Portfolio Manager at Integrity Advisors
Boston, MA
Joined August 2015
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Updates on $CMPS and $DFTX after Usono NDA news
$CMPS: Hold, but do not initiate new positions. Usona's MDD psilocybin NDA (reported Nov 2 but unconfirmed, also on a fast-track voucher) turns Compass's launch into a likely two-player race decided by price. My scenario value is about $7.57 (upside-to-downside 0.68×), so the 28% drop was roughly justified.
What would make CMPS buyable. Either a price at or below about $6.50, or proof that Usona partners and prices close to Compass. Another trigger is Usona's drug substance proving to be Compass's patented crystal form, which would open the door to an injunction.
$DFTX: Still Buy, but reducing DCF PT to $43, 29% upside, modest overreaction. I estimate the fair hit at 2.5–6% versus the about 10% drop. Usona competes only with its MDD program, not the lead GAD program, and an early psilocybin approval clears the regulatory path for the class.
No position at present, not investment advice #stocks #biotech #investing
Bright Minds ($DRUG): should we buy the dip after FDA hold? Not yet; we're waiting for FDA's letter
What happened: On Nov 2, 2026, FDA put a partial clinical hold on BMB-101's planned U.S. Phase 2 study in severe childhood epilepsies (DEE), citing toxicity seen in mice and too little pediatric safety and dosing data. The stock fell about 55%, from $54.98 to roughly $24.50. No patients can enroll in that study until the hold lifts. Trials in Australia continue.
What we expect: Holds like this are usually lifted eventually; we estimate about a 65% probability. Fixing it will likely require a new juvenile animal study, which points to a 12–24 month delay. Meanwhile, Lundbeck's competing drug, bexicaserin, reports Phase 3 results around year-end 2026.
How it compares:
Edges: BMB-101 is dosed twice daily, versus three times daily for Lundbeck's bexicaserin (Phase 3). It has no measurable activity at the 5-HT2B receptor linked to the heart-valve risk of UCB's Fintepla (approved; €427M sales in 2025). In lab tests it is "biased," meaning far less β-arrestin recruitment, which may reduce drug tolerance over time. It also has early data in absence seizures, which competitors lack.
Caveats: These edges come from lab work and an 11–17-patient open-label study with no head-to-head data. BMB-101 is now 3+ years behind bexicaserin. Stoke's zorevunersen (Dravet, Phase 3 data mid-2027) adds pressure.
Valuation: The company holds about $215M in net cash, or roughly $21 per share. At today's price the market values the drug pipeline at only about $40M. Our scenario-weighted estimate of fair value is about $20 per share, with a range of $10 to $37. The stock is not clearly cheap at current levels.
Our stance: We are not buying now. FDA's detailed letter (expected around early December) and the bexicaserin results will set the timeline. A pullback toward cash value (about $19–21 per share) or a favorable FDA letter could justify a small, risk-sized position.
No position, not investment advice. #biotech #stocks #investing
New medical tech idea posted for subscribers (see profile), 31% upside, revenue stage growing company. #biotech #pharma #stocks #investing
Bicara Therapeutics ($BCAX): Hold, do not initiate at $9.85; probability-weighted value $7.40, 1-year PT $8.40
Shares fell 44% on Oct 28, 2026 after Genmab's rival EGFR drug, petosemtamab, cut the risk of death by 50% (HR 0.50) in a first-line head and neck cancer Phase 3. The result validates Bicara's approach, so we raise the odds that its ficerafusp alfa wins: 79% for the mid-2027 response-rate interim and 74% for overall survival after that. But FDA weighs drugs already approved when it decides, which cuts the odds of an early accelerated approval to 26%. The base-case launch moves to 2029, second to market, with an HPV-negative-only label (moat rank #4 of 10).
The market took 72% off enterprise value (now about $228M; est. net cash about $452M, or $6.62/share). Our model fell only 18–30%, but it never supported the $17.48 pre-crash price. Today's price implies about 27% peak market share (about $1.16B in sales) versus our 22% (about $0.95B), and the risk/reward is skewed to the downside (convexity 0.23×). Scenario values: bull $29, base $6–8, bear $2.
Buy triggers: We would start a position of 1–2% of NAV at ≤$7.00, near cash. Upgrade if any two occur: FDA confirms an accelerated-approval path, the full Genmab data show weakness in HPV-negative patients or on safety, or a strategic bid emerges. Exit if the mid-2027 interim slips, the company raises money below $8 with warrants, or its China-based manufacturer (WuXi Biologics) is restricted under Biosecure.
