Fate Therapeutics Inc (FATE)

[jondoeuk]

New PR https://www.globenewswire.com/news-release/2021/06/04/2241947/24675/en/Fate-Therapeutics-Highlights-Positive-Interim-Data-from-its-Phase-1-Study-of-FT516-in-Combination-with-Rituximab-for-B-cell-Lymphoma-at-2021-ASCO-Annual-Meeting.html

[jondoeuk]

They have just filed (S-1) https://www.sec.gov/Archives/edgar/data/1850119/000110465921074278/tm218551-6_s1.htm

[jondoeuk]

Preclinical data from the second https://www.prnewswire.com/news-releases/exacis-biotherapeutics-presents-data-on-its-stealth-mrna-engineered-nk-cell-platform-at-american-society-of-gene--cell-therapy-annual-meeting-301298920.html

https://www.exacis.com

[jondoeuk]

Interim PhI clinical data for AML programs https://onlinexperiences.com/scripts/Server.nxp?LASCmd=AI:4;F:QS!10100&ShowUUID=E94308D2-1601-44A0-B7E7-F3952FF8E08B

[jondoeuk]

Two others https://shorelinebio.com/programs https://www.prnewswire.com/news-releases/exacis-biotherapeutics-develops-mrna-engineered-ipsc-derived-nk-cells-for-difficult-to-treat-tumors-301255010.html

[jondoeuk]

(OT) Preclinical data (to be presented at the ASCGT meeting) from another company (private) working on iPSC (CAR)NK and (CAR/TCR)T-cell therapies

Abstract: ''Induced-pluripotent stem cells (iPSCs) offer a unique opportunity to create novel cell therapies for cancer with advantages over conventional cell therapies that are derived from leukapheresis products. These advantages include: 1) ability to perform multiple genetic editing steps at the renewable iPSC stage, 2) ability to select and fully characterize single cell clones for genetic integrity and functionality before selecting final product candidate, and 3) ability to generate a clonal master cell bank that is used to produce highly uniform drug products at low cost. Here we describe a highly-engineered iPSC derived natural killer cell (iNK) with six precise genetic modifications intended for the treatment of cancer. These modifications include the use of stealth edits to reduce alloreactivity, a safety switch for product elimination if necessary, the expression of a homeostatic cytokine for improved functionality and persistence, and a chimeric antigen receptor (CAR) targeting CD19 to mediate tumor cell engagement and killing.

For resistance to CD8 T cell-mediated allogenic immune rejection, the beta-2-microbulin (ß2M) gene is disrupted with simultaneous insertion of a transgene encoding the HLA-E protein with tethered ß2M and a peptide. HLA-E was introduced to prevent NK cell cytotoxicity against the engineered cells, which lack HLA-I. For resistance to CD4 T cell-mediated allogenic immune rejection, the class II major histocompatibility complex transactivator (CIITA) gene is disrupted with simultaneous insertion of a transgene encoding both the extracellular and transmembrane domains of EGFR, and the NK cell growth factor IL-15. EGFR provides an elimination tag that can be engaged by clinically approved anti-EGFR antibodies, such as Cetuximab. Finally, a CAR targeting the CD19 antigen is encoded by a transgene delivered into a safe harbor locus.

From the engineered, clonal iPSC bank, iNK cells are differentiated using a 30-day long feeder cell-free process. These iNK cells resemble peripheral blood derived CD3- CD56+ NK cell lymphocytes based on cell surface phenotype. They eliminate HLA-I negative tumor cells comparable to peripheral blood NK cells and when exposed to CD19+ target cells, CAR-iNK cells, they demonstrate potent antigen specific killing that is comparable to conventional CART cells. The multi-engineered iNK cell platform provides a new paradigm for cancer cell therapies through an off-the-shelf product that can be delivered in repeated doses with reduced risk of allo-rejection.''

[jondoeuk]

ASH abstracts:

FT576: Multi-Specific Off-the-Shelf CAR-NK Cell Therapy Engineered for Enhanced Persistence, Avoidance of Self-Fratricide and Optimized Mab Combination Therapy to Prevent Antigenic Escape and Elicit a Deep and Durable Response in Multiple Myeloma https://ash.confex.com/ash/2020/webprogram/Paper142750.html

Novel Method for Clonal Selection of Multiplexed Engineered CAR-T Cells Which Uniquely Demonstrate Anti-Tumor Functionality in the Tumor Microenvironment https://ash.confex.com/ash/2020/webprogram/Paper141506.html

Development of a Novel MICA/B-Specific CAR As a Pan-Tumor Targeting Strategy for Off-the-Shelf, Cell-Based Cancer Immunotherapy https://ash.confex.com/ash/2020/webprogram/Paper141095.html

