🧬 BIOTECH CATALYST AI SCANNER — February WK4

Alex

18 Feb 2026 — 20 min read

(Editor's note : I'm releasing the Week 4 Scanner a bit early, as I'm currently tied up with a new project at work.

A quick heads-up on something not covered in this week’s issue: MoonLake Immunotherapeutics ($MLTX) is hosting its Investor Day on February 23rd. This catalyst could generate significant movement. I'm currently holding a long position, but I plan to trim it slightly to manage risk ahead of the event. On a separate note, Kodiak Sciences ($KOD) has increasingly been catching my attention lately.)

After a blockbuster 2025 that saw the XBI surge nearly 36% and the Nasdaq Biotech Index climb 33.8%, the sector has entered 2026 in consolidation mode. XBI is trading around $120, up modestly YTD (~2.3%) but pulling back from its 52-week high of $132. The recent softness reflects a healthy digestion of gains rather than deteriorating fundamentals — M&A activity remains robust, the FDA approved over 44 drugs in 2025, and Big Pharma's patent cliff continues to create acquisition hunger for clinical-stage assets.

This week's scan reveals a dense cluster of Q1 2026 catalysts, with several companies approaching data inflection points under significant financial pressure. What stands out: multiple names are trading below their cash value (negative enterprise value), a handful face existential cash crunches that make upcoming readouts truly binary, and we're tracking several first-in-human datasets that could reshape therapeutic categories. The tension between strong science and thin balance sheets defines this week's landscape.

The gene therapy and rare disease space dominates the top ranks, with entries spanning Duchenne muscular dystrophy, inherited retinal diseases, and Sanfilippo syndrome. Meanwhile, the autoimmune revolution continues to accelerate, with allogeneic CAR-T approaches targeting lupus making Phase 2 moves. Oncology remains well-represented through novel mechanisms including molecular glue degraders and biomarker-guided checkpoint kinase inhibition.

What We're Tracking:

Trading Below Cash: ACET, ACRV, FGEN, BIVI
Cash Pressure: ALZN, RGNX, MDCX, SPRB, HOTH, MBRX
Initial Data / First Human Data: ALZN, MDCX, KOD, ACET, KPTI, IRD, PALI, ACIU, MBRX
Multi-Catalyst: None this week — all entries carry single focused catalysts

#1. ALZN — Alzamend Neuro Inc.

🎯 THE CATALYST
Event: AL001 — Phase 2 in Alzheimer's / CNS disorders
Date: Q1 2026 (Est.)
⭐ BSI SCORE: 8.39/10

AL001 is a reformulated lithium-delivery system using ionic cocrystal technology (lithium + salicylate + L-proline) designed to penetrate the brain more effectively while avoiding the systemic toxicity that makes conventional lithium therapy so burdensome. The key innovation: eliminating the need for therapeutic drug monitoring (TDM) — the frequent blood tests that currently limit lithium prescribing across Alzheimer's, bipolar disorder, MDD, and PTSD.

The Setup: With just $3.0M cash and a 7-month runway, Alzamend is the definition of a pressure cooker. Phase 2 dosing began in May 2025 and topline data are due imminently this quarter. At a $6.3M market cap — barely above its cash — this is a pure binary: positive data could revalue the stock multiple-fold, while a miss or delay accelerates a cash crisis that leaves little room for negotiation.

Science & Edge: Phase 1/2 results in healthy subjects and Alzheimer's patients identified a maximum tolerated dose (240 mg lithium carbonate equivalent, three times daily) that appears unlikely to require TDM — the central clinical advantage. Preclinical work showed higher brain uptake at lower blood lithium levels than conventional salts, and proprietary lithium brain imaging provided dosing calibration data that competitors lack. If confirmed in Phase 2, this would be a meaningful advance for a drug class that's been hamstrung by its toxicity profile for decades.

Risk/Reward:
🐂 Bull: Phase 2 validates TDM-free dosing across a 43M+ patient opportunity spanning four major CNS indications. A positive readout at this valuation could trigger rapid rerating and attract partnership interest.
🐻 Bear: Delayed readout or safety signals would burn through remaining cash within months. Lithium's mechanism in Alzheimer's remains unproven, and the competitive landscape includes established anti-amyloid antibodies. Dilutive financing at these levels would be severe.

