Part of the Pharma & Life Sciences sector
Core investment principles and frameworks for this industry
Capital allocation is central for US biotechnology: buybacks, dividends, M&A, capex, and debt reduction must be judged against returns from the specific reinvestment cycle around clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration. Management teams that repurchase stock while underinvesting in core capacity can create short-term EPS growth but weaken long-term advantage.
Durable US winners in biotechnology usually combine scale, data, distribution, switching costs, brand strength, regulatory approvals, or low-cost supply. The key question is whether those moats are widening in the latest 10-K, 10-Q, and earnings call evidence around clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration.
US-listed companies in biotechnology often face federal and state oversight, antitrust review, tax-credit rules, tariff exposure, or agency-specific regulation. A strong thesis should identify which rules directly affect clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration, and which rules expand barriers to entry versus cap pricing, volumes, or returns.
For US biotechnology, revenue quality depends on recurring demand, contract durability, customer concentration, and how clearly management reconciles segment performance in SEC filings. Analysts should separate one-time demand spikes from repeatable growth drivers tied to clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration.
US GAAP margins can hide important business-model shifts when mix, rebates, depreciation, stock compensation, or capitalized costs move faster than reported revenue. Track gross margin, operating leverage, cash conversion, and the operating KPIs tied to clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration to judge whether biotechnology companies are compounding or only growing nominal sales.
Active trends shaping the industry landscape
Demand for US biotechnology should be read through the industry-specific indicators behind clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration. A thesis should distinguish cyclical recovery from structural growth using volumes, pricing, backlog, bookings, usage, or guidance commentary that management discloses in SEC filings and earnings materials.
AI, automation, software, data analytics, and connected operations are changing cost structures across US biotechnology. Companies that convert these tools into measurable productivity, pricing power, or share gains in clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration deserve different treatment from firms only using technology language in investor materials.
Consolidation, vertical integration, platform power, private-label competition, and new entrants are reshaping US biotechnology. Track whether profit pools around clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration are moving toward scale leaders, low-cost operators, regulated incumbents, or specialist challengers.
Federal rules, state policy, tax incentives, agency approvals, procurement cycles, and antitrust enforcement can materially change US biotechnology economics. The strongest analysis links policy changes to clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration, specific revenue pools, cost lines, and balance-sheet needs.
US companies are adapting to tariffs, reshoring incentives, supplier concentration, logistics disruption, and China exposure. Watch inventory days, gross margin bridges, sourcing disclosures, and capex location only where they affect the real economics of clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration.
Events and factors that could trigger significant change
Quarterly guidance, margin bridges, segment disclosures, and management tone can quickly reset expectations for US biotechnology. Large revisions to metrics tied to clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration should be treated as first-order catalysts, especially when management changes full-year assumptions.
Changes in Fed policy influence discount rates, consumer credit, corporate capex, housing activity, and refinancing risk. For US biotechnology, the rate-cycle catalyst matters most when financing conditions, capex appetite, or long-duration valuation assumptions change the outlook for clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration.
Spin-offs, acquisitions, divestitures, activist campaigns, and private-equity interest can reprice US biotechnology. A good catalyst view compares strategic fit, leverage impact, synergy credibility, and regulatory approval risk under US antitrust review.
New products, capacity additions, platform launches, procurement awards, infrastructure builds, approvals, or manufacturing ramps can change the growth profile for US biotechnology. Focus on timing, execution risk, and whether the spend tied to clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration earns returns above the cost of capital.
Tax credits, tariffs, agency decisions, antitrust actions, procurement rules, infrastructure programs, and state-level policy can alter economics for US biotechnology. Analysts should map each policy catalyst to the companies most exposed to clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration rather than treating it as a broad macro headline.
Critical financial and operational metrics for evaluation
Net debt, liquidity, maturity schedule, pension obligations, and covenant flexibility determine whether US biotechnology companies can invest through downturns. Higher-rate refinancing risk should be weighed against cash generation and the capital intensity of clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration.
