Black Diamond Therapeutics Inc (BDTX)

Notes from a chat with Mark Velleca at Jefferies
1. PFS. We are at 15.2 months. Important to realize that more than half of the patients are still on therapy, it is a 43-patient data set, and a median follow up time is 11.2 months, and we are already at 15.2 months. Given the CNS activity of the drug, we think this is a number that could get substantially longer.
2. Dose reduction from 200 mg to 150 mg and then in some patients to 100 mg has not sacrificed depth or durability of response. The average response is in the first cycle. The deepest response is at 7 months and most of these dose reductions are happening in a 1st cycle. Again, deepening of response after dose reduction. The fact that 23 patients, more than half, stay on drug also speaks to a durability we’re seeing at lower doses.
3. We have mountain of PK data coupled with response, efficacy-exposure data, to really understand a PK profile of the drug. It’s very well behaved, it’s dose linear.
4. Patients on Afatinib, if you look at them after they’ve progressed, 85% of them will have progressed through the CNS. So why is it important? It is obviously important for front-line patients for long term survival. It is critical if you’re thinking about using this therapy in adjuvant setting which is enormous opportunity to benefit patients. Osimertinib in adjuvant setting. Where these patients break through when they’re given adjuvant therapy, the CNS.
5. Preventing brain mets. Can you use it as a novel co-primary or at least secondary endpoint in a pivotal trial? I talked to the docs over the past couple of weeks, they all have patients with CNS disease, and other than radiologists giving radiation, they don’t really have anything adequate to treat them. So, if they had a systemic therapy to both shrink the existing mets and prevent the new ones they would use it. As far as trial design, you could focus on those patients with highest unmet medical needs, those with brain mets. Or you could, to your point, focus on CNS progression.
6. The PFS numbers that I gave for Osimertinib or afatinib, 8, 9, 10, maybe 11 months, they are in half for those patients with CNS disease. Patients with baseline brain mets, getting Afatinib or Osimertinib in three recently published studies, have 5 or 6 months PFS.
7. What phase 3 should potentially target like, do you have a streamlined path or should you get a faster path for approval or should it be something different? Feedback from KOLs at ASCO. We can get the drug to market quite quickly by focusing on this distinct patient population with the highest unmet need where the endpoint will happen again quickly if we focus on patients with just CNS disease at baseline, or if you focus on certain mutation in classes like PACC where there’s considerable resistance to Osimertinib.
8. We only see EGFR mediated AEs. We don’t have QTC, we don’t have any liver signal. The rate of grade 3 or greater AEs is 28% after dose reduction and we expect to see something similar, something in low thirties, when we start at 150 which would be identical to what Osimertinib showed in Flaura, 34%. We need to demonstrate it at 150 and we will. As far as Firmo, it clearly has QTC, liver signal as well as EGFR mediated toxicities.
9. Meeting with FDA, what are the key open questions that still need to be addressed, specifically around the feasibility of accelerated path and the selection of the comparator arm? We expect this meeting to happen in the 3dQ and we will be able to give feedback early 4thQ. We have a couple of strategies I can’t really comment on specific other than to say they will focus on patients with highest unmet medical needs and those fall basically into two categories, those patients with CNS disease at diagnosis where again PFS outcomes are 5, 6 months on standard of care, and that’s potentially one trial, could be randomized, would address project front runner. There is potential single arm path as well in patients with PACC mutations which are known to be resistant to Osimertinib and response rates in the thirties. It could be a combination of two smaller trials that would give us an accelerated path and obviously full approval based on randomized trial.
10. Is there any reason to believe it could be as large as Firmo study, or could it be more streamlined? We definitely think it could be more streamlined because it’s a very different drug, as two distinct differentiation advantages to Firmo. Remember, Firmo is a third-generation drug given at three times the dose of its approved dose for classical mutations and they are doing 480-patient randomized phase 3 with PFS as the endpoint. So our drug hits a very broad spectrum of NCMs, their drug they’ve only shown data really in two mutations, we’ve seen data with dozens of mutations. Their drug does not have a CNS activity that ours does. They’ve seen erosion of CNS, the response rate is 60ish percent, their CNS response rate is low forties. Our response rate is 60%, and CNS is 86%. So that afford us these pathways that could accelerate the approval of the drug that aren’t available or were not available to arrive at with Firmonertinib.
11. J&J updated ASCO data, Amy plus Lazer to name. How does it inform you path as well? A couple of important things to remember. One, all of patients with CNS disease, they had to have prior treatment. They did not allow patients with untreated brain mets onto the trial. That tells you about the lack of CNS activity of this regimen. Two, 70% of grade 3 AEs. It is cumbersome IV, soon to be sub-q regimen. It is not getting good uptake in patients with classical mutations. I don’t expect that it will get a good uptake in patients with NCM. And it is not a regimen that will ever get moved into the adjuvant setting.
12. GBM program, first line. PFS for this population is 6 months. Should we show 3, 4 months’ improvement, we would certainly take those data to the agency while it is a randomized phase 2 trial, its PFS by BICR, it is monitored by IBMC. It has all the features that could be converted to a registrational trial. Data 1H28. This trial we can execute with a reasonable capital raise.
13. We are 18 people. We have cash up to 2H28, so it funds a GBM trial. We do need to raise or our partner for the pivotal in lung. Key catalyst is FDA feedback. More data coming in the 4thQ, initial OS data potentially late 27, and then GBM piece coming in 1H28.

