Q&A

 

Questions Answers
1.       Kan man inte jämföra your technology lite med det man gör vid envisa infektioner? Dvs. man tar ett bakterieprov och kollar vilka eller vilket antibiotika som de infekterande bakterierna är känsliga emot? Och så använder man det. The comparison with precision for treating infections is quite good. Even though the technologies are different the end goal is the same: Precision Medicine – only treating high likelihood responders.
2.       Om jag har förstått saken rätt – efter att ha sett presentationer från både i Sverige och Köpenhamn – är det exakt DET ni sysslar med. Fast inte med infektioner utan med cancer. Ni screenar med “companion diagnostics verktyg” ut de patienter som troligtvis kommer att svara på på behandling med t.ex. Irofulven INNAN patienten behandlas med – i detta fallet – Irofulven. Hur stor chans är det att ni lyckas tror ni? In all the drugs and all the cancer indications we have looked at in clinical trials, we have had around 80% accuracy, meaning that in 8 out of 10 drugs – and drug combinations -we have been able to with a very high precision to correctly predict a response (with a significant P-value).

We expect that our DRP technology is stronger in some drugs than others, and because of this we expect that our technology will work in 2 out of 5 drugs.

 

3.       Fråga: Finns det andra firmor som håller på med samma sorts upplägg? Det vore ju konstigt om det inte finns det. Hur framgångsrika har dessa i så fall varit hittlls? This is a strong field of competition.

Our competitors use a technology that identifies already known mutations in the cancer – and in those cases where drugs exist that hit that exact mutation the patients sometimes can receive a qualified guidance.

Our approach is unique since it encompasses the complexity of cancer (!) and uses a multitude of genetic signatures to predict response to a drug.

To sum up, our competitors use a knowledge driven approach, whereas we are totally data driven: we get a high resolution look at how the cancer cell is operating.

 

4.       What is the cost of a DRP? OV pays 125t DKK to MPI for each fully developed DRP for 2 years. This can be repeated at OV’s discretion.
5.       How long do you have the rights to the DRPs? The DRP rights are OV’s when 1 million DKK has been invested in a project. OV therefore has obtained all DRP rights to APO010, LiPlaCis and Irofulven with no further payments to MPI – except of course for the 10% license fee on OV income from the specific drug.
6.       What is the difference between your technology and Next Generation Sequencing (NGS)? NGS is looking for mutation in the DNA. But in order for a DNA to have any function it needs to be expressed via RNA. That is why we look at RNA expression.

By looking at RNA expression we get information about what is actually going on in the cell – how the individual cancer operates – and not what the cell potentially can do.

7.       What is the DRP patent situation? The DRP is currently patented in more than 70 anti cancer drugs. New DRPs are continually patented.
8. You say that the chip – on which you measure RNA-  is a part of the product when out-licensing and that it cost 700 USD. Is the 700 USD what OV earns when screening individual patients? Today a newly approved cancer drug typically cost >10.000 USD per month per patient.

In OV the drug specific DRP is used to identify those patients who have a high likelihood of effect of the treatment. The DRP uses raw data from the chip (hardware) and the big data algorithm (software).

Each drug is to be developed and approved in combination with its specific DRP in a so-called Co-Development and the price of the chip will be included in the price of the combined solution.

9. Can the chip/DRP be used alone for Personalized Medicine? About Personalized Medicine: This is what our partners in MPI is developing. Technologies not similar, but in the same field, usually sell for ~USD 3000/test.
10.  Does LiPlaCis “only” have a positive effect on ~10% of the patients with metastatic breast cancer? Will the DRP make it possible to determine which ~10% this is? The DRP identifies the response likelihood for each patient. We can define the cutoff (i.e. top 10 or 20%) depending on our goal e.g. competition and the number of patients to be enrolled.

It may well be that a cutoff of 30-40% is more relevant if or when the drug goes to market.

11. When you write that you have succeeded in 80% of the studies you have performed with your DRP analysis, does that mean that you cannot predict any effect in 20% of the studies? This means that we have not been able to predict with a p value below .05 (highly significant). This can be caused by several things: Too small a trial population to be significant or no effect of the drug on cells (which is required for the DRP to work). In some cases, our DRP is not stronger than a combination of other clinical covariates (information already utilized in clinic, such as hormone receptor status, age, etc).
12. You state that the DRP is correct in 80% of the studies, yet you expect it to work in only 40% of the studies you initiate, why is that? 80% success in clinical studies is demonstrated. Expecting success in 40% of the cases is conservative.

 

 

13. What is the deal potential of Oncology products if the product is sold after successful phase 2? The reported financials from 119 Oncology Phase 2 deals in USA 2011-2016:

Average up-front: 54 million USD Average milestones: 404 million USD (Source: Global data, Prospect 2016)

 

In general, upfront payments for Phase 2 compounds appear to be in the range of 30-100 million USD, development milestones 300-700 million USD and royalties.

(Source: Global data)

 

This significant spread in value depends on a number of parameters such as stage of out-licensing (small Phase 2 versus a large Phase 2), technology, indications and potential market, novelty and competition, the Phase 2 data, the associated future development and commercial risks etc.

14. What is the potential market size for LiPlaCis®? LiPlaCis will be tested in several indications:
LiPlaCis Sales potential in Breast Cancer  > 700 million USD.(Same market expectations as Halaven® which sold 482 million USD in 2015).
LiPlaCis® will also be tested in Lung Cancer which is estimated to 7,5 Billion USD market in 2016.(Source: Global data)The estimated market value for prostate cancer drugs estimated in 2016 to 5,0 Billion USD.(Source: Global data)
15. Are there any analyst coverage of Oncology Venture? Coverage in Sweden:

Coverage from Smallcap.se:

http://www.smallcap.se/company/44/analysis/0/

 

Please also listen to:

Danish “Millionærklubben”:

http://www.oncologyventure.com/wp-content/uploads/2015/07/millionaerklubben-22-07-2015-audio.mp3

16. Are the any investor discussions about OV? See e.g:

Avanza: Bank: https://www.avanza.se/placera/forum/forum/oncology-venture-swe.0.html

 

Euroinvestor: http://www.euroinvestor.dk/boerser/nasdaq-omx-stockholm/oncology-venture-sweden-ab/27779826/debat

 

Nordnet – Shareville: https://www.shareville.dk/aktier/oncology-venture-sweden-ab/kommentarer

 

Questions Answers