$21M cash on hand Beginning Q4
Q3 Net Burn of $6.9M, subtracting 1x costs down from $7.5M in Q2 and $8.6M in Q1 - declining burn, will continue to decline as the p3 Closes out - and will be $1M less per MONTH, once its Done.
\--- Q4 Burn range $6.2/6.7, Q1 Burn $6.0 / $6.4, Q2 Burn $5/6M
\--- Current Runway into Q3 / Aug Sept Oct in a Cash Conserve Mode.
Conserve Mode: includes Pushing Payables, Q2 Accrued expenses were 7.8M / Q3 were down to $5M - gives SLS nearly $3M in ActualCash Flow to Push Payables - Also, Prepaid Expenses Increased to $3M in Q3, up from 500K in Q2 -- Just the Prepaid Expenses will/could reduce Q4 Burn 1 to 2M.
Not that it matters, with the P3 results Now Due in January - This Month.
Some Key Cash Matters
A. IDMC Halt for Efficacy Vs IDMC No Futility Statement, Recommendation to FA - Ceo has stated, the time to FA, if need be, is 3, 4 or 5 months. The IDMC will Also Provide Guidance on the Timeline to FA, just as they have previously, guided to IA, 'by Q4'.
Implications:
1. A positive P3 and GPs will Be Generating Billions in Revenue, beginning in H2 2025, and SLS is worth multiple billions. A Positive P3 and GPs gets the FDA Green light to treat upwards of 25,000 AML remission patients each year, a $6B Total Addressable Market, that is worth $10's of Billions to Big Pharma.
2. An IDMC recommendation to continue to FA, after reviewing 5 years of Unblinded P3 Data, it essentially means, and will be WELL Understood, by Institutional Investors, and BIG Pharma alike, that Trial is Not Futile - and this deep into 5 year data, the CURVE is Baked in - and Gps is Golden, and SLS is worth Billions. It will only take the time needed to achieve Statistical Significance
3. Statistical Significance Discussion: - Stat Sig at IA, .52 HR Gps ≥24 vs ≤12.48 / or Stat Sig at FA .636 HR Gps ≥ 24 vs ≤ 15.26 - again we know from the previous Blinded Regal Update: All Pooled OS, Gps + Control arms OS is 16 months - we also have seen 3 Dr's who treat actual patients state point Blank Os for Control is dismal, extremely Poor, 6 to 8 months, 5 -7 months. There have been seven published trials for AZA VEN in Cr2 w an Os of 8.1 months or Less. Gps achieved a statistically significant Phase 2 result of 21 months OS in an Older, less healthy All MRD+ setting. Gps achieved 67.9 months of OS in the AML Cr1 MSKCC Phase 2 trial, and Immune responses have directly correlated with Relapse Prevention and Extended Survival in all Previous Gps trials.
4. A positive P3 and 3D MED will be borrowing/offering to Pay the $63M they'll Owe SLS to Maintain their Rights - $13M for Joining the P3, overdue. $25M for a Positive P3 Result. $25M for BLA filing. Arbitration began Early DEC 2023, 13 months ago, Hong Kong International Court publicly states average time for Judgements is about 15 months. THERE Likely Will be a Settlement/Resolution this Quarter.
5. SLS eliminated the Commercialization Team, and requires NO CASH for SALES AND MARKETING. Once the P3 Concludes there will be no need to raise Cash for a Massive Sales and Marketing Campaign.
6. SLS first Disclosed engaging STIFEL/Torreya Partners for IB services in Dec 2023, And By March of 2024, SLS management Completely changes its Business Plan, Eliminating the Direct Commercialization Team and publicly announces STIFEL is engaged for Development/Commercialization Partnerships. This means 1/ SLS is going to be bought out and or 2/ any further 009 Development Costs will be in conjunction with a partner. The only reason SLS would eliminate the Commercial team is because STIFEL has let them know they have deals in the works.
7. Rare Pediatric Priority Review Vouchers - SLS has 3 RPPR Designations, 2 for SLS009 and 1 for GPS. The Most Recent Sale was for $150M, these Vouchers allow Pharma's to begin Marketing/Selling their drugs much earlier, 6 months to a year sooner. And Given Some blockbuster drugs will Generate billions, a 6 month to 1 year head start is worth Much more than the Retail Sale Value. The FDA discontinued offering New Designations, the GOP failed to fund the children's Cancer program, this will make all those Existing Vouchers worth Even More. Any SLS, Buyer / Partner Can Conservatively add an additional $500M to $750M to the SLS Balance Sheet.
![img](jwbijd1dilee1)
![img](lmdtwmjzilee1 "2.904M Prepaid Expenses / accrued reduced to 5.5 from 7.65")
[https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs#2024update](https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs#2024update)
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I took my 2-year old for a f/u on her ear tubes at a large ENT practice. The first step was hearing screening. The screener introduced herself as “Dr. X.” I was surprised that a physician was doing hearing screening and asked “Are you a medical doctor.” She replied she was a doctor of audiology.
This was pretty off-putting, and I considered raising it with the ENT (MD), but decided not to. Should I have? I don’t care how this person introduces herself in a social setting, but in a medical office, this seems misleading.
I found a general diagram for the ESP32-C3 on the manufacturer's website. Will this diagram also work for the ESP32-C3FH4 or other members of the ESP32-C3 family? Additionally, how do you program them? I read that an external programmer is needed and GPIO0 must be connected to GND, but connecting GPIO0 to GND every time seems inconvenient. Is there an easier way?
Are there any code words I can say in the chat to trigger them sending me a new one? It is hard locking(even the web interface is inaccessible) every 4-5 days.
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Please help. Is this even a font? Also can you tell me any other fonts like this..
Like when you see a paper there's one big, fancy designed letter at the beginning. Any fonts like that?
For those of you who are playing sengoku basara in Japanese, how do you know what buttons to hit to advance the story? I am currently playing 4 and the gameplay is dope but I am worried that I am not progressing due to not pressing the right buttons. How do you guys translate the game? I don't necessarily care about the voices.
Many of you might be master fishermen, but for anyone like me who was having a hard time with reeling the fish in without using the 'hold to reel' option, I found that if I hold the analog stick with my pinkey and thumb, and then rotate my palm it is much simpler and quicker to reel fish in than simply using my thumb.
Hope this helps someone if they're struggling with that mechanic but don't want to make fishing too easy by switching the controls.
Hi all - I’m a male that has had pelvic floor tightness of varying degrees for past 7 years or so. I just recently found a PT in NYC who specializes in Pelvic Therapy for men.
So far, the whole thing consists of an external/internal “massage” and then recommending foam rolling the abs, and a type of wall sit stretch. There’s not really any tests they do to diagnose, more just symptom based it sounds like.
Is this kind of the best of what to expect? Unsure if other PT’s have more extensive therapy / tests / practices.