CAR19 iPSC-Derived NK Cells Utilize the Innate Functional Potential Mediated through NKG2A-Driven Education and Override the HLA-E Check Point to Effectively Target B Cell Lymphoma https://ash.confex.com/ash/2020/webprogram/Paper138527.html

Generation of Multiplexed Engineered, Off-the-Shelf CAR T Cells Uniformly Carrying Multiple Anti-Tumor Modalities to Prevent Tumor Relapse https://ash.confex.com/ash/2020/webprogram/Paper138930.html

Triple Gene-Modified iPSC-Derived NK Cells Combined with Daratumumab for Targeted Immunotherapy Against AML https://ash.confex.com/ash/2020/webprogram/Paper137138.html

Engineered iPSC-Derived NK Cells Expressing Recombinant CD64 for Enhanced ADCC https://ash.confex.com/ash/2020/webprogram/Paper139760.html

cGMP Mass Production of FT538, a First-of-Kind, Off-the-Shelf, Multiplexed Engineered Natural Killer Cell Cancer Immunotherapy Derived from a Clonal Master Induced Pluripotent Stem Cell Line https://ash.confex.com/ash/2020/webprogram/Paper141922.html

Initial Clinical Activity of FT596, a First-in-Class, Multi-Antigen Targeted, Off-the-Shelf, iPSC-Derived CD19 CAR NK Cell Therapy in Relapsed/Refractory B-Cell Lymphoma https://ash.confex.com/ash/2020/webprogram/Paper141606.html

A Phase I Study of FT819, a First-of-Kind, Off-the-Shelf, iPSC-Derived TCR-Less CD19 CAR T Cell Therapy for the Treatment of Relapsed/Refractory B-Cell Malignancies https://ash.confex.com/ash/2020/webprogram/Paper142423.html

Multiplexed Engineered, Off-the-Shelf T Cells Carrying Three Tumor-Associated Antigen-Targeting Modalities: CAR + Pan-Tumor Targeting TCR + CD16 Fc Receptor https://ash.confex.com/ash/2020/webprogram/Paper141507.html

A Phase I Study of FT538, a First-of-Kind, Off-the-Shelf, Multiplexed Engineered, iPSC-Derived NK Cell Therapy As Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination with Daratumumab or Elotuzumab in Relapsed/Refractory Multiple Myeloma https://ash.confex.com/ash/2020/webprogram/Paper137715.html

[CogDiss 1188X]

FATE’s engineered NK cells in trial for covid-19. NK cells fight viral infections, so this is a reasonable new long-term opportunity for FATE’s technology beyond treating cancer. Still very early phase 1 stage investigation but could contribute an unexpected kicker to the stock when results are reported in the next 12 to 18 months.

FT516 uses induced pluripotent stem cells (iPSCs), which are a kind of stem cell made from reprogrammed skin or blood cells. These newly made stem cells have the potential to become any kind of cell in the body. For FT516, iPSCs are transformed into natural killer (NK) cells, which are a type of white blood cell that are a vital part of the immune system and play a role in fighting off viral infections.

Prior to the coronavirus pandemic, FT516 was used in a clinical trial to treat patients with acute myeloid leukemia (AML) and B-cell lymphoma, which are two different kinds of blood cancer.

Due to the natural ability of NK cells to fight off viruses, it is believed that FT516 may also help play a role in diminishing viral replication of the novel coronavirus in COVID-19 patients. In fact, Fate Therapeutics, in partnership with the University of Minnesota, has treated their first COVID-19 patient with FT516 in a new clinical trial.

“We know that NK cells play an important role in responding to SARS-CoV-2, the virus responsible for COVID-19, and that these cells often become depleted in infected patients. Our intent is to replenish NK cells in order to restore a functional immune system and directly target the virus.”

http://blog.cirm.ca.gov/2020/08/12/therapy-developed-with-cirm-award-used-in-new-clinical-trial-for-covid-19

[ClayTrader]

* * $FATE Video Chart 12-09-2019 * *

Link to Video - click here to watch the technical chart video

[Spideyboy]

To JRMKE:

We see again that I was correct that the expenses have increased again, now to 29.5 million in this last quarter. This will again go up with initiation of FT596 for phase I trial. Their quarterly expenses have gone up by almost 10 million per quarter since just over a year ago, and still 7 years away from any potential product approval.

I hadn't even seen the massive 190 million additional injection that they raised in September. Much earlier than even I had expected.

With 303 million in cash, that's good to go another 2.5 years. But at the current rate they are seeking injections maybe about 1.5 - 2 years tops before another massive dilution.

Still wondering how your cash expense calculations are going?

[jondoeuk]

At ASH the company is going to present comprehensive clinical data on ten to twelve patients from the FT500 trial.