#2. OKYO — OKYO Pharma Limited

🎯 THE CATALYST
Event: Urcosimod (OK-101) — Phase 2a in Neuropathic Corneal Pain (NCP)
Date: Apr 11, 2026
🛡️ FDA Status: FTD
⭐ BSI SCORE: 7.60/10

OKYO is developing urcosimod, a topical anti-inflammatory eyedrop for neuropathic corneal pain — a severe, chronic condition where damaged corneal nerves cause debilitating pain with no FDA-approved treatment. Think of NCP as the cornea's equivalent of phantom limb pain: the nerves are damaged, but the pain signals keep firing.

The Setup: The near-term catalyst is an ASCRS (American Society of Cataract and Refractive Surgery) presentation on April 11, with Phase 2b/3 initiation expected in H1 2026. A key de-risking event already occurred: FDA's Type C meeting in January 2026 endorsed the study design and CMC (chemistry, manufacturing, controls) strategy. Cash is critically thin at $6.3M with effectively zero runway, so the company will need to raise capital — but FDA alignment and Fast Track designation improve the terms of any financing.

Science & Edge: Phase 2 data showed 75% of patients achieved greater than 80% pain reduction at the 0.05% dose. More importantly, December 2025 data demonstrated directional improvements in corneal nerve fiber count and length — mechanistic evidence of actual nerve regeneration, not just symptom masking. This nerve regeneration signal was absent in placebo patients. The micellar formulation enhances ocular surface delivery, and OKYO holds first-mover status in NCP clinical development.

Risk/Reward:
🐂 Bull: First-in-class therapy for an unmet need. FDA alignment on trial design, Fast Track designation, and nerve regeneration data support a clear path to Phase 3 and potential approval.
🐻 Bear: Phase 2 enrolled only 18 patients with early termination — statistical power is questionable. NCP is ultra-rare, limiting commercial upside. Near-zero cash forces imminent dilution regardless of clinical progress.

#3. RGNX — REGENXBIO Inc.

🎯 THE CATALYST
Event: RGX-202 (AFFINITY DUCHENNE) — Phase 1/2 in Duchenne Muscular Dystrophy (DMD)
Date: Mar 31, 2026
🛡️ FDA Status: FTD, ODD
⭐ BSI SCORE: 7.51/10

RGX-202 is an AAV8 gene therapy that delivers a microdystrophin protein with the C-Terminal (CT) domain — a structural element absent from every other DMD gene therapy in development. In simple terms: dystrophin is the molecular shock absorber that protects muscle fibers during contraction. DMD patients lack it, and their muscles progressively deteriorate. The CT domain helps the replacement protein anchor more securely and function more like the natural version.

The Setup: RGNX has been punished hard — RSI at 11.4 signals extreme oversold conditions, and the stock has dropped 41% over 21 days. With $186.5M cash providing roughly 10 months of runway, the company needs positive data to either sustain the story or attract a partner. Key milestones align tightly: MDA conference in March 2026, topline data in Q2 2026, and potential BLA filing mid-2026. This is a rare disease play where the runway and the catalyst timeline are in a footrace.

Science & Edge: The NAV AAV8 vector uses a muscle-specific promoter to express CT-inclusive microdystrophin that localizes to the sarcolemma (muscle cell membrane). Clinical data have shown 43.5% CK reduction (CK is a blood marker of muscle damage — lower is better) and high expression relative to normal dystrophin levels. Preclinical head-to-head comparisons showed the CT-containing construct produced superior muscle force and damage resistance versus non-CT versions. Unlike steroids or exon-skipping therapies that manage symptoms, this aims for a one-time functional trajectory shift.

Risk/Reward:
🐂 Bull: Best-in-class preclinical profile in DMD. Positive topline data and BLA submission could drive partnership or acquisition interest, with multi-fold rerating potential.
🐻 Bear: Functional data in the Phase 1/2 may not match preclinical promise. Gene therapy manufacturing and pricing in rare disease remain challenging. Cash runway forces the company into a corner if data disappoint.

#4. MDCX — Medicus Pharma Ltd.

