🧬 BIOTECH CATALYST AI SCANNER — December WK1

Alex

27 Nov 2025 — 18 min read

The XBI just logged a +10.72% gain over 21 days—and the beaten-down clinical-stage names are stirring. This week's scanner combed through 250+ catalyst events expected within 10-45 days.

What jumps off the screen? Eight companies currently trade below their cash balances. The market has essentially written off their pipelines as worthless. That's either peak pessimism or justified skepticism—the data will decide. Meanwhile, a handful of well-funded operators sit on multi-year runways with pivotal readouts approaching, facing zero dilution risk while executing.

Then there's the opposite end: companies with sub-6-month cash against existential data readouts. These "cash-clock" setups can deliver spectacular wins—but mistiming means watching a successful trial followed by a brutal equity raise.

What We're Tracking:

Trading Below Cash: PLRX, OVID, ACRV, RLYB, BLRX (the market says pipeline = $0)
Well-Funded, Multi-Year Runway: JANX, GPCR, ORKA, RAPT (no financing overhang)
Cash vs. Catalyst Collision: DBVT, WVE, SONN, GRI, ONCY, CLNN (data must hit or else)
Novel Mechanisms: CDK7 inhibition, KCC2 activation, LPA1R antagonism, PKP2 gene replacement

TIER A — Top 10

#1. RXRX — Recursion Pharmaceuticals Inc.

🎯 THE CATALYST
Event: REC-617 (ELUCIDATE) — Phase 1 in CDK7 inhibitor; Advanced Solid Tumors
Date: Year-End 2025
⭐ BSI AI SCORE: 8.8/10

🏢 Company Profile: Salt Lake City-based Recursion merged with Exscientia in late 2024 to become one of the largest AI-driven drug discovery platforms globally. Their proprietary Recursion OS integrates automation, high-throughput biology, and machine learning to industrialize what has traditionally been a trial-and-error process. Major pharma partnerships (including Roche, Bayer, and more recently a collaboration with MIT on their Boltz-2 model) have generated $450M+ in upfront and milestone payments. The company has cut its workforce 20% to extend runway through late 2027 without additional funding.

🧠 The Setup:
Down nearly 25% over 21 days—and more than 55% from 52-week highs—Recursion enters year-end at a price that implies minimal value for its AI platform beyond existing partnerships. Initial AACR data showed 1 confirmed partial response and 4 stable disease signals. That's promising but far from conclusive. The upcoming full Phase 1 data will determine whether REC-617 validates Recursion's platform thesis or exposes its limitations. With $587M in cash, they aren't going anywhere—but the stock could move sharply either direction.

🔬 Science & Edge:
CDK7 sits at the heart of the cell's transcription machinery. Unlike CDK4/6 inhibitors (already approved for breast cancer), CDK7 inhibition targets transcriptional regulation itself—potentially disrupting cancer cell gene expression programs more broadly. It's a compelling target that's seen limited clinical development. Recursion's AI platform claims to identify targets more efficiently; this readout will test whether that efficiency translates into real clinical outcomes.

⚖️ Risk/Reward Scenario:
• Bull: Meaningful clinical activity validates the platform—not just the molecule. Partnership interest accelerates; the stock re-rates based on technology validation rather than single-asset value.
• Bear: Underwhelming data reinforces the "all hype, no hits" narrative around AI drug discovery. The 20% workforce cut looks like the first of many austerity measures. No approved products through 2027+ remains the reality.

#2. JANX — Janux Therapeutics Inc.

🎯 THE CATALYST
Event: EGFR-TRACTr (JANX008) — Phase 1 update in Metastatic colorectal cancer (mCRC), SCCHN and NSCLC
Date: Year-End 2025
⭐ BSI AI SCORE: 8.7/10

🏢 Company Profile: San Diego-based Janux has built its platform around a clever engineering solution: tumor-activated T-cell engagers (TRACTr) that stay "masked" until reaching the tumor microenvironment. The approach aims to solve the toxicity problem that has plagued conventional bispecific antibodies. Janux has partnerships with Merck (which dosed its first patient in a TRACTr collaboration in August 2025) and recently showcased additional platforms including TROP2-TRACTr for solid tumors and CD19-ARM for autoimmune diseases. Management has expanded beyond oncology, signaling confidence in the platform's versatility.

