Gilead Sciences Inc (GILD)

[Monksdream]

GILD a new 52 week high

[Monksdream]

GILD new 52=week high

[jondoeuk]

Two years later, and here are some of my takeaways...

- They know they need to expand into more (rural) areas and that might include pre-built clean rooms. Slides 21-26 show how difficult it is to drive uptake further. "Majority of future growth expected from establishing new ATC's in community." These centres need to establish new relationships with others for apheresis, local ER's for (CRS/ICANS) emergencies and even local freezer storage requirements, which is it's own thing. So much goes into treatment that has nothing to do with manufacturing.

- Forgot ZUMA-12 data was that good. A 86% CR rate and 81% three-year survival from 1L patients. Not sure how to compare that to later line trials, but decades from now, let's hope we are at the point we treat this front line (vs SOC now). Kite said their COGS is <50% from day one, which is now likely <$75k, but who knows how to account for all the R&D and acquisitions. Another 25% reduction coming via automation and scale. So an ~80% margin by 2030.

- Non-viral and in vivo have been moved to the back of their timeline. Anito-cel, dual CARs, autoimmune, allo NKs, solid tumours and three day manufacturing ahead of it. Transposons gets a mention on slide 84. I hope they drop the latter and go with CRISPR as it allows for site-specific integration.

- 20k Kite patients treated

[jondoeuk]

''There have been more than 250 HIV vaccine trials, most of them early-stage, looking at whether the vaccine is safe and whether we mount an immune response following vaccination. There have been very few vaccine trials—10 or so—that have advanced to the point of looking at efficacy. Of those, one showed 31% efficacy at 42 months. That was the most promising trial, but the efficacy fell off very quickly, and it was only 31% and only against clade B. Whether that would translate to the other clades is not clear.'' https://publichealth.jhu.edu/2022/why-dont-we-have-an-hiv-vaccine

[jondoeuk]

How the hell is Dan O'Day still making 26 mil? A monkey throwing dart would have been better than this dimwit

— Jack Shaw (@JackSha90859576) October 19, 2024

[TechandBio]

Wants to go higher!

$GILD

[Monksdream]

GILD approaching a 52 week high

[north40000]

Featured on CNBC-TV this morning, 8:40 a.m. time frame.

[TechandBio]

NICE!

clutch stock with a disruptive cure prevention vaccine for HIV people would rather take 2 shots a year not to get HIV then taking oral pills for treatment!

$GILD

[TechandBio]

Adding shares and calls under $80..00

HIV Cure Vaccine is a big deal data is incredible flawless. Oncology pipeline is building nicely.



$GILD
$GILD

[midastouch017]

Compugen Announces FDA Clearance of IND for COM503 for the Treatment of Solid Tumors

https://finance.yahoo.com/news/compugen-announces-fda-clearance-ind-110000034.html

FDA clearance triggers a $30 million milestone payment from Gilead

[Monksdream]

GILD under $100

[TechandBio]

Target is $100-$120 by Q2 2025

$GILD

[TechandBio]

HIV Prevention CURE Shot 2x a year

Great growing oncology pipeline!

my $80 vertical Calls from last week are looking golden!

$GILD

[north40000]

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174602784

"Gilead plans to share new preclinical data for an oral GLP-1 at the upcoming American Diabetes Association conference starting June 21… The asset, dubbed GS-4571, has previously demonstrated 5% to 8% weight loss in monkeys in 28 to 30 days…"

[north40000]

How about oral GLP-1 news? CNBC-TV AH today. Portal Innovations CEO interview.

[jondoeuk]

There is barely any move on this news. Seems the market had already written it off. O'Day needs to go, they need to rebuild in areas they have expertise in and refocus in oncology.

[jondoeuk]

A double whammy https://www.oncologypipeline.com/apexonco/asco-2024-full-evoke-01-result-adds-gileads-trodelvy-problems

[jondoeuk]

They guided that a third of revenues will be from oncology by 2030...! https://www.businesswire.com/news/home/20240530516266/en/Gilead-Provides-Update-on-Phase-3-TROPiCS-04-Study

[jondoeuk]

''Using independent datasets, we validate that CD8-fit T cells (1) are present premanufacture and are associated with clinical responses in individuals treated with axicabtagene ciloleucel, (2) longitudinally persist in individuals after treatment with CAR T cells and (3) are tumor migrating cytolytic cells capable of intratumoral expansion in solid tumors.'' https://www.nature.com/articles/s43018-024-00768-3

https://medicalxpress.com/news/2024-05-cancer-optimal-cells.html

[jondoeuk]

The oNKo-Innate team, along with scientists at Kite, have just published a research article https://onlinelibrary.wiley.com/doi/10.1002/cti2.1507

Optimised manufacturing dramatically improves lentiviral transduction efficiency of primary human NK cells. The field has progressed greatly with CAR transduction rates in human NK cells (it was ~5% just a few years ago). The oNKo-Innate R&D team were able to raise CAR transduction efficiency to ~80%. After testing various NK cell sources, they conclude that the exponential expansion pre- and post-transduction and high on-target cytotoxicity make PB-derived NK cells a feasible and attractive CAR-NK cell product for clinical utility.