🎯 THE CATALYST
Event: Doxorubicin (SKNJCT-003) — Phase 2 in Basal Cell Carcinoma (BCC)
Date: Q1 2026 (Est.)
⭐ BSI SCORE: 7.47/10

SkinJect delivers the chemotherapy drug doxorubicin directly into skin cancer lesions via a dissolving microneedle patch — imagine a tiny adhesive array of drug-loaded needles that penetrate just deep enough to reach the tumor, then dissolve and release the drug locally. This eliminates the need for surgical excision in basal cell carcinoma, the most common human cancer (~3.6 million U.S. cases annually), while avoiding the systemic toxicity of IV chemotherapy.

The Setup: This is the most cash-critical name on the list. With $3.2M and roughly one month of runway, Medicus faces an existential financing decision that will coincide almost exactly with its Phase 2 topline readout. A 90-patient, 9-site Phase 2 trial is winding down with data expected this quarter, and an FDA End-of-Phase-2 meeting is targeted for H1 2026. The binary nature here is extreme: positive data could attract a licensing deal or favorable financing, while a miss would likely force a deeply dilutive raise or worse.

Science & Edge: Prior interim data showed greater than 60% clinical clearance in 26 patients, and Phase 1 demonstrated 6 of 13 patients achieving complete histologic responses — meaning no cancer cells detectable under the microscope. The dissolvable microneedle array (D-MNA) delivers high local drug concentration with minimal systemic exposure. The FDA has indicated the 505(b)(2) regulatory pathway is appropriate, which could shorten the approval timeline versus a full NDA. The addressable market is massive at $2B+, though displacing entrenched surgical standards will require compelling Phase 2 data.

Risk/Reward:
🐂 Bull: Positive topline data validates a non-invasive BCC treatment with clear quality-of-life advantages over surgery. Strong interim efficacy and favorable safety could attract pharma partnership.
🐻 Bear: 1-month cash runway creates existential risk independent of clinical outcome. Any efficacy miss or delay destroys shareholder value. Physician adoption of a novel modality over established surgical standards is never guaranteed.

#5. IRD — Opus Genetics Inc.

🎯 THE CATALYST
Event: OPGx-BEST1 — Phase 1/2 in BEST1-related Inherited Retinal Disease (IRD)
Date: Q1 2026 (Est.)
⭐ BSI SCORE: 7.46/10

OPGx-BEST1 is a gene therapy that delivers a functional copy of the BEST1 gene via a one-time injection under the retina. BEST1 mutations cause Best disease (vitelliform macular dystrophy), where defective chloride channels in retinal pigment epithelium cells lead to waste accumulation and progressive vision loss. There are no approved treatments — patients currently receive only supportive care while their vision deteriorates.

The Setup: Unlike many names on this list, Opus has breathing room: $46.2M cash and 22+ months of runway. The stock has surged 85% over 21 days on momentum heading into Q1 2026 data from Cohort 1 (3-month results) expected at the Macula Society meeting. First patients were dosed in November 2025, making this genuine first-in-human data for BEST1 gene therapy. Full Cohort 1 data arrive mid-2026, with the current readout serving as an early signal.

Science & Edge: The AAV-based platform targets RPE (retinal pigment epithelium) chloride channels via subretinal injection. Preclinical models showed restoration of BEST1 protein expression and retinal function. Opus holds a dominant position in the BEST1 space with no direct competitors — the closest precedent is Spark Therapeutics' Luxturna (approved for RPE65-LCA, a different inherited retinal disease). Opus has seven AAV programs across multiple IRD targets (LCA5, RHO, etc.), making the BEST1 readout a platform validation event.

Risk/Reward:
🐂 Bull: Positive safety and early efficacy signals at Macula Society trigger regulatory designation interest, partnership discussions, and validation of the AAV platform for pipeline acceleration.
🐻 Bear: Gene therapy carries inherent surgical and immunogenicity risks. The addressable population is small (~9,000 U.S. patients). Early-stage data may be insufficient to drive sustained valuation at current momentum-inflated levels.

#6. KOD — Kodiak Sciences Inc

🎯 THE CATALYST
Event: Tarcocimab tedromer (KSI-301) — GLOW2 Phase 3 in Non-Proliferative Diabetic Retinopathy (NPDR)
Date: Q1 2026 (Est.)
⭐ BSI SCORE: 7.42/10

KSI-301 is an anti-VEGF antibody conjugated to a large biopolymer that extends its duration inside the eye. For patients with diabetic retinopathy — where leaky, abnormal blood vessels damage the retina — this means fewer injections. Current anti-VEGF treatments like Eylea require injections every 8-12 weeks; KSI-301's extended pharmacokinetics aim to stretch that interval significantly, reducing the treatment burden that drives poor patient compliance.