🧠 The Setup:
Everything's clicking: 25% momentum, elevated volume ratio (1.57x), and nearly $1B in cash providing runway through 2028 and beyond. Prior Phase 1 data showed encouraging efficacy in heavily pretreated patients with a differentiated safety profile. The elevated RSI (69.7) signals enthusiasm—perhaps too much—but institutional positioning ahead of year-end data suggests this is more than retail speculation. The Merck partnership adds credibility.

🔬 Science & Edge:
EGFR inhibitors like cetuximab are decades old and carry significant toxicity. JANX008's masking technology keeps the T-cell engager inactive until tumor enzymes activate it locally. If this achieves meaningful efficacy without systemic toxicity, it could open EGFR-targeting to patients who've failed current options—a massive population across colorectal, head/neck, and lung cancers.

⚖️ Risk/Reward Scenario:
• Bull: Differentiated safety + meaningful efficacy = best-in-class positioning. Large pharma takes notice. Potential for premium acquisition or lucrative partnership expansion.
• Bear: EGFR is a crowded target with multiple approved options. The bar for "meaningfully better" is high. Masked bispecifics have theoretical appeal but limited clinical track record.

#3. PLRX — Pliant Therapeutics Inc.

🎯 THE CATALYST
Event: PLN-101095 — Phase 1 initial data in Solid Tumors
Date: Year-End 2025
⭐ BSI AI SCORE: 8.4/10

🏢 Company Profile: Originally focused on fibrosis, Pliant pivoted after discontinuing its lead program (BEACON-IPF) and cutting ~60% of its workforce. What remains is $230M in cash against a $97M market cap—meaning the market assigns negative value to the pipeline. The company now focuses on PLN-101095, an oncology asset targeting integrin-mediated TGF-β signaling in the tumor microenvironment.

🧠 The Setup:
This is a pure optionality play. The market has essentially priced the oncology program at zero (or negative). If Phase 1 data shows meaningful activity with acceptable tolerability, the re-rating potential is substantial—you're paying below cash for a shot at oncology asset validation. If data disappoints, downside is cushioned by the balance sheet. The risk? Early-stage oncology has a high failure rate, and Pliant's track record in fibrosis didn't inspire confidence.

🔬 Science & Edge:
PLN-101095 is an oral dual-selective integrin inhibitor (αvβ8/αvβ1) designed to block TGF-β activation in tumors. TGF-β creates an immunosuppressive environment; blocking it could enhance checkpoint inhibitor efficacy. The oral, small-molecule format offers convenience over antibody approaches. The thesis is combination potential, not replacement of existing therapies.

⚖️ Risk/Reward Scenario:
• Bull: Clean Phase 1 data + partnership interest = rapid re-rating. Even modest valuation multiple applied to advancing oncology asset generates 3-5x from current levels.
• Bear: Declining response rates at higher doses or emerging safety signals end the program. The company becomes a cash shell seeking strategic alternatives.

#4. NBTX — Nanobiotix S.A.

🎯 THE CATALYST
Event: NBTXR3 — Phase 1/2 initial data in Esophageal Cancer
Date: Year-End 2025
⭐ BSI AI SCORE: 8.3/10

🏢 Company Profile: Paris-based Nanobiotix developed NBTXR3, a first-in-class radioenhancer based on hafnium oxide nanoparticles. The particles are injected directly into tumors and amplify radiation energy approximately nine-fold. Johnson & Johnson is sponsoring global development—a significant validation from Big Pharma. Phase 1 data (n=13) presented at ASTRO 2025 showed early signals in esophageal cancer.

🧠 The Setup:
JNJ partnership substantially reduces execution risk—they're handling global development infrastructure and regulatory strategy. The ~$967M market cap against early-phase data suggests the market is pricing in some probability of success but plenty of room for upside if expansion cohorts confirm efficacy. Positive momentum (+13%) reflects growing interest as the data matures.