No position, not investment advice. #biotech #stocks #investing
Profound Medical, PROF: Reviewed it after Cook distribution deal. Avoid new longs: $3.75/share scenario-weighted value vs $6.23 price, −39%; bull $9.93 / base $3.27 / bear $0.09
The October 30 Cook Medical deal adds a U.S. capital channel (Cook buys at an undisclosed transfer price; Profound keeps disposables, service and its direct sales team) worth only about $0.10/share in the base case and about $1.09 in the bull. Cook's iMRI Suite scanner (Siemens Free.Xl) is still pending FDA 510(k) and TULSA-on-Free.Max clearance is pending; no minimum purchases or exclusivity are disclosed, and the contract has not been filed.
At $6.23 the market prices a about 29% sustained operating margin (industry 15.3%) or a about 50% chance of the bull case. Fundamentals don't yet show that: preliminary Q3 revenue was $9.8–10.0M, but about $3.1M was a Q2 shipment slip. Recurring revenue was about $77K per system per year in Q2 across 84 installed systems. Major commercial payers (UnitedHealthcare, Aetna, Cigna) still call TULSA unproven, and the proposed 2027 Medicare ambulatory surgery center (ASC) rate falls 36.85% (hospital rate +14.95%).
Funding risk is real: cash was $38.3M at June 30 after $19.9M of H1 operating cash burn. The CIBC revolver ($4.5M) matures March 3, 2027 and requires cash at least equal to the larger of the trailing six-month EBITDA loss or $10M, so a raise is likely. CAPTAIN 12-month cancer-control data is still pending (one Mayo series showed 22% recurrence).
Upgrade triggers, starting with Q3 results Nov 5 after the close: rising recurring revenue per system, a guide raised above $25M, cash and covenant headroom that remove the need for a raise, Cook contract terms with minimums, Free.Xl and TULSA-on-0.55T clearances, and positive CAPTAIN histology.
No position, not investment advice. #stocks #investing #healthcare
$ARTV: AlloNK was killed for poor durability, plus two deaths, one of them fludarabine-related. The company is cutting staff 94%, and the pipeline is worth ~$0 because the licensed rights revert to GC Cell.
Value is cash only. The company has $319.1M ($6.25 per fully diluted share), which nets to approx. $5.1/share after a approx. $54M wind-down. Probability-weighted value is approx. $4.45–4.64, with upside capped near $5 in a reverse merger scenario which is most likely exit.
Watch: buy at ≤ $4.00 or if the company commits to returning cash. RA Capital (38% stake) controls the outcome. The risks are a reverse merger, litigation holdbacks, and the mid-November Q3 10-Q. No position. #biotech #stocks #investing
Profound Medical ($PROF): Avoid new positions
Profound's TULSA prostate procedure looks clinically promising: its randomized CAPTAIN trial showed better preservation of continence and sexual function than robotic surgery. Even so, we would not buy the stock at today's $5.69. Our probability-weighted value is about $3 per share.
The October revenue preview ($9.8–10.0M for Q3) was largely a delayed shipment from Q2, and full-year guidance did not change. The stock jumped to $7.25 on the news and has since fallen back to where it started.
The key questions are unresolved. Cancer-control data from CAPTAIN have not been released, major commercial insurers still treat TULSA as unproven, and Medicare's proposed 2027 rates would cut surgery-center payment by about 37%. Cash was falling, and the company has raised equity in each of the last two Decembers.
To justify the current price, investors would need roughly a two-in-three chance of our most optimistic scenario; we put it at about one in five. We will revisit after Q3 results on November 5, Medicare's final rule, and CAPTAIN's 12-month cancer data. Strong data or an acquisition offer would change our view..
No position, not investment advice. #biotech #stocks #investing
$CORT update: BELLA Part A was mixed against my forecast: 7.2-month PFS missed (forecast 9.2), while the 59% response rate beat (forecast 52%). It still trails Genmab’s Rina-S, and its best results came in bevacizumab-naive patients, outside Lifyorli's label. It barely changes my SOTP fair value (still about $56; 1-year target about $62 versus about $87 now), so I stay bearish/Avoid. The next catalysts are Genmab's Rina-S update on Oct 28, Q3 Lifyorli sales around Nov 4, and the Cushing's FDA decision on Dec 17. No position. #biotech #stocks #investing
New biotech trade today. 66 pct upside. Derisked. #biotech #stocks #investing seekingalpha.com/checkout/mp…
Veradermics ($MANE): Underweight/Hold based on valuation after recent phase 3 data in male pattern baldness
The company has now twice shown that its extended-release oral minoxidil regrows hair in men with a cleaner safety profile than off-label tablets, and FDA approval in 2028 looks more likely than not. The problem is the price: at $127 the market is paying for $3–4 billion of peak sales for a cash-pay cosmetic pill benchmarked against an $88 supplement, when no hair-loss product has ever exceeded about $1 billion and the same molecule costs $6–27 a month as a generic.
Our probability-weighted value is roughly $39 a share (bear=$11, base = $35, bull = $91), and the two issued patents are method-of-use claims on a 1979 drug, so exclusivity may be closer to three years than seventeen. Sell-side analysts seem to be pricing in the bull case with 25% likelihood only.