The Setup: Kodiak is the largest company on this week's list at $1.36B, with $204.5M cash providing 18+ months of runway. The GLOW2 Phase 3 readout (Q1 2026) is a confirmatory trial — GLOW1 already met its primary endpoint in November 2023, showing superiority over sham in DRSS improvement (the standard measure of diabetic retinopathy severity). However, there's baggage: the earlier DAZZLE trial in wet AMD failed on its durability endpoint versus Eylea, so GLOW2 needs a clean win to rebuild credibility.

Science & Edge: The ABC (Antibody Biopolymer Conjugate) platform links an anti-VEGF antibody to a phosphorylcholine biopolymer, creating a 950 kDa molecule with picomolar VEGF binding affinity (KD 6.75 pM) — tighter than ranibizumab or aflibercept. The large molecular weight slows clearance from the eye, extending durability. GLOW1 demonstrated DRSS superiority and favorable safety without inflammation or metabolic issues. Importantly, NPDR currently has no approved therapy — this would be a first-to-market opportunity.

Risk/Reward:
🐂 Bull: GLOW2 replicates GLOW1 success, enabling BLA filing in an untapped NPDR market. ABC durability drives premium pricing and potential partnership with an ophthalmology major.
🐻 Bear: NPDR patient variability could muddy results. The DAZZLE failure still weighs on credibility. Even with positive data, overcoming physician inertia around established injection protocols takes time.

#7. ACET — Adicet Bio Inc.

🎯 THE CATALYST
Event: ADI-001 — Phase 2 in Lupus Nephritis / Systemic Lupus Erythematosus (SLE)
Date: Q1 2026 (Est.)
🛡️ FDA Status: FTD
⭐ BSI SCORE: 7.38/10

ADI-001 is an off-the-shelf (allogeneic) CAR-T cell therapy that uses gamma delta T cells — a specialized immune cell type — to target and deplete CD20-positive B cells in autoimmune diseases. Think of it as an immune system reset: by eliminating the rogue B cells driving lupus, the therapy aims to induce sustained remission. The "off-the-shelf" part is critical — unlike conventional CAR-T that requires harvesting each patient's own cells (weeks of manufacturing), ADI-001 comes ready-made from a donor.

The Setup: This is one of the most compelling valuation anomalies on the list. Adicet has $148.2M in cash against a $67.4M market cap — a negative enterprise value, meaning the market is pricing the entire pipeline at less than zero. Phase 1 data from October 2025 showed all seven evaluable lupus patients achieved rapid disease activity reductions. The company holds Fast Track designation and has a Q1 2026 FDA meeting followed by Phase 2 initiation in Q2 2026. With 20 months of runway and a micro float of 9.6M shares, any positive catalyst could move the stock sharply.

Science & Edge: Gamma delta T cells naturally home to lymphoid tissue, achieving complete B-cell depletion in peripheral blood and secondary lymphoid organs. Phase 1 oncology data established the safety credentials: no significant cytokine release syndrome (CRS), no neurotoxicity (ICANS), and no graft-versus-host disease (GvHD) — the three major safety concerns with conventional alpha-beta CAR-T. A single allogeneic dose replacing chronic immunosuppression would be transformative for refractory lupus.

Risk/Reward:
🐂 Bull: Negative EV with strong Phase 1 efficacy data (7/7 responders), FDA fast track, and allogeneic manufacturing advantages. If Phase 2 confirms, this becomes a clear acquisition target in the autoimmune CAR-T race.
🐻 Bear: Seven patients is a very small sample. Durability of response in autoimmune disease is unproven for CAR-T. Established biologics (belimumab, anifrolumab) and emerging cell therapy competitors create a crowded landscape. Allogeneic immunogenicity with repeated dosing remains a theoretical concern.

#8. KPTI — Karyopharm Therapeutics Inc.

