Black Diamond Therapeutics Inc (BDTX)

[dcaf7]

Several EGFR TKIs received BTD based on Ph1/2 data. For example, CLN-081, Sunvozertinib, Mobocertinib.

[FACT-MASTER]

BDTX: Osimertinib history/BTD designation

https://www.drugs.com/history/tagrisso.html

June 6/2017 - data presentation ( see above link)

October 9/2017 - BTD granted

https://www.astrazeneca.com/media-centre/press-releases/2017/tagrisso-granted-breakthrough-therapy-designation-by-us-fda-for-the-1st-line-treatment-of-patients-with-egfr-mutation-positive-non-small-cell-lung-cancer-09102017.html#

April 18/2018 - FDA approval for first line treatment (see first link above)

July 30/2020 - BTD granted for adjuvant therapy

https://www.cancernetwork.com/view/fda-grants-breakthrough-therapy-designation-to-osimertinib-for-early-stage-egfr-nsclc

December 18/2020 - FDA approval for adjuvant therapy

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-adjuvant-therapy-non-small-cell-lung-cancer-egfr-mutations

[FACT-MASTER]

Interesting institutional purchase by BIOTECH GROWTH N V

( there is a huge Dutch connection here with BDTX, imo, including myself at 50% Dutch)

Check out the details here:

https://www.sec.gov/Archives/edgar/data/924223/000089924323016705/xslF345X04/doc4.xml

and Cuarcao here:

https://en.wikipedia.org/wiki/Cura%C3%A7ao

[dcaf7]

Stifel upgraded Black Diamond Therapeutics (BDTX) to Buy from Hold with a price target of $10, up from $2, following the company's BDTX-1535 phase 1 data released this week. Compared to novel developments that have modest monotherapy efficacy in 2L post-Tagrisso and are forced into combinations or lengthy randomized trials, the BDTX-1535 effect size may potentially allow for rapid monotherapy regulatory paths, the firm says.

[FACT-MASTER]

Thank you for the summary of the presentation.

Could be an incredible story in the making here.

BDTX mgmt doing an excellent job here, imo.

( i am swamped with work for the time being but will have a listen to the presentation when i can)

[FACT-MASTER]

Black Diamond Therapeutics Announces Pricing of Public Offering of Common Stock

https://www.globenewswire.com/news-release/2023/06/30/2697495/0/en/Black-Diamond-Therapeutics-Announces-Pricing-of-Public-Offering-of-Common-Stock.html

This is all happening very quickly, imo - it's still Thursday and it's still June. This is lightening fast, imo,

Considering where the price has been for the last 6 months or so, the $5 offering price is actually pretty good, imo.

Be slightly over 50 million shares outstanding, excluding potential option grants

[dcaf7]

HC Wainwright upgraded shares of Black Diamond Therapeutics from a neutral rating to a buy rating in a research report sent to investors on Wednesday. The brokerage currently has $11.00 target price on the stock.

[FACT-MASTER]

It will be interesting to see who steps up to the plate for BDTX shares in the upcoming offering.

I'm not 100% sure, but instead of a collaboration agreement, AstraZeneca and/or Merck could participate in the funding and development of BDTX 1535 via share purchasing in the upcoming offering.

BDTX 1535 appears to be developing into a vital asset of interest.

https://finance.yahoo.com/news/black-diamond-therapeutics-announces-proposed-202300478.html

Just wondering, Wedbush target of $10/share x 50 million shares would put market cap at 500 million, that doesn't seem unreasonable, imo.

[dcaf7]

What I learned from yesterday's presentation:
1. Drug demonstrated dose linear PK. It allows for greater predictability in drug response, simplifies the dosing process, reduces risk of dose-related toxicity, and makes drug development process easier.
2. Manageable EGFR TKI safety profile. In fact, at the proposed 200 mg QD dose, safety profile of BDTX-1535 is similar to Osimertinib.
3. Drug is active. ORR of 50% in patients progressed on Osimertinib, although it is true for evaluable population.
4. Clear anti-tumor activity in CNS. One comment from invited KOL was that many patients have CNS only resistance. Very high unmet medical need.
5. Robust reduction of ctDNA carrying mutant alleles. In a few cases, mutant clones were eliminated completely after 1535 treatment.
6. Activity against acquired and intrinsic mutations in this study. Preclinical studies indicate that drug is active for more than 50 different EGFR mutations.
7. Plan to initiate dose expansion cohorts in newly diagnosed patients with intrinsic driver mutations as well as in 2nd line Osimertinib R/R patients. One cohort will study patients with CNS mets.
8. First pivotal trial may be a single arm trial with ORR as a primary endpoint for accelerated approval. I expect a BTD designation.
9. Patient population in NSCLC in the US only: 4000 patients with intrinsic driver mutations and 6000 patients with acquired resistance mutations, including C797S and a number of complex mutations. It is 10,000 not even counting GBM patients.