Free cash flow after capex is the cleanest check on reported earnings for US biotechnology. Watch working capital, lease obligations, capitalized software, maintenance capex, and cash taxes relative to the investment needs created by clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration.
Gross margin, operating margin, EBITDA margin, and segment margin reveal whether US biotechnology firms have pricing power or only scale without profitability. Compare margin movement against the mix, input costs, depreciation, stock-based compensation, and operating leverage behind clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration.
Return on invested capital, asset turns, and reinvestment runway determine whether US biotechnology companies create value while growing. ROIC should be compared with the weighted average cost of capital and with management's claims about reinvesting into clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration.
Track reported and organic revenue growth for US biotechnology, separating price, volume, FX, acquisitions, and accounting changes. Durable growth should be visible in both GAAP revenue and supporting operating metrics tied to clinical readouts, regulatory pathways, cash runway, platform productivity, partnership economics, and pipeline concentration in SEC filings or investor decks.
Cybin Inc. Common Shares
AMEX:CYBNAMEX
CYBN
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NASDAQ:SGMONASDAQ
SGMO
Abpro Holdings, Inc - Common Stock
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ABP
Arcellx, Inc. - Common Stock
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ACLX
Apellis Pharmaceuticals, Inc. - Common Stock
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APLS
Applied Therapeutics, Inc. - Common Stock
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APLT
Athira Pharma, Inc. - Common Stock
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ATHA
Astria Therapeutics, Inc. - Common Stock
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ATXS
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CDTX
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COEP
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CVAC
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FGEN
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Generation Bio Co. - Common stock
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GBIO
Galapagos NV - American Depositary Shares
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GLPG
Galecto, Inc. - Common Stock
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GLTO
IO Biotech, Inc. - Common Stock
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IOBT
Kezar Life Sciences, Inc. - Common Stock
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KZR
Mind Medicine (MindMed) Inc. - Common Shares
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MNMD
Mersana Therapeutics, Inc. - Common Stock
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MRSN
Mainz Biomed N.V. - Ordinary Shares
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MYNZ