🎯 THE CATALYST
Event: Selinexor (SENTRY) — Phase 3 in JAK inhibitor-naïve Myelofibrosis
Date: Q1 2026 (Est.)
🛡️ FDA Status: FTD
⭐ BSI SCORE: 7.34/10

Karyopharm is testing selinexor — a nuclear export inhibitor that blocks the XPO1 protein — in combination with ruxolitinib for myelofibrosis, a rare blood cancer where abnormal cells scar the bone marrow and impair blood cell production. The logic: ruxolitinib (the current standard JAK inhibitor) helps with symptoms but doesn't change disease trajectory. Adding selinexor targets a different mechanism — nuclear export dysregulation — potentially overcoming resistance patterns that limit monotherapy benefit.

The Setup: SENTRY enrolled 353 patients at 2:1 randomization (selinexor+rux vs. placebo+rux), with topline data expected this quarter. The stock has already rallied 49% on momentum, pushing RSI into overbought territory at 71.5. This creates a tricky setup: the anticipation trade has already happened, meaning the data need to be convincingly positive to sustain the move. Cash of $57.3M provides about 14 months of runway, adequate but not comfortable for a Phase 3 company.

Science & Edge: The SENTRY trial measures two co-primary endpoints: spleen volume response ≥35% (SVR35) at week 24 and total symptom score reduction ≥50% (TSS50). Selinexor's XPO1 inhibition targets the nuclear-cytoplasmic transport machinery that is dysregulated in myeloproliferative neoplasms, offering a mechanistically distinct approach from JAK inhibition alone. If the combination proves superior, it would be the first approved combination regimen for frontline myelofibrosis — a significant commercial milestone in a ~20,000 U.S. patient population.

Risk/Reward:
🐂 Bull: Positive SENTRY data validates first-in-class combination therapy for myelofibrosis, with Fast Track designation accelerating the approval pathway. Selinexor is already commercially validated in multiple myeloma, reducing manufacturing and distribution risk.
🐻 Bear: Overbought technicals mean positive data may already be priced in. The myelofibrosis market is limited at ~20,000 U.S. patients, and competitive JAK inhibitors (pacritinib, momelotinib) offer alternative combinations. Negative data would create a violent reversal given the momentum premium.

#9. ACRV — Acrivon Therapeutics Inc.

🎯 THE CATALYST
Event: ACR-368 — Phase 2b in Platinum-Resistant Ovarian, Endometrial, and Urothelial Cancers
Date: Feb 27, 2026
🛡️ FDA Status: BTD, FTD
⭐ BSI SCORE: 7.34/10

ACR-368 is a checkpoint kinase 1/2 (CHK1/2) inhibitor — it blocks the DNA damage repair machinery that cancer cells rely on to survive chemotherapy. What sets Acrivon apart is OncoSignature, a proprietary proteomics-based biomarker test that predicts which patients will respond before they're treated. In an era where precision oncology is the goal but biomarker-drug co-development is rare, Acrivon is building both the therapy and the companion diagnostic simultaneously.

The Setup: Another negative EV name — $110M cash against a $50.5M market cap. Acrivon holds both Breakthrough Therapy and Fast Track designations, yet trades at a deep discount to its cash position. The catalyst is only 9 days away: ESGO (European Society of Gynaecological Oncology) data presentation on February 27. Prior Phase 2b data showed 39% ORR (objective response rate) in biomarker-positive patients overall, jumping to 67% in the serous subtype with ≤2 prior lines — response rates that would be exceptional in platinum-resistant ovarian cancer, where standard chemotherapy yields single-digit ORR.

Science & Edge: CHK1/2 inhibition forces cancer cells into mitotic catastrophe by preventing them from repairing DNA damage. The OncoSignature test uses AP3 proteomics to identify activated signaling networks predictive of response — this was validated prospectively in blinded studies and patient-derived xenograft models. Phase 2b endometrial data showed 62.5% ORR in OncoSignature-positive patients who had all progressed on prior anti-PD-1 therapy. Arm 3 is enriching for the serous subtype with ≤2 prior lines — the highest-responding cohort. Prior CHK1 inhibitor prexasertib showed only modest activity in unselected populations, highlighting the value of biomarker selection.

Risk/Reward:
🐂 Bull: ESGO data confirms 67% ORR in the enriched serous cohort. FDA grants approval pathway with OncoSignature as companion diagnostic. At negative EV with 27 months of runway, the risk/reward is heavily skewed if data deliver.
🐻 Bear: ORR could regress in the broader population. CHK1 inhibitors have a mixed track record (prexasertib's limitations). OncoSignature adoption among oncologists is unproven at scale, and biomarker co-development adds regulatory complexity.