Slides for today's ASCO presentation are posted.
https://blackdiamondtherapeutics.com/assets/files/asco-2026-cohort-3-rapid-oral-final-29may2026.pdf

What stands out: The CNS data is exceptional. 86% CNS ORR with zero de novo brain metastases. For a population with high baseline CNS involvement, this level of intracranial activity is amazing.
https://oncodaily.com/voices/aakash-desai-508614

Yeah, they should have run two-dose phase 2 trial. This kind of setback is pretty common for small oncology biotech companies. Silevertinib is a real drug with distinct differentiation profile and there is a good chance that FDA will let the company to go forward with 150 mg dose. I don't expect this dose will shorten PFS or DoR, although it can slightly reduce ORR. If SP goes futher down, I consider it a buying opportunity.

I hope this stock hits it out of the park but for now i am out. I dont see how the FDA will give them a break on the 150 mg dosage. How can they fck that up as much as they did is mind-boggling. They are going to have to spend money and take a year to get the proper data in my humble opinion. Asia, given the high rash percentage, is out of the picture as a global player. They will need to see the 150 mg dosage data first

I think if the drug is to have a chance, BDTX needs to sell the entire company to some large pharma for the cheap. It was very irresponsible of management to not do a proper dosage study. They wanted to save a few million and half year to get the complete mess they now have. It is a shame, a very big shame. Dilution is coming before any partner news unless they sell it all on the cheap. It will also come at a very low share price. I wouldnt be surprised if they arent diluting already or right after the oral presentation.

The "new" dosage optimization requirements is a must read along with how PK studies are to be used. Compare that with what BDTX is going to present to the FDA. I dont see how anyone will want to touch this thing until the dosage data is done according to rules and not based on a hunch or lets just meet in the middle on the dosage. Really really irresponsible.

Fair takeaway from yesterday presentation. https://www.oncologypipeline.com/apexonco/asco-2026-preview-black-diamond-tries-catch-arrivent

Typical pump and dump stock

it is not good but also not a total disaster. this thing has best of class written all over it. Shame they didnt get the dosage right. Oral presentation and a thumbs up on the 150g from the lady doc presenting will go a long way with the FDA. But will it be enough? They will most likely have to add to their phase 3 a bunch of patients that start with the 150g dosage to prove its all good. Hoping FDA meeting request happens sooner than later. Dream valuation has been put on hold. Incredible stats nonetheless.

From the company website, Preliminary median Progression-free Survival (mPFS) is 15.2 months (95% CI: 10.8; NE)
Median duration of response (DOR) had not been reached (95%CI: 7.0, NE). Looks good

From the abstract, As of December 27, 2025, the 6-month PFS rate was 86% overall and 80% in pts with CNSm; available PFS and DOR data will be presented.

page on the asco site not showing the data on my end - guess to many people trying to get access to all the poster data

with volume being close to 8 million, still alot of shorts in this stock. I would assume margin calls will be around 52 week high. Short interest is a bit less than 4.5 million based on April month end. Squeeze scenario by the time the oral presentation is looking less and less likely. Wont need it if this is best in class.

that is impossible. No way will BDTX go against the rules of ASCO. They are very specific and strict. They are doing the webcast, in my opinion, to get information out to shareholders so they can freely discuss this info with potential partners, They will only discuss the info on the abstract withhin the webcast otherwise they couldnt disclose much to them. The saturday event is where the updated info will be presented, never before. I think we will see a detailed 8k on saturday following the oral presentation. But i think we can easily see tomorrow if this is best in class or not. I am really counting on that they will explain why immature or a NR is the best news possible. This is why they got the oral, in my opinion. I hope you are right that they will talk about C797S as this is the white night to crazy valuation :) However, i feel this info comes only from the FDA meeting notes.