🔬 Science & Edge:
NBTXR3 works through dual pathways: direct radiation amplification within tumors and immune priming via damage-associated molecular pattern release. Unlike molecular-targeted therapies, it doesn't require patient stratification—any solid tumor receiving radiation is potentially treatable. The esophageal cancer application is particularly compelling: surgical esophagectomy is brutal, and avoiding it would dramatically improve quality of life.

⚖️ Risk/Reward Scenario:
• Bull: Phase 2 confirms efficacy → JNJ accelerates path to approval → platform validated across tumor types. Potential to disrupt radiation oncology standard-of-care.
• Bear: Small n=13 cohort may not replicate in larger populations. Intratumoral injection adds workflow complexity that limits adoption. Checkpoint inhibitor combos may saturate market.

#5. OVID — Ovid Therapeutics Inc.

🎯 THE CATALYST
Event: OV350 — Phase 1 PK data in Healthy volunteers
Date: Q4 2025
⭐ BSI AI SCORE: 8.3/10

🏢 Company Profile: Ovid focuses on CNS disorders, developing novel mechanisms for epilepsy and related conditions. After pivoting from failed programs, the company now advances OV350—a first-in-class KCC2 activator. With nearly $196M in cash against a $116M market cap, the market assigns negative value to the pipeline. Runway extends beyond 3 years.

🧠 The Setup:
Another "trading below cash" story with a near-term readout. OV350's Q4 PK data will establish whether the drug achieves adequate exposure and clean safety in humans. It's early-stage data, but for a first-in-class mechanism, healthy volunteer PK is the gating event. Positive momentum (+12%) suggests some investors are positioning ahead.

🔬 Science & Edge:
KCC2 is a potassium-chloride co-transporter that restores inhibitory neurotransmission in the CNS. Unlike conventional anticonvulsants that modify existing pathways, KCC2 activation represents a genuinely novel approach. Preclinical data shows seizure reduction and neuroprotection. Ovid is developing both IV and oral formulations, enabling acute and chronic applications across epilepsy, neuropathic pain, and potentially broader CNS indications.

⚖️ Risk/Reward Scenario:
• Bull: Clean PK + safety → Phase 2 patient studies → platform validation → partnership interest. KCC2 could become a new drug class.
• Bear: Inadequate CNS exposure or safety signals stall development. Despite the cash cushion, serial failures erode investor confidence and limit funding options.

#6. DBVT — DBV Technologies S.A.

🎯 THE CATALYST
Event: Viaskin Peanut (VITESSE) — Phase 3 topline data in Peanut allergy
Date: Q4 2025
⭐ BSI AI SCORE: 8.3/10

🏢 Company Profile: France-based DBV Technologies has spent years developing an epicutaneous immunotherapy patch for peanut allergy. The road has been rocky: a previous Complete Response Letter from FDA, clinical hold drama, and chronic cash concerns. But they've persevered—VITESSE, enrolling 654 patients across 86 sites, is the largest peanut allergy intervention trial ever conducted. Last patient visit completed November 2025; topline data due Q4. The company just hired a Chief Commercial Officer, signaling confidence in near-term approval. BLA submission targeted for H1 2026.

🧠 The Setup:
High risk, high reward. The science has shown durability—3-year EPITOPE data showed 68% of toddlers tolerating 12-14 peanut kernels with no treatment-related anaphylaxis. But the cash situation is dire: less than 7 months of runway. Data must be positive AND financing must close at reasonable terms. Negative 15% momentum and depressed RSI (37) suggest the market is nervous.

🔬 Science & Edge:
Epicutaneous immunotherapy (EPIT) works differently than oral immunotherapy like Palforzia. The VIASKIN patch leverages the skin's immune-tolerizing properties to gradually desensitize patients without requiring daily oral dosing. The format is far more convenient for children (and parents). Three-year durability data showing sustained benefit without ongoing treatment is particularly compelling—suggesting true immune reprogramming rather than temporary desensitization.

⚖️ Risk/Reward Scenario:
• Bull: VITESSE replicates EPITOPE signals → BLA submission H1 2026 → approval 2026/2027 in a ~1.5M US pediatric population with limited options. Stock multiples on positive data + financing.
• Bear: Efficacy gaps in larger population. Even positive data may come with punitive financing terms that dilute current holders substantially. Palforzia competition remains.