#10. SPRB — Spruce Biosciences Inc.

🎯 THE CATALYST
Event: Tralesinidase alfa (TA-ERT) — BLA Filing for Sanfilippo Syndrome Type B (MPS IIIB)
Date: Q1 2026 (Est.)
🛡️ FDA Status: BTD
⭐ BSI SCORE: 7.33/10

Tralesinidase alfa is an enzyme replacement therapy for Sanfilippo Syndrome Type B — an ultra-rare, fatal childhood disease where a missing enzyme (NAGLU) causes toxic sugar molecules (heparan sulfate) to accumulate in the brain, destroying neurons and causing progressive cognitive decline. There are no approved treatments. The therapy delivers the replacement enzyme directly into the brain's fluid (intracerebroventricular infusion), bypassing the blood-brain barrier that blocks IV enzyme therapies from reaching CNS tissue.

The Setup: Spruce has submitted or is about to submit a BLA under the accelerated approval pathway, with Breakthrough Therapy designation in hand. Cash is critically low at $2.3M with roughly one month of runway, but a $15M loan tranche funded in January 2026 provides bridge financing, and an additional $35M is contingent on BLA progress and approval milestones. The micro float of just 1.1M shares means any positive FDA signal could produce outsized price moves. A priority review voucher (PRV), if approved, could be sold for $100M+, transforming the company's financial position overnight.

Science & Edge: Phase 1/2 data (22 patients, up to 5 years of follow-up) demonstrated profound reduction in CSF heparan sulfate non-reducing end (HS-NRE) — the toxic biomarker — along with stabilized cortical gray matter volume and preserved cognitive function versus natural history decline. The FDA has accepted HS-NRE as a surrogate endpoint for accelerated approval. No competing ERT has CNS penetration in MPS IIIB; gene therapy approaches from other developers have stalled, leaving Spruce with a clear first-mover advantage.

Risk/Reward:
🐂 Bull: BLA acceptance and approval via accelerated pathway yields PRV sale, milestone funding, and first-in-class launch with orphan drug pricing power. Five-year durability data is rare in this space and strengthens the application.
🐻 Bear: Cash situation is dire — any BLA delay could force operational halt. Accelerated approval still requires confirmatory Phase 3 (starting H1 2026). ICV delivery requires specialized neurosurgical administration, limiting commercial scalability. Patient population is extremely small.

WATCHLIST

#11. PEPG — PepGen Inc. [Neuromuscular]

📊 Price: $6.79 | Cap: $466.8M | Cash: $133.5M | RSI: 61.7 | Momentum: +30.6% 🎯 PGN-EDODM2 (FREEDOM-DM1) — Phase 1/2 in Myotonic Dystrophy Type 1 (Q1 2026 (Est.)) 🛡️ FTD, ODD ⭐ BSI: 7.28/10

The Intel: PepGen's Enhanced Delivery Oligonucleotide (EDO) platform aims to achieve deep tissue penetration in muscle — a critical hurdle for neuromuscular diseases. Myotonic dystrophy type 1 affects ~40,000 U.S. patients with no approved therapies. Healthy runway and dual FDA designations provide a solid foundation, but Phase 1/2 data details remain limited. Momentum is strong; watch for data clarity this quarter.

#12. HOTH — Hoth Therapeutics Inc. [Metabolic]

📊 Price: $0.98 | Cap: $15.2M | Cash: $3.9M | RSI: 47.4 | Momentum: -5.7% 🎯 GDNF (VA trial) — Phase 1 in Obesity and Fatty Liver Disease (Q1 2026 (Est.)) ⭐ BSI: 7.26/10

The Intel: Hoth is exploring glial cell line-derived neurotrophic factor (GDNF) for obesity and fatty liver disease in a VA-sponsored trial — an unconventional approach targeting neuroprotective pathways in metabolic disease. The thesis is early and speculative with just $3.9M cash and a sub-$20M market cap. Worth tracking for the mechanistic novelty, but this is deep-risk territory.

