Genincode Share Discussion Threads

[hedgehog 100] 30/11/2021 17:05

I don't think it's likely that he would try to sell an institutional-sized stake on the market: more likely he would place it, especially with his contacts.

But he's a specialist investor in this sector, so he will know how good GENI is:


He's also extremely wealthy.

So I think it's far more likely that he's become aware of a periodic seller of GENI shares, and wishes to take advantage of that.

[toffeeman] 30/11/2021 16:42

or if he chooses to sell..................

one hell of an overhang

[hedgehog 100] 30/11/2021 14:15

29/11/2021 07:00 UKREG GENinCode PLC Directorate Change
"GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces that David Evans, Non-Executive Director, has notified the Board of his intention to stand down from his role with immediate effect.
Bill Rhodes, Non-Executive Chairman of GENinCode Plc said: " We would like to thank David for his invaluable contribution to GENinCode during his tenure. David has worked with members of the GENinCode management team for many years, and he has always provided instrumental strategic advice and counsel from his wealth of experience in the sector. On behalf of the Board, I would like to wish him the very best for the future.""


David Evans has already been removed from the board of directors page on GENI's website:


He owns 3.46% of GENI's shares:


Now he's resigned he will have more leeway to add to his holding, to take advantage of the depressed GENI s.p.

[hedgehog 100] 25/11/2021 11:09

"The FDA's Breakthrough Devices Program
... Requirements for participation
For a manufacturer to be able to obtain approval for their devices through the Breakthrough Devices Program, it must meet several requirements.
▪ The medical device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions. Examples would include strokes, heart attacks, cancer, severe trauma and ALS.
▪ At least one of the following criteria must be met:
▪ The device is a technological breakthrough (breakthrough technology). For example, a new genetic test that would allow the treatment options to be evaluated better.
▪ There are no approved alternatives. According to the FDA, there is currently no device that can diagnose Parkinson's disease directly.
▪ It offers a significant improvement compared to approved alternatives.
The device is in the best interest of patients. This would be the case if the alternatives have major side effects or if the new device significantly improves the diagnostic options and their use. ..."


25/11/2021 06:59 UK Regulatory (RNS & others) GENinCode PLC Trading update LSE:GENI Genincode Plc
" ... -- Cardio inCode(R) de-novo submission for US regulatory approval with the FDA - The Company continues to have constructive and ongoing discussions with the FDA and is finalising its de-novo application. The de-novo submission is expected to be filed by the end of this year.
-- Breakthrough Device Designation (FDA) for Cardio inCode(R) - Discussions continue to progress with the FDA to advance Cardio inCode(R) as a 'Breakthrough device'. Discussions have been extended partly due to FDA workload, but also resulting from a detailed assessment of GENinCode's CVD prognostic device which, in turn, has given the Company confidence to file its de-novo submission earlier than it might otherwise have planned. The Company remains well placed to complete this process over the coming months. ..."



The FDA seem to be very seriously considering Cardio inCode(R) for Breakthrough Device Designation.

Which is not surprising, as it appears to meet the qualifying criteria well.

If it gets it, the pathway to approval and sales in the US would clearly be accelerated.

But it would also provide a real boost in terms of kudos and distinction.

[t0pgrader] 25/11/2021 09:15

Seemingly on track

[hedgehog 100] 10/11/2021 14:17

Thanks Toffeeman - good work.

[toffeeman] 10/11/2021 09:49

Hedgehog - thanks for the suggestion - should be there now

[hedgehog 100] 09/11/2021 18:04

Toffeeman,

Thanks for starting this thread.

Please could you add Fundamentals & News to the thread header: you can do this by clicking on edit at the start of your header post above, which will bring up the following boxes which you can click:

Fundamentals News

And also perhaps a link to GENI website (with the HTTP part in upper case to hypertext the link), and some material from it.

Thanks in advance.

[hedgehog 100] 08/11/2021 17:18

A good recent example of spin-out outperformance is BYIT, which IPOed in December at 270p, since when it has doubled.

Current share price 558.5p, market cap. £1.33 billion.

GENI looks to have even more potential though, starting from a much lower market cap., and with such huge business growth prospects.

17/12/2020 08:01 UK Regulatory (RNS & others) Bytes Technology Group PLC Completion of Demerger and Admission to Trading LSE:BYIT Bytes Technology Group Plc
"Following the announcement by Bytes Technology Group on 11 December 2020 of the Offer Price of its IPO, the Company announces the completion of the Demerger of the Bytes Group from the Altron Group, which took effect at 8.00 a.m. (UK time) today.
In addition, the Company announces its entire ordinary share capital consisting of 239,482,333 Ordinary Shares of GBP0.01 each has today been admitted to the premium listing segment of the Official List of the FCA and to trading on the LSE's Main Market for listed securities under the ticker "BYIT" and the Main Board of the JSE by way of a secondary inward listing under the symbol "BYI"."


Bytes Technology (BYIT):

[diversification] 06/11/2021 17:39

News must now be imminent as the November window closes and we should see both a winter rally in the broader markets and a deluge of news from Genincode. Time to be excited.

