Feb 20

Q: Dear Peter Høngaard what are the upcoming goals in your role as Chairman of the board for the remaining time of 2020?

 

A: Our most important goals for 2020 are clear: 1st. priority is to execute on our first phase II in drug-resistant metastatic colorectal cancer, 2nd. priority is to get our second phase II in pancreatic cancer patients off the ground and 3rd. priority is to keep pressure on the business development activities, i.e. meet with relevant pharma companies and update them on our progress and finally 4ht priority is to bring compensation package of the Board up to benchmark level, something we will bring forward at the upcoming General Assembly.

Comment from Peter Hønggaard on his decision to join Scandion Oncology

Modified

25.Feb 20

Q: Dear Peter Høngaard, your decision to join Scandion Oncology has been quite noticeable and appreciated by the stock market. It is been fantastic to see how you have transformed the company to newer strategies and towards to a possible exit. Can you put any comment to your decision to join Scandion Oncology? Aren’t Pharma companies usually interested in acquiring companies with complete phase 2 data?

 

A: First, I would like to describe briefly what’s behind my decision to accept the board position and later the role as chairman of the board in Scandion Oncology. When I’m approached on roles like this, I always start by debating with my wife (and myself) if I have the time to do a proper job; if not I will go no further but say “no thx” upfront. But timing was perfect in this case, so I continued into my own due diligence of the company, the technology, the competition and the team. This process took me a few weeks and turned out quite positive, and I knew Nils from before Scandion Oncology and highly respect his scientific and clinical insight into the oncology area and with the team he put together – in reality there wasn’t much doubt in my mind, I accepted to join the board. I was a bit surprised that I was also asked to step into the role as chair – but accepted if timing could be pushed to the fall.

 

In my due diligence, I noticed, that the business development activities in Scandion Oncology were rather limited and I took the discussion with Nils and Jørgen, the former Chairman. I realized that this was deliberately, thinking that no exit could be expected before end of both of the planned phase II’s. Thus, the plan was to initiate business development activities by late 2020 shortly before the first phase II data was expected. However, this was in my mind not the right way to do it, and as we as board and management have the task to optimize shareholder value, it is critical we perform business development in a way that optimizes value and reduces risk for the shareholders. But to do business development in an optimal way it’s a must you understand how the industry works. It’s an industry with huge risks. More than 80% of all development projects entering humans fail one way or the other. So how to reduce risk is what it’s all about. Obviously, the first thing you look at as a potential buyer of a company/asset is the science and the quality of the work done preclinically and clinically, but even as important is confidence in the team, the people that have done the work and their capability to work out a plan and deliver to this plan. Whereas the science can be digested during a due diligence, confidence in the team takes time and requires that you meet the future potential buyers several times and present progress relative to your plan – to put it in another way – you build a relationship with your future, potential buyers. This relationship and confidence in the science is typically seen as critical in reducing risk for the buyer, and thus, it’s a process you need to start long time before you can expect to exit. Therefore, we are contacting bankers and pharma companies to let them know about Scandion Oncology and our technology. Obviously, it has given us a head start on this process that I know a lot of people in the pharma sector.

 

So, coming to the last part of your question, when does a pharma company prefer to buy an asset? Well, coming back to one of my earlier remarks, pharma is a business with huge risks. Thus, everybody would prefer to buy market ready assets, however, an asset being market ready means that it’s almost completely de-risked and consequently will be very expensive. So, what I’m trying to outline is that it’s a balance between risk and price. The large companies typically have so much cash that they can afford waiting to acquire an asset until it has been highly de-risked, i.e., minimum after phase II and often after phase IIIa. Mid-and small-cap companies can’t afford to wait for this level of de-risking and typically are willing to take a bid with a higher level of risk, i.e., after phase I or during phase II. So, with our business efforts right now we are primarily targeting the mid-size pharmas but keeping the big pharmas in the loop.

Extrapolation of pre-clinical studies to clinical studies?

Modified

24.Feb 20

Q: How ”easy” is it to extrapolate data from previous in-vivo/vitro studies, and ”hope” to have the same effects in human during this study?

 

A: Pre-clinical in vitro and in vivo studies are mandatory in order to initiate clinical trials. The way that his is done is to provide the best possible pre-clinical proof-of-concept and toxicity studies before entering clinical trials. Unfortunately, it is not possible to predict how well pre-clinical studies will be reflected in clinical trials. However, 37% of drugs in Clinical Phase I fails to reach Phase II. Therefore, it is very important to stress that SCO-101 has successfully passed 4 different Phase I trials, thereby reducing the risk of failure.