#13. PALI — Palisade Bio Inc. [Gastroenterology]

📊 Price: $1.70 | Cap: $253.3M | Cash: $158.2M | RSI: 44.1 | Momentum: +2.4% 🎯 PALI-2108 — Phase 1b in Fibrostenotic Crohn's Disease (Q1 2026 (Est.)) ⭐ BSI: 7.14/10

The Intel: PALI-2108 is an oral PDE4 inhibitor prodrug designed to activate selectively in the ileum and colon, concentrating anti-inflammatory and anti-fibrotic activity at the disease site while minimizing the systemic side effects (nausea, diarrhea) that plague existing PDE4 inhibitors. First human data arriving this quarter for an unaddressed fibrotic Crohn's subtype with strong cash backing. Execution risk is the main concern — this is a Phase 1b readout.

#14. FGEN — Kyntra Bio Inc (formerly FibroGen) [Oncology]

📊 Price: $9.71 | Cap: $39.3M | Cash: $115.9M | RSI: 64.6 | Momentum: +4.5% 🎯 FG-3246 (FOR46) + enzalutamide — Phase 2 in mCRPC (Q1 2026 (Est.)) ⭐ BSI: 7.07/10

The Intel: Another negative EV name — $115.9M cash versus $39.3M market cap. FG-3246 is a first-in-class CD46-targeting antibody-drug conjugate (ADC) for metastatic castration-resistant prostate cancer, offering a non-PSMA mechanism. Phase 1b/2 combination data showed 10.2-month median radiographic progression-free survival in biomarker-unselected patients. Topline Q1 2026 results could establish CD46 as a viable target in prostate cancer.

#15. ACIU — AC Immune SA [Neuroscience]

📊 Price: $2.91 | Cap: $292.2M | Cash: $36.3M | RSI: 27.7 | Momentum: -17.1% 🎯 [18F]ACI-15916 PET — Phase 1 in Parkinson's Disease (Q1 2026 (Est.)) ⭐ BSI: 7.01/10

The Intel: AC Immune is developing a PET imaging tracer to detect alpha-synuclein aggregates in Parkinson's disease — the "holy grail" diagnostic that the field has been chasing for years. An effective alpha-synuclein PET tracer would enable earlier diagnosis, better clinical trial enrollment, and treatment monitoring. Oversold at RSI 27.7 with first human data approaching, but this is a diagnostic asset, not a therapeutic — commercial value depends on partnering.

#16. GLUE — Monte Rosa Therapeutics Inc. [Oncology]

📊 Price: $18.36 | Cap: $1.20B | Cash: $848.6M | RSI: 21.4 | Momentum: -22.6% 🛡️ FTD, ODD 🎯 MRT-2359 — Phase 1/2 in MYC-driven Solid Tumors (Feb 28, 2026) ⭐ BSI: 6.95/10

The Intel: Monte Rosa is pioneering molecular glue degraders (MGDs) — a next-generation approach to targeted protein degradation. MRT-2359, an oral GSPT1 degrader, is the first MGD to enter clinical trials for solid tumors. At $1.2B cap with $848.6M cash, the company is well-capitalized, but the stock is deeply oversold (RSI 21.4). February 28 data could validate the MGD platform in MYC-driven cancers, where MYC has been considered "undruggable" for decades.

#17. LSTA — Lisata Therapeutics Inc. [Oncology] (ACQUIRED)

📊 Price: $4.56 | Cap: $40.2M | Cash: $13.8M | RSI: 49.1 | Momentum: +111.1% 🎯 LSTA1 + gemcitabine/nab-paclitaxel (ASCEND) — Phase 2b in 1L Pancreatic Cancer (Q1 2026 (Est.)) ⭐ BSI: 6.94/10

The Intel: Lisata's CendR platform technology enhances tumor drug delivery by exploiting the tumor's own vascular permeability pathways. The ASCEND trial combines their lead asset with standard-of-care chemotherapy in first-line metastatic pancreatic cancer — a devastating disease with a median survival of ~11 months. The stock has surged 111% on momentum, but cash is thin at $13.8M. Pancreatic cancer is one of the hardest indications to crack; data need to be strong.