''No doubt CAR-NK cells have faced several challenges in oncology settings, and we hope our new findings assist researchers in addressing some of these challenges while also improving the potential for CAR-NK cell therapies in treating autoimmune disease such as lupus'' said Nicholas Huntington, PhD, oNKo-innate's CSO.

[jondoeuk]

The management has been substandard for many years https://www.fiercebiotech.com/biotech/gilead-gives-49b-antibody-solid-tumor-plan-unravels and https://www.fiercepharma.com/pharma/gilead-writes-24b-trodelvy-ceo-underscores-time-focused-execution

[jondoeuk]

IL-12 is the new IL-2! https://www.oncologypipeline.com/apexonco/xilio-gets-gilead-shaped-reprieve

[jondoeuk]

Interesting (preclinical) data from another company. It summarises two distinct phenotypes of cells within the product (they are manufacturing), each of which plays a different role in responding to cancer cells. Each cell population were separated based on whether they produced CD4 on their surface (CD4+ vs. CD4-). Cells negative for CD4 (CD4-) were better able to kill target cancer cells via the CD19 CAR. In contrast, CD4+ cells proliferated faster in response to CD19+ cancer cells. The two groups of cells also produced a different cytokine response in response to CAR activation.

[jondoeuk]

Kite Analyst & Investor Event https://s29.q4cdn.com/585078350/files/doc_events/2024/Mar/14/gild_kite-analyst-investor-event-14-march-2024.pdf

[jondoeuk]

I found the poster, but nothing on the design of the CARs, data on ex vivo expansion, or the percentage of CD62L+ NKTs https://www.jci.org/articles/view/83476 https://journals.aai.org/jimmunol/article/201/7/2141/107140/IL-21-Selectively-Protects-CD62L-NKT-Cells-and

[jondoeuk]

Some more https://www.abstractsonline.com/pp8/#!/20272/presentation/10568

[Monksdream]

GILD new 52 week high

[jondoeuk]

Preclinical API-192 data https://ash.confex.com/ash/2023/webprogram/Paper181271.html

It is a first-in-class OTS CAR-NKT cell therapy that expresses dual CARs (targeting CD19 and CD20) and sIL-15. API-192 is the first development candidate out of a '21 collaboration and license agreement with Kite.

[jondoeuk]

Another next-gen collab https://www.businesswire.com/news/home/20231030344859/en/Kite-and-Epic-Bio-Announce-Collaboration-to-Develop-New-Therapies-for-Cancer

There have been a number of these over the years, but nothing seems to come of them

[jondoeuk]

The ACLX partnership looks like it could be be a gold mine. The ASH data completely dooms TSVT https://ash.confex.com/ash/2023/webprogram/Paper189761.html

If Breyanzi can't take share from Yescarta, Abecma doesn't stand a chance. They made sure to point out how Carvytki is giving some Parkinsonian-like events where they have not seen it (yet). Carvykti vs ddBCMA is going to be a battle down the road.

[Greedy G]

~bought 9/22 $80 calls .08c

[jondoeuk]

Q1 results https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171789595

[DewDiligence]

Why is an oral prodrug of Remdesivir anything to get excited about?

[jondoeuk]

Obeldesivir (an oral prodrug of remdesivir) https://news.yahoo.com/gilead-details-promising-early-covid-223448308.html

[jondoeuk]

Kite just released ZUMA-7 results for 2L https://www.businesswire.com/news/home/20230320005701/en/Kite%E2%80%99s-Yescarta%C2%AE-CAR-T-cell-Therapy-Demonstrates-a-Statistically-Significant-Improvement-in-Overall-Survival-for-Initial-Treatment-of-RelapsedRefractory-Large-B-cell-Lymphoma

What's big is that the trial reached five year maturity instead of just the number of deaths. Looking at it, more than 210 of the 359 (58%) are still alive at five years compared to 43% in ZUMA-1 (3L+). Sure, these were healthier patients, but the CR rate was more double (65% vs. 32%) against the standard of care. So, treatment works better in healthier patients. ZUMA-23 in 1L (against R-CHOP) is ongoing.

The next question is whether treating healthier patients with multiple myeloma (if they can resolve supply issues with auto) can (significantly) improve PFS.