History of SCO-101?

Modified

08.Jul 19

Q: I have a question regarding the history of SCO-101. As I understand it NeuroSearch A/S was the earlier owner of SCO-101 and back then the name was Endovion (NS3728)? SCO-101 (Endovion/NS3728) was developed for sickle-cell anemia but was stopped in 2002 before Phase 2 clinical studies. What happened between 2002 and 2015 (when university of Copenhagen started to test it again).

 

A: Thank you for your question.

Yes, indeed, SCO-101 was previously named Endovion (or NS3728) and was owned by NeuroSearch A/S in Denmark. NeuroSearch completed 4 different Phase I clinical studies with a total of 92 persons. However, NeuroSearch decided to stop after Phase I and never started Phase II clinical studies. This was most likely due to a slight and reversible increase in serum unconjugated bilirubin, which is incompatible with Sickle Cell Anemia but of no concern in the treatment of cancer. So, after the Phase I studies no further development of SCO-101 was initiated in NeuroSearch.

In 2004, NeuroSearch announced collaboration with the Danish biotech company TopoTarget A/S. This collaboration allowed TopoTarget to conduct pre-clinical cancer research. However, the collaboration did not lead to any clinical studies and the collaboration was terminated in 2006. TopoTarget did not file any patent applications and all rights and data were transferred back to NeuroSearch.

A management buy-out of NeuroSearch resulted in the formation of the company Saniona in 2011. Nils Brünner had a discussion with the CEO and CFO of Saniona about testing some of the 130,000 compounds that Saniona had acquired from NeuroSearch. Among the compounds tested in our (University of Copenhagen) new screening platform established to find drugs that interfere with anti-cancer drug resistance, we identified Endovion as such a drug. These discoveries lead to the formation of Scandion Oncology as a spin-out from Saniona and University of Copenhagen. As mentioned, Endovion had by NeuroSearch been taken through 4 different clinical phase I studies and is therefore ready for phase II testing in humans. Scandion Oncology has had a meeting with the Danish Medicines Agency and they confirmed that Scandion Oncology can take SCO-101 (Endovion) together with chemotherapy directly into clinical phase II trials. In the phase II trials, we will include patients with drug resistant cancer and without any other treatment options.

 

New member proposed for the Board of Directors

Modified

16.May 19

Q: I can see that you are proposing a new member of the Board of Directors. Can you tell us a more about his background and future role in the Board?

A: Scandion Oncology is very pleased that Peter Høngaard Andersen has accepted to be proposed as member of Scandion Oncology Board of Directors. Peter is one of the most experienced Danes within biotech and business development. Not only has he been involved in the upstart of several biotech companies, but he has also secured very valuable exits for the share owners (e.g. Prexton Therapeutics and Epitherapeutics). Until recently he has been the CEO of the Danish Innovation Fund, the largest public fund in Denmark, targeting all industries and research areas and the complete value chain from basic research to market.

Moreover, he has solid experience as Chair for Boards of biotech companies, a strong scientific background, deep insight and hands on experience in Public Private Partnerships in EU, US and DK, year-long experience in collaborations with biotech and academia, and a successful career in life science within R&D, IP, litigation, public affairs strategic development, business development and mergers and acquisitions

Peter will be a very important person to bring Scandion Oncology to the next level.

SCO-301

Modified

26.Apr 19

Q: Regarding the PR released on April 16, 2019, on SCO-301: Is it correct that SCO-301 has gone through phase I and perhaps phase II but is not a registered drug?

A: SCO-301 is a registered drug but it is registered for a non-cancer indication. Scandion Oncology wants to develop SCO-301 for cancer treatment. At the same time we develop, together with University of Copenhagen, novel analogs of this drug. We expect to develop analogs with even better anti-cancer effects. The new analogs will be patented.

Since SCO-301 is a registered drug it can be bought at the Pharmacy so we do not need any own production – it is ready for testing in cancer patients with drug resistant disease.

Collaboration with Solural Pharma and Cambrex

Modified

20.Mar 19

Q: Scandion Oncology announced on March 19 that a contract has been signed with Solural Pharma, Denmark, regarding formulation of SCO-101 in tablets for clinical test. Does that mean that Scandion Oncology is no longer working with Cambrex regarding the production of SCO-101?