[biosectinvestor]

[avav1001]

Thanks, FYI. I take it the genetic engineering steps used by FATE are good enough to stop rejection for the transfer of NK or T-cells derived from iPSC. Do you think it's somewhat similar to the procedures used by Universal Cells? http://www.universalcells.com/technology/

[jondoeuk]

The cells aren't matched as they use iPSCs in order to provide a renewable cell source for consistent and repeated manufacture of homogeneous cell products.

The company uses addition genetic engineering to try and reduced (or stop) rejection by the recipient's T and NK cells. They have shown already they can administer up to six treatments without any DLTs.

[avav1001]

Does "off the shelf" mean cells without matching can be used for short durations like a few months for treatment?

[Spideyboy]

To JRMKE:

Now the last quarterly burn was a whopping 26.9 (27) million dollars. And has increased again as I predicted.

160 million dollars left, so they have enough to last a total of 1 year and 2 quarters, meaning at their burn which will probably still go up a couple million, probably about 1 year to go before new massive dilution.

In the meantime clinical advances are slow and any product still many many years away. Even a partner will usually only look to get in after Phase II results so not likely for the foreseeable future. It boggles the mind how buzzwords are keeping this company's market cap where it is.

How is your reading up on cash-burns going now?

[Spideyboy]

To JRMKE:

As you can see my conclusions were correct that their cash burn has increased to over 20 million per quarter, standing currently at least 23 million per quarter. This figure will probably continue to show increases going forwards.

Thus the 144 million they raised earlier will last them 1 year and about an extra quarter before they will need to raise again. And at what will probably average at a 25 million per quarter burn, expect heavy heavy raises afoot for a long while. Remember their most advanced candidate is in Phase I trials, many many years away from potential commercialisation.

The newly published 10q states they have a total of 183 million as of March 31st 2019, so giving them about another 40 million of emergency cash, but to which they will probably raise before going into those funds.

I hope you are now reading into company cash burns more deeply and will avoid calling others negligent.

good luck!

[Spideyboy]

To JRMKE: Apologies for sending this as a public reply back to your private message, but I have not paid for and see no need to pay to upgrade my account to allow for private messages.

In-following from you post that for reference I have copied at the end of this post, please see my reply here:
--

Incorrect JRMKE.

https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-reports-third-quarter-2018-financial-results

If you look properly at the 2018 third quarter results PR you will see,

"R&D Expenses: Research and development expenses were $13.6 million for the third quarter of 2018"

"G&A Expenses: General and administrative expenses were $4.1 million for the third quarter of 2018"

Thus adding up to 17.7 million for the third quarter, rounding up to 18 million, and so including higher expenses relating to the new clinical trials we are looking at about or more than 20 million cash burn per quarter.

A company's running costs are more than just its R&D Expenses, which it appears is the only number you are referring to with your "13M", for their quarterly burn.

Therefore the recent raise of 144 million will last them about 1 year and a couple months as I previously stated.

Please refrain from writing replies insinuating negligence on the part of others when you haven't looked at all the relevant numbers, which is indeed negligent on your part.

Thank you.

--

JRMKE
Friday, December 28, 2018 8:37:09 AM

FATE's cash burn rate is not 20M per quarter, it is 13M! Yes, the IND clearance for FT500 will increase their burn rate, but that will be mitigated by their recent HQ exapnsion (Summer 2018) and their ability to manufacture the IPSC cells in house. Their cash runaway should last them 3-4 quarters more than you state and their recent partnership with Ono will also save them desperately needed cash to get to commercialization. Will more capital raises be needed, between now and then--absolutely! However, posting a burn rate numbers that are off by almost 100% is negligent on your part.

[Spideyboy]

The science behind the company's technology is both interesting and would seem sound in theory, however do we not think the SP is a bit high considering that, they have a cash burn of about 20 million per quarter and that is without the just approved IND for Phase I trial start.

So they will be needing about 80-100 million per year. So their recent September 140 million dollar offering will take them max 1 year and a couple months before they'll need another massive injection. These clinical trial programmes are likely to need near a decade to complete and come to approval.

I'm not saying it won't happen but they are going to need serious serious cash to get there and at the current Phase I stages this will mean plenty of dilution to come to keep things running. Thus, don't we think the SP and M/C are presently a little overvalued?

[jondoeuk]

https://www.fiercebiotech.com/research/off-shelf-cell-therapy-for-cancer-fate-therapeutics-to-make-its-case-at-ash

[Spideyboy]

Anybody know why this stock is so high right now?

From 1.53 In May 2016, to 12.84 now seems like a crazy run for a company which as I can see pretty much doesn't have anything real yet.

Looking at their pipeline and clinicaltrials.gov, their most advanced candidate, FATE-NK100, is in 3 Phase I trials, so about 8 years away from anything.

And the other most advanced immuno-regulation product is ProTmune in Phase I/II.

Looking at this board, the only 'event' I see recently is a private placement in Aug 2016.

