I sold my entire position on the day of FDA approval. The price has since dropped to a level I find attractive, and with commercialization right around the corner, I've started buying back in and rebuilding my position.
Recent insider buying has been hard to ignore, too...
Maybe something good is coming for all of us?
Jonathan Rothberg's whole career basically runs on one question: if a life-science tool is expensive, bulky, and centralized, why hasn't this been moved onto silicon yet?
He's already answered it twice.
With 454 Life Sciences and later Ion Torrent, he pulled DNA sequencing onto a semiconductor platform. Gordon Moore ended up being the first individual sequenced on a semiconductor chip, which is one of the moments that opened the NGS era and a big part of why Rothberg got the National Medal of Technology under Obama. Then at Butterfly Network, he did it again with ultrasound — replacing the piezoelectric crystal architecture with a silicon chip, getting FDA clearance across 13 applications, and bringing the iQ down to roughly $2,000. Yale MedicineWikipedia
What's interesting is how identical the playbook is. A legacy medical device is expensive, specialized, and hand-assembled. Move the core function to CMOS and the cost collapses, the form factor shrinks, the tool moves from centralized institutions out to broader access. And then the second-order effect kicks in: the device keeps generating data, and the data eventually becomes more valuable than the hardware itself. Razor, blade, data.
The third target is protein.
DNA's been decoded, but the actual machinery of biology runs at the protein level. ~20k genes, but the protein universe is orders of magnitude bigger once you account for isoforms, modifications, PTMs. And the dominant tool for analyzing all of it is still mass spectrometry. Powerful, sure, but the high-end systems run hundreds of thousands to millions of dollars, require PhD-level operators, and are mostly built around bulk averaging rather than true single-molecule readouts. Structurally this looks a lot like where DNA sequencing was sitting before the NGS shift, and Rothberg has already lived through that exact transition.
That's why Quantum-Si is on my radar.
The core asset is Proteus. Investor Day last November laid out the roadmap, but what changed this year is that the thesis stopped being theoretical and started being something you can actually track through data releases.
On April 8, Quantum-Si ran its first customer samples on a Proteus prototype. Versus Platinum Pro, Proteus showed significant improvements across amino acid coverage, read length, peptides identified, and sequencing output. Three weeks later, on April 28, they reported automated end-to-end sequencing on integrated Proteus instruments, detecting 17 amino acids — up from 15 just four months earlier. Quantum-SiStock Titan
The pace is the thing I keep coming back to. The company currently uses six recognizers to detect 14 amino acids and believes an eight-recognizer set can cover all 20. The Proteus optical system has already demonstrated it can distinguish eight dyes. The hardware is basically waiting on the chemistry. That's a meaningful shift in risk profile — from "can this work at all" to "how fast do they close out the recognizer set." Those aren't the same risk and they don't deserve the same valuation. GenomeWeb
Guided timeline from management: early access customers this summer, pricing announcement in Q2 (range previously guided at $300k–$500k), launch capabilities and Platinum Pro upgrade program in Q3, commercial launch end of 2026 with 18 AA coverage, and full 20 AA coverage to market in 2027. Q2 earnings likely land in early August based on reporting cadence.
I want to be careful with the BFLY parallel because the easy version of it is wrong. Chip-based disruption takes time, and Butterfly's stock has been painful even when the underlying technology was directionally right. So that's not the lesson. The lesson is that once the chip version starts working, the category eventually has to deal with it. When Butterfly raised $250M in 2018 from Fidelity, the Gates Foundation, and Fosun Pharma at a $1.25B valuation, the piezo vs CMUT debate had already shifted. The market timing was a different question, but the direction of the technology wasn't really in dispute anymore. Wikipedia
Proteus may be approaching a similar moment. If single-molecule protein sequencing on a semiconductor actually works at production scale, I don't see how legacy mass spec wins long-term on cost, form factor, or decentralization. Orbitrap will probably remain more accurate for a while — but accuracy gaps narrow with better reagents, chemistry, and algorithms. Unit economics and distributed access don't narrow. Those are structural advantages.