A: Scandion Oncology is still working actively with Cambrex and expects them to deliver the raw SCO-101 material (API) in June 2019. The API will then be transported to Solural Pharma, Denmark, to make tablets for the clinical study. Cambrex, Sweden, does not offer to make tablets. So, everything is according to plans and we are very satisfied with the work being performed at Cambrex.

Could SCO-101 affect the toxin pumps in healthy cells, or does it only affect cancer cells?

Modified

15.Jan 19

Yes it is likely that the toxin pumps (which are also the P-gp and BCRP pumps) in healthy cells are effected as well . We circumvent this problem by introducing a SCO-101 treatment pause between chemotherapy treatment. There have been toxicity studies of SCO-101 (clinical phase I) showing that SCO-101 is well tolerated for prolonged use (14 days) at the dose that we intend to use as our starting dose.

When we combine SCO-101 with chemotherapy we do not expect additional  toxicity based on the published Tariquidar clinical data. Please see this recent review with relevant references (Robey et al., Nature Reviews Cancer (vol. 18, p.452–464 (2018)).

Is it the P-gp and BCRP drug efflux pumps that you are trying to block?

Modified

15.Jan 19

Yes, these efflux pumps are considered as the most important in anti-cancer drug resistance.

There is a general notion that cancer stem cells are more resistant to chemotherapy than normal cancer cells. Do you have any indication that SCO-101 and/or SCO-201 will work on cancer stem cells?

Modified

30.Dec 18

Cancer stem cells are characterized by surviving cancer treatment and hence be responsible for recurrence of the cancer. Cancer stem cells have high expression of the ABCG2 drug efflux pump and they most probably use this pump to avoid the effects of chemotherapy. The ABCG2 drug efflux pump is being inhibited by SCO-101. Thus, we expect to kill cancer stem cells by combining chemotherapy with SCO-101. We have yet not looked at this but it is definitely in our development plans for 2019.

Immunotherapy has become a growing part of cancer treatment. How well will the old chemotherapies, which SCO-101 and SCO-201 hopefully will enhance, compete with new immunotherapies?

Modified

30.Dec 18

This is a very interesting and timely question. Roche, the big pharma company, has recently published that their check point inhibitors (immuno-oncology) works better if it is combined with chemotherapy. They showed this by combining their check point inhibitor with the chemotherapeutic drug Abraxane. Abraxane is paclitaxel bound to albumin. SCO-101 enhances the effects of paclitaxel and reverses paclitaxel resistance. Since quite a few of these patients will have paclitaxel resistant cancer cells, SCO-101 should be part of this combination to ensure cancer cell kill in the tumor thereby recruiting the immune cells. Thus, SCO-101 could be a very important addition to current immuno-oncology treatment.

You are currently a very small organization, do you see any risk of overreaching by aiming to develop at least 3 different drugs concomitantly?

Modified

30.Dec 18

This is a very good comment. We are certainly aware of such a “positive” problem and we therefore have the clinical development of SCO-101 as our main focus. This also appears from our budget presented in the memorandum published in connection with the IPO. For the two other compounds, further development is related to securing economical support for these.

What sets your company apart from those within your industry?

Modified

26.Oct 18

As far as we are aware, we are the only company having a drug against drug resistance in cancer in clinical development. So our “X factor” is a unique and safe oral drug that targets the perhaps most important problem in today’s cancer treatment: Existing or acquired drug resistance leading to the death of millions every year.

During your time at Scandion Oncology what has been in your eyes your greatest achievement thus far?

Modified

26.Oct 18

To discover that SCO-101 could reverse drug resistance in cancer and to identify the mechanisms of actions for this effect.

Could you please share with us your favorite memory and or event since you joined the company?

Modified

26.Oct 18

The day we decided to spin-out Scandion Oncology from University of Copenhagen and Saniona. It was a dream that came through for us – to establish our own company based on our own cancer research. Only by taking SCO-101 through a commercialization process, we will be able to bring our many years of research out to the benefit of cancer patients.

Could you please give our viewers a brief history of your company.

Modified

26.Oct 18

In brief, SCO-101 was originally developed by the Danish biotech company Neurosearch A/S to treat patients with Sickle Cell Anemia, which is a non-cancer hemoglobin disease. However, they were not satisfied with their first results and further development was stopped.

