Forum: Kiadis Pharma » Kiadis Pharma Augustus 2018 » Pagina: 20 | Belegger.nl

Kiadis Pharma Augustus 2018

461 Posts, Pagina: « 1 2 3 4 5 6 ... 15 16 17 18 19 20 21 22 23 24 » | Laatste
Aantal posts per pagina:  20 50 100 | Omlaag ↓
PGV
0
quote:

Biobert schreef op 30 aug 2018 om 12:41:


[...]

Ik denk aan Novo Nordisk als overnemende partij


En wat voor een bedrag denk je dan aan, 3 a 4 miljard
Boort
1
quote:

DeZwarteRidder schreef op 30 aug 2018 om 15:30:


Molmed wordt niet overgenomen, dus waarom Kiadis wel...???


Gezien het fundamentele verschil in de behandeling; ATIR richt zich op het voorkomen van GVHD, Zalmoxis op het behandelen in GVHD zich voordoet. Bovendien wordt aangenomen dat ATIR een goedkopere behandeling is in directe zin (de behandeling zelf) en in indirecte zin (het niet hoeven behandelen van GVHD).

En omdat Kiadis Maarten van der Weijden als ambassadeur heeft... :)
StandaardVerlies
0
quote:

BlijvenHopen schreef op 30 aug 2018 om 14:26:


Waarom stapt Robbert van Heekeren eigenlijk op? Zo vlak voor de belangrijkste tijd in de geschiedenis van Kiadis Phrama (of toch niet?). Is hij het niet eens met het nieuw te voeren (amerikaanse) beleid? En gaat er nog heeel veel geld opgehaald worden (lees aandelen uitgegeven worden)…..



Nou, denk je dat dit opstappen is. Niet dat hij eruit moet, maar op een gegeven moment past een ander profiel beter bij de huidige situatie en toekomst.
el pato loco
0
kiadis.com/news-and-events/events/

kiadis is weer aanwezig in September op

Goldman Sachs 8th Annual Biotech Symposium
Oppenheimer Fall Summit focused on Specialty Pharma and Rare Disease
KBC Securities 6th Biotech and Healthcare Conference

DeZwarteRidder
0
CytoDyn receives ODD for PRO 140 for prevention of GvHD
Stock MarketsOct 05, 2017 08:42AM ET

CytoDyn (OTCQB:CYDY) announces that the FDA has granted Orphan Drug designation to PRO 140 for the prevention of graft versus host disease (GvHD).
Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
PRO 140 is a humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T cells.
Sjonnie2
0
quote:

DeZwarteRidder schreef op 30 aug 2018 om 20:54:


CytoDyn receives ODD for PRO 140 for prevention of GvHD
Stock MarketsOct 05, 2017 08:42AM ET


CytoDyn (OTCQB:CYDY) announces that the FDA has granted Orphan Drug designation to PRO 140 for the prevention of graft versus host disease (GvHD).
Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
PRO 140 is a humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T cells.


www.cytodyn.com/new-developments

We have initiated our first clinical trial with PRO 140 in an immunological indication – a Phase 2 clinical trial with PRO 140 for Graft versus Host Disease (GvHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are undergoing bone marrow stem cell transplantation. GvHD represents an unmet medical need, with patients who contract GvHD during stem cell transplant having a significantly decreased 1-year survival rate with relapsed GvHD as the leading cause of death. PRO 140 is also being investigated in animal models of cancer progression and autoimmunity with positive results. Our animal studies in GvHD have been submitted for publication in peer-reviewed journals.

Heb het even doorgelezen maar ik denk dat Kiadis een heel stuk verder is in Europa. Voor de USA moet ik er even verder induiken....maar nu even niet.
Wat me wel opvalt is dat je bericht van 5 oktober 2017 is.


BIOcoin
0


Kiadis Pharma announces Financial Results for the six months ended June 30, 2018 and Company update


Amsterdam, The Netherlands, August 31, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces its unaudited interim Financial Results for the six months ended June 30, 2018, which have been prepared in accordance with IAS 34 as adopted by the European Union.

Arthur Lahr, CEO of Kiadis Pharma, commented: “We have made tremendous progress in the last six months: ATIR101 is now very close to potential CHMP opinion in 2018, we are on track with our Phase 3 trial, and obtained further confirmatory data from our Phase 2 trials. To allow us to ramp up our Phase 3 trial and prepare for commercialization in the EU we also raised substantial equity and debt facilities that extended our cash runway into the third quarter of 2019, and, upon positive CHMP opinion, potentially into the first quarter of 2020. We have also significantly strengthened our organization in medical, operations, commercial and finance functions. Kiadis is in great shape and well positioned to deliver on the promise of ATIR101.”

