Open Orphan Share Discussion Threads

[tom218] 01/7/2022 12:23

Thanks all. My mistake. Am aware of where to see RNSs, thought Judijudis post was referring to the value of the new covid contract, rereading I see she was referring to the flu one. I was hoping she'd found a source for the new contract value.

[digger2779] 01/7/2022 11:22

tom218 - all contract news can be found here.

Alternatively scroll down to bottom of this page and click on news in the ORPH box.

[m5] 01/7/2022 11:21

Here you go.

"Open Orphan" or the "Company")

GBP14.7m influenza contract signed

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO , a subsidiary of Open Orphan plc, has signed a GBP14.7m contract for an influenza characterisation study and a follow on influenza human challenge study with an existing top five global pharmaceutical client. Revenue from the contract will be recognised across 2022 and 2023.

This follows a challenge virus manufacturing contract signed with the same client, announced on 4 May 2022. Following completion of the challenge agent manufacturing, the characterisation study will identify a dose of the flu challenge agent that causes a safe and reliable infection in healthy volunteers. The study, which is sponsored by hVIVO, is expected to start in Q3 2022, subject to the relevant regulatory approvals, and will enrol volunteers recruited from the Company's clinical trial volunteer recruitment arm, FluCamp .

As part of the study, hVIVO Labs will develop and validate challenge agent specific assays for the new flu challenge agent to US Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards. This includes quantitative polymerase chain reaction (qPCR) for viral load determination, viral infectivity assay and serological assays for antibody level determination.

Following completion of the characterisation study, hVIVO will conduct a human challenge study, expected to commence in Q1 2023. The study will enable the Company to determine the efficacy of a number of different vaccine candidates for the reduction in incidence of symptomatic flu infection and disease severity in healthy volunteers. This will help select which of the candidates to progress further into later stage clinical trials. The vaccine study can be initiated, subject to receipt of the relevant regulatory approvals, as soon as the Company completes the infectivity and safety data review from the characterisation study and establishes the best challenge agent dose for safe volunteer inoculation.

Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said: "This is another important milestone for hVIVO in that, in addition to the previously announced manufacture of a bespoke challenge agent, we have now been contracted to conduct the characterisation and the challenge studies with this big pharma customer. Moreover, we will also be providing full recruitment and laboratory services. This highlights hVIVO's unique full-service offering in running complex human challenge studies. Our team has a long history of manufacturing challenge agents and conducting human challenge studies. In regard to challenge studies our experience is unrivalled, our scientific expertise unmatched, and our operational delivery in a class of its own."

Alex Mann, Senior Director of Clinical Science of hVIVO, Sponsor Representative and Scientific Design Lead, commented: "This major contract win solidifies hVIVO's position in the market in offering the full spectrum of support to clients, from start to finish of the vaccine and drug discovery process. Furthermore, the development of challenge agent specific assays underlines the skill and expertise of our experienced lab scientific team to validate bespoke assays to international standards for use in good clinical practice (GCP) clinical trials.

The threat of influenza has never been greater, with an estimated one billion cases per year. Our continued work to support our clients' vaccine and antiviral programme's will support the quick, efficient and cost-effective development of these lifesaving medicines."

[tom218] 01/7/2022 10:54

Hi Judijudi, where did the near £15 million figure come from?Regards

[m5] 01/7/2022 07:44

Judijudi 30 Jun '22 - 19:48 - 4165 of 4167(premium)

I dont think they dare to be honest.

[gregb] 01/7/2022 06:44

hTTps://youtu.be/Uv5jvP-y0jsMo talking about 1st Omicron challenge model.

[supernumerary] 30/6/2022 22:30

Good to see this: 'a contract with Vaxart, which will fund the manufacture of an Omicron challenge virus as well as a characterisation study', as payment is not mentioned in the RNS.

[manc10] 30/6/2022 19:53

UK Covid cases surge towards 300,000 PER DAY with one in 21 Brits now infected as of june 30th 2022

[chica1] 30/6/2022 19:41

Nice 1 Sev..

[sev22] 30/6/2022 19:09

Note from House Broker:

OPEN ORPHAN (ORPH): CORP

Another first: developing an Omicron human challenge model.

Having successfully manufactured a Delta challenge virus and developed the world’s first COVID-19 challenge model in 2021, hVIVO is developing a new human challenge model, having signed a contract with Vaxart, which will fund the manufacture of an Omicron challenge virus as well as a characterisation study. Subject to the successful completion of the characterisation study and receipt of relevant regulatory approvals, hVIVO expects to be able to offer Omicron human challenge studies in 2023. Given the rapid emergence of additional Omicron variants (e.g. BA.4 and BA.5) and the focus of Vaxart on developing oral recombinant vaccines, with its first oral COVID-19 vaccine due to report Phase II results in Q3 20222, we expect Vaxart to want to test their vaccine in an Omicron human challenge study. This represents another milestone for the company, further positioning it as the world’s leading expert on challenge studies. We leave FY 2022 forecasts unchanged and reiterate our 44p target price.

[sev22] 30/6/2022 19:08

Note from House Broker:

OPEN ORPHAN (ORPH): CORP

Another first: developing an Omicron human challenge model.

Having successfully manufactured a Delta challenge virus and developed the world’s first COVID-19 challenge model in 2021, hVIVO is developing a new human challenge model, having signed a contract with Vaxart, which will fund the manufacture of an Omicron challenge virus as well as a characterisation study. Subject to the successful completion of the characterisation study and receipt of relevant regulatory approvals, hVIVO expects to be able to offer Omicron human challenge studies in 2023. Given the rapid emergence of additional Omicron variants (e.g. BA.4 and BA.5) and the focus of Vaxart on developing oral recombinant vaccines, with its first oral COVID-19 vaccine due to report Phase II results in Q3 20222, we expect Vaxart to want to test their vaccine in an Omicron human challenge study. This represents another milestone for the company, further positioning it as the world’s leading expert on challenge studies. We leave FY 2022 forecasts unchanged and reiterate our 44p target price.

[ironman22] 30/6/2022 18:11

The ever optimistic M5, go on my son!

[m5] 30/6/2022 16:40

Well given the carnage today I will take that. Time for a beer.

[sikhthetech] 30/6/2022 12:45

1gw,

Still no comment on the results from you, why's that?. 3 weeks now.
Were they that bad that you and your mates don't want to comment?

You also forgot to mention the large 'sells' today. Why only mention the 250k buy, they're not exactly ground breaking, is it?


Klosters,

Nothing wrong with my opinion on the company or posters on here.

I'm sure they can speak for themselves.

[gregb] 30/6/2022 12:44

I'm happy with the 25k sells as long as the 250k and 350k buys keep popping up ;-)

[digger2779] 30/6/2022 12:42

See someone is still banging out 25k sells. When will it stop!!!

[m5] 30/6/2022 12:24

Good luck with that, it tells you everything you need to know.

[klosters65] 30/6/2022 12:21

Sikh, I have no problem with you spouting your contrarian views but I think you should retract - Is it you and your mates buying again to sway PIs to hold? The same ones which you and your mates will sell again -.

[sikhthetech] 30/6/2022 12:03

M5,

That's jam tomorrow.

How much cash did they have as of the fy results date, 7th June? Given H1 ends today, they would have had a very good idea of the cash amount expected as of end H1.
Why didn't they publish it?