Neurosearch A/S was acquired by Saniona AB, which is on First North in Stockholm. At that time Nils Brünner, CEO of Scandion Oncology was CEO for WntResearch and the CFO in WntResearch, Thomas Feldthus, was one of the founders of Saniona. He introduced Nils Brünner to the CEO of Saniona, Jørgen Drejer, and several conversations about drug development were initiated. At the same time, Nils Brünner together with Associate Professor Jan Stenvang, at the University of Copenhagen, established a novel drug screening platform consisting of pairs of drug sensitive and drug resistant cancer cell lines. Nils Brünner and CSO Jan Stenvang obtained SCO-101 from Saniona and tested it in the screenings platform. The studies showed that SCO-101 by itself has no anti-cancer effects but when combined with standard cancer treatments in drug resistant cancer cell lines, SCO-101 blocked important resistance mechanisms rendering the cancer cells sensitive to treatment again. SCO-101 had been tested in 92 humans already at the time of Neurosearch and is now ready for phase II in cancer. We established Scandion Oncology in May 2017 and money is currently being raised to continue the clinical development in patients with drug resistant cancer.

Pre-clinical

Pre-clinical study on MoA in endocrine resistant breast cancer cells

Modified

07.Jan 20

Q: When will the pre-clinical study on MoA in endocrine resistant breast cancer cells from the Netherlands be presented?

A: As previously reported, researchers at Radboud University Medical Center in Nijmegen, The Netherlands, have studied the role of SRPK1 in endocrine resistant breast cancer cell lines. The study was supported by a small EU grant. Scandion Oncology previously identified the SRPK1 kinase as a potential molecular target for the lead drug candidate SCO-101. The pre-clinical data from Radboud University was analyzed by two different methods and both convincingly demonstrated that the viability of fulvestrant (an anti-estrogen) resistant breast cancer cells is reduced when exposed to a synthetic SRPK1 inhibitor. These pre-clinical data thus demonstrate that SRPK1 is important for the viability of fulvestrant resistant breast cancer cells, and that it could be an important target in endocrine resistant breast cancer. That SCO-101 inhibits SRPK1 and also reverses anti-estrogen resistance further support the importance of SCO-101 treatment in patients with anti-estrogen resistant breast cancer.

Scandion Oncology is presently establishing methods for immunohistochemical detection of the SRPK1 protein in formalin-fixed paraffin embedded cancer tissue. With the above described data, we believe that measurements of SRPK1 protein in patient cancer tissue samples could constitute an important method to preselect patients with an increased probability to obtain benefit from SCO-101 treatment.

Status on EU grant regarding endocrine treatment of breast cancer cell lines?

Modified

20.Aug 19

Q: I understand that you received an EU grant that is being used to have Dutch scientists to work on SCO-101 and endocrine treatment resistance in breast cancer cell lines. Can you tell us more about the type of work they are performing?

 

A: Thank you very much for your question. Yes, the Dutch research group, which has many years of experience in endocrine treatment of breast cancer cell lines, is now testing SCO-101 in relation to its Mechanism of Action when reverting endocrine resistance. In particular, they are focusing their research on the kinase that Scandion Oncology has identified as one key target for SCO-101. Thus, this research will support Scandion Oncology in the development of so-called predictive biomarkers (molecules that predict effect of a particular treatment) to be used when later selecting endocrine treatment resistant breast cancer patients for SCO-101 and endocrine treatment. We have seen the first results showing that inhibition of this specific kinase with synthetic kinase inhibitors reduces cancer cell growth. This is in line with already published data showing that breast cancer patients with high tumor levels of this kinase do worse than patients with low levels despite treatment.

Can you tell more about your results within antibiotic resistance in bacteria?

Modified

21.Mar 19

Q: Your findings that your substances might prevent antibiotic resistance are very interesting and of course very important since resistant bacteria can become a big threat to mankind.

Can you tell us more in detail what you have done and what results you saw?

A: The reason for our studies in antibiotics and bacteria was an idea that cancer cells and bacteria might share common resistance mechanisms. That this is a possibility is supported by the many publications on drug efflux pumps being responsible for drug resistance in both cancer cells and in bacteria. Therefore, Scandion Oncology contacted researchers at University of Copenhagen, who work in the area of antibiotic resistance. They received our drugs under a Material Transfer Agreement securing that Scandion Oncology retains all rights to any new invention made regarding our drugs when used at the University of Copenhagen. Our colleagues then tested the drugs in their repository of antibiotic resistant bacteria. What they observed was that our drugs could kill several types of antibiotic resistant bacteria including some of the most common antibiotic resistant bacteria strains. Moreover, in some bacteria, our drugs showed additive effects in combination with antibiotics suggesting that our drugs improve the effects of antibiotics.