There's also a layer most people aren't pricing in. Just like Butterfly was never only about hardware, QSI isn't only about instruments and consumables. Platinum and Proteus generate sequence data that flows into QSI Cloud, and over time that can become a proprietary peptide identification database. The 23andMe comparison gets thrown around here but I think it cuts the other way. 23andMe didn't fail because biological data has no value. It failed because the data wasn't embedded tightly enough into clinical or drug-development workflows. If Proteus gets adopted inside pharma proteomics pipelines, that trap is avoidable.
Balance sheet is fine too. As of March 31, QSI had $190.4M in cash, with operations funded into Q2 2028. 2026 guidance is roughly $1M in revenue, adjusted opex below $98M, total cash usage below $93M. Most pre-revenue medtech dies or dilutes badly right before launch, and QSI looks like it can reach the Proteus launch window without slamming into that wall. BriefGlance
The thesis can break, obviously. The things I'm watching: amino acid progress stalling over the next six months, especially around the 17 → 19 transition (suggests recognizer engineering is plateauing). Early access customers going silent or peer feedback turning negative (workflow fit problems). Nasdaq minimum bid moving into a real deficiency stage without a reset (separate but real risk). Until one of those triggers, I think the bigger picture holds.
Rothberg has run this pattern twice. Take a centralized, expensive life-science tool and move the core function onto silicon.
BFLY was the first act. QSI looks like the next one.
Position: long QSI.
Either they timed it with the May 29 shareholder meeting,
or there's a bigger catalyst we don't know about yet.
Disclosure: I am long MDAI. This is not financial advice. Do your own due diligence.
Underneath the surface, three things became significantly clearer:
I think the market got this one wrong. Let me walk through why.
On May 12, 2026 (after market close), MDAI reported Q1 2026 results and held its earnings call. The numbers themselves were largely in line with what anyone tracking BARDA contract revenue should have expected:
The stock traded at $2.31 going into the call, hit $2.46 in the spike before, and dropped as low as $2.02 in the aftermath. Currently sitting around $2.15-$2.20.
If you read just the headline numbers, you'd think this was a bad quarter. It wasn't. It was a quarter that revealed strategic clarity.
Capone's prepared remarks and Q&A responses painted a clear picture of a CEO running a company. Specifically:
Commercial timeline: "We hope to move quickly to commercialize our DeepView system by the end of 2026."
CCO search: "We have expanded our Chief Commercial Officer search, we're working towards completing that in the near term."
Deloitte engagement: Continued engagement to "finalize our commercialization strategy."
Outcome study: Initiating a 240-patient, 12-site clinical outcome study.
Product roadmap: TBSA 2 software upgrade planned for 2027. TBSA 3 mentioned as potential follow-on. Handheld device prototype delivered to MTEC last week.
International strategy: UKCA expanded labeling planned post-FDA, initial international sales in UK, Australia, GCC countries by late 2026.
For anyone holding with a 2-5 year horizon, this earnings call was actually clarifying in a positive way.
Everything in MDAI's investment case ultimately depends on FDA De Novo clearance. Every commercial plan, every Hudson Bay calculation starts with: "After FDA clearance..."
A delay would be catastrophic. A rejection would be fatal. An approval unlocks everything.
When BTIG's Ryan Zimmerman directly asked about FDA timeline confidence, Capone's answer was as strong as a CEO can responsibly give:
"We had a number of pre-submission meetings with the FDA prior to the submission of our application in June of 2025. Frankly, I mean, we had a number of those, so I felt like our submission was strong. We kinda knew what we needed to provide to the FDA. Since our submission date, some of the responses we've had, some of the additional requests for information, we've maintained an active dialogue with the FDA."
And then the key sentence:
"I think we're in as good a position as we can be, and I think our timeline has remained solid, where we expect a resolution of our application by the end of the second quarter."
Capone is a lawyer by training (Reed Smith corporate/securities practice). He chooses his words deliberately. Several things stand out:
For De Novo submissions in 2024:
So a decision by end of Q2 (June 30, 2026) would actually be slightly faster than median. But MDAI has Breakthrough Device Designation (2018), which provides priority review treatment.