RAPT Therapeutics, Inc. - Common Stock
NASDAQ:RAPTNASDAQ
RAPT
Repare Therapeutics Inc. - Common Shares
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RPTX
Cassava Sciences, Inc. - Common Stock
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SAVA
Soleno Therapeutics, Inc. - Common Stock
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TERN
Ventyx Biosciences, Inc. - Common Stock
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VTYX
Day One Biopharmaceuticals, Inc. - Common Stock
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DAWN
CRISPR Therapeutics AG - Common Shares
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CRSP
Amgen Inc. - Common Stock
NASDAQ:AMGNNASDAQ
AMGN
Gilead Sciences, Inc. - Common Stock
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GILD
argenx SE - American Depositary Shares
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ARGX
Revolution Medicines, Inc. - Common Stock
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RVMD
Biogen Inc. - Common Stock
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BIIB
BioNTech SE - American Depositary Shares
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BNTX
Incyte Corporation - Common Stock
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INCY
Moderna, Inc. - Common Stock
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MRNA
Neurocrine Biosciences, Inc. - Common Stock
NASDAQ:NBIXNASDAQ
NBIX
Exelixis, Inc. - Common Stock
NASDAQ:EXELNASDAQ
EXEL
Krystal Biotech, Inc. - Common Stock
NASDAQ:KRYSNASDAQ
KRYS
Halozyme Therapeutics, Inc. - Common Stock
NASDAQ:HALONASDAQ
HALO
Bio-Techne Corp - Common Stock
NASDAQ:TECHNASDAQ
TECH
Qiagen N.V. Common Shares
NYSE:QGENNYSE
QGEN
ImmunityBio, Inc. - Common Stock
NASDAQ:IBRXNASDAQ
IBRX
Repligen Corporation - Common Stock
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RGEN
Vaxcyte, Inc. - Common Stock
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PCVX
Lantheus Holdings, Inc. - Common Stock
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LNTH
Apogee Therapeutics, Inc. - Common Stock
NASDAQ:APGENASDAQ
APGE
Immunovant, Inc. - Common Stock
NASDAQ:IMVTNASDAQ
IMVT
Kymera Therapeutics, Inc. - Common Stock
NASDAQ:KYMRNASDAQ
KYMR
Scholar Rock Holding Corporation - Common Stock
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SRRK
CG Oncology, Inc. - Common stock
NASDAQ:CGONNASDAQ
CGON
Twist Bioscience Corporation - Common Stock
NASDAQ:TWSTNASDAQ
TWST
Anbio Biotechnology - Class A Ordinary Shares
NASDAQ:NNNNNASDAQ
NNNN
Denali Therapeutics Inc. - Common Stock
NASDAQ:DNLINASDAQ
DNLI
Beam Therapeutics Inc. - Common Stock
NASDAQ:BEAMNASDAQ
BEAM
Adaptive Biotechnologies Corporation - Common Stock
NASDAQ:ADPTNASDAQ
ADPT
Relay Therapeutics, Inc. - Common Stock
NASDAQ:RLAYNASDAQ
RLAY
Tarsus Pharmaceuticals, Inc. - Common Stock
NASDAQ:TARSNASDAQ
TARS
Celldex Therapeutics, Inc. - Common Stock
NASDAQ:CLDXNASDAQ
CLDX
BioCryst Pharmaceuticals, Inc. - Common Stock
NASDAQ:BCRXNASDAQ
BCRX
Neogen Corporation - Common Stock
NASDAQ:NEOGNASDAQ
NEOG
Kodiak Sciences Inc - Common Stock