We now have the first indications of the mechanisms of action of our drugs when killing antibiotic resistant bacteria. We are presently continuing these studies to be able to select candidate drugs for in vivo testing. Importantly, it is not SCO-101 that is being developed for anti-biotic resistance. Scandion Oncology owns the invention and a patent application has been filed.

In one of your slides that you use for presentations, it says that you have identified a non-cancer indication for SCO-101. Can you tell us more about this other indication?

Modified

26.Oct 18

It is correct that we now have preclinical data on SCO-101 and a non-cancer indication. We are presently preparing for a new patent application for this. The only information I can give right now is that this other indication could be as big as the cancer indication. We will initiate screening of our approximately 800 SCO-101 analogs in order to select a candidate for this indication.

Clinical

SCO-101 mCRC Phase2 clinical trial

Modified

02.Apr 20

Q: Scandion Oncology communicated that recruitment is ongoing in the Phase II study with metastatic colorectal cancer patinets. However, clinicaltrials.gov seems not to be updated for this study (NCT04247256). Can you clarify this?

A: Recruitment for this ongoing study is open as stated in our latest CEO Newsletter and we are in constant contact with our clinical partners to enroll patients. We have also contacted ClinicalTrials.gov in order to have them to change the status update for the NCT04247256 entry, which does not reflect the trials current status (RECRUITMENT ONGOING). Scandion Oncology holds no power over clinicaltrials.gov, their data integrity nor processing time of new updates. We flagged this discrepancy to clinicaltrials.gov and expect this to be rectified and updated soon.

How many patients must respond to SCO-101 to achieve proof of concept?

Modified

19.Mar 20

Q: How many patients are required to respond to SCO-101 treatment to achieve proof of concept for the study to be deemed successful? What does the company expect the outcome to be?

A: The Phase II colorectal cancer study is divided into a “run-in-phase” (safety-toxicity and optimal dose finding) and a second part (measure of effect). The primary end-point of the second part of the Phase II colorectal cancer study is objective response rate, meaning how many patients will experience tumor regression (the tumor gets smaller) or stabilized disease (the patients are all coming with progression on chemotherapy). A success of the study is when we have two or more patients with tumor regression or stabilized disease.

Will the study plan change if objective responses are observed in the first part of the Phase II colorectal cancer study?

Modified

19.Mar 20

Q: The Phase II colorectal cancer study is divided into a “run-in-phase” (safety-toxicity and optimal dose finding) and a second part (measure of effect). If you succeed to show effect already during the run-in-phase, will you change the study and continue with the ”effect-phase”?

 

A: In the run-in-phase we have decided on a maximal dose of SCO-101 to be used (350 mg per day). If we observe effects even before we reach that dose it would be great but we will most probably continue until we see some kind of toxicity. The reason is that we want to make sure that as many patients as possible will benefit from SCO-101 treatment. We are targeting SRPK1 and ABCG2 and we want to make sure that the inhibition of these two proteins are as effective as possible, which we believe will be most likely to obtain with the highest acceptable dose.

Success rates in clinical trials: Generally and in oncology

Modified

24.Feb 20

Q: What are the success rates in the different phases of clinical trials in general and specifically in oncology?

A: Obviously, there are difference in the success rates of individual clinical trials due to different drugs, clinical designs and disease types.

Generally (all diseases, all modalities), the numbers are approximately that of the drugs that enter a Clinical Phase I trial 63% will make it to Phase II. Of the drugs that enter a Clinical Phase II approximately 30% will make it to Phase III. Of the drugs that enter a Clinical Phase III approximately 50% will be approved. In other words, approximately 10% of the drugs that enter a Clinical Phase I study will eventually be approved.

In Oncology, slightly fewer drugs progress from phase I to phase II and the success rate of drugs in Phase II clinical trials is slightly lower than for drugs generally. Of the oncology drugs that enters Phase II approximately 25% enters Phase III, and of the oncology drugs that enters Phase III approximately 33% are approved. Overall, approximately 5% of the oncology drugs that enter Phase I will eventually be approved.

It is however, important to notice that in most oncology trials, the new drug is toxic and therefore the risk of failure in Phase I is higher. This was not true for SCO-101 which is not a common anti-cancer drug and it has proven to be safe with very limited toxicity in Phase I.