Combined factors supporting timely approval:
My base-rate estimate for outcomes:
Total approval probability (including conditional): ~70-80%.
If the timeline were slipping further, Capone would have signaled it. CEOs don't reaffirm timelines they don't believe in — the legal liability for that kind of statement is real. The fact that he explicitly used the word "solid" for the timeline is a meaningful tell.
If the decision were going to be negative, you'd typically see:
None of these are happening. The opposite is happening — they're hiring a CCO, contracting with Deloitte for commercialization strategy, planning an outcome study. These are not the actions of a company expecting rejection.
At $2.15-$2.20 entering a binary catalyst in the next 4-6 weeks:
Expected value math, even with conservative assumptions, works out positive. This is the asymmetry that makes the trade interesting.
A lot of bearish commentary focuses on Hudson Bay as a dilution overhang. The May 29 vote to authorize 8M shares of issuance gets framed as "imminent 25% dilution" or "death spiral risk." This is mostly wrong, and understanding why requires actually reading the Hudson Bay terms.
From the October 22, 2025 Securities Purchase Agreement:
| Instrument | Shares | Price | Status |
|---|---|---|---|
| Common stock (already purchased) | 3,065,000 | $1.90 | Held |
| Pre-funded warrants | 935,000 | $1.8999 paid + $0.0001 exercise | Exercisable immediately |
| Common warrants | 4,000,000 | $2.51 exercise | Already exercisable (6mo post-issue passed) |
Total possible dilution from this structure: ~5M new shares above what's already outstanding (the 3,065,000 commons already trade in the float).
The 8M number in the proxy refers to the maximum authorization needed under Nasdaq Rule 5635(d), which includes the warrants and pre-funded warrants. Not new issuance beyond what was already contracted.
Pre-funded warrants (935K): These are essentially already issued shares. Hudson Bay paid $1.8999 upfront and pays $0.0001 to exercise. They convert whenever Hudson Bay wants, subject to a 4.99% beneficial ownership blocker. These create slow, drip-fed dilution as Hudson Bay rotates positions.
Common warrants (4M at $2.51 strike): These only get exercised if MDAI trades above $2.51. Below $2.51, they're out of the money and Hudson Bay would be lighting cash on fire to exercise them.
This is where Hudson Bay's incentives become clear. Their total potential investment:
At current $2.20 price:
At $2.51 (warrants at the money):
At $4.00:
If fully exercised:
At $5.00:
If fully exercised:
Hudson Bay made this investment expecting a price catalyst. Their warrant strike at $2.51 — set against an October 2025 price of around $1.90 — implied they believed a price re-rating of 30%+ was likely within the warrant life. Their real money is made if MDAI gets above $3.00, with substantial gains above $4.00.
But there's a second variable: volume. Hudson Bay holds enough shares (currently ~3M with pre-funded warrants effectively making it ~4M, and potentially 8M if warrants exercised) that they cannot exit gracefully into normal trading volume of 400-600K shares per day. They need a volume event to monetize.
The combination they need:
The single most likely catalyst that produces both? FDA approval.
Think about who benefits from FDA approval + price spike + volume event:
Everyone is aligned. The narrative of "Hudson Bay vs retail" is wrong. The actual narrative is "everyone wants the FDA catalyst to hit." The structural dilution that bears worry about is largely contingent on the same event that makes the bull case work.
Hudson Bay can't hold more than 4.99% of outstanding shares at any one time. Outstanding is currently 31.8M, so the cap is ~1.59M shares.
Because of the 4.99% blocker, Hudson Bay cannot simply exercise everything at once. They would likely need to rotate — sell some, exercise some, sell some, exercise some.
This means:
For a holder planning to exit on FDA approval news, this is structurally favorable. The dilution gets metabolized over time, not instantly.
The bear case on MDAI after the Q1 call goes like this: the company is burning cash, dilution is overhang, miss on EPS, no guidance raise, why hold?
