$TNXP | Raymond James Initiates Tonix Pharma at Strong Buy with $26.00 PT on TONMYA Commercial Launch Inflection
Raymond James starts bullish as TONMYA access expansion and early commercial traction drive potential upside re-rating.
@ripster47 | @TENETTRADEGROUP | @TenetCharts
NWBO '26 Q1 10Q
https://t.co/6CnSZhYu73
At this point I’m skimming the filings for information regarding $NWBO's commercialization of their lead product and steps $NWBO might take to address their cash crunch. The information on additional trials and US manufacturing is great, but those trials and US manufacturing are many many years away from positively impacting the finances. Here is what stood out to me in $NWBO's recent '26 Q1 10Q.
➡️Significant Reduction in Net Loss
The net loss for the 3 months ended March 31st from 2025 was $19.343m and for 2026 it was reduced to $3.069m. I’d imagine we are starting to feel the Advent merger synergies.
➡️Another Approval Timeline Hint
First, lets look my at the prior speculation on timelines.
Speculation #1: Per data posted by Tunnelvisionplenty, there is a big batch of approvals coming 6 months post the 2nd CHM meeting. $NWBO had their 2nd CHM meeting on November 27/28 of 2025. Six months past this date is late May 2026.
Speculation #2: For the first time in the ’25 10k we saw that Advent started DCVax-L specific training which typically takes about six months. I assume they wanted this training to be complete prior to approval. This statement wasn’t in the ’25 Q3 10Q. So, this training likely started October-December ’25 timeframe. That means the training would be complete in the April-June ’26 timeframe.
Speculation #3 (contained in recent 10Q): In this ’26 Q1 10Q we see that $NWBO started a leukapheresis buildout in the UK. I assume this is being timed to be done for the approval decision. The 10Q states that $NWBO expects the buildout “…to be completed by June…”
So, we have three separate signals pointing to approval in May, April-June and finally June. There is an ongoing CHM meeting for May 21/22. Hopefully $NWBO is on the agenda at this CHM and we have an approval decision in mid ’26 as a few speculative timelines are starting to align.
➡️Potential UK Property Sale
"The Company owns a 17-acre parcel of land on the edge of Sawston, UK...If zoned for residential development, the Company has been advised that its property would be extremely valuable."
This is a positive step to possibly address $NWBO’s cash crunch and something to keep an eye on. I would also like to know what the company means by "extremely valuable".
➡️Spoofing Lawsuit Settlement Language
“The funds are being held in escrow while the Company pursues discussions with other lesser defendants about resolution of the case against them. The Company anticipates that the funds will be released from escrow when the discussions with the lesser defendants have been completed.”
That’s a positive sign that some of the smaller players are possibly talking settlement. I’m surprised $NWBO put this language in a public filing. Regarding the statement that the funds will remain in escrow until discussions with lesser defendants have been completed is puzzling. I’m not sure why those funds would be required to stay in escrow until discussions with other parties are complete. The only thing I can think of with my limited knowledge of the situation is that $NWBO sold interest in the lawsuit to certain investors and maybe their agreement stated that the first [insert dollar value] of the settlement goes to paying off the investors. Maybe $NWBO is required to hold the funds in escrow until the settlement has reached a certain amount to pay off the initial investment of the investors. Who knows. It's an unusual statement so I figure it has something to do with the possible unusual arrangement of selling lawsuit interests to investors.
That's all that stood out to me on the commercialization/cash front. Fingers crossed for mid '26 approval decision!
I wrote an article about $NWBO:
https://t.co/sOhaEsuQJU
I encourage everyone to read it. What is happening with NWBO is astounding and our persistent retail investor has hung on through it all.
I believe we will all be much better off when this story comes to its' ending.
Today we announced a new commercial payer coverage agreement for our #fibromyalgia medicine. Read more about this important milestone in expanding patient access: https://t.co/uXJ82rjfG5
#ChronicPain#Tonix
NWBO's 2025 10K
https://t.co/zWAKo2YT2K
Apologies, this is a bit late! I did a quick glance through. Mainly I looked at the MD&A and financials. A few quick thoughts.
TLDR: $NWBO has lots of good plans but no resources to execute said plans. Hints of an approval decision to come middle of '26. Hopefully an approval helps to alleviate the resource constraints.
1. Advent Revenue doesn't appear to be showing up.
2. Net loss of roughly $60m which is an improvement of ~$24m from the year prior.
3. Lots of trials that were supposed to start that don't appear to be close to starting.
4. A supposed acquisition that has disappeared from the MD&A section.
5. Very slow/delayed Advent buildout.
6. $NWBO has a money problem. A (hopefully) positive approval decision can't come soon enough.
7. This happened sometime in 2025:
"Advent recruited substantial additional manufacturing personnel and began their DCVax-specific training, which typically takes about six months."
8. Recall, the CHM data per tunnelvisionplenty showed two big approval windows. One at 3 months post 2nd CHM meeting (we're past that date) and one at 6 months post 2nd CHM meeting. That is coming up in late May.
9. Both the Advent training schedule (assuming it started in late '25) and the second CHM approval window are pointing to an approval decision in the May/June '26 timeframe.