The above numbers are based on the publication by Dowden H, Munro J. Nat Rev Drug Discov. 2019 Jul;18(7):495-496, ”Trends in clinical success rates and therapeutic focus” and numbers from Amplion that can be downloaded here: https://www.amplion.com/

What if there is no effect after 8 weeks of treament with the lowest SCO-101 dose in combination with chemotherapy?

Modified

21.Feb 20

Q: If there is no effect on the tumor after the first report (8 weeks of treatment), what are the probability to see any effect with higher dose-escalation?

A: We are doing the dose escalation in order to increase the likelihood of a positive response. So, in general the more drug the better effects. It is important to stress that the primary end-points in this first part of the study is safety and toxicity. Thus, if there is no toxicity and also no effect on the tumor is observed after 8 weeks with the initial dose of SCO-101, this is no problem, and we will follow the clinical trial design and increase the dose of SCO-101.

 

What is the probability of “positive data” for Phase II clinical studies?

Modified

24.Feb 20

Q: What can be said about the probability of “positive data” in general, for clinical studies within Phase II?

 

A: This is difficult to answer since no general numbers can be given that will represent a specific study. In some cases with targeted therapy (like SCO-101) the probability can be very high if the target is present in the patients. We have included measurements of the two known SCO-101 targets.

Generally, the chances of success of eventual approval for a compound entering Phase I trials is slightly under 10%. So, this is probably the single most important figure in the pharmaceutical industry, since yhis number has not increased for many years. Therefore, it is extremely important that SCO-101 has passed four different Phase I trials. Regarding Phase II clinical studies, the chances to pass Phase II and enter Phase III is approximately 30% in general and approximately 25% in oncollogy. Around 50% (general) and 33% (oncology) of drugs in Phase III clinical studies are eventually aproved.

Data from the clinical Phase II study after 8 weeks of treatment

Modified

21.Feb 20

Q: If Scandion will provide data from the study after 8 weeks of treatment, what are the potential outcome that the study will be successful?

What are the goals to achieve in the ”first run” after 8 weeks? What end-points/effects are you hoping to see? What can you except and what do you except?

A: The first part of the phase II study is a dose escalation of SCO-101 in combination with standard dose of chemotherapy. This dose escalation is mandatory to do this since SCO-101 has never before been combined with chemotherapy in cancer patients. The primary end-points in this first part of the study is safety and toxicity. SCO-101 has proven as monotherapy to be almost non-toxic when given as a tablet to humans. We will follow the same administration and we do not expect any toxicity from SCO-101. Thus, we expect that the dose escalation study will identify the most optimal dose of SCO-101 to be combined with chemotherapy, and this dose will be used in the second part of the study.

The patients in the first part will also be scanned before treatment and then every 8 weeks to examine if the cancer growth has stopped. So even with the initial low doses of SCO-101 we will look for effects on tumor size. Importantly, the starting dose of SCO-101 gives serum SCO-101 concentrations being active in our preclinical models.

A product called Tariquidar that inhibits drug efflux pumps was abandoned in phase III: Was this due to toxicology issues?

Modified

15.Jan 19

Yes, indeed Tariquidar was abandoned in Phase III clinical trials. We are well aware of these clinical studies. Based on the published literature on these clinical trial with Tariquidar it seems that there is not very much added toxicity when combining Tariquidar with chemotherapy (the phase I and II trials). However, it was observed that there were responders in patients with a favorable biomarker profile. Unfortunately, it is not totally clear how they selected patients for their trials. It seems unclear why they decided to terminate future development of Tariquidar and there seems not to be any publications describing unacceptable toxicities. We are of course looking closely into the Tariquidar papers when we plan our clinical studies. More information and references can be found in this review: Robey et al., Nature Reviews Cancer (vol. 18, p.452–464 (2018)

Has Scandion Oncology plans to collaborate with 2CureX or Oncology Venture in order to select the most relevant patients for the future clinical studies?

Modified

17.Dec 18

Scandion Oncology is currently investigating several possibilities to apply predictive biomarkers in order to personalize the treatment with SCO-101. These predictive biomarkers will eventually be used to select the patients who are most likely to respond to treatment with SCO-101.

Jag undrar lite om era fas 1 studier, då jag inte hittar så mycket information om dessa. Hur kommer det sig att det gjorts hela fyra fas 1 studier? Då man oftast vill söka effekt i fas 2.