[dcaf7]

Jun. 27, 2023
Wedbush has upgraded Black Diamond Therapeutics (NASDAQ:BDTX) to outperform from neutral after the biotech reported positive phase 1 data on lead asset BDTX-1535 for lung cancer.
The firm also boosted its target price to $10 from $3 (~443% return based on Monday's close).
Analyst Robert Driscoll said that based on the results in non-small cell lung cancer, he believes BDTX-1535 has potential in patients with a wide range of EGFR mutations, including as a first-line treatment for intrinsic (non-classical) such mutations.

[TheFinalCD]

PRETTY SICK MOVE...


WATCH OUT FOR A CAPITAL RAISE

[Invest-in-America]

BDTX: A Godzilla-Class, Monster, CONGRATS to all here (like ME!!) who scored some HUGE profits on this cute little puppy today!!!!

[FACT-MASTER]

https://www.precisionmedicineonline.com/cancer/astrazeneca-q1-oncology-product-sales-increase-14-percent-led-tagrisso

The EGFR-inhibiting lung cancer treatment Tagrisso (osimertinib) continued to be AstraZeneca's top-selling oncology product in Q1 2022, with revenues growing 14 percent to $1.30 billion from the prior year's quarter. The company is looking to expand the drug's indications, such as for refractory, advanced non-small cell lung patients who have already received and progressed on Tagrisso due to acquired MET overexpression or amplifications.

[FACT-MASTER]

Osimertinib (Tagrisso) broke the $5 billion mark for the first time this year, up 13% year-over-year. Sales in the United States were US$1.780 billion (+14%), mainly due to first-line and adjuvant treatment indications, covering more patient populations, but some of them were reduced by second-line treatment drugs, and difficulties in diagnosis and testing brought about by the epidemic offset.

https://www.echemi.com/cms/484962.html

[FACT-MASTER]

Congratulations to BDTX management.

Nice initial data news release.

[FACT-MASTER]

https://www.sec.gov/Archives/edgar/data/1701541/000110465923074995/tm2319750d1_ex99-1.htm

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001701541/000110465923074995/tm2319750d1_8k.htm

Remember osimertinib (Tagrisso) is AstraZeneca which received FDA fast track pathway to approval during it's development back a few years ago.

No mention today of cohort 3 with temozolomide = Merck

Clinical site for 1535:
https://classic.clinicaltrials.gov/ct2/show/NCT05256290

[Invest-in-America]

BDTX: See UP-dated 'Chart', below!!!

[Invest-in-America]

BDTX: See the 'CHART', right now, below!!!

[Invest-in-America]

BDTX: Are you feelin' LUCKY?? Bet your damn ASK I am!!!!

[Awl416]

Wild

[Invest-in-America]

BDTX: Hey, Mr. dcaf7, I'm tryin' to get through this day gulpin' lots of DCAF COFFEE, Dude!!

[Invest-in-America]

BDTX: Delighted that I WAITED my standard 1.5-hrs. into the Open before I grabbed this puppy!!! (I.e., when it was only up by circa 77%.)

[dcaf7]

Encouraging data. BDTX-1535 looks like a real deal.

[TheFinalCD]

BDTX NEWS https://finance.yahoo.com/news/black-diamond-therapeutics-announces-initial-110000974.html

https://finviz.com/quote.ashx?t=BDTX&ty=c&ta=1&p=d

[FACT-MASTER]

That is true to a certain point.

imo, the addition of cohort 3 sort of leans the P1 data to being positive. We know that Temozolomide is an older therapy with limited results. The question remains though, what did they find in the cohort 1 and 2 that precipitated cohort 3 - could be interesting.

I'm sure BDTX mgmt.is aware of what Nimbus was able to do with their P1 results from their psoriasis therapeutic. 1535 for NSCLC / GBM is a much more serious illness, however i concur, it would all depend on how good P1 data is for someone, say Merck for example, to step up, ante up, and continue 1535 development.

[dcaf7]

They don't need to worry about cash now. Company's future depends on Ph1 data.

[FACT-MASTER]

Funds are insufficient, imo.

Page 8

https://www.sec.gov/ix?doc=/Archives/edgar/data/1701541/000170154123000032/bdtx-20230331.htm

We need P1 data / further financing / partner and/or collaboration with a major, imo.

Is that asking too much? ( of course that is if P1 data has met the endpoints)

Could be some dilution coming up and what/where does "Launchpad Therapeutics" fit into this equation?

[FACT-MASTER]

Looking this over, imo this looks like a talented and industry experienced mgmt.group here at BDTX:

https://www.blackdiamondtherapeutics.com/about/board-of-directors

https://www.blackdiamondtherapeutics.com/about/leadership

Check out Mr. Dan Darley in above link, interesting connection to Takeda.

