Hva er historien til Bækkelaget Holding AS i TRVX ? Har ikke fulgt nøye med på listene på lang tid, men ser at det er notert en reduksjon på 70K på siste oppdatering. Er det her volumet kommer fra ?
PS: hadde jeg ikke vært på forumet her, hadde jeg tolket posteren ganske negativt.
Tror mannen bak Bækkelaget er tilknyttet Meyerløkka, er forhatt navn i Trvx kretser;)
Det er en til fra Meyerløkka blandt topp 50 … sitter rolig om jeg husker rett.
Mistenker at det har vært litt skatteplanlegging blande eierne tidligere.
Har ikke sett denne før nå. IOVAXIS etablerer et eller annet i unaiten:
https://opencorporates.com/companies/us_ca/C4575830
Edit:lenka ble feil
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Åpenbart en link her ja. Samme navn både på person (John Wang) og selskap (IOVaxis). Dette er en materie som det er vanskelig å grave i, og som ikke gir mye håndfaste opplysninger av verdi. Mest grunnlag for spekulasjoner som man nesten bør holde for seg selv. Men når Locust Walk (Targovax sin rådgiver) hevder å ha sendt ut teasere til +90 mulige kandidater, så ender man altså opp med å signere en opsjonsavtale for et verdens aller største marked med et lite selskap med 2 ansatte, ingen synlige aktiviteter, og en aksjekapital på MUSD 2. JW`s nettverk bør være av det meget solide slaget dersom dette var den åpenbare kandidaten for TG i Kina som ellers viser en stor interesse for samarbeid av dette slaget.
Igjen, kun spekulasjon, men det kan være at JW/IOVaxis kun skal være en slags agent/fasilitator for Targovax og TG. Både i Kina og i verden forøvrig. Kan jo synes rimelig det også, dersom staben forøvrig er 100% fokusert på ONCOS. Sånn sett kan dette være et spennende funn som gir beskjed om flere nyheter om TG.
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Kursmål, analyser og anbefalinger fra meglerhus kan man tolke som man vil selvsagt, da de ofte har sin egen agenda.
Som blant annet kunde i DNB sitter jeg dog nå og ser hva dem har for kursmål fra 8.mai.
Det er NOK 19.- og anbefaling KJØP.
Så opplever man altså at man knapt kommer oss over 8 kroner et par tre dager før noen plent skal kjøre den godt under igjen, det synes merkelig må innrømme det. Men slik er dette.
Den rette melding en morgen vil kunne endre bildet totalt og la oss for guds skyld håpe at det er nettopp det vi våkner opp til snart, en kruttmelding fra Targovax.
Vel, som tidligere kommunisert idag benyttet undertegnede dagens dipp til å laste opp flere aksjer i selskapet, jeg tror det er snakk om kort tid før vi våkner opp til slik kruttmelding og da kan priser som idag vise seg gull verdt.
Dette er bare mine høyst personlige betraktninger og skal ikke tolkes som annet. Det er opp til alle og enhver å vurdere hva man tror vil skje framover.
Fra rapporten:
Q1 operating loss of cNOK29m less than our cNOK41m forecast. The difference
stemmed mainly from lower external R&D spending; as we have previously highlighted,
this is the company’s most volatile cost item. We have trimmed our operating cost
estimates to better reflect the ongoing clinical development and management’s
guidance. The end-Q1 cash position was cNOK135m, following a successful NOK101m
capital raise. The Q1 cash burn was cNOK36m.
Updated 9-month mesothelioma data in line with previously released data. During
the quarter, Targovax announced that mPFS remains in line with previously published
data and continues to compare favourably with historical controls. In the 6-month data
mPFS in first-line patients was 8.9 months. No new data on the ORR was provided,
which so far has painted an unclear picture. The previous ORR was essentially the
same in the control arm and the experimental arm in first-line patients, while it was
higher in the control arm than in the experimental arm in second and later lines.
However, we believe the key end-point for the regulatory authorities will most likely be
mPFS and OS. More detailed 12-month data is expected during the summer.