Modified

13.Nov 18

When Scandion Oncology was established in 2017 we received all documentation on the four Phase I clinical trials from Saniona. These trials were conducted around 2002 and the data were not published. We plan to include some of these data in our coming publications. All studies were performed in healthy volunteers. The four studies comprised

  1. Single doses
  2. Escalation doses
  3. Females and males
  4. Food interaction (since SCO-101 is delivered in a capsule)

The original plans for SCO-101 were to use it to treat a disease named sickle cell anemia. This is an inherited blood disease where the erythrocytes (red blood cells) have a sickle shape and they are more fragile. However, SCO-101 caused a slight and reversible increase in serum bilirubin and was therefore found unsuitable for treatment of a disease that results in increased serum bilirubin by itself.

This I fortunately not considered a problem when combining with anti-cancer treatment.

Do you have any plans to initiate clinical studies with SCO-101 in other indications than breast cancer?

Modified

26.Oct 18

Yes, we plan to initiate clinical studies also in colorectal cancer and most probably also in pancreatic cancer but we will need more resources in order to do this.

When do you expect that breast cancer patients can receive your drug?

Modified

26.Oct 18

We plan to initiate in late 2019 the clinical phase II study with metastatic breast cancer patients and docetaxel/paclitaxel resistant disease. Please contact Nils Brünner CEO (nb@scandiononcology.com) for further information.

Financials

Cash burn rate in Q3 2019?

Modified

11.Dec 19

Q: The cash burn rate in Q3 2019 report seems to be approximately DKK 7 million.  If this cash burn is extrapolated, somebody might conclude that there is a new rights issue coming soon. Is that the case?

A: Scandion Oncology has finalised the production and formulation of SCO-101 tablets in the autumn 2019. For a status of the production and formulation of SCO-101 please see e.g. BioStock article from November 22, 2019. The production and formulation activities have increased the cash burn in especially Q2 and Q3 of 2019. As the production and formulation is now finalised the cash burn in the recent quarter cannot be applied to predict future cash burn rates. Scandion Oncology is preparing for the first Phase II clinical trial and the running of this trial will be a main driver for future expenses.

Scandion Oncology is following its plans and the next planned capital raise is the warrants of series TO 1 (Exercise period: 10 September 2020 – 1 October 2020).

How long will the capital raised from the announced Rights Issue last?

Modified

03.Jun 19

Q: Regarding our announcement on May 27, 2019, of a new issue of shares and warrants (the “Rights Issue”): How long do you estimate that the capital raised from the Rights Issue will last, taking the new strategy into consideration?

 

A: Thank you very much for the timely and relevant question. As announced, we have decided to perform one additional clinical phase II study with SCO-101 and chemotherapy to increase the commercial potential of the drug candidate. This study will be different from our first study which will be in colorectal cancer with irinotecan resistant patients. The second study will be in breast cancer in taxane resistant patients.

This is a new strategy for Scandion Oncology and has been chosen due to our continued and increased belief in the Company’s success, which is based on our progress since our IPO in 2018.

By initiating two Phase II clinical studies in parallel, colorectal and breast cancer, and with two different types of chemotherapy the company will mitigate the risk by pursuing different cancer indications and increase the commercial value for SCO-101. This new strategy will create added value for Scandion Oncology in future partner negotiations as the company will have more complete clinical studies and more directions to show, thereby creating even greater value to Scandion Oncology’s shareholders.

Furthermore, we have produced enough SCO-101 to run additional studies, and we have the management team employed and they can in addition to the first study take care of the additional study.

In addition to covering the cost of the second clinical study, we will use the proceeds from the capital raise to further advance our two other drug candidates. Finally, we will use a smaller part of the proceeds to perform a limited number of in vivo experiments to further develop the commercial aspects for antibiotic resistance, to assess the full financial potential of this discovery.

We have so far been successful in obtaining soft money grants. We will continue to apply and particularly we will apply for soft money to cover a third clinical trial with SCO-101 + anti-estrogen treatment of anti-estrogen resistant breast cancer patients. Scandion Oncology will only proceed with the third clinical Phase II study if the company receives the needed EU grants.

With this new strategy and with the expectations of results from the two clinical Phase II studies within the next 1.5-2.5 years, it is expected that Scandion Oncology over the next 2.5 years will receive income from partners/licensees. Therefore, through fully subscribed rights issue and warrant exercise, Scandion Oncology will be financed until end 2021. We therefore do not expect to have any future capital need after the ongoing Rights Issue is completed.