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Tomorrow at 5 pm is when the embargo on ASCO abstracts is lifted. I expect that at tomorrow's event, the company will bring new, improved data not described in the abstract. Possibly, it is the reason for this event. I don't expect any C797S update, since tomorrow presentation is on 1st line NSCLC and C797S belongs to 2nd+ lines. What would be nice is an announcement of a partner.

looks as if BDTX is going to have a price reset, if it achieves best in class status. They didnt have that on the November data but i think they achieved it on the poster submission data. This is a massive difference! The doctor presenting the data is top notch, not sure if you can get anyone better than her. If anything positive comes out of C797S and they mention that they already met with the FDA or the meeting is just around the corner, we are golden for a partnership. GBM must be taken seriously as the company has hit on positives multiiple times., this stuff works in medical terms lol. All three and we have is a buyout scenario,in my opinion, with Asia and Astra having a bidding war. Tomorrow will give us a very big clue if that is true. or it could just dump :)

given end of day price action, i can only hope, that the poster data to be released at 5pm on the 21st will have the letters NR in stats such as DOR and PFS. I also hope that the webcast is being done to avoid the disaster when the november data readout was done in December. What I would love to hear on the webcast is that NR is the best news we can have. There should also be a significant Nonchanged in the number of patients still in the trial. This in my opinion is why BDTX has received the oral. I do not think C797S had much to do with the granting of an oral presentation. Binary event is getting close - glad it is happening on a Saturday.

Black Diamond Therapeutics to Host Webcast for Investors Highlighting Updated Results from Phase 2 Trial of Silevertinib in 1L EGFRm NSCLC. Webcast will be held Thursday, May 21, 2026, at 5:30 p.m. ET
I hope to hear good news.

Love that the first highlight of todays press release is about DOR and PFS. I find that very very encouraging. Could be nothing but you dont lead off with that if you are not confidant.

in other words, its all about DOR and PFS

H.C. Wainwright raised its price target on Black Diamond Therapeutics shares to $11 from $10 while maintaining a Buy rating.
H.C. Wainwright said it is maintaining its long-term forecasts for silevertinib pending results from partnering discussions. The firm uses a discounted cash flow-based valuation for the company.
In other recent news, Black Diamond Therapeutics will present data on silevertinib at the American Society of Clinical Oncology Annual Meeting in Chicago. The company is set to showcase Phase 2 results for silevertinib in treatment-naive non-small cell lung cancer patients with non-classical EGFR mutations. Dr. Julia Rotow from Dana-Farber Cancer Institute will present the findings during an oral session. Meanwhile, Freedom Capital Markets has raised its price target for Black Diamond Therapeutics shares from $6.00 to $7.00. The firm maintained a Buy rating, citing preliminary Phase 2 data that showed promising objective response rates for silevertinib in non-small cell lung cancer. The data suggested a potentially meaningful progression-free survival signal, with a full readout expected in the second quarter of 2026. These developments highlight ongoing interest and analysis surrounding Black Diamond’s clinical advancements.
https://www.investing.com/news/analyst-ratings/hc-wainwright-raises-black-diamond-stock-price-target-on-trial-data-93CH-4644663

Silevertinib ASCO presentation noticed.
The second confirmed presentation focuses on a high-need molecular space: frontline non-classical EGFR NSCLC with silevertinib (BDTX-1535). The prior dataset cited in the cards reported ORR 60%, CNS ORR 86%, and disease control rate 91%, while targeting more than 50 non-classical EGFR mutations, including exon 20 insertions. The update will likely be watched closely because this is exactly the kind of setting where durability matters as much as early activity. If duration of response and progression-free survival remain strong, silevertinib could become one of the most important emerging drugs in a space still lacking a clean frontline standard.
https://oncodaily.com/oncolibrary/lung-oncology/asco-2026-lung

but they differed is my guess

The abstract submission deadline was January 27, 2026. The data submitted are unlikely to differ materially from those disclosed in December 2025.

so it is really only one board in essence. One thing that I overlooked and perhaps is the reason why the nice little upward momentum is that this smallcap pharma has been given an oral presentation. This does not happen often. That is pretty good. Doubt they would have been given an oral based on the November data. So something looks to be improved in a short span. I still say, It all depends on DOR and PFS. If we can get anything over 9 on DOR with a tail, and over 13 on the PFS, we are partner bound. If C797S has any positive new info, where it is worth a meeting with the FDA, i think we are golden and will see a surge over the next 15 months. Buyers want more than just one treatment, BDTX will hopefully give them 3, with potential to take market share from competitors. That is why I am holding.