Operating highlights – ATIR101 (including post reporting period)
European marketing authorization application for ATIR101: Responses to the Day 120 List of Questions submitted in March 2018;
Day 180 List of Issues received in May 2018 and responses submitted in August 2018;
On track to obtain CHMP opinion from the European Medicines Agency in the fourth quarter of 2018.

Phase 3 trial CR-AIR-009, comparing ATIR101 against the post-transplant cyclophosphamide (PTCy) or ‘Baltimore’ protocol: Progress in line with internal plans: 14 clinical sites are currently open for recruitment, 16 patients have been enrolled;
Protocol amendment submitted to regulatory authorities: number of patients increased to 250 to further increase power [80% power to detect 16% Graft-versus-host-disease-free and Relapse-Free Survival (GRFS) difference]; interim analysis to occur after 2/3 of GRFS events to increase chance of positive read out, now expected in the second half of 2020; conditioning regimens harmonized between the two treatment arms to reduce heterogeneity.

Phase 2 trial CR-AIR-008 (‘008’): The last patient received a single dose of ATIR101 in January 2018.
Pooled analysis: Further analysis of 1-year Phase 2 pooled data [Intention-To-Treat (ITT), 37 patients] from studies CR-AIR-007 and single dose CR-AIR-008 shows GRFS 53% [95% confidence interval (CI), 39%-72%]; Overall Survival (OS) 58% (95% CI, 44%-77%), in line with Phase 2 CR-AIR-007 trial. For the PTCy/Baltimore protocol, single site data from Johns Hopkins (McCurdy et al. 2017) and Atlanta (Solh et al, 2016) show a disease-risk index (DRI) normalized 1-year GRFS value of 40% and 30%, respectively.

Operating highlights – Organization (including post reporting period)
Robbert van Heekeren resigned as Chief Financial Officer and as member of the Management Board.
Scott A. Holmes appointed as new Chief Financial Officer.
Organization strengthened across all functions, comprises 73 employees, up from 51 a year ago. Key new appointments include head of Medical US (former Iovance/ Dendreon), head of Medical EU (former Genzyme/ AstraZeneca), head of market access EU (former Genzyme/ Novo Nordisk), head of pharmacovigilance (former Astellas), head of facilities (former Merck/ Douwe Egberts).
Otto Schwarz, former Chief Operating Officer of Actelion and Mr. Subhanu Saxena, former Chief Executive Officer of Cipla and former member of the senior executive team of Novartis, were appointed as Supervisory Board members of the Company at the Annual General Meeting of shareholders in June 2018. Mr. Stuart Chapman resigned from the Supervisory Board following the shareholders’ meeting.

Financial highlights (including post reporting period)



FINANCIAL SUMMARY For the six months ended
(Amounts in EUR million, except per share data) June 30, 2018 June 30, 2017 Change

Total revenue and other income – – –
Total operating expenses (11.1) (8.2) (2.9)
Research and development (7.7) (5.9) (1.8)
General and administrative (3.4) (2.3) (1.1)
Operating result (11.1) (8.2) (2.9)
Net financial result (3.0) (0.4) (2.6)
Net result (14.1) (8.5) (5.6)

Net operating cash flow (10.6) (7.6) (3.0)

Cash position at end of period 41.7 10.7 31.0

Equity 25.3 3.5 21.8

Earnings per share before dilution (EUR) (0.74) (0.61) (0.13)


In the first six months of 2018, the Company did not generate any revenues. Total operating expenses increased by EUR2.9 million from EUR8.2 million in the first six months of 2017 to EUR11.1 million in the same period of 2018. This increase was primarily caused by a further expansion of the workforce in all areas of the organization, the move to a larger building which includes a commercial manufacturing facility, laboratories and office space, and consultancy expenses for business development and market access.
In the first six months of 2018, net financial result came in at EUR3.0 million compared to EUR0.4 million for the same period of 2017. Higher finance costs were mainly the result of higher interest expenses on loans and borrowings, and a net foreign exchange loss in the first six months of 2018 compared to a net foreign exchange gain in 2017.
The net loss for the six months ended June 30, 2018 came at a level of EUR14.1 million compared to a loss of EUR8.5 million for the six months ended June 30, 2017. Operating expenses and net result for the first six months of 2018 were in line with management expectations.
The Company ended the first six months of 2018 with EUR41.7 million in cash and cash equivalents. In March 2018, the Company issued 2.6 million shares and raised EUR23.4 million in gross proceeds.
On July 31, 2018, the Company received a new debt facility from Kreos Capital V (UK) Ltd providing the Company with up to EUR20 million of additional financing.
Jeroen_The_Man
0
Verlies Kiadis Pharma loopt op
Gepubliceerd op 31 aug 2018 om 07:27

AMSTERDAM (AFN) - Kiadis Pharma heeft zijn verlies in het afgelopen halfjaar zien oplopen ten opzichte van een jaar eerder. Het in Amsterdam genoteerde farmaceutisch oncologiebedrijf maakte onder meer kosten voor het verder op peil brengen van het personeelsbestand. Verder kampte Kiadis met hoger rentekosten en negatieve wisselkoerseffecten.