[hedgehog 100] 06/11/2021 17:12

Well Toffeeman, you seem to have a good eye for a quality health sector growth stock, so hopefully RMD's success is a good sign for GENI ... RMD's rise looks like pure GENIus!

[toffeeman] 06/11/2021 16:15

Hi Hedgehog,

Shame I sold my RMD - but I still keep watching them.

I've only ever started two threads, because no one else had!

[hedgehog 100] 06/11/2021 12:35

The last health sector share thread Toffeeman started was nearly four years ago, on US-Oz listed stock ResMed, a leader in CPAP (continuous positive airway pressure) tech.



Current share price: US$260.55, up from about US$5 in January 2000.

Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
Healthcare 3,196.83 479.52 3.24 77.0 37,968




ResMed (RMD):

[hedgehog 100] 31/10/2021 12:09

22/07/2021 07:00 UK Regulatory (RNS & others) GENinCode PLC Admission to trading on AIM & First Day of Dealing LSE:GENI Genincode Plc
"... On 28 April 2021, the Company announced a partnership to provide genetic testing from labs based at Royal Brompton and Harefield Hospitals. Following this, it was announced on 14 June 2021 that a product commercialisation agreement had been entered into with EVERSANA in the US. The Directors believe that the partnership with EVERSANA, a leading provider of global commercial services to the life science industry, will provide a significant opportunity for the Group to progress its commercialisation plans for the US. ..."



"GENinCode announces major US commercialisation partnership with EVERSANA
Posted on June 14, 2021

Oxford, UK. — 14, June 2021 — GENinCode UK Limited, the cardiovascular disease company focused on predictive genetics for the prevention of cardiovascular disease, announces its partnership with EVERSANA Life Sciences LLC (“EVERSANA”) as its launch and commercialisation partner to access the United States market for the GENinCode portfolio of polygenic cardiovascular disease (“CVD”) products focused on genetic risk.

EVERSANA is a leading provider of global commercial services to the life sciences industry. In the United States, GENinCode will utilise EVERSANA’s COMPLETE Commercialisation model fully integrating services that include market access, agency services, clinical and commercial field teams, medical science liaisons, channel management, health economics and outcomes research and compliance, with each service optimised by data and predictive analytics. The suite of expertise will underpin and accelerate the launch of GENinCode’s first product Cardio inCode for the risk assessment of CVD in primary prevention. The EVERSANA group comprises over 4,000 employees.

GENinCode specialises in polygenic risk assessment for the onset of cardiovascular disease with the Company’s technology providing clinicians with genetic risk assessment and AI bioinformatics to inform, predict and prevent cardiovascular events. CVD is the leading cause of death and disability worldwide accounting for one in every four deaths in the United States. In 2010, the global cost of CVD was approximately US $863 billion. By 2030, this figure is set to rise to US $1,044 billion and is both a major health issue and global economic burden.

CVD is a broad disease classification which encompasses conditions such as coronary artery disease (causing angina, heart attacks, heart failure), cerebrovascular disease (causing stroke, and some dementia), peripheral vascular disease (causing limb ischaemia, and some chronic kidney disease) and venous thromboembolism.

GENinCode will deliver its portfolio of polygenic CVD products through its partnership with EVERSANA.

GENinCode and EVERSANA have a vision to inform patients about their cardiovascular risk and to improve public health by using the predictive capability of genomics to assist in making lifestyle choices and targeting treatment to improve patient outcomes. Over the past 15 years GENinCode has amassed significant investment in its research, data, bioinformatics technology and product development to assess disease risk to prevent the onset of CVD.

Matthew Walls, CEO, GENinCode said: “We have worked closely with the EVERSANA team over the past 12 months and are delighted to announce our US partnership. EVERSANA provide proven launch and commercialisation expertise to support our market access and will help accelerate our speed to market.”

Jim Lang, CEO of EVERSANA said: “GEN inCode’s approach to understanding and addressing genetic risk is revolutionary and as such, these products demand a commercialisation model that bypasses traditionally strategies to acceleration launch, access and impact. EVERSANA is eager to put the full power of our platform to work.”

For more information visit www.genincode.com

Enquiries:

GENinCode UK Limited

Tamsin Jeffs
Tel [phone]
EVERSANA

Sarah Zwicky
Tel [phone]
About GENinCode

GENinCode is a UK based company specializing in cardiovascular disease risk. Cardiovascular disease is the leading cause of death and disability worldwide. GENinCode UK Limited operates business units in Europe and Latin America through GENinCode S.L.U, and in the United States through GENinCode U.S. Inc. GENinCode’s predictive technology provides patients and physicians with globally leading preventative care and treatment strategies. Our CE marked invitro-diagnostic molecular tests combine clinical algorithms and bioinformatics to provide advanced patient risk assessment to predict disease onset. To learn more about GENinCode, visit www.genincode.com or connect through LinkedIn and Twitter.