Phase IIb trial in mesothelioma likely to start in a year’s time. Targovax plans to
initiate a phase IIb trial of c100 patients in two arms in early 2021. We estimate that such
a trial would cost cNOK200m (assuming the company has access to a CPI through a
partnership deal). During the call, management made references to ongoing discussions
with a pharma partner about being supplied with a CPI as well as collaborating on trial
design and protocols.
Impact from Covid-19 appears limited so far. According to management, clinical
development has been largely unaffected by Covid-19 to date, with the mesothelioma
and melanoma trials fully recruited. Recruitment in the peritoneal trial, however, is
somewhat slower due to the pandemic. Management did not exclude that timelines for
readout may be affected, but maintained its guidance. We are encouraged that patient
treatment has not been interrupted.
BUY and NOK19 target price reiterated. We continue to believe the data from the
mesothelioma trial in H1 and the melanoma trial in H2 2020 will be important share price
triggers. We have trimmed our operating cost assumptions and updated the number of
shares following the private placement, resulting in an unchanged target price.
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Saxo-Bank har operert med kursmål 19 og KJØP i over et år. Har hatt de mistenkt for kopiering av DNO like lenge.
Nei, Per-Øyvind Wold i Bækkelaget har ingenting med Meyerløkka å gjøre. Han er selvstendig investor, og salgene er ren rebalansering av porteføljen. Samme agenda i NANO, men har ingenting med redusert tro å gjøre.
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Så. Siste pasient i meso innrullert 08.mai 2019. Spent på når i juni vi får 12mnd data. Hadde gjort seg med en godmelding snart 
Ikke umulig.
Som TF sa på q1, de er i samtaler om nye studier med TG i både EU og US, både mtp kommersielle avtaler og akademiske avtaler.
Så det kan fortsatt komme mye spennende ut fra TG(som pdd er verdsatt til kr 0 i analyser).
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Ja, håper på nyheter om TG også. Troverdigheten vil falme hen jo lengre tid det går før man hører noe mer om avtalene med Zelluna og IOVaxis. I det siste tilfellet så hadde det f.eks vært til stor hjelp om man kunne anskueliggjøre en tentativ timeline. Nå er vi liksom helt i det blå om videre utvikling.
Måtte ikke IoVaxis signere dealen innen 12 mnd da?
The option can be exercised into an exclusive license by the earlier of i) the first regulatory approval to start a clinical trial in the territory, or ii) one year from the effective date of the Option Agreement. IOVaxis will pay Targovax USD 250.000 for this exclusive option. The milestone payment for the exercise of the option to license TG01/02 is USD 3 million.
Så var det hadde de vel 14 dager eller lignende på å signere ved tommel opp fra kinesisle myndigheter for oppstart av kliniske studier.
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Ja, eller walk away. Tror jeg.
Jeg har en slags beskrivelse av mulig timeline her, som ikke er noe annet enn synsing basert på tilgjengelig info og tolkning av reguleringsbestemmelser:
Disclose whether the 2 pending applications are clinical trials of Targovax mutant RAS vaccines TG01 and TG02
I couldn’t find any info about this company filing any IND in China or abroad, but what’s interesting is the below info:
From the above info what we can see is they haven’t filed IND application in China or any other countries yet by the time the report was release (March 11, 2020).
I talked with some CRO friends. IND applications needed approval before. However, there was a new regulation issued in late 2018. The objective of that regulation was to speedup the clinical trials in China. For IND applications, there is no such a thing called “approval” anymore (JW`s LinkedIn profil sier f.eks "IND applications pending approval)
After you file IND application, the government agency will review it and let you know if more information/dossier is needed. If after 60 days, you haven’t received anything from them, you can start your trials right away. Meanwhile you must register your trials in the database at www.chinadrugtrials.org.cn.
So there is no such a thing called “pending approval” for IND application anymore in China.
I also asked them what if they hired some other companies to help them with the trials, say CROs, will I be able to find the trials in the database using its company name. They said yes.
So I feel this whole thing a bit strange. If it’s not in a rush, you can wait for 60 days. Because by then, if they really plan to do the trial, they’d get oked by the government authority anyway (even if they submitted the application today).
source: http://epaper.cnpharm.com/zgyyb/html/2018-11/13/content_584439.htm?div=0
http://www.nmpa.gov.cn/WS04/CL2080/332139.html
We discussed about why I don’t feel like they’ve submitted IND application for TG01 and/or TG02 because the timeline doesn’t quite add-up the other day.