Het bedrijf, dat nog geen omzet draait, sprak zelf van operationele uitgaven conform de verwachtingen. Het nettoverlies kwam uiteindelijk uit op 14,1 miljoen euro, tegenover een tekort van 8,5 miljoen een jaar eerder. De kaspositie werd aanzienlijk verbeterd van 10,7 miljoen vorig jaar naar 41,7 miljoen euro eind juni, door de uitgifte van nieuwe aandelen en een nieuwe financiering.

Kiadis heeft nu naar eigen zeggen voldoende middelen in kas om het zeker tot in het derde kwartaal van volgend jaar uit te zingen. Het bedrijf zegt verder goede vooruitgang te hebben geboekt met het uiteindelijk op de markt brengen van zijn belangrijkste middel ATIR101.
Endless
1
Arthur Lahr, CEO of Kiadis Pharma, commented: “We have made tremendous progress in the last six months: ATIR101 is now very close to potential CHMP opinion in 2018, we are on track with our Phase 3 trial, and obtained further confirmatory data from our Phase 2 trials. To allow us to ramp up our Phase 3 trial and prepare for commercialization in the EU we also raised substantial equity and debt facilities that extended our cash runway into the third quarter of 2019, and, upon positive CHMP opinion, potentially into the first quarter of 2020. We have also significantly strengthened our organization in medical, operations, commercial and finance functions. Kiadis is in great shape and well positioned to deliver on the promise of ATIR101.”
Dit stukje vind ik belangrijker dan de cashburn.
DeZwarteRidder
0
quote:

BlijvenHopen schreef op 31 aug 2018 om 07:20:


14,1 miljoen verlies........

Ze hebben toch geld zat.....!!

Ze kunnen best een dividenduitkering doen...!!
Windkracht
0
Lahr is overtuigd van de enorme progressie die de afgelopen 6 maanden gemaakt is en is erg positief over de verwachte goedkeuring. Organisatie staat nu helemaal klaar om de goedkeuring te gaan ontvangen!
List of issues na de beantwoording van april ontvangen door Kiadis in de maand Mei en deze issues zijn deze maand weer beantwoord door Kiadis.
Laat die goedkeuring binnen 7 weken nu maar komen.

Voor de rest, financials, geen inkomsten en wel kosten. Niets nieuws onder de zon. Benieuwd of de markt vanaf 9 uur nog een mening heeft over de update.
Sjonnie2
2
Het enige nieuws waar ik op zat te wachten:

Day 180 List of Issues received in May 2018 and responses submitted in August 2018
Goed nieuws, de goedkeuringsprocedure is weer opgestart na de Dag 180 stop.



Endless
0
quote:

Sjonnie2 schreef op 31 aug 2018 om 07:37:


Het enige nieuws waar ik op zat te wachten:

Day 180 List of Issues received in May 2018 and responses submitted in August 2018
Goed nieuws, de goedkeuringsprocedure is weer opgestart na de Dag 180 stop.





Ze liggen goed op schema en de goedkeuring ligt nu binnen handbereik. een hogere cashburn is evident,hoe verder in process Hoe hoger deze is.
Windkracht
0
er worden nu 450 stukken in de laat gelegd op 9,35......het orderboek begint wederom weer rare patronen te tonen, de contollers worden wakker.
Endless
1
quote:

Windkracht schreef op 31 aug 2018 om 07:58:


er worden nu 450 stukken in de laat gelegd op 9,35......het orderboek begint wederom weer rare patronen te tonen, de contollers worden wakker.

Geen weldenkend mens verkoopt nu zo laag, manupilatie mijn idee. Er zijn ook beleggers die amper weten waar ze in beleggen en die lezen grotere verlies... maar goed ik hou ze vast wat voor rare koerssprongen er vandaag ook zullen zijn.
DeZwarteRidder
0
quote:

Windkracht schreef op 31 aug 2018 om 07:58:


er worden nu 450 stukken in de laat gelegd op 9,35......het orderboek begint wederom weer rare patronen te tonen, de contollers worden wakker.

Er zijn heel veel teleurgestelde aandeelhouders.
461 Posts, Pagina: « 1 2 3 4 5 6 ... 15 16 17 18 19 20 21 22 23 24 » | Laatste
Aantal posts per pagina:  20 50 100 | Omhoog ↑

Plaats een reactie

Meedoen aan de discussie?

Word nu gratis lid of log in met uw e-mailadres en wachtwoord.

Direct naar Forum

Detail

Vertraagd 23-aug-19 17:35
Koers 4,962
Verschil +0,052 (+1,06%)
Hoog 5,000
Laag 4,910
Volume 55.748
Volume gemiddeld 101.868
Volume gisteren 158.609