OncoSec Medical Inc (ONCSQ)

[Titan V]

Hi Pazzo, I interpreted that as them being able to say that they have enough cash till Q1 2018, because of the drug supply agreement lifting the burden to purchase the anti-PD-1 from their own pockets. I don't believe they are hinting at some inflow of cash from the drug supplier. They've said a commercial partnership will be possible after data has been generated from this registration trial.

Few things that stood out to me:

1.

In an effort to help us achieve these objectives, we intend to be opportunistic about bringing in non-dilutive capital, as well as Wall Street validation by attracting healthcare institutional funds.

Non-dilutive captial, as in research grants?

Wall Street validation - are they finally going to disclose the "healthcare dedicated fund" that has been funding them $10M+ a year since 2014? It wouldn't be validation if they raised the next round without mentioning again who the fund(s) is (are). Btw I expect the next dilution to take place sometime in Q3'17. It could be fewer shares if the share price gains some ground after drug supply partnership and validation from big pharma. Let's see. Anyway, a few more million shares to the 19.7M outstanding will be nothing if the registration trial meets endpoints and they are able to secure a commercial deal.

2. They had $20.5M in cash & equivalents a/o January 2017. Focusing only on melanoma seems to have helped in conserving cash.

3. This is new - besides Australia, the registration trial will recruit patients in Europe as well. Is a new subsidiary in the works in Europe?

Yes. Thanks again. So Jason, so the expectation there is that we would – we're expecting to start first patient in by Q2 of 2017 and then we – this calendar 2017, its going to be a study conducted in the US and Australia for starters and then we'll add European sites as well, roughly 10 to 20 centers across those three geographies, which would give us estimation of finishing enrollment by Q2 of 2018.

4. Preliminary data as early as Q4 2017 - Is this the basis for the 2017 milestones list that has a bullet point for licensing / collaboration? Will the data from the first cohort, if good, be enough to strike a commercial deal with MRK?

So we're looking for very concise quick enrollment within a year on this particular population of anti-PD-1 failures and then we would have data along the way. It is an open label study. So we would have the initial data based on a strong cohort of patients and a six month follow-up. So it could be as early as Q4 calendar year 2017 and then final data by Q1 of 2019.

5. Looks like they are planning to (maybe already have) apply for Orphan Drug Designation or BTD.

Roshni Mahadeo

Okay. And my last question is, now that you have Fast Track, are you applying for orphan drug designation for IL-12?

Punit Dhillon

Yes. So we are working through a pretty - several different components of a regulatory framework here that does include orphan drug designation and breakthrough designation, an accelerated approval framework.

I was looking for ODDs involving IL-12 and found out that Celsion received ODD for their DNA plasmid IL-12 therapy in ovarian cancer in 2005. The treatment didn't get FDA approval eventually though.
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=198304

What's the benefit of getting ODD followed by FDA approval? (Extract from a Celsion 10-Q below)

Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. However, if a product which has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity. Orphan drug designation can also provide opportunities for grant funding towards clinical trial costs, tax advantages and FDA user-fee benefits.

"receives the first FDA approval for the indication" - Does treating anti-pd-1 refractory patients meet the definition if no one else has obtained approval in treating this subset of patients?

More details on ODD in below link. Not really sure if melanoma fits the bill for ODD but I wouldn't mind a surprise PR in the coming months.
https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/ucm2005525.htm

Another IL-12 related ODD:
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=377012

CC Transcript: https://seekingalpha.com/article/4055990-oncosec-medicals-oncs-ceo-punit-dhillon-q2-2017-results-earnings-call-transcript?part=single