[fink]

Christmas sell off over, last day to lock in any paper tax loss. LOL

Who’s losing money here?

I think we start the trend back up into Q1

[fink]

It wants $90.
I got a sell order in @88, but think it will continue up.
Gilead is moving away from HIV and more into this cancer thingy.

That’s not enough in my mind to justify the rise. But I do think as World central banks default and the Fed starts to absorb these other world bank’s debt on foreign currency collapse, private money has to go somewhere safe. Pharma has always been recession proof. Gilead was a great stock to load. Like LNG was 7 years ago. No end is sight there too

Gilead still needs revenue from its new cancer avenues. HIV, they own and always will. Just already built into the $60 stock price

[PennyPusher786]

It's at a 3 year high

[fung_derf]

Very funny that you posted this to me. I couldn't recall, but knew there were a couple of you who followed me over here. It has had a pretty nice month.

I_luv_cydy

Re: fung_derf post# 3875

Tuesday, May 19, 2020 2:32:23 PM

Post#
3878
of 4839
Fung: Why do you suppose GILD keeps dropping? I'm a shareholder for a while.

[fink]

Nice to see GILD over $80

Wonder if I should trim some? It’s been eating chit pie for some time.
Still don’t see why the spike.

[jondoeuk]

Kite and Refuge Biotechnologies Announce Exclusive License Agreement for Investigational Gene Expression Platform for Blood Cancers https://www.businesswire.com/news/home/20221020005633/en/Kite-and-Refuge-Biotechnologies-Announce-Exclusive-License-Agreement-for-Investigational-Gene-Expression-Platform-for-Blood-Cancers

Some preclinical data from Refuge Bio https://jitc.bmj.com/content/8/Suppl_3/A86.2 https://jitc.bmj.com/content/9/Suppl_2/A162 https://jitc.bmj.com/content/9/Suppl_2/A164 https://jitc.bmj.com/content/8/Suppl_3/A458.2

[Zeppo]

Gilead has underperformed for so long, given the size of the company as well, that I could encourage Bill Ackman to make a run at it.

[DewDiligence]

GILD details why the purportedly-positive Trodelvy data from Mar 2022 weren’t:

https://www.businesswire.com/news/home/20220603005437/en

The study met its primary endpoint of progression-free survival (PFS) with a statistically significant and clinically meaningful 34% reduction in the risk of disease progression or death (median PFS 5.5 vs. 4 months; HR: 0.66; 95% CI: 0.53-0.83; P<0.0003). The first interim analysis of the key secondary endpoint of overall survival (OS) demonstrated a trend in improvement.

In this context, a “trend in improvement” means non-statsig. OS could conceivably turn statsig in a later data cut, but that’s pretty unlikely.

The viewpoint in #msg-158260565 (from 2020) has not changed.

[mick]

Gilead Sciences Inc (GILD)
59.77 ? -1.79 (-2.91%)
Volume: 10,483,423 @04/29/22 7:42:23 PM EDT
Bid Ask Day's Range
59.53 60.0 59.27 - 62.06
GILD Detailed Quote

[jondoeuk]

ZUMA-11. Improved CAR-T responses with 4-1BB agonist utomilumab added to axi-cel. The cells were more of central and effector phenotype. No (S)AE concerns.

[jondoeuk]

Link to the audio recording https://investors.gilead.com/events/event-details/gilead-sciences-oncology-deep-dive

[jondoeuk]

Oncology Deep Dive https://investors.gilead.com/static-files/332d0c81-fa18-44fa-82d3-babf96ca12d0

https://endpts.com/with-more-than-30-oncology-partners-gilead-lays-out-its-2030-vision-of-20-new-approvals/

[jondoeuk]

ZUMA-12 https://www.nature.com/articles/s41591-022-01731-4

The CR rate was higher than standard frontline chemo, with just a single treatment vs. six cycles over about four months.

No reason to think long-term curve won't flatten like ZUMA-1 (which was post ~two years).

PDUFA date (for 2nd line) is April 1.

[mick]

GILD News: Gilead price target slashed at Barclays following new Trodelvy data 03/10/2022 05:38:07 AM
GILD News: Current Report Filing (8-k) 03/07/2022 03:31:07 AM
GILD News: Phase 3 TROPiCS-02 Study Met the Primary Endpoint of Progression-Free Survival in Late-Line HR+/HER2- Metastatic Breast Cancer 03/07/2022 03:30:00 AM
GILD News: Robert W. Baird Sticks to Their Hold Rating for Gilead Sciences (GILD) 03/03/2022 12:10:51 AM
GILD News: Jefferies Thinks Gilead Sciences’ Stock is Going to Recover 03/02/2022 03:35:55 AM