The bull case I see is:
The fundamental thesis — FDA approval unlocks commercial path and re-rates the stock — is intact. If anything, it's clearer than it was before the call.
I'm holding through the FDA event. My exit framework is built around the catalyst:
The 70-80% approval probability against the 5-10% rejection tail makes the math work even without giving credit to commercial value. Anything on top is upside.
None of these are happening today. The Q1 call, despite the market reaction, actually strengthened the operational thesis.
Position: Long. Will update post-FDA decision.
Been digging into MDAI for a while and wanted to lay out everything chronologically because when you see it this way, the pattern becomes hard to ignore. Not financial advice, do your own DD.
The foundation (2013-2021)
BARDA gave Spectral AI its first contract in 2013. Fast forward and total non-dilutive government funding is around $282.5M. The company's entire DNA is government-sponsored. In 2018 FDA gave DeepView Breakthrough Device Designation. In 2021 they went public via SPAC (Rosecliff Acquisition Corp I), not a traditional IPO. Already a tell about the company's character.
Spinoff game begins (2023-2024)
2023: BARDA signs a new contract worth up to $150M ($54.9M initial commit).
Feb 2024: Founder Wensheng Fan steps down as CEO. Peter Carlson takes over. Vincent Capone (General Counsel) adds CFO hat. First leadership flip.
March 2024: Spectral IP subsidiary announced. Board member Erich Spangenberg named CEO of the sub.
Nov 2024: Spectral IP gets renamed SIM IP and spun off via deal with Sauvegarder Investment Management.
Q4 2024: Hudson Bay Capital Management quietly opens a position (~$2.17M). Stock was around $2.00-2.50 at the time.
Trump Jr. connection surfaces (H1 2025)
March 17, 2025: Burn Validation Study results released. 164 patients, DeepView scoring 86.6% vs physician CJA 40.8%. Crushing results.
March 20, 2025: IP Fray breaks that Donald Trump Jr. is a shareholder in SIM IP (per their S-1 filing). Bloomberg Law confirms next day. This is the moment Trump political network connection becomes public.
March 24, 2025: Avenue Venture Opportunities deal - up to $15M debt financing, $8.5M initial draw. Warrants at $1.80 strike. That strike price becomes important later.
May 28, 2025: Spangenberg resigns from Spectral AI board.
June 30, 2025: DeepView De Novo 510(k) submitted to FDA. Expected decision: H1 2026. Stock jumps +16.98% on the announcement. The FDA countdown starts.
The structured PIPE setup (H2 2025)
Aug 2025: Q2 miss. Revenue $5.07M vs $5.44M consensus. 2025 guidance cut to ~$18.5M citing government shutdown impact.
Oct 24, 2025: Hudson Bay Master Fund Ltd. signs Securities Purchase Agreement with the company. This is the contract that becomes the centerpiece of the May 2026 annual meeting vote. Remember this date.
Oct 30: S-3 shelf for $150M filed.
Oct 31: Spangenberg's MDAI stake drops below 5%.
Nov 11: Q3 results. Revenue $3.8M (down 53.6% YoY). Cash $10.5M. Company acknowledges FDA "additional information" request received and responded to.
Dec 19: Unusual FTD event - 47,018 shares fail to deliver. Naked short flag.
Commercialization pre-run (early 2026)
Feb 1, 2026: CCO Jeremiah Sparks leaves. They're launching commercialization and the commercial head just walked out the door. 90-day transition at $4k/week.
Feb 9: Vincent Capone named CEO. He was already CFO and General Counsel. Office of the Chairman dissolved. Second leadership flip in 2 years, right before commercial launch.
Feb 2026: Hudson Bay files 13G. Discloses 7.80% position (4.99% common stock blocker + 939,904 warrants). The structure is now public.
Feb-March: CEO Capone publicly buys 16,750 shares at $1.52. Holds 186,450 shares directly. Has options at $1.20 strike. Insider buying signal.
March 18, 2026: Stock crashes -34.07% to $1.18 on abnormal 507k volume sell spike. Same day BARDA announces $31.7M additional funding. The BARDA news required $9.7M company match, which the market read as disguised dilution risk.