$NWBO Northwest Biotherapeutics
"The Company's Welbeck facility is designed to support a substantial volume of patient treatments, with built-in flexibility to scale operations further as demand grows. The facility will be able to provide leukapheresis procedures for 4 patients per day, and may also offer extended hours and weekend operations. In combination with the Company's ongoing activities to expand its manufacturing capacity, the Company is working to build a strong internal foundation capable of supporting a significant number of patients."
https://t.co/fM5rHoZctg
@Arhdan9 Can you offer some insight as to why the SP is continuing to fall as the sales continue to accelerate 😅 what is going on. Is it progressing slower than expected or is this caused by some sort of suppression?
Can we only expect to see “real” SP with profitable businesses ?
$TNXP
Huge News:
Insurance coverage is a critically important issue determining whether we will have 10bagger or 100bagger in our pocket. It seems things have been going very well.
Now #Tonmya is added to the Michigan Preferred Drug List (PDL)/Single PDL effective May 1, 2026.
We’re excited to share a new peer-reviewed publication in the @ACCP’s journal on the differentiated pharmacokinetics of our approved medicine for fibromyalgia. Read more: https://t.co/SQBsI3aD38
#Tonix#Fibromyalgia#ClinicalPharmacology#Biotech
$NWBO Spoofing Case Update – Motion Battle
The Case: Northwest Biotherapeutics, Inc v. Canaccord Genuity LLC, 1:22-cv-10185, (S.D.N.Y.)
The Docket: https://t.co/FhgxuPIxim
In this post we will discuss the Court’s ruling on a recent discovery related motion filed by Defendants.
You can see the history of this motion from my posts in this thread: https://t.co/G1i0apcatV
Essentially, the Defendants are asking $NWBO to specifically identify the spoofing orders and then limit the case to said spoofing orders. It is a very important ruling that could impact the scope of $NWBO’s claims, and thus their damages. Here is what the Defendants are asking for:
"The Court should order NWBO to provide—within seven days and for all Spoofing Episodes that survived the motion to dismiss—the same color-coded, calculation-explained identification it provided in its Appendix. Consistent with Judge Schofield’s order in Harrington, NWBO should further be limited to using only the identified orders at summary judgment and trial."
Last week, the Defendants’ Motion was DENIED.
This is a big win for $NWBO.
$NWBO already provided the Defendants the trading data. The Court is telling Defendants they have to analyze the raw data themselves and not depend on $NWBO to do that for them. There is one small caveat:
“If, as, and when Defendants are unable to reconcile their own calculations with the allegations of the SAC with respect to a particular Spoofing Episode based on the methodology NWBO has explained, Defendants may bring the issue to NWBO’s attention and ask NWBO to identify how the particular calculation(s) were derived. The Court hereby orders NWBO to provide such identifications to Defendants upon request.”
This ruling was a big win for $NWBO. We lost the first round of this motion battle, but won the second round. Discovery goes on!
@Arhdan9@SethLederman How are you estimating the value of TNXP. 1% market penetration would require an extremely high P/S ratio right?
Just curious as I cannot come to the same conclusion.
Fellow long here trying to figure out where we are headed ☺️
📢What can we speculate knowing $NWBO's DCVax-L had its' 2nd CHM Meeting on November 27/28, 2025?
In a prior post I included a link and screenshot of what is highly likely to be $NWBO DCVax-L’s 2nd CHM meeting on November 27/28, 2025. That post can be found here (screenshot below):
https://t.co/JlZvfoW9jf
In that post I stated that historical data points towards a likely regulatory decision on DCVax-L within 3 months. In this post I’ll expand on that statement and offer one additional tidbit. First, the additional tidbit.
➡️What is the likelihood of approval of a new non-IRP medicine that has gone through a 2nd CHM meeting with the MHRA?
91.3% +
The 91.3% is based on data showing 21/23 companies receiving approval after a 2nd CHM meeting. I say "+" because the two companies that haven't received approval were not rejected. Instead, it's assumed those companies applications will be rejected, but they hadn't been rejected at the time said data was posted.
Source: https://t.co/dzHfjn9IJH (look at prior posts for more data on this point)
➡️What is the MHRA approval decision timeframe following a 2nd CHM meeting?
"For the most part, for drugs that had a second CHM meeting and then got approved, approval came within about 3 weeks at the earliest and about 3 months at the latest."
Source:
https://t.co/zUDAlcMkG7
The same poster goes on to give further information pointing to a possible 6 month approval decision window, but noting that most decisions happen within three weeks to three months of the 2nd CHM meeting:
"New MAAs can be approved anywhere from 3 weeks to 6 months after their second CHM meeting
Based on the available information..."
Source: https://t.co/ztuP5GXHUt
➡️Thoughts
Data shows there is a high chance of approval (91.3%+) and that a decision will likely come by late February '26 and as an outlier, late May '26. These numbers are based on data provided by Tunnelvisionplenty and I would like to thank him/her for said data!
$NWBO
This is a good sign. While not 100% there is a lot of data showing that a regulatory decision usually happens within 3 months of a second CHM meeting.
https://t.co/YS38Sy9SIG
Thanks Lykiri