Takeda recent acquisition = Nimbus
https://www.takeda.com/newsroom/newsreleases/2023/takeda-completes-acquisition-of-nimbus-therapeutics-tyk2-program-subsidiary/

[FACT-MASTER]

o.k., i see that on the clinical trial site that dosage was the primary endpoint.

It's positive that they revealed that, imo, however the crunch data of efficacy/secondary endpoints,ORR, adverse events, (ie: whole spread of Phase 1 data) imo, will be the tell tale details, imo for the go forward (P2) basis.

The FDA recently released some guidelines regarding dosage/optimization level - article of interest here:
https://www.pharmaceutical-technology.com/features/fda-drug-dosage-optimisation-guidelines-signal-clinical-trial-reform/

imo, if P1 data is very positive,(and that would truly be monumental,imo) releasing the data at either of the 2 conferences you mentioned in earlier posts would be appropriate. However, if results are negative then just in a pr would suffice.

At this point it's hard to say. Looking for clues i notice Ecor1 Capital took a sizeable position as of March 31/23, we know insiders have bought at points in the last 12 months, and addition of cohort 3 also raises Merck collaboration curiosity, imo.

https://www.nasdaq.com/market-activity/stocks/bdtx/institutional-holdings

Interesting and credible management here at BDTX, imo

[dcaf7]

They didn't say how phase 1 data will be presented. Primary endpoint of dose-escalation part of their study was finding a RP2D. They said it was done.

[FACT-MASTER]

My apologies, couldn't make it to the presentation, but i'm assuming that's for cohort 1 and 2.

Any mention of attendance at upcoming conferences? Phase 1 data - ORR/CR/PR? cohort 3?

If they are speaking in terms of RP2D, (and opening cohorts for that) then it may appear that primary endpoints of P1 were met, No?

[dcaf7]

In today's presentation, David Epstein said that they have completed dose-escalation part of Phase 1, identified a RP2D and will open dose-expansion cohorts later this summer.

[FACT-MASTER]

BDTX: GlobalData Report available for BDTX 4933

https://www.pharmaceutical-technology.com/data-insights/bdtx-4933-black-diamond-therapeutics-solid-tumor-likelihood-of-approval/

4933 Trial in progress - 2 locations - Site 1003 NEXT Virginia and Site 1030 South Texas Accelerated Research Therapeutics (START) Midwest

https://clinicaltrials.gov/ct2/history/NCT05786924?A=3&B=4&C=merged#StudyPageTop

European Journal of Cancer Article - 4933

https://www.ejcancer.com/article/S0959-8049(22)01027-9/fulltext

[FACT-MASTER]

Thank you for the finer details - all understood.

Hopefully we get some further insight at Jeffries on the timeline for Phase 1 data - NSCLC and GBM and further information on attendance at future conferences in 2023.

I'm honestly only expecting data on cohort 1 and 2 in the 2nd half of 2023, if we get some early data on cohort 3 would be a major bonus, imo.

Article of interest here on Expansion Cohorts:( note: all 5 examples in Key Point 3 were for NSCLC)

https://www.clinicalleader.com/doc/fda-issues-guidance-on-expansion-cohorts-in-clinical-trials-of-oncology-drugs-0001

[dcaf7]

This is an open label dose escalation study. They need to collect data for current dose, present it to FDA and get a green light to start a higher dose. They don't need to report it in 8-K. They can present these data at conferences when they feel the number of patients is adequate to discuss safety and potential efficacy. Most of oncology meetings have a policy prohibiting disclosure of your data before the abstracts are published or before actual meeting presentation.

[FACT-MASTER]

Usually, material data of a trial is released to the public (8-K) prior to being used in a presentation. At times a day before or at times even on the same day as the presentation.

I don't see any events past this Friday's Jeffries Conference on the BDTX website, so it would be good to ask about the upcoming agenda for Events/Presentations for the rest of 2023.

https://investors.blackdiamondtherapeutics.com/events-presentations#target-1

I'm not 100% sure, however, imo, the logical course for providing data would be the NSCLC and GBM monotherapy data from the 2 original cohorts.

Here is a side by side of the January 26/23 study and the March 28/23 study - see arms and interventions
https://clinicaltrials.gov/ct2/history/NCT05256290?A=11&B=12&C=Side-by-Side#StudyPageTop

imo, data from the 2 original cohorts, may provide insight into the reason why the third cohort ( combo with SOC Temozolomide) was added.

In addition, since GBM is a serious condition requiring urgent clinical intervention, i would also be watching at the Jefferies conference for any language management might use regarding any of the FDA expedited programs and/or the FDA RTOR Program( if still available). Of course that info can come out in a PR at
anytime.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics

Hopefully the recent positive stock performance is reflective of upcoming positive clinical data.