#18. MBRX — Moleculin Biotech Inc. [Oncology]

📊 Price: $4.56 | Cap: $12.3M | Cash: $1.9M | RSI: 51.0 | Momentum: +9.6% 🎯 Annamycin — Phase 1/2 in Acute Myeloid Leukemia (Q1 2026 (Est.)) ⭐ BSI: 6.93/10

The Intel: Annamycin is a next-generation anthracycline engineered to avoid multidrug resistance and the cardiotoxicity that limits standard anthracyclines like daunorubicin. The FDA-aligned MIRACLE Phase 3 trial (Annamycin + cytarabine) follows successful Phase 1B/2 data. However, at $1.9M cash and a $12.3M market cap, financing risk dominates the thesis. Only relevant if the company can secure funding to advance.

#19. KLRS — Kalaris Therapeutics Inc. [Ophthalmology]

📊 Price: $8.27 | Cap: $154.6M | Cash: $109.2M | RSI: 37.1 | Momentum: -15.1% 🎯 TH103 — Phase 1/2 in Retinal Disease (Feb 26, 2026) ⭐ BSI: 6.92/10

The Intel: TH103 is an engineered anti-VEGF therapy designed by VEGF pioneer Dr. Napoleone Ferrara (the scientist who discovered VEGF's role in angiogenesis). The therapy aims for increased potency and longer durability than existing anti-VEGFs, reducing injection frequency for patients with wet AMD and diabetic eye disease. Well-funded with $109.2M cash, Feb 26 data could provide early proof-of-concept. Competitive with KOD (#6) in the extended-durability anti-VEGF space.

#20. BIVI — BioVie Inc. [Neuroscience]

📊 Price: $1.28 | Cap: $9.7M | Cash: $18.1M | RSI: 54.4 | Momentum: +6.2% 🎯 Bezisterim (NE3107) Biomarker Trial — Phase 2 in Alzheimer's Disease (Feb 26, 2026) ⭐ BSI: 6.89/10

The Intel: Bezisterim targets neuroinflammation and insulin resistance simultaneously — two pathological mechanisms increasingly recognized as drivers of Alzheimer's beyond amyloid alone. Another negative EV name ($18.1M cash vs. $9.7M cap). The Feb 26 biomarker trial readout could validate the dual-mechanism approach, but the Alzheimer's graveyard is vast, and small biomarker studies rarely move the needle without robust clinical endpoints.

The Strategist's Take

This week's scan tells a story of two biotechs. On one side, you have the cash-strapped binary plays — ALZN, MDCX, SPRB, MBRX — where the science may be compelling but survival depends entirely on the next data readout. These are the names where timing is everything: a week's delay in a data release can be the difference between a financing lifeline and a death spiral. For risk-tolerant investors, the reward potential is enormous (SPRB's PRV alone could be worth more than its current market cap), but position sizing must reflect the real possibility of near-total loss.

On the other side, the negative EV cohort — ACET, ACRV, FGEN, BIVI — presents a different puzzle. When the market prices a company's pipeline at less than zero, it's either a screaming inefficiency or a statement that the pipeline is genuinely worthless. ACET's 7-for-7 lupus response data and ACRV's 67% ORR in platinum-resistant ovarian cancer suggest the former. The allogeneic CAR-T and biomarker-guided oncology themes represented by these companies are among the hottest areas in biopharma dealmaking, making them potential acquisition candidates if data continue to mature.

Three names deserve particular attention this week for their near-term catalysts: ACRV (ESGO data Feb 27), KLRS (Phase 1/2 data Feb 26), and BIVI (biomarker data Feb 26). These are days away, not weeks. Further out, the ophthalmology theme is worth watching closely — KOD's GLOW2 readout and KLRS's TH103 data could reshape the anti-VEGF competitive landscape in a market worth tens of billions. And RGNX at RSI 11.4 is the most technically oversold name we've scanned in months; whether that's a value trap or a coiled spring depends entirely on whether the CT domain microdystrophin story translates from preclinical advantage to clinical proof.

About This Scanner

This weekly report identifies biotech catalyst opportunities using quantitative screening combined with fundamental analysis.

What the Score Means: The BSI Score (0-10) reflects overall opportunity quality based on technical setup and fundamental characteristics. Higher scores indicate more favorable setups; lower scores indicate elevated uncertainty. This is NOT a prediction of catalyst outcomes or stock direction.

Data Sources: Financial data from market feeds and regulatory filings. Catalyst dates are estimates based on company guidance and subject to change.

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

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.