#7. SLS — SELLAS Life Sciences Group Inc.

🎯 THE CATALYST
Event: Galinpepimut-S (REGAL) — Phase 3 results in Acute Myeloid Leukemia (AML)
Date: Year-End 2025
⭐ BSI AI SCORE: 8.3/10

🏢 Company Profile: SELLAS develops cancer immunotherapies targeting the WT1 protein, which is overexpressed in multiple malignancies. Lead asset Galinpepimut-S (GPS) is in Phase 3 for AML maintenance—a setting with significant unmet need where standard-of-care remains observation.

🧠 The Setup:
The REGAL trial has already passed a critical milestone: the interim analysis at 60 deaths cleared the futility bar with the IDMC recommending continuation. That's unusual—most trials that pass interim analysis reach final readout. Prior Phase 2 showed 21-month median overall survival vs. 5.4 months for SOC. The 80% immune response rate in Phase 3 exceeds Phase 2's 64%. Despite this, the stock is down nearly 30% over 21 days. The market seems skeptical of reaching the 80-event threshold by year-end.

🔬 Science & Edge:
GPS activates the patient's own immune system to target leukemia cells expressing WT1 protein. It's mechanistically distinct from chemotherapy and represents the only immunotherapy specifically targeting maintenance in AML. The Phase 2 survival signal was striking (21 months vs. 5.4 months), and the immune response rate improvement in Phase 3 suggests the mechanism is robust.

⚖️ Risk/Reward Scenario:
• Bull: Statistical significance on OS at final analysis → first-mover in AML maintenance → BLA pathway → meaningful commercial opportunity in large patient population.
• Bear: Final analysis misses primary endpoint despite passing interim. Delays into 2026 compress value. AML maintenance remains a difficult commercial market to penetrate.

#8. RZLT — Rezolute Inc.

🎯 THE CATALYST
Event: RZ358 (sunRIZE) — Phase 3 topline data in Congenital hyperinsulinism (HI)
Date: December 2025
🏛️ FDA Status: BTD
⭐ BSI AI SCORE: 8.3/10

🏢 Company Profile: Rezolute focuses on rare endocrine diseases. Lead asset ersodetug (RZ358) targets congenital hyperinsulinism (cHI), a condition where the pancreas produces excess insulin, causing dangerous hypoglycemia. The only approved therapy—diazoxide—fails in over half of patients. FDA granted Breakthrough Therapy Designation, and Rezolute exceeded enrollment targets (62 vs. 56 planned), completing the sunRIZE trial ahead of schedule.

🧠 The Setup:
This is about as clean a setup as rare disease gets. BTD secured, enrollment exceeded targets, trial completed early. Phase 2 showed median hypoglycemia improvements exceeding 80%. The regulatory pathway is well-defined. December topline data is the defining moment. Flat momentum and neutral RSI suggest the market is waiting, not positioned.

🔬 Science & Edge:
Ersodetug works downstream of the pancreas—it's a monoclonal antibody that binds insulin receptors in liver, fat, and muscle to block excess insulin's effects. This is crucial: diazoxide targets insulin secretion and fails across multiple genetic etiologies. By working downstream, ersodetug could address cHI regardless of the underlying genetic defect (GCK, HADH, ABCC8, etc.).

⚖️ Risk/Reward Scenario:
• Bull: Positive Phase 3 → first-in-class for diazoxide-refractory cHI → BTD accelerates to 2026 BLA. Opportunity extends to acquired hyperinsulinism (FDA signaled streamlined Phase 3 path with 16 patients).
• Bear: Orphan diseases are unforgiving—failure to show superiority over placebo is terminal. Even with approval, commercial upside is capped by ~1,000-3,000 symptomatic US patients.

#9. MTVA — MetaVia Inc.

🎯 THE CATALYST
Event: DA-1726 — Phase 1 topline data (48mg cohort) in NASH and obesity
Date: Year-End 2025
⭐ BSI AI SCORE: 8.2/10

🏢 Company Profile: MetaVia is developing DA-1726, a dual GLP-1/glucagon receptor agonist for obesity. The company trades at ~$18M market cap with ~$13M in cash—essentially valued at minimal premium to liquidation. Prior 32mg data showed up to 6.3% body weight reduction (4.3% placebo-adjusted), 3.9-inch waist circumference reduction, and 83% early satiety.