Titles of silevertinib presentations at ASCO 2026 are posted:
1. Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in treatment-naïve patients with non-small cell lung cancer with non-classical EGFR mutations. Rapid Oral Abstract Session, May 30, 2026.
2. Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in previously treated patients with non-small cell lung cancer with non-classical and C797S EGFR mutations. Poster Session, May 31, 2026.
3. Randomized phase 2 study to evaluate the efficacy and safety of silevertinib in combination with temozolomide in newly diagnosed patients with EGFRvIII-positive IDHwt MGMT unmethylated glioblastoma. Poster Session, Jun 1, 2026. This is TPS presentation, only about trial design, don't expect any clinical data.
The full, final text of these abstracts will be available on May 21 at 05:00 PM EST. I suspect that the first and possibly second abstracts are placeholders, with final data to be disclosed during the presentations.

what a disappointment on the poster pr. Really was hoping that c797S would of been separated. Hoping its because the sample size was not enough for ASCO. Again, BDTX teases alot but says nothing.

expecting poster board PR today, hopefully they will have 3 boards

So far, FDA has approved only one TKI for non-classical EGFR mutations in first line NSCLC, Afatinib/Gilotrif. But only for three mutations, L861Q, G719X and S768I. Another TKI, Osimertinib/Tagrisso is recommended by NCCN for the same three mutations, but it is not FDA approved. And the third patient's option is chemotherapy. Silevertinib, if approved, will compete with these three treatment regimens. And in addition to three approved NCMs, Silevertinib will be indicated for patients with many more other NCMs.

a slight correction to post below, she did talk a little about dor and pfs. It is the only thing that matters come asco. I interpreteed the general presentation as they are bundling silevir into an all purpose type drug, currently they have 3 "separate" products, the lung, the GBM and this c795sc or whatever its called. I would love to see three posters presented at ASCO for these three. Not sure if i understood correctly, but now they are saying it can do more and take over some market share of other products? Anyway, just as last december was to be a binary event, so is ASCO. I think it is make or break for bdtx. Seems more of a make than break but who knows.

did not like how she just read the 7.2 months and did not even mention that they will provide a follow-up on both dor and pfs at end of may. It is the by far the most important statistic to present come ASCO.

In April slide deck, they said DoR and PFS data that will be presented are preliminary. One thing that I found interesting is that for EGFR TKIs used in lung cancer, the mDoR is almost always shorter than the mPFS, or at most, very close to it. This is the opposite of many other cancer treatments (like immunotherapy), where mDoR is often much longer than mPFS.

thank you for the summary:
I just hope when it comes to all these comparisons the company clearly lays out what they mean, so we avoid the 7.2 months fiasco as last data readout. I would assume if they are showing a pfs of 15 months, they will have hard data to support this and not just make a blanket statement, that is our benchmark and not have anything backing it up. The general benchmark statement of 15 months has already been told.
In addition, the dor data has to be understood by everyone, i hope and highly doubt they will have 50% events come end of may to have an actual calculation. If they do, not sure it will look good.
I thought they always used 4th gen best in class. Now they put the word potentially in front of it. but i could be mistaken.

April corporate presentation has been posted. It includes several new slides as well as updates to previously presented data.
In slide 8, the company presents mPFS with currently available therapies and notes that a >40% improvement versus existing TKIs would be practice-changing, setting a target of approximately 15 months mPFS.
Slide 11 compares CNS ORR of silevertinib with firmonertinib, osimertinib, and afatinib, where silevertinib appears to show the strongest results, with CNS ORR around 86% (rather than 100% which was possible before one patient confirmation scan).
Slides 15 and 16 use words “best-in-class” for silevertinib for the first time.
https://investors.blackdiamondtherapeutics.com/events-presentations

April is the month for poster submission. Would be nice to see an unexpected poster board submitted and accepted. Price action still a mystery.