NASDAQ:KODNASDAQ
KOD
Iovance Biotherapeutics, Inc. - Common Stock
NASDAQ:IOVANASDAQ
IOVA
Intellia Therapeutics, Inc. - Common Stock
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NTLA
ADMA Biologics Inc - Common Stock
NASDAQ:ADMANASDAQ
ADMA
Vericel Corporation - Common Stock
NASDAQ:VCELNASDAQ
VCEL
Mesoblast Limited - American Depositary Shares
NASDAQ:MESONASDAQ
MESO
Recursion Pharmaceuticals, Inc. - Class A Common Stock
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RXRX
Taysha Gene Therapies, Inc. - Common Stock
NASDAQ:TSHANASDAQ
TSHA
Novavax, Inc. - Common Stock
NASDAQ:NVAXNASDAQ
NVAX
Vir Biotechnology, Inc. - Common Stock
NASDAQ:VIRNASDAQ
VIR
Monte Rosa Therapeutics, Inc. - Common Stock
NASDAQ:GLUENASDAQ
GLUE
Immunocore Holdings plc - American Depositary Shares
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IMCR
Maze Therapeutics, Inc. - Common Stock
NASDAQ:MAZENASDAQ
MAZE
Immatics N.V. - Ordinary Shares
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IMTX
Inhibrx Biosciences, Inc. - Common Stock
NASDAQ:INBXNASDAQ
INBX
Alvotech - Ordinary Shares
NASDAQ:ALVONASDAQ
ALVO
Absci Corporation - Common Stock
NASDAQ:ABSINASDAQ
ABSI
DBV Technologies S.A. - American Depositary Shares
NASDAQ:DBVTNASDAQ
DBVT
Cullinan Therapeutics, Inc. - Common Stock
NASDAQ:CGEMNASDAQ
CGEM
MeiraGTx Holdings plc - Ordinary Shares
NASDAQ:MGTXNASDAQ
MGTX
Replimune Group, Inc. - Common Stock
NASDAQ:REPLNASDAQ
REPL
Sana Biotechnology, Inc. - Common Stock
NASDAQ:SANANASDAQ
SANA
Vor Biopharma Inc. - Common Stock
NASDAQ:VORNASDAQ
VOR
Aura Biosciences, Inc. - Common Stock
NASDAQ:AURANASDAQ
AURA
Allogene Therapeutics, Inc. - Common Stock
NASDAQ:ALLONASDAQ
ALLO
Solid Biosciences Inc. - Common Stock
NASDAQ:SLDBNASDAQ
SLDB
Candel Therapeutics, Inc. - Common Stock
NASDAQ:CADLNASDAQ
CADL
Prime Medicine, Inc. - Common Stock
NASDAQ:PRMENASDAQ
PRME
Tectonic Therapeutic, Inc. - Common Stock
NASDAQ:TECXNASDAQ
TECX
ProKidney Corp. - Class A Ordinary Shares
NASDAQ:PROKNASDAQ
PROK
Cabaletta Bio, Inc. - Common Stock
NASDAQ:CABANASDAQ
CABA
Achieve Life Sciences, Inc. - Common Shares
NASDAQ:ACHVNASDAQ
ACHV
Ginkgo Bioworks Holdings, Inc. Class A Common Stock
NYSE:DNANYSE
DNA
Valneva SE - American Depositary Shares
NASDAQ:VALNNASDAQ
VALN
Kyverna Therapeutics, Inc. - Common Stock
NASDAQ:KYTXNASDAQ
KYTX
4D Molecular Therapeutics, Inc. - Common Stock
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FDMT
Ocugen, Inc. - Common Stock
NASDAQ:OCGNNASDAQ
OCGN
Myriad Genetics, Inc. - Common Stock
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MYGN
Sutro Biopharma, Inc. - Common Stock
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STRO
C4 Therapeutics, Inc. - Common Stock
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CCCC
Autolus Therapeutics plc - American Depositary Shares
NASDAQ:AUTLNASDAQ
AUTL
Century Therapeutics, Inc. - Common Stock
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IPSC
Compass Therapeutics, Inc. - Common Stock
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CMPX
X4 Pharmaceuticals, Inc. - Common Stock
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XFOR
OmniAb, Inc. - Common Stock
NASDAQ:OABINASDAQ
OABI
Lexeo Therapeutics, Inc. - Common Stock
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LXEO
Zura Bio Limited - Class A Ordinary shares
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ZURA
REGENXBIO Inc. - Common Stock
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RGNX
Neumora Therapeutics, Inc. - Common Stock
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NMRA
Fennec Pharmaceuticals Inc. - Common Stock
NASDAQ:FENCNASDAQ
FENC
Humacyte, Inc. - Common Stock
NASDAQ:HUMANASDAQ
HUMA
Palisade Bio, Inc. - Common Stock
NASDAQ:PALINASDAQ
PALI
Lineage Cell Therapeutics, Inc. Common Stock
AMEX:LCTXAMEX
LCTX
Invivyd, Inc. - Common Stock
NASDAQ:IVVDNASDAQ
IVVD
Armata Pharmaceuticals, Inc. Common Stock
AMEX:ARMPAMEX
ARMP
Editas Medicine, Inc. - Common Stock
NASDAQ:EDITNASDAQ
EDIT
SAB Biotherapeutics, Inc. - Common Stock
NASDAQ:SABSNASDAQ
SABS
Surrozen, Inc. - Common Stock
NASDAQ:SRZNNASDAQ
SRZN
Alpha Teknova, Inc. - Common Stock
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TKNO
Anavex Life Sciences Corp. - Common Stock
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AVXL
Protara Therapeutics, Inc. - Common Stock
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TARA
Fate Therapeutics, Inc. - Common Stock
NASDAQ:FATENASDAQ
FATE
Coherus Oncology, Inc. - Common Stock
NASDAQ:CHRSNASDAQ
CHRS
Cellectis S.A. - American Depositary Shares
NASDAQ:CLLSNASDAQ
CLLS
LENZ Therapeutics, Inc. - Common Stock
NASDAQ:LENZNASDAQ
LENZ
Inhibikase Therapeutics, Inc. - Common Stock
NASDAQ:IKTNASDAQ
IKT
Voyager Therapeutics, Inc. - Common Stock
NASDAQ:VYGRNASDAQ
VYGR
Compugen Ltd. - Ordinary Shares
NASDAQ:CGENNASDAQ
CGEN
Caribou Biosciences, Inc. - Common Stock
NASDAQ:CRBUNASDAQ
CRBU
Alector, Inc. - Common Stock
NASDAQ:ALECNASDAQ
ALEC
Insight Molecular Diagnostics Inc. - Common Stock
NASDAQ:IMDXNASDAQ
IMDX
Artiva Biotherapeutics, Inc. - Common Stock
NASDAQ:ARTVNASDAQ
ARTV
Innate Pharma S.A. - American Depositary Shares
NASDAQ:IPHANASDAQ
IPHA
Molecular Partners AG - American Depositary Shares
NASDAQ:MOLNNASDAQ
MOLN
Precision BioSciences, Inc. - Common Stock
NASDAQ:DTILNASDAQ
DTIL
Protalix BioTherapeutics, Inc. (DE) Common Stock
AMEX:PLXAMEX
PLX
Tenaya Therapeutics, Inc. - Common Stock
NASDAQ:TNYANASDAQ
TNYA
Acumen Pharmaceuticals, Inc. - Common Stock
NASDAQ:ABOSNASDAQ
ABOS
Agenus Inc. - Common Stock
NASDAQ:AGENNASDAQ
AGEN
Cardiol Therapeutics Inc. - Class A Common Shares
NASDAQ:CRDLNASDAQ
CRDL
Alpha Cognition Inc. - Common Stock
NASDAQ:ACOGNASDAQ
ACOG
MaxCyte, Inc. - Common Stock
NASDAQ:MXCTNASDAQ
MXCT
Black Diamond Therapeutics, Inc. - Common Stock
NASDAQ:BDTXNASDAQ
BDTX
Cognition Therapeutics, Inc. - Common Stock
NASDAQ:CGTXNASDAQ
CGTX
enGene Holdings Inc. - Common Stock
NASDAQ:ENGNNASDAQ
ENGN
Outlook Therapeutics, Inc. - Common Stock
NASDAQ:OTLKNASDAQ
OTLK
Kalaris Therapeutics, Inc. - Common Stock
NASDAQ:KLRSNASDAQ
KLRS
Cardiff Oncology, Inc. - Common Stock
NASDAQ:CRDFNASDAQ
CRDF
Atara Biotherapeutics, Inc. - Common Stock
NASDAQ:ATRANASDAQ
ATRA
Pelthos Therapeutics Inc. Common Stock
AMEX:PTHSAMEX
PTHS
ImmuCell Corporation - Common Stock
NASDAQ:ICCCNASDAQ
ICCC
eXoZymes Inc. - Common Stock
NASDAQ:EXOZNASDAQ
EXOZ
Champions Oncology, Inc. - Common Stock
NASDAQ:CSBRNASDAQ
CSBR
TScan Therapeutics, Inc. - Common Stock
NASDAQ:TCRXNASDAQ
TCRX
ImageneBio, Inc. - Common Stock
NASDAQ:IMANASDAQ
IMA
MiNK Therapeutics, Inc. - Common Stock
NASDAQ:INKTNASDAQ
INKT
Scilex Holding Company - Common Stock
NASDAQ:SCLXNASDAQ
SCLX
Entera Bio Ltd. - Ordinary Shares
NASDAQ:ENTXNASDAQ
ENTX
OKYO Pharma Limited - Ordinary Shares
NASDAQ:OKYONASDAQ
OKYO
Instil Bio, Inc. - Common Stock
NASDAQ:TILNASDAQ
TIL
Estrella Immunopharma, Inc. - Common Stock
NASDAQ:ESLANASDAQ
ESLA
Genenta Science S.p.A. - American Depositary Shares
NASDAQ:GNTANASDAQ
GNTA
Metagenomi, Inc. - Common Stock
NASDAQ:MGXNASDAQ
MGX
aTyr Pharma, Inc. - Common Stock
NASDAQ:ATYRNASDAQ
ATYR
Elutia, Inc. - Class A Common Stock
NASDAQ:ELUTNASDAQ
ELUT
Tevogen Bio Holdings Inc. - Common Stock
NASDAQ:TVGNNASDAQ
TVGN
INmune Bio Inc. - Common stock
NASDAQ:INMBNASDAQ
INMB
Senti Biosciences, Inc. - Common Stock
NASDAQ:SNTINASDAQ
SNTI
Aligos Therapeutics, Inc. - Common stock
NASDAQ:ALGSNASDAQ
ALGS
Evaxion A/S - American Depositary Share
NASDAQ:EVAXNASDAQ
EVAX
Q/C Technologies, Inc. - Common Stock
NASDAQ:QCLSNASDAQ
QCLS
Pluri Inc. - Common Stock
NASDAQ:PLURNASDAQ
PLUR
Dyadic International, Inc. - Common Stock
NASDAQ:DYAINASDAQ
DYAI
Passage Bio, Inc. - Common Stock
NASDAQ:PASGNASDAQ
PASG
Curis, Inc. - Common Stock
NASDAQ:CRISNASDAQ
CRIS
Quince Therapeutics, Inc. - Common Stock
NASDAQ:QNCXNASDAQ
QNCX
VolitionRX Limited Common Stock
AMEX:VNRXAMEX
VNRX
IN8bio, Inc. - Common Stock
NASDAQ:INABNASDAQ
INAB
Jasper Therapeutics, Inc. - Class A Common Stock
NASDAQ:JSPRNASDAQ
JSPR
Trinity Biotech plc - American Depositary Shares
NASDAQ:TRIBNASDAQ
TRIB
BioCardia, Inc. - Common Stock
NASDAQ:BCDANASDAQ
BCDA
Cel-Sci Corporation Common Stock
AMEX:CVMAMEX
CVM
Intensity Therapeutics, Inc. - Common Stock
NASDAQ:INTSNASDAQ
INTS
AIM ImmunoTech Inc. Common Stock
AMEX:AIMAMEX
AIM
bioAffinity Technologies, Inc. - Common Stock
NASDAQ:BIAFNASDAQ
BIAF
Creative Medical Technology Holdings, Inc. - Common Stock
NASDAQ:CELZNASDAQ
CELZ
PharmaCyte Biotech, Inc. - Common Stock
NASDAQ:PMCBNASDAQ
PMCB
BiomX Inc. COmmon Stock
AMEX:PHGEAMEX
PHGE
Biomerica, Inc. - Common Stock
NASDAQ:BMRANASDAQ
BMRA
Liminatus Pharma, Inc. - Class A Common Stock
NASDAQ:LIMNNASDAQ
LIMN
Cardio Diagnostics Holdings Inc. - Common stock
NASDAQ:CDIONASDAQ
CDIO
BioAtla, Inc. - Common Stock
NASDAQ:BCABNASDAQ
BCAB
iSpecimen Inc. - Common Stock
NASDAQ:ISPCNASDAQ
ISPC
Avalon GloboCare Corp. - Common Stock
NASDAQ:ALBTNASDAQ
ALBT
Silexion Therapeutics Corp - Ordinary Shares
NASDAQ:SLXNNASDAQ
SLXN
VivoSim Labs, Inc. - Common Stock
NASDAQ:VIVSNASDAQ
VIVS
Calidi Biotherapeutics, Inc. Common Stock
AMEX:CLDIAMEX
CLDI
Scinai Immunotherapeutics Ltd. - American Depositary Shares
NASDAQ:SCNINASDAQ
SCNI
Virax Biolabs Group Limited - Ordinary Shares
NASDAQ:VRAXNASDAQ
VRAX
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