🧠 The Setup:
Obesity is a $50B+ market, and the dual-agonist approach (combining GLP-1's appetite suppression with glucagon's energy expenditure boost) is generating significant Big Pharma interest. MetaVia's 48mg cohort data will reveal whether higher doses maintain efficacy with acceptable tolerability. The stock is beaten down (-24% momentum, 0.08x volume ratio)—suggesting minimal expectations. That creates optionality if data surprises.

🔬 Science & Edge:
DA-1726's 3:1 GLP-1/glucagon ratio aims to maximize metabolic benefit while minimizing tolerability concerns. Preclinical head-to-heads showed enhanced lipid-lowering vs. pemvidutide and greater weight loss vs. tirzepatide despite similar food intake—suggesting metabolic benefits beyond appetite suppression. The ~80-hour half-life enables once-weekly dosing without titration.

⚖️ Risk/Reward Scenario:
• Bull: 48mg confirms efficacy + tolerability → Phase 2 positioning → dual-agonist partnerships emerge. Success justifies 100x+ valuation expansion.
• Bear: Dose-limiting tolerability (nausea, vomiting) forces dose reduction, eliminating efficacy advantage. 12-month runway means dilution is coming regardless.

#10. XOMA — XOMA Royalty Corporation

🎯 THE CATALYST
Event: RZ358 (sunRIZE) — Phase 3 topline data in Congenital hyperinsulinism (HI)
Date: December 2025
🏛️ FDA Status: BTD
⭐ BSI AI SCORE: 8.2/10

🏢 Company Profile: XOMA is a royalty aggregator—they acquire revenue interests in clinical-stage programs rather than developing drugs themselves. Their RZ358 royalty provides exposure to Rezolute's sunRIZE trial without the operational cash burn. The model: zero COGS, zero commercialization expense, pure margin on any approval.

🧠 The Setup:
This is a "derivative trade" on Rezolute's readout. While Rezolute (RZLT) bears the $100M+ development cost, XOMA holds a perpetual claim on future revenue. The enrollment is complete, IDMC signals are favorable, and December topline approaches. For investors wanting ersodetug exposure without single-asset concentration risk, XOMA offers a diversified vehicle.

🔬 Science & Edge:
The edge here is financial structure, not biological innovation. XOMA's royalty converts approval into 100% margin cash flow that drops directly to the bottom line. A successful RZ358 validates the aggregator model and potentially funds future royalty acquisitions without equity dilution.

⚖️ Risk/Reward Scenario:
• Bull: Positive readout = immediate NAV accretion. Approval drives non-dilutive cash flow starting 2026/2027. Model validated for future deals.
• Bear: Trial failure writes off the royalty asset. While XOMA is diversified, losing a key growth driver reprices the stock based on remaining portfolio. Likely less violent decline than RZLT would experience.

TIER B — BRIEF INTEL

#11. BLTE — Belite Bio Inc

📊 Price: $129.62 | Cap: $4.18B | Cash: $105.89M | RSI: 60.47 | Momentum: +32.27%
🎯 Tinlarebant (LBS-008) — Phase 3 DRAGON trial in Adolescent Stargardt disease (Q4 2025)
🏛️ FDA Status: BTD, FTD, ODD
⭐ BSI AI SCORE: 8.1/10

The Intel: Enrollment complete, final visits done—topline imminent. The +32% momentum signals serious institutional positioning. Tinlarebant targets RBP4, addressing root cause pathology in retinal degeneration. Triple designation (BTD/FTD/ODD) provides regulatory runway. Success = first-in-class approval for Stargardt within 12-18 months. Failure = near-total loss given limited alternative indications.

#12. CAPR — Capricor Therapeutics Inc.