Freedom Capital Markets raises Black Diamond stock price target on trial data.
Published 03/23/2026, 07:04 AM
Freedom Capital Markets raised its price target on Black Diamond Therapeutics shares (NASDAQ:BDTX) to $7.00 from $6.00 while maintaining a Buy rating.
The firm cited preliminary Phase 2 objective response rate data for silevertinib in Non-Small Cell Lung Cancer released in December, which showed encouraging signs and suggested a potentially meaningful progression-free survival signal.
https://www.investing.com/news/analyst-ratings/freedom-capital-markets-raises-black-diamond-stock-price-target-on-trial-data-93CH-4574772

BDTX looks to be doubling down that its DOR is good enough to show in both recurrent and frontline. I guess they want to show that it is ok in both. I dont think they would show both if it didnt look good. If they can deliver on a 15-month fps - i do believe we are golden. Options are being handed out, which while dilution i still take it as a positive. Price action still makes zero sense to me, which is a very big concern. Bring on ASCO! Nothing new in the actual numbers.

exactly, thus the financials should have come out like past history. No bad news on Friday night so maybe the delay is good news? Share price is a complete mystery.

I don’t see much visible activity at the company. The GBM trial has not started recruiting yet, while the NSCLC trial has completed enrollment and is now simply waiting for events to mature. They cannot realistically sit idle while waiting for a partner.

weird no financials yet. They could have them ready on the first day after quarter end as it is all real time costs. Hoping for a quiet friday after hours.

without a decent DOR that has a long tail - its not best in class. DOR is what matters. Iif it doesnt show improvement ( over 9 ), it is going to be a tough sell. PFS is nice but DOR is what makes the money. Price action not looking good as it seems that 2.0 - 2.06 is the new range. Less than cash value. Not even trying to get back to the 2.4 range. Something isnt right obviously.

Possible reason for recent SP decline.
Servier pays $2.5bn for Day One and its approved drug Ojemda. The main draw is Day One’s Ojemda, a pan-RAF inhibitor that was FDA approved in 2024 for a common childhood brain cancer, relapsed/refractory, BRAF-altered low-grade glioma.
The question is what the deal might mean for Black Diamond’s BDTX-4933, a rival RAF inhibitor that Servier licensed last year for a much less demanding $70m up front. That project, previously deprioritised by Black Diamond and now known as S241656, is currently in a phase 1/2 trial in RAS and RAF-mutated solid tumours that hasn’t yet yielded results.
https://www.oncologypipeline.com/apexonco/servier-makes-rare-big-buy

Good recap of yesterday’s TD Cowen conference presentation.
https://finance.yahoo.com/news/black-diamond-therapeutics-teases-next-134802234.html?err=1

If they deliver PFS of 12–15 months, I wouldn’t worry too much about DoR.

wow never would i have thought that we would be sitting close to 2 usd and still going lower. A Fund got out due to the lack of clarity and focus on DOR yesterday? Two funds sold millions of shares on December 3 readout, I am assuming its the same today, is all i can come up with. Friday afterhours now is scary.

yes , i had to listen to that part twice to catch that he completely avoided the question as it was about DOR. He is trying to get everyone to focus on pfs rather than dor. Which isnt good as DOR is where the money is made. He sounds very confidant and it may be a stretch but if they can get DOR above 9, and everything else holds, with a strong pfs, we should see a nice spike in price. If DOR declines, time to sell in my opinion. Looks like they aren't going to have a partner anytime soon either.

He was asked what would constitute good numbers for DoR and PFS. Interestingly, his response focused only on PFS. He noted that mPFS with current treatments is approximately 4–10 months, and that 15 months would be clinically meaningful. We therefore view 15 months as a reasonable benchmark. My interpretation is that this may be close to what will be reported at ASCO.

listened to the crow conference - i think it is worth a listen especially about the DOR/PFS, i have always liked this ceo as he just gives the vibe that they know what they have and they know what they are doing. Last question to him was - why is the market valuing the company at basically zero enterprise value, what is the market not understanding - his response, maybe it was typical but i liked the confidance - i wont comment on the share price but sometimes the market just gets it wrong

everything riding at ASCO

my 3.5 prediction - cant get more wrong than that

Looks like the typical push towards quarterly results. Hopefully, it will be a boring press release only, saying everything is on schedule and a MENTION that they will report results at the cancer convention. 3.5 by press release time isnt that aggressive, with over 5 after announcing results.

Wouldnt be surprised if they dont have a partner prior to the convention.

Servier is running 554-patient study with S241656 (BDTX-4933). It has 16 arms studying both monotherapy and combos in NSCLC, PDAC, CRC and BTC with different mutation backgrounds. https://clinicaltrials.gov/study/NCT05786924?intr=S241656&rank=1