March 24-27: Short sale volume ratio hits 42-59% of total volume. March 24-25 specifically at 59.38% and 54.80%. Coordinated short attack on the dip.
March 24: Q4 2025 results. FY revenue $19.7M, net loss -$7.6M (improving). Cash $15.4M. 2026 guidance $18.5M - lower than 2025, no DeepView product sales included. Stock drops -29.11%.
Countdown - right now (April 2026)
April 1: Record date for annual meeting. 31,823,985 shares outstanding.
April 6: Preliminary Proxy filed. May 29 meeting agenda includes authorization to issue up to 8,000,000 shares to Hudson Bay under the Oct 24, 2025 SPA. That's a 25% dilution vote.
April 8: David McGuire named CFO (filling Capone's vacated seat).
April 9: ABA 2026 Annual Meeting participation announced. Booth 601.
April 14-17: ABA conference in Orlando. Stock hits $2.03 on April 15 (+13.40%), then fades as no market-moving news comes out of the conference. Classic sell-the-event.
April 20: Formal meeting notice filed. May 29, 9:30am. Hudson Bay vote confirmed.
April 21-22: Stock drops to $1.79 on thin volume. RSI 29.59 (15min), oversold.
Where we are today:
Price: $1.79
Short interest: 1.46M (5.21% of float)
Off-exchange volume: 56.91% (high dark pool activity)
Borrow rate: 2.41% (recently collapsed)
Insider ownership: 13.7% (per DEF 14A, not Finviz's 28.53% which lumps in 5%+ holders)
Institutional transactions: +11.20% (new money coming in)
Hudson Bay: 7.80% (including warrants)
FTD history present
Upcoming:
May 7: Q1 2026 earnings
May 29, 9:30am: Annual Meeting - the Hudson Bay 8M share authorization vote
End of Q2 2026: FDA De Novo decision expected
Q4 2026: BARDA Phase II review
What the timeline actually shows
Five patterns jump out when you line everything up:
Government funding → private structured finance → government funding loop. BARDA in 2013, expanded 2023, another $31.7M in March 2026. Every 3-5 years. In between, private bridge financing from Avenue Capital and Hudson Bay. The government essentially won't let this company die - DeepView is part of BMCI (Burn Mass Casualty Incident) preparedness, a national security thing.
Leadership swaps at every inflection. CEO twice in 2 years, CCO gone right before commercial launch, new CFO installed. Either this is governance chaos OR deliberate sequencing - Fan (founder), Carlson (financial cleanup), Capone (law + PE + CFO background = transaction-ready skillset).
Trump political network syncs up with the financing. SIM IP spinoff in Nov 2024, Trump Jr. connection public in March 2025, Hudson Bay SPA in Oct 2025 (same Hudson Bay that loaded up on DJT stock). This isn't random. MDAI has been positioned as a MAGA-adjacent ticker by design.
Everything converges on May 29. Every major event - the Hudson Bay SPA, the leadership moves, the BARDA timing, the ABA conference, the CFO appointment - is calendar-aligned to the annual meeting and the FDA decision right after. This is a pre-run.
Sustained short-side pressure. FTDs in Sept and Dec 2025, short ratio at 54-59% during the March crash. Someone's been actively shorting every rally. There are at least two institutional sides fighting over this stock.
My read
This isn't an organic penny stock. It's a designed event vehicle with a clear window in May-June 2026. Hudson Bay signed the SPA in October specifically to deploy around the FDA decision. The 8M share authorization vote on May 29 is the green light for their ATM machine.
For me, the play is straightforward: ride the setup into FDA approval, get out on the event. I'm not staying in post-event because the whole point of this structure is Hudson Bay distributing into retail FOMO. You don't want to be the counterparty to their exit - you want to exit alongside them or just before.
Not saying it can't run to $4+ on a good approval + moderate squeeze, but the clock runs out after June. Plan your exit before you plan your entry.
Positions: long, will post exits when I take them.