📊 Price: $5.19 | Cap: $237.28M | Cash: $84.14M | RSI: 36.74 | Momentum: -25.0%
🎯 CAP-1002 (HOPE-3) — Phase 3 topline data in Duchenne Muscular Dystrophy (Q4 2025)
⭐ BSI AI SCORE: 8.1/10

The Intel: Beaten down (-25% momentum, RSI 36.7) ahead of a pivotal BLA-supporting readout. Prior Phase 2: 71% slowing of mid-PUL decline (p=0.01), LVEF improvement (p=0.02). CAP-1002 targets DMD cardiomyopathy—the leading cause of death—rather than attempting gene therapy. FDA endpoint alignment achieved post-prior CRL. Strong data needed to overcome regulatory skepticism.

#13. GPCR — Structure Therapeutics Inc.

📊 Price: $34.22 | Cap: $2.08B | Cash: $698.42M | RSI: 52.29 | Momentum: +15.73%
🎯 GSBR-1290 (ACCESS) — Phase 2b data in Type 2 Diabetes, obesity (Q4 2025)
⭐ BSI AI SCORE: 8.1/10

The Intel: Nearly $700M in cash through 2028+ runway. Phase 2a showed 6.2% average weight loss over placebo with one-third achieving ≥10% reduction. GSBR-1290 translates GLP-1 mechanism into oral small-molecule format—a significant technical achievement. The ACCESS trial (36 weeks) determines whether they compete with Eli Lilly's orforglipron for oral first-mover positioning. Tolerability (nausea/vomiting) remains the key question.

#14. ACRV — Acrivon Therapeutics Inc.

📊 Price: $2.36 | Cap: $74.47M | Cash: $119.89M | RSI: 62.5 | Momentum: +24.87%
🎯 ACR-2316 — Phase 1 data in Dual WEE1/PKMYT1 inhibitor, Solid tumors (Year-End 2025)
⭐ BSI AI SCORE: 8.0/10

The Intel: Another "below cash" play ($74M cap vs. $120M cash). Early signals: ~25% RECIST tumor shrinkage, confirmed partial responses, no dose-limiting toxicities through three cohorts. WEE1 inhibitors have disappointed despite preclinical promise; ACR-2316's dual WEE1/PKMYT1 inhibition addresses a known resistance mechanism. Rapid dose escalation suggests favorable tolerability. Success = partnership/acquisition at substantial premiums.

#15. RLYB — Rallybio Corporation

📊 Price: $0.643 | Cap: $27.16M | Cash: $54.76M | RSI: 50.83 | Momentum: +6.23%
🎯 RLYB116 — Phase 1 PK/PD Cohort 2 data in Immune platelet transfusion refractoriness (Q4 2025)
⭐ BSI AI SCORE: 7.9/10

The Intel: $27M market cap vs. $55M cash—extreme discount. First cohort dosed September 2025; Cohort 2 PK/PD data represents Phase 1 efficacy read in underserved immunological space. The valuation provides cushion; the catalyst provides optionality. Even acceptable PK/PD faces efficacy uncertainty, but the math works if anything positive emerges.

#16. BLRX — BioLineRx Ltd.

📊 Price: $3.445 | Cap: $12.82M | Cash: $66.96M | RSI: 53.41 | Momentum: -1.43%
🎯 Motixafortide (St Jude Trial) — Phase 1 ASH presentation in HSC mobilization for sickle cell disease (December 2025)
⭐ BSI AI SCORE: 7.9/10

The Intel: Most extreme discount on the list: $12.8M market cap vs. $66.96M cash. Low float (<3.72M shares). December ASH data shows motixafortide achieves 2.8-3.2x higher CD34+ HSC mobilization vs. plerixafor in sickle cell patients (n=9). This matters because gene therapies require 16-22 million CD34+ cells, often necessitating multiple apheresis cycles. Better mobilization = easier gene therapy manufacturing. Small cohort limits conclusions, but the setup is compelling.

#17. WVE — Wave Life Sciences Ltd.