A CRO friend provided the following information yesterday. This should give a clearer picture of the timeline:
- Pre-submission/dossier preparation: This really depends on the capability of the medical team of each company. Usually takes several months .
a. Animal trial results
b. Clinical trial plan and protocol. If it’s phase 1 and 2, it should be in details. If it’s phase 3, a high-level one should work
-
Fill-in the form at CDE and request for CDE expert discussion
-
CDE feedback about the request : takes 10 days .
-
Meeting with CDE experts: usually 3 months after CDE feedback
-
If the CDE experts are okay with the protocol and the plan, the applicant can submit paper dossier.
-
CDE will send acceptant letter to the applicant in 5 days .
-
The applicant will need to pay the fee. If no deny or questions received after that, 60 days after submission, the applicant can start its trial as designed right away and register at the trial in the database.
-
However, trials usually start 6 months later because a lot of preparations (people, sites, communications, etc.) need to be done.
So from the above timeline, it’s not likely that IOVaxis could have submitted IND for Targovax’s products already. Let’s say they’d got everything, they’d still need at least 100 days (10 days + 90 days) to finally submit the application for CDE to review.
If we add that 100 days to March 11 (according to Targovax’ slide, IOVasix hasn’t submitted the application(s) yet that day) that will send us to Mid-June.
Det som kan være en betydelig faktor X i et slikt (fåfengt) forsøk på å sette en timeline, blir jo overføringsverdien som ligger i Targovax egne studier, og om partene kan ha tjuvstartet på samarbeidet før formell signering.
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Blir kanskje mye, og delvis unyttig info dette, men som et apropos til IOVaxis etablering i US så kan det vises til siste avsnittet i Locust Walks beskrivelse av historien om denne opsjonsavtalen:
SELL-SIDE ENGAGEMENT LEADING TO OPTION AGREEMENT FOR GREATER CHINESE RIGHTS TO A RAS PEPTIDE CANCER VACCINE
https://www.locustwalk.com/targovas-iovaxis-case-study/
Situation Assessment
- Targovax is a clinical stage immuno-oncology company developing cancer vaccines and oncolytic viruses to target hard-to-treat solid tumors
- Targovax’ TG vaccine is a multiple antigen peptide mix designed to induce T-cell responses to RAS driver mutations, covering ~99% of all codon 12 and 13 RAS mutations and all three isoforms
- Despite encouraging data from the phase I/II vaccine trial, the company announced a strategic shift to dedicate all its resources to the ONCOS oncolytic virus program in May
Key Activities
- Prepared high-impact marketing materials (teasers and management presentations) to emphasize differentiated advantages of the TG program and potential pan-RAS efficacy
- Conducted a comprehensive, targeted, and global outreach campaign to over 90 strategic partners with a focus on immuno-oncology focused players
- Provided strategic advice on deal structure, term sheet, and final agreement negotiations. Locust Walk suggested an option structure to match IOVaxis and Targovax’ desired aims of cIND certainty and financial commitment
- Conducted a comprehensive analysis of the terms as compared to value based on a risked NAV using high level commercial analysis and as compared to similar Chinese deals
- Worked extensively in tandem with their BD team and CEO to drive deal across the finish line
Successful Outcome
- Option deal included a $250K option fee, $3M option exercise fee (deferred upfront), and up to $100M in milestones plus tiered royalties on net sales up to mid-double digits
- IOVaxis is a leading pioneer in neoantigen cancer vaccine development in China
- Deal breathes life into a de-prioritized program, enables Targovax to continue building a robust data package for their RAS vaccine program, and possibly find a global partner
Men hva så med Parker ? Død og begravet ? Og dersom “global partner” - bør det øke interessen for identiteten bak det BVI-registrerte selskapet som aksjonær i IOVaxis ?
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Bristol-baserte vaksinestart Imophoron kunngjør i dag utnevnelsen av seriell biotech-gründer og direktør Damian Marron som deres styreleder
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Hvad siger ændringerne på de daglige aktionærlister?
At noen selger. Mye. Trenger ingen liste for å se det.
Siste aksjonærliste viser knapt endring på topp 50.