SME Instrument phase I grant from EU

Modified

26.Apr 19

Q: Congratulations for the 350,000 DKK SME Instrument phase I grant from EU. Given that you were awarded this grant, can it be estimated what will be the likelihood that Scandion Oncology will also receive a phase II grant? Can you also give an estimation of the amount you might get in phase II or at least a lower and upper limit?

A: We surely are very happy to have his EU grant awarded. Although it does not automatically leads to a SME Instruments Phase II grant, our chances to get such a grant have significantly improved by this award. The phase I grant will be used to optimize our success rate for the Phase II grant. Moreover, it will be used to initiate the regulatory process regarding our breast cancer taxane study. We also got awarded 3 days of training from an international expert.

The SME Instrument Phase II grants can amount to 2.5 million EURO.

Possibilities to attract funding for antibiotic resistance?

Modified

21.Mar 19

Q: There seems to be a big interest from several governments to solve this problem. Last week Germany gave 40 MEUR to research within the field. Can you comment on your chances to get funding for the project from EU (or elsewhere)?

A: Indeed, there is a big interest in this field from governmental levels around Europe. In Denmark, there is also a big interest for antibiotic resistance with the Novo Nordic Foundation having their REPAIR Fund and their BioInnovation Institute (BII) now having antibiotic resistance on its agenda. Importantly, Denmark is going to host an international antibiotic resistance knowledge center. Therefore, Scandion Oncology feels confident about having soft money awarded to proceed with the development of drugs that can kill antibiotic resistant bacteria.

Market potential in antibiotic resistance?

Modified

21.Mar 19

Q: Do you have any idea about your market potential in antibiotic resistance compared to cancer resistance?

A: It is difficult to compare but based on all the information Scandion Oncology has collected, these two markets could be at the same magnitude, which means reaching blockbuster levels (annual sales of at least $1 billion). In a recent report from the UK government, it has been forecasted that in 2050 there will be 10 million deaths attributable to antibiotic resistance. Among the marketed antibiotics since 2000, the most valuable antibiotics, linezolid from Pfizer and daptomycin from Merck, had a global peak sale of 1,000-1,353 million US$ and generated sales above 1,000 million US$ for seven years and three years, respectively.

Burn rate and cash position

Modified

22.Feb 19

Q: I noticed from the Q4 2018 report that the burn rate is quite high and that the cash position is lower than expected. Why is that?

A: Scandion Oncology has in Q4 2018 paid the majority of the total production cost including a pre-payment of 2019 production cost. Moreover, we also paid the expenses related to the IPO.

What are Scandion Oncology´s medium to long-term goals and have these goals been consistent for some time?

Modified

26.Oct 18

To successfully pass clinical phase II with SCO-101, thereby obtaining clinical proof-of-concept, and then find a partner or a licensee. Next step will be to take our second drug candidate, SCO-201 through preclinical and clinical development.

Do any of the staff and or management team hold any shares within the company?

Modified

26.Oct 18

We all do and we have all invested in the Scandion Oncology.

How many staff do you have currently on the team

Modified

26.Oct 18

We have a CEO (Nils Brünner), a CSO (Jan Stenvang), a CMO (Peter Michael Vestlev) and a CFO (Carit Andersen).

When does Scandion Oncology plan to have investor meetings in 2018?

Modified

26.Oct 18

There will be investor meetings at

Investerarträff Copenhagen, October 4, 2018

From 17:30-19:30

Radisson Royal Copenhagen,
Hammerichsgade 1,
1611 København V

Sedermeradagen Göteborg, October 11, 2018

From 11:00-18:00

Elite Park Avenue Hotel,
Kungsportsavenyen 36,
411 36 Göteborg

Investerarträff Stockholm, October 12, 2018

From 11:30-13:00

Scandic Klara,
Slöjdgatan 7,
111 57 Stockholm

Is it correct that we can now pre-invest in Scandion Oncology?

Modified

26.Oct 18

We have just finalized the presubscription period, which went extremely well. From October 4, it will be possible to subscribe to Scandion Oncology shares at Spotlight. Please contact Nils Brünner, CEO (NB@ScandionOncology.com) for further information.

Presentation

Media coverage

Co-funded by the Horizon 2020 programme of the European Union
Co-funded by the COSME programme of the European Union