📊 Price: $7.67 | Cap: $1.28B | Cash: $165.10M | RSI: 46.98 | Momentum: -7.14%
🎯 WVE-007 (INLIGHT) — Phase 1 three-month follow-up data in Obesity (Q4 2025)
⭐ BSI AI SCORE: 7.9/10

The Intel: Proof-of-concept in hand (October 2025): dose-dependent Activin E reduction up to 85% one month post single dose. That's compelling for once/twice-yearly therapy in obesity. Unlike GLP-1 agonists, WVE-007 manipulates lipid metabolism directly with preclinical evidence of muscle preservation. But: <11 months runway creates urgency. Successful data could catalyze partnerships; disappointing signals force distressed capital raise.

#18. FENC — Fennec Pharmaceuticals Inc.

📊 Price: $7.89 | Cap: $222.84M | Cash: $60.98M | RSI: 48.31 | Momentum: -6.85%
🎯 STS-J01 — Trial data in Japan (Q4 2025)
⭐ BSI AI SCORE: 7.9/10

The Intel: Commercial-stage company with PEDMARK growing (79% Q3 revenue growth). Strong balance sheet (36mo+ runway). STS-J01 data could unlock Japan market entry in pediatric oncology ototoxicity reduction. PEDMARK's mechanism is validated through two Phase 3 trials with NCCN 2A endorsement. No competing agents exist. Six patents provide exclusivity until 2039.

#19. TLSA — Tiziana Life Sciences Ltd

📊 Price: $1.79 | Cap: $199.52M | Cash: $12.71M | RSI: 49.39 | Momentum: -5.29%
🎯 Foralumab (INFORM-MS) — Phase 2a data in Non-active, secondary-progressive MS (Year-End 2025)
🏛️ FDA Status: FTD, ODD
⭐ BSI AI SCORE: 7.9/10

The Intel: Pivotal Phase 2a at five leading US centers (Yale, Johns Hopkins, Brigham, UMass, Weill Cornell). Preliminary signals: improvement or stability in all 14 EAP patients within 6 months. Intranasal foralumab (anti-CD3 mAb) selectively expands regulatory T cells while dampening CNS inflammation. Fast Track + Orphan Drug designations. But: $12.7M cash creates existential pressure. Single data point determines survival.

#20. ORKA — Oruka Therapeutics Inc.

📊 Price: $30.46 | Cap: $1.47B | Cash: $336.34M | RSI: 59.65 | Momentum: +10.32%
🎯 ORKA-002 — Phase 1 PK and healthy volunteer data in Dermatologic/inflammatory indications (Year-End 2025)
⭐ BSI AI SCORE: 7.8/10

The Intel: $335M cash through 2028+ runway. Phase 1 PK data will validate ORKA-002's preclinical half-life claims—a key read that determines Phase 2 dosing assumptions. Dual IL-17A/F targeting is validated (bimekizumab), but ORKA-002's extended half-life engineering is the edge: 2-3x yearly dosing would meaningfully improve quality-of-life vs. monthly alternatives. ORKA-001 (IL-23) already progressing Phase 2 creates halo effect.

📋 TIER C — Watchlist Radar

Rare Disease & Genetic
• IPSEY ($36.72) — Fidrisertib (FALKON), Phase 2b in Fibrodysplasia ossificans progressiva. H2 2025. Score: 7.7
• TNYA ($1.36) — TN-401 (RIDGE-1), Phase 1b in Arrhythmogenic Right Ventricular Cardiomyopathy. Q4 2025. Score: 7.0
• IPSC ($0.54) — CNTY-101 (ELiPSE-1), Phase 1 in Lymphoma. Year-End 2025. Score: 6.7

Metabolic & Pain
• CTNM ($10.76) — PIPE-791, Phase 1b in Osteoarthritis and low back pain. Q4 2025. Score: 7.7

Immunology & Autoimmune
• RAPT ($33.26) — RPT904, Phase 2 in Asthma. H2 2025. Score: 7.7
• KYTX ($7.68) — KYV-101 (KYSA-1), Phase 1/2 in Refractory Lupus Nephritis. H2 2025. Score: 7.0

Oncology & Solid Tumors
• RADX ($4.64) — RAD202 (HEAT), Phase 1 in HER2+ solid tumors. Year-End 2025. Score: 7.5
• SONN ($4.155) — SON-1010/atezolizumab (SB221), Phase 1b/2 in Platinum-resistant ovarian cancer. Q4 2025. Score: 7.4
• AUTL ($1.37) — AUTO6NG, Phase 1 in Small cell lung cancer. 2025. Score: 6.9
• ONCY ($1.04) — Pelareorep (BRACELET-1), Phase 2 in HR+/HER2- breast cancer. Year-End 2025. Score: 6.8