About EVERSANA

EVERSANA™ is the leading provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life science solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter."

[hedgehog 100] 30/10/2021 13:35

22/07/2021 07:00 UK Regulatory (RNS & others) GENinCode PLC Admission to trading on AIM & First Day of Dealing LSE:GENI Genincode Plc
"... The Company's commercialisation strategy in the US is a significant part of GENinCode's long-term growth and commercial strategy. The Directors expect Cardio inCode to be reviewed by the FDA as a De Novo device. The Company submitted an initial application to the FDA in February 2021 for Breakthrough Device designation for its Cardio inCode product. The FDA review is ongoing with a decision expected in Q3 2021. ..."



"HOW TO USE THE DE NOVO PATHWAY FOR YOUR MEDICAL DEVICE

By Tom Rish, January 12, 2021 , in Regulatory Compliance and Regulatory Affairs and Medical Device Product and Medical Device Industry and Process / Planning

... How is De Novo different from the 510(k) route? While devices using the 510(k) pathway rely on predicate devices for proving substantial equivalence to a previously marketed device, De Novo begins with a completely clean slate. With no equivalence criteria required, De Novo uses a risk-based approach to assessing medical devices. ..."




"The FDA's Breakthrough Devices Program

The FDA is trying to facilitate quicker access for critically ill patients to novel medical devices through a new program for breakthrough devices.

In December 2018, it published a guidance document on the program.

In this article, we will explain how the Breakthrough Devices Program works and what requirements manufacturers must meet in order to be able to participate in it.

... Requirements for participation

For a manufacturer to be able to obtain approval for their devices through the Breakthrough Devices Program, it must meet several requirements.

▪ The medical device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions. Examples would include strokes, heart attacks, cancer, severe trauma and ALS.

▪ At least one of the following criteria must be met:

▪ The device is a technological breakthrough (breakthrough technology). For example, a new genetic test that would allow the treatment options to be evaluated better.

▪ There are no approved alternatives. According to the FDA, there is currently no device that can diagnose Parkinson's disease directly.

▪ It offers a significant improvement compared to approved alternatives.

The device is in the best interest of patients. This would be the case if the alternatives have major side effects or if the new device significantly improves the diagnostic options and their use. ..."

[hedgehog 100] 28/10/2021 17:29

The fact that GENI is a spin-out is a major bull point, as spin-outs on average greatly outperform the market as a whole. -

"Mar 5, 2019,10:38am EST|4,108 views

Spin-Offs Outperforming The Market This Year

Joe Cornell Contributor

Markets

You can beat the Street. At a time when many professional investors lament that the proliferation of ETFs and widespread use of screening techniques have made it harder to find bargains in the stock market, one simple investing approach continues to outperform: spin-offs.

Spin-offs have long been a fruitful investment area; a number of academic studies show that they historically have generated far better returns than the overall stock market. A spin-off occurs when a corporation issues stock in a subsidiary to its shareholders to create a new public company. A related corporate event is an IPO carve-out, through which a company sells the public a stake in a unit, while retaining the rest of the division. (Sometimes, the remainder is later distributed to shareholders).

The Bloomberg U.S. Spin-Off Index, composed of companies spun off from larger companies within the past three years, has outperformed the broader market by nine percentage points since the start of the year through Tuesday (February 26th). The 35 member index contains equities with a value over $1 billion that were spun-off from U.S. companies. ..."

[diversification] 10/9/2021 17:52

'@Stifel initiate coverage for @GenIncode with a BUY rating - "With US launch planned for 2022 and potential for sales to reach $225m by 2028E, we see significant upside to the shares." Target price 175p #GENI

[t0pgrader] 07/9/2021 09:20

Cenkos note published today with 70p share price target

[barbello] 04/9/2021 11:01

Have registered for results preso...good chance to hear management again

[cj91] 11/8/2021 08:43

Ha! I certainly think GENI will come good a lot sooner than AGL. The money raised in the IPO is to commercially launch their products across key markets - US, EU and the UK. With various regulatory approvals, commercial launches and partnership deals to be signed - I think a modest valuation of £25mil (excluding the £17m fund raise) should be worth a lot more once management delivers on their targets. The directors hold 33% so are also incentivised to drive shareholder value.

[barbello] 10/8/2021 17:19

Thanks, the old adage 'better to be lucky than good' applies I can assure youI bought AGL over 15 years ago so hope this delivers a little sooner.

[cj91] 10/8/2021 15:34

Well done Barbello, I wish I had stumbled across this a couple of weeks ago to be able to buy in lower but pleased to have bought in at IPO price (i.e. c44p). Extremely hard to buy given the low free float. What an opportunity to be involved given the market cap and valuation! c£20m in cash out of the £42m mcap. Directors own 33% so fully aligned with shareholders! Institutions hold a further 50% and I think looking at trades over the last couple of days are probably adding further at current valuation.

The CVD industry has a market of over 1 trillion dollars! FDA approval in Q3 is the next big milestone due and with commercialisation planning in full swing, it won't be long before good revenues start to trickle in.