I like the look of their allogeneic CAR-T idea, but still has a long way to go to prove itself. Thus I'm assuming share-price has just been riding the CAR-T excitable wave, but with nothing really to hold it up right now?

Going to be major cash burn with no-revenues for this company for a long time, how come it's valued at 680 million dollars?

[WheresMyPhone]

Why nobody talking about this market? It topped at 14 and now trickling down it seems. What gives?

[mj66b]

Wainwright is the house that destroyed CRMD if I'm not mistaken.

[now invest]

H.C. Wainwright initiated coverage with a $7.00 Buy rating...

Raymond James also has a $7.00 target... NICE !!!!

[now invest]

a nice 15K bid came in at 4.23 large for Fate.. so I added more at 4.24... see another over 10K bid and I think it could get interesting... remember RJ has a 7 target..

[now invest]

What a great move!!

[now invest]

Hmmm well could be setting up a nice chart... could break 200 day MA today !!

[now invest]

Nice move today.... added a little at 3.29 Raymond James still has this as a strong buy.... with a target of 7.... would LOVE to see it move even to 6 !!

[Fibanotch]

trade, flip, then north maybe

[MotoManiac]

Whatever we gained yesterday we lost today. Seems like a 1 day news bump that couldn't hold.

[Fibanotch]

still going higher

[Triple9]

Webcast recording of CEO Scott Wolchko on Feb 15, 2017 at the Leerink Partners 6th Annual Global Healthcare Conference

http://ir.fatetherapeutics.com/events.cfm

[Triple9]

Pipeline for $FATE http://fatetherapeutics.com/our-immuno-pipeline/

[Triple9]

The Barchart Technical Opinion rating for $FATE is a 96% Buy with a Average short term outlook on maintaining the current direction.

Longer term, the trend strength is Maximum. Long term indicators fully support a continuation of the trend.

https://www.barchart.com/stocks/quotes/FATE

[Triple9]

In at $4.09-$4.10

[crazy horse 0]

Yes, I sold today

The CC yesterday was good.

Like AVEO

[mick]

did they release them ?????

[mick]

http://www.barchart.com/interactive_charts/stocks/fate

[crazy horse 0]

Fate Net loss per common share 29 cents compared to 33 cents,

(.29) This Quarter June 30, 2016

(.33) Last Year June 30, 2015

http://ir.fatetherapeutics.com/secfiling.cfm?filingID=1564590-16-23312&CIK=1434316


Weighted-average common shares used to compute basic and diluted net loss per share











)


































28,868,464

[crazy horse 0]

Fate CC 5pm today Today's Conference Call and Webcast
The Company will conduct a conference call today, Monday, August 8, 2016 at 5:00 p.m. ET to review financial and operating results for the quarter ended June 30, 2016. In order to participate in the conference call, please dial 1-877-303-6235 (domestic) or 1-631-291-4837 (international) and refer to conference ID 52471261. The live webcast can be accessed under "Events & Presentations" in the Investors & Media section of the Company's website at www.fatetherapeutics.com. The archived webcast will be available on the Company's website beginning approximately two hours after the event.

[crazy horse 0]

"Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that it has entered into a securities purchase agreement for a private placement with a select group of institutional investors, including funds managed by Franklin Advisers, Inc., under which the investors have agreed to purchase 5,250,000 shares of the Company’s common stock at a price of $1.96 per share, for gross proceeds of approximately $10.3 million. The Company expects to use the proceeds from the transaction primarily to advance its pipeline of programmed cellular immunotherapies and for general corporate purposes.

The Company did not use a placement agent in connection with the transaction. The purchase and sale is expected to close on or before August 10, 2016, subject to customary closing conditions."

http://ih.advfn.com/p.php?pid=nmona&article=72160259

[mick]

http://www.barchart.com/interactive_charts/stocks/FATE

[mick]

Fate Therapeutics, I (FATE)
2.44 ? 0.33 (15.64%)
Volume: 719,109 @ 11:27:43 AM ET
Bid Ask Day's Range
2.41 2.44 2.06 - 2.59
FATE Detailed Quote

[crazy horse 0]

Fate is moving

eom

[crazy horse 0]

Back in Fate

eom

[mick]

i like share structure/ 'Fate Therapeutics Inc. (FATE)'

[crazy horse 0]

What is your opinion

on ARNA

[mick]

Fate Therapeutics, I (FATE)
2.07 ? 0.09 (4.55%)
Volume: 525,273 @ 4:04:23 PM ET
Bid Ask Day's Range
1.65 2.3 1.92 - 2.12
FATE Detailed Quote

[TrendTrade2016]

yep, out at resistance. BIOS bit unstable today.

GLTA
TRENDTRADE2016

[crazy horse 0]

Sold my FATE

EOM take a look at AVEO