Infectious Disease
• EBS ($11.05) — Brincidofovir (MOSA), Phase 2/3 in Monkey pox. Q4 2025. Score: 7.4

Neurology & CNS
• TLX ($9.75) — TLX101-CDx, NDA resubmission in Progressive/recurrent glioma. Q4 2025. Score: 7.2
• RVPH ($0.5225) — Brilaroxazine (RECOVER), Phase 3/FDA meeting in Schizophrenia. Q4 2025. Score: 7.0
• CLNN ($10.15) — CNM-Au8 (VISIONARY-MS), Phase 2/EoP2 meeting in Multiple Sclerosis. 2025. Score: 6.9

Pulmonary/Fibrosis
• GRI ($1.98) — GRI-0621, Phase 2 topline in Idiopathic pulmonary fibrosis. 2025. Score: 7.2

The Strategist's Take

Two distinct playbooks emerge from this week's scanner.

The Value Hunt: Eight companies trading below cash (PLRX, OVID, ACRV, RLYB, BLRX, and others) represent the market's verdict that their pipelines are worthless. That's either correct—in which case downside is limited to the cash-burn rate—or incorrect, in which case any positive clinical signal triggers violent re-rating. The math favors waiting for catalysts rather than catching falling knives, but the valuations are genuinely extreme.

The Cash-Clock Collision: DBV Technologies, Wave Life Sciences, Tiziana, and GRI Bio are running trials against depleting bank accounts. Even positive data may not prevent painful financing. These are conviction plays—you need to believe in both the science AND management's ability to execute fundraising at reasonable terms. The upside is substantial, but the execution risk is real.

Where the Setup Looks Cleanest: Janux (JANX), Structure (GPCR), Oruka (ORKA), and Fennec (FENC) combine substantial cash runways with near-term catalysts. No financing distraction, no existential cash pressure—just science and execution. Rezolute (RZLT) offers similar clarity in rare disease with BTD backing.

The obesity plays deserve attention: MetaVia (MTVA), Structure (GPCR), and Wave (WVE) each bring differentiated mechanisms to a market that has validated multi-billion-dollar valuations. Dual-agonists, oral formulations, and Activin E silencing all represent shots-on-goal beyond pure GLP-1 agonism.

For catalyst-focused capital, the strongest profiles combine adequate cash, clear regulatory pathway, and imminent data. Position sizing should reflect the binary nature of these events—even the best setups fail more often than they succeed.

About This Scanner

This weekly report combines ML-based screening with AI-powered due diligence.

How It Works: The core engine uses a model trained on 15+ years of historical biotech catalyst data, identifying technical setups that have preceded significant price movements. Candidates passing ML screening undergo real-time AI analysis covering mechanism of action, competitive landscape, financial health, and risk factors.

What the Score Means: The BSI AI Score (1-10) reflects overall setup quality—it is not a prediction of catalyst outcomes. Higher scores indicate more favorable characteristics; lower scores indicate elevated uncertainty or risk.

Data Sources: Financial data from market feeds and regulatory filings. Catalyst dates are estimates based on company guidance and subject to change. AI-generated analysis may contain errors despite quality controls.

Important: This report is for informational and educational purposes only. It does not constitute investment, financial, or medical advice. Conduct your own due diligence and consult qualified advisors before making investment decisions.

Disclaimer

The information provided is for informational purposes only and should not be construed as financial, investment, legal, or professional advice. While efforts are made to ensure accuracy, no guarantee is given regarding completeness or reliability.

Key Risks:

Clinical trials: Most drug candidates fail in development
Regulatory: FDA decisions remain unpredictable
Financing: Companies may dilute at any time
Volatility: Small-cap biotech stocks experience extreme price swings

Past performance does not guarantee future results.

Scanner Version: 19.0 | Generated: November 27, 2025 | Total Candidates Analyzed: 250+