We would not buy here; the 12-month safety data this quarter and the female readout in early 2027 are likely positive, so this is a stock to underweight, not to short.
No position, not investment advice. #biotech #stocks #investing
Disc Medicine ($IRON): Post-APOLLO data note (we closed it around $81 in June at 20% profit ahead of APOLLO data), we can still get back in cheaper than what we sold it at
EPP moat: Bitopertin swept all APOLLO endpoints (+12.2 h/month pain-free light, PPIX −41%, phototoxic reactions −71%, zero discontinuations) and ranks #1 of 9 in our EPP/XLP moat scoring (72/100), the only oral agent that reduces the underlying PPIX toxin rather than tanning the skin, with approx. 2× the clinical effect of Leo's dersimelagon (whose first Phase 3 missed its primary, PDUFA Feb 2027) and a once-daily pill versus Scenesse's bimonthly implant at accredited centers.
Pipeline differentiation: Beyond EPP, Disc owns both sides of the hepcidin axis, selcodebart (anti-HJV, lowers hepcidin; 56–72% anemia response in myelofibrosis on top of any JAK inhibitor) and DISC-3405 (anti-TMPRSS6, raises hepcidin; 85% phlebotomy reduction in polycythemia vera with monthly dosing versus weekly rusfertide), both guided to Phase 3 in 2027, funded by approx. $1B pro forma cash.
Next 12 months catalysts: $350M offering pricing (this week); Q3 results (early Nov); RALLY-MF update, FDA end-of-Phase 2 and RESTORE-PV/SCD data (Q4/ASH); NDA resubmission by YE2026; dersimelagon FDA decision (Feb 2027); full APOLLO data at a medical meeting; FDA decision on bitopertin by mid-2027; two Phase 3 starts (2027).
Our plan: We are waiting for the offering to price and for the stock's reaction before initiating a starter position on the long side, a print at or below approx. $74 with a close that holds the deal price is our entry; we will likely not chase above $80, and we cap the position at approx. 5% of NAV because the binary asymmetry has now been collected.
Valuation: Scenario-weighted 1-year DCF SOTP PT $110 (bear $45 / 15%, base $105 / 55%, bull $135 / 30%), +39% from $78.93 with ~0.9× convexity (prior 1.86×) , Buy, Moderate conviction. No position; not investment advice. #biotech #stocks #investing
$PBLS: setup into Oct 24 ESMO Phase 1/ 2 trial follow-up desmoid data
PBLS jumped about 12% on the presentation announcement, before any new data. November options price a ±18% move, and the stock can't react until Monday, Oct 26, because the data come out on a Saturday.
Our estimate is a combined response rate around 50–70% (decreasing vs previous cutoff) (versus the 74–80% investors remember), mostly because the dose-optimization patients have little follow-up so far. That makes how the market reads a lower headline number, plus bone safety and durability, the key swing factors. The scenarios roughly cancel out (expected move about zero, with ±20–35% swings), so this is a defined-risk event at best, not a clear directional call. Watch response rates in Arms A/B versus C, confirmed responses, any tumor progression, and bone density, fractures and ALP.
Neutral rating ahead of above data, maybe some opportunity to play momentum but I wouldn't hold through the data. Phase 3 is already planned and scheduled to start in 2027.
No position. Not investment advice. #biotech #stocks #investing
My latest report on Seeking Alpha premium, uniQure $QURE: Rating Spec.. Buy PT $47 (115% upside). #biotech #stocks #investing
seekingalpha.com/article/495…
Peace at a price.
$LQDA pays $UTHR $380.7M ($3.73/share) to end the litigation and gives up PH-ILD. The market bid it to $38 after hours.
We ran the numbers. Buy/Hold or Sell?
#biotech #stocks #investing
Full note for members:
seekingalpha.com/mp/1074-vas…
TRexBio ($TRXB): New IPO: Watchlist: wholly owned TRB-061, a TNFR2 agonist, aims to restore tissue immune regulation in atopic dermatitis; Phase 1a showed encouraging tolerability and Treg pharmacodynamics, but patient efficacy remains unproven.
Key catalyst: Phase 1b patient data expected around mid-2027; watch for clinical improvement alongside skin-level pharmacodynamics, not merely circulating Treg expansion.
Additional optionality includes preclinical CD30 agonist TRB-071 and Lilly-partnered TRB-051; main scientific risk is that TNFR2 activation is not inherently Treg-selective and can also stimulate inflammatory immune cells. #biotech #stocks #investing
$PCVX’s OPUS-1 data released today are a strong pivotal success that meaningfully de-risks VAX-31, though two stricter noninferiority misses versus Capvaxive prevent an unequivocal best-in-class claim.
My view: eventual adult approval is the base case, contingent on remaining studies and manufacturing; broader coverage is compelling differentiation, but commercial dominance remains unproven. No position. #biotech #stocks #investing