[dcaf7]

If they want to present both NSCLC and GBM data at same meeting, I think "AACR-NCI-EORTC INTERNATIONAL CONFERENCE ON MOLECULAR TARGETS AND CANCER THERAPEUTICS" is more appropriate. Meeting dates: October 11-15, 2023. I am sure they will be asked about it on Friday at Jefferies.
https://www.aacr.org/meeting/aacr-nci-eortc-international-conference-on-molecular-targets-and-cancer-therapeutics-2/

[FACT-MASTER]

Sorry about the double link, meant to copy these on the Samsung Medical Clinic.

https://www.samsunghospital.com/gb/language/english/main/index.do

https://www.samsunghospital.com/gb/language/english/about/vision.do

[FACT-MASTER]

Noticed as well - 4933 clinical site 1030 South Texas Accelerated Research Therapeutics (START) - Grand Rapids Michigan location.

https://sigma.larvol.com/facility.php?FacilityId=22213906

https://www.thechc.com/clinical-trials/start-midwest/

Any thoughts on this? - this is Dutch country (i think the wooden shoes are hanging in the closet, buying Italian shoes now, lol)

4933 clinical trial:
https://clinicaltrials.gov/ct2/history/NCT05786924?A=1&B=4&C=Side-by-Side#StudyPageTop

[FACT-MASTER]

Back last December, i was sort of thinking 1535 data would be coming in the first half of 2023 - recurrent GBM monotherapy cohorts.

However, the additional cohort of patients added and being treated by the combo of BDTX-1535 and Temozolomide, I think will delay the overall release of data.

Is there anyway to determine if BDTX submitted an abstract for WCLC 2023 / or if the agenda is available yet?

Just going back to your link regarding the trial site changes here:
https://clinicaltrials.gov/ct2/history/NCT05256290?A=12&B=13&C=Side-by-Side#StudyPageTop

Scroll down to the Korea, Republic of, and what i found of interest was the involvement of the Samsung Medical Clinic, contact - Dr.DoHyun Nam

https://www.samsunghospital.com/gb/language/m_english/common/doctorProfile.do?dr_no=361

https://www.samsunghospital.com/gb/language/m_english/common/doctorProfile.do?dr_no=361

Impressive involvement for BDTX, in the 1535 clinical trial, imo.

[dcaf7]

I don't expect major news at Jefferies. Wonder when 1535 data will be presented? They guided 2H 2023, possibly at some meeting. Thinking about WCLC in September.

[FACT-MASTER]

BDTX: Presenting at Jefferies Healthcare Conference on Friday, June 9, 2023, at 12:45 p.m. ET in New York, NY.

https://ca.finance.yahoo.com/news/black-diamond-therapeutics-present-jefferies-120000001.html

Nice Close at $2.34

[FACT-MASTER]

NIce Close! at $1.80

Volume 89,342

[dcaf7]

They started "A Study of BDTX-4933 in Patients With BRAF and Select RAS/MAPK Mutation-Positive Cancers"
https://clinicaltrials.gov/ct2/show/NCT05786924?term=NCT05786924&draw=2&rank=1

[dcaf7]

Good read on Nimbus. Unfortunately it is non publicly traded company. Their approach and structure remind me Cullinan Oncology (CGEM). Besides, CGEM also has HPK1 targeting program.
https://cullinanoncology.com/programs/

[FACT-MASTER]

Here's an update on a buy rating i came across for BDTX.

https://markets.businessinsider.com/news/stocks/berenberg-bank-remains-a-buy-on-black-diamond-therapeutics-bdtx-1032309100

and here's a link to the Berenberg Bank:

https://www.berenberg.de/en/institutional-clients/

Looks like an old school European bank.

[FACT-MASTER]

That's a nice update, thanks for posting the side by side.

Interesting that they have some sites in South Korea.

Not sure how that came about, however, it could be a positive.

I'm always impressed with this company (link to story below) as well, and the story here is humbling, imo. It's not exactly related except to say that BDTX is also researching the kinase inhibitors. Thought i would post as informative articles on Nimbus and interesting example.

https://www.biopharmadive.com/news/nimbus-takeda-deal-jeb-keiper-llc-troubled-water/638931/

https://www.biopharmadive.com/news/nimbus-takeda-tyk2-inhibitor-drug-deal/638614/

[dcaf7]

Yes, only information about trial sites was updated.
https://clinicaltrials.gov/ct2/history/NCT05256290?A=12&B=13&C=Side-by-Side#StudyPageTop

[FACT-MASTER]

Did something else change on April 19/23?

or is it just an update on trial sites?

https://clinicaltrials.gov/ct2/show/NCT05256290

[dcaf7]

BDTX-1535 trial was updated. New cohort of patients with GBM was introduced. They will be treated by combo of BDTX-1535 and Temozolomide in first line setting. Interesting, what did